A Study To Assess The Effect Of Linezolid On QTc Interval

Pfizer

Status and phase: Completed; Phase 1

Conditions: Bacterial Infections

Treatments: Drug: Moxifloxacin 400 mg; Drug: Placebo; Drug: Linezolid 900 mg; Drug: Linezolid 600 mg; Drug: Linezolid 1200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00795145

A5951151

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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49 participants in 7 patient groups, including a placebo group

Cohort 1: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Cohort 1: 900 mg linezolid

Experimental group

Treatment:

Drug: Linezolid 900 mg

Cohort 1: 1200 mg linezolid

Experimental group

Treatment:

Drug: Linezolid 1200 mg

Drug: Linezolid 1200 mg

Cohort 2: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Cohort 2: 600 mg linezolid

Experimental group

Treatment:

Drug: Linezolid 600 mg

Cohort 2: 1200 mg linezolid

Experimental group

Treatment:

Drug: Linezolid 1200 mg

Drug: Linezolid 1200 mg

Cohort 2: 400 mg Moxifloxacin

Active Comparator group

Treatment:

Drug: Moxifloxacin 400 mg