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

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

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.

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).