Lesinurad Tablet Relative Bioavailability

Completed · Phase 1

Conditions studied: Healthy

In brief

This study will assess the relative bioavailability of lesinurad tablets, manufactured at two different sites.

Key facts

Study ID

NCT01986556

Run by

Ardea Biosciences, Inc.

People needed

36

Starts

2013-11-01

Expected to finish

2014-05-01

Last updated by the study team

2014-09-22

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Subject has a body weight ≥ 50 kg (110 lbs) and a body mass index (BMI) ≥ 18 and ≤ 40 kg/m2.
• Subject has a Screening sUA value ≤ 7.0 mg/dL.
• 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 per the Investigator's judgment.

You may not qualify if…

• Subject has a history or clinical manifestations of significant metabolic, hematological, 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.

Where it is running

• Study site — Glendale, California, United States

Full record on ClinicalTrials.gov

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