Single and Multiple Dose Study in Japanese Subjects
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 RDEA3170 in healthy Japanese males to allow comparison with the Western population.
Key facts
- Study ID
- NCT01872832
- Run by
- Ardea Biosciences, Inc.
- People needed
- 46
- Starts
- 2013-06-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2014-01-09
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 and the risks involved, and willing to provide written informed consent before the first study related activity.
- Healthy adult male subject born in Japan.
- Subject has parents and grandparents who are Japanese.
- Subject is in possession of a valid Japanese passport.
- All laboratory parameters should be within normal limits or considered not clinically significant by the investigator.
- Screening serum urate level ≥ 4.5 mg/dL.
- Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
- Subject has a normal or clinically acceptable physical examination.
- Subject has no clinically relevant abnormalities in blood pressure, heart rate, and body temperature, per the Investigator's judgment.
You may not qualify if…
- Positive serology to human immunodeficiency virus (HIV-1 or HIV-2).
- Positive test for active hepatitis B or hepatitis C infection.
- History or suspicion of kidney stones.
- Undergone major surgery within 3 months prior to Day 1.
- Exposed to an investigational drug (or a medical device) within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to Day 1 or is currently participating in another study of an investigational drug (or medical device).
- Prior exposure to RDEA3170.
Where it is running
- Study site — Glendale, California, United States
Full record on ClinicalTrials.gov
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