Clinical trial NCT02169934: A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male Subjects
Official title: A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 Following Single Intravenous Dose Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130
timeFrame: Day 1 - Day 13
measure: To determine plasma concentrations of total radioactivity
timeFrame: Day 1 - Day 13
measure: To determine whole blood concentrations of total radioactivity
timeFrame: Day 1 - Day 13
measure: To determine urine concentrations of total radioactivity
timeFrame: Day 1 - Day 13
measure: To determine fecal concentration of total radioactivity
timeFrame: Day 1 - Day 13
Secondary outcomes:
measure: To identify metabolites associated with TRV130 in blood, urine and feces
timeFrame: Day 1 - Day 13
measure: Number of patients experiencing an Adverse Event
timeFrame: Day 1 - Day 13
Other outcomes:
Locations:
city: Madison
country: United States
facility: Madison Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Trevena Inc.
name: Trevena Inc
role: STUDY_DIRECTOR
References: