Single and Multiple Dose Study in Japanese

NCT ID: NCT01744379

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-05-31

Brief 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.

Detailed Description

While there is extensive clinical experience with lesinurad in the Western population, it is recognized that both intrinsic and extrinsic factors may impact the PK, PD, safety, and dose response in different ethnic populations. The purpose of this study is to explore the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of single and multiple doses of lesinurad in healthy Japanese males, and to allow comparison of these parameters with the Western population.

Conditions

Gout

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

200 mg lesinurad

200 mg lesinurad or placebo fasted and fed

Group Type: EXPERIMENTAL

Lesinurad

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

400 mg lesinurad

400 mg lesinurad or placebo fasted and fed

Group Type: EXPERIMENTAL

Lesinurad

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

100 mg lesinurad

100 mg lesinurad or placebo fasted and fed

Group Type: EXPERIMENTAL

Lesinurad

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

50 mg lesinurad

50 mg lesinurad or placebo fasted and fed

Group Type: EXPERIMENTAL

Lesinurad

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

600 mg lesinurad

600 mg lesinurad or placebo fasted and fed

Group Type: EXPERIMENTAL

Lesinurad

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Lesinurad

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ardea Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

S Bradley, MD

Role: STUDY_DIRECTOR

Ardea Biosciences, Inc.

Locations

Glendale, California, United States

Countries

United States

Other Identifiers

RDEA594-125

Identifier Type: -

Identifier Source: org_study_id