Status:
COMPLETED
Single and Multiple Dose Study in Japanese Subjects
Lead Sponsor:
Ardea Biosciences, Inc.
Conditions:
Gout
Eligibility:
MALE
20-55 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
While clinical studies of RDEA3170 to date have been limited to a Western population, it is recognized that both intrinsic and extrinsic factors may impact the PK, PD, safety, and dose response in dif...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01872832
Start Date
June 1 2013
End Date
November 1 2013
Last Update
January 9 2014
Active Locations (1)
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1
Glendale, California, United States, 91206