Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-22 @ 3:58 AM
Study NCT ID:
NCT02470702
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2015-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Oritavancin Doses on Safety, Tolerability, and Pharmacokinetics in Healthy Subjects
Sponsor:
Melinta Therapeutics, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: