Healthy
Conditions
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.
Interventions
DRUGRadiolabeled TRV130
A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes
Sponsors
Trevena Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine plasma concentrations of total radioactivity | Day 1 - Day 13 |
| To determine urine concentrations of total radioactivity | Day 1 - Day 13 |
| To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130 | Day 1 - Day 13 |
| To determine fecal concentration of total radioactivity | Day 1 - Day 13 |
| To determine whole blood concentrations of total radioactivity | Day 1 - Day 13 |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients experiencing an Adverse Event | Day 1 - Day 13 |
| To identify metabolites associated with TRV130 in blood, urine and feces | Day 1 - Day 13 |
Countries
United States
Outcome results
None listed