Study S002398

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)

ClinicalTrials.gov record

Registration

Registration: NCT06996886
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 16
Start: 2025-05-22
Primary completion: 2025-07-15
Lead sponsor: AstraZeneca
Conditions: Healthy Participants
Interventions: DRUG:AZD5004
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

Area under concentration-time curve from time 0 to infinity (AUCinf) [Day 1-6, Day 8-13, Day 15-20 and Day 22-27]
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) [Day 1-6, Day 8-13, Day 15-20 and Day 22-27]
Maximum observed drug concentration (Cmax) [Day 1-6, Day 8-13, Day 15-20 and Day 22-27]
Time to reach maximum observed concentration (tmax) [Day 1-6, Day 8-13, Day 15-20 and Day 22-27]
Half-life (t½) [Day 1-6, Day 8-13, Day 15-20 and Day 22-27]
Apparent total body clearance (CL/F) [Day 1-6, Day 8-13, Day 15-20 and Day 22-27]

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