NCT03347331已完成早期 1 期
First-in-man Study of [18F]-F13640, a PET Radiopharmaceutical for Functional 5-HT1A Receptor Imaging
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Binding potentials
研究概览
简要总结
This clinical assay is designed to validate that [18F]F13640 as a radiotracer of 5-HT1A functional receptors. A first group of healthy subjects underwent a PET scan with arterial blood sampling to determine the kinetic model of the tracer. A second group of healthy subjects underwent a classical test-retest study (i.e two distant PET scans) to determine the reproducibility of measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Subjects
- •Weight between 50 kg and 90 kg
- •Affiliated to a social security or similar scheme
- •Not subject to any legal protection measures
排除标准
- •Subjects with neurologic or psychiatric disease including all substance addictions
- •Daily smokers
- •Active infectious disease
- •MRI contraindications
- •PET contraindications determined with FDG injection
- •Subjects deprived of their liberty by judicial or administrative decision
- •Subjects unable to sign written consent for participation in the study.
- •Severe and progressive medical pathology
- •Volunteer who has exceeded the annual amount of compensation authorized for participation in research protocols
研究组 & 干预措施
Input function group
Experimental
Each subject underwent a 90 min acquisition PET scan with concomitant arterial blood sampling
干预措施: [18F]F13640 (Drug)
Test-retest group
Experimental
Each subject underwent 2 PET scans distant from 1 to 3 weeks
干预措施: [18F]F13640 (Drug)
结局指标
主要结局
Binding potentials
时间窗: 180 minutes
Binding potentials are calculated using compartimental modelling techniques.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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