Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-27 @ 7:43 AM
Study NCT ID:
NCT02169934
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2014-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male Subjects
Sponsor:
Trevena Inc.
Organization:
Study Overview
Official Title:
A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 Following Single Intravenous Dose Administration in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: