NCT00892944已完成1 期
An Open Label Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2516 After Oral Administration to 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
- AstraZeneca
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Positron emission tomography to determine if AZD2516 can displace the radioligand [11C]AZ12713580 and describe relationship between AZD2516 exposure and mGluR5 receptor occupancy
研究概览
简要总结
The purpose of this study is to determine if AZD2516 binds to mGluR5 receptors in the brain. This will then help to make accurate predictions of efficacy and dosing in the future development programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Normal MRI scan
- •Healthy male or non-fertile females
- •Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg
排除标准
- •History of disease or condition that may interfere with the objectives of the study
- •History of previous or ongoing psychiatric disease/condition
- •Concomitant medication
研究组 & 干预措施
1
Experimental
AZD2516
干预措施: AZD2516 (Drug)
结局指标
主要结局
Positron emission tomography to determine if AZD2516 can displace the radioligand [11C]AZ12713580 and describe relationship between AZD2516 exposure and mGluR5 receptor occupancy
时间窗: 1 Month: Baseline and 3 PET examinations
次要结局
- Safety and tolerability of AZD2516 by adverse events, vitals signs, ECG, body temperature and laboratory variables(Assessed at each visit from baseline to follow-up visit)
- To investigate the Pharmacokinetics of AZD2516(1 Month: 3 doses AZD2516 and 16 planned PK samples after each dose)
研究者
研究点 (1)
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