Single and Multiple Dose Study in Japanese Subjects

NCT ID: NCT01872832

Last Updated: 2014-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-11-30

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 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 RDEA3170 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: SINGLE

Study Groups

5 mg RDEA3170

RDEA3170 5 mg or placebo fasted and fed

Group Type: EXPERIMENTAL

RDEA3170 and Placebo

Intervention Type: DRUG

10 mg RDEA3170

RDEA3170 10 mg or placebo fasted and fed

Group Type: EXPERIMENTAL

RDEA3170 and Placebo

Intervention Type: DRUG

15 mg RDEA3170

RDEA3170 15 mg or placebo fasted and fed

Group Type: EXPERIMENTAL

RDEA3170 and Placebo

Intervention Type: DRUG

2.5 mg RDEA3170

RDEA3170 2.5 mg or placebo fasted and fed

Group Type: EXPERIMENTAL

RDEA3170 and Placebo

Intervention Type: DRUG

Interventions

RDEA3170 and Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• 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 Baumgartner, MD

Role: STUDY_DIRECTOR

Ardea Biosciences, Inc.

Locations

Glendale, California, United States

Countries

United States

Other Identifiers

RDEA3170-104

Identifier Type: -

Identifier Source: org_study_id