Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AZD3366 in Healthy Subjects, Japanese and Chinese Subjects

Study identifier:D2911C00001

ClinicalTrials.gov identifier:NCT04588727

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3366 in Healthy Men and Women of Non-Childbearing Potential Following: Part A: Single Ascending Dose Administration (Including Populations of Japanese and Chinese Subjects) Part B: Single Dose Administration of AZD3366 at One Dose Level or Placebo with Concomitant Repeated Dosing of Ticagrelor and Acetylsalicylic Acid

Medical condition

cardiovascular disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD3366, Placebo, Ticagrelor, acetylsalicylic acid (ASA)

Sex

All

Actual Enrollment

103

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 15 Oct 2020

Primary Completion Date: 19 Jan 2022

Study Completion Date: 19 Jan 2022

Study design

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

Verification:

Verified 01 Dec 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Healthy men and women of non-childbearing potential
2. Females must have a negative pregnancy test at Screening and on admission to the study center, must not be lactating, and must be of non-childbearing potential, confirmed at Screening, by fulfilling one of the below criteria:
• Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and Follicle stimulating hormone levels in the postmenopausal range.
• Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not bilateral tubal ligation.
3. Subjects described as healthy subjects are defined as not having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent [for example, Cambodia, China, India, Indonesia, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam] except for subjects enrolled into the Japanese (subject for whom both parents and all grandparents are Japanese; born in Japan and not lived outside Japan for more than 10 years) and Chinese (a subject for whom both parents and all grandparents are Chinese and not lived outside of China for more than 10 years) cohorts.
4. Body mass index: 18 and 30 kg/m^2, and weigh minimum 50 kg and not >100 kg.

Exclusion Criteria

1. Subjects having history of the following are excluded:
• Any clinically important disease or disorder which, may put the subject at risk, or influence the results or the subject’s ability to participate in the study.
• History or presence of gastrointestinal, hepatic or renal disease or other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
• Hemophilia, von Willebrand´s disease, lupus anticoagulant or other diseases/syndromes that can either alter or increase the propensity of bleeding.
• Any clinically significant non-traumatic bleed or clinically significant enhanced bleeding.
• Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD3366 or to ASA or ticagrelor.
2. Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results, coagulation parameters, including but not limited to the list below:
• Alanine aminotransferase > upper limit of normal (ULN)
• Aspartate aminotransferase > ULN
• Creatinine > ULN
• White blood cell count < lower limit of normal (LLN)
• Hemoglobin < LLN
• Platelet count < 150,000/µL
• Total bilirubin 1.2 x > ULN
3. Subjects with positive serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus.
4. Any abnormal vital signs, after 10 minutes supine rest, as defined in the list below, at the Screening Visit and/or Day -1:
− Systolic blood pressure (BP) < 90 mmHg or > 140 mmHg.
− Diastolic BP < 50 mmHg or > 90 mmHg.
− Heart rate <45 or >85 beats per minute.
5. Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG, which may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology.
6. Current smokers or those who have smoked or used nicotine products within the previous 3 months, or history of alcohol abuse or excessive intake of alcohol.
7. Use of drugs with enzyme inducing properties such as St John’s Wort within 3 weeks prior to the first administration of IMP.
8. Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega-dose vitamins and minerals during the 2 weeks prior to the first administration of IMP or 5 x the half-life of the drug (whichever is longer).
9. Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
10. COVID-19 vaccination has been administered and a period of less than 14 days has elapsed after the second dose of the vaccine prior to randomization.
11. Received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days (or 5 half-lives, whichever is longer) of the first administration of IMP in this study.
12. Scheduled surgery, including dental surgery, within 8 weeks of the scheduled completion date of the study.
13. Anti-platelet therapy, anticoagulation therapy (i.e., warfarin, factor Xa inhibitors, direct thrombin inhibitors, or heparin), or thrombolytic use, in the past month prior to randomization or planned use during the duration of the study.
14. Use of non-steroidal anti-inflammatory drugs (including ibuprofen) within 3 days prior to the randomization.
15. Use of potent cytochrome 3A4/3A5 and/or P-glycoprotein inhibiting or inducing drugs during the 2 weeks prior to the first administration of IMP or 5 x the half-life of the drug (whichever is longer).
16. Subjects who are vegans.
17. Subjects who cannot communicate reliably with the investigator.
18. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

Location

Research Site

Glendale, CA, United States, 91206

Arms	Assigned Interventions
Experimental: AZD3366 Dose 1 Part A Randomized healthy subjects will receive Dose 1 of AZD3366.	Drug: AZD3366 In Part A, subjects will be randomized to receive intravenous infusion AZD3366 dose 1-7, single ascending dose (SAD). In Part A, Dose 2-7 may be adjusted based on PK data from previous cohort[s]. In Part B, subjects will be randomized to receive intravenous infusion AZD3366 dose X (a dose resulting in predicted therapeutic exposure).
Experimental: AZD3366 Dose 2 Part A Randomized healthy subjects will receive Dose 2 of AZD3366.	Drug: AZD3366 In Part A, subjects will be randomized to receive intravenous infusion AZD3366 dose 1-7, single ascending dose (SAD). In Part A, Dose 2-7 may be adjusted based on PK data from previous cohort[s]. In Part B, subjects will be randomized to receive intravenous infusion AZD3366 dose X (a dose resulting in predicted therapeutic exposure).
Experimental: AZD3366 Dose 3 Part A Randomized healthy subjects will receive Dose 3 of AZD3366.	Drug: AZD3366 In Part A, subjects will be randomized to receive intravenous infusion AZD3366 dose 1-7, single ascending dose (SAD). In Part A, Dose 2-7 may be adjusted based on PK data from previous cohort[s]. In Part B, subjects will be randomized to receive intravenous infusion AZD3366 dose X (a dose resulting in predicted therapeutic exposure).
Experimental: AZD3366 Dose 4 Part A Randomized healthy subjects will receive Dose 4 of AZD3366.	Drug: AZD3366 In Part A, subjects will be randomized to receive intravenous infusion AZD3366 dose 1-7, single ascending dose (SAD). In Part A, Dose 2-7 may be adjusted based on PK data from previous cohort[s]. In Part B, subjects will be randomized to receive intravenous infusion AZD3366 dose X (a dose resulting in predicted therapeutic exposure).
Experimental: AZD3366 Dose 5 Part A Randomized healthy subjects and healthy Japanese subjects will receive Dose 5 of AZD3366.	Drug: AZD3366 In Part A, subjects will be randomized to receive intravenous infusion AZD3366 dose 1-7, single ascending dose (SAD). In Part A, Dose 2-7 may be adjusted based on PK data from previous cohort[s]. In Part B, subjects will be randomized to receive intravenous infusion AZD3366 dose X (a dose resulting in predicted therapeutic exposure).
Experimental: AZD3366 Dose 6 Part A Randomized healthy subjects and healthy Japanese subjects will receive Dose 6 of AZD3366.	Drug: AZD3366 In Part A, subjects will be randomized to receive intravenous infusion AZD3366 dose 1-7, single ascending dose (SAD). In Part A, Dose 2-7 may be adjusted based on PK data from previous cohort[s]. In Part B, subjects will be randomized to receive intravenous infusion AZD3366 dose X (a dose resulting in predicted therapeutic exposure).
Experimental: AZD3366 Dose 7 Part A Randomized healthy subjects, healthy Japanese subjects, and healthy Chinese subjects will receive Dose 7 of AZD3366.	Drug: AZD3366 In Part A, subjects will be randomized to receive intravenous infusion AZD3366 dose 1-7, single ascending dose (SAD). In Part A, Dose 2-7 may be adjusted based on PK data from previous cohort[s]. In Part B, subjects will be randomized to receive intravenous infusion AZD3366 dose X (a dose resulting in predicted therapeutic exposure).
Placebo Comparator: Placebo Part A Randomized healthy subjects, healthy Japanese subjects, and healthy Chinese subjects will receive Placebo matched to AZD3366.	Drug: Placebo In Part A and Part B, subjects will be randomized to receive intravenous infusion of placebo (0.9% sodium chloride solution).
Experimental: AZD3366 Dose X Part B Randomized healthy subjects will receive Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.	Drug: AZD3366 In Part A, subjects will be randomized to receive intravenous infusion AZD3366 dose 1-7, single ascending dose (SAD). In Part A, Dose 2-7 may be adjusted based on PK data from previous cohort[s]. In Part B, subjects will be randomized to receive intravenous infusion AZD3366 dose X (a dose resulting in predicted therapeutic exposure). Drug: Ticagrelor In Part B, subjects will receive oral ticagrelor tablets. Other Name: Brilinta Drug: acetylsalicylic acid (ASA) In Part B, subjects will receive oral ASA chewable tablets. Other Name: Chewable aspirin
Placebo Comparator: Placebo Dose X Part B Randomized healthy subjects will receive Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA.	Drug: Placebo In Part A and Part B, subjects will be randomized to receive intravenous infusion of placebo (0.9% sodium chloride solution). Drug: Ticagrelor In Part B, subjects will receive oral ticagrelor tablets. Other Name: Brilinta Drug: acetylsalicylic acid (ASA) In Part B, subjects will receive oral ASA chewable tablets. Other Name: Chewable aspirin

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 15 October 2020 to 10 January 2022.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who met all the inclusion and none of the exclusion criteria were randomized at single study center. The screening period comprised of maximum 21 days before first dose. Informed consent form (ICF) was signed prior to screening procedures. All the study assessments were performed as per the schedule of assessments.

Reporting Groups

	Description
AZD3366 Dose 1 Part A	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
Pooled Placebo (Non-Asian)-Part A	Total Randomized healthy Non-Asian subjects who received placebo.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
Pooled Placebo (Japanese)-Part A	Total Randomized healthy Japanese subjects who received placebo.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.
Pooled Placebo Part A (Chinese)	Randomized healthy Chinese subjects received placebo.
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Placebo Part B	Randomized healthy subjects received placebo in conjunction with concomitant administration of ticagrelor and ASA.

Participant Flow: Overall Study

	AZD3366 Dose 1 Part A	AZD3366 Dose 2 Part A	AZD3366 Dose 3 Part A	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	Pooled Placebo (Non-Asian)-Part A	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	Pooled Placebo (Japanese)-Part A	AZD3366 Dose 7 Part A (Chinese)	Pooled Placebo Part A (Chinese)	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Placebo Part B
STARTED	6	7	6	6	6	6	6	14	4	4	4	3	6	2	12	12
COMPLETED	6	6	6	6	6	6	6	13	4	4	4	3	6	2	11	12
NOT COMPLETED	0	1	0	0	0	0	0	1	0	0	0	0	0	0	1	0
Protocol Violation	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Adverse Event	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0

Baseline Characteristics

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

The randomised set consisted of all participants randomised into the study.

Reporting Groups

	Description
Total Part A (Non-Asian)	Randomized healthy Non-Asian subjects received AZD3366 or placebo
Total Part A (Japanese)	Randomized healthy Japanese subjects received AZD3366 or placebo.
Total Part A (Chinese)	Randomized healthy Chinese subjects received AZD3366 or placebo.
Total Part B	Total Randomized healthy subjects who received single IV administration of AZD3366 or placebo with concomitant loading doses (LDs) followed by repeated maintenance dosing of ticagrelor and ASA.

Baseline Measures

	Total Part A (Non-Asian)	Total Part A (Japanese)	Total Part A (Chinese)	Total Part B	Total
Number of Participants [units: Participants]	57	15	8	24	104
Age Continuous [units: years] Mean ± Standard Deviation	35.9 ± 9.1	37.8 ± 7.1	41.6 ± 8.3	37.9 ± 10.3	NA ± NA ^[1]
Sex: Female, Male [units: participants]
Female	1	0	1	3	5
Male	56	15	7	21	99
Race/Ethnicity, Customized [units: participants]
White	42	0	0	14	56
Black or African American	12	0	0	8	20
Asian	0	15	8	0	23
Others	3	0	0	2	5
Ethnicity (NIH/OMB) [units: ]
Hispanic or Latino	20	0	0	4	24
Not Hispanic or Latino	37	15	8	20	80
Unknown or Not Reported	0	0	0	0	0

Outcome Measures

1. Primary Outcome Measure: Number of subjects with adverse events and serious adverse events in both Part A and Part B [ Time Frame: From screening (Day -21) to follow-up (Day 60 for Part A and Day 50 for Part B) ]

Measure Type	Primary
Measure Name	Number of subjects with adverse events and serious adverse events in both Part A and Part B
Measure Description	The safety and tolerability of intravenous administration of AZD3366 in healthy subjects, healthy Japanese subjects and healthy Chinese subjects was assessed.
Time Frame	From screening (Day -21) to follow-up (Day 60 for Part A and Day 50 for Part B)
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 included all participants who received a dose of AZD3366 or placebo and for whom any safety post-dose data were available.

Reporting Groups

	Description
AZD3366 Dose 1 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 7 of AZD3366.
Pooled Placebo Part A (Non-Asian)	Randomized healthy Non-Asian subjects received placebo.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
Pooled Placebo Part A (Japanese)	Randomized healthy Japanese subjects received placebo.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.
Pooled Placebo Part A (Chinese)	Randomized healthy Chinese subjects received placebo.
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Placebo Part B	Randomized healthy subjects received placebo in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	AZD3366 Dose 1 Part A (Non-Asian)	AZD3366 Dose 2 Part A (Non-Asian)	AZD3366 Dose 3 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	Pooled Placebo Part A (Non-Asian)	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	Pooled Placebo Part A (Japanese)	AZD3366 Dose 7 Part A (Chinese)	Pooled Placebo Part A (Chinese)	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Placebo Part B
Number of Participants Analyzed [units:participants]	6	6	6	6	6	6	6	14	4	4	4	3	6	2	12	12
Number of subjects with adverse events and serious adverse events in both Part A and Part B [units: Participants]
Any AEs	1	1	3	3	4	4	0	5	0	4	1	1	3	2	2	7
Any AEs leading to death	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Any SAEs	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Any AEs leading to discontinuation of IMP	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Any AEs leading to dose reduction	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Any AEs leading to study withdrawal	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0

No statistical analysis provided for Number of subjects with adverse events and serious adverse events in both Part A and Part B

2. Secondary Outcome Measure: Area under plasma concentration-time curve from time zero extrapolated to infinity (AUCinf) of AZD3366 Part A [ Time Frame: Pre-dose, and post-dose (Day 1 to Day 60) ]

Measure Type	Secondary
Measure Name	Area under plasma concentration-time curve from time zero extrapolated to infinity (AUCinf) of AZD3366 Part A
Measure Description	PK of AZD3366 following IV administration of single doses of AZD3366 in Part A
Time Frame	Pre-dose, and post-dose (Day 1 to Day 60)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received AZD3366 (Part A) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
AZD3366 Dose 1 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.

Measured Values

	AZD3366 Dose 1 Part A (Non-Asian)	AZD3366 Dose 2 Part A (Non-Asian)	AZD3366 Dose 3 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	AZD3366 Dose 7 Part A (Chinese)
Number of Participants Analyzed [units:participants]	6	6	6	6	6	6	6	4	4	4	6
Area under plasma concentration-time curve from time zero extrapolated to infinity (AUCinf) of AZD3366 Part A [units: h*mg/L] Geometric Mean (Geometric Coefficient of Variation)	52.66 (13.48%)	283.8 (13.05%)	849.1 (12.51%)	2737 (4.984%)	5416 (10.80%)	12260 (18.69%)	21960 (10.93%)	2841 (9.316%)	6660 (17.19%)	21990 (9.156%)	20710 (16.37%)

No statistical analysis provided for Area under plasma concentration-time curve from time zero extrapolated to infinity (AUCinf) of AZD3366 Part A

3. Secondary Outcome Measure: Terminal half life (t½λz), estimated as (ln2)/λz of AZD3366 in Part A [ Time Frame: Pre-dose, and post-dose (Day 1 to Day 60) ]

Measure Type	Secondary
Measure Name	Terminal half life (t½λz), estimated as (ln2)/λz of AZD3366 in Part A
Measure Description	PK of AZD3366 following IV administration of single doses of AZD3366 in Part A was evaluated.
Time Frame	Pre-dose, and post-dose (Day 1 to Day 60)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received AZD3366 (Part A) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
AZD3366 Dose 1 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.

Measured Values

	AZD3366 Dose 1 Part A (Non-Asian)	AZD3366 Dose 2 Part A (Non-Asian)	AZD3366 Dose 3 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	AZD3366 Dose 7 Part A (Chinese)
Number of Participants Analyzed [units:participants]	6	6	6	6	6	6	6	4	4	4	6
Terminal half life (t½λz), estimated as (ln2)/λz of AZD3366 in Part A [units: hours] Geometric Mean (Geometric Coefficient of Variation)	129.7 (7.899%)	144.0 (13.30%)	140.4 (5.558%)	140.3 (4.785%)	154.1 (7.086%)	140.1 (8.980%)	135.9 (6.031%)	128.8 (17.15%)	143.0 (4.431%)	149.7 (9.737%)	137.5 (9.203%)

No statistical analysis provided for Terminal half life (t½λz), estimated as (ln2)/λz of AZD3366 in Part A

4. Secondary Outcome Measure: Total body clearance of drug from plasma after intravascular administration (CL) of AZD3366 in Part A [ Time Frame: Pre-dose, and post-dose (Day 1 to Day 60) ]

Measure Type	Secondary
Measure Name	Total body clearance of drug from plasma after intravascular administration (CL) of AZD3366 in Part A
Measure Description	PK of AZD3366 following IV administration of single doses of AZD3366 in Part A was evaluated.
Time Frame	Pre-dose, and post-dose (Day 1 to Day 60)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received AZD3366 (Part A) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
AZD3366 Dose 1 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.

Measured Values

	AZD3366 Dose 1 Part A (Non-Asian)	AZD3366 Dose 2 Part A (Non-Asian)	AZD3366 Dose 3 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	AZD3366 Dose 7 Part A (Chinese)
Number of Participants Analyzed [units:participants]	6	6	6	6	6	6	6	4	4	4	6
Total body clearance of drug from plasma after intravascular administration (CL) of AZD3366 in Part A [units: litre/hour] Geometric Mean (Geometric Coefficient of Variation)	0.03798 (13.48%)	0.03523 (13.05%)	0.03533 (12.51%)	0.03288 (4.984%)	0.03323 (10.80%)	0.02935 (18.69%)	0.02915 (10.93%)	0.03168 (9.316%)	0.02703 (17.19%)	0.02911 (9.156%)	0.03091 (16.37%)

No statistical analysis provided for Total body clearance of drug from plasma after intravascular administration (CL) of AZD3366 in Part A

5. Secondary Outcome Measure: Volume of distribution at steady state from a systemic dose (Vss) of AZD3366 in Part A [ Time Frame: Pre-dose, and post-dose (Day 1 to Day 60) ]

Measure Type	Secondary
Measure Name	Volume of distribution at steady state from a systemic dose (Vss) of AZD3366 in Part A
Measure Description	PK of AZD3366 following IV administration of single doses of AZD3366 in Part A was evaluated
Time Frame	Pre-dose, and post-dose (Day 1 to Day 60)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received AZD3366 (Part A) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
AZD3366 Dose 1 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.

Measured Values

	AZD3366 Dose 1 Part A (Non-Asian)	AZD3366 Dose 2 Part A (Non-Asian)	AZD3366 Dose 3 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	AZD3366 Dose 7 Part A (Chinese)
Number of Participants Analyzed [units:participants]	6	6	6	6	6	6	6	4	4	4	6
Volume of distribution at steady state from a systemic dose (Vss) of AZD3366 in Part A [units: Litres] Geometric Mean (Geometric Coefficient of Variation)	5.874 (12.27%)	5.755 (15.98%)	5.421 (17.32%)	4.998 (4.825%)	5.291 (13.09%)	4.116 (15.77%)	4.234 (10.97%)	4.388 (12.97%)	4.333 (15.00%)	4.100 (9.982%)	4.504 (18.03%)

No statistical analysis provided for Volume of distribution at steady state from a systemic dose (Vss) of AZD3366 in Part A

6. Secondary Outcome Measure: Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast) to characterize the PK of AZD3366 in Part A [ Time Frame: Pre-dose, and post-dose (Day 1 to Day 60) ]

Measure Type	Secondary
Measure Name	Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast) to characterize the PK of AZD3366 in Part A
Measure Description	PK of AZD3366 following IV administration of single doses of AZD3366 in Part A
Time Frame	Pre-dose, and post-dose (Day 1 to Day 60)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received AZD3366 (Part A) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
AZD3366 Dose 1 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.

Measured Values

	AZD3366 Dose 1 Part A (Non-Asian)	AZD3366 Dose 2 Part A (Non-Asian)	AZD3366 Dose 3 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	AZD3366 Dose 7 Part A (Chinese)
Number of Participants Analyzed [units:participants]	6	6	6	6	6	6	6	4	4	4	6
Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast) to characterize the PK of AZD3366 in Part A [units: h*mg/L] Geometric Mean (Geometric Coefficient of Variation)	50.44 (13.63%)	271.2 (12.78%)	841.4 (12.59%)	2734 (5.004%)	5409 (10.78%)	12260 (18.68%)	21940 (10.91%)	2839 (9.286%)	6653 (17.18%)	21970 (9.133%)	20690 (16.37%)

No statistical analysis provided for Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast) to characterize the PK of AZD3366 in Part A

7. Secondary Outcome Measure: Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC(0-48)] of AZD3366 in Part A [ Time Frame: Pre-dose, and post-dose (Day 1 to Day 60) ]

Measure Type	Secondary
Measure Name	Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC(0-48)] of AZD3366 in Part A
Measure Description	PK of AZD3366 following IV administration of single doses of AZD3366 in healthy subjects, healthy Japanese subjects and healthy Chinese subjects in Part A
Time Frame	Pre-dose, and post-dose (Day 1 to Day 60)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received AZD3366 (Part A) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
AZD3366 Dose 1 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.

Measured Values

	AZD3366 Dose 1 Part A (Non-Asian)	AZD3366 Dose 2 Part A (Non-Asian)	AZD3366 Dose 3 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	AZD3366 Dose 7 Part A (Chinese)
Number of Participants Analyzed [units:participants]	6	6	6	6	6	6	6	4	4	4	6
Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC(0-48)] of AZD3366 in Part A [units: h*mg/L] Geometric Mean (Geometric Coefficient of Variation)	17.61 (14.30%)	94.03 (13.88%)	286.3 (15.11%)	927.8 (5.041%)	1756 (14.57%)	4364 (12.27%)	7138 (11.80%)	1001 (9.969%)	2047 (15.33%)	8269 (12.97%)	6936 (17.56%)

No statistical analysis provided for Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC(0-48)] of AZD3366 in Part A

8. Secondary Outcome Measure: Observed maximum plasma concentration (Cmax) of AZD3366 in Part A [ Time Frame: Pre-dose, and post-dose (Day 1 to Day 60) ]

Measure Type	Secondary
Measure Name	Observed maximum plasma concentration (Cmax) of AZD3366 in Part A
Measure Description	PK of AZD3366 following IV administration of single doses of AZD3366 in healthy subjects, healthy Japanese subjects and healthy Chinese subjects in Part A
Time Frame	Pre-dose, and post-dose (Day 1 to Day 60)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received AZD3366 (Part A) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
AZD3366 Dose 1 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.

Measured Values

	AZD3366 Dose 1 Part A (Non-Asian)	AZD3366 Dose 2 Part A (Non-Asian)	AZD3366 Dose 3 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	AZD3366 Dose 7 Part A (Chinese)
Number of Participants Analyzed [units:participants]	6	6	6	6	6	6	6	4	4	4	6
Observed maximum plasma concentration (Cmax) of AZD3366 in Part A [units: mg/L] Geometric Mean (Geometric Coefficient of Variation)	0.5684 (13.97%)	3.124 (18.78%)	10.11 (16.15%)	32.55 (10.01%)	59.70 (16.24%)	146.0 (10.62%)	263.9 (11.07%)	32.71 (5.776%)	76.33 (12.88%)	300 (10.70%)	258.1 (20.77%)

No statistical analysis provided for Observed maximum plasma concentration (Cmax) of AZD3366 in Part A

9. Secondary Outcome Measure: Time to reach peak or maximum observed concentration following drug administration (tmax) of AZD3366 in Part A [ Time Frame: Pre-dose, and post-dose (Day 1 to Day 60) ]

Measure Type	Secondary
Measure Name	Time to reach peak or maximum observed concentration following drug administration (tmax) of AZD3366 in Part A
Measure Description	PK of AZD3366 following IV administration of single doses of AZD3366 in Part A was evaluated.
Time Frame	Pre-dose, and post-dose (Day 1 to Day 60)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received AZD3366 (Part A) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
AZD3366 Dose 1 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.

Measured Values

	AZD3366 Dose 1 Part A (Non-Asian)	AZD3366 Dose 2 Part A (Non-Asian)	AZD3366 Dose 3 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	AZD3366 Dose 7 Part A (Chinese)
Number of Participants Analyzed [units:participants]	6	6	6	6	6	6	6	4	4	4	6
Time to reach peak or maximum observed concentration following drug administration (tmax) of AZD3366 in Part A [units: hours] Median (Full Range)	0.28 (0.17 to 1.03)	1.02 (0.18 to 1.15)	0.17 (0.08 to 0.22)	0.51 (0.17 to 1.12)	0.90 (0.17 to 1.18)	0.43 (0.25 to 1.05)	0.48 (0.47 to 0.50)	0.24 (0.18 to 1.07)	0.51 (0.20 to 0.97)	0.57 (0.47 to 1.02)	0.52 (0.10 to 1.03)

No statistical analysis provided for Time to reach peak or maximum observed concentration following drug administration (tmax) of AZD3366 in Part A

10. Secondary Outcome Measure: Inhibition of ADP-induced Platelet Aggregation of AZD3366 in Part A [ Time Frame: Day 1 to Day 60 ]

Measure Type	Secondary
Measure Name	Inhibition of ADP-induced Platelet Aggregation of AZD3366 in Part A
Measure Description	Descriptive statistics for inhibition of ADP-induced platelet aggregation using LTA are presented as change from baseline results. Parameter: G-Platelet Aggregation (AUC)
Time Frame	Day 1 to Day 60
Safety Issue?

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 Pharmacodynamic (PD) analysis set consisted of all participants in the safety analysis set who had evaluable PD data, with only non-important protocol deviations or no AEs thought to impact on the analysis of the PD data.

Reporting Groups

	Description
AZD3366 Dose 1 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.

Measured Values

	AZD3366 Dose 1 Part A (Non-Asian)	AZD3366 Dose 2 Part A (Non-Asian)	AZD3366 Dose 3 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	AZD3366 Dose 7 Part A (Chinese)
Number of Participants Analyzed [units:participants]	6	6	6	6	6	6	6	4	4	4	6
Inhibition of ADP-induced Platelet Aggregation of AZD3366 in Part A [units: % inhibition] Mean (Full Range)
Day 1/ 0.17 h	NA (92 to 92) ^[1]	96.9 (95 to 98)	98.6 (98 to 99)	98.9 (98 to 100)	99.6 (99 to 100)	100 (100 to 100)	99.9 (99 to 100)	98.8 (98 to 99)	100 (100 to 100)	100 (100 to 100)	99.6 (98 to 100)
Day 1/ 0.5 h		97.1 (93 to 98)	98.6 (98 to 99)	99.1 (98 to 100)	99.5 (99 to 100)	99.7 (99 to 100)	100 (100 to 100)	98.7 (98 to 99)	99.1 (99 to 100)	100 (100 to 100)	99.8 (99 to 100)
Day 1/1 h	NA (83 to 91) ^[1]	97.1 (95 to 99)	98.2 (97 to 99)	99.0 (98 to 100)	99.5 (99 to 100)	99.8 (99 to 100)	100 (100 to 100)	98.6 (98 to 99)	100 (100 to 100)	100 (100 to 100)	100 (100 to 100)
Day 1/ 4 h		96.1 (90 to 99)	98.3 (98 to 99)	98.8 (98 to 100)	99.5 (99 to 100)	99.6 (99 to 100)	100 (100 to 100)	98.7 (98 to 100)	99.6 (99 to 100)	99.8 (99 to 100)	100 (100 to 100)
Day 1/ 8 h	NA (87 to 91) ^[1]	96.4 (92 to 98)	98.1 (98 to 99)	98.7 (98 to 100)	99.4 (99 to 100)	99.7 (99 to 100)	100 (100 to 100)	99.0 (98 to 99)	63.5 (23 to 100)	99.4 (98 to 100)	99.8 (99 to 100)
Day 2/ 24 h	NA (77 to 82) ^[1]	95.9 (94 to 98)	98.2 (98 to 99)	98.9 (98 to 100)	99.4 (99 to 100)	99.7 (99 to 100)	100 (100 to 100)	99 (99 to 99)	67.6 (-28 to 100)	100 (100 to 100)	99.6 (99 to 100)
Day 3/ 48 h		94.5 (90 to 97)	97.7 (97 to 99)	98.9 (97 to 100)	99.4 (99 to 100)	99.7 (99 to 100)	100 (100 to 100)	76.7 (12 to 98)	99.6 (99 to 100)	100 (100 to 100)	99.8 (99 to 100)
Day 5/ 96 h	NA (19 to 54) ^[1]	90.1 (82 to 95)	96.5 (95 to 97)	97.7 (96 to 99)	98.9 (98 to 100)	99.4 (99 to 100)	99.7 (99 to 100)	97.5 (97 to 98)	99.3 (99 to 100)	99.5 (99 to 100)	99.7 (99 to 100)
Day 7/ 144 h	NA (14 to 60) ^[1]	88.9 (78 to 95)	94.1 (90 to 96)	97.2 (96 to 98)	98.6 (98 to 99)	99 (98 to 100)	99.5 (99 to 100)	97.1 (96 to 98)	98.8 (98 to 99)	99.4 (99 to 100)	99.5 (99 to 100)
Day 11/ 240 h	NA (-30 to 29) ^[1]	71.7 (40 to 86)	90.4 (83 to 95)	95.0 (91 to 97)	97.7 (97 to 98)	98.2 (98 to 100)	99.2 (98 to 100)	95.1 (93 to 96)	98.3 (97 to 99)	99.3 (99 to 100)	99.4 (99 to 100)
Day 15/ 336 h	NA (-53 to 25) ^[1]	59.5 (34 to 82)	85.4 (77 to 92)	92.9 (90 to 96)	96.3 (92 to 98)	98.1 (97 to 100)	98.8 (97 to 100)	91.2 (86 to 95)	97.2 (94 to 99)	98.4 (98 to 99)	98.6 (96 to 100)
Day 19/ 432 h	NA (4 to 32) ^[1]	22.6 (-15 to 41)	59.2 (44 to 81)
Day 23/ 528 h		14.0 (-31 to 72)	32.0 (4 to 50)
Day 26/ 600 h	NA (4 to 4) ^[1]	9.4 (-21 to 39)	6.7 (-39 to 30)
Day 44/ 1032 h				-13.2 (-72 to 18)	51.5 (30 to 74)	34.4 (-25 to 66)	72.0 (50 to 90)	-8.2 (-46 to 13)	19.1 (-14 to 40)	61.2 (-6 to 89)	63.3 (41 to 80)
Day 60/ 1416 h				-7.5 (-70 to 27)	44.6 (18 to 100)	21.6 (-10 to 99)	14.3 (-10 to 48)	-2.5 (-13 to 22)	13.0 (-11.0 to 45)	NA (-95 to 63) ^[1]	15 (-42 to 100)

No statistical analysis provided for Inhibition of ADP-induced Platelet Aggregation of AZD3366 in Part A

11. Secondary Outcome Measure: Inhibition of TRAP-induced Platelet Aggregation in Part A [ Time Frame: Day 1 to Day 60 ]

Measure Type	Secondary
Measure Name	Inhibition of TRAP-induced Platelet Aggregation in Part A
Measure Description	Descriptive statistics for inhibition of TRAP-induced platelet aggregation using LTA are presented as change from baseline results. Parameter: G-Platelet Aggregation (AUC)
Time Frame	Day 1 to Day 60
Safety Issue?

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 Pharmacodynamic (PD) analysis set consisted of all participants in the safety analysis set who had evaluable PD data, with only non-important protocol deviations or no AEs thought to impact on the analysis of the PD data.

Reporting Groups

	Description
AZD3366 Dose 1 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.

Measured Values

	AZD3366 Dose 1 Part A (Non-Asian)	AZD3366 Dose 2 Part A (Non-Asian)	AZD3366 Dose 3 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	AZD3366 Dose 7 Part A (Chinese)
Number of Participants Analyzed [units:participants]	6	6	6	6	6	6	6	4	4	4	6
Inhibition of TRAP-induced Platelet Aggregation in Part A [units: % inhibition] Mean (Full Range)
Day 1/ 0.17 h	NA (-14 to -14) ^[1]	24.3 (-29 to 99)	24.6 (-17 to 55)	-73.5 (-549 to 35)	61.6 (32 to 86)	70.0 (44 to 95)	68.8 (40 to 81)	7.4 (-100 to 60)	49.6 (-10 to 100)	36.2 (-53 to 79)	71.4 (19 to 92)
Day 1/ 0.5 h		46.1 (3 to 98)	20.2 (-32 to 48)	-68.3 (-536 to 68)	54.1 (28 to 85)	76.0 (57 to 93)	70.9 (50 to 82)	-8.0 (-89 to 35)	47.8 (19 to 78)	26.8 (-86 to 70)	71.7 (23 to 89)
Day 1/ 1 h	NA (-9 to -9) ^[1]	22.3 (-69 to 65)	15.5 (-30 to 41)	-104.7 (-671 to 48)	58.3 (19 to 96)	67.1 (38 to 84)	70.1 (53 to 82)	15.6 (-96 to 67)	45.5 (-1 to 74)	25.1 (-135 to 100)	71.5 (18 to 99)
Day 1/ 4 h		47.1 (4 to 100)	11.9 (-29 to 32)	-110.9 (-738 to 41)	46.6 (4 to 86)	51.2 (-19 to 88)	52.8 (24 to 100)	19.0 (-91 to 60)	23.9 (1 to 51)	19.6 (-149 to 92)	69.2 (42 to 99)
Day 1/ 8 h		44.9 (22 to 77)	22.7 (-13 to 49)	-77.3 (-576 to 52)	40.3 (15 to 79)	60.0 (-6 to 100)	43.7 (2 to 79)	30.7 (-31 to 89)	57.0 (14 to 100)	0.1 (-163 to 72)	59.5 (11 to 81)
Day 2/ 24 h		10.5 (-31 to 29)	6.9 (-7 to 21)	-224.5 (-1382 to 22)	26.2 (-1 to 64)	59.4 (40 to 76)	58.3 (44 to 74)	-2.5 (-78 to 54)	17.0 (-22 to 65)	27.2 (-114 to 90)	66.8 (50 to 80)
Day 3/ 48 h	NA (75 to 75) ^[1]	7.2 (-38 to 45)	-0.5 (-36 to 18)	-85.4 (-644 to 76)	45.0 (-4 to 83)	49.9 (30 to 80)	62.9 (33 to 83)	-3.6 (-109 to 50)	8.4 (-10 to 44)	-23.2 (-242 to 67)	59.9 (-1 to 88)
Day 5/ 96 h		5.6 (-118 to 61)	4.4 (-17 to 27)	-137.1 (-856 to 24)	32.0 (9 to 70)	30.9 (-2 to 65)	36.3 (23 to 69)	-21.5 (-146 to 23)	35.0 (8 to 78)	-55.8 (-235 to 43)	57.8 (17 to 95)
Day 7/ 144	NA (-5 to -5) ^[1]	18.8 (-47 to 98)	1.3 (-46 to 32)	-134.2 (-851 to 41)	24.3 (-34 to 73)	32.6 (8 to 71)	41.5 (14 to 84)	-3.0 (-99 to 46)	6.6 (-21 to 29)	-54.2 (-284 to 49)	57.7 (28 to 83)
Day 11/ 240 h		21.3 (-11 to 46)	8.8 (-54 to 67)	-216.7 (-1351 to 31)	20.5 (-28 to 70)	17.1 (-27 to 67)	38.3 (11 to 75)	-16.2 (-107 to 20)	24.4 (12 to 43)	-75.1 (-375 to 45)	55.3 (15 to 83)
Day 15/ 336 h		22.3 (3 to 40)	13.9 (-10 to 52)	-107.3 (-718 to 50)	15.5 (-87 to 75)	23.5 (-63 to 64)	42.1 (10 to 76)	17.5 (-23 to 45)	24.3 (-9 to 43)	-92.2 (-454 to 35)	49.0 (8 to 73)
Day 19/ 432 h		-10.6 (-100 to 27)	13.9 (-47 to 67)
Day 23/ 528 h		18.8 (-14 to 54)	-10.1 (-60 to 24)
Day 26/ 600 h		-10.4 (-62 to 42)	7.9 (-38 to 49)
Day 30/ 696 h				-112.6 (-700 to 28)	28.0 (-9 to 67)	8.2 (-51 to 56)	19.3 (-27 to 39)	-3.7 (-107 to 39)	9.7 (-10 to 29)	-82.2 (-374 to 43)	40.1 (7 to 69)
Day 38/ 888 h
Day 44/ 1032 h				-134.4 (-820 to 39)	38.5 (0 to 83)	-34.8 (-208 to 62)	26.8 (1 to 61)	-14.0 (-84 to 24)	31.2 (-5 to 73)	-70.2 (-326 to 55)	37.6 (20 to 61)
Day 60/ 1416 h				-100.3 (-627 to 32)	33.4 (-30 to 97)	-22.4 (-171 to 62)	2.0 (-38 to 39)	-16.3 (-79 to 38)	36.3 (14 to 78)	NA (-117 to 100) ^[1]	2.6 (-45 to 78)

No statistical analysis provided for Inhibition of TRAP-induced Platelet Aggregation in Part A

12. Secondary Outcome Measure: Change from baseline of capillary bleeding time (CBT) in Part A [ Time Frame: Day 1 ]

Measure Type	Secondary
Measure Name	Change from baseline of capillary bleeding time (CBT) in Part A
Measure Description	Analysis of capillary bleeding time on Day 1 are presented using geometric mean change from baseline values.
Time Frame	Day 1
Safety Issue?

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 Pharmacodynamic (PD) analysis set consisted of all participants in the safety analysis set who had evaluable PD data, with only non-important protocol deviations or no AEs thought to impact on the analysis of the PD data.

Reporting Groups

	Description
AZD3366 Dose 1 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.

Measured Values

	AZD3366 Dose 1 Part A (Non-Asian)	AZD3366 Dose 2 Part A (Non-Asian)	AZD3366 Dose 3 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Non-Asian)	AZD3366 Dose 5 Part A (Non-Asian)	AZD3366 Dose 6 Part A (Non-Asian)	AZD3366 Dose 7 Part A (Non-Asian)	AZD3366 Dose 4 Part A (Japanese)	AZD3366 Dose 5 Part A (Japanese)	AZD3366 Dose 7 Part A (Japanese)	AZD3366 Dose 7 Part A (Chinese)
Number of Participants Analyzed [units:participants]	6	6	6	6	6	6	6	4	4	4	6
Change from baseline of capillary bleeding time (CBT) in Part A [units: minutes] Geometric Mean (95% Confidence Interval)	1.02 (0.61 to 1.68)	1.11 (0.67 to 1.84)	1.08 (0.65 to 1.79)	1.16 (0.70 to 1.93)	2.33 (1.40 to 3.88)	9.24 (5.35 to 15.98)	10.32 (5.96 to 17.87)	1.56 (0.91 to 2.68)	4.09 (2.43 to 6.90)	23.15 (10.88 to 49.26)	7.61 (4.92 to 11.77)

No statistical analysis provided for Change from baseline of capillary bleeding time (CBT) in Part A

13. Secondary Outcome Measure: Inhibition of ADP-induced Platelet Aggregation in Part B [ Time Frame: Day 1 to Day 3, Day 15, Day 29, and Day 50 ]

Measure Type	Secondary
Measure Name	Inhibition of ADP-induced Platelet Aggregation in Part B
Measure Description	Descriptive statistics for inhibition of ADP-induced platelet aggregation using LTA are presented as CFB results for Part B. Parameter: G-Platelet Aggregation (AUC)
Time Frame	Day 1 to Day 3, Day 15, Day 29, and Day 50
Safety Issue?

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 Pharmacodynamic (PD) analysis set consisted of all participants in the safety analysis set who had evaluable PD data, with only non-important protocol deviations or no AEs thought to impact on the analysis of the PD data.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Dose X Placebo Part B	Randomized healthy subjects received Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Dose X Placebo Part B
Number of Participants Analyzed [units:participants]	12	12
Inhibition of ADP-induced Platelet Aggregation in Part B [units: % inhibition] Mean (Full Range)
Day 1/ 0.17 h	98.8 (90 to 100)	13.6 (-31 to 95)
Day 1/ 3.67 h	99.4 (97 to 100)	53.0 (28 to 81)
Day 2/ 25.67 h	99.6 (99 to 100)	23.5 (-26 to 82)
Day 3/ 51.67 h	98.8 (90 to 100)	36.5 (2 to 71)
Day 15/ 336 h	79.0 (-110 to 98)	10.8 (-38 to 74)
Day 29/ 672 h	-36.3 (-1234 to 91)	20.6 (-30 to 100)
Day 50/ 1176 h	-136.4 (-1497 to 38)	9.8 (-41 to 82)

No statistical analysis provided for Inhibition of ADP-induced Platelet Aggregation in Part B

14. Secondary Outcome Measure: Inhibition of TRAP-induced Platelet Aggregation Using LTA and Change from Baseline Results - Part B [ Time Frame: Day 1 to Day 3, Day 15, Day 29, and Day 50 ]

Measure Type	Secondary
Measure Name	Inhibition of TRAP-induced Platelet Aggregation Using LTA and Change from Baseline Results - Part B
Measure Description	Descriptive statistics for inhibition of TRAP-induced platelet aggregation using LTA are presented as CFB results for Part B. Parameter: G-Platelet Aggregation (AUC)
Time Frame	Day 1 to Day 3, Day 15, Day 29, and Day 50
Safety Issue?

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 Pharmacodynamic (PD) analysis set consisted of all participants in the safety analysis set who had evaluable PD data, with only non-important protocol deviations or no AEs thought to impact on the analysis of the PD data.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Dose X Placebo Part B	Randomized healthy subjects received Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Dose X Placebo Part B
Number of Participants Analyzed [units:participants]	12	12
Inhibition of TRAP-induced Platelet Aggregation Using LTA and Change from Baseline Results - Part B [units: % inhibition] Mean (Full Range)
Day 1/ 0.17 h	44.2 (-39 to 77)	-0.5 (-173 to 96)
Day 1/ 3.67 h	63.0 (-18 to 86)	31.0 (-169 to 87)
Day 2/ 25.67 h	72.2 (35 to 88)	15.5 (-131 to 73)
Day 3/ 51.67 h	57.8 (-63 to 90)	19.3 (-94 to 67)
Day 15/ 336 h	1.8 (-154 to 55)	19.8 (-103 to 94)
Day 29/ 672 h	-13.1 (-156 to 41)	32.3 (-75 to 100)
Day 50/ 1176 h	8.3 (-125 to 94)	-34.5 (-237 to 94)

No statistical analysis provided for Inhibition of TRAP-induced Platelet Aggregation Using LTA and Change from Baseline Results - Part B

15. Secondary Outcome Measure: Change from baseline of CBT Part B [ Time Frame: Day 1 to Day 3, Day 15, Day 29, and Day 50 ]

Measure Type	Secondary
Measure Name	Change from baseline of CBT Part B
Measure Description	Analysis of capillary bleeding time on Day 1 are presented using geometric mean change from baseline values.
Time Frame	Day 1 to Day 3, Day 15, Day 29, and Day 50
Safety Issue?

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 Pharmacodynamic (PD) analysis set consisted of all participants in the safety analysis set who had evaluable PD data, with only non-important protocol deviations or no AEs thought to impact on the analysis of the PD data.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Dose X Placebo Part B	Randomized healthy subjects received Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Dose X Placebo Part B
Number of Participants Analyzed [units:participants]	12	12
Change from baseline of CBT Part B [units: min] Geometric Mean (95% Confidence Interval)
Day 1/ 0.17 h	14.80 (12.12 to 18.07)	2.13 (1.77 to 2.56)
Day 1/ 3.67 h	55.33 (18.92 to 161.76)	11.10 (6.25 to 19.73)
Day 3/ 51.67 h	45.20 (21.34 to 95.75)	21.59 (11.21 to 41.60)

No statistical analysis provided for Change from baseline of CBT Part B

16. Secondary Outcome Measure: AUCinf of AZD3366 in Part B [ Time Frame: Pre-dose and post dose (Day 1 to Day 3, Day 15, Day 29, and Day 50) ]

Measure Type	Secondary
Measure Name	AUCinf of AZD3366 in Part B
Measure Description	Plasma exposure and PD (inhibition of platelet aggregation and CBT) of AZD3366 at 1 dose level in healthy subjects with concomitant loading dose and repeated dosing of ticagrelor and ASA in Part B is studied.
Time Frame	Pre-dose and post dose (Day 1 to Day 3, Day 15, Day 29, and Day 50)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B
Number of Participants Analyzed [units:participants]	12
AUCinf of AZD3366 in Part B [units: h*mg/L] Geometric Mean (Geometric Coefficient of Variation)	6171 (20.53%)

No statistical analysis provided for AUCinf of AZD3366 in Part B

17. Secondary Outcome Measure: AUClast of AZD3366 in Part B [ Time Frame: Pre-dose and post-dose (Day 1 to Day 3, Day 15, Day 29, and Day 50) ]

Measure Type	Secondary
Measure Name	AUClast of AZD3366 in Part B
Measure Description	Plasma exposure and PD (inhibition of platelet aggregation and CBT) of AZD3366 at 1 dose level in healthy subjects with concomitant loading dose and repeated dosing of ticagrelor and ASA in Part B is studied.
Time Frame	Pre-dose and post-dose (Day 1 to Day 3, Day 15, Day 29, and Day 50)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B
Number of Participants Analyzed [units:participants]	12
AUClast of AZD3366 in Part B [units: h*mg/L] Geometric Mean (Geometric Coefficient of Variation)	6149 (20.54%)

No statistical analysis provided for AUClast of AZD3366 in Part B

18. Secondary Outcome Measure: AUC(0-48) of AZD3366 in Part B [ Time Frame: Pre-dose and post-dose (Day 1 to Day 3, Day 15, Day 29, and Day 50) ]

Measure Type	Secondary
Measure Name	AUC(0-48) of AZD3366 in Part B
Measure Description	The effect of AZD3366 on the PK of ticagrelor was assessed using Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC (0-48)].
Time Frame	Pre-dose and post-dose (Day 1 to Day 3, Day 15, Day 29, and Day 50)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B
Number of Participants Analyzed [units:participants]	12
AUC(0-48) of AZD3366 in Part B [units: h*mg/L] Geometric Mean (Geometric Coefficient of Variation)	2081 (20.52%)

No statistical analysis provided for AUC(0-48) of AZD3366 in Part B

19. Secondary Outcome Measure: Cmax of AZD3366 in Part B [ Time Frame: Pre-dose and post-dose (Day 1 to Day 3, Day 15, Day 29, and Day 50) ]

Measure Type	Secondary
Measure Name	Cmax of AZD3366 in Part B
Measure Description	The effect of AZD3366 on the PK of ticagrelor was assessed through observed maximum plasma concentration [Cmax].
Time Frame	Pre-dose and post-dose (Day 1 to Day 3, Day 15, Day 29, and Day 50)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B
Number of Participants Analyzed [units:participants]	12
Cmax of AZD3366 in Part B [units: mg/L] Geometric Mean (Geometric Coefficient of Variation)	69.12 (16.33%)

No statistical analysis provided for Cmax of AZD3366 in Part B

20. Secondary Outcome Measure: tmax of AZD3366 in Part B [ Time Frame: Pre-dose and post-dose (Day 1 to Day 3, Day 15, Day 29, and Day 50) ]

Measure Type	Secondary
Measure Name	tmax of AZD3366 in Part B
Measure Description	The effect of AZD3366 on the PK of ticagrelor was assessed using time to reach peak or maximum observed concentration or response following drug administration.
Time Frame	Pre-dose and post-dose (Day 1 to Day 3, Day 15, Day 29, and Day 50)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B
Number of Participants Analyzed [units:participants]	12
tmax of AZD3366 in Part B [units: hours] Median (Full Range)	0.48 (0.07 to 0.97)

No statistical analysis provided for tmax of AZD3366 in Part B

21. Secondary Outcome Measure: AUCinf of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [ Time Frame: Pre-dose and post-dose (Day 1 to Day 3) ]

Measure Type	Secondary
Measure Name	AUCinf of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B
Measure Description	The effect of AZD3366 on the PK of ticagrelor in Part B was assessed using Area under plasma concentration-time curve from time zero extrapolated to infinity.
Time Frame	Pre-dose and post-dose (Day 1 to Day 3)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Dose X Placebo Part B	Randomized healthy subjects received Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Dose X Placebo Part B
Number of Participants Analyzed [units:participants]	12	12
AUCinf of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [units: h*mg/L] Geometric Mean (Geometric Coefficient of Variation)
Ticagrelor	5559 (19.71%)	5892 (34.74%)
AR C124910XX	2155 (25.63%)	2244 (26.45%)

No statistical analysis provided for AUCinf of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B

22. Secondary Outcome Measure: AUClast of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [ Time Frame: Pre-dose and post-dose (Day 1 to Day 3) ]

Measure Type	Secondary
Measure Name	AUClast of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B
Measure Description	The effect of AZD3366 on the PK of ticagrelor in Part B was assessed using Area under the plasma concentration-curve from time zero to time of last quantifiable concentration.
Time Frame	Pre-dose and post-dose (Day 1 to Day 3)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Dose X Placebo Part B	Randomized healthy subjects received Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Dose X Placebo Part B
Number of Participants Analyzed [units:participants]	12	12
AUClast of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [units: h*ng/mL] Geometric Mean (Geometric Coefficient of Variation)
Ticagrelor	4507 (19.77%)	4959 (33.21%)
AR C124910XX	1482 (21.82%)	1632 (24.47%)

No statistical analysis provided for AUClast of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B

23. Secondary Outcome Measure: tmax of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [ Time Frame: Pre-dose and post-dose (Day 1 to Day 3) ]

Measure Type	Secondary
Measure Name	tmax of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B
Measure Description	The effect of AZD3366 on the PK of ticagrelor in Part B was assessed using Time to reach peak or maximum observed concentration or response following drug administration.
Time Frame	Pre-dose and post-dose (Day 1 to Day 3)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Dose X Placebo Part B	Randomized healthy subjects received Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Dose X Placebo Part B
Number of Participants Analyzed [units:participants]	12	12
tmax of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [units: hours] Median (Full Range)
Ticagrelor	1.94 (0.87 to 4.00)	2.00 (1.00 to 4.00)
AR C124910XX	2.00 (1.87 to 4.00)	2.01 (1.98 to 6.00)

No statistical analysis provided for tmax of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B

24. Secondary Outcome Measure: t½λz of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [ Time Frame: Pre-dose and post-dose (Day 1 to Day 3) ]

Measure Type	Secondary
Measure Name	t½λz of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B
Measure Description	The effect of AZD3366 on the PK of ticagrelor in Part B was assessed using Half-life associated with terminal slope (λz) of a semi logarithmic concentration time curve.
Time Frame	Pre-dose and post-dose (Day 1 to Day 3)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Dose X Placebo Part B	Randomized healthy subjects received Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Dose X Placebo Part B
Number of Participants Analyzed [units:participants]	12	12
t½λz of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [units: hours] Geometric Mean (Geometric Coefficient of Variation)
Ticagrelor	4.726 (22.57%)	4.430 (17.41%)
AR C124910XX	6.432 (36.75%)	5.680 (10.87%)

No statistical analysis provided for t½λz of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B

25. Secondary Outcome Measure: AUC(0-12) of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [ Time Frame: Pre-dose and post-dose (Day 1 to Day 3) ]

Measure Type	Secondary
Measure Name	AUC(0-12) of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B
Measure Description	The effect of AZD3366 on the PK of ticagrelor in Part B was assessed using Area under the plasma concentration-time curve from time zero to 12 hours after dosing.
Time Frame	Pre-dose and post-dose (Day 1 to Day 3)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Dose X Placebo Part B	Randomized healthy subjects received Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Dose X Placebo Part B
Number of Participants Analyzed [units:participants]	12	12
AUC(0-12) of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [units: h*ng/mL] Geometric Mean (Geometric Coefficient of Variation)
Ticagrelor	4538 (19.61%)	4976 (33.09%)
AR C124910XX	1496 (21.74%)	1637 (24.48%)

No statistical analysis provided for AUC(0-12) of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B

26. Secondary Outcome Measure: Cmax of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [ Time Frame: Pre-dose and post-dose (Day 1 to Day 3) ]

Measure Type	Secondary
Measure Name	Cmax of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B
Measure Description	The effect of AZD3366 on the PK of ticagrelor in Part B was assessed using observed maximum plasma concentration
Time Frame	Pre-dose and post-dose (Day 1 to Day 3)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Dose X Placebo Part B	Randomized healthy subjects received Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Dose X Placebo Part B
Number of Participants Analyzed [units:participants]	12	12
Cmax of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [units: ng/mL] Geometric Mean (Geometric Coefficient of Variation)
Ticagrelor	999.9 (18.60%)	1168 (41.05%)
AR C124910XX	294.0 (29.23%)	314.6 (33.48%)

No statistical analysis provided for Cmax of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B

27. Secondary Outcome Measure: Observed trough plasma concentration after the first dose (Ctrough) of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [ Time Frame: Pre-dose and post-dose (Day 1 to Day 3) ]

Measure Type	Secondary
Measure Name	Observed trough plasma concentration after the first dose (Ctrough) of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B
Measure Description	The effect of AZD3366 on the PK of ticagrelor in Part B was assessed.
Time Frame	Pre-dose and post-dose (Day 1 to Day 3)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Dose X Placebo Part B	Randomized healthy subjects received Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Dose X Placebo Part B
Number of Participants Analyzed [units:participants]	12	12
Observed trough plasma concentration after the first dose (Ctrough) of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [units: ng/mL] Geometric Mean (Geometric Coefficient of Variation)
Ticagrelor	143.9 (31.38%)	140.7 (42.81%)
AR C124910XX	67.0 (26.19%)	72.22 (26.61%)

No statistical analysis provided for Observed trough plasma concentration after the first dose (Ctrough) of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B

28. Secondary Outcome Measure: Arithmetic mean of plasma concentration (C) at 12, 24, 36 and 48 hrs post-dose [Cmean (12, 24, 36, 48 hrs)] of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [ Time Frame: Pre-dose and post-dose (Day 1 to Day 3) ]

Measure Type	Secondary
Measure Name	Arithmetic mean of plasma concentration (C) at 12, 24, 36 and 48 hrs post-dose [Cmean (12, 24, 36, 48 hrs)] of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B
Measure Description	The effect of AZD3366 on the PK of ticagrelor in Part B was assessed.
Time Frame	Pre-dose and post-dose (Day 1 to Day 3)
Safety Issue?

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 PK analysis set consisted of all participants in the safety analysis set who received ticagrelor (Part B) and who had at least one post-dose plasma concentration measurement, with no important protocol deviations or no AEs thought to significantly affect the PK.

Reporting Groups

	Description
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Dose X Placebo Part B	Randomized healthy subjects received Dose X of placebo in conjunction with concomitant administration of ticagrelor and ASA.

Measured Values

	Ticagrelor + ASA + Dose X AZD3366 Part B	Ticagrelor + ASA + Dose X Placebo Part B
Number of Participants Analyzed [units:participants]	12	12
Arithmetic mean of plasma concentration (C) at 12, 24, 36 and 48 hrs post-dose [Cmean (12, 24, 36, 48 hrs)] of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B [units: ng/mL] Geometric Mean (Geometric Coefficient of Variation)
Ticagrelor	151.3 (28.80%)	155.1 (49.36%)
AR C124910XX	78.35 (18.12%)	91.25 (32.57%)

No statistical analysis provided for Arithmetic mean of plasma concentration (C) at 12, 24, 36 and 48 hrs post-dose [Cmean (12, 24, 36, 48 hrs)] of ticagrelor and ticagrelor active metabolite, AR-C124910XX in Part B

Serious Adverse Events

Time Frame	From screening (Day -21) to follow-up (Day 60 for Part A and Day 50 for Part B)
Additional Description	No text entered.

Reporting Groups

	Description
AZD3366 Dose 1 Part A	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
Pooled Placebo (Non-Asian)-Part A	Total Randomized healthy Non-Asian subjects who received placebo.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
Pooled Placebo (Japanese)-Part A	Total Randomized healthy Japanese subjects who received placebo.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.
Pooled Placebo Part A (Chinese)	Randomized healthy Chinese subjects received placebo.
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Placebo Part B	Randomized healthy subjects received placebo in conjunction with concomitant administration of ticagrelor and ASA.

Serious Adverse Events

AZD3366 Dose 1 Part A

AZD3366 Dose 2 Part A

AZD3366 Dose 3 Part A

AZD3366 Dose 4 Part A (Non-Asian)

AZD3366 Dose 5 Part A (Non-Asian)

AZD3366 Dose 6 Part A (Non-Asian)

AZD3366 Dose 7 Part A (Non-Asian)

Pooled Placebo (Non-Asian)-Part A

AZD3366 Dose 4 Part A (Japanese)

AZD3366 Dose 5 Part A (Japanese)

AZD3366 Dose 7 Part A (Japanese)

Pooled Placebo (Japanese)-Part A

AZD3366 Dose 7 Part A (Chinese)

Pooled Placebo Part A (Chinese)

Ticagrelor + ASA + Dose X AZD3366 Part B

Ticagrelor + ASA + Placebo Part B

Total, serious adverse events

# participants affected / at risk

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

Gastrointestinal disorders

Colitis¹

# participants affected / at risk

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Gastrointestinal disorders

Pancreatitis¹

# participants affected / at risk

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA version 23.1

Other Adverse Events

Time Frame	From screening (Day -21) to follow-up (Day 60 for Part A and Day 50 for Part B)
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
AZD3366 Dose 1 Part A	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
AZD3366 Dose 2 Part A	Randomized healthy Non-Asian subjects received Dose 2 of AZD3366.
AZD3366 Dose 3 Part A	Randomized healthy Non-Asian subjects received Dose 3 of AZD3366.
AZD3366 Dose 4 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 5 of AZD3366.
AZD3366 Dose 6 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 6 of AZD3366.
AZD3366 Dose 7 Part A (Non-Asian)	Randomized healthy Non-Asian subjects received Dose 1 of AZD3366.
Pooled Placebo (Non-Asian)-Part A	Total Randomized healthy Non-Asian subjects who received placebo.
AZD3366 Dose 4 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 4 of AZD3366.
AZD3366 Dose 5 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 5 of AZD3366.
AZD3366 Dose 7 Part A (Japanese)	Randomized healthy Japanese subjects received Dose 7 of AZD3366.
Pooled Placebo (Japanese)-Part A	Total Randomized healthy Japanese subjects who received placebo.
AZD3366 Dose 7 Part A (Chinese)	Randomized healthy Chinese subjects received Dose 7 of AZD3366.
Pooled Placebo Part A (Chinese)	Randomized healthy Chinese subjects received placebo.
Ticagrelor + ASA + Dose X AZD3366 Part B	Randomized healthy subjects received Dose X of AZD3366 in conjunction with concomitant administration of ticagrelor and ASA.
Ticagrelor + ASA + Placebo Part B	Randomized healthy subjects received placebo in conjunction with concomitant administration of ticagrelor and ASA.

Other Adverse Events

AZD3366 Dose 1 Part A

AZD3366 Dose 2 Part A

AZD3366 Dose 3 Part A

AZD3366 Dose 4 Part A (Non-Asian)

AZD3366 Dose 5 Part A (Non-Asian)

AZD3366 Dose 6 Part A (Non-Asian)

AZD3366 Dose 7 Part A (Non-Asian)

Pooled Placebo (Non-Asian)-Part A

AZD3366 Dose 4 Part A (Japanese)

AZD3366 Dose 5 Part A (Japanese)

AZD3366 Dose 7 Part A (Japanese)

Pooled Placebo (Japanese)-Part A

AZD3366 Dose 7 Part A (Chinese)

Pooled Placebo Part A (Chinese)

Ticagrelor + ASA + Dose X AZD3366 Part B

Ticagrelor + ASA + Placebo Part B

Total, other (not including serious) adverse events

# participants affected / at risk

1/6 (16.67%)

3/6 (50.00%)

4/6 (66.67%)

0/6 (0.00%)

5/14 (35.71%)

0/4 (0.00%)

4/4 (100.00%)

1/4 (25.00%)

1/3 (33.33%)

3/6 (50.00%)

2/2 (100.00%)

2/12 (16.67%)

7/12 (58.33%)

General disorders

Vessel puncture site haematoma¹

# participants affected / at risk

0/6 (0.00%)

2/6 (33.33%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

General disorders

Impaired healing¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

General disorders

Medical device site dermatitis¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

2/14 (14.29%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

1/12 (8.33%)

# events

General disorders

Non-cardiac chest pain¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Neck pain¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Muscle tightness¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹

# participants affected / at risk

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Gastrointestinal disorders

Constipation¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Gastrointestinal disorders

Nausea¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

1/6 (16.67%)

0/2 (0.00%)

0/12 (0.00%)

# events

Gastrointestinal disorders

Tongue haemorrhage¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Gastrointestinal disorders

Colitis¹

# participants affected / at risk

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Gastrointestinal disorders

Pancreatitis¹

# participants affected / at risk

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Nervous system disorders

Dizziness¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Nervous system disorders

Headache¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Nervous system disorders

Head discomfort¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Cardiac disorders

Palpitations¹

# participants affected / at risk

1/6 (16.67%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

1/4 (25.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Injury, poisoning and procedural complications

Contusion¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

1/6 (16.67%)

2/2 (100.00%)

0/12 (0.00%)

# events

Injury, poisoning and procedural complications

Sunburn¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Injury, poisoning and procedural complications

Alcohol poisoning¹

# participants affected / at risk

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal congestion¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Sneezing¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Throat irritation¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Skin and subcutaneous tissue disorders

Keloid scar¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Skin and subcutaneous tissue disorders

Pruritus¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Skin and subcutaneous tissue disorders

Rash¹

# participants affected / at risk

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

# events

Skin and subcutaneous tissue disorders

Skin discolouration¹

# participants affected / at risk

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Vascular disorders

Flushing¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Vascular disorders

Phlebitis¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Ear and labyrinth disorders

Ear discomfort¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Eye disorders

Ocular hyperaemia¹

# participants affected / at risk

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Psychiatric disorders

Suicidal ideation¹

# participants affected / at risk

0/6 (0.00%)

1/14 (7.14%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

General disorders

Vessel puncture site haemorrhage¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

General disorders

Chest discomfort¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

1/4 (25.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

General disorders

Vessel puncture site bruise¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

1/4 (25.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

1/12 (8.33%)

# events

General disorders

Catheter site discolouration¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

1/12 (8.33%)

# events

General disorders

Fatigue¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

1/12 (8.33%)

# events

General disorders

Injection site bruising¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

1/12 (8.33%)

# events

Gastrointestinal disorders

Abdominal pain¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

1/6 (16.67%)

0/2 (0.00%)

0/12 (0.00%)

# events

Gastrointestinal disorders

Flatulence¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

1/6 (16.67%)

0/2 (0.00%)

0/12 (0.00%)

# events

Injury, poisoning and procedural complications

Skin abrasion¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

1/4 (25.00%)

0/4 (0.00%)

0/3 (0.00%)

1/6 (16.67%)

1/2 (50.00%)

0/12 (0.00%)

# events

Injury, poisoning and procedural complications

Skin laceration¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

# events

Injury, poisoning and procedural complications

Arthropod bite¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

1/12 (8.33%)

# events

Respiratory, thoracic and mediastinal disorders

Epistaxis¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

1/2 (50.00%)

0/12 (0.00%)

# events

Gastrointestinal disorders

Abdominal distension¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

1/12 (8.33%)

# events

Skin and subcutaneous tissue disorders

Dry skin¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

2/4 (50.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Skin and subcutaneous tissue disorders

Skin lesion¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

1/4 (25.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dermatitis contact¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

1/3 (33.33%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

# events

Skin and subcutaneous tissue disorders

Skin fissures¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

1/6 (16.67%)

0/2 (0.00%)

0/12 (0.00%)

# events

Skin and subcutaneous tissue disorders

Purpura¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

1/12 (8.33%)

# events

Eye disorders

Ocular discomfort¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

1/6 (16.67%)

0/2 (0.00%)

0/12 (0.00%)

# events

Psychiatric disorders

Grief reaction¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

1/12 (8.33%)

# events

Psychiatric disorders

Insomnia¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

1/12 (8.33%)

# events

Nervous system disorders

Paraesthesia¹

# participants affected / at risk

0/6 (0.00%)

0/14 (0.00%)

0/4 (0.00%)

0/3 (0.00%)

0/6 (0.00%)

0/2 (0.00%)

0/12 (0.00%)

1/12 (8.33%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA version 23.1

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 AB. Access to this document must be restricted to relevant parties.

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
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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

David Han

PAREXEL Early Phase Clinical Unit Los Angeles 1560 Chevy Chase Drive, Suite 140 Glendale, CA 91206 United States of America

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site