NCT00990756已完成1 期
A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03526299 In Healthy Male Subjects
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
- Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
研究概览
简要总结
The purpose of this study is to investigate safety and toleration of multiple inhaled doses as well as the time course of PF-03526299 concentration in the blood following dosing by dry powder inhaler.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects and females of non-childbearing potential between the ages of 21 and 55 years.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).
- •Subjects who had a normal chest X-ray in the previous 6 months prior to Screening
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •A positive urine drug screen.
- •History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.
研究组 & 干预措施
PF-03526299 1.396 mg
Experimental
干预措施: PF-03526299 (Drug)
PF-03526299 4mg
Experimental
干预措施: PF-03526299 (Drug)
结局指标
主要结局
Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
时间窗: 17 days
次要结局
- Pharmacokinetic parameters: Plasma Day 1: Cmax, Tmax, AUCτau.(Day 1 - 17)
- Plasma Day 7: Cmax, Tmax.(7 Days)
- Plasma Day 14: Cmax, Tmax, CL/F, AUCτau, t½, accumulation ratio, time to steady state.(14 Days)
研究者
研究点 (1)
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