NCT05320302已完成1 期
Interventional, Open-Label, Positron Emission Tomography (PET) Study With [11C]-Lu AF88370 Investigating Blood-Brain Barrier Penetration of Lu AF88370 in Healthy Men
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
- 6
- 试验地点
- 1
- 主要终点
- Whole Brain Total Distribution Volume (VT) of [11C]-Lu AF88370
研究概览
简要总结
The main goals of the study are to assess uptake and distribution of Lu AF88370 in the brain when given at tracer levels (microdose) in healthy young men.
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
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The participant has a body mass index (BMI) ≥18.5 and ≤30.0 kilograms (kg)/square meter (m^2) at the Screening Visit.
- •The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical and neurological examination, vital signs, an ECG, and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.
排除标准
- •The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives prior to the Screening Visit for any medication taken.
- •The participant has received a COVID-19 vaccination within the last 30 days before receiving first dose of study drug.
- •The participant has had surgery or trauma with significant blood loss <6 months prior to the first dose of the study drug.
- •The participant is exposed to significant levels of ionising radiation at work.
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
[11C]-Lu AF88370
Experimental
Participants will receive [11C]-Lu AF88370 via an intravenous cannula on Day 1.
干预措施: [11C]-Lu AF88370 (Drug)
结局指标
主要结局
Whole Brain Total Distribution Volume (VT) of [11C]-Lu AF88370
时间窗: Day 1
VT of [11C]-Lu AF88370 in Regions of Interest (ROI)
时间窗: Day 1
次要结局
未报告次要终点
研究者
研究点 (1)
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