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A Study To Assess The Effect Of Linezolid On QTc Interval

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Infections

Intervention: Placebo (Drug); Linezolid 900 mg (Drug); Linezolid 1200 mg (Drug); Placebo (Drug); Linezolid 600 mg (Drug); Linezolid 1200 mg (Drug); Moxifloxacin 400 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome:

Cohort 1: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Cohort 2: Mean Time-Matched Difference in Time Corresponding to Beginning of Depolarization to Repolarization of the Ventricles, Corrected for Heart Rate Using Fridericia's Formula (QTcF Interval) Between Linezolid 600 mg and 1200 mg Compared to Placebo

Secondary outcome:

Cohort 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) and Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC Last)

Cohort 1: Maximum Observed Plasma Concentration (Cmax)

Cohort 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half-Life (t1/2)

Cohort 1: Clearance of Linezolid (CL)

Cohort 1: Steady-State Volume of Distribution (Vss)

Cohort 2: Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin and Placebo

Cohort 2: Mean Time-Matched Difference in Uncorrected QT Intervals Between Linezolid 600 mg and 1200 mg Compared to Placebo

Cohort 2: AUC Inf and AUC Last

Cohort 2: Cmax

Cohort 2: Tmax and t1/2

Cohort 2: CL

Cohort 2: Vss

Cohort 2: Number of Subjects With AEs and SAEs


Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.


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


- Abnormal liver function tests.

- A positive urine drug screen, history of excessive alcohol and tobacco use.

Locations and Contacts

Pfizer Investigational Site, Singapore 188770, Singapore
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: December 2008
Last updated: May 17, 2010

Page last updated: August 23, 2015

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