NSAID Drug Interaction Study

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: Male

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-steroidal anti-inflammatory drugs.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ardea Biosciences, Inc.
• Treatments: Indomethacin; Lesinurad; Naproxen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.