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
- 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
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Subject who had a bacterial/viral infection within 2 weeks prior to the first dose of
- Subjects with current or prior neutropenia (eg, <1.4 x 109 neutrophils /L).
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Change from baseline in phagocytosis of gram-negative bacteria by neutrophils
Outcome Time Frame:
Baseline, day 4 and day 5
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United States: IntegReview Ethical Review Board
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