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Lesinurad Tablet Relative Bioavailability

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: NCT01986556
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE November 12, 2013
First Posted Date  ICMJE November 18, 2013
Last Update Posted Date September 22, 2014
Study Start Date  ICMJE November 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
PK profile of lesinurad from plasma [ Time Frame: Day 1 and Day 5 ]
PK endpoints in terms of maximum observed concentration (Cmax); time of occurrence of maximum observed concentration (Tmax); area under the plasma concentration time curve (AUC); and apparent terminal half-life (t1/2).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
Incidence of Adverse Events [ Time Frame: 5 weeks ]
Changes in Laboratory, Electrocardiogram and Vital Signs Parameters
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lesinurad Tablet Relative Bioavailability
Official Title  ICMJE A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Lesinurad Tablets Manufactured at Two Different Sites
Brief Summary This study will assess the relative bioavailability of lesinurad tablets, manufactured at two different sites.
Detailed Description A change in manufacturing site of lesinurad tablets has been implemented. This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the two different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Lesinurad 400 mg (Site 1)
  • Drug: Lesinurad 400 mg (Site 2, Lot A)
  • Drug: Lesinurad 400 mg (Site 2, Lot B)
Study Arms  ICMJE
  • Experimental: Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot A)
    Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A)
    Interventions:
    • Drug: Lesinurad 400 mg (Site 1)
    • Drug: Lesinurad 400 mg (Site 2, Lot A)
  • Experimental: Lesinurad 400 mg Fed (Site 1 and Site 2, Lot A)
    Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A)
    Interventions:
    • Drug: Lesinurad 400 mg (Site 1)
    • Drug: Lesinurad 400 mg (Site 2, Lot A)
  • Experimental: Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot B)
    Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B)
    Interventions:
    • Drug: Lesinurad 400 mg (Site 1)
    • Drug: Lesinurad 400 mg (Site 2, Lot B)
  • Experimental: Lesinurad 400 mg Fed (Site 1 and Site 2, Lot B)
    Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B)
    Interventions:
    • Drug: Lesinurad 400 mg (Site 1)
    • Drug: Lesinurad 400 mg (Site 2, Lot B)
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: November 12, 2013)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has a body weight ≥ 50 kg (110 lbs) and a body mass index (BMI) ≥ 18 and ≤ 40 kg/m2.
  • Subject has a Screening sUA value ≤ 7.0 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 no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.

Exclusion Criteria:

  • Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
  • Subject has a history or suspicion of kidney stones.
  • Subject has a history of asthma.
  • Subject has undergone major surgery within 3 months prior to Day 1.
  • Subject has donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
  • Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older 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 NCT01986556
Other Study ID Numbers  ICMJE RDEA594-129
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: J. Hall, MD Ardea Biosciences, Inc.
PRS Account Ardea Biosciences, Inc.
Verification Date September 2014

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