A Study To Assess The Effect Of Linezolid On QTc Interval

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NCT00795145

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Study Location
Pfizer Investigational Site
Singapore, , 188770, Singapore
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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 CenterPfizer
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