NCT03180762

A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64140284 in Healthy Participants

A 3-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64140284 in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration (ascending dose levels) under fasted condition, to characterize the pharmacokinetics (PK) of JNJ-64140284 in plasma, cerebrospinal fluid (CSF) and urine after single oral dose administration and to investigate the effect of food (high fat/high calorie) on the PK of JNJ-64140284 following single oral dose administration.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-64140284 0.1 mg	0.1 mg of JNJ-64140284 will be administered as an oral solution.
DRUG	JNJ-64140284 0.5 mg	0.5 mg of JNJ-64140284 will be administered as an oral solution.
DRUG	JNJ-64140284 2.5 mg	2.5 mg of JNJ-64140284 will be administered as an oral solution.
DRUG	JNJ-64140284 10 mg	10 mg of JNJ-64140284 will be administered as an oral solution.
DRUG	JNJ-64140284 50 mg	50 mg of JNJ-64140284 will be administered as an oral solution.
DRUG	JNJ-64140284 150 mg	150 mg of JNJ-64140284 will be administered as an oral solution.
DRUG	JNJ-64140284 (dose to be determined [TBD])	JNJ-64140284 (dose to be determined) will be administered as an oral solution.
DRUG	Placebo	Matching placebo will be administered.

Timeline

• Start date: 2017-05-30
• Primary completion: 2017-09-25
• Completion: 2017-09-25
• First posted: 2017-06-08
• Last updated: 2018-10-30

Locations

1 site across 1 country: Belgium