NCT02039700

Bioavailability of Lesinurad and Intravenous [14C]Lesinurad

A Phase 1, Open-Label Study to Assess the Absolute Bioavailability of a Single Oral Dose of Lesinurad With Respect to an Intravenous Micro Tracer Dose of [14C]Lesinurad in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will assess the absolute bioavailability of a single oral dose of lesinurad and evaluate the pharmacokinetic (PK) parameters of lesinurad and \[14C\]lesinurad in healthy adult male subjects.

Detailed description

In this study a single dose of lesinurad will be administered after an overnight fast followed by a single 15-minute infusion of a radiolabeled intravenous micro tracer dose of \[14C\]lesinurad to assess the in vivo performance of lesinurad.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lesinurad 400 mg
DRUG	[14C]lesinurad (100 μg per 10 mL)

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-02-01
• Completion: 2014-04-01
• First posted: 2014-01-20
• Last updated: 2014-05-20

Locations

1 site across 1 country: United States