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

NCT02169934 | Completed Phase 1

• 1 other identifier: CP130-1007
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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

Study Arms (1)

Radiolabeled TRV130

EXPERIMENTAL

Drug: Radiolabeled TRV130

Interventions

Radiolabeled TRV130 DRUG

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

Radiolabeled TRV130

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trevena Inc.: lead

Study Sites (1)

Madison Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Trevena Inc

  Trevena Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

US (1)