Lesinurad Interaction Study With Ranitidine

• Status: Completed
• Trial end date: 2013-11-01
• 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 ranitidine on lesinurad.

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

Details

• Lead Sponsor: Ardea Biosciences, Inc.
• Treatments: Lesinurad; Ranitidine; Ranitidine bismuth citrate

Criteria

Inclusion Criteria:

• body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.

• Screening sUA value ≤ 7.0 mg/dL.

• 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 abnormalties in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.

Exclusion Criteria:

• history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic renal,urological, or psychiatric disorders.

• history or suspicion of kidney stones.

• undergone major surgery within 3 months prior to Day 1.

• 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.

• inadequate venous access or unsuitable veins for repeated venipuncture.