drugset
drugset / Trial / NCT02169973

A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand 11C-MK-3168 and the Blocking of the Retention of the Ligand in the Human Brain by JNJ-42165279

NCT02169973 ↗

Phase 1 Completed 15 enrolled Janssen Research & Development, LLC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to measure the uptake, distribution, and clearance of 11C-MK-3168 by Positron Emission Tomography (PET) scan and to model the tissue specific kinetics of 11C-MK-3168 with the appropriate input function in human brain in Part A; to measure blocking of retention of 11C-MK-3168 at the estimated time to maximum plasma concentration after dosing (tmax) following each single oral doses of JNJ-42165279 and model the exposure/enzyme interaction of JNJ-42165279 in Part B; to measure the saturation of enzyme inhibition in the brain at steady state plasma concentrations of JNJ-42165279 (on Day 8) after 7 once-daily doses of JNJ-42165279 by conducting PET studies with 11C-MK-3168 at trough plasma concentrations on Day 2 in Part C.

Timeline

Start
2014-02
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject 11C-MK-3168 Diagnostic / imaging agent 185 mbq Intravenous
Subject 11C-MK-3168 Diagnostic / imaging agent 370 mbq Intravenous
Subject JNJ-42165279 Small molecule 100 mg Oral
Subject JNJ-42165279 Small molecule 250 mg Oral

Indications

No indication recorded.