NCT00686413已完成1 期
An Open Label Positron Emission Tomography (PET) Study Using 2-[18F]-F-A85380 to Determine α4β2 Neuronal Nicotinic Receptor Occupancy of AZD3480 After Oral Administration to Healthy Male Subjects (Non Nicotine Users)
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
- AstraZeneca
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Plasma concentration (AUC, Cmax, tmax)
研究概览
简要总结
The study is being performed in order to learn more about AZD3480 (potential as treatment for patients with Alzheimer's Disease) and to investigate how much of AZD3480 is bound to the nicotinic receptors in the brain at different concentrations of AZD3480 in blood, as well as to investigate the period of time for this binding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Physically Healthy volunteers
- •Genotyped with regard to CYP2D6
- •Normal MRI scan at Visit 2
排除标准
- •Known or suspected drug or alcohol abuse or positive drugs of abuse screen as judged by the investigator.
- •Participation in a PET examination as part of a scientific study during the past twelve months.
- •Prescribed or non-prescribed from two weeks prior to the first PET examination. Occasional paracetamol and nasal spray for congestion will be allowed as medication.
研究组 & 干预措施
1
Experimental
干预措施: AZD3480 (Drug)
2
Experimental
干预措施: 2-[18F]-F-A85380 (Radiation)
结局指标
主要结局
Plasma concentration (AUC, Cmax, tmax)
时间窗: During time period of the PET assessement
The whole brain uptake and regional distribution of radioligand 2-[18F]-F-A85380 following single intravenous (iv) microdose will be assessed (using derived radioactivity measurements).
时间窗: One on baseline day and one at the drug treatment day
次要结局
- SafetyAEs and vital signs.(During the whole study)
研究者
研究点 (1)
Loading locations...
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