Single and Multiple Dose Study in Japanese
- Registration Number
- NCT01744379
- Lead Sponsor
- Ardea Biosciences, Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 200 mg lesinurad Lesinurad 200 mg lesinurad or placebo fasted and fed 200 mg lesinurad Placebo 200 mg lesinurad or placebo fasted and fed 400 mg lesinurad Placebo 400 mg lesinurad or placebo fasted and fed 100 mg lesinurad Placebo 100 mg lesinurad or placebo fasted and fed 50 mg lesinurad Placebo 50 mg lesinurad or placebo fasted and fed 600 mg lesinurad Placebo 600 mg lesinurad or placebo fasted and fed 100 mg lesinurad Lesinurad 100 mg lesinurad or placebo fasted and fed 400 mg lesinurad Lesinurad 400 mg lesinurad or placebo fasted and fed 50 mg lesinurad Lesinurad 50 mg lesinurad or placebo fasted and fed 600 mg lesinurad Lesinurad 600 mg lesinurad or placebo fasted and fed
- Primary Outcome Measures
Name Time Method 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. Day -1 through 12 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
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
- Secondary Outcome Measures
Name Time Method