Single and Multiple Dose Study in Japanese

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of Lesinurad in Healthy Male Japanese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: Placebo; Drug: Lesinurad

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 200 mg lesinurad; 200 mg lesinurad or placebo fasted and fed	Drug: Placebo; Drug: Lesinurad
Experimental: 400 mg lesinurad; 400 mg lesinurad or placebo fasted and fed	Drug: Placebo; Drug: Lesinurad
Experimental: 100 mg lesinurad; 100 mg lesinurad or placebo fasted and fed	Drug: Placebo; Drug: Lesinurad
Experimental: 50 mg lesinurad; 50 mg lesinurad or placebo fasted and fed	Drug: Placebo; Drug: Lesinurad
Experimental: 600 mg lesinurad; 600 mg lesinurad or placebo fasted and fed	Drug: Placebo; Drug: Lesinurad

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events and Changes in Laboratory Parameters		5 to 6 weeks
Pharmacokinetic (PK) profile of lesinurad from plasma and urine in terms of AUC, tmax, cmax and t1/2.	AUC: area under the plasma concentration time curve from zero to 24 hours post dose and from zero to infinity; tmax: time to maximum plasma concentration; cmax: maximum observed plasma concentration t1/2: terminal elimination half life	Day -1 through 12
Pharmacodynamic (PD) profile of lesinurad from serum and urine in terms of sUA concentration, renal clearance, urine uric acid excretion, and fractional excretion.		Day 1 through 12

Collaborators and Investigators

• Sponsor: Ardea Biosciences, Inc.
• Investigators: Study Director: S Bradley, MD, Ardea Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 18, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antirheumatic Agents; Gout Suppressants; Renal Agents; Uricosuric Agents; Lesinurad
• Other Study ID Numbers: RDEA594-125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No