NCT01982201

Antacid Interaction Study

A Phase 1, Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interaction Between Lesinurad and Calcium Carbonate and Aluminum/Magnesium Hydroxide-Containing Antacids in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

In this study, lesinurad and antacid will be administered in the fed state, antacid doses will be attenuated to reflect the more commonly used doses, baseline PD assessments will be performed both in presence and absence of antacid treatment, and the sequence of treatments (lesinurad +/- antacid) will be randomized.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lesinurad 400 mg
DRUG	Tums 500 mg and 750 mg
DRUG	MINTOX 10 mL

Timeline

• Start date: 2013-11-01
• Primary completion: 2013-12-01
• Completion: 2014-03-01
• First posted: 2013-11-13
• Last updated: 2014-05-20

Locations

1 site across 1 country: United States