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NCT02471690 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers

A Phase 1 study, sponsored by The Medicines Company.

Completed
Registry status
Phase 1
Development phase
56
Enrollment target

NCT02471690: Completed Phase 1 study, sponsored by The Medicines Company.

NCT02471690 is a Phase 1 study that has completed, run by The Medicines Company. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02471690, a Phase 1 study, has completed, sponsored by The Medicines Company.

COMPLETED
Registry status
Phase 1
Development phase
56 participants
Enrollment target

Study Summary

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

Primary Outcome

A composite measure of the number and types of AE/SAEs encountered and relationship to time of dosing

Interventions

  • DRUG Dextrose
  • DRUG Oritavancin

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2015-07
Est. Completion 2016-04
Phase Phase 1
The Medicines Company

35 total trials

What the finished NCT02471690 record still lists

NCT02471690 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Dextrose is the first listed.

NCT02471690 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02471690 about?

NCT02471690 is a clinical study titled "Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers". 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

What is the current status of trial NCT02471690?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2015-07. Estimated completion is 2016-04.

What interventions are being tested in trial NCT02471690?

The interventions under investigation include: Dextrose (DRUG), Oritavancin (DRUG).

Who is sponsoring clinical trial NCT02471690?

This trial is sponsored by The Medicines Company, which has 35 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02471690's enrollment target sits among peer trials

56 902nd of 2000 higher than 1,083 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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Source: ClinicalTrials.gov NCT02471690, the US trial registry maintained by the National Library of Medicine. NCT02471690 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.