drugset / Trial / NCT03089918

A Study to Investigate the Regional Brain Kinetics of Brain Drug Transporters Using P-glycoprotein and Breast Cancer Resistance Protein Substrates and by Using the Positron Emission Tomography Ligand 11C-JNJ-63779586 in the Human Brain

NCT03089918 ↗

Phase 1 Completed 11 enrolled Janssen Research & Development, LLC
Non-randomizedParallel-groupOpen-labelBasic science

Summary

The purpose of this study is to investigate the total body biodistribution and radiation dosimetry of 11C-JNJ-63779586 by Positron Emission Tomography (PET) in healthy young adult males (Part A); to estimate and compare the uptake, distribution, and clearance of 11C-JNJ-63779586 in the brain by PET between mild Alzheimer Disease (AD) participants (males/females) and age- and gender-matched control participants (Part B), corrected for regional cerebral blood flow differences; and to model the tissue specific kinetics of 11C-JNJ-63779586 in human brain with the appropriate input function (IF) (Part B).

Timeline

Start
2017-05-17
Primary completion
2018-08-24
Completion
2018-08-24

Drugs

EvaluationDrugModalityDoseRoute
Subject 11C-JNJ-63779586 Unknown 370 mbq Intravenous

Indications