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    Summary
    EudraCT Number:2007-007669-20
    Sponsor's Protocol Code Number:37822681SCH2003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-007669-20
    A.3Full title of the trial
    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
    A.4.1Sponsor's protocol code number37822681SCH2003
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ-37822681/F002
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Schizophrenia
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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:
    – postmenopauzal (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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 36
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
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