CLINICAL TRIALS PROFILE FOR ORITAVANCIN DIPHOSPHATE
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All Clinical Trials for oritavancin diphosphate
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01762839 ↗ | A Study to Assess the Cardiac Safety of Oritavancin in Healthy Volunteers | Completed | The Medicines Company | Phase 1 | 2013-01-01 | The purpose of the study is to generate cardiac safety data using a supratherapeutic oritavancin dose of 1600 mg. |
| NCT01784536 ↗ | Open Label Study Evaluating the Effects of a Single Oritavancin Infusion on Cytochrome P450 in Healthy Volunteers | Completed | The Medicines Company | Phase 1 | 2013-01-01 | The purpose of this study is to examine the effects of oritavancin on the in vivo activities of CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A, NAT 2, and XO using a Cooperstown 5 + 1 cocktail in an open label, single arm manner. |
| 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. |
| NCT05599295 ↗ | Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin | Not yet recruiting | Melinta Therapeutics, Inc. | Phase 2 | 2022-10-31 | This protocol describes a randomized, open-label study to evaluate the safety and tolerability of single-dose intravenous (IV) oritavancin diphosphate (oritavancin) versus standard of care (SoC) antibiotics for the treatment of pediatric subjects with acute bacterial skin and skin structure infections (ABSSSIs). This study involves two oritavancin products, ORBACTIV® and KIMYRSATM. Oritavancin is the active drug substance in both ORBACTIV and KIMYRSA. This study protocol distinguishes the differences between ORBACTIV and KIMYRSA by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data, and information and guidance that is not specific to ORBACTIV or KIMYRSA (i.e., applies to both). The study involves pharmacokinetic (PK) sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to subjects and their caregivers. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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