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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02127775

Enrollment

Registered

2014-05-01

Start date

2014-04-30

Completion date

2014-07-31

Last updated

2014-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGLesinurad 400 mg (manufactured at Site 1)

DRUGLesinurad 400 mg (manufactured at Site 2)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Incidence of Adverse Events	5 weeks	Changes in Laboratory, Electrocardiogram and Vital Signs Parameters

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026