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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2013-001523-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 May 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    11 Jul 2016
    First version publication date
    30 May 2014
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Updating editorial discrepancies

    Trial information

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    Trial identification
    Sponsor protocol code
    D1050300
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01620060
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sunovion Pharmaceuticals Inc.
    Sponsor organisation address
    One Bridge Plaza North Suite 510, Fort Lee, NJ, United States, 07024
    Public contact
    Yu-Yuan Chiu, Sunovion Pharmaceuticals Inc., 001 201228-8178, Yu-Yuan.Chiu@Sunovion.com
    Scientific contact
    Yu-Yuan Chiu, Sunovion Pharmaceuticals Inc., 001 201228-8178, Yu-Yuan.Chiu@Sunovion.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001230-PIP01-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Jun 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 May 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    06 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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 hydrochloride (HCl) in subjects 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric disorders
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Jun 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 105
    Worldwide total number of subjects
    105
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    49
    Adolescents (12-17 years)
    56
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A Phase I, open-lable, mulitcenter,United States only study. Pediatric subjects with schizophernia spectrum, bipolar spectrum, autistic spectrum or other psychiatric disorders were enrolled. Study started enrollement on 19Jun2012.

    Pre-assignment
    Screening details
    		 All subjects received a single dose of lurasidone hydrochloride (HCl) followed by a 2-day washout period, then once-daily dosing of lurasidone hydrochloride for 7 days (20 mg through 120 mg lurasidone HCl cohort) or 9 days (160 mg lurasidone HCl cohort)

    Period 1
    Period 1 title
    Overall Period Trial
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 20 mg Lurasidone hydrochloride cohort
    Arm description
    		 20 mg Lurasidone hydrochloride cohort
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lurasidone hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily

    Arm title
    		 40 mg cohort Lurasidone hydrochlorid
    Arm description
    		 40 mg Lurasidone hydrochloride cohort
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lurasidone hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily

    Arm title
    		 80 mg Lurasidone hydrochloride cohort
    Arm description
    		 80 mg Lurasidone hydrochloride cohort
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lurasidone hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily

    Arm title
    		 120 mg Lurasidone hydrochloride cohort
    Arm description
    		 120 mg Lurasidone hydrochloride cohort
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lurasidone hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily

    Arm title
    		 160 mg Lurasidone hydrochloride cohort
    Arm description
    		 160 mg Lurasidone hydrochloride cohort
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lurasidone hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily

    Number of subjects in period 1
    		20 mg Lurasidone hydrochloride cohort 40 mg cohort Lurasidone hydrochlorid 80 mg Lurasidone hydrochloride cohort 120 mg Lurasidone hydrochloride cohort 160 mg Lurasidone hydrochloride cohort
    Started
    20
    25
    19
    25
    16
    Completed
    19
    21
    18
    18
    14
    Not completed
    1
    4
    1
    7
    2
         Consent withdrawn by subject
    -
    -
    -
    -
    1
         Did not comply with Study procedures
    1
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    3
    1
    4
    1
         family emergency
    -
    -
    -
    1
    -
         Per Sponsor Decision
    -
    -
    -
    2
    -
         Protocol deviation
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    20 mg Lurasidone hydrochloride cohort
    Reporting group description
    		 20 mg Lurasidone hydrochloride cohort

    Reporting group title
    40 mg cohort Lurasidone hydrochlorid
    Reporting group description
    		 40 mg Lurasidone hydrochloride cohort

    Reporting group title
    80 mg Lurasidone hydrochloride cohort
    Reporting group description
    		 80 mg Lurasidone hydrochloride cohort

    Reporting group title
    120 mg Lurasidone hydrochloride cohort
    Reporting group description
    		 120 mg Lurasidone hydrochloride cohort

    Reporting group title
    160 mg Lurasidone hydrochloride cohort
    Reporting group description
    		 160 mg Lurasidone hydrochloride cohort

    Reporting group values
    		 20 mg Lurasidone hydrochloride cohort 40 mg cohort Lurasidone hydrochlorid 80 mg Lurasidone hydrochloride cohort 120 mg Lurasidone hydrochloride cohort 160 mg Lurasidone hydrochloride cohort Total
    Number of subjects
    		 20 25 19 25 16 105
    Age categorical
    Units: Subjects
        6-9 years old
    		 5 5 4 6 0 20
        10-12 years old
    		 6 7 5 5 6 29
        13-15 years old
    		 5 7 5 8 6 31
        16-17 years old
    		 4 6 5 6 4 25
    Gender categorical
    Units: Subjects
        Female
    		 8 10 6 8 5 37
        Male
    		 12 15 13 17 11 68

    End points

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    End points reporting groups
    Reporting group title
    20 mg Lurasidone hydrochloride cohort
    Reporting group description
    		 20 mg Lurasidone hydrochloride cohort

    Reporting group title
    40 mg cohort Lurasidone hydrochlorid
    Reporting group description
    		 40 mg Lurasidone hydrochloride cohort

    Reporting group title
    80 mg Lurasidone hydrochloride cohort
    Reporting group description
    		 80 mg Lurasidone hydrochloride cohort

    Reporting group title
    120 mg Lurasidone hydrochloride cohort
    Reporting group description
    		 120 mg Lurasidone hydrochloride cohort

    Reporting group title
    160 mg Lurasidone hydrochloride cohort
    Reporting group description
    		 160 mg Lurasidone hydrochloride cohort

    Primary: Lurasidone Hydrochloride PK profile

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    End point title
    		 Lurasidone Hydrochloride PK profile
    End point description
    Primary PK parameters: Cmax, AUClast, and AUC0-∞ (Day 1), and Cmax and AUC0-24 (Day 10 or Day 12)
    End point type
    Primary
    End point timeframe
    Day 1 through Day 12
    End point values
    		 20 mg Lurasidone hydrochloride cohort 40 mg cohort Lurasidone hydrochlorid 80 mg Lurasidone hydrochloride cohort 120 mg Lurasidone hydrochloride cohort 160 mg Lurasidone hydrochloride cohort
    Number of subjects analysed
    20
    25
    19
    25
    16
    Units: ng/ml
    arithmetic mean (standard deviation)
        Cmax ng/ml (Day 1)
    24.4 ( 14.1 )
    38.3 ( 22.4 )
    68.2 ( 37.5 )
    0 ( 0 )
    0 ( 0 )
        Cmax ng/ml (Day 10 or Day 12)
    30 ( 18 )
    36.2 ( 17.5 )
    80 ( 59.6 )
    94.2 ( 46.6 )
    99.7 ( 44.3 )
        AUC0-24 ng.h/ml (Day 10 or Day 12)
    115 ( 72.2 )
    154 ( 67.4 )
    387 ( 194 )
    494 ( 271 )
    590 ( 227 )
        AUClast ng.h/ml (Day1)
    78 ( 44.9 )
    140 ( 65.4 )
    300 ( 140 )
    0 ( 0 )
    0 ( 0 )
        AUC0-∞ ng.h/ml (Day 1)
    83.8 ( 48.3 )
    153 ( 69.8 )
    328 ( 163 )
    0 ( 0 )
    0 ( 0 )
    Statistical analysis title
    		 Discriptive Summary
    Comparison groups
    20 mg Lurasidone hydrochloride cohort v 40 mg cohort Lurasidone hydrochlorid v 80 mg Lurasidone hydrochloride cohort v 120 mg Lurasidone hydrochloride cohort v 160 mg Lurasidone hydrochloride cohort
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 ANCOVA
    Parameter type
    		 Discriptive Summary
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    June 19, 2012 through May 6, 2013
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Lurasidone 20 mg oral tablets
    Reporting group description
    		 Lurasidone 20 mg oral tablets

    Reporting group title
    Lurasidone 40 mg oral tablets
    Reporting group description
    		 Lurasidone 40 mg oral tablets

    Reporting group title
    Lurasidone 80 mg oral tablets
    Reporting group description
    		 Lurasidone 80 mg oral tablets

    Reporting group title
    Lurasidone 120 mg oral tablets
    Reporting group description
    		 Lurasidone 120 mg oral tablets

    Reporting group title
    Lurasidone 160 mg oral tablets
    Reporting group description
    		 Lurasidone 160 mg oral tablets

    Serious adverse events
    		 Lurasidone 20 mg oral tablets Lurasidone 40 mg oral tablets Lurasidone 80 mg oral tablets Lurasidone 120 mg oral tablets Lurasidone 160 mg oral tablets
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 25 (0.00%)
    2 / 19 (10.53%)
    0 / 25 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Nervous system disorders
    Parkinsonism
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 25 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dystonia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 25 (0.00%)
    1 / 19 (5.26%)
    0 / 25 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Lurasidone 20 mg oral tablets Lurasidone 40 mg oral tablets Lurasidone 80 mg oral tablets Lurasidone 120 mg oral tablets Lurasidone 160 mg oral tablets
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 20 (20.00%)
    17 / 25 (68.00%)
    15 / 19 (78.95%)
    24 / 25 (96.00%)
    16 / 16 (100.00%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    0 / 20 (0.00%)
    11 / 25 (44.00%)
    7 / 19 (36.84%)
    16 / 25 (64.00%)
    10 / 16 (62.50%)
         occurrences all number
    0
    27
    17
    50
    10
    Sedation
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 25 (12.00%)
    5 / 19 (26.32%)
    7 / 25 (28.00%)
    4 / 16 (25.00%)
         occurrences all number
    0
    5
    9
    13
    8
    Dystonia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 25 (0.00%)
    0 / 19 (0.00%)
    3 / 25 (12.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    4
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 25 (12.00%)
    6 / 19 (31.58%)
    2 / 25 (8.00%)
    6 / 16 (37.50%)
         occurrences all number
    1
    4
    7
    2
    6
    Vomiting
         subjects affected / exposed
    0 / 20 (0.00%)
    4 / 25 (16.00%)
    4 / 19 (21.05%)
    5 / 25 (20.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    4
    5
    6
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 25 (0.00%)
    1 / 19 (5.26%)
    4 / 25 (16.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    1
    4
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 25 (0.00%)
    1 / 19 (5.26%)
    1 / 25 (4.00%)
    4 / 16 (25.00%)
         occurrences all number
    0
    0
    1
    1
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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