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A Study To Assess The Effect Of Linezolid On QTc Interval

NCT00795145 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2010-06-22

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00795145 on ClinicalTrials.gov