We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Single and Multiple Dose Study in Japanese

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01744379
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : June 19, 2013
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
Drug Information available for: Lesinurad

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744379

Layout table for location information
United States, California
Glendale, California, United States, 91206
Sponsors and Collaborators
Ardea Biosciences, Inc.
Layout table for investigator information
Study Director: S Bradley, MD Ardea Biosciences, Inc.
Layout table for additonal information
Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01744379    
Other Study ID Numbers: RDEA594-125
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Gout Suppressants
Antirheumatic Agents
Uricosuric Agents
Renal Agents