NCT02471690

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

A Randomized, Double-Blind, Single Center Cohort Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of a Single 1200MG IV Dose of Oritavancin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

Oritavancin has been approved in the United States for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. This is a Phase I, single center, double-blind, study evaluating the PK 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 in healthy adult subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oritavancin	IV - Single dose 1200 mg Oritavancin
DRUG	Dextrose	D5W 5% in Water

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-06-15
• Last updated: 2023-12-19

Locations

1 site across 1 country: United States