Positron Emission Tomography Study of alpha2-adrenergic Receptors With [11C]Yohimbine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Binding potentials
研究概览
简要总结
The main purpose of this study is to model tissue specific kinetics of [11C]Yohimbine in healthy male participants by positron emission tomography (PET) and the appropriate arterial input function (part A) ; to determine the reproducibility of measures (classical test-retest study, part B1) and to measure the blocking of [11C]Yohimbine uptake in the brain following single oral dose administration of clonidine (part B2).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers
- •Age between 20 years and 35 years
- •Weight between 50kg and 90kg
- •Without neurologic or psychiatric history
- •Without head trauma history including loss of consciousness superior to 30 minutes.
- •Affiliated to a social security or similar scheme
- •Not subject to any legal protection measures
- •Participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions
排除标准
- •Allen test (assessing the arterial blood flow to the hand) indicating abnormal blood supply to the hand
- •Subject with orthostatic hypotension
- •Subject with alcohol or substance abuses history
- •Subject with somatic drug therapies
- •MRI contraindications (implanted or embedded metal objects in the head or body)
- •PET contraindications
- •Clonidine contraindications
- •Exposed to 1 millisievert or more of ionizing radiation in the year before the start of this study
- •Subject unable to sign written consent for participation in the study
研究组 & 干预措施
Part A : Imput function
Compartmental model of the volume of distribution of [11C]Yohimbine in Brain by PET
干预措施: [11C]Yohimbine (Drug)
Part B : validity of the measure
Part B1 : Test Retest Variability in the distribution of [11C]Yohimbine Part B2 : Percentage of alpha2-adrenergic receptor occupancy
干预措施: [11C]Yohimbine (Part B1) and [11C]Yohimbine + clonidine (Part B2) (Drug)
结局指标
主要结局
Binding potentials
时间窗: 180 minutes
Binding potentials are calculated using compartmental modelling techniques
次要结局
- Number of participants with adverse events as a measure of safety and tolerability(Up to 7 days after part B)