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    Summary
    EudraCT Number:2006-004783-31
    Sponsor's Protocol Code Number:D3690C00007
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-11
    Trial 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 ConcernedLatvia - SAM
    A.2EudraCT number2006-004783-31
    A.3Full title of the trial
    A Double-Blind, Randomised, Parallel-Group, Placebo-Controlled, MultiCentre, Phase IIa Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Multiple Oral Doses of AZD3480 in Schizophrenic Patients on Stable Antipsychotic Monotherapy with quetiapine, risperidone or olanzapine
    A.4.1Sponsor's protocol code numberD3690C00007
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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.3.2Product code AZD3480
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNispronicline
    D.3.9.1CAS number 691882-47-0
    D.3.9.2Current sponsor codeTC-1734-226
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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.3.2Product code AZD3480
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNispronicline
    D.3.9.1CAS number 691882-47-0
    D.3.9.2Current sponsor codeTC-1734-226
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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, hard
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety and tolerability of multiple ascending oral doses of AZD3480 when administered to schizophrenic patients on stable antipsychotic monotherapy with either quetiapine, risperidone or olanzapine.
    E.2.2Secondary objectives of the trial
    1. To investigate the pharmacokinetic (PK) interaction between AZD3480 and three commonly used antipsychotic drugs.
    2. To investigate the dose-concentration-effect relationship by exploring the AZD3480 effect on cognition in schizophrenic patients on stable antipsychotic monotherapy.
    3. To explore the effect of AZD3480 on severity of schizophrenic illness.
    4. To explore the effect of AZD3480 on antipsychotic drug-related extra pyramidal symptoms (EPS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study patients must fulfil all of the following criteria:
    1. Patients able to communicate with the study personnel, able to understand and are willing to comply with study procedures, restrictions and requirements.
    2. Provision of signed Informed Consent, including genetic sampling for CYP2D6.
    3. Genotyped to be rapid metabolisers or slow metabolisers with regard to CYP2D6. Rapid metabolisers, in this study, is defined as individuals with at least one fully functional CYP2D6 allele (CYP2D6*1, CYP2D6*2, CYP2D6*35) on one of the two chromosomes and slow metabolisers as the rest of the genotypes. (Patients receiving potent CYP2D6 inhibitors such as paroxetine and fluoxetine will functionally be characterised as belonging to the slow metaboliser group).
    4. Male and female schizophrenic patients, aged 20 to 65 years (inclusive), clinically stable and in the residual (non-acute) phase of their illness for at least 3 months.
    5. Receiving treatment with oral quetiapine, risperidone or olanzapine for at least 2 months, at the current dose schedule for at least the last month.
    6. At screening, showing not more than “moderate” severity of hallucinations and delusions (PANSS item P3: Hallucinatory Behaviour ≤ 4 , and PANSS item G9: Unusual Thought Content item score ≤ 4), positive formal thought disorder (PANSS item P2: Conceptual Disorganization item score ≤ 4), or negative symptoms (PANSS negative syndrome total score ≤ 22, scale range 1-7). Minimal level of EPS (SAS total score ≤ 6) and depressive symptoms (CDS for Schizophrenia total score ≤ 10).
    7. Clinically normal physical findings, including BP, heart rate, baseline ECG and laboratory assessments as judged by the investigator.
    8. Documented clinical diagnosis meeting DSM-IV criteria for any of the following:
    Schizophrenia DSM-IV
    catatonic 295.20
    disorganised 295.10
    paranoid 295.30
    undifferentiated 295.90
    residual 295.60

    9. BMI (body weight/height2) 19 to 30 kg/m2.
    10. Female must be surgically sterile or postmenopausal in at least 12 months prior to enrolment or, if of childbearing potential, use of safe contraception from at least 3 months before randomization and until follow up. Safe contraception is defined as the use of a method with less than 1% yearly failure (eg, oral combined contraceptive pills, intrauterine device, hormonal implant


    For inclusion in the additional genetic component of the study, patients must fulfil the following criterion:
    1. Provision of informed consent for additional genetic research.
    If a patient declines to participate in the additional genetic component of the study, there will be no penalty or loss of benefit to the patient and the patient will not be excluded from other aspects of the study described in the Clinical Pharmacology Study Protocol, as long as they have given consent.
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    1. Clinically significant illness, apart from schizophrenia, within the two weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to World Health Organisation (WHO) risk categories 2, 3 or 4, as judged by the investigator.
    2. Diagnosis of any DSM-IV Axis I disorder other than those included in inclusion criteria (3) above (eg, alcohol dependence or psychoactive substance dependence not in full remission, concurrent organic mental disorder, schizophreniform and schizoaffective disorder) or mental retardation, of a degree that may interfere with the patient’s ability to co-operate.
    3. History of clinically significant cardio-or cerebrovascular, pulmonary, renal, hepatic, neurological, mental (apart from schizophrenia), heamatologic or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the investigator.
    4. ECG result considered showing clinically significant abnormality as determined by an experienced cardiologist.
    5. QT interval corrected for heart-rate, where the QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QTc) Bazett >450 ms taken from the ECG at baseline as determined by an experienced cardiologist.
    6. A patient with diabetes mellitus (DM) fulfilling one of the following criteria (Note: If a diabetic patient meets one of these criteria the patient will be excluded even if the treating physician believes that the patient is stable and can participate in the study):
    -unstable DM defined as enrolment glycated haemoglobin A1c (HbA1c) >8.5%
    - admitted to hospital for treatment of DM or DM related illness in the past 12 weeks
    - not under care of physician responsible for patient’s DM care
    - physician responsible for patient’s DM care has not indicated that the patient’s DM is controlled
    - physician responsible for patient’s DM care has not approved patient’s participation in the study
    - has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the last 4 weeks prior to enrolment. For thiazolidinediones (glitazones) this period should not be less than 8 weeks
    - taking insulin where the daily dose on one occasion has been more than 10% above or below the patient’s mean dose in the 4 weeks preceding enrolment.
    7. Known or suspected drug or alcohol abuse or positive drugs of abuse test as judged by the investigator.
    8. Patient who has received any investigational drug and/or has participated in a clinical study during the last 3 months before first administration of investigational drug.
    9. Donation of blood within 3 months prior to enrolment.
    10. Donation of plasma within 14 days prior to enrolment.
    11. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity (except for seasonal hay fever) as judged by the investigator.
    12. Excessive use of caffeine containing drinks (equivalent to more than 5 cups of coffee per day).
    13. Pregnancy or lactation.
    14. Patients injected with depot antipsychotic drugs during the last 3 months, including depot, risperidone and olanzapine.
    15. Previous bone marrow transplant.
    16. Whole blood transfusion within 120 days prior to enrolment.
    17. Intake of alcohol within 48 hours prior to visit 2.
    18. Patients on anticholinergic medication for treatment of EPS for a treatment period of less than two weeks before randomisation.
    19. Use of any prescribed or non-prescribed (OTC) medication and/or herbal medication (eg, St Johns Wort) that could possibly interfere with the objectives of this study (eg, drugs inducing or inhibiting the potential of drug metabolic enzymes or transporter proteins or drugs with sedative components that might confound cognition tests) during the 3 weeks prior to the first administration of the investigational product (or 5 half-lives of the compound, whichever is the longer) until the follow-up visit are not allowed. However, paracetamol (acetaminophen) may be administered (up to a maximum dose of 3 g/day) for headache and other benign pain, and OTC adrenergic nasal spray medication will be allowed for the relief of nasal congestion.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints:

    Safety & tolerability: laboratory assessments, vital signs, physical examination, concomitant medication and adverse events (AEs)
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    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
    End of trial is defined in the protocol as last database lock (the timepoint after which no patient will be exposed to study related activities). There will be separate database locks for each group of concomitant antipsycotics when completed.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 80
    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 Decision2006-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-27
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