Lesinurad Tablet Bioequivalence


This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.

Full Title of Study: “A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Bioequivalence of Lesinurad Tablets From Two Manufacturing Sites in Healthy Adult Male Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

Detailed Description

This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the 2 different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.


  • Drug: Lesinurad 400 mg (manufactured at Site 1)
  • Drug: Lesinurad 400 mg (manufactured at Site 2)

Arms, Groups and Cohorts

  • Experimental: Sequence B
    • Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1)
  • Experimental: Sequence A
    • Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2)

Clinical Trial Outcome Measures

Primary Measures

  • 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 from zero to 24 hours post dose (AUC last) and from zero to infinity (AUC ∞); and apparent terminal half-life (t1/2). Point estimates and 90% confidence intervals for the ratio of geometric means for Cmax, AUC last and AUC∞ between test and reference formulations.

Secondary Measures

  • Incidence of Adverse Events
    • Time Frame: 5 weeks
    • Changes in Laboratory, Electrocardiogram and Vital Signs Parameters

Participating in This Clinical Trial

Inclusion Criteria

  • Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
  • Subject has a Screening serum urate level ≤ 7 mg/dL. ˗ Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria

  • Subject has any gastrointestinal disorder that affects motility and/or absorption.
  • Subject has a history or suspicion of kidney stones.
  • Subject has undergone major surgery within 3 months prior to Screening.
  • 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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ardea Biosciences, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • J. Hall, Study Director, Ardea Biosciences, Inc.

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