NCT02340988

Drug-Drug Interaction Potential of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Single-Dose IV Oritavancin Diphosphate and Warfarin	Oritavancin will be administered as a single IV infusion simultaneously with Warfarin. The infusion will last approximately 3 hours.
DRUG	Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose	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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-01-19
• Last updated: 2023-12-19

Locations

1 site across 1 country: United States