NCT01908257

Lesinurad Interaction Study With Ranitidine

A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Effects of Ranitidine on the Pharmacokinetics of Lesinurad in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of ranitidine on lesinurad.

Detailed description

This study will evaluate the potential effect of ranitidine on the pharmacokinetics of lesinurad. An earlier study demonstrated an effect on lesinurad PK in the presence of both calcium-containing and magnesium- and aluminum-containing antacids. The current study will assess whether raising gastric pH, without the presence of these cations, affects lesinurad PK and PD under the fasted state. If an impact is seen, then the optional second cohort will be conducted under the fed state.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	lesinurad 400 mg
DRUG	ranitidine 150 mg
DRUG	lesinurad 400 mg + ranitidine 150 mg

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-09-01
• Completion: 2013-11-01
• First posted: 2013-07-25
• Last updated: 2014-01-09

Locations

1 site across 1 country: United States