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Last Updated: December 8, 2021

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CLINICAL TRIALS PROFILE FOR ORBACTIV

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505(b)(2) Clinical Trials for ORBACTIV

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT02471690 ↗ Study to Evaluate the Safety,Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers Completed The Medicines Company Phase 1 2015-07-01 The protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a new formulation of oritavancin by adjusting infusion time, concentration and reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of oritavancin
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for ORBACTIV

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02340988 ↗ Drug-Drug Interaction Potential of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects Completed The Medicines Company Phase 1 2015-04-01 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.
NCT02452918 ↗ A Study to Evaluate the Safety of a Single IV Dose of Orbactiv (Oritavancin) in Subjects on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI) Completed The Medicines Company Phase 4 2015-06-01 This is a Phase 4, multicenter, open-label safety study of a single 1200 mg intravenous (IV) infusion of oritavancin in adult subjects on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. An additional group of patients with ABSSSI, who are not on concomitant warfarin therapy, will also be enrolled to obtain information regarding the potential for antibody production following a single dose of oritavancin administration in patients.
NCT02470702 ↗ Multiple Oritavancin Doses on Safety, Tolerability, and Pharmacokinetics in Healthy Subjects Completed The Medicines Company Phase 1 2015-06-01 This protocol describes a double-blind study to evaluate the safety and pharmacokinetics of multiple IV doses of 1200 mg ORBACTIV (oritavancin) in healthy subjects.
NCT02471690 ↗ Study to Evaluate the Safety,Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers Completed The Medicines Company Phase 1 2015-07-01 The protocol describes a double-blind study to evaluate the Pharmacokinetics and safety of a new formulation of oritavancin by adjusting infusion time, concentration and reconstitution/administration solutions, of a single 1200 mg intravenous (IV) infusion of oritavancin
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ORBACTIV

Condition Name

Condition Name for ORBACTIV
Intervention Trials
Healthy 3
Skin Diseases, Bacterial 1
Acute Bacterial Skin and Skin Structure Infection 1
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Condition MeSH

Condition MeSH for ORBACTIV
Intervention Trials
Skin Diseases, Bacterial 2
Infection 1
Communicable Diseases 1
Skin Diseases 1
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Clinical Trial Locations for ORBACTIV

Trials by Country

Trials by Country for ORBACTIV
Location Trials
United States 5
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Trials by US State

Trials by US State for ORBACTIV
Location Trials
Wisconsin 3
New Jersey 2
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Clinical Trial Progress for ORBACTIV

Clinical Trial Phase

Clinical Trial Phase for ORBACTIV
Clinical Trial Phase Trials
Phase 4 2
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for ORBACTIV
Clinical Trial Phase Trials
Completed 5
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Clinical Trial Sponsors for ORBACTIV

Sponsor Name

Sponsor Name for ORBACTIV
Sponsor Trials
The Medicines Company 5
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Sponsor Type

Sponsor Type for ORBACTIV
Sponsor Trials
Industry 5
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
AstraZeneca
Express Scripts
McKinsey
Harvard Business School

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