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Active (not recruiting) Phase 1 NCT07444424

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

Phase 1 – testing safety in a small group of people
Conditions: Healthy Participants

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
The purpose of the study is to assess the effect of AZD5004 on the pharmacokinetics (PK) of mitiglinide and pioglitazone in healthy participants.
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
Who can participate
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. * 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.
Interventions
AZD5004
DRUG
Mitiglinide
DRUG
Pioglitazone
DRUG
Locations 1
Japan (1)
Research Site
Fukuoka
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
No
Start date
13.03.2026
Completion date
02.07.2026
Registry ID
NCT07444424
Source
clinicaltrials.gov
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