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| Name | Class |
|---|---|
| World Wide Clinical Trials Early Phase Services, LLC | UNKNOWN |
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This is an open-label, single-dose, non-randomized study in healthy male subjects to characterize the mass balance, metabolic disposition, and identification of the metabolites and general metabolic pathways following administration of a single dose of IV solution containing 200 mg of PER977 plus a tracer amount of 14C PER977 in health male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C PER977 | Experimental | Open-label, single-dose, non-randomized study of 14C PER977 in six healthy male subjects |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C PER977 | Drug | Open-label, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Mass balance of PER977 and metabolite | To characterize the mass balance, metbaolic disposition, and identification of the metabolites and general metabolic pathways following administration of a single dose of IV solution containing 200 mg of PER977 plus a tracer amount of 14C PER977 to healthy male subjects | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | To assess the safety and tolerability of a single intravenous dose of 200 mg PER977 | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia A Zamora, MD | Worldwide Clinical Trials Early Phase Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials Early Phase Services | San Antonio | Texas | 78217 | United States |
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