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