A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Single Inhaled Doses Of Pf-05212372 In Healthy Subjects
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
- Urine pharmacokinetics
研究概览
简要总结
The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of PF-05212372.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
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.
- •Treatment with an investigational drug within the past 30 days (or local regulations) or 5 half-lives preceding the first dose of study medication.
研究组 & 干预措施
Cohort 1
Subjects will be assigned to receive either PF-05212372 or placebo in each period
干预措施: PF-05212372 (Drug)
Cohort 1
Subjects will be assigned to receive either PF-05212372 or placebo in each period
干预措施: Placebo (Drug)
Cohort 2
Subjects will be assigned to receive either PF-05212372 or placebo in each period
干预措施: PF-05212372 (Drug)
Cohort 2
Subjects will be assigned to receive either PF-05212372 or placebo in each period
干预措施: Placebo (Drug)
结局指标
主要结局
Urine pharmacokinetics
时间窗: up to 24 hours post dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 14 days
Plasma pharmacokinetics
时间窗: up to 72 hours post dose
Urine Pharmacodynamics
时间窗: up to 24 hours post dose
次要结局
未报告次要终点