NCT02028689

Metformin and Furosemide Drug-Drug Interaction Study

A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate Potential Pharmacokinetic Interaction Between Lesinurad and Metformin and Between Lesinurad and Furosemide in Health Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (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 lesinurad on the pharmacokinetics (PK) of metformin and furosemide in healthy, adult male subjects.

Detailed description

Leinurad is a weak in vitro inhibitor of the hepatic transporter OCT1 and the renal transporters OAT1 and OAT3 (OAT1/3). To assess the clinical relevance of these in vitro findings, this clinical study will evaluate the effect of lesinurad on the PK of metformin (OCT1 substrate) and furosemide (OAT1/3 substrate).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lesinurad 400 mg
DRUG	Metformin 850 mg
DRUG	Furosemide 40 mg

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-11-01
• Completion: 2014-01-01
• First posted: 2014-01-07
• Last updated: 2014-02-14

Locations

1 site across 1 country: United States