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临床试验/NCT04575727
NCT04575727已完成早期 1 期

Exploratory Evaluation of [11C]MPC6827 Pharmacokinetics With Positron Emission Tomography (PET)

Columbia University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年1月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
17
试验地点
1
主要终点
Estimation of clearance of [11C]MPC6827

研究概览

简要总结

This is a phase 0 study that will enable an assessment of biodistribution and estimation of absorbed dose in humans based on data collected from five healthy volunteers, which is typically the minimum number required by the FDA for first-in-human studies to assess dosimetry of a new tracer. The evaluation of the brain imaging of thirty additional subjects in the 2nd part of the study will lead to a descriptive assessment of the targeting and pharmacokinetics of MPC6827 in the brain and between normal and diseased brain.

详细描述

Neurodegenerative diseases are conditions where the brain cells break down, causing mental and/or physical impairment. Alzheimer's Disease is a neurodegenerative disorder that affects millions of individuals and causes irreversible memory loss and cognitive impairment. Amyotrophic lateral sclerosis is also and incurable disorder that causes patients irreversible paralysis, which results in death due to inability to breath and suffocation. These disease have been shown to be associated with abnormalities in an important scaffolding called microtubules, a cellular structure that help support the shape of the cells. This study will explore an experimental imaging test to see if it can be used to help doctors identify early microtubule changes. The test involves the injection of a radioactive compound that has been shown to go to cells and bind to microtubules. Special cameras called Positron Emission Tomography (PET)/CT cameras will be used to allow doctors to view where the radioactive compound goes in the body, as this is the first time this radiolabeled agent is being used in humans. In this study, doctors will give the new compound to up to five healthy volunteers to see where it goes in the body of people who presumable have normal microtubule function. Then doctors will give [11C]MPC6827 to up to 30 additional subjects (healthy controls and patients with Alzheimers Disease or ALS) to focus on imaging the brain for extended times. The research-imaging drug in this study is [11C]MPC6827. The radioactive drug in this study is experimental, meaning it is not approved by the FDA and can only be used in research studies.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • 未提供

排除标准

  • Participants with evidence of brain disease other than ALS or Alzheimer's Disease at the time of enrolment up to agent administration are to be excluded from the study.
  • Concomitant medication use that, in the judgement of the investigator, would make the participant inappropriate for enrolment.
  • Severe concurrent disease, infection, or medical co-morbidity that, in the judgement of the investigator, would make the participant inappropriate for enrolment.
  • Participants who are receiving other investigational radiation drugs.
  • Women who are pregnant or breast feeding.
  • Subjects who are unable to tolerate PET/CT imaging

研究组 & 干预措施

Health Volunteers

Experimental

In the first stage, five healthy human subjects will receive a microdose (10 µg) of [11C]MPC6827, immediately followed by whole body PET/CT to determine dosimetry and perform an initial safety evaluation of the radiotracer. A dose of 20 mCi [11C]MPC6827 will be administered and serial whole body PET scans will be acquired up to 2 hours post injection.

干预措施: [11C]MPC6827 (Drug)

Patients with Neurodegenerative Disorders

Experimental

Up to 30 patients with neurodegenerative disorders will receive a microdose (10 µg) of [11C]MPC6827 and be imaged dynamically for up to 90 minutes using PET/CT for research purposes.

干预措施: [11C]MPC6827 (Drug)

结局指标

主要结局

Estimation of clearance of [11C]MPC6827

时间窗: Up to 48 hours from injection

Serial venous blood draws (about 5 ml per sample) will be taken for estimation of clearance of \[11C\]MPC6827.

Biodistribution of [11C]MPC6827

时间窗: up to 48 hours from injection

Total body residence time and visual examination of whole body PET/CT images will be used to determine biodistribution of \[11C\]MPC6827.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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