Lesinurad Tablet Relative Bioavailability

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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lesinurad 400 mg (Site 1)
* Drug: Lesinurad 400 mg (Site 2, Lot A)
* Drug: Lesinurad 400 mg (Site 2, Lot B)


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 (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.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot A)<br>Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A) | Drug: Lesinurad 400 mg (Site 1)<br> <br> Drug: Lesinurad 400 mg (Site 2, Lot A)<br> <br> |
| Experimental: Lesinurad 400 mg Fed (Site 1 and Site 2, Lot A)<br>Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A) | Drug: Lesinurad 400 mg (Site 1)<br> <br> Drug: Lesinurad 400 mg (Site 2, Lot A)<br> <br> |
| Experimental: Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot B)<br>Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B) | Drug: Lesinurad 400 mg (Site 1)<br> <br> Drug: Lesinurad 400 mg (Site 2, Lot B)<br> <br> |
| Experimental: Lesinurad 400 mg Fed (Site 1 and Site 2, Lot B)<br>Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B) | Drug: Lesinurad 400 mg (Site 1)<br> <br> Drug: Lesinurad 400 mg (Site 2, Lot B)<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 (AUC); and apparent terminal half-life (t1/2). | 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 |