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This study will determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Samidorphan IV | Experimental | Samidorphan solution for IV administration |
|
| Samidorphan sublingual | Experimental | [14c]-Samidorphan for sublingual administration |
|
| Samidorphan oral | Experimental | [14c]-Samidorphan for oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samidorphan IV | Drug | Single IV administration |
| |
| [14c]-Samidorphan sublingual |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-t | Area under the concentration time curve of total radioactivity from time 0 to last observed concentration in blood and plasma | Up to 120 hours after each dose |
| Cmax | Maximum concentration of total radioactivity in blood and plasma | Up to 120 hours after each dose |
| Tmax | Time to maximum concentration of total radioactivity in blood and plasma | Up to 120 hours after each dose |
| Fe%0-t | Fraction of dose excreted in urine and feces | Up to 120 hours after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability will be measured by the incidence of Adverse Events | Up to 35 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arielle Stanford, MD | Alkermes Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Austin | Texas | 78744 | United States |
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| Drug |
Single sublingual administration containing radiolabel |
|
| [14c]-Samidorphan oral | Drug | Single oral administration containing radiolabel |
|