Assessment of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
研究概览
简要总结
The purpose of this study is to evaluate the biodistribution, safety and tolerability of a single dose of [18F]GTP1 as a tau targeted radiopharmaceutical in healthy Japanese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older 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
结局指标
主要结局
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
时间窗: Day 1
Decay corrected \[18F\]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID).
Source Organ Residence Time (Total Number of Disintegrations)
时间窗: Day 1
Source organ uptake and washout with calculation of total number of disintegrations (or residence time, or kinetic values) using the area under the time-activity curve divided by the injected dose of radiopharmaceutical
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
时间窗: Day 1
Radiation absorbed dose estimates based on the Medical Internal Radiation Dose (MIRD) methodology utilizing urine data and International Commission on Radiological Protection (ICRP) gastrointestinal (GI) tract kinetics
Percentage of Participants With Adverse Events
时间窗: Up to 5 days
An AE is the appearance or worsening of any undesirable sign, symptom, or medical condition, even if the event is not considered to be related to study drug. Study drug includes the investigational drug under evaluation during any phase of the study. Medical conditions/diseases present before starting study drug are only considered AEs if they worsen after starting study drug. Abnormal laboratory values or test results constitute AEs only if they induce clinical signs or symptoms, are considered clinically significant, or require therapy.
次要结局
未报告次要终点
