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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiolabeled TRV130 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiolabeled TRV130 | Drug | A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trevena Inc | Trevena Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madison Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
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