Single and Multiple Dose Study in Japanese
Completed · Phase 1 · Has a placebo group
Conditions studied: Gout
In brief
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.
Key facts
- Study ID
- NCT01744379
- Run by
- Ardea Biosciences, Inc.
- People needed
- 40
- Starts
- 2012-12-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2013-06-19
Who can join
Age: 20 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Glendale, California, United States
Full record on ClinicalTrials.gov
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