NCT01103726已完成1 期
Evaluation Of Regional Glucose Metabolism In Striatum As Measured By [18f]-Fluorodeoxyglucose Positron Emission Tomography Following Single Oral Dose Administration Of PF-02545920 In Healthy Subjects
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
- 34
- 试验地点
- 1
- 主要终点
- Glucose metabolic rates in striatum using standard Region of Interest (ROI) analysis method.
研究概览
简要总结
We hypothesize that PF-02545920 will increase glucose metabolism in a part of the brain called the striatum.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy right-handed male and female subjects between the ages of 18 and 55 years, inclusive
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
- •An informed consent document signed and dated by the subject
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
排除标准
- •Women of reproductive potential
- •History of agranulocytosis or movement disorder
- •Positron Emission Tomography (PET) or Magnetic Resonance Imaging (MRI) contraindications
研究组 & 干预措施
Stage 1
Experimental
干预措施: PF-02545920 (Drug)
Stage 1
Experimental
干预措施: Placebo (Drug)
Stage 2
Experimental
干预措施: PF-02545920 (Drug)
Stage 2
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Glucose metabolic rates in striatum using standard Region of Interest (ROI) analysis method.
时间窗: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
次要结局
- Whole brain glucose metabolic rate.(Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.)
- Relative glucose metabolic rate in striatum.(Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.)
- Glucose metabolic rate in striatal subregions: putamen and caudate nucleus.(Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.)
- Relative glucose metabolic rate in striatal subregions: putamen and caudate nucleus.(Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.)
- Glucose metabolic rate in striatum determined using data-driven ROI analysis method.(Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.)
- Relative glucose metabolic rate in striatum determined using data-driven ROI analysis method.(Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.)
- Effect size comparison between standard ROI and data-driven ROI analysis methods using both regional glucose metabolic rate and relative regional glucose metabolic rate.(Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.)
研究者
研究点 (1)
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