Bioavailability of Lesinurad and Intravenous [14C]Lesinurad
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.
Drug: Lesinurad 400 mg
Drug: [14C]lesinurad (100 μg per 10 mL)
|Study Design:||Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|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|
- Characteristics of bioavailability in terms of lesinurad Pharmacokinetics (PK) profile from plasma. [ Time Frame: Day 1 to Day 5 ] [ Designated as safety issue: No ]PK profile in terms of maximum observed concentration (Cmax), time of occurrence of maximum observed concentration (Tmax), area under the concentration-time curve (AUC), apparent terminal half-life (t½), mean residence time (MRT), mean absorption time (MAT), and absolute bioavailability (F).
- PK profile of [14C]lesinurad from plasma [ Time Frame: Day 1 to Day 5 ] [ Designated as safety issue: No ]PK profile in terms of Cmax, AUC, t½, MRT, total body clearance (CL), and volume of distribution at steady state (Vss).
- Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2014|
|Study Completion Date:||April 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Lesinurad and [14C]lesinurad
Single oral dose of lesinurad and single infusion of [14C]lesinurad
|Drug: Lesinurad 400 mg Drug: [14C]lesinurad (100 μg per 10 mL)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02039700
|United States, Wisconsin|
|Madison, Wisconsin, United States, 53704|
|Study Director:||J. Hall||Ardea Biosciences, Inc.|