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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change from baseline in phagocytosis of gram-negative bacteria by neutrophils
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
Arm A
干预措施: linezolid (Drug)
Arm B
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in phagocytosis of gram-negative bacteria by neutrophils
时间窗: Baseline, day 4 and day 5
Change from baseline in phagocytosis of gram-negative bacteria by monocytes
时间窗: Baseline, day 4 and day 5
Change from baseline in interleukin-1 receptor antagonist secretion in response to lipopolysaccharide stimulation
时间窗: Baseline, day 4 and day 5
Change from baseline in interleukin-1-beta secretion in response to lipopolysaccharide stimulation
时间窗: Baseline, day 4 and day 5
Change from baseline in interleukin-6 secretion in response to lipopolysaccharide stimulation
时间窗: Baseline, day 4 and day 5
Change from baseline in interleukin-8 secretion in response to lipopolysaccharide stimulation
时间窗: Baseline, day 4 and day 5
Change from baseline in tumor necrosis factor alpha secretion in response to lipopolysaccharide stimulation
时间窗: Baseline, day 4 and day 5
次要结局
- Linezolid peak concentration on day 4(day 4)
- Linezolid peak concentration on day 5(day 5)
- Linezolid trough concentration on day 5(day 5)