Study identifier:D7260C00008
ClinicalTrials.gov identifier:NCT07455825
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy Participants
Phase 1
Yes
AZD5004
All
64
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2026 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort A: Treatment Sequence ABC Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen B (formulation 5, fasted state), followed by Regimen C (formulation 5, fed state) of AZD5004. | Drug: AZD5004 AZD5004 will be administered orally. |
| Experimental: Cohort A: Treatment Sequence ACB Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen C (formulation 5, fed state), followed by Regimen B (formulation 5, fasted state) of AZD5004. | Drug: AZD5004 AZD5004 will be administered orally. |
| Experimental: Cohort B: Treatment Sequence ADE Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen D (formulation 6, fasted state), followed by Regimen E (formulation 6, fed state). | Drug: AZD5004 AZD5004 will be administered orally. |
| Experimental: Cohort B: Treatment Sequence AED Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen E (formulation 6, fed state), followed by Regimen D (formulation 6, fasted state). | Drug: AZD5004 AZD5004 will be administered orally. |