Single and Multiple Dose Study in Japanese

Study identifier:RDEA594-125

ClinicalTrials.gov identifier:NCT01744379

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of Lesinurad in Healthy Male Japanese Subjects

Medical condition

Gout

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Lesinurad, Placebo

Sex

Male

Actual Enrollment

40

Study type

Interventional

Age

20 Years - 55 Years

Date

Study Start Date: 01 Dec 2012
Primary Completion Date: 01 Mar 2013
Study Completion Date: 01 May 2013

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2013 by Ardea Biosciences, Inc.

Sponsors

Ardea Biosciences, Inc.

Collaborators

-

Inclusion and exclusion criteria