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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
47
50mg nanosuspension (sort of liquid formulation) once daily (single dose)
Once daily (single dose)
200mg nanosuspension (sort of liquid formulation) once daily (single dose)
Unnamed facility
Berlin, Germany
Unnamed facility
Erlangen, Germany
Unnamed facility
München, Germany
Unnamed facility
Neuss, Germany
Improvement of deficits (i.e. sensory gating deficits) in event related potentials like Auditory Evoked Potentials P50 and P300 and Mismatch Negativity.
Time frame: Predose and 2 and 5 hours post dose during each treatment period.
Improvement in continuous performance testing
Time frame: Predose, 2h and 5 post dosing during each treatment period
Plasma concentrations of JNJ-39393406 (PK blood samples)
Time frame: Predose, 1h, 1h45, 3h, 4h45 and 6h postdose during each treatment period
Number of patients with clinical significant changes in vitals signs
Time frame: Baseline, predose and 6h post dose during each treatment period and follow up visit.
Number of patients with clinical significant changes in ECG parameters
Time frame: baseline, predose and 6h post dose during each treatment period and follow up
Number of patients with clinical clinical significant changes in clinical laboratory parameters
Time frame: baseline, predose and 6h post dose during each treatment period and Follow Up
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100mg nanosuspension (sort of liquid formulation) once daily (single dose)
10mg nanosuspension (sort of liquid formulation) once daily (single dose)
30mg nanosuspension (sort of liquid formulation) once daily (single dose)