NCT01613703已完成1 期
Open-Label, Single-Center, Single Dose Positron Emission Topography (PET) Using [11C]PBR28 to Evaluate Brain Translocator Protein 18KDa (TSPO) Occupancy of ONO-2952 in Healthy Adult 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
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for TSPO
研究概览
简要总结
The primary objective of this study is to evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for TSPO. The secondary objective is to evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952 and to investigate the safety and tolerability of ONO-2952 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smoking male or female subjects (18-55 inclusive)
- •Body mass index (BMI) of 19-35 kg/m2 (inclusive)
- •For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception
排除标准
- •History or presence of clinically significant disease
研究组 & 干预措施
Experimental
Experimental
干预措施: ONO-2952 (Drug)
结局指标
主要结局
To evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for TSPO
时间窗: 2 days
次要结局
- To evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952(2 days)
- To investigate the safety and tolerability of ONO-2952 in healthy adult subjects(14 days)
研究者
研究点 (1)
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