NA

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2010-023369-23-ES
• Date of registration: 03/11/2011
• Prospective Registration: No
• Primary sponsor: Janssen-Cilag International NV
• Public title: NA
• Scientific title: FIRST-IN-PATIENT STUDY TO ASSESS THE SAFETY ANDTOLERABILITY AND TO EXPLORE THE POTENTIAL THERAPEUTIC EFFICACY OF A NOVEL GLUTAMATE MODULATOR AS MONOTHERAPY AND AS ADD-ON THERAPY IN PATIENTS WITH SCHIZOPHRENIA - NA
• Date of first enrolment: 13/09/2011
• Target sample size: 105
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023369-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Open for patients in Part A. Double-blind and open label phase for patients in Part B.; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Bulgaria, Germany, Spain

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen Research and Development, a Division of Janssen Pharmaceutica NV

• Name: Clinical Registry Group
• Affiliation: Janssen Research and Development, a Division of Janssen Pharmaceutica NV

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female between 18 and 65 years of age, inclusive
2. Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive (BMI =
weight/height2)
3. Medically stable on the basis of physical examination, medical history,
vital signs and 12-lead ECG performed at screening.
4. 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 not be clinically significant or to be appropriate and
reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the
investigator.
5. In- or outpatients who have been diagnosed with schizophrenia
according to DSM-IV (295.10, 295.20, 295.30, 295.60, 295.90) at least 1
year prior to screening.
6. Known by the recruiting or referring psychiatrist for at least 12
months.
7. Men must agree to use a double barrier method of birth control at
each sexual intercourse (at least a condom) and to not donate sperm
during the study and for 90 days after receiving the last dose of study
drug.
8. Women must meet one of the following:
? postmenopausal (amenorrhoea for at least 12 months prior to
screening or amenorrhoea for at least 6 months prior to screening and
follicle stimulating hormone [FSH] concentrations of >40 mIU/mL),
? surgically sterile (have had a hysterectomy or bilateral oophorectomy,
tubal ligation, or otherwise be incapable of pregnancy),
? or if sexually active, be practicing an effective method of birth control
(e.g., prescription oral contraceptives, contraceptive injections,
contraceptive patch, intrauterine device, double-barrier method [e.g.,
condoms, diaphragm, or cervical cap with spermicidal foam, cream, or
gel], male partner sterilization) as local regulations permit, before entry,
and must agree to continue to use the same method of contraception at
least 3 months after the last intake of study drug.
9. Women of childbearing potential must have a negative serum
pregnancy test at screening and a negative urine pregnancy test at
baseline before receiving the study drug.
10. Must be able and willing to describe subjective experiences while
receiving JNJ-40411813.
11. Subjects themselves or the relatives they are living with have to be
reachable by phone on a regular basis.
12. Must be willing and able to adhere to the prohibitions and
restrictions specified in this protocol.
13. Must have agreed to frequent blood sampling during the course of
the study.
14. Subjects (or their legally acceptable representative) must have
signed a separate written ICF for pharmacogenomic (DNA) research
indicating willingness to participate in Part 1 (genetic analyses related
to the study) of the pharmacogenomic component of the study; and
indicating either consent or refusal for Part 2 (DNA storage for future
research) (where local regulations permit). Subject participation in Part
1 is required. Subject participation in Part 2 is optional and refusal to
participate in Part 2 will not result in ineligibility for the main study.
Inclusion criteria specific to Acute Subjects (Part A, JNJ-40411813
monotherapy)
15. Subjects preferring treatment with an antipsychotic with a novel
mode-ofaction over currently available antipsychotics. Subjects should
not have received any oral antipsychotic for at least 5 days, and no
Exclusion criteria:
1. A current DSM-IV axis I diagnosis other than schizophrenia
2. A DSM-IV diagnosis of substance abuse or dependence within 6
months prior to screening evaluation (nicotine and caffeine dependence
are not exclusionary; subjects with a positive drug screen at screening
may be included provided use does not lead to a DSM-IV diagnosis of
substance dependence and subjects should be encouraged to abstain
from alcohol and illegal drugs within 3 days prior to Day 1 and at any
time during the study)
3. Any medical condition that could potentially alter the absorption,
metabolism, or excretion of the study medication, such as Crohn's
disease, liver disease, or renal disease
4. Relevant history of any significant and/or unstable cardiovascular,
respiratory, neurologic (including seizures or significant cerebrovascular
disorders), renal, hepatic, endocrine, or immunologic diseases
5. PANSS score <50 or >120
6. Other significant and/or unstable systemic illnesses
7. Allergy or hypersensitivity to any known antipsychotic compounds
8. Inability to swallow the study medication whole with the aid of water
(subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile)
9. Subjects who have never been treated with antipsychotics
10. Exposure to an experimental drug or experimental medical device
within 90 days before screening
11. Significant risk of suicidal or violent behavior
12. Female subjects who are pregnant or breastfeeding
13. 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
14. Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C
antibodies or HIV antibodies at screening
15. 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.
16. Clinically significant abnormal observations in ECG defined as:
? A confirmed screening visit QTcB interval ?470 msec
? A history of additional risk factors for torsades des pointes (e.g. heart
failure, hypokalemia, family history of Long QT Syndrome)
17. Use of monoamine oxidase inhibitors within 4 weeks or fluoxetine
within 5 weeks before screening. Use of all tricyclic antidepressants
within 2 weeks before screening
18. Use of mood stabilizers (e.g., anticonvulsants and/or lithium) within
2 weeks before Day 1.
19. Received electroconvulsive therapy within 3 months before
screening
20. Have been involuntarily committed to psychiatric hospitalization
21. Alcohol dependence and/or illicit drug use
22. Any condition that, in the opinion of the investigator, would
compromise the well-being of the subject or the study or prevent the
subject from meeting or performing study requirements
23. Donation of 1 or more units (approximately 450 mL) of blood or
acute loss of an equivalent amount of blood within 90 days prior to study
drug administration
24. Employees of the investigator or study center, with direct
involvement in the proposed study or other studies under the direction
of that investigator or study center, as well as family members of the
employe

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Schizophrenia
MedDRA version: 14.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: JNJ-40411813-AAA-capsula-50 mg
Product Code: JNJ-40411813
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
CAS Number: 1127498-03-6
Current Sponsor code: JNJ-40411813-AAA
Other descriptive name: R600737
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: NA

Secondary Objective: -To assess the pharmacokinetics of JNJ-40411813 in a patient
population using a population PK approach and explore its relationship
with efficacy (e.g., change in Positive and Negative Syndrome Scale
[PANSS] scores) and safety parameters

Main Objective: The primary objectives of this study are to investigate, with JNJ-
40411813 as monotherapy or as add-on to antipsychotics:
- Safety and tolerability in subjects with schizophrenia;
- Explore potent effect in subjects with schizophrenia

Primary end point(s): La posible eficacia clínica de JNJ 40411813 se evaluará utilizando la escala PANSS, la escala de Impresión Clínica Global-Esquizofrenia (CGI-SCH) y la versión abreviada de la Escala de Bienestar Subjetivo con Neurolépticos (SWN) en todos los sujetos. Algunas escalas se usarán únicamente en los sujetos estables que, según se determine clínicamente mediante una entrevista psiquiátrica, presenten síntomas relevantes en las dimensiones evaluadas; la Escala de Depresión de Calgary para la Esquizofrenia (CDSS), la Escala de Valoración de la Ansiedad de Hamilton (HAM-A) y la Escala de Síntomas Obsesivos y Compulsivos de Yale-Brown (Y-BOCS).
Las escalas de seguridad y tolerabilidad que se aplicarán a todos los sujetos son la Escala de evaluación efectos secundarios Udvalg for Klinische Undersogelser (UKU), las constantes vitales, el peso corporal, los análisis clínicos (incluidos biomarcadores y prolactina [PRL]) y una escala de suicidalidad (la Escala de valoración de la intensidad del comportamiento suicida de Columbia [CSSRS]).
Además, el investigador elaborará un informe detallado por escrito sobre cada sujeto basándose en sus observaciones y en una entrevista con el sujeto al final del ensayo. Estas descripciones se utilizarán para respaldar la evaluación de la eficacia.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: NA

Secondary end point(s): NA

Secondary ID(s)

2010-023369-23-DE

40411813SCH2001

Source(s) of Monetary Support

Janssen Research & Development, a Division of Janssen Pharmaceutica NV

Ethics review

Status: Approved
Approval date: 28/07/2011
Contact:

Results

• Results available: Yes
• Date Posted: 16/09/2016
• Date Completed: 04/12/2012
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-023369-23/results