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Trial record 1 of 1 for:    NCT01544673
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Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Males

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ClinicalTrials.gov Identifier: NCT01544673
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : April 30, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 29, 2012
First Posted Date  ICMJE March 6, 2012
Last Update Posted Date April 30, 2012
Study Start Date  ICMJE March 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2012)
  • Change from baseline in phagocytosis of gram-negative bacteria by neutrophils [ Time Frame: Baseline, day 4 and day 5 ]
  • Change from baseline in phagocytosis of gram-negative bacteria by monocytes [ Time Frame: Baseline, day 4 and day 5 ]
  • Change from baseline in interleukin-1 receptor antagonist secretion in response to lipopolysaccharide stimulation [ Time Frame: Baseline, day 4 and day 5 ]
  • Change from baseline in interleukin-1-beta secretion in response to lipopolysaccharide stimulation [ Time Frame: Baseline, day 4 and day 5 ]
  • Change from baseline in interleukin-6 secretion in response to lipopolysaccharide stimulation [ Time Frame: Baseline, day 4 and day 5 ]
  • Change from baseline in interleukin-8 secretion in response to lipopolysaccharide stimulation [ Time Frame: Baseline, day 4 and day 5 ]
  • Change from baseline in tumor necrosis factor alpha secretion in response to lipopolysaccharide stimulation [ Time Frame: Baseline, day 4 and day 5 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2012)
  • Linezolid peak concentration on day 4 [ Time Frame: day 4 ]
  • Linezolid peak concentration on day 5 [ Time Frame: day 5 ]
  • Linezolid trough concentration on day 5 [ Time Frame: day 5 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Males
Official Title  ICMJE An Open-label, Placebo-controlled Phase 1 Study to Evaluate the Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Male Subjects
Brief Summary Results from previous studies have been inconclusive and the effect of linezolid on cytokines remains unclear. This study is designed to evaluate the effect of linezolid on the functionality of white blood cells (neutrophils and monocytes) in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Gram Positive Infection
Intervention  ICMJE
  • Drug: linezolid
    600 mg oral tablet twice daily for 4.5 days
    Other Name: Zyvox
  • Drug: Placebo
    500 mg oral placebo twice daily for 4.5 days
Study Arms  ICMJE
  • Active Comparator: Arm A
    Intervention: Drug: linezolid
  • Placebo Comparator: Arm B
    Intervention: Drug: Placebo
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: February 29, 2012)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects between the ages of 20 and 45 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • Subject who had a bacterial/viral infection within 2 weeks prior to the first dose of study medication.
  • Subjects with current or prior neutropenia (eg, <1.4 x 109 neutrophils /L).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01544673
Other Study ID Numbers  ICMJE A5951164
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2012

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