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

Gram Positive Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544673
• Other study ID #: A5951164
• Status: Completed
• Phase: Phase 1
• First received: February 29, 2012
• Last updated: April 26, 2012
• Start date: March 2012
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: IntegReview Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gram Positive Infection

Intervention

Drug:
• linezolid
600 mg oral tablet twice daily for 4.5 days
• Placebo
500 mg oral placebo twice daily for 4.5 days

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in phagocytosis of gram-negative bacteria by neutrophils		Baseline, day 4 and day 5	Yes
Primary	Change from baseline in phagocytosis of gram-negative bacteria by monocytes		Baseline, day 4 and day 5	Yes
Primary	Change from baseline in interleukin-1 receptor antagonist secretion in response to lipopolysaccharide stimulation		Baseline, day 4 and day 5	Yes
Primary	Change from baseline in interleukin-1-beta secretion in response to lipopolysaccharide stimulation		Baseline, day 4 and day 5	Yes
Primary	Change from baseline in interleukin-6 secretion in response to lipopolysaccharide stimulation		Baseline, day 4 and day 5	Yes
Primary	Change from baseline in interleukin-8 secretion in response to lipopolysaccharide stimulation		Baseline, day 4 and day 5	Yes
Primary	Change from baseline in tumor necrosis factor alpha secretion in response to lipopolysaccharide stimulation		Baseline, day 4 and day 5	Yes
Secondary	Linezolid peak concentration on day 4		day 4	No
Secondary	Linezolid peak concentration on day 5		day 5	No
Secondary	Linezolid trough concentration on day 5		day 5	No

External Links

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