Lesinurad Tablet Relative Bioavailability
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01986556
- Lead Sponsor
- Ardea Biosciences, Inc.
- Brief Summary
This study will assess the relative bioavailability of lesinurad tablets, manufactured at two different sites.
- Detailed Description
A change in manufacturing site of lesinurad tablets has been implemented. This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the two different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
- Subject has a body weight ≥ 50 kg (110 lbs) and a body mass index (BMI) ≥ 18 and ≤ 40 kg/m2.
- Subject has a Screening sUA value ≤ 7.0 mg/dL.
- Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
- Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.
Exclusion Criteria
- Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
- Subject has a history or suspicion of kidney stones.
- Subject has a history of asthma.
- Subject has undergone major surgery within 3 months prior to Day 1.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lesinurad 400 mg Fed (Site 1 and Site 2, Lot B) Lesinurad 400 mg (Site 1) Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Lesinurad 400 mg Fed (Site 1 and Site 2, Lot A) Lesinurad 400 mg (Site 2, Lot A) Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Lesinurad 400 mg Fed (Site 1 and Site 2, Lot A) Lesinurad 400 mg (Site 1) Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot A) Lesinurad 400 mg (Site 2, Lot A) Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot B) Lesinurad 400 mg (Site 2, Lot B) Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot B) Lesinurad 400 mg (Site 1) Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot A) Lesinurad 400 mg (Site 1) Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Lesinurad 400 mg Fed (Site 1 and Site 2, Lot B) Lesinurad 400 mg (Site 2, Lot B) Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B)
- Primary Outcome Measures
Name Time Method 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 (AUC); and apparent terminal half-life (t1/2).
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events 5 weeks Changes in Laboratory, Electrocardiogram and Vital Signs Parameters