NCT02084485已完成1 期
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study to Determine the Effects of a Single Oral Dose of Ph-797804 on Induced Sputum Inflammatory Markers Following Inhaled Lipopolysaccharide (Lps) Challenge in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Sputum Cell Counts
研究概览
简要总结
The study was performed to assess the effect of PH-797804 on neutrophils (white cells) in the sputum after a challenge with an endotoxin (inhaled LPS). Neutrophils are a sign of inflammation and PH-797804 is being developed as a potential anti-inflammatory treatment for patients with Chronic Obstructive Pulmonary Disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female (WONCBP), non atopic volunteers aged 18-50 years
- •Able to produce sputum
排除标准
- •Current Smokers
- •Abnormal liver function test
- •Respiratory Tract Infection within 4 weeks
研究组 & 干预措施
Arm A
Experimental
干预措施: PH-797804 (Drug)
Arm B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Sputum Cell Counts
时间窗: 6 hours post LPS challenge
Neutrophil \& Macrophage count (total and differential)
Sputum Cytokines
时间窗: 6 hours post LPS challenge
TNF-α, MIP-1β, IL-6, MPO, MCP-1, GRO-α
次要结局
- Systemic Inflammatory Indices(1, 4, 6 and 7 hours post LPS)
研究者
研究点 (1)
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