An Investigator And Subject-Blind, Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Doses Of PF-04447943 In Healthy Elderly Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints
研究概览
简要总结
To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects.
详细描述
Additional Study Purpose Details: Phase I safety and pharmacokinetics study.
Detailed Description:
The study was terminated on 11/12/2008. There were no safety findings in this trial that resulted in the decision to terminate the trial. The study was closed in order to change the amount of drug that subjects would take and to shorten the number of days that the drug would be taken in a new study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Evidence or history of clinically significant unstable disease
研究组 & 干预措施
PF-04447943 05 mg dose
干预措施: PF-04447943 (Drug)
PF-04447943 15 mg dose
干预措施: PF-04447943 (Drug)
PF-04447943 45 mg dose
干预措施: PF-04447943 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints
时间窗: 14 days
Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax
时间窗: 14 days
次要结局
- Changes in cognition from baseline(14 days)