The purpose of this study is to determine the routes of excretion for TRV130 and it's metabolites, and to determine and characterize, structurally, the metabolites present in plasma, urine, and feces in healthy male subjects.
This study is an open-label, non-randomized, metabolism and excretion study of a single 2 mg IV dose of \[14C\] TRV130 (approximately 100 µCi) administered as a 10 mL manual IV push over 2 minutes in a fasted state.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes
Madison Clinical Research Unit
Madison, Wisconsin, United States
To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130
Time frame: Day 1 - Day 13
To determine plasma concentrations of total radioactivity
Time frame: Day 1 - Day 13
To determine whole blood concentrations of total radioactivity
Time frame: Day 1 - Day 13
To determine urine concentrations of total radioactivity
Time frame: Day 1 - Day 13
To determine fecal concentration of total radioactivity
Time frame: Day 1 - Day 13
To identify metabolites associated with TRV130 in blood, urine and feces
Time frame: Day 1 - Day 13
Number of patients experiencing an Adverse Event
Time frame: Day 1 - Day 13
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