NCT02357524

Oritavancin on the Results of Multiple Coagulation Tests in Healthy Volunteers

A Single Center, Open-label Study to Evaluate the Effects of a Single 1200mg IV Dose of Oritavancin on the Results of Multiple Coagulation Tests in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study will determine the magnitude and duration (time to resolution i.e., returning to normal ranges) of elevations in the following coagulation test results after a single 1200 mg dose of oritavancin: Prothrombin Time/International Normalized Ratio (PT/INR), Activated clotting time (ACT), Activated Partial Thromboplastin Time (APTT), Chromogenic Factor Xa Assay, D-dimer, Silica Clot Time and Dilute Russell's Viper Venom Time (DRVVT).

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. Antibiotics of this class (lipoglycopeptide and lipopeptide antibiotics) artificially prolong phospholipid-dependent coagulation tests such as prothrombin time (PT) and activated partial thromboplastin time (aPTT) by binding to and preventing the action of the phospholipid reagents needed to activate coagulation. Because precipitation of oritavancin has been shown to occur in human plasma at concentrations as low as 50 μg/mL in vitro, a relevant approach to further elucidate the full range of effects of oritavancin plasma concentrations on coagulation testing would be to conduct a clinical study in healthy volunteers in which coagulation tests are monitored following a single 3 hour infusion of 1200 mg oritavancin. The data from this study will help inform physicians about how to manage patients who require coagulation monitoring in the setting of treatment with oritavancin.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Oritavancin

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2015-02-06
• Last updated: 2023-12-19

Locations

1 site across 1 country: New Zealand