Lesinurad Tablet Relative Bioavailability
Study identifier:RDEA594-129
ClinicalTrials.gov identifier:NCT01986556
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Lesinurad 400 mg (Site 1), Lesinurad 400 mg (Site 2, Lot A), Lesinurad 400 mg (Site 2, Lot B)
Sex
Male
Actual Enrollment
36
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Nov 2013
Primary Completion Date: 01 Apr 2014
Study Completion Date: 01 May 2014
Study design
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Sept 2014 by Ardea Biosciences, Inc.
Sponsors
Ardea Biosciences, Inc.
Collaborators
-
Inclusion and exclusion criteria
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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) | - |
Contacts
Investigators
Principal Investigator
J. Hall
Ardea Biosciences, Inc.
