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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single dose of [14C]AR882 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 144 hours following the single dose of AR882 to measure total radioactivity and plasma drug concentrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mass Balance | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]AR882 | Drug | Single dose of [14C]AR882 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity (TRA) in urine | Days 1-14 | |
| TRA in feces | Days 1-14 | |
| TRA concentration equivalents in plasma | Days 1-14 | |
| TRA concentration equivalents in whole blood | Days 1-14 | |
| Area under the curve (AUC) for plasma [14C]-AR882 | Profile from plasma in terms of AUC following a single dose of [14C]-AR882 | 7 Days |
| Time to maximum plasma concentration (Tmax) for [14C]-AR882 | Profile from plasma in terms of Tmax following a single dose of [14C]-AR882 | 7 Days |
| Maximum plasma concentration (Cmax) for [14C]-AR882 | Profile from plasma in terms of Cmax following a single dose of [14C]-AR882 | 7 Days |
| Apparent terminal half-life (t1/2) for [14C]-AR882 | Profile from plasma in terms of t1/2 following a single dose of [14C]-AR882 | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882 | Days 1-14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Lincoln | Nebraska | 68502 | United States |
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