Lesinurad Tablet Bioequivalence

Ardea Biosciences, Inc.54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Lesinurad 400 mg (manufactured at Site 1)DRUG

Lesinurad 400 mg (manufactured at Site 2)DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Austin, Texas, United States

Outcomes

Primary Outcomes

PK profile of lesinurad from plasma

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.

Time frame: Day 1 and Day 5

Secondary Outcomes

Incidence of Adverse Events

Changes in Laboratory, Electrocardiogram and Vital Signs Parameters

Time frame: 5 weeks

Data from ClinicalTrials.gov

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