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A Study to Investigate the Effect of AZD5004 on Mitiglinide and Pioglitazone in Healthy Participants | Clinical Trials | Clareo Health

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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

NCT07444424•AstraZeneca

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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:
•1. Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal (GI) tract
•2. Cardiovascular disease
•3. Neuromuscular or neurogenic disease
•4. 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.
+7 more criteria

Locations (1)

Research Site

Fukuoka, Japan

Key Dates

Start Date

March 13, 2026

Primary Completion Date

July 2, 2026

Completion Date

July 2, 2026

Last Updated

March 2, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy Participants

Interventions

AZD5004

DRUG

Mitiglinide

DRUG

Pioglitazone

DRUG

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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