Single and Multiple Dose Study in Japanese Subjects

Phase 1

Completed

• Conditions: Gout
• Interventions: Drug: RDEA3170 and Placebo

• Registration Number: NCT01872832
• Lead Sponsor: Ardea Biosciences, Inc.

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-07
• Primary Completion: 2013-09
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 mg RDEA3170	RDEA3170 and Placebo	RDEA3170 15 mg or placebo fasted and fed
5 mg RDEA3170	RDEA3170 and Placebo	RDEA3170 5 mg or placebo fasted and fed
2.5 mg RDEA3170	RDEA3170 and Placebo	RDEA3170 2.5 mg or placebo fasted and fed
10 mg RDEA3170	RDEA3170 and Placebo	RDEA3170 10 mg or placebo fasted and fed

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters	5 to 6 weeks
PD profile of RDEA3170 from serum and urine	Day 1 through 15	Profile in terms of sUA concentration; CLr; urine uric acid excretion amount; fractional excretion of uric acid; sUA: serume urate; CLr: renal clearance
PK profile of RDEA3170 from plasma and urine	Day 1 through 15	Profile in terms of AUC, Tmax, Cmax, and t1/2; AUC: area under the plasma concentration versus time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life