NCT01213355已完成1 期
A Randomized, Double-Blind, Sponsor Unblinded, Placebo Controlled, 5-Way, Crossover Study To Evaluate The Effects Of Single Oral Administrations of PF-05212377 (SAM-760), A 5-HT6 Antagonist, On Scopolamine Induced Deficits In Psychomotor And Cognitive Function In Healthy Young Adults
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
- 38
- 试验地点
- 1
- 主要终点
- Groton Maze Learning Task (Total Errors); included in CogState Battery of Tests.
研究概览
简要总结
It is hypothesized that PF-05212377 (SAM-760) will reverse scopolamine induced cognitive impairments in healthy adults subjects.
详细描述
Proof of mechanism
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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 male and/or female subjects of non child bearing potential (WONCBP) between the ages of 18 and 55 years, inclusive.
- •Body Mass index (BMI) of between 17.5 to 30.5 kg/m2 inclusive; and a total body weight greater than or equal to 50 kg (110 lbs).
排除标准
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
研究组 & 干预措施
Placebo
Experimental
placebo, plus scopolamine 0.5 mg
干预措施: Placebo (Drug)
Placebo
Experimental
placebo, plus scopolamine 0.5 mg
干预措施: scopolamine (Drug)
PF-05212377 5 mg, plus scopolamine 0.5 mg;
Experimental
干预措施: PF-05212377 (Drug)
PF-05212377 5 mg, plus scopolamine 0.5 mg;
Experimental
干预措施: scopolamine (Drug)
PF-05212377 20 mg, plus scopolamine 0.5 mg;
Experimental
干预措施: PF-05212377 (Drug)
PF-05212377 20 mg, plus scopolamine 0.5 mg;
Experimental
干预措施: scopolamine (Drug)
PF-05212377 60 mg, plus scopolamine 0.5 mg;
Experimental
干预措施: PF-05212377 (Drug)
PF-05212377 60 mg, plus scopolamine 0.5 mg;
Experimental
干预措施: scopolamine (Drug)
donepezil 10 mg, plus scopolamine 0.5 mg.
Active Comparator
干预措施: Donepezil (Drug)
donepezil 10 mg, plus scopolamine 0.5 mg.
Active Comparator
干预措施: scopolamine (Drug)
结局指标
主要结局
Groton Maze Learning Task (Total Errors); included in CogState Battery of Tests.
时间窗: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
次要结局
- Continuous Paired Associate Learning Task (Number of errors; included in CogState Test Battery)(Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period)
- Bond-Lader Visual Analog Scales (included in CogState Test Battery)(Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period)
- One Card Learning Task (Accuracy of performance; included in CogState Test Battery)(Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period)
- Identification Task (Speed; included in CogState Test Battery)(Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period)
- Detection Task (Speed; included in CogState Test Battery)(Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period)
研究者
研究点 (1)
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