Single and Multiple Dose Study in Japanese
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|ClinicalTrials.gov Identifier: NCT01744379|
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : June 19, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Gout||Drug: Lesinurad Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||May 2013|
Experimental: 200 mg lesinurad
200 mg lesinurad or placebo fasted and fed
Experimental: 400 mg lesinurad
400 mg lesinurad or placebo fasted and fed
Experimental: 100 mg lesinurad
100 mg lesinurad or placebo fasted and fed
Experimental: 50 mg lesinurad
50 mg lesinurad or placebo fasted and fed
Experimental: 600 mg lesinurad
600 mg lesinurad or placebo fasted and fed
- Incidence of Adverse Events and Changes in Laboratory Parameters [ Time Frame: 5 to 6 weeks ]
- Pharmacokinetic (PK) profile of lesinurad from plasma and urine in terms of AUC, tmax, cmax and t1/2. [ Time Frame: 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. [ Time Frame: Day 1 through 12 ]
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|Ages Eligible for Study:||20 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744379
|United States, California|
|Glendale, California, United States, 91206|
|Study Director:||S Bradley, MD||Ardea Biosciences, Inc.|
|Responsible Party:||Ardea Biosciences, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 6, 2012 Key Record Dates|
|Last Update Posted:||June 19, 2013|
|Last Verified:||June 2013|