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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo
干预措施: placebo (Drug)
active comparator
干预措施: active comparator (Drug)
PF-03635659
干预措施: Low Dose PF-03635659 (Drug)
PF-03635659
干预措施: Mid Dose PF-03635659 (Drug)
PF-03635659
干预措施: High Dose PF-03635659 (Drug)
结局指标
主要结局
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
时间窗: 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.
Maximum Observed Plasma Concentration (Cmax)
时间窗: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Dose Normalized Maximum Observed Plasma Concentration
时间窗: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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).
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: 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).
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration
时间窗: 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).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]
时间窗: 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-∞).
Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time
时间窗: 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).
Plasma Decay Half-Life (t1/2)
时间窗: 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.
次要结局
- Peak Forced Expiratory Volume in 1 Second (FEV1)(Baseline up to 48 hrs post-dose)
- Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response(Baseline up to 24.5 hrs post-dose)
- Change From Baseline in Force Vital Capacity (FVC)(Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose)
- Change From Baseline in Inspiratory Capacity (IC)(Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose)