CLINICAL TRIALS PROFILE FOR ORBACTIV
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505(b)(2) Clinical Trials for Orbactiv
| 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 |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >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 |
| NCT02925416 ↗ | Safety of Either a Single or Two IV Doses of Orbactiv in Subjects With ABSSSI | Completed | The Medicines Company | Phase 4 | 2017-01-01 | The purpose of this study is to evaluate the safety and tolerability of two 1200-mg IV infusions of oritavancin when administered one week apart. |
| 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 |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for Orbactiv
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