Lesinurad Interaction Study With Ranitidine

Completed · Phase 1

Conditions studied: Healthy

In brief

This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of ranitidine on lesinurad.

Key facts

Study ID

NCT01908257

Run by

Ardea Biosciences, Inc.

People needed

16

Starts

2013-07-01

Expected to finish

2013-11-01

Last updated by the study team

2014-01-09

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Cypress, California, United States

Full record on ClinicalTrials.gov

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