Single and Multiple Dose Study in Japanese

• ClinicalTrials.gov Identifier: NCT01744379
• Recruitment Status: Completed
• First Posted: December 6, 2012
• Last Update Posted: June 19, 2013
• Sponsor: Ardea Biosciences, Inc.
• Information provided by (Responsible Party): Ardea Biosciences, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gout	Drug: Lesinurad; Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: December 2012
• Actual Primary Completion Date: March 2013
• Actual Study Completion Date: May 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Incidence of Adverse Events and Changes in Laboratory Parameters [ Time Frame: 5 to 6 weeks ]
2. Pharmacokinetic (PK) profile of lesinurad from plasma and urine in terms of AUC, tmax, cmax and t1/2. [ Time Frame: Day -1 through 12 ]
   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
3. Pharmacodynamic (PD) profile of lesinurad from serum and urine in terms of sUA concentration, renal clearance, urine uric acid excretion, and fractional excretion. [ Time Frame: Day 1 through 12 ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 55 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, California

Glendale, California, United States, 91206

Sponsors and Collaborators

Ardea Biosciences, Inc.

Investigators

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

More Information

• Responsible Party: Ardea Biosciences, Inc.
• ClinicalTrials.gov Identifier: NCT01744379
• Other Study ID Numbers: RDEA594-125
• First Posted: December 6, 2012
• Last Update Posted: June 19, 2013
• Last Verified: June 2013

Additional relevant MeSH terms:

Lesinurad; Gout Suppressants; Antirheumatic Agents; Uricosuric Agents; Renal Agents