A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
2016年1月22日 更新者：Pfizer
A Phase 2A, Double Blind, Placebo-Controlled, Single Dose, 5-Way Crossover Study Assessing The Pharmacodynamic, Pharmacokinetic And Safety Profiles Of Oral Inhaled PF-03635659 In Patients With Moderate Chronic Obstructive Pulmonary Disease.
PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease.
This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
22
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Berlin、德国、10117
- Pfizer Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
- Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88 lbs).
- Current smokers, or ex-smokers who have abstained from smoking for at least 6 months
Exclusion Criteria:
- Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
- History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
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oral inhaled formulation, single dose
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有源比较器：有源比较器
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oral inhaled formulation, single dose
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实验性的：PF-03635659
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oral inhaled formulation, single dose, low dose
oral inhaled formulation, single dose, mid dose
oral inhaled formulation, single dose, high dose
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
大体时间：Baseline, 24, 24.5 hrs post-dose
|
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath.
Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose.
Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period.
Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.
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Baseline, 24, 24.5 hrs post-dose
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Maximum Observed Plasma Concentration (Cmax)
大体时间：1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Dose Normalized Maximum Observed Plasma Concentration
大体时间：1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
大体时间：1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
大体时间：1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
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Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration
大体时间：1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
|
1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]
大体时间：1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞).
It was obtained from AUC (0 - t) plus AUC (t-∞).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
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Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time
大体时间：1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞).
It was obtained from AUC (0 - t) plus AUC (t-∞).
AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
|
1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
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Plasma Decay Half-Life (t1/2)
大体时间：1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
|
1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Peak Forced Expiratory Volume in 1 Second (FEV1)
大体时间：Baseline up to 48 hrs post-dose
|
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath.
Peak FEV1 was defined as change from baseline in maximum FEV1.
Maximum FEV1 = maximum forced expiratory volume in 1 second, recorded between 0.5 hrs to 48 hrs post-dose.
Baseline FEV1 value was calculated as average of two largest pre-dose readings on Day 1 for each period.
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Baseline up to 48 hrs post-dose
|
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Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response
大体时间：Baseline up to 24.5 hrs post-dose
|
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath.
Weighted average FEV1 was defined as the average area under the effect curve (AUEC) change from baseline FEV1 (the area under the FEV1 effect curve over 24.5 hrs post-dose for each study period corrected for the pre-dose baseline value) divided by 24.5.
Baseline FEV1 value was calculated as the average of two largest pre-dose readings on Day 1 for each period.
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Baseline up to 24.5 hrs post-dose
|
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Change From Baseline in Force Vital Capacity (FVC)
大体时间：Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose
|
FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible.
Baseline FVC value was calculated as average of two largest pre-dose readings on Day 1 for each period.
Change from baseline in FVC was the difference between FVC and baseline FVC.
|
Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose
|
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Change From Baseline in Inspiratory Capacity (IC)
大体时间：Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose
|
IC was the maximum volume of air that can be inhaled in to the lungs after breathing out normally.
Baseline IC value was calculated as average of two largest pre-dose readings on Day 1 for each period.
Change from baseline in IC was the difference between IC and baseline IC.
|
Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年1月1日
初级完成 (实际的)
2010年6月1日
研究完成 (实际的)
2010年6月1日
研究注册日期
首次提交
2009年12月15日
首先提交符合 QC 标准的
2009年12月15日
首次发布 (估计)
2009年12月16日
研究记录更新
最后更新发布 (估计)
2016年2月19日
上次提交的符合 QC 标准的更新
2016年1月22日
最后验证
2016年1月1日
更多信息
与本研究相关的术语
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