Single and Multiple Dose Study in Japanese

Study Overview
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Brief Summary
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This study will explore the safety, tolerability, and serum uric acid lowering effect of lesinurad in healthy Japanese males to allow comparison with the Western population.

Detailed Description
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While there is extensive clinical experience with lesinurad in the Western population, it is recognized that both intrinsic and extrinsic factors may impact the PK, PD, safety, and dose response in different ethnic populations. The purpose of this study is to explore the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of single and multiple doses of lesinurad in healthy Japanese males, and to allow comparison of these parameters with the Western population.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of Lesinurad in Healthy Male Japanese Subjects

Conditions
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Gout

Intervention / Treatment
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* Drug: Lesinurad
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand the study procedures, the risks involved and willing to provide written Informed Consent before the first study related activity. Healthy adult subjects born in Japan All laboratory parameters should be within normal limits or considered not clinically significant by the investigator. Screening serum uric acid level >= 4.5 mg/dL. Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures. Subject does not have clinically relevant abnormalities in blood pressure, heart rate, body temperature, and respiratory rate, as per the Investigator's judgment. Exclusion Criteria: Positive serology to Human Immunodeficiency Virus (HIV-1 and HIV-2). Positive test for active Hepatitis B or Hepatitis C infection. History of kidney stones. Undergone major surgery within 3 months of Day 1. Subject has received the last dose of an investigational drug (or treatment with a medical device) within 30 days or 5 half-lives (whichever is longer) of the investigational drug prior to Day 1 or are currently participating in another study of an investigational drug (or medical device). Prior exposure to lesinurad (RDEA594) or RDEA806.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200 mg lesinurad<br>200 mg lesinurad or placebo fasted and fed | Drug: Lesinurad<br> <br> Drug: Placebo<br> <br> |
| Experimental: 400 mg lesinurad<br>400 mg lesinurad or placebo fasted and fed | Drug: Lesinurad<br> <br> Drug: Placebo<br> <br> |
| Experimental: 100 mg lesinurad<br>100 mg lesinurad or placebo fasted and fed | Drug: Lesinurad<br> <br> Drug: Placebo<br> <br> |
| Experimental: 50 mg lesinurad<br>50 mg lesinurad or placebo fasted and fed | Drug: Lesinurad<br> <br> Drug: Placebo<br> <br> |
| Experimental: 600 mg lesinurad<br>600 mg lesinurad or placebo fasted and fed | Drug: Lesinurad<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events and Changes in Laboratory Parameters |  | 5 to 6 weeks | 
| Pharmacokinetic (PK) profile of lesinurad from plasma and urine in terms of AUC, tmax, cmax and t1/2. | AUC: area under the plasma concentration time curve from zero to 24 hours post dose and from zero to infinity; tmax: time to maximum plasma concentration; cmax: maximum observed plasma concentration t1/2: terminal elimination half life | Day -1 through 12 | 
| Pharmacodynamic (PD) profile of lesinurad from serum and urine in terms of sUA concentration, renal clearance, urine uric acid excretion, and fractional excretion. |  | Day 1 through 12 |