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An Open-Label Study to Assess the Drug-Drug Interaction Potential of a Single 1200 mg IV Dose of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects.
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.
Details
| Lead sponsor | Melinta Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2015-04 |
| Completion | 2015-09 |
Conditions
- Healthy
Interventions
- Single-Dose IV Oritavancin Diphosphate and Warfarin
- Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose
Primary outcomes
- 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. — Day 1-14
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.
Countries
United States