A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Radiolabeled TRV130
- Registration Number
- NCT02169934
- Lead Sponsor
- Trevena Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiolabeled TRV130 Radiolabeled TRV130 -
- Primary Outcome Measures
Name Time Method To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130 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 To determine plasma concentrations of total radioactivity Day 1 - Day 13
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Madison Clinical Research Unit
🇺🇸Madison, Wisconsin, United States