Lesinurad Tablet Bioequivalence

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lesinurad 400 mg (manufactured at Site 1); Drug: Lesinurad 400 mg (manufactured at Site 2)

• Registration Number: NCT02127775
• Lead Sponsor: Ardea Biosciences, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-19
• Last Update Posted: 2014-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	Lesinurad 400 mg (manufactured at Site 1)	Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2)
Sequence A	Lesinurad 400 mg (manufactured at Site 2)	Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2)
Sequence B	Lesinurad 400 mg (manufactured at Site 1)	Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1)
Sequence B	Lesinurad 400 mg (manufactured at Site 2)	Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1)

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 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 Outcome Measures

Name	Time	Method
Incidence of Adverse Events	5 weeks	Changes in Laboratory, Electrocardiogram and Vital Signs Parameters