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

NCT01544673 | Completed Phase 1

• 1 other identifier: A5951164
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Gram Positive Infection

Outcome Measures

Primary Outcomes (7)

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

  Baseline, day 4 and day 5

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

  Baseline, day 4 and day 5

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

  Baseline, day 4 and day 5

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

  Baseline, day 4 and day 5

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

  Baseline, day 4 and day 5

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

  Baseline, day 4 and day 5

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

  Baseline, day 4 and day 5

Secondary Outcomes (3)

• Linezolid peak concentration on day 4

  day 4

• Linezolid peak concentration on day 5

  day 5

• Linezolid trough concentration on day 5

  day 5

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Drug: linezolid

Arm B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

linezolid DRUG

600 mg oral tablet twice daily for 4.5 days

Also known as: Zyvox

Arm A

Placebo DRUG

500 mg oral placebo twice daily for 4.5 days

Arm B

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Linezolid

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 6, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 30, 2012

Record last verified: 2012-04

Locations

US (1)