A Phase 1 interventional study of Single-Dose IV Oritavancin Diphosphate in Healthy, sponsored by Melinta Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Melinta Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
Melinta Therapeutics, Inc. is the lead sponsor of 30 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.
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Single-Dose IV Oritavancin Diphosphate
Drug: Single-Dose IV Oritavancin Diphosphate
Oritavancin will be administered as a single IV infusion. The infusion will last approximately 3 hours.
Also known as: Oritavancin Diphosphate
Change in the phenotyping measures of each probe drug in the absence and presence of oritavancin
Time frame: Day 1 through Day 5
Safety of probe drug administration and prolonged infusion of oritavancin as assessed by AEs/SAEs, clinical safety laboratory results, vital sign measurements, 12 lead ECG results, and physical examination findings
Time frame: Day 1 through Day 28
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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Melinta Therapeutics, Inc.