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Trial record 1 of 1 for:    NCT00795145
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A Study To Assess The Effect Of Linezolid On QTc Interval

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00795145
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : June 22, 2010
Last Update Posted : June 22, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 20, 2008
First Posted Date  ICMJE November 21, 2008
Results First Submitted Date  ICMJE March 2, 2010
Results First Posted Date  ICMJE June 22, 2010
Last Update Posted Date June 22, 2010
Study Start Date  ICMJE December 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2010)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2008)
  • Cohort 2: Assessment of the effect on QT interval [ Time Frame: 31-Mar-2009 ]
  • Cohort 1: Assessment of safety and tolerability [ Time Frame: 31-Jan-2009 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2010)
  • 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).
  • 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 ]
  • 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.
  • 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
  • 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
  • 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.
  • 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.
  • 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).
  • Cohort 2: Cmax [ Time Frame: Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose ]
  • 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.
  • Cohort 2: CL [ Time Frame: Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose ]
    Drug clearance = Dose / AUC inf
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2008)
  • Cohort 1: Safety and Pharmacokinetics [ Time Frame: 31-Jan-2009 ]
  • Cohort 2: QT interval, Pharmacokinetics, and Safety [ Time Frame: 31-Mar-2009 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Assess The Effect Of Linezolid On QTc Interval
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Bacterial Infections
Intervention  ICMJE
  • Drug: Placebo
    Intravenous, Placebo control for blinding, Normal Saline, Single dose
  • Drug: Linezolid 900 mg
    Intravenous, 900 mg linezolid, single dose
    Other Name: Zyvox
  • Drug: Linezolid 1200 mg
    Intravenous, 1200 mg linezolid, single dose
    Other Name: Zyvox
  • Drug: Linezolid 600 mg
    Intravenous, 600 mg linezolid, single dose
    Other Name: Zyvox
  • Drug: Moxifloxacin 400 mg
    Oral, 400 mg moxifloxacin, single dose
    Other Name: Avelox
Study Arms  ICMJE
  • Placebo Comparator: Cohort 1: Placebo
    Intervention: Drug: Placebo
  • Experimental: Cohort 1: 900 mg linezolid
    Intervention: Drug: Linezolid 900 mg
  • Experimental: Cohort 1: 1200 mg linezolid
    Intervention: Drug: Linezolid 1200 mg
  • Placebo Comparator: Cohort 2: Placebo
    Intervention: Drug: Placebo
  • Experimental: Cohort 2: 600 mg linezolid
    Intervention: Drug: Linezolid 600 mg
  • Experimental: Cohort 2: 1200 mg linezolid
    Intervention: Drug: Linezolid 1200 mg
  • Active Comparator: Cohort 2: 400 mg Moxifloxacin
    Intervention: Drug: Moxifloxacin 400 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2008)
49
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00795145
Other Study ID Numbers  ICMJE A5951151
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP