Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Males

April 26, 2012 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm B
Drug: Placebo
500 mg oral placebo twice daily for 4.5 days
Active Comparator: Arm A
Drug: linezolid
600 mg oral tablet twice daily for 4.5 days
Other Names:
  • Zyvox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in phagocytosis of gram-negative bacteria by neutrophils
Time Frame: Baseline, day 4 and day 5
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
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
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
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
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
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
Baseline, day 4 and day 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Linezolid peak concentration on day 4
Time Frame: day 4
day 4
Linezolid peak concentration on day 5
Time Frame: day 5
day 5
Linezolid trough concentration on day 5
Time Frame: day 5
day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

February 29, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

April 30, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5951164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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