Lesinurad Tablet Bioequivalence

Completed · Phase 1

Conditions studied: Healthy

In brief

This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.

Key facts

Study ID

NCT02127775

Run by

Ardea Biosciences, Inc.

People needed

54

Starts

2014-04-01

Expected to finish

2014-07-01

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 ≥ 18 and ≤ 40 kg/m2.
• Subject has a Screening serum urate level ≤ 7 mg/dL. ˗ Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

You may not qualify if…

• Subject has any gastrointestinal disorder that affects motility and/or absorption.
• Subject has a history or suspicion of kidney stones.
• Subject has undergone major surgery within 3 months prior to Screening.
• 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 — Austin, Texas, United States

Full record on ClinicalTrials.gov

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