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NCT02340988 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction Potential of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects
A Phase 1 study, sponsored by Melinta Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT02340988: Completed Phase 1 study, sponsored by Melinta Therapeutics.
NCT02340988 is a Phase 1 study that has completed, run by Melinta Therapeutics. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02340988, a Phase 1 study, has completed, sponsored by Melinta Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Single-Dose IV Oritavancin Diphosphate and Warfarin
- DRUG Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2015-04 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT02340988 record still lists
NCT02340988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Single-Dose IV Oritavancin Diphosphate and Warfarin is the first listed.
NCT02340988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02340988 about?
NCT02340988 is a clinical study titled "Drug-Drug Interaction Potential of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects". 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.
What is the current status of trial NCT02340988?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2015-04. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02340988?
The interventions under investigation include: Single-Dose IV Oritavancin Diphosphate and Warfarin (DRUG), Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose (DRUG).
Who is sponsoring clinical trial NCT02340988?
This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02340988's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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