NCT06996886

A Study in Healthy Participants to Investigate Relative Bioavailability of AZD5004 in Three Solid Oral Formulations

An Open-Label, Randomized, Four-Treatment, Four-Period, Single-Dose Crossover Study in Healthy Participants to Assess the Relative Bioavailability of AZD5004 in Three Solid Oral Formulations (F1, F3, F4)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the relative bioavailability of a single dose AZD5004 in healthy participants, among 3 different oral tablet formulations.

Detailed description

This study will be an open-label, randomized, 4-period, 4-treatment, single-dose crossover study in healthy participants. Participants will receive one single dose of AZD5004 at the beginning of each of the four Treatment Periods, and a total of 4 doses of AZD5004. Three different formulations (F1, F3, and F4) will be used across the Treatment Periods. The study comprises of total four treatment periods. * A Screening Period of maximum 27 days. Four Treatment Periods of 7 days each. * Treatment Period 1 (Day -1 to Day 6) * Treatment Period 2 (Day 7 to Day 13) * Treatment Period 3 (Day 14 to Day 20) * Treatment Period 4 (Day 21 to Day 27) * A final Follow-up Visit within 7 to 10 days after the last study intervention administration (Day 22 of Treatment Period 4). The treatments are as follows: * Treatment 1: Single dose of AZD5004 in Formulation 1 (F1) -fasted * Treatment 2: Single dose of AZD5004 in Formulation 4 (F4) -fasted * Treatment 3: Single dose of AZD5004 in F4- fed * Treatment 4: Single dose of AZD5004 in Formulation 3 (F3) - fasted Participants will be randomized equally to one of the following treatment sequences: * Treatment Sequence A: F1, F4, F4 (fed), F3 * Treatment Sequence B: F4, F4 (fed), F3, F1 * Treatment Sequence C: F4 (fed), F3, F1, F4 * Treatment Sequence D: F3, F1, F4, F4 (fed)

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD5004	Participants will be receiving three different formulations (F1, F3, and F4) as single dose of AZD5004 orally in fasted and fed state.

Timeline

• Start date: 2025-05-22
• Primary completion: 2025-07-15
• Completion: 2025-07-25
• First posted: 2025-05-30
• Last updated: 2025-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study