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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01544673
First received: February 29, 2012
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Gram Positive Infection
Drug: linezolid
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in phagocytosis of gram-negative bacteria by neutrophils [ Time Frame: Baseline, day 4 and day 5 ] [ Designated as safety issue: Yes ]
  • Change from baseline in phagocytosis of gram-negative bacteria by monocytes [ Time Frame: Baseline, day 4 and day 5 ] [ Designated as safety issue: Yes ]
  • Change from baseline in interleukin-1 receptor antagonist secretion in response to lipopolysaccharide stimulation [ Time Frame: Baseline, day 4 and day 5 ] [ Designated as safety issue: Yes ]
  • Change from baseline in interleukin-1-beta secretion in response to lipopolysaccharide stimulation [ Time Frame: Baseline, day 4 and day 5 ] [ Designated as safety issue: Yes ]
  • Change from baseline in interleukin-6 secretion in response to lipopolysaccharide stimulation [ Time Frame: Baseline, day 4 and day 5 ] [ Designated as safety issue: Yes ]
  • Change from baseline in interleukin-8 secretion in response to lipopolysaccharide stimulation [ Time Frame: Baseline, day 4 and day 5 ] [ Designated as safety issue: Yes ]
  • Change from baseline in tumor necrosis factor alpha secretion in response to lipopolysaccharide stimulation [ Time Frame: Baseline, day 4 and day 5 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Linezolid peak concentration on day 4 [ Time Frame: day 4 ] [ Designated as safety issue: No ]
  • Linezolid peak concentration on day 5 [ Time Frame: day 5 ] [ Designated as safety issue: No ]
  • Linezolid trough concentration on day 5 [ Time Frame: day 5 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A Drug: linezolid
600 mg oral tablet twice daily for 4.5 days
Other Name: Zyvox
Placebo Comparator: Arm B Drug: Placebo
500 mg oral placebo twice daily for 4.5 days

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544673

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01544673     History of Changes
Other Study ID Numbers: A5951164
Study First Received: February 29, 2012
Last Updated: April 26, 2012
Health Authority: United States: IntegReview Ethical Review Board

Additional relevant MeSH terms:
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014