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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 29, 2012

Last Updated Date

April 26, 2012

Start Date ^ICMJE

March 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01544673 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Gram Positive Infection

Intervention ^ICMJE

Drug: linezolid
600 mg oral tablet twice daily for 4.5 days

Other Name: Zyvox
Drug: Placebo
500 mg oral placebo twice daily for 4.5 days

Study Arm (s)

Active Comparator: Arm A
Intervention: Drug: linezolid
Placebo Comparator: Arm B
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Male

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01544673

Other Study ID Numbers ^ICMJE

A5951164

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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