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

NCT ID: NCT01544673

Last Updated: 2012-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-04-30

Brief Summary

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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

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Conditions

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Gram Positive Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm A

Group Type ACTIVE_COMPARATOR

linezolid

Intervention Type DRUG

600 mg oral tablet twice daily for 4.5 days

Arm B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

500 mg oral placebo twice daily for 4.5 days

Interventions

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linezolid

600 mg oral tablet twice daily for 4.5 days

Intervention Type DRUG

Placebo

500 mg oral placebo twice daily for 4.5 days

Intervention Type DRUG

Other Intervention Names

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Zyvox

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5951164&StudyName=Effect%20of%20Linezolid%20on%20Ex%20Vivo%20Neutrophil%20and%20Monocyte%20Function%20in%20Healthy%20Males%20

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

Other Identifiers

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A5951164

Identifier Type: -

Identifier Source: org_study_id