A Study To Assess The Effect Of Linezolid On QTc Interval

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort 1: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous, Placebo control for blinding, Normal Saline, Single dose

Cohort 1: 900 mg linezolid

Group Type EXPERIMENTAL

Linezolid 900 mg

Intervention Type DRUG

Intravenous, 900 mg linezolid, single dose

Cohort 1: 1200 mg linezolid

Group Type EXPERIMENTAL

Linezolid 1200 mg

Intervention Type DRUG

Intravenous, 1200 mg linezolid, single dose

Cohort 2: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous, Placebo control for blinding, Normal Saline, Single dose

Cohort 2: 600 mg linezolid

Group Type EXPERIMENTAL

Linezolid 600 mg

Intervention Type DRUG

Intravenous, 600 mg linezolid, single dose

Cohort 2: 1200 mg linezolid

Group Type EXPERIMENTAL

Linezolid 1200 mg

Intervention Type DRUG

Intravenous, 1200 mg linezolid, single dose

Cohort 2: 400 mg Moxifloxacin

Group Type ACTIVE_COMPARATOR

Moxifloxacin 400 mg

Intervention Type DRUG

Oral, 400 mg moxifloxacin, single dose

Interventions

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Placebo

Intravenous, Placebo control for blinding, Normal Saline, Single dose

Intervention Type DRUG

Linezolid 900 mg

Intravenous, 900 mg linezolid, single dose

Intervention Type DRUG

Linezolid 1200 mg

Intravenous, 1200 mg linezolid, single dose

Intervention Type DRUG

Placebo

Intravenous, Placebo control for blinding, Normal Saline, Single dose

Intervention Type DRUG

Linezolid 600 mg

Intravenous, 600 mg linezolid, single dose

Intervention Type DRUG

Linezolid 1200 mg

Intravenous, 1200 mg linezolid, single dose

Intervention Type DRUG

Moxifloxacin 400 mg

Oral, 400 mg moxifloxacin, single dose

Intervention Type DRUG

Other Intervention Names

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Zyvox Zyvox Zyvox Zyvox Avelox

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects between the ages of 21 and 55 years.
* Body mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \> 45 kg (99 lbs).
* An informed consent document signed and dated.

Exclusion Criteria

* Evidence or history of clinically significant abnormality.
* 12-lead ECG demonstrating QTc \>450 msec at Screening.
* Receiving selective serotonin reuptake inhibitors (SSRIs) and/or sympathomimetic agents.
* Abnormal liver function tests.
* A positive urine drug screen, history of excessive alcohol and tobacco use.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes