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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Oritavancin will be administered as a single IV infusion simultaneously with Warfarin. The infusion will last approximately 3 hours.
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.
Spaulding Clinical
West Bend, Wisconsin, United States
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.
Time frame: Day 1-14
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).
Time frame: Day 1 through Day 21
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