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A Study To Assess The Effect Of Linezolid On QTc Interval

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
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.

NCT00795145
Pfizer
Completed
A Study To Assess The Effect Of Linezolid On QTc Interval

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A Study To Assess The Effect Of Linezolid On QTc Interval
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Bacterial Infections
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
March 2009
March 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT00795145
A5951151
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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