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

Completed · Phase 1 · Has a placebo group

Conditions studied: Gram Positive Infection

In brief

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.

Key facts

Study ID

NCT01544673

Run by

Pfizer

People needed

18

Starts

2012-03-01

Expected to finish

2012-04-01

Last updated by the study team

2012-04-30

Who can join

Age: 20 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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