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.
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Locations near you
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Full eligibility criteria for NCT01744379
Ages eligible for Study
20 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
Able to understand the study procedures, the risks involved and willing to provide written Informed Consent before the first study related activity.
Healthy adult subjects born in Japan
All laboratory parameters should be within normal limits or considered not clinically significant by the investigator.
Screening serum uric acid level >= 4.5 mg/dL.
Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
Subject does not have clinically relevant abnormalities in blood pressure, heart rate, body temperature, and respiratory rate, as per the Investigator's judgment.
Positive serology to Human Immunodeficiency Virus (HIV-1 and HIV-2).
Positive test for active Hepatitis B or Hepatitis C infection.
History of kidney stones.
Undergone major surgery within 3 months of Day 1.
Subject has received the last dose of an investigational drug (or treatment with a medical device) within 30 days or 5 half-lives (whichever is longer) of the investigational drug prior to Day 1 or are currently participating in another study of an investigational drug (or medical device).
Prior exposure to lesinurad (RDEA594) or RDEA806.
All locations for NCT01744379
United States (1)
Glendale, California, United States, 91206
View full eligibility
Tris trial is registered with FDA with number: NCT01744379. The sponsor of the trial is Ardea Biosciences, Inc. and it is looking for 40 volunteers for the current phase.
Official trial 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
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