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

NCT ID: NCT06555822

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-03-06

Brief Summary

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.

Detailed 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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Participants will receive repeated dosing of AZD5004 orally.

Group Type: EXPERIMENTAL

AZD5004

Intervention Type: DRUG

Participants will receive oral tablets of AZD5004 in Part A and Part B of the study as per arms they are assigned.

Part A: Placebo

Participants will receive matching Placebo orally.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered as an oral tablet once daily.

Part B: Treatment 1 (AZD5004)

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.

Group Type: EXPERIMENTAL

AZD5004

Intervention Type: DRUG

Participants will receive oral tablets of AZD5004 in Part A and Part B of the study as per arms they are assigned.

Part B: Treatment 2 (AZD5004)

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.

Group Type: EXPERIMENTAL

AZD5004

Intervention Type: DRUG

Participants will receive oral tablets of AZD5004 in Part A and Part B of the study as per arms they are assigned.

Interventions

AZD5004

Participants will receive oral tablets of AZD5004 in Part A and Part B of the study as per arms they are assigned.

Intervention Type: DRUG

Placebo

Placebo will be administered as an oral tablet once daily.

Intervention Type: DRUG

Other Intervention Names

ECC5004

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Brooklyn, Maryland, United States

Countries

United States

Other Identifiers

D7260C00004

Identifier Type: -

Identifier Source: org_study_id