NCT02169934

A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male Subjects

A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 Following Single Intravenous Dose Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Trevena Inc. · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Radiolabeled TRV130	A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-01-01
• Completion: 2015-05-01
• First posted: 2014-06-23
• Last updated: 2015-11-18

Locations

1 site across 1 country: United States