Assessment of the Biodistribution and Safety of [18F]MNI-968 (Aka PF-06730110) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Whole body tomographic PET images will be obtained for 6 healthy volunteers, and reviewed visually for assessment of body organ distribution of radioactivity.
研究概览
简要总结
The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-968 as a D1 receptor targeted radiopharmaceutical.
详细描述
The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-968 as a D1 receptor targeted radiopharmaceutical. The specific objectives are:
- To determine the radiation dosimetry of [18F]MNI-968
- To assess the safety and tolerability of a single dose of [18F]MNI-968
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
[18F]MNI-968
To assess the safety and tolerability and to determine the radiation dosimetry of [18F]MNI-968.
干预措施: [18F]MNI-968 (Drug)
结局指标
主要结局
Whole body tomographic PET images will be obtained for 6 healthy volunteers, and reviewed visually for assessment of body organ distribution of radioactivity.
时间窗: 2 Months
Volumes of interest (VOI) will be placed on the visually identified source organs, and subsequently used for all the study PET frames. Activity within these volumes of interest is expressed in units of total radioactivity (kBq). Radioactivity will be corrected for body attenuation, but not for decay, and time activity data (TAC) generated for each source organ.
次要结局
未报告次要终点