NCT04575727

Exploratory Evaluation of [11C]MPC6827

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Neurodegenerative Diseases
• Alzheimer Disease
• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	[11C]MPC6827	Subjects will receive a microdose ( 10 µg) of \[11C\]MPC6827 (dose of 20 mCi)

Timeline

• Start date: 2021-01-08
• Primary completion: 2024-06-21
• Completion: 2024-06-21
• First posted: 2020-10-05
• Last updated: 2025-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study