M4 Receptor PET Radioligand Validation Study in Healthy Adults
A Validation Study of M4 Receptor PET Radioligand [11C]ABBV-112i in Healthy Subjects
A radioligand is a small amount of a radioactive imaging compound used during a positron emission tomography (PET) scan. This study aims to validate a new positron emission tomography (PET) ligand for measuring M4 receptors in the brain. M4 receptors are proteins that may play a role in various psychiatric and neurological conditions. This study will evaluate the PET ligand [11C]ABBV-112i in healthy adult participants to assess how well the ligand can measure the distribution of the M4 receptors across brain regions and the test-retest variability of the binding measurements.
研究概览
研究类型
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习联系方式
- 姓名：ABBVIE CALL CENTER
- 电话号码：844-663-3742
- 邮箱：abbvieclinicaltrials@abbvie.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- BMI is >= 18.5 to <= 29.9 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Exclusion Criteria:
- History of previous radiation exposure for research purposes such that participation in this study will result in cumulative ionizing radiation exposure >10 mSv in the past 12 months, in addition to normal background exposure
- Unable or unwilling to undergo CT, PET, or arterial cannulation procedures.
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：[11C]ABBV-112i
Participants will receive two single intravenous bolus doses of [11C]ABBV-112i, with each dose followed by up to approximately 90 minutes dynamic PET scan. |
Intravenous Bolus |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Regional brain volume of distribution (VT) of ABBV-112i across brain regions
大体时间：Up to Approximately Up to Day 1
|
VT defined as the ratio of radioligand concentration in the tissue region of interest to that observed in plasma at equilibrium. |
Up to Approximately Up to Day 1
|
合作者和调查者
赞助
调查人员
- 研究主任：ABBVIE INC.、AbbVie
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- M26-222
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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