NCT01097876已完成1 期
A Phase 1, Double-Blind, Placebo-Controlled, Sponsor Open, Randomized, Multiple Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04447943 In Healthy Volunteers When Combined With Donepezil
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
- Steady state PF 04447943 Cmax and AUCtau.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil.
详细描述
Evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil.
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female of non-childbearing potential subjects between the ages of 21 and 55 years, inclusive (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).
- •Pregnant or nursing females; females of childbearing potential.
研究组 & 干预措施
Active PF-04447943
Experimental
干预措施: PF-04447943 25 mg (Drug)
Placebo PF-04447943
Placebo Comparator
干预措施: Placebo PF (Drug)
结局指标
主要结局
Steady state PF 04447943 Cmax and AUCtau.
时间窗: up through day 44
Steady state Donepezil Cmax and AUCtau.
时间窗: up through day 44
Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical examinations, and adverse events.
时间窗: up through day 44
次要结局
- There are no Secondary Endpoints(There are no Secondary Endpoints)
研究者
研究点 (1)
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