Subject And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 2-Way, 4-Period Crossover Study To Assess Effects Of PF-02545920 On Ketamine-Induced Aberrant Prefrontal Response To Associative Learning In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Lateral prefrontal cortex activation as measured by functional MRI (fMRI) BOLD imaging during causal learning and working memory tasks
研究概览
简要总结
To evaluate whether PF-02545920 reduces the effects of ketamine on brain activation during causal learning as measured by fMRI compared to placebo in healthy human subjects, and to evaluate whether behavioral measures of abnormal causal learning under ketamine are reduced by treatment with PF 02545920.
详细描述
The study was terminated on November 2, 2012 due to a reassessment of the likelihood of the study meeting its scientific objectives in light of data with the investigational drug obtained from another clinical study. The decision to terminate the trial was not based on any safety concerns.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects between the ages of 21 and 45 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). (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).
- •Right handed as determined by handedness questionnaire.
- •Able to read and write English as a primary language.
排除标准
- •Female subjects who are pregnant or breastfeeding.
- •Any evidence of significant psychosis-like symptoms.
- •Known sensitivity to ketamine.
研究组 & 干预措施
Saline/PF-02545920
Treatments are co-administered
干预措施: Saline (Other)
Saline/PF-02545920
Treatments are co-administered
干预措施: PF-02545920 (Drug)
Ketamine/PF-02545920
Treatments are co-administered
干预措施: Ketamine (Other)
Ketamine/PF-02545920
Treatments are co-administered
干预措施: PF-02545920 (Drug)
Saline/Placebo
Treatments are co-administered
干预措施: Saline (Other)
Saline/Placebo
Treatments are co-administered
干预措施: Placebo (Other)
Ketamine/Placebo
Treatments are co-administered
干预措施: Ketamine (Other)
Ketamine/Placebo
Treatments are co-administered
干预措施: Placebo (Other)
结局指标
主要结局
Lateral prefrontal cortex activation as measured by functional MRI (fMRI) BOLD imaging during causal learning and working memory tasks
时间窗: Day 1 of each treatment period
次要结局
- Lateral prefrontal cortex activation during causal learning and working memory tasks as measured by arterial spin labelling imaging(Day 1 of each treatment period)
- Causal learning task prediction error score for stimulus/outcome associations across 3 stages of learning and expectancy violation(Day 1 of each treatment period)
- N-back working memory task number correct(Day 1 of each treatment period)
- Positive and Negative Syndrome Scale (PANSS) positive and negative subscale total score(Day 1 of each treatment period)
- Clinician administered dissociative states scale (CADSS) total score(Day 1 of each treatment period)