Lesinurad Tablet Relative Bioavailability

A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Lesinurad Tablets Manufactured at Two Different Sites

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01986556

Enrollment

Registered

2013-11-18

Start date

2013-11-30

Completion date

2014-05-31

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 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.

Interventions

DRUGLesinurad 400 mg (Site 1)

DRUGLesinurad 400 mg (Site 2, Lot A)

DRUGLesinurad 400 mg (Site 2, Lot B)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

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 (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.

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 (AUC); and apparent terminal half-life (t1/2).

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