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

NCT01137799 | Terminated Phase 1

• 1 other identifier: CR016762
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Schizophrenia; Alzheimer's Disease; Cognition Disorders

Keywords

symptomatic treatment; cognition; cognitive deficits; schizophrenia; Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Improvement of deficits (i.e. sensory gating deficits) in event related potentials like Auditory Evoked Potentials P50 and P300 and Mismatch Negativity.

  Predose and 2 and 5 hours post dose during each treatment period.

Secondary Outcomes (5)

• Improvement in continuous performance testing

  Predose, 2h and 5 post dosing during each treatment period

• Plasma concentrations of JNJ-39393406 (PK blood samples)

  Predose, 1h, 1h45, 3h, 4h45 and 6h postdose during each treatment period

• Number of patients with clinical significant changes in vitals signs

  Baseline, predose and 6h post dose during each treatment period and follow up visit.

• Number of patients with clinical significant changes in ECG parameters

  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

  baseline, predose and 6h post dose during each treatment period and Follow Up

Study Arms (6)

001

EXPERIMENTAL

JNJ-39393406 10mg nanosuspension (sort of liquid formulation) once daily (single dose)

Drug: JNJ-39393406

002

EXPERIMENTAL

JNJ-39393406 30mg nanosuspension (sort of liquid formulation) once daily (single dose)

Drug: JNJ-39393406

003

EXPERIMENTAL

JNJ-39393406 50mg nanosuspension (sort of liquid formulation) once daily (single dose)

Drug: JNJ-39393406

004

EXPERIMENTAL

JNJ-39393406 100mg nanosuspension (sort of liquid formulation) once daily (single dose)

Drug: JNJ-39393406

005

EXPERIMENTAL

JNJ-39393406 200mg nanosuspension (sort of liquid formulation) once daily (single dose)

Drug: JNJ-39393406

006

PLACEBO COMPARATOR

placebo Once daily (single dose)

Drug: placebo

Interventions

JNJ-39393406 DRUG

50mg nanosuspension (sort of liquid formulation) once daily (single dose)

003

placebo DRUG

Once daily (single dose)

006

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male between 18 and 55 years of age, inclusive
• A known history of schizophrenia of at least 12 months by the referring psychiatrist
• DSM-IV criteria for Schizophrenia (including all subtypes)
• Stable treatment for at least 3 months (minor changes are acceptable upon confirmation by the sponsor representative)
• Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population
• Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject source documents and initialed by the investigator
• BMI between 18 and 35 kg/m² inclusive (BMI = weight/height²)
• For the pharmacogenomic component of this study subjects must have signed a separate written informed consent indicating willingness to participate in Part 1 genetic testing (mandatory), and indicate either consent or refusal for Part 2 DNA storage. Subject participation in the genetic testing component of the study (Part 1) is mandatory. Participation in the DNA storage component (Part 2) is voluntary and refusal to participate will not result in ineligibility for the main part of the study

You may not qualify if:

• A DSM-IV axis I diagnosis other than schizophrenia
• Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening or admission. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable. Values of ALT/AST \< 2 fold the upper limit of normal will be allowed
• Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening. Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable
• QTcb \>470ms
• Treatment-resistant subjects (failure to respond to two different antipsychotic drugs in the past)
• PANSS scores \> 70
• Suicidal risk (assessed by the investigator such as, prior attempts to suicide, command hallucinations and / or hopelessness)
• Use of clozapine within 3 months before screening until follow-up
• Use of more than two antipsychotic drugs within 3 months before dosing until follow up

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (4)

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Erlangen, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Neuss, Germany

Location

Related Publications (1)

• Winterer G, Gallinat J, Brinkmeyer J, Musso F, Kornhuber J, Thuerauf N, Rujescu D, Favis R, Sun Y, Franc MA, Ouwerkerk-Mahadevan S, Janssens L, Timmers M, Streffer JR. Allosteric alpha-7 nicotinic receptor modulation and P50 sensory gating in schizophrenia: a proof-of-mechanism study. Neuropharmacology. 2013 Jan;64:197-204. doi: 10.1016/j.neuropharm.2012.06.040. Epub 2012 Jul 2.

  PMID: 22766391 DERIVED

MeSH Terms

Conditions

Schizophrenia; Alzheimer Disease; Cognition Disorders

Interventions

JNJ-39393406

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 4, 2010
• Study Start: August 1, 2009
• Study Completion: March 1, 2011
• Last Updated: November 8, 2012

Record last verified: 2012-11

Locations

DE (4)