drugset / Trial / NCT00795145

A Study To Assess The Effect Of Linezolid On QTc Interval

NCT00795145

Phase 1 Completed 49 enrolled Pfizer
RandomizedCrossoverTriple-blindBasic science

Summary

The FDA has asked Pfizer to assess the risk of linezolid on QT interval (obtained from ECG readings) which could predispose patients to ventricular arrhythmias. This study is conducted to satisfy this requirement.

Timeline

Start
2008-12
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Linezolid Other / unclassified 600 mg Intravenous
Subject Linezolid Other / unclassified 900 mg Intravenous
Subject Linezolid Other / unclassified 1200 mg Intravenous
Comparator Moxifloxacin Small molecule 400 mg Oral