Lesinurad Tablet Bioequivalence

Overview

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.

Interventions

  • 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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.