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Completed

NCT Number: NCT00795145

A Study To Assess The Effect Of Linezolid On QTc Interval

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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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

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

Linezolid 900 mg

Drug

Intravenous, 900 mg linezolid, single dose

Other names: Zyvox

Linezolid 1200 mg

Drug

Intravenous, 1200 mg linezolid, single dose

Other names: Zyvox

Linezolid 600 mg

Drug

Intravenous, 600 mg linezolid, single dose

Other names: Zyvox

Moxifloxacin 400 mg

Drug

Oral, 400 mg moxifloxacin, single dose

Other names: Avelox

Primary outcomes

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

    Time frame: From the time the subject had taken at least one dose of study treatment up to 5 weeks

    All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.

  2. 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

    Time frame: 0.5, 1, 2, 4, 8, 12, 24 hours post-dose

    The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for ventricular rate (VR) using the QT and VR from each electrocardiogram by Fridericia's formula (QTcF = QT divided by cube root of VR in seconds). A measure of dispersion is not available.

Secondary outcomes

  1. 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)

    Time frame: predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion

    AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.

    AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).

  2. Cohort 1: Maximum Observed Plasma Concentration (Cmax)

    Time frame: predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion

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

    Time frame: predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  4. Cohort 1: Clearance of Linezolid (CL)

    Time frame: predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion

    Drug clearance = Dose / AUC inf

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

    Time frame: predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion

    Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL

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

    Time frame: 0.5, 1, 2, 4, 8, 12, 24 hours post-dose

    A measure of dispersion is not available.

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

    Time frame: 0.5, 1, 2, 4, 8, 12, 24 hours post-dose

    A measure of dispersion is not available.

  8. Cohort 2: AUC Inf and AUC Last

    Time frame: Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose

    AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.

    AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).

  9. Cohort 2: Cmax

    Time frame: Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose

  10. Cohort 2: Tmax and t1/2

    Time frame: Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Tmax is the time to reach Cmax.

  11. Cohort 2: CL

    Time frame: Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose

    Drug clearance = Dose / AUC inf

  12. Cohort 2: Vss

    Time frame: Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose

    Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL

  13. Cohort 2: Number of Subjects With AEs and SAEs

    Time frame: From the time the subject had taken at least one dose of study treatment up to 5 weeks

    All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 21, 2008
Registry last updated
Jun 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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