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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
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE November 29, 2012
First Posted Date  ICMJE December 6, 2012
Last Update Posted Date June 19, 2013
Study Start Date  ICMJE December 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2013)
  • Incidence of Adverse Events and Changes in Laboratory Parameters [ Time Frame: 5 to 6 weeks ]
  • 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
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
  • Incidence of Adverse Events and Changes in Laboratory Parameters [ Time Frame: 5 to 6 weeks ]
  • 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
  • Pharmacodynamic (PD) profile of lesinruad from serum and urine in terms of sUA concentration, renal clearance, urine uric acid excretion, and fractional excretion. [ Time Frame: Day 1 through 12 ]
Change History Complete list of historical versions of study NCT01744379 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single and Multiple Dose Study in Japanese
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gout
Intervention  ICMJE
  • Drug: Lesinurad
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 200 mg lesinurad
    200 mg lesinurad or placebo fasted and fed
    Interventions:
    • Drug: Lesinurad
    • Drug: Placebo
  • Experimental: 400 mg lesinurad
    400 mg lesinurad or placebo fasted and fed
    Interventions:
    • Drug: Lesinurad
    • Drug: Placebo
  • Experimental: 100 mg lesinurad
    100 mg lesinurad or placebo fasted and fed
    Interventions:
    • Drug: Lesinurad
    • Drug: Placebo
  • Experimental: 50 mg lesinurad
    50 mg lesinurad or placebo fasted and fed
    Interventions:
    • Drug: Lesinurad
    • Drug: Placebo
  • Experimental: 600 mg lesinurad
    600 mg lesinurad or placebo fasted and fed
    Interventions:
    • Drug: Lesinurad
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01744379
Other Study ID Numbers  ICMJE RDEA594-125
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ardea Biosciences, Inc.
Study Sponsor  ICMJE Ardea Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: S Bradley, MD Ardea Biosciences, Inc.
PRS Account Ardea Biosciences, Inc.
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP