NCT01762839

A Study to Assess the Cardiac Safety of Oritavancin in Healthy Participants

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Design, Study With an Open-Label Positive-Control, to Assess the Cardiac Safety of Oritavancin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study was to generate cardiac safety data using a supratherapeutic oritavancin dose of 1600 milligrams (mg).

Detailed description

This study was a single-center, double-blind, randomized, placebo-controlled, parallel-design study with an open-label, positive-control moxifloxacin arm to evaluate the effect of supratherapeutic dose of oritavancin on the QT and QT corrected for pulse rate (QTc) intervals.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Single-Dose IV Oritavancin Diphosphate	Intravenous oritavancin was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours.
DRUG	Placebo	Intravenous placebo was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours.
DRUG	Moxifloxacin	Participants randomized to the open-label moxifloxacin treatment arm only received a 400-mg moxifloxacin tablet and did not receive a placebo infusion.

Timeline

• Start date: 2012-12-27
• Primary completion: 2013-01-01
• Completion: 2013-02-11
• First posted: 2013-01-08
• Last updated: 2024-02-01

Locations

1 site across 1 country: United States