NCT02470702

Multiple Oritavancin Doses on Safety, Tolerability, and Pharmacokinetics in Healthy Subjects

A Double-Blind Randomized Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple 1200 mg Dose Intravenous Oritavancin Infusions in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This protocol describes a double-blind study to evaluate the safety and pharmacokinetics of multiple IV doses of 1200 mg ORBACTIV (oritavancin) in healthy subjects.

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. The purpose of this study is to determine the (a) safety and tolerability and (b) pharmacokinetic profile of multiple doses of Oritavancin given over a 7-8 week period. Cohort 1 will consist of 14 subjects, randomized to receive a total of four doses of either oritavancin or placebo, given once every two weeks in a double-blind fashion. After completion of cohort 1, a Data Safety Monitoring Board will review the blinded safety data and pharmacokinetics (PK) for cohort 1 and determine whether to continue with cohort 2, modify cohort 2 or end the study. The cohorts for this study are sequential. Cohort 2 will consist of 14 subjects, randomized to receive a total of eight doses of either oritavancin or placebo (4 subjects) given once every week in a double-blind fashion.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oritavancin
DRUG	Placebo (D5W)

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-06-12
• Last updated: 2023-12-19

Locations

1 site across 1 country: United States