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The purpose of this study is to assess the drug interaction potential and time course of the effect of oritavancin on warfarin pharmacokinetics in an open label, single arm manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oritavancin and Warfarin | Experimental | Oritavancin 1200 mg Single-Dose IV Oritavancin Diphosphate given simultaneously with 25mg dose of Warfarin |
|
| Warfarin 24 hours post dose | Experimental | 25mg dose of Warfarin given 24 hours post 1200 mg Single-Dose IV Oritavancin Diphosphate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-Dose IV Oritavancin Diphosphate and Warfarin | Drug | Oritavancin will be administered as a single IV infusion simultaneously with Warfarin. The infusion will last approximately 3 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure: Ratio of warfarin PK parameters - AUC and Cmax (area under the plasma concentration time curve and maximum plasma concentration) pre and post oritavancin dose and duration of effect. | Ratio of warfarin PK parameters - AUC and Cmax (area under the plasma concentration time curve and maximum plasma concentration) pre and post oritavancin dose and duration of effect. | Day 1-14 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measures: Safety of the administration of warfarin and oritavancin will be assessed according to clinical laboratory parameters, and adverse events (AEs) and serious adverse events | Safety of the administration of warfarin and oritavancin will be assessed according to clinical laboratory parameters, and adverse events (AEs) and serious adverse events (SAEs). | Day 1 through Day 21 |
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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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| Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose | Drug | Oritavancin will be administered as a single IV infusion and 24 hours post dose subjects will receive 25mg of Warfarin. The infusion will last approximately 3 hours. |
|
|
| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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