Bioavailability of Lesinurad and Intravenous [14C]Lesinurad

Study identifier:RDEA594-131

ClinicalTrials.gov identifier:NCT02039700

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Lesinurad 400 mg, [14C]lesinurad (100 μg per 10 mL)

Sex

Male

Actual Enrollment

10

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Jan 2014
Primary Completion Date: 01 Feb 2014
Study Completion Date: 01 Apr 2014

Study design

Allocation: N/A
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 May 2014 by Ardea Biosciences, Inc.

Sponsors

Ardea Biosciences, Inc.

Collaborators

-

Inclusion and exclusion criteria