Single and Multiple Dose Study in Japanese

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ardea Biosciences, Inc.
• Treatments: Lesinurad

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.