Study identifier:RDEA594-129
ClinicalTrials.gov identifier:NCT01986556
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Lesinurad Tablets Manufactured at Two Different Sites
Healthy
Phase 1
Yes
Lesinurad 400 mg (Site 1), Lesinurad 400 mg (Site 1), Lesinurad 400 mg (Site 1), Lesinurad 400 mg (Site 1), Lesinurad 400 mg (Site 2, Lot A), Lesinurad 400 mg (Site 2, Lot A), Lesinurad 400 mg (Site 2, Lot B), Lesinurad 400 mg (Site 2, Lot B)
Male
36
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Sept 2014 by Ardea Biosciences, Inc.
Ardea Biosciences, Inc.
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot A) Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A) | - |
Experimental: Lesinurad 400 mg Fed (Site 1 and Site 2, Lot A) Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A) | - |
Experimental: Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot B) Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B) | - |
Experimental: Lesinurad 400 mg Fed (Site 1 and Site 2, Lot B) Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B) | - |