NCT04575727CompletedEarly phase 1
Exploratory Evaluation of [11C]MPC6827
Exploratory Evaluation of [11C]MPC6827 Pharmacokinetics With Positron Emission Tomography (PET)
Source: ClinicalTrials.gov · Last updated 13 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 29 Sept 2020
- Start date
- 8 Jan 2021
- Primary completion date
- 21 Jun 2024
- Lead sponsor
- Columbia University
- NCT number
- NCT04575727
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 17
- From 8 Jan 2021 to the primary completion date, 21 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Women who are pregnant or breast feeding.
- Subjects who are unable to tolerate PET/CT imaging
Who the study is looking for
- All volunteers must be 18 years of age or older, able to read, understand and voluntarily sign and informed consent document.
- Volunteers must have no current medical history of brain disease
- Negative pregnancy test if female of childbearing potential.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of study participation.
- All volunteers must be 18 years of age or older, able to read, understand and voluntarily sign and informed consent document.
- Subjects must have a diagnosis of Alzheimer's Disease or ALS for which they are under a physician's care.
- Subjects must have a negative pregnancy test if female of childbearing potential
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of the study participation.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cuimc / Nyp Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.