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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Radiolabeled TRV130

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Madison Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Key Inclusion Criteria:

• Males, between 18 and 64 years of age, inclusive
• With body weight ≥ 50 kg and body mass index (BMI) between 18 and 32 kg/m2, inclusive
• In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
• Negative test for selected drugs of abuse at Screening and at Check-in
• Able to comprehend and willing to sign an Informed Consent Form (ICF) prior to any study procedure
• A typical minimum of 1 to 2 bowel movements per day

Key Exclusion Criteria:

• History of sensitivity to any of the study medications or components thereof or a history of medication or other allergy that, in the opinion of the Investigator, contraindicates their participation
• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days prior to Check-in
• Participation in any other radiolabeled investigational study drug trial within 12 months prior to Check-in
• Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Check-in
• Has current malignancy, current systemic chemotherapy, or cancer diagnosis within 5 years prior to Screening (excluding squamous or basal cell carcinoma of the skin that has been clinically stable and fully excised in a curative procedure);
• Use of any tobacco- or nicotine-containing products within 6 months prior to Screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiolabeled TRV130	Drug: Radiolabeled TRV130; A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130	Day 1 - Day 13
To determine plasma concentrations of total radioactivity	Day 1 - Day 13
To determine whole blood concentrations of total radioactivity	Day 1 - Day 13
To determine urine concentrations of total radioactivity	Day 1 - Day 13
To determine fecal concentration of total radioactivity	Day 1 - Day 13

Secondary Outcome Measures

Outcome Measure	Time Frame
To identify metabolites associated with TRV130 in blood, urine and feces	Day 1 - Day 13
Number of patients experiencing an Adverse Event	Day 1 - Day 13

Collaborators and Investigators

• Sponsor: Trevena Inc.
• Investigators: Study Director: Trevena Inc, Trevena Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: June 17, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CP130-1007