NCT03693391

A Study to Investigate Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic Acid (AMPA Gamma 8) Receptor Occupancy of JNJ-64140284 With Newly Developed Transmembrane AMPA Receptor Regulatory Protein (TARP)-Gamma 8 Positron Emission Tomography (PET) [18F]JNJ-64511070 in Healthy Men

An Open-Label Study to Investigate the AMPAɣ8 Receptor Occupancy of JNJ-64140284 With the Newly Developed TARP-γ8 PET Tracer [18F]JNJ-64511070 in Healthy Men

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to measure the blocking of \[18F\]JNJ-64511070 binding in the brain at the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination (tmax) of JNJ-64140284 and determine the exposure/receptor interaction of JNJ-64140284 in healthy male participants following single oral dose administration of JNJ-64140284.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-64140284	Single dose of JNJ-64140284 up to 3 mg oral solution will be administered under fasted conditions.
DRUG	Fluorine-18 Labeled [18F]-JNJ-64511070	An intravenous (IV) bolus injection of 185 MegaBecquerel (MBq) \[18F\]JNJ-64511070 will be administered.

Timeline

• Start date: 2018-10-17
• Primary completion: 2019-03-02
• Completion: 2019-03-13
• First posted: 2018-10-03
• Last updated: 2025-04-27

Locations

1 site across 1 country: Belgium