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

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:

• A screening period of maximum 28 days.
• Four sequential treatment periods during which the participants will receive the study interventions.
• A final follow-up visit

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:

• 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.
• 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.