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

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

Clinical Study Information Center

AstraZeneca

One Medimmune Way, Gaithersburg, Maryland, 20878, USA

information.center@astrazeneca.com

Rosario Chikako

Parexel International Inc.

Kayabacho Tower, 1-21-2, Shinkawa, Chuo-ku, Tokyo, 104-0033

+81-80-8929-3137

Clinicaltrial-registration@parexel.com

Not Recruiting

Mar. 13, 2026

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

- 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/m^2 and weigh at least 50 kg.

- 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.

Both

Healthy participants

Part A: Mitiglinide + AZD5004
Part B: Pioglitazone + AZD5004

- AZD5004 will be administered orally.
- Mitiglinide will be administered orally.
- Pioglitazone will be administered orally.

- Area under concentration-time curve from time 0 to infinity (AUCinf)
- Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
- Maximum observed drug concentration (Cmax)

- Number of participants with adverse events (AEs) and AE of special interest (AESI)
- Terminal elimination half-life (t1/2(lambda)z)
- Terminal rate constant ((lambda)z)
- Time to reach maximum observed concentration (tmax)
- Part A: Ratio of mitiglinide + AZD5004to mitiglinide (alone) based on AUCinf (RAUCinf)
- Part A: Ratio of mitiglinide + AZD5004to mitiglinide (alone) based on AUClast (RAUClast)
- Part A: Ratio of mitiglinide + AZD5004to mitiglinide (alone) based on Cmax (RCmax)
- Part B: Ratio of pioglitazone +AZD5004 to pioglitazone (alone) based on AUCinf (RAUCinf)
- Part B: Ratio of pioglitazone +AZD5004 to pioglitazone (alone) based on AUClast (RAUClast)
- Part B: Ratio of pioglitazone +AZD5004 to pioglitazone (alone) based on Cmax (RCmax)

+81-92-283-7701

Feb. 27, 2026

Yes

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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