Skip to main content
OpenTrials
Completed

NCT Number: NCT01544673

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gram Positive Infection

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Linezolid

Drug

600 mg oral tablet twice daily for 4.5 days

Other names: Zyvox

Placebo

Drug

500 mg oral placebo twice daily for 4.5 days

Primary outcomes

  1. Change from baseline in phagocytosis of gram-negative bacteria by neutrophils

    Time frame: Baseline, day 4 and day 5

  2. Change from baseline in phagocytosis of gram-negative bacteria by monocytes

    Time frame: Baseline, day 4 and day 5

  3. Change from baseline in interleukin-1 receptor antagonist secretion in response to lipopolysaccharide stimulation

    Time frame: Baseline, day 4 and day 5

  4. Change from baseline in interleukin-1-beta secretion in response to lipopolysaccharide stimulation

    Time frame: Baseline, day 4 and day 5

  5. Change from baseline in interleukin-6 secretion in response to lipopolysaccharide stimulation

    Time frame: Baseline, day 4 and day 5

  6. Change from baseline in interleukin-8 secretion in response to lipopolysaccharide stimulation

    Time frame: Baseline, day 4 and day 5

  7. Change from baseline in tumor necrosis factor alpha secretion in response to lipopolysaccharide stimulation

    Time frame: Baseline, day 4 and day 5

Secondary outcomes

  1. Linezolid peak concentration on day 4

    Time frame: day 4

  2. Linezolid peak concentration on day 5

    Time frame: day 5

  3. Linezolid trough concentration on day 5

    Time frame: day 5

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 6, 2012
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.