Study identifier:RDEA594-125
ClinicalTrials.gov identifier:NCT01744379
EudraCT identifier:N/A
CTIS identifier:N/A
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
Gout
Phase 1
Yes
Lesinurad, Placebo
Male
40
Interventional
20 Years - 55 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jun 2013 by Ardea Biosciences, Inc.
Ardea Biosciences, Inc.
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This study will explore the safety, tolerability, and serum uric acid lowering effect of lesinurad in healthy Japanese males to allow comparison with the Western population.
While there is extensive clinical experience with lesinurad in the Western population, it is recognized that both intrinsic and extrinsic factors may impact the PK, PD, safety, and dose response in different ethnic populations. The purpose of this study is to explore the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of single and multiple doses of lesinurad in healthy Japanese males, and to allow comparison of these parameters with the Western population.
Location
Location
Glendale, CA, United States, 91206
Arms | Assigned Interventions |
---|---|
Experimental: 200 mg lesinurad 200 mg lesinurad or placebo fasted and fed | - |
Experimental: 400 mg lesinurad 400 mg lesinurad or placebo fasted and fed | - |
Experimental: 100 mg lesinurad 100 mg lesinurad or placebo fasted and fed | - |
Experimental: 50 mg lesinurad 50 mg lesinurad or placebo fasted and fed | - |
Experimental: 600 mg lesinurad 600 mg lesinurad or placebo fasted and fed | - |
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