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This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single IV infusion of [14C]-VVZ-149 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 72 hours following the start of infusion to measure total radioactivity and plasma drug concentrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VVZ-149 Injections | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-VVZ-149 | Drug | A single IV infusion of radio-labeled VVZ-149 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance | Sum of the percent of the total radioactivity recovered in urine and feces relative to the administered radioactivity dose | Day 15 |
| Total radioactivity (TRA) concentration equivalents in plasma | Day 15 | |
| TRA concentration equivalents in urine | Day 15 | |
| TRA concentration equivalents in feces | Day 15 | |
| Drug concentrations in plasma | Hour 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events | Day 15 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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