Interventional Open-Label Positron Emission Tomography Study Investigating Blood-Brain-Barrier Penetration and Pharmacokinetic Properties of [11C]-Lu AF90103 in Healthy Young Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Area Under the Time-Activity Curves for Brain up to 90 Minutes (AUCbrain 0-90 min)
研究概览
简要总结
The main goals of the study are to assess uptake and distribution of Lu AF90103 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 45 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 examination; vital signs; an electrocardiogram (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 or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
- •The participant has had surgery or trauma with significant blood loss <3 months prior to the first dose of study drug.
- •The participant is exposed to significant levels of ionizing radiation at work. Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
[11C]-Lu AF90103
Participants will receive [11C]-Lu AF90103 via an intravenous bolus injection on Day 1.
干预措施: [11C]-Lu AF90103 (Drug)
结局指标
主要结局
Area Under the Time-Activity Curves for Brain up to 90 Minutes (AUCbrain 0-90 min)
时间窗: Day 1 (predose and up to 90 minutes postdose)
Area Under the Blood Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCblood 0-90 min)
时间窗: Day 1 (predose and up to 90 minutes postdose)
Area Under the Plasma Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCplasma 0-90 min)
时间窗: Day 1 (predose and up to 90 minutes postdose)
Whole Brain-to-Plasma Ratio Expressed by AUCbrain 0-90 min/AUCplasma 0-90 min
时间窗: Day 1 (predose and up to 90 minutes postdose)
Total Distribution Volume in the Whole Brain (VT brain)
时间窗: Day 1 (predose and up to 90 minutes postdose)
Ratio Between the Free Concentrations [11C]-Lu AF90103 in Brain Tissue and Plasma (Kp,uu)
时间窗: Day 1 (predose and up to 90 minutes postdose)
次要结局
未报告次要终点