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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
Unnamed facility
Madison, Wisconsin, United States
Characteristics of bioavailability in terms of lesinurad Pharmacokinetics (PK) profile from plasma.
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).
Time frame: Day 1 to Day 5
PK profile of [14C]lesinurad from plasma
PK profile in terms of Cmax, AUC, t½, MRT, total body clearance (CL), and volume of distribution at steady state (Vss).
Time frame: Day 1 to Day 5
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
Time frame: 5 weeks
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