NCT07455825

A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years

A Phase I, Randomized, Single-dose, 3-Period, Open-Label Study to Assess the Pharmacokinetic Formulation Bridging, Safety, and Food Effect of Different Oral Formulations of AZD5004 in Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the pharmacokinetics (PK), safety and tolerability of different oral formulations of AZD5004, and to evaluate the effect of food on these formulations in healthy participants.

Detailed description

This is a Phase I, randomized, single-dose, 2 part, 3-period, open-label study. There will be 2 Parts (Part A and Part B). In each part, participants will be randomized to a treatment sequence in each cohort. In Period 1, participants in Part A and Part B will receive Regimen A (AZD5004 Formulation 1 \[reference\]). In Periods 2 and 3, participants in Part A will receive Regimen B or Regimen C (AZD5004 Formulation 5) and participants in Part B will receive Regimen D or Regimen E per assigned treatment sequence. The study will comprise: * A Screening Period of maximum 28 days * 3 Treatment Periods during which participants will be resident at the Clinical Unit * A final Follow-up Visit within 3 to 7 days after being discharged.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD5004	AZD5004 will be administered orally.

Timeline

• Start date: 2026-03-05
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2026-03-06
• Last updated: 2026-03-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study