Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT02470702
Brief 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.
Study:
NCT02470702
Study Brief:
Protocol Section:
NCT02470702