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

Trevena

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Radiolabeled TRV130

Study type

Interventional

Funder types

Industry

Identifiers

NCT02169934

CP130-1007

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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