NCT01314885已完成1 期
Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study To Determine The Effects Of Single Inhaled Doses Of PF-03715455 (20 Mg) And PH-797804 (30 Mg) On Induced Sputum Neutrophils 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
- 39
- 试验地点
- 1
- 主要终点
- Post LPS sputum neutrophil % is being evaluated at the end of each treatment period to establish the effect of treatment on this endpoint
研究概览
简要总结
A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an internal control for the study.
详细描述
Proof of Mechanism
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Male or female (of non-child bearing potential) subjects, aged 18-50 years.
- •Subjects whose FEV1 and FVC at screening are both greater than or equal to 80% of their predicted value for age, race, sex and height.
- •Subjects who have normoresponsive airways.
- •Subjects who are able to successfully complete screening sputum inductions.
排除标准
- •Subjects who have evidence, on review of pre-study laboratory data and full physical examination, or history of any clinically significant hematological, renal, endocrine, gastrointestinal, dermatological, hepatic, psychiatric, neurologic diseases. Specifically liver function tests and CRP must be within the reference range.
- •Subjects with a medical history of asthma symptomatology (ie, wheeze and/or dyspnea at rest).
- •Subjects who have experienced a respiratory tract infection within the previous 4 weeks or any other infection within 1 week of dosing
研究组 & 干预措施
PF-03715455
Experimental
干预措施: PF-03715455 (Drug)
PH-797804
Experimental
干预措施: PH-797804 (Drug)
Placebo for PF-03715455
Placebo Comparator
干预措施: Placebo for PF-03715455 (Drug)
Placebo for PH-797804
Placebo Comparator
干预措施: Placebo for PH-797804 (Drug)
结局指标
主要结局
Post LPS sputum neutrophil % is being evaluated at the end of each treatment period to establish the effect of treatment on this endpoint
时间窗: 6 hours
次要结局
- Cell counts, IL-6, MPO, MCP-1, MIP1b are individual endpoints which will be evaluated in sputum however they are collected as a single sample.(6 hours)
- Post-LPS systemic inflammatory indices: Neutrophil count, IL-6, IL-10, MPO, MCP-1, MIP1b, fibrinogen, CC16 and CRP. These are individual endpoints which will be evaluated in blood however they are collected as a single sample.(1, 4, 6 and 7 hours)
- Number of participants with adverse events(Baseline, Day 1 and Day 2)
- Change from baseline in ECG parameters(Baseline, Day 1 and Day 2)
- Change from baseline in BP parameters(Baseline, Day 1 and Day 2)
- Change from baseline in lab safety parameters(Baseline, Day 1 and Day 2)
研究者
研究点 (1)
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