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

The purpose of the study is to assess the effect of AZD5004 on the pharmacokinetics (PK) of 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:

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

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.