drugset / Trial / NCT04575727

Exploratory Evaluation of [11C]MPC6827

NCT04575727 ↗

Phase 0 Completed 17 enrolled Columbia University
Non-randomizedSingle-groupOpen-labelBasic science

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.

Timeline

Start
2021-01-08
Primary completion
2024-06-21
Completion
2024-06-21

Drugs

EvaluationDrugModalityDoseRoute
Subject [11C]MPC6827 Diagnostic / imaging agent 10 ug Other
Subject [11C]MPC6827 Diagnostic / imaging agent 740 mbq Other