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The purpose of this study is to examine the effects of oritavancin on the in vivo activities of CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A, NAT 2, and XO using a Cooperstown 5 + 1 cocktail in an open label, single arm manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oritavancin | Experimental | Single-Dose IV Oritavancin Diphosphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-Dose IV Oritavancin Diphosphate | Drug | Oritavancin will be administered as a single IV infusion. The infusion will last approximately 3 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the phenotyping measures of each probe drug in the absence and presence of oritavancin | Day 1 through Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of probe drug administration and prolonged infusion of oritavancin as assessed by AEs/SAEs, clinical safety laboratory results, vital sign measurements, 12 lead ECG results, and physical examination findings | Day 1 through Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Sanabria, MD | Spaulding Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical | West Bend | Wisconsin | 53095 | United States |
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