MedTrace Logo

Oritavancin on the Results of Multiple Coagulation Tests in Healthy Volunteers

NCT02357524 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-12-19

No results posted yet for this study

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).

Conditions

  • Healthy Volunteers

Interventions

DRUG

Oritavancin

Sponsors & Collaborators

  • Christchurch Clinical Studies Trust Ltd

    collaborator INDUSTRY

  • Melinta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Information · Melinta Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • New Zealand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02357524 on ClinicalTrials.gov