A Phase 1 interventional study of Single-Dose IV Oritavancin Diphosphate and Warfarin and Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose in Healthy, sponsored by Melinta Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Melinta Therapeutics, Inc. (part of CorMedix Therapeutics) · Phase 1, Interventional, and Treatment
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.
Melinta Therapeutics, Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
First submitted before Melinta Therapeutics, Inc. became part of CorMedix Therapeutics.
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Oritavancin 1200 mg Single-Dose IV Oritavancin Diphosphate given simultaneously with 25mg dose of Warfarin
Drug: Single-Dose IV Oritavancin Diphosphate and Warfarin
25mg dose of Warfarin given 24 hours post 1200 mg Single-Dose IV Oritavancin Diphosphate.
Drug: Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose
Oritavancin will be administered as a single IV infusion simultaneously with Warfarin. The infusion will last approximately 3 hours.
Also known as: Oritavancin Diphosphate
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.
Also known as: Oritavancin Diphosphate
Primary Outcome Measure: Ratio of warfarin PK parameters - AUC and Cmax (area under the plasma concentration time curve and maximum plasma concentration) pre and post oritavancin dose and duration of effect.
Ratio of warfarin PK parameters - AUC and Cmax (area under the plasma concentration time curve and maximum plasma concentration) pre and post oritavancin dose and duration of effect.
Time frame: Day 1-14
Secondary Outcome Measures: Safety of the administration of warfarin and oritavancin will be assessed according to clinical laboratory parameters, and adverse events (AEs) and serious adverse events
Safety of the administration of warfarin and oritavancin will be assessed according to clinical laboratory parameters, and adverse events (AEs) and serious adverse events (SAEs).
Time frame: Day 1 through Day 21
The record gives a start of Apr 2015, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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