Lesinurad Tablet Bioequivalence

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.

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

Primary outcomes

• PK profile of lesinurad from plasma [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 outcomes

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

Sex: Male, ages: 18 Years to 65 Years, accepts healthy volunteers

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.

• J. Hall, Study director, Ardea Biosciences, Inc.