Lesinurad Tablet Bioequivalence

Study Overview
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Brief Summary
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This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.

Detailed Description
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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.

Official Title
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A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Bioequivalence of Lesinurad Tablets From Two Manufacturing Sites in Healthy Adult Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lesinurad 400 mg (manufactured at Site 1)
* Drug: Lesinurad 400 mg (manufactured at Site 2)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence B<br>Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1) | Drug: Lesinurad 400 mg (manufactured at Site 1)<br> <br> Drug: Lesinurad 400 mg (manufactured at Site 2)<br> <br> |
| Experimental: Sequence A<br>Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2) | Drug: Lesinurad 400 mg (manufactured at Site 1)<br> <br> Drug: Lesinurad 400 mg (manufactured at Site 2)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 and Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Changes in Laboratory, Electrocardiogram and Vital Signs Parameters | 5 weeks |