A Study to Investigate Multiple Ascending Doses and Relative Bioavailability of AZD5004 in Healthy Participants

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: AZD5004

Study type: Interventional

Funder types: Industry

Identifiers

NCT06555822

D7260C00004

Details and patient eligibility

About

The main purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of AZD5004 administered as multiple oral doses in healthy participants and to compare the relative bioavailability of two oral tablet strengths of AZD5004.

Full description

This study comprises of 2 parts - Part A and Part B.

Part A is a placebo-controlled study to assess the safety, efficacy, tolerability, and PK of repeated dosing of AZD5004 compared with placebo.

Participants who are eligible according to the inclusion/exclusion criteria will be randomized to receive AZD5004 or matching placebo.

Part A will comprise:

1. A Screening Period of maximum 28 days.
2. A Treatment Period of 106 days.
3. A final Follow-up Visit approximately 14 days after the last study intervention administration.

Part B is a two-way cross-over study to compare the relative bioavailability of 2 oral tablet strengths of Formulation 1 (F1) of AZD5004.

The purpose of this study is to expand product knowledge between the 2 oral tablet strengths on plasma exposure levels to guide Phase 3 drug product development. The participants will be split into 2 groups. Group 1 will be dosed with Treatment 1 of AZD5004 and then dosed with Treatment 2 of AZD5004. Group 2 will be dosed with Treatment 2 of AZD5004 and then dosed with Treatment 1 of AZD5004.

Part B of the study will comprise:

1. A Screening Period of maximum 28 days.
2. Two Treatment Periods, each consisting of 7 days.
3. A final Follow-up Visit approximately 6 days after the last dose of study intervention administration.

Enrollment: 31 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must have suitable veins for cannulation or repeated venipuncture.
• Female(s) of Childbearing Potential must use adequate contraception (oral contraceptives are not permitted).
• Have a BMI ≥ 23 kg/m2 and not exceeding 35 kg/m2 inclusive and weigh at least 60 kg.
• No or off statin treatment for ≥ 4 weeks prior to the study treatment.

Exclusion criteria

• History of any clinically important disease or disorder.
• History of acute pancreatitis, chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.
• History or presence of gastrointestinal, hepatic, or renal disease.
• Clinically significant hepatic disease, inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gastrointestinal tract.
• Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
• Any clinically important abnormalities in rhythm, blood pressure, heart rate, conduction or morphology of the resting electrocardiogram (ECG).
• Uncontrolled thyroid disease, defined as thyroid-stimulating hormone > 6.0 mIU/L or < 0.4 mIU/L at Screening.
• Current smokers or known history of alcohol or drug abuse.
• History of severe allergy/hypersensitivity or excessive intake of caffeine-containing drinks or food.
• Use of any prescribed or nonprescribed medication including antacids or analgesics.
• Participants who are on or are planning to undertake a weight loss program.
• History of psychosis, major depressive disorder, suicide attempt or suicidal ideation within the past year.
• Lactating, breastfeeding, or pregnant females or females who intend to become pregnant.
• Participants who are vegans or have medical dietary restrictions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 4 patient groups, including a placebo group

Part A: Multiple Ascending dose (MAD) (AZD5004)

Experimental group

Description:

Participants will receive repeated dosing of AZD5004 orally.

Treatment:

Drug: AZD5004

Part A: Placebo

Placebo Comparator group

Description:

Participants will receive matching Placebo orally.

Treatment:

Drug: Placebo

Part B: Treatment 1 (AZD5004)

Experimental group

Description:

Participants in Group 1 will receive Treatment 1 of AZD5004 and then Treatment 2 of AZD5004. Participants in Group 2 will receive Treatment 2 of AZD5004 and then Treatment 1 of AZD5004.

Treatment:

Drug: AZD5004

Part B: Treatment 2 (AZD5004)

Experimental group

Description:

Participants in Group 1 will receive Treatment 1 of AZD5004 and then Treatment 2 of AZD5004. Participants in Group 2 will receive Treatment 2 of AZD5004 and then Treatment 1 of AZD5004.

Treatment:

Drug: AZD5004