Study identifier:RDEA594-501
ClinicalTrials.gov identifier:NCT02581553
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Relative Bioavailability of Lesinurad/Allopurinol Fixed Dose Combination Tablets and Coadministered Lesinurad and Allopurinol Tablets and the Effect of Food on the Pharmacokinetics of Lesinurad/Allopurinol Fixed Dose Combination Tablets in Healthy Adult Male Subjects
Healthy
Phase 1
Yes
lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, allopurinol 300 mg, lesinurad/allopurinol 200/200 FDC tablets, allopurinol 200 mg
Male
116
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Bio-availability
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jun 2017 by Ardea Biosciences, Inc.
Ardea Biosciences, Inc.
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Sequence AB Day 1: lesinurad/allopurinol FDC tablets (Treatment A); Day 8: lesinurad + allopurinol (Treatment B) | - |
Experimental: Sequence BA Day 1: lesinurad + allopurinol (Treatment B); Day 8: lesinurad/allopurinol FDC tablets (Treatment A). | - |
Experimental: Sequence CD Day 1: lesinurad/allopurinol FDC tablets (Treatment C [fasted]); Day 8: lesinurad/allopurinol FDC tablets (Treatment D [fed]). | - |
Experimental: Sequence DC Day 1: lesinurad/allopurinol FDC tablets (Treatment D [fed]); Day 8: lesinurad/allopurinol FDC tablets (Treatment C [fasted]). | - |
Experimental: Sequence EF Day 1: lesinurad/allopurinol 200/200 FDC tablets (Treatment E); Day 8: coadministered lesinurad 200 mg + allopurinol 200 mg (100 mg × 2) | - |
Experimental: Sequence FE Day 1: coadministered lesinurad 200 mg + allopurinol 200 mg (100 mg × 2) (Treatment F); Day 8: lesinurad/allopurinol 200/200 FDC tablets (Treatment E). | - |