Antacid Interaction Study

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

• Lead Sponsor: Ardea Biosciences, Inc.
• Treatments: Aluminum hydroxide, magnesium hydroxide, drug combination; Antacids; Lesinurad

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.