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

NCT07444424 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: D7260C00024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

Pharmacokinetics; Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (3)

• Area under concentration-time curve from time 0 to infinity (AUCinf)

  To assess the effect of AZD5004 on the PK (AUCinf) of mitiglinide and pioglitazone in healthy participants

  Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70

• Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

  To assess the effect of AZD5004 on the PK (AUClast) of mitiglinide and pioglitazone in healthy participants

  Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70

• Maximum observed drug concentration (Cmax)

  To assess the effect of AZD5004 on the PK (Cmax) of mitiglinide and pioglitazone in healthy participants

  Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70

Secondary Outcomes (10)

• Number of participants with adverse events (AEs) and AE of special interest (AESI)

  Part A: Up to follow-up visit [Day 54 (± 3 days)]; Part B: Up to follow-up visit [Day 74 (± 3 days)]

• Terminal elimination half-life (t½λz)

  Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70

• Terminal rate constant (λz)

  Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70

• Time to reach maximum observed concentration (tmax)

  Part A: From Day 1 to Day 50; Part B: From Day 1 to Day 70

• Part A: Ratio of mitiglinide + AZD5004 to mitiglinide (alone) based on AUCinf (RAUCinf)

  From Day 1 to Day 50

Study Arms (2)

Part A: Mitiglinide + AZD5004

EXPERIMENTAL

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; Drug: Mitiglinide

Part B: Pioglitazone + AZD5004

EXPERIMENTAL

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; Drug: Pioglitazone

Interventions

AZD5004 DRUG

AZD5004 will be administered orally.

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

Mitiglinide DRUG

Mitiglinide will be administered orally.

Part A: Mitiglinide + AZD5004

Pioglitazone DRUG

Pioglitazone will be administered orally.

Part B: Pioglitazone + AZD5004

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• History of any clinically important disease or disorder which may put the participant at risk or influence the results, including:
• Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal (GI) tract
• Cardiovascular disease
• Neuromuscular or neurogenic disease
• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Fukuoka, 813-0017, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

mitiglinide; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 2, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): July 2, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

JP (1)