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Exploratory Evaluation of [11C]MPC6827

NCT04575727 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-04-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

[11C]MPC6827

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

Sponsors & Collaborators

Principal Investigators

  • Akiva Mintz, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-08
Primary Completion
2024-06-21
Completion
2024-06-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575727 on ClinicalTrials.gov