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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Gram Positive Infection

Treatments

Drug: linezolid

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01544673

A5951164

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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).