drugset / Trial / NCT03088644

A Study to Investigate P2X7 Receptor Occupancy by JNJ-54175446 With the Newly Developed P2X7 Receptor Positron Emission Tomography (PET) Tracer 18F-JNJ-64413739

NCT03088644

Phase 1 Completed 16 enrolled Janssen-Cilag International NV
Non-randomizedParallel-groupOpen-labelBasic science

Summary

The primary purpose of this study is to measure the whole body distribution and radiation dosimetry of 18F-JNJ-64413739 (Part A), to measure the uptake, distribution, and clearance (CL) of 18F-JNJ-64413739 in the brain of healthy male subjects by Positron Emission Tomography (PET) and to model tissue specific kinetics of 18F-JNJ-64413739 with the appropriate input function (IF) (Part B), to measure subject test retest variability in the distribution of 18F-JNJ-64413739 in the brain of healthy male subjects by comparing PET scans obtained at least 1 week apart (Part C) and following single oral dose administration of JNJ-54175446, to measure the blocking of 18F-JNJ-64413739 uptake in the brain at the time to reach maximum plasma concentration (tmax) of JNJ-54175446 and model the exposure/receptor interaction of JNJ-54175446 in healthy male subjects (Part D).

Timeline

Start
2017-03-24
Primary completion
2017-11-14
Completion
2017-11-14

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-JNJ-64413739 Diagnostic / imaging agent Intravenous
Subject JNJ-54175446 Small molecule 600 mg Oral

Indications

No indication recorded.