Exploratory Evaluation of [11C]MPC6827
Completed · Early Phase 1
Conditions studied: Neurodegenerative Diseases, Alzheimer Disease, Amyotrophic Lateral Sclerosis
In brief
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.
Key facts
- Study ID
- NCT04575727
- Run by
- Columbia University
- People needed
- 17
- Starts
- 2021-01-08
- Expected to finish
- 2024-06-21
- Last updated by the study team
- 2025-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- 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
Where it is running
- Cuimc / Nyp — New York, New York, United States
Full record on ClinicalTrials.gov
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