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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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9 October 2012 |
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Main ID: |
EUCTR2007-007669-20-SE |
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Date of registration:
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17/03/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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A Double-Blind, Multiple Dose Titration Study to Investigate the Safety,
Tolerability and Pharmacokinetics of Once Daily and Twice Daily Doses of
JNJ-37822681 in Male and Female Patients With Stable Schizophrenia
Protocol 37822681SCH2003; Phase IIa
EudraCT Number: 2007-007669-20
JNJ-37822681
Amendment INT-1/SWE-2
Site Specific-2
27 February 2008
Incorporating Amendment INT-1/SWE-2/SS-2 – 23 April 2008
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Date of first enrolment:
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12/05/2008 |
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Target sample size:
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36 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007669-20 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: yes
Other trial design description: multi-center, multiple dose titration study
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Belgium
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Germany
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Subjects must have signed an informed consent document indicating that
they understand the purpose of and procedures required for the study and
are willing to participate in the study
• Male or female between 20 and 55 years of age, inclusive; subjects who
will have a PET scan will be aged between 20 and 45 years, inclusive.
• Female subjects must meet one of the following:
– postmenopausal (amenorrhoea for at least 12 months and FSH levels
of >40 MIU/mL at screening),
– surgically sterile, (have had a hysterectomy or bilateral oophorectomy,
tubal ligation, or otherwise be incapable of pregnancy)
• Men participating in this study have to use a condom at each sexual
intercourse even when their partner is pregnant. They should not father a
child and not donate sperm during the study and for 3 months after
receiving the last dose of study drug. For men that have been clinically
determined to be vasectomized, this restriction applies for 5 days after
receiving the last dose of study drug. Also their female partner should use
an effective method of contraception above the condom used by the male
study subject. (Effective methods of contraception include prescription
oral contraceptives, contraceptive injections, intrauterine device, doublebarrier
method, contraceptive patch).
• In- or outpatients with schizophrenia stably treated for at least 6 months
with antipsychotic monotherapy (= 200mg/d chlorpromazine equivalent
dose) or stable for at least 3 months without drug therapy; patients who
receive a second antipsychotic at doses < recommended for
antipsychotic efficacy may participate provided the second antipsychotic
will be discontinued at least 2 weeks prior to first dose administration.
• PANSS at screening < 70
• DSM-IV criteria for Schizophrenia
• In the opinion of the investigator and in compliance with local
regulations, the subject can be withdrawn from current antipsychotic
medication.
• A known history of schizophrenia of at least 12 months by the referring
psychiatrist.
• Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive (BMI =
weight/height2)
• Willing to be hospitalized during the double-blind treatment period of
the study.
• Willing to adhere to the prohibitions and restrictions specified in this
protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
• A DSM-IV axis I diagnosis other than schizophrenia
• A DSM-IV diagnosis of substance dependence within 6 months prior to
screening evaluation (nicotine and caffeine dependence are not
exclusionary; patients with a positive drug screen at screening may be
included provided use does not lead to a DSM-IV diagnosis of substance
dependence and patients consent to abstain from alcohol and illegal
drugs within 3 days prior to Day –1 and at any time during the study)
• 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
• Relevant history of any significant and/or unstable cardiovascular,
respiratory, neurologic (including seizures or significant
cerebrovascular), renal, hepatic, endocrine, or immunologic diseases
• History of neuroleptic malignant syndrome (NMS)
• Other significant and/or unstable systemic illnesses
• Allergy or hypersensitivity to any known antipsychotic compounds
• 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)
• Exposure to an experimental drug or experimental medical device within
90 days before screening
• Significant risk of suicidal or violent behavior
• Female subjects of childbearing potential
• Female subjects who are pregnant or breastfeeding
• Alanine aminotransferase or aspartate aminotransferase levels more than
2 times the upper limit of normal at screening or baseline
• Other biochemistry, hematology, or urinalysis results that are not within
the laboratory’s reference range, and that are deemed by the investigator
to be clinically significant
• Use of beta-blockers (if used for any indication other than hypertension
and still present at baseline)
• Injection of a depot antipsychotic within 120 days before screening, or
use of paliperidone palmitate within 10 months before screening
• Use of fluoxetine or monoamine oxidase inhibitors within 4 weeks before
screening
• Use of all other antidepressants, anticonvulsants, or lithium within
2 weeks before baseline
• Received electroconvulsive therapy within 3 months before screening
• Have been involuntarily committed to psychiatric hospitalization
• 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.
• Any condition that, in the opinion of the investigator, would compromise
the well-being of the subject or the study
• 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 employees or the
investigator.
• Additional exclusion criteria for subjects enrolled at the PET centers:
• Any clinically significant MRI abnormalities as determined by a
neuroradiologist, which are relevant for the study.
• Metal implants (pacemakers, joint replacements, etc.), which are
relevant for MRI or PET procedures or data.
• The total effective radiation dose for the subject should not exceed
10 mSv during the time period from 12 months before to 12 months
after the study.
• Use of sertindole and aripiprazole within 4 weeks before screening.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Product Name: JNJ-37822681/F002
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: The secondary objectives of this study include:
·To investigate the plasma pharmacokinetic (PK) profile of JNJ-37822681 administered as once daily (qd) or twice daily (bid) in male and female patients with stable schizophrenia;
·To investigate the effect of JNJ-37822681 on plasma prolactin (PRL) levels.
·To investigate the occupancy of striatal dopamine D2 receptors of JNJ-37822681 following multiple dose administration in relation to the plasma pharmacokinetic (PK) profile using [11C]-raclopride PET.
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Main Objective: Primary Objectives
The primary objective is to investigate the safety and tolerability of JNJ-37822681 administered as qd or bid following a dose titration in male and female patients with stable schizophrenia.
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Primary end point(s): To evaluate the safety, tolerability, striatal D2 dopamine receptor occupancy and
plasma pharmacokinetics of JNJ-37822681 in patients with schizophrenia in
the predicted clinical dose range. This study will be performed as a dosetitration
study within a single patient rather than a parallel-group study as it
is anticipated that a gradual increase in JNJ-37822681 dose levels (and
plasma concentrations) will be better tolerated in schizophrenic patients who
are washing out from previous antipsychotic medication.
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Secondary ID(s)
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2007-007669-20-DE
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37822681SCH2003
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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