NCT01137799

The Effect of JNJ-39393406 on Event Related Potentials in Stable Schizophrenic Patients

A Double-Blind, Placebo-Controlled, Randomized, Four-Way Cross-Over Study To Investigate Effect Of Single Oral Doses Of JNJ-39393406 On Event-Related Potentials In Subjects With Stable Schizophrenia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Janssen Pharmaceutica N.V., Belgium · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study in patients with stable schizophrenia will investigate the effect of JNJ-39393406 on Event Related Potentials (Auditory Evoked Potential \[AEP\] P50, AEP P300 and Mismatch Negativity \[MMN\]) after single dose administration.

Detailed description

This is a double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled, randomized (study drug assigned by chance), four-way-crossover trial (participants may receive different interventions sequentially during the trial) in patients with stable schizophrenia. The four-way-crossover treatment phase will consist of four blinded treatment periods separated by a wash out period (the period allowed for the entire administered drug to be eliminated from the body) of 6 to 14 days. The study duration for each patient will be approximately 12 weeks. Each patient enrolled will receive 3 (out of 5) dose levels of JNJ-39393406 and one dose of placebo. Part A of the study will include smoking patients with schizophrenia and will precede part B which will include non-smoking patients with schizophrenia. Safety evaluations include adverse event monitoring, vital signs and clinical laboratory tests. The study drug will be given as a single dose on Day 1 of each treatment period as a kind of liquid formulation with 240 mL non-carbonated water between 7:00 AM and 10:30 AM. Before dosing patients will be given a standard breakfast. The proposed dose levels for this study (Part A and Part B) will range from 10 to 200 mg.

Conditions

• Schizophrenia
• Alzheimer's Disease
• Cognition Disorders

Interventions

Type	Name	Description
DRUG	JNJ-39393406	50mg nanosuspension (sort of liquid formulation) once daily (single dose)
DRUG	placebo	Once daily (single dose)
DRUG	JNJ-39393406	200mg nanosuspension (sort of liquid formulation) once daily (single dose)
DRUG	JNJ-39393406	100mg nanosuspension (sort of liquid formulation) once daily (single dose)
DRUG	JNJ-39393406	10mg nanosuspension (sort of liquid formulation) once daily (single dose)
DRUG	JNJ-39393406	30mg nanosuspension (sort of liquid formulation) once daily (single dose)

Timeline

• Start date: 2009-08-01
• Completion: 2011-03-01
• First posted: 2010-06-04
• Last updated: 2012-11-08

Locations

4 sites across 1 country: Germany