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

NCT07444424

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Healthy Participants

Interventions: AZD5004, Mitiglinide, Pioglitazone

Countries: Japan

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

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • Fukuoka, Japan