Status:
COMPLETED
NSAID Drug Interaction Study
Lead Sponsor:
Ardea Biosciences, Inc.
Conditions:
Gout
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and leinurad on the non-steroid...
Detailed Description
Naproxen and indomethacin are non-steroidal anti-inflammatory drugs (NSAIDs) used both prophylactically for the prevention of, and as a treatment for, acute gout flares. RDEA594-126 is an open-label s...
Eligibility Criteria
Inclusion
- Subject has a body weight ≥ 50 kg (110 lbs) and a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
- 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.
Exclusion
- Subject has clinically significant 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01884272
Start Date
June 1 2013
End Date
October 1 2013
Last Update
November 8 2013
Active Locations (1)
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1
Kalamazoo, Michigan, United States, 49007