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    Summary
    EudraCT Number:2013-001523-39
    Sponsor's Protocol Code Number:D1050300
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2013-11-08
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2013-001523-39
    A.3Full title of the trial
    A PHASE 1 OPEN-LABEL, MULTICENTER, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF LURASIDONE IN SUBJECTS 6 TO 17 YEARS OLD WITH SCHIZOPHRENIA SPECTRUM, BIPOLAR SPECTRUM, AUTISTIC SPECTRUM DISORDER, OR OTHER PSYCHIATRIC DISORDERS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lurasidone for the treatment of schizophrenia in paediatric patients
    A.3.2Name or abbreviated title of the trial where available
    D1050300
    A.4.1Sponsor's protocol code numberD1050300
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/145/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSunovion Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    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 supportSunovion Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSunovion Pharmaceuticals Inc.
    B.5.2Functional name of contact pointYu-Yuan Chiu
    B.5.3 Address:
    B.5.3.1Street AddressOne Bridge Plaza, Suite 510
    B.5.3.2Town/ cityFort Lee
    B.5.3.3Post codeNJ 07024
    B.5.3.4CountryUnited States
    B.5.4Telephone number001201228-8178
    B.5.5Fax number001201592-5939
    B.5.6E-mailYu-Yuan.Chiu@Sunovion.com
    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 Yes
    D.2.1.1.1Trade name Lurasidone
    D.2.1.1.2Name of the Marketing Authorisation holderSunovion Pharmaceuticals Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLurasidone
    D.3.2Product code SM-13496
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNLurasidone
    D.3.9.1CAS number 367514-88-3
    D.3.9.3Other descriptive nameLurasidone Hydrochloride
    D.3.9.4EV Substance CodeSUB34204
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 80
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboTablet
    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
    E.1.1.1Medical condition in easily understood language
    schizophrenia
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001064
    E.1.2Term Acute schizophrenia
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the pharmacokinetics (PK) and assess safety and tolerability of single and multiple oral doses of 20, 40, 80, 120, or 160 mg/day lurasidone in subjects 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric disorders
    E.2.2Secondary objectives of the trial
    To characterize the PK for metabolites of lurasidone (ID 14283, ID 14326, ID-11614, ID 20219, and ID-20220) following single and multiple oral doses of 20, 40, 80, 120, or 160 mg/day lurasidone in subjects 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric disorders
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must provide written informed assent and be willing to participate in the study.
    Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects’ adherence to the study procedures.
    2. Male or female subjects 6 to 17 years of age, inclusive.
    3. Subject is judged by the investigator to be clinically stable (i.e., no psychiatric hospitalization within the past 12 weeks; no imminent risk of suicide or injury to self, others or property; no recent addition, or change in dosage, of psychotropic medication intended for the treatment of the primary psychiatric condition in the past 4 weeks) but symptomatic (i.e., some active symptoms of the primary psychiatric condition are present for which an atypical antipsychotic agent is judged to be an acceptable treatment option).
    4. Subjects with the following diagnoses will be eligible for participation: primary schizophrenia spectrum diagnosis (schizophrenia, schizoaffective, schizophreniform or psychotic disorder Not Otherwise Specified (NOS), bipolar spectrum disorder (bipolar I, II or bipolar NOS), pervasive developmental disorder (PDD) including autistic spectrum disorder (autistic disorder, Asperger’s syndrome, or Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS), attention-deficit hyperactivity (ADHD) with aggressive behavior [meeting co-morbid diagnostic criteria for Conduct Disorder/Disruptive Behavior Disorders Not Otherwise Specified (CD/DBD NOS)], or Tourette’s syndrome, via clinical interview (using MINI-Kid plus diagnostic interview and the Diagnostic and Statistical Manual of Mental Disorders, 4th edition Text Revision (DSM-IV-TR) as a reference). Autistic disorder should also be confirmed by the Autism Diagnostic Interview, Revised (ADI-R).
    5. Willing and able to remain off any antipsychotic medication other than lurasidone for the duration of the study, if, in the investigator’s opinion the subject is not at risk for worsening symptoms.
    6. Willing and able to swallow the size and number of lurasidone tablets specified per protocol.
    7. Have a stable living arrangement for at least 3 months prior to Day -1 and agrees to return to a similar living arrangement after discharge on Day 11. Homeless subjects may not be enrolled.
    E.4Principal exclusion criteria
    1. Clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal,
    hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological
    disorder such as unstable angina, congestive heart failure (uncontrolled), or central
    nervous system (CNS) infection that would pose a risk to the subjects if they were to
    participate in the study or that might confound the results of the study.
    2. Known presence or history of hepatic insufficiency or subject’s estimated creatinine
    clearance is < 80 mL/min/1.73 m2 by the following Bedside Schwartz equation for use
    with creatinine methods with calibration traceable to isotope dilution mass spectrometry
    (IDMS): Creatinine clearance (mL/min/1.73 m2) = (0.41 x height) / serum creatinine
    concentration, where height in cm and serum creatinine in mg/dL.
    3. A history or presence of abnormal ECG, which in the investigator’s opinion is clinically
    significant. Screening ECGs will be centrally over-read, and eligibility will be
    determined based on the over-read.
    4. Clinically significant alcohol abuse/dependence or drug abuse/dependence based on
    MINI-Kid criteria within the last 6 months prior to screening.
    5. Clinically significant orthostatic hypotension (i.e., a drop in systolic blood pressure of
    20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 3 minutes of standing up).
    6. Use of any inhibitor or inducer of CYP3A4 taken within 28 days prior to drug administration and until discharge on Day 11. Exceptions (e.g., for grapefruit juice consumption) may be discussed on a case-by-case basis with the medical monitor.
    7. Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to Day -1 to follow-up.
    8. Use of any antipsychotic medication (other than study drug), carbamazepine,
    oxcarbazepine or fluvoxamine, within 3 days prior to Day -1 (7 days prior to Day -1 for
    aripiprazole) and until follow-up.
    E.5 End points
    E.5.1Primary end point(s)
    Characterize the pharmacokinetics (PK) of lurasidone following single and multiple oral doses of 20, 40, 80, 120 or 160 mg/day lurasidone
    E.5.1.1Timepoint(s) of evaluation of this end point
    approximately 53 days
    E.5.2Secondary end point(s)
    Determine the and tolerability of 20, 40, 80, 120 or 160 mg/day lurasidone
    E.5.2.1Timepoint(s) of evaluation of this end point
    approximately 53 days
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetic in subjects
    E.7.2Therapeutic exploratory (Phase II) No
    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 Yes
    E.8.1.2Open Yes
    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.8.2.4Number of treatment arms in the trial5
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    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 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-11-08. Yes
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Sunovion Pharmaceuticals Inc.
    G.4.3.4Network Country United States
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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