Lesinurad Tablet Bioequivalence

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

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

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.

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.