Study identifier:D7260C00012
ClinicalTrials.gov identifier:NCT06996886
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Healthy Participants
Phase 1
Yes
AZD5004
All
16
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2025 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Treatment Sequence A Participants will receive single dose of AZD5004 on Day 1 in F1 (fasted) (Treatment period 1), on Day 8 in F4 (fasted) (Treatment period 2), on Day 15 in F4(fed) (Treatment Period 3) followed by on Day 22 in F3 (fasted) (Treatment Period 4) respectively. | Drug: AZD5004 Participants will be receiving three different formulations (F1, F3, and F4) as single dose of AZD5004 orally in fasted and fed state. |
Experimental: Treatment Sequence B Partcipants will receive single dose of AZD5004 on Day 1 in F4 (fasted) (Treatment Period 1), on Day 8 in F4 (fed) (Treatment Period 2), on Day 15 in F3 (fasted) (Treatment Period 3) followed by on Day 22 in F1 (fasted) (Treatment Period 4) respectively. | Drug: AZD5004 Participants will be receiving three different formulations (F1, F3, and F4) as single dose of AZD5004 orally in fasted and fed state. |
Experimental: Treatment Sequence C Participants will receive single dose of AZD5004 on Day 1 in F4 (fed) (Treatment Period 1), on Day 8 in F3 (fasted) (Treatment Period 2, on Day 15 in F1 (fasted) (Treatment Period 3 followed by on Day 22 in F4 (fasted) (Treatment Period 4) respectively. | Drug: AZD5004 Participants will be receiving three different formulations (F1, F3, and F4) as single dose of AZD5004 orally in fasted and fed state. |
Experimental: Treatment Sequence D Participants will receive single dose of AZD5004 on Day 1 in F3 (fasted) (Treatment Period 1), Day 8 in F1 (fasted) (Treatment Period 2), on Day 15 in F4 (fasted) (Treatment Period 3) followed by Day 22 in F4 (fed) (Treatment Period 4) respectively. | Drug: AZD5004 Participants will be receiving three different formulations (F1, F3, and F4) as single dose of AZD5004 orally in fasted and fed state. |