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CLINICAL TRIALS PROFILE FOR ORBACTIV

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
New Formulation	NCT03873987 ↗	Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients	Completed	Melinta Therapeutics, Inc.	Phase 1	2019-07-16	This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of oritavancin

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.

Clinical Trial Conditions for ORBACTIV

Condition Name

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

Condition MeSH

Condition MeSH for ORBACTIV
Intervention	Trials
Skin Diseases, Bacterial	4
Infections	2
Infection	1

Clinical Trial Locations for ORBACTIV

Trials by Country

Trials by Country for ORBACTIV
Location	Trials
United States	9

Trials by US State

Trials by US State for ORBACTIV
Location	Trials
New Jersey	3
Wisconsin	3
Illinois	1
California	1
Georgia	1

Clinical Trial Progress for ORBACTIV

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for ORBACTIV
Clinical Trial Phase	Trials
Completed	6
Not yet recruiting	1

Clinical Trial Sponsors for ORBACTIV

Sponsor Name

Sponsor Name for ORBACTIV
Sponsor	Trials
The Medicines Company	5
Melinta Therapeutics, Inc.	2

Sponsor Type

Sponsor Type for ORBACTIV
Sponsor	Trials
Industry	7