Antacid Interaction Study

Completed · Phase 1

Conditions studied: Healthy

In brief

This study will assess the potential effects of calcium carbonate and aluminum/magnesium hydroxide-containing antacids on the pharmacokinetics (PK) and pharmacodynamics (PD) of lesinurad in healthy, adult male subjects.

Key facts

Study ID

NCT01982201

Run by

Ardea Biosciences, Inc.

People needed

24

Starts

2013-11-01

Expected to finish

2014-03-01

Last updated by the study team

2014-05-20

Who can join

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

You may qualify if…

• Subject has a body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
• Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment

You may not qualify if…

• Subject has a history or suspicion of kidney stones.
• Subject has undergone major surgery within 3 months prior to Screening.
• Subject donated blood or experienced significant blood loss (>450 mL) within 12 weeks prior to Screening or gave a plasma donation within 4 weeks prior to Screening.
• Subject has inadequate venous access or unsuitable veins for repeated venipuncture.

Where it is running

• Study site — Kalamazoo, Michigan, United States

Full record on ClinicalTrials.gov

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