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

NCT ID: NCT02169934

Last Updated: 2015-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-05-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiolabeled TRV130

Group Type: EXPERIMENTAL

Radiolabeled TRV130

Intervention Type: DRUG

A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes

Interventions

Radiolabeled TRV130

A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Trevena Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Trevena Inc

Role: STUDY_DIRECTOR

Trevena Inc.

Locations

Madison Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

CP130-1007

Identifier Type: -

Identifier Source: org_study_id