A study to investigate the effect of AZD5004 on mitiglinide and pioglitazone in healthy participants

Study identifier:D7260C00024

ClinicalTrials.gov identifier:NCT07444424

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

An Open-label, Fixed-sequence, Two-part Study to Assess the Effect of AZD5004 on the Pharmacokinetics of Mitiglinide and Pioglitazone in Healthy Participants

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5004, Mitiglinide, Pioglitazone

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 13 Mar 2026

Estimated Primary Completion Date: 02 Jul 2026

Estimated Study Completion Date: 02 Jul 2026

Study design

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

Verification:

Verified 01 Feb 2026 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

Inclusion Criteria:
- Participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative serum pregnancy test at the Screening Visit and on admission to the study site.
- Females of childbearing potential must agree to use a highly effective contraception method from enrollment.
- Male Participants, if heterosexually active, must practice true abstinence or use condoms during the trial and their female partners of childbearing potential must use additional effective contraception during the trial.
- Body Mass Index (BMI) between 18 and 35 kg/m² and weigh at least 50 kg.
Exclusion Criteria:
- History of any clinically important disease or disorder which may put the participant at risk or influence the results, including:
a. Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal (GI) tract
b. Cardiovascular disease
c. Neuromuscular or neurogenic disease
d. Type 1 or type 2 diabetes mellitus
- History of acute pancreatitis, chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.
- History of clinically significant cardiovascular, dermatological, respiratory, neurological, psychiatric or GI disease disorder.
- History of malignant neoplastic disease.
- History or presence of GI disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma.
- Any clinically important abnormalities in clinical chemistry, hematology, coagulation, or urinalysis results.
- Basal calcitonin level ≥ 35 ng/L or history/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2).
- Uncontrolled thyroid disease.
- Any positive result on screening for serum human immunodeficiency virus (HIV).
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to AZD5004, or to mitiglinide and/or pioglitazone.
- Participants who have previously received AZD5004.

No locations available

Arms	Assigned Interventions
Experimental: Part A: Mitiglinide + AZD5004 In Period 1, participants receive a single dose of mitiglinide on Day 1, followed by single doses of AZD5004 Dose A once daily from Days 3-9, then single doses of AZD5004 Dose B once daily from Days 10-16. In Period 2, participants receive single dose of mitiglinide co-administered with single dose of AZD5004 Dose B on Day 17, followed by a single dose of AZD5004 Dose B on Day 18, then single doses of AZD5004 Dose C once daily from Days 19-25, followed by single doses of AZD5004 Dose D once daily from Days 26-32. In Period 3, participants receive single dose of mitiglinide co-administered with single dose of AZD5004 Dose D on Day 33, followed by a single dose of AZD5004 Dose D on Day 34, then single doses of AZD5004 Dose E once daily from Days 35-41. In Period 4, participants receive single dose of mitiglinide co-administered with single dose of AZD5004 Dose E on Day 42, followed by a single dose of AZD5004 Dose E on Day 43.	Drug: AZD5004 AZD5004 will be administered orally. Drug: Mitiglinide Mitiglinide will be administered orally.
Experimental: Part B: Pioglitazone + AZD5004 In Period 1, participants receive a single dose of pioglitazone on Day 1, followed by single doses of AZD5004 Dose A once daily from Days 8-14, then single doses of AZD5004 Dose B once daily from Days 15-21. In Period 2, participants receive single dose of pioglitazone co-administered with single dose of AZD5004 Dose B on Day 22, followed by single doses of AZD5004 Dose B once daily from Days 23-28, then single doses of AZD5004 Dose C once daily from Days 29-35, followed by single doses of AZD5004 Dose D once daily from Days 36-42. In Period 3, participants receive single dose of pioglitazone co-administered with single dose of AZD5004 Dose D on Day 43, followed by single doses of AZD5004 Dose D once daily from Days 44-49, then single doses of AZD5004 Dose E once daily from Days 50-56. In Period 4, participants receive single dose of pioglitazone co-administered with single dose of AZD5004 Dose E on Day 57, followed by single doses of AZD5004 Dose E once daily from Days 58-63.	Drug: AZD5004 AZD5004 will be administered orally. Drug: Pioglitazone Pioglitazone will be administered orally.

Arms

Assigned Interventions

Experimental: Part A: Mitiglinide + AZD5004
In Period 1, participants receive a single dose of mitiglinide on Day 1, followed by single doses of AZD5004 Dose A once daily from Days 3-9, then single doses of AZD5004 Dose B once daily from Days 10-16. In Period 2, participants receive single dose of mitiglinide co-administered with single dose of AZD5004 Dose B on Day 17, followed by a single dose of AZD5004 Dose B on Day 18, then single doses of AZD5004 Dose C once daily from Days 19-25, followed by single doses of AZD5004 Dose D once daily from Days 26-32. In Period 3, participants receive single dose of mitiglinide co-administered with single dose of AZD5004 Dose D on Day 33, followed by a single dose of AZD5004 Dose D on Day 34, then single doses of AZD5004 Dose E once daily from Days 35-41. In Period 4, participants receive single dose of mitiglinide co-administered with single dose of AZD5004 Dose E on Day 42, followed by a single dose of AZD5004 Dose E on Day 43.

Drug: AZD5004
AZD5004 will be administered orally.

Drug: Mitiglinide
Mitiglinide will be administered orally.

Experimental: Part B: Pioglitazone + AZD5004
In Period 1, participants receive a single dose of pioglitazone on Day 1, followed by single doses of AZD5004 Dose A once daily from Days 8-14, then single doses of AZD5004 Dose B once daily from Days 15-21. In Period 2, participants receive single dose of pioglitazone co-administered with single dose of AZD5004 Dose B on Day 22, followed by single doses of AZD5004 Dose B once daily from Days 23-28, then single doses of AZD5004 Dose C once daily from Days 29-35, followed by single doses of AZD5004 Dose D once daily from Days 36-42. In Period 3, participants receive single dose of pioglitazone co-administered with single dose of AZD5004 Dose D on Day 43, followed by single doses of AZD5004 Dose D once daily from Days 44-49, then single doses of AZD5004 Dose E once daily from Days 50-56. In Period 4, participants receive single dose of pioglitazone co-administered with single dose of AZD5004 Dose E on Day 57, followed by single doses of AZD5004 Dose E once daily from Days 58-63.

Drug: AZD5004
AZD5004 will be administered orally.

Drug: Pioglitazone
Pioglitazone will be administered orally.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]