Study to Assess the Bioavailability of Different Formulations of AZD9977 and Dapagliflozin and Influence of Food in Selected Formulations in Healthy Volunteers

Study identifier:D6402C00003

ClinicalTrials.gov identifier:NCT04798222

EudraCT identifier:2021-000483-30

CTIS identifier:N/A

Study Complete

Official Title

An Open-label, Randomized, Parallel Group, Four/Five Period, Eight Treatment Cross-over, Single Oral Dose Study to Assess the Relative Bioavailability of Different Formulations of AZD9977 and Dapagliflozin and Influence of Food in Selected Formulations in Healthy Volunteers

Medical condition

heart failure

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Treatment A, Treatment B, Treatment C, Treatment D, Treatment E, Treatment F, Treatment G, Treatment H

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 29 Jun 2021

Primary Completion Date: 03 Sept 2021

Study Completion Date: 03 Sept 2021

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Basic Science

Verification:

Verified 01 Jun 2023 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

- Healthy participants of non-childbearing potential with suitable veins for cannulation or repeated venipuncture at screening
- Females must have a negative pregnancy test at the screening Visit and a negative urine pregnancy test at admission to the study center, must not be lactating and must be of non childbearing potential
- Have a body mass index between 18 and 29.9 kg/m^2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive, at screening

Exclusion Criteria

- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at screening, as judged by the Investigator
- Any clinically significant abnormal findings in vital signs, and 12-lead electrocardiogram as judged by the Investigator
- Any positive result on screening for serum hepatitis B surface antigen or anti-hemoglobin antibody, hepatitis C antibody, and human immunodeficiency virus antibody
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months (or 5 half lives, whichever is longer) of the first administration of IMP in this study
- Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD9977 or dapagliflozin
- Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the 3 months prior to screening
- Participant has a positive test result for Severe acute respiratory syndrome coronavirus 2 reverse transcriptase polymerase chain reaction at admission
- Use of drugs with enzyme-inducing properties such as St John’s Wort within 3 weeks prior to the first administration of IMP
- Use of any prescribed or non prescribed medication including antacids, analgesics, hormone replacement therapy, herbal remedies, megadose vitamins and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life
- Participants who have previously received AZD9977 or dapagliflozin
- Judgment by the Investigators that the participant should not participate in the study if they have any ongoing or recent minor medical complaints
- Participants who cannot communicate reliably with the Investigator and/or is not able to read, speak and understand the German language
- Participant has clinical signs and symptoms consistent with corona virus disease 2019 (COVID-19), or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on first admission
- History of severe COVID-19 infection (hospitalization, extracorporeal membrane oxygenation, mechanically ventilated) as judged by the Investigator

Location

Research Site

Berlin, Germany, 14050

Arms	Assigned Interventions
Experimental: Group 1: Treatment Sequence ABECD Participants will receive a single oral dose of Treatments A, B, E, C, and D in Treatment periods 1 to 5 on Day 1 of the study.	Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment B Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition. Drug: Treatment C Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition Drug: Treatment D Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition. Drug: Treatment E Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.
Experimental: Group 1: Treatment Sequence BACED Participants will receive a single oral dose of Treatments B, A, C, E, and D in Treatment periods 1 to 5 on Day 1 of the study.	Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment B Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition. Drug: Treatment C Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition Drug: Treatment D Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition. Drug: Treatment E Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.
Experimental: Group 1: Treatment Sequence CDBEA Participants will receive a single oral dose of Treatments C, D, B, E, and A in Treatment periods 1 to 5 on Day 1 of the study.	Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment B Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition. Drug: Treatment C Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition Drug: Treatment D Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition. Drug: Treatment E Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.
Experimental: Group 1: Treatment Sequence EADBC Participants will receive a single oral dose of Treatments E, A, D, B, and C in Treatment periods 1 to 5 on Day 1 of the study.	Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment B Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition. Drug: Treatment C Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition Drug: Treatment D Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition. Drug: Treatment E Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.
Experimental: Group 2: Treatment Sequence AFHG Participants will receive a single oral dose of Treatments A, F, H, and G in Treatment periods 1 to 4 on Day 1 of the study.	Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment F Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition. Drug: Treatment G Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition. Drug: Treatment H Participants will receive oral dose of dapagliflozin capsule in fasted condition.
Experimental: Group 2: Treatment Sequence FGAH Participants will receive a single oral dose of Treatments F, G, A, and H in Treatment periods 1 to 4 on Day 1 of the study.	Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment F Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition. Drug: Treatment G Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition. Drug: Treatment H Participants will receive oral dose of dapagliflozin capsule in fasted condition.
Experimental: Group 2: Treatment Sequence GHFA Participants will receive a single oral dose of Treatments G, H, F, and A in Treatment periods 1 to 4 on Day 1 of the study.	Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment F Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition. Drug: Treatment G Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition. Drug: Treatment H Participants will receive oral dose of dapagliflozin capsule in fasted condition.
Experimental: Group 2: Treatment Sequence HAGF Participants will receive a single oral dose of Treatments H, A, G, and F in Treatment periods 1 to 4 on Day 1 of the study.	Drug: Treatment A Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition. Drug: Treatment F Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition. Drug: Treatment G Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition. Drug: Treatment H Participants will receive oral dose of dapagliflozin capsule in fasted condition.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted between 29-June-2021 and 03-September-2021 in two sites in Germany.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who met the inclusion and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.

Reporting Groups

	Description
Experimental: Group 1: Treatment Sequence ABECD	Participants will receive a single oral dose of treatments A, B, E, C, and D in treatment periods 1 to 5 on Day 1 of the study.
Experimental: Group 1: Treatment Sequence BACED	Participants will receive a single oral dose of treatments B, A, C, E, and D in treatment periods 1 to 5 on Day 1 of the study.
Experimental: Group 1: Treatment Sequence CDBEA	Participants will receive a single oral dose of treatments C, D, B, E, and A in treatment periods 1 to 5 on Day 1 of the study.
Experimental: Group 1: Treatment Sequence EADBC	Participants will receive a single oral dose of treatments E, A, D, B, and C in treatment periods 1 to 5 on Day 1 of the study.
Experimental: Group 2: Treatment Sequence AFHG	Participants will receive a single oral dose of treatments A, F, H, and G in treatment periods 1 to 4 on Day 1 of the study.
Experimental: Group 2: Treatment Sequence FGAH	Participants will receive a single oral dose of treatments F, G, A, and H in treatment periods 1 to 4 on Day 1 of the study.
Experimental: Group 2: Treatment Sequence GHFA	Participants will receive a single oral dose of treatments G, H, F, and A in treatment periods 1 to 4 on Day 1 of the study.
Experimental: Group 2: Treatment Sequence HAGF	Participants will receive a single oral dose of treatments H, A, G, and F in treatment periods 1 to 4 on Day 1 of the study.

Participant Flow: Overall Study

	Experimental: Group 1: Treatment Sequence ABECD	Experimental: Group 1: Treatment Sequence BACED	Experimental: Group 1: Treatment Sequence CDBEA	Experimental: Group 1: Treatment Sequence EADBC	Experimental: Group 2: Treatment Sequence AFHG	Experimental: Group 2: Treatment Sequence FGAH	Experimental: Group 2: Treatment Sequence GHFA	Experimental: Group 2: Treatment Sequence HAGF
STARTED	2	2	3	3	3	3	2	2
COMPLETED	2	2	3	3	3	3	2	2
NOT COMPLETED	0	0	0	0	0	0	0	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

The Randomized Set will consist of all subjects randomized into the study.

Reporting Groups

	Description
Experimental: Group 1: Treatment Sequence ABECD	Participants will receive a single oral dose of treatments A, B, E, C, and D in treatment periods 1 to 5 on Day 1 of the study.
Experimental: Group 1: Treatment Sequence BACED	Participants will receive a single oral dose of treatments B, A, C, E, and D in treatment periods 1 to 5 on Day 1 of the study.
Experimental: Group 1: Treatment Sequence CDBEA	Participants will receive a single oral dose of treatments C, D, B, E, and A in treatment periods 1 to 5 on Day 1 of the study.
Experimental: Group 1: Treatment Sequence EADBC	Participants will receive a single oral dose of treatments E, A, D, B, and C in treatment periods 1 to 5 on Day 1 of the study.
Experimental: Group 2: Treatment Sequence AFHG	Participants will receive a single oral dose of treatments A, F, H, and G in treatment periods 1 to 4 on Day 1 of the study.
Experimental: Group 2: Treatment Sequence FGAH	Participants will receive a single oral dose of treatments F, G, A, and H in treatment periods 1 to 4 on Day 1 of the study.
Experimental: Group 2: Treatment Sequence GHFA	Participants will receive a single oral dose of treatments G, H, F, and A in treatment periods 1 to 4 on Day 1 of the study.
Experimental: Group 2: Treatment Sequence HAGF	Participants will receive a single oral dose of treatments H, A, G, and F in treatment periods 1 to 4 on Day 1 of the study.

Baseline Measures

	Experimental: Group 1: Treatment Sequence ABECD	Experimental: Group 1: Treatment Sequence BACED	Experimental: Group 1: Treatment Sequence CDBEA	Experimental: Group 1: Treatment Sequence EADBC	Experimental: Group 2: Treatment Sequence AFHG	Experimental: Group 2: Treatment Sequence FGAH	Experimental: Group 2: Treatment Sequence GHFA	Experimental: Group 2: Treatment Sequence HAGF	Total
Number of Participants [units: Participants]	2	2	3	3	3	3	2	2	20
Age Continuous [units: years] Median ( Full Range )	NA (40 to 50) ^[1]	NA (21 to 38) ^[1]	31.0 (23 to 36)	36.0 (34 to 47)	46.0 (43 to 49)	29.0 (26 to 42)	NA (23 to 48) ^[1]	NA (24 to 43) ^[1]	37.0 (21 to 50)
Sex/Gender, Customized [units: Participants] Male	2	2	3	3	3	3	2	2	20
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0
Asian	0	0	0	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0
Black or African American	0	0	0	0	1	0	0	1	2
White	2	2	3	3	2	3	1	1	17
More than one race	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	1	0	1
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	0	0	0	0	0	0	0	1	1
Not Hispanic or Latino	2	2	3	3	3	3	2	1	19
Unknown or Not Reported	0	0	0	0	0	0	0	0	0

Outcome Measures

1. Primary Outcome Measure: Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin [ Time Frame: Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose) ]

Measure Type	Primary
Measure Name	Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin
Measure Description	Comparison of AUCinf for AZD9977 (AZD9977 capsule, Dose A, fasted state) and dapagliflozin (dapagliflozin tablet/capsule, Dose B, fasted/fed state).
Time Frame	Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The pharmacokinetic(s) [PK] analysis set consists of all subjects in the safety analysis set with at least one quantifiable postdose concentration and who have no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.
Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.

Measured Values

	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment H: Dapagliflozin, Dose B, fasted state	Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Number of Participants Analyzed [units:participants]	10	10	10	10	10	10	10	10	10	20
Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin [units: hnmol/L (hournanomole/litre)] Geometric Mean (Geometric Coefficient of Variation)
AZD9977	12110 (26.35%)	12740 (25.65%)	14860 (23.92%)	12860 (24.83%)	14310 (24.59%)	14710 (21.89%)	15280 (24.92%)	15370 (21.26%)	NA (NA%)^[1]	13350 (25.69%)
Dapagliflozin	513.3 (9.727%)	523.0 (11.44%)	540.7 (12.95%)	535.9 (12.36%)	531.6 (14.03%)	503.8 (17.98%)	517.3 (20.05%)	547.2 (20.70%)	533.2 (21.14%)	508.5 (14.08%)

Statistical Analysis 1 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	98.10
90% Confidence Interval	( 89.26 to 107.83 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	104.82
90% Confidence Interval	( 96.08 to 114.36 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	104.31
90% Confidence Interval	( 98.64 to 110.29 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	105.10
90% Confidence Interval	( 99.35 to 111.18 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	100.17
90% Confidence Interval	( 96.25 to 104.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapaglifozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	102.95
90% Confidence Interval	( 99.22 to 106.81 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	102.73
90% Confidence Interval	( 97.82 to 107.89 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	108.76
90% Confidence Interval	( 103.53 to 114.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 9 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment H: Dapagliflozin, Dose B, fasted state
Method^[3]	ANOVA
Other^[5]	105.93
90% Confidence Interval	( 100.86 to 111.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 10 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state
Method^[3]	ANOVA
Other^[5]	118.07
90% Confidence Interval	( 108.27 to 128.76 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 11 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	102.17
90% Confidence Interval	( 92.25 to 113.16 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 12 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state
Method^[3]	ANOVA
Other^[5]	103.65
90% Confidence Interval	( 99.92 to 107.52 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 13 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	98.47
90% Confidence Interval	( 94.31 to 102.82 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 14 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	97.10
90% Confidence Interval	( 88.43 to 106.63 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 15 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	102.97
90% Confidence Interval	( 93.39 to 113.54 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 16 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	93.59
90% Confidence Interval	( 88.63 to 98.82 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 17 for Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD9977 and dapagliflozin

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	101.69
90% Confidence Interval	( 96.08 to 107.62 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

2. Primary Outcome Measure: Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast) [ Time Frame: Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose) ]

Measure Type	Primary
Measure Name	Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)
Measure Description	Comparison of AUClast for AZD9977 (AZD9977 capsule, Dose A, fasted state) and dapagliflozin (dapagliflozin tablet/capsule, Dose B, fasted/fed state).
Time Frame	Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The pharmacokinetic(s) [PK] analysis set consists of all subjects in the safety analysis set with at least one quantifiable postdose concentration and who have no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.
Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.

Measured Values

	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment H: Dapagliflozin, Dose B, fasted state	Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Number of Participants Analyzed [units:participants]	10	10	10	10	10	10	10	10	10	10
Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast) [units: h*nmol/L (litre)] Geometric Mean (Geometric Coefficient of Variation)
AZD9977	11790 (27.65%)	12290 (26.94%)	14730 (24.00%)	12330 (26.86%)	14170 (24.70%)	14390 (22.77%)	14670 (27.94%)	14760 (20.22%)	NA (NA%)^[1]	13030 (26.79%)
Dapagliflozin	504.3 (10.20%)	511.1 (11.55%)	530.9 (13.29%)	527.6 (12.45%)	521.6 (14.86%)	493.0 (17.94%)	507.4 (20.16%)	532.1 (19.44%)	525.5 (21.24%)	498.6 (14.23%)

Statistical Analysis 1 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	96.41
90% Confidence Interval	( 86.59 to 107.34 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	103.29
90% Confidence Interval	( 93.55 to 114.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	102.50
90% Confidence Interval	( 95.22 to 110.33 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	103.43
90% Confidence Interval	( 96.03 to 111.40 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	99.81
90% Confidence Interval	( 95.98 to 103.80 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	103.24
90% Confidence Interval	( 99.57 to 107.04 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	103.05
90% Confidence Interval	( 98.05 to 108.31 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	108.17
90% Confidence Interval	( 102.90 to 113.72 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 9 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment H: Dapagliflozin, Dose B, fasted state
Method^[3]	ANOVA
Other^[5]	106.71
90% Confidence Interval	( 101.53 to 112.15 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 10 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state
Other^[5]	121.24
90% Confidence Interval	( 109.87 to 133.79 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in a fed vs fasted condition.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 11 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	103.96
90% Confidence Interval	( 92.57 to 116.76 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 12 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state
Method^[3]	ANOVA
Other^[5]	104.19
90% Confidence Interval	( 100.51 to 108.00 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 13 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	98.36
90% Confidence Interval	( 94.28 to 102.62 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 14 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	97.33
90% Confidence Interval	( 87.55 to 108.20 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 15 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	102.82
90% Confidence Interval	( 92.03 to 114.87 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 16 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	93.66
90% Confidence Interval	( 88.64 to 98.95 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 17 for Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast)

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	101.59
90% Confidence Interval	( 95.94 to 107.58 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

3. Primary Outcome Measure: Maximum observed plasma (peak) drug concentration [Cmax] [ Time Frame: Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose) ]

Measure Type	Primary
Measure Name	Maximum observed plasma (peak) drug concentration [Cmax]
Measure Description	Comparison of Cmax for AZD9977 (AZD9977 capsule, Dose A, fasted state) and dapagliflozin (dapagliflozin tablet/capsule, Dose B, fasted/fed state).
Time Frame	Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The pharmacokinetic(s) [PK] analysis set consists of all subjects in the safety analysis set with at least one quantifiable postdose concentration and who have no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.
Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.

Measured Values

	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment H: Dapagliflozin, Dose B, fasted state	Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Number of Participants Analyzed [units:participants]	10	10	10	10	10	10	10	10	10	10
Maximum observed plasma (peak) drug concentration [Cmax] [units: nmoL/L (litre)] Geometric Mean (Geometric Coefficient of Variation)
AZD9977	2401 (34.49%)	2346 (48.80%)	3570 (22.53%)	2260 (48.11%)	3466 (42.64%)	2872 (14.73%)	2542 (50.18%)	2390 (20.93%)	NA (NA%)^[1]	2626 (27.29%)
Dapagliflozin	142.5 (17.13%)	128.7 (35.98%)	83.68 (21.39%)	135.0 (11.09%)	93.89 (38.43%)	159.1 (24.02%)	122.5 (24.33%)	151.5 (21.08%)	116.8 (25.08%)	150.6 (21.08%)

Statistical Analysis 1 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	86.20
90% Confidence Interval	( 65.92 to 112.72 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	92.82
90% Confidence Interval	( 72.49 to 118.85 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	89.69
90% Confidence Interval	( 70.83 to 113.57 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	84.32
90% Confidence Interval	( 66.46 to 106.97 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	88.96
90% Confidence Interval	( 70.52 to 112.22 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	90.94
90% Confidence Interval	( 73.41 to 112.64 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	77.78
90% Confidence Interval	( 64.90 to 93.22 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	96.64
90% Confidence Interval	( 80.56 to 115.93 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 9 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment H: Dapagliflozin, Dose B, fasted state
Method^[3]	ANOVA
Other^[5]	73.76
90% Confidence Interval	( 61.54 to 88.40 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 10 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state
Method^[3]	ANOVA
Other^[5]	130.59
90% Confidence Interval	( 122.20 to 199.86 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 11 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	130.59
90% Confidence Interval	( 97.71 to 174.53 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 12 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state
Method^[3]	ANOVA
Other^[5]	65.78
90% Confidence Interval	( 53.16 to 81.39 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 13 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	72.12
90% Confidence Interval	( 56.11 to 92.71 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 14 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	101.64
90% Confidence Interval	( 79.49 to 129.97 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 15 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	111.17
90% Confidence Interval	( 85.56 to 144.45 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 16 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	84.30
90% Confidence Interval	( 69.52 to 102.22 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 17 for Maximum observed plasma (peak) drug concentration [Cmax]

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	107.37
90% Confidence Interval	( 87.33 to 132.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

4. Primary Outcome Measure: Drug concentration in plasma at 24 hours postdose (C24) [ Time Frame: Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose) ]

Measure Type	Primary
Measure Name	Drug concentration in plasma at 24 hours postdose (C24)
Measure Description	Comparison of C24 for AZD9977 (AZD9977 capsule, Dose A, fasted state) and dapagliflozin (dapagliflozin tablet/capsule, Dose B, fasted/fed state).
Time Frame	Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The pharmacokinetic(s) [PK] analysis set consists of all subjects in the safety analysis set with at least one quantifiable postdose concentration and who have no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.
Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.

Measured Values

	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment H: Dapagliflozin, Dose B, fasted state	Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Number of Participants Analyzed [units:participants]	10	10	10	10	10	10	10	10	10	10
Drug concentration in plasma at 24 hours postdose (C24) [units: nmoL/L (litre)] Geometric Mean (Geometric Coefficient of Variation)
AZD977	48.27 (78.21%)	64.24 (71.82%)	21.09 (40.73%)	62.56 (64.51%)	24.11 (34.94%)	70.91 (62.29%)	79.41 (81.51%)	102.6 (127.4%)	NA (NA%)^[1]	58.50 (72.28%)
Dapagliflozin	3.663 (27.10%)	4.128 (19.02%)	4.588 (25.06%)	4.073 (27.24%)	4.521 (25.09%)	3.451 (33.99%)	3.715 (40.31%)	3.862 (31.97%)	3.973 (37.45%)	3.555 (30.02%)

Statistical Analysis 1 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	148.86
90% Confidence Interval	( 101.28 to 218.77 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	123.17
90% Confidence Interval	( 86.40 to 175.60 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	110.97
90% Confidence Interval	( 64.09 to 192.14 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	142.88
90% Confidence Interval	( 82.17 to 248.46 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	106.51
90% Confidence Interval	( 93.73 to 121.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	111.24
90% Confidence Interval	( 98.88 to 125.14 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	107.49
90% Confidence Interval	( 97.02 to 119.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	111.47
90% Confidence Interval	( 100.57 to 123.56 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 9 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment H: Dapagliflozin, Dose B, fasted state
Method^[3]	ANOVA
Other^[5]	114.85
90% Confidence Interval	( 103.67 to 127.24 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different formulations in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 10 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state
Method^[3]	ANOVA
Other^[5]	30.73
90% Confidence Interval	( 21.60 to 43.72 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 11 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	44.04
90% Confidence Interval	( 28.71 to 67.56 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 12 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state
Method^[3]	ANOVA
Other^[5]	111.96
90% Confidence Interval	( 99.58 to 125.89 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 13 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	101.36
90% Confidence Interval	( 88.28 to 116.38 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in a fed vs fasted condition.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 14 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	99.02
90% Confidence Interval	( 64.74 to 151.47 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 15 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	70.72
90% Confidence Interval	( 44.92 to 111.35 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to AZD9977 given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 16 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	101.53
90% Confidence Interval	( 89.73 to 114.89 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 17 for Drug concentration in plasma at 24 hours postdose (C24)

Groups^[1]	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state, Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Method^[3]	ANOVA
Other^[5]	108.09
90% Confidence Interval	( 94.91 to 123.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	This analysis refers to dapagliflozin given in different capsules in a fasted state.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Result based on a linear mixed effect analysis of variance (ANOVA) of log transformed PK parameter.
[5]	Other relevant estimation information:
	No text entered.

5. Secondary Outcome Measure: Time to reach peak or maximum observed concentration or response following drug administration (tmax) [ Time Frame: Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose) ]

Measure Type	Secondary
Measure Name	Time to reach peak or maximum observed concentration or response following drug administration (tmax)
Measure Description	Comparison of tmax for AZD9977 (AZD9977 capsule, Dose A, fasted state) and dapagliflozin (dapagliflozin tablet/capsule, Dose B, fasted/fed state).
Time Frame	Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The pharmacokinetic(s) [PK] analysis set consists of all subjects in the safety analysis set with at least one quantifiable postdose concentration and who have no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.
Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.

Measured Values

	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment H: Dapagliflozin, Dose B, fasted state	Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Number of Participants Analyzed [units:participants]	10	10	10	10	10	10	10	10	10	10
Time to reach peak or maximum observed concentration or response following drug administration (tmax) [units: hour (h)] Median (Full Range)
AZD9977	1.50 (1.00 to 3.00)	1.75 (1.00 to 3.02)	3.00 (1.03 to 4.00)	1.00 (0.50 to 2.50)	3.00 (0.50 to 8.00)	1.25 (0.50 to 2.50)	2.00 (1.00 to 3.02)	1.25 (0.50 to 2.50)	NA (NA to NA) ^[1]	1.50 (0.50 to 3.00)
Dapagliflozin	1.00 (0.50 to 2.02)	1.01 (0.50 to 2.50)	3.50 (1.50 to 4.00)	1.01 (1.00 to 2.50)	2.75 (0.50 to 8.00)	0.50 (0.50 to 1.50)	1.26 (1.00 to 2.50)	1.00 (0.50 to 1.50)	1.49 (0.48 to 2.50)	0.76 (0.50 to 2.02)

No statistical analysis provided for Time to reach peak or maximum observed concentration or response following drug administration (tmax)

6. Secondary Outcome Measure: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz) [ Time Frame: Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose) ]

Measure Type	Secondary
Measure Name	Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz)
Measure Description	Comparison of t½λz for AZD9977 (AZD9977 capsule, Dose A, fasted state) and dapagliflozin (dapagliflozin tablet/capsule, Dose B, fasted/fed state).
Time Frame	Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The pharmacokinetic(s) [PK] analysis set consists of all subjects in the safety analysis set with at least one quantifiable postdose concentration and who have no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.
Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.

Measured Values

	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment H: Dapagliflozin, Dose B, fasted state	Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Number of Participants Analyzed [units:participants]	10	10	10	10	10	10	10	10	10	10
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz) [units: hour (h)] Geometric Mean (Geometric Coefficient of Variation)
AZD9977	9.332 (60.96%)	10.54 (60.93%)	4.901 (22.65%)	10.38 (57.47%)	5.138 (48.17%)	11.57 (24.07%)	11.38 (56.41%)	11.56 (61.88%)	NA (NA%)^[1]	10.39 (45.54%)
Dapagliflozin	12.17 (32.25%)	12.95 (26.39%)	11.56 (29.97%)	11.87 (24.27%)	11.47 (27.57%)	13.72 (27.46%)	13.72 (25.41%)	14.14 (61.90%)	12.04 (28.84%)	12.92 (29.81%)

No statistical analysis provided for Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz)

7. Secondary Outcome Measure: Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf) [ Time Frame: Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose) ]

Measure Type	Secondary
Measure Name	Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf)
Measure Description	Comparison of MRTinf for AZD9977 (AZD9977 capsule, Dose A, fasted state) and dapagliflozin (dapagliflozin tablet/capsule, Dose B, fasted/fed state).
Time Frame	Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The pharmacokinetic(s) [PK] analysis set consists of all subjects in the safety analysis set with at least one quantifiable postdose concentration and who have no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.
Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.

Measured Values

	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment H: Dapagliflozin, Dose B, fasted state	Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Number of Participants Analyzed [units:participants]	10	10	10	10	10	10	10	10	10	10
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf) [units: hour (h)] Geometric Mean (Geometric Coefficient of Variation)
AZD9977	7.664 (46.61%)	9.147 (60.59%)	5.235 (14.77%)	8.765 (51.98%)	5.425 (31.46%)	8.144 (29.90%)	9.571 (52.37%)	10.62 (55.53%)	NA (NA%)^[1]	7.900 (37.96%)
Dapagliflozin	9.749 (13.03%)	10.91 (18.79%)	12.00 (20.77%)	10.16 (16.51%)	11.70 (26.37%)	10.10 (28.98%)	10.42 (17.46%)	10.45 (37.64%)	9.930 (18.52%)	9.923 (21.82%)

No statistical analysis provided for Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf)

8. Secondary Outcome Measure: Terminal rate constant estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz) [ Time Frame: Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose) ]

Measure Type	Secondary
Measure Name	Terminal rate constant estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)
Measure Description	Comparison of λz for AZD9977 (AZD9977 capsule, Dose A, fasted state) and dapagliflozin (dapagliflozin tablet/capsule, Dose B, fasted/fed state)
Time Frame	Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The pharmacokinetic(s) [PK] analysis set consists of all subjects in the safety analysis set with at least one quantifiable postdose concentration and who have no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.
Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.

Measured Values

	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment H: Dapagliflozin, Dose B, fasted state	Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Number of Participants Analyzed [units:participants]	10	10	10	10	10	10	10	10	10	10
Terminal rate constant estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz) [units: litre/hour (l/h)] Geometric Mean (Geometric Coefficient of Variation)
AZD9977	0.07427 (60.96%)	0.6579 (60.93%)	0.1414 (22.65%)	0.06678 (57.47%)	0.1349 (48.17%)	0.05993 (24.07%)	0.06093 (56.41%)	0.05996 (61.88%)	NA (NA%)^[1]	0.06672 (45.54%)
Dapagliflozin	0.05698 (32.25%)	0.05351 (26.39%)	0.05995 (29.97%)	0.05837 (24.27%)	0.06044 (27.57%)	0.05053 (27.46%)	0.05052 (25.41%)	0.04901 (61.90%)	0.05756 (28.84%)	0.05366 (29.81%)

No statistical analysis provided for Terminal rate constant estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)

9. Secondary Outcome Measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) [ Time Frame: Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose) ]

Measure Type	Secondary
Measure Name	Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Measure Description	Comparison of CL/F for AZD9977 (AZD9977 capsule, Dose A, fasted state) and dapagliflozin (dapagliflozin tablet/capsule, Dose B, fasted/fed state)
Time Frame	Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The pharmacokinetic(s) [PK] analysis set consists of all subjects in the safety analysis set with at least one quantifiable postdose concentration and who have no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.
Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.

Measured Values

	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment H: Dapagliflozin, Dose B, fasted state	Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Number of Participants Analyzed [units:participants]	10	10	10	10	10	10	10	10	10	10
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) [units: Litre/hour (L/h)] Geometric Mean (Geometric Coefficient of Variation)
AZD9977	31.00 (26.35%)	29.48 (25.65%)	25.28 (23.92%)	29.20 (24.83%)	26.24 (24.59%)	25.53 (21.89%)	24.57 (24.92%)	24.44 (21.26%)	NA (NA%)^[1]	28.14 (25.69%)
Dapagliflozin	19.48 (9.727%)	19.12 (11.44%)	18.49 (12.95%)	18.66 (12.36%)	18.81 (14.03%)	19.85 (17.98%)	19.33 (20.05%)	18.28 (20.70%)	18.75 (21.14%)	19.67 (14.08%)

No statistical analysis provided for Apparent total body clearance of drug from plasma after extravascular administration (CL/F)

10. Secondary Outcome Measure: Apparent volume of distribution at steady-state following extravascular administration (Vz/F) [ Time Frame: Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose) ]

Measure Type	Secondary
Measure Name	Apparent volume of distribution at steady-state following extravascular administration (Vz/F)
Measure Description	Comparison of tmax for AZD9977 (AZD9977 capsule, Dose A, fasted state) and dapagliflozin (dapagliflozin tablet/capsule, Dose B, fasted/fed state).
Time Frame	Day 1 through Day 4 of each treatment period (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The pharmacokinetic(s) [PK] analysis set consists of all subjects in the safety analysis set with at least one quantifiable postdose concentration and who have no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.
Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.

Measured Values

	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment H: Dapagliflozin, Dose B, fasted state	Treatment A: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state
Number of Participants Analyzed [units:participants]	10	10	10	10	10	10	10	10	10	10
Apparent volume of distribution at steady-state following extravascular administration (Vz/F) [units: Litre (L)] Geometric Mean (Geometric Coefficient of Variation)
AZD9977	417.4 (81.86%)	448.2 (77.33%)	178.7 (31.74%)	437.3 (81.94%)	194.5 (43.36%)	426.0 (37.59%)	403.3 (71.28%)	407.7 (47.40%)	NA (NA%)^[1]	421.7 (59.79%)
Dapagliflozin	341.9 (32.51%)	357.3 (25.49%)	308.5 (29.67%)	319.7 (22.73%)	311.2 (33.05%)	392.9 (26.95%)	382.7 (23.07%)	372.9 (48.90%)	325.8 (25.57%)	366.5 (29.94%)

No statistical analysis provided for Apparent volume of distribution at steady-state following extravascular administration (Vz/F)

11. Secondary Outcome Measure: Number of participants with adverse events and serious adverse events [ Time Frame: From screening day until follow-up visit (5 to 7 days post final dose) ]

Measure Type	Secondary
Measure Name	Number of participants with adverse events and serious adverse events
Measure Description	Comparison of the safety and tolerability of AZD9977 and dapagliflozin.
Time Frame	From screening day until follow-up visit (5 to 7 days post final dose)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis set includes all subjects who received at least one dose of AZD9977 or dapagliflozin and for whom any safety postdose data are available.

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.

Measured Values

	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment H: Dapagliflozin, Dose B, fasted state
Number of Participants Analyzed [units:participants]	10	10	10	10	10	10	10	10	10
Number of participants with adverse events and serious adverse events [units: Participants]
Any Adverse Event (AE)	3	2	3	2	4	2	2	1	2
Any Serious Adverse Event (SAE)	0	0	0	0	0	0	0	0	0
Any SAE with outcome death	0	0	0	0	0	0	0	0	0
Any AE leading to discontinuation of Investigational Product (IP)	0	0	0	0	0	0	0	0	0
Any possibly related AE	3	2	3	2	2	2	2	1	1
Any possibly related SAE	0	0	0	0	0	0	0	0	0

No statistical analysis provided for Number of participants with adverse events and serious adverse events

Serious Adverse Events

Time Frame	From screening day until follow-up visit (5 to 7 days post final dose)
Additional Description	MedDRA version 24.0

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.

Serious Adverse Events

	Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Treatment H: Dapagliflozin, Dose B, fasted state
Total, serious adverse events
# participants affected / at risk	0/10 (0.00%)	0/10 (0.00%)	0/10 (0.00%)	0/10 (0.00%)	0/10 (0.00%)	0/10 (0.00%)	0/10 (0.00%)	0/10 (0.00%)	0/20 (0.00%)

Other Adverse Events

Time Frame	From screening day until follow-up visit (5 to 7 days post final dose)
Additional Description	MedDRA version 24.0

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fed condition.
Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state	Participants received oral AZD9977 Dose A capsule and Dose B dapagliflozin tablet in fasted condition.
Treatment H: Dapagliflozin, Dose B, fasted state	Participants received Dose B dapagliflozin capsule in fasted condition.

Other Adverse Events

Treatment A1: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state

Treatment B: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state

Treatment C: AZD9977 (Dose A) +Dapagliflozin (Dose B), fed state

Treatment D: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state

Treatment E: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state

Treatment A2: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state

Treatment F: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state

Treatment G: AZD9977 (Dose A) + Dapagliflozin (Dose B), fasted state

Treatment H: Dapagliflozin, Dose B, fasted state

Total, other (not including serious) adverse events

# participants affected / at risk

3/10 (30.00%)

2/10 (20.00%)

3/10 (30.00%)

2/10 (20.00%)

4/10 (40.00%)

2/10 (20.00%)

1/10 (10.00%)

2/10 (20.00%)

Metabolism and nutrition disorders

Decreased appetite

# participants affected / at risk

1/10 (10.00%)

0/10 (0.00%)

# events

Nervous system disorders

Headache

# participants affected / at risk

2/10 (20.00%)

1/10 (10.00%)

2/10 (20.00%)

1/10 (10.00%)

2/10 (20.00%)

1/10 (10.00%)

2/10 (20.00%)

1/10 (10.00%)

2/10 (20.00%)

# events

Nervous system disorders

Hypogeusia

# participants affected / at risk

0/10 (0.00%)

1/10 (10.00%)

0/10 (0.00%)

# events

Gastrointestinal disorders

Abdominal distension

# participants affected / at risk

0/10 (0.00%)

1/10 (10.00%)

0/10 (0.00%)

# events

Gastrointestinal disorders

Paraesthesia oral

# participants affected / at risk

0/10 (0.00%)

1/10 (10.00%)

0/10 (0.00%)

# events

Skin and subcutaneous tissue disorders

Alopecia

# participants affected / at risk

1/10 (10.00%)

0/10 (0.00%)

# events

Renal and urinary disorders

Micturition urgency

# participants affected / at risk

1/10 (10.00%)

0/10 (0.00%)

# events

General disorders

Asthenia

# participants affected / at risk

0/10 (0.00%)

1/10 (10.00%)

0/10 (0.00%)

# events

General disorders

Catheter site pain

# participants affected / at risk

0/10 (0.00%)

1/10 (10.00%)

0/10 (0.00%)

# events

Injury, poisoning and procedural complications

Sunburn

# participants affected / at risk

0/10 (0.00%)

1/10 (10.00%)

0/10 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary,

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Global Clinical Lead
Organization:	AstraZeneca Clinical Study Information Center
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

Redacted CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Ozan Dursun

Parexel Early Phase Clinical Unit Berlin Campus DRK Kliniken Berlin Westend, Haus 31 Spandauer Damm 130 14050 Berlin Germany

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site