NCT00795145

A Study To Assess The Effect Of Linezolid On QTc Interval

Single Dose Safety, Tolerability And Pharmacokinetics Of Escalating Intravenous Doses Of Linezolid Followed By Evaluation Of The Effect Of Single Intravenous Doses Of Linezolid On QTc Interval In Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	Placebo	Intravenous, Placebo control for blinding, Normal Saline, Single dose
DRUG	Linezolid 900 mg	Intravenous, 900 mg linezolid, single dose
DRUG	Linezolid 1200 mg	Intravenous, 1200 mg linezolid, single dose
DRUG	Placebo	Intravenous, Placebo control for blinding, Normal Saline, Single dose
DRUG	Linezolid 600 mg	Intravenous, 600 mg linezolid, single dose
DRUG	Linezolid 1200 mg	Intravenous, 1200 mg linezolid, single dose
DRUG	Moxifloxacin 400 mg	Oral, 400 mg moxifloxacin, single dose

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-11-21
• Last updated: 2010-06-22
• Results posted: 2010-06-22

Locations

1 site across 1 country: Singapore