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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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This is a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of [14C]-plazomicin in healthy, adult male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-plazomicin | Drug | single intravenous dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sum of percent of total radioactivity recovered in urine and feces relative to the administered radioactive dose minus any radioactivity lost due to emesis | 15 days | |
| Total radioactivity concentration equivalents in plasma and blood | 15 days | |
| Plazomicin concentrations in plasma and urine | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | 21 days | |
| Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure) | 1 day | |
| Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Due to nature of radio-labeled drug studies and the inherent risk to fertility and reproduction, females are ineligible to participate in this study
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| Name | Affiliation | Role |
|---|---|---|
| Shyeilla Dhuria | Achaogen, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Lincoln | Nebraska | 68502 | United States |
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| 4 days |
| Physical examination | Screening |