NSAID Drug Interaction Study
Study identifier:RDEA594-126
ClinicalTrials.gov identifier:NCT01884272
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1 Study to Evaluate the Potential Two-Way Pharmacokinetic Interaction Between Lesinurad and Naproxen and Between Lesinurad and Indomethacin in Healthy Adult Male Subjects
Medical condition
Gout
Phase
Phase 1
Healthy volunteers
Yes
Study drug
lesinurad 400 mg, naproxen 250 mg, indomethacin 25 mg
Sex
Male
Actual Enrollment
24
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jun 2013
Primary Completion Date: 01 Aug 2013
Study Completion Date: 01 Oct 2013
Study design
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by Ardea Biosciences, Inc.
Sponsors
Ardea Biosciences, Inc.
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lesinurad 400 mg and naproxen 250 mg Lesinurad once daily (qd) Day 1, naproxen twice daily (bid) Day 2-6, lesinurad qd with naproxen bid Day 7-14. | - |
| Active Comparator: Lesinurad 400 mg and indomethacin 25 mg Lesinurad qd Day 1, indomethacin bid Day 2-6, lesinurad qd with indomethacin bid Day 7-14. | - |
Contacts
Investigators
Principal Investigator
S Bradley
Ardea Biosciences, Inc.
