NCT07444424

A Study to Investigate the Effect of AZD5004 on Mitiglinide and Pioglitazone in Healthy Participants

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the effect of AZD5004 on the pharmacokinetics (PK) of mitiglinide and pioglitazone in healthy participants.

Detailed description

This is an open-label, fixed-sequence, two-part study of mitiglinide (Part A) and pioglitazone (Part B) in healthy participants. Part A will assess the PK of mitiglinide when administered alone and in combination with AZD5004 while Part B will assess the PK of pioglitazone when administered alone and in combination of AZD5004. Both parts are independent and non-sequential to each other. Each study part will comprise of: 1. A screening period of maximum 28 days. 2. Four sequential treatment periods during which the participants will receive the study interventions. 3. A final follow-up visit

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD5004	AZD5004 will be administered orally.
DRUG	Mitiglinide	Mitiglinide will be administered orally.
DRUG	Pioglitazone	Pioglitazone will be administered orally.

Timeline

• Start date: 2026-03-13
• Primary completion: 2026-07-02
• Completion: 2026-07-02
• First posted: 2026-03-02
• Last updated: 2026-03-30

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study