NCT00681720已完成1 期
An Open Label Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325 After Oral Administration to Healthy Volunteers
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
- 4
- 试验地点
- 1
- 主要终点
- Positron emission tomography using the radioligand (11C)flumazenil
研究概览
简要总结
The study is carried out in order to determine the relationship between the dose of AZD7325 and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to the GABAA receptors.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 18-30 kg/m2 and weight of 60-100 kg
- •Clinically normal physical findings, medical history and laboratory values.
排除标准
- •Clinically significant illness or clinical relevant trauma within 2 weeks before the study start.
- •Intake of another investigational drug or participation in a clinical study the past 12 weeks.
- •Previous participation in a PET study within the past 12 months. Suffer from claustrophobia and would be unable to undergo MRI (magnetic resonance imaging) or PET scanning.
研究组 & 干预措施
1
Experimental
干预措施: AZD7325 (Drug)
1
Experimental
干预措施: Radioligand (11C) flumazenil (Drug)
结局指标
主要结局
Positron emission tomography using the radioligand (11C)flumazenil
时间窗: 4 times per subject
次要结局
- To assess safety of AZD7325 by assessment of adverse events, vital signs, ECGs, physical examination, psychometric tests and laboratory variables.(6 visits with tests for the 2 subjects in the first group (Panel 1). 7 visits with tests for the 2 subjects in the second group (Panel 2). Some tests will be done several times per visit. All tests will not be done at every visit)
- Investigate the pharmacokinetics of AZD7325 following single doses of AZD7325 by assessment of drug concentration in plasma(3 times per subject. Up to 48 hours each time.)
研究者
研究点 (1)
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