NCT00686504已完成1 期
An Open Label, Non-randomized Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2066 After Oral Administration to Healthy Subjects
适应症
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
- 6
- 试验地点
- 1
- 主要终点
- Positron emission tomography using the radioligand radioligand [11C]AZ12713580
研究概览
简要总结
The study is carried out in order to determine the relationship between AZD2066 exposure and mGluR5 receptor occupancy in the brain and to demonstrate that AZD2066 can displace [11C]AZ12713580 from mGluR5 binding-sites in the Central Nervous System
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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent
- •BMI (Body Mass Index) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg
- •Normal MRI (Magnetic Resonance Imaging) scan at visit 2
排除标准
- •History of previous or ongoing psychiatric disease or condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders
- •History of psychotic disorder among first degree relatives (parents, siblings)
- •History of use of antipsychotic, antidepressant or anxiolytic (anxiety treatment) drugs, prescribed or non-prescribed use. History of antidepressants or anxiolytics for non-psychiatric conditions such as pain or post-operative insomnia is allowed
结局指标
主要结局
Positron emission tomography using the radioligand radioligand [11C]AZ12713580
时间窗: 4 times
次要结局
- To investigate the safety and tolerability of AZD2066 by assessment of Adverse Events (AEs), vital signs measurements (blood pressure and pulse), electrocardiogram (ECG), physical examination, clinical chemistry, haematology and urinalysis.(7 visits with tests for all subjects. Some tests will be done several times per visit. All tests will not be performed at every visit.)
- To investigate pharmacokinetics of AZD2066(15 times per subject. Up to 48 hours each time)
研究者
研究点 (1)
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