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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: June 2014
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
- 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.
- Incidence of Adverse Events
- Time Frame: 5 weeks
- Changes in Laboratory, Electrocardiogram and Vital Signs Parameters
Participating in This Clinical Trial
- 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.
- 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
- Lead Sponsor
- Ardea Biosciences, Inc.
- Provider of Information About this Clinical Study
- Overall Official(s)
- J. Hall, Study Director, Ardea Biosciences, Inc.
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