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    Clinical Trial Results:
    Open-Label, Multicentre, Multiple Dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Cariprazine in Adolescent Subjects with Schizophrenia, Schizoaffective- and Schizophreniform Disorders Compared to Adults

    Summary
    EudraCT number
    		 2016-002327-29
    Trial protocol
    		 BG  
    Global end of trial date
    19 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Aug 2019
    First version publication date
    15 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RGH-188-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gedeon Richter Plc
    Sponsor organisation address
    Gyömrői út 19-21, Budapest, Hungary, 1103
    Public contact
    Herta Pálfi Goóts, Gedeon Richter Plc., 0036 14314040, RA.ctaRichter@richter.hu
    Scientific contact
    Herta Pálfi Goóts, Gedeon Richter Plc., 0036 14314040, RA.ctaRichter@richter.hu
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001652-PIP01-14
    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
    08 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •Assess PK, safety and tolerability of up to 3 doses of once daily cariprazine capsules •Investigate dosing requirements of cariprazine in adolescents •Determination of the PK parameters of cariprazine (CAR) and its two metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR) in adolescents at steady state, compared to adults •Estimation of the inter-individual variability of the PK parameters in the adolescent population •Evaluation of the relationship between different covariates (age, body weight) and the PK parameters •Examination of the dose linearity of exposure in adolescents
    Protection of trial subjects
    Measures to reduce pain during blood draws may be applied if needed (lidocaine/prilocaine cream, etc).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Mar 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 28
    Country: Number of subjects enrolled
    Bulgaria: 35
    Worldwide total number of subjects
    63
    EEA total number of subjects
    35
    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)
    0
    Adolescents (12-17 years)
    43
    Adults (18-64 years)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adolescent (13 to < 15 or 15 to < 18 years old) and adult (18 to 40 years old) patients with schizophrenia, schizoaffective, or schizophreniform disorder (per DSM-5).

    Pre-assignment
    Screening details
    		 During the screening phase of up to 14 days the patients were evaluated for inclusion and exclusion criteria, followed by 28 days of treatment and 14 days of follow-up phase.

    Period 1
    Period 1 title
    Treatment phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1, Age group A
    Arm description
    		 Cariprazine 1.5 mg, age 13 to < 15 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 1.5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1.5 mg Cariprazine capsule, once daily

    Arm title
    		 Cohort 1, Age group B
    Arm description
    		 Cariprazine 1.5 mg, age 15 to < 18 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 1.5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1.5 mg Cariprazine capsule, once daily

    Arm title
    		 Cohort 1, Age group C
    Arm description
    		 Cariprazine 1.5 mg, age 18 to < 40 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 1.5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1.5 mg Cariprazine capsule, once daily

    Arm title
    		 Cohort 2, Age group A
    Arm description
    		 Cariprazine 3.0 mg, age 13 to < 15 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 3.0 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    3.0 mg cariprazine capsule, hard, once daily

    Arm title
    		 Cohort 2, Age group B
    Arm description
    		 Cariprazine 3.0 mg, age 15 to < 18 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 3.0 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    3.0 mg cariprazine capsule, hard, once daily

    Arm title
    		 Cohort 2, Age group C
    Arm description
    		 Cariprazine 3.0 mg, age 18 to < 40 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 3.0 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    3.0 mg cariprazine capsule, hard, once daily

    Arm title
    		 Cohort 3, Age group A
    Arm description
    		 Cariprazine 6.0 mg, age 13 to < 15 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 6.0 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    6.0 mg Cariprazine capsule, once daily

    Arm title
    		 Cohort 3, Age group B
    Arm description
    		 Cariprazine 6.0 mg, age 15 to < 18 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 6.0 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    6.0 mg Cariprazine capsule, once daily

    Arm title
    		 Cohort 3, Age group C
    Arm description
    		 Cariprazine 6.0 mg, age 18 to < 40 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 6.0 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    6.0 mg Cariprazine capsule, once daily

    Number of subjects in period 1
    		Cohort 1, Age group A Cohort 1, Age group B Cohort 1, Age group C Cohort 2, Age group A Cohort 2, Age group B Cohort 2, Age group C Cohort 3, Age group A Cohort 3, Age group B Cohort 3, Age group C
    Started
    6
    6
    6
    10
    9
    8
    6
    6
    6
    Completed
    6
    6
    6
    9
    8
    8
    6
    6
    6
    Not completed
    0
    0
    0
    1
    1
    0
    0
    0
    0
         early discontinuation
    -
    -
    -
    1
    1
    -
    -
    -
    -
    Period 2
    Period 2 title
    Follow-up phase
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    		 Follow-up arm
    Arm description
    		 IMP was discontinued without down-titration. Safety and PK follow-up performed.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Follow-up arm
    Started
    61
    Completed
    61

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment phase
    Reporting group description
    		 -

    Reporting group values
    		 Treatment phase Total
    Number of subjects
    		 63 63
    Age categorical
    Units: Subjects
        13 to <15 years
    		 22 22
        15 to <18 years
    		 21 21
        18 to <40 years
    		 20 20
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 44 44

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1, Age group A
    Reporting group description
    		 Cariprazine 1.5 mg, age 13 to < 15 years

    Reporting group title
    Cohort 1, Age group B
    Reporting group description
    		 Cariprazine 1.5 mg, age 15 to < 18 years

    Reporting group title
    Cohort 1, Age group C
    Reporting group description
    		 Cariprazine 1.5 mg, age 18 to < 40 years

    Reporting group title
    Cohort 2, Age group A
    Reporting group description
    		 Cariprazine 3.0 mg, age 13 to < 15 years

    Reporting group title
    Cohort 2, Age group B
    Reporting group description
    		 Cariprazine 3.0 mg, age 15 to < 18 years

    Reporting group title
    Cohort 2, Age group C
    Reporting group description
    		 Cariprazine 3.0 mg, age 18 to < 40 years

    Reporting group title
    Cohort 3, Age group A
    Reporting group description
    		 Cariprazine 6.0 mg, age 13 to < 15 years

    Reporting group title
    Cohort 3, Age group B
    Reporting group description
    		 Cariprazine 6.0 mg, age 15 to < 18 years

    Reporting group title
    Cohort 3, Age group C
    Reporting group description
    		 Cariprazine 6.0 mg, age 18 to < 40 years
    Reporting group title
    Follow-up arm
    Reporting group description
    		 IMP was discontinued without down-titration. Safety and PK follow-up performed.

    Primary: Determination of the Cmax

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    End point title
    		 Determination of the Cmax [1]
    End point description
    End point type
    Primary
    End point timeframe
    at steady state on Day 28
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was provided for plasma concentrations and PK parameters.
    End point values
    		 Cohort 1, Age group A Cohort 1, Age group B Cohort 1, Age group C Cohort 2, Age group A Cohort 2, Age group B Cohort 2, Age group C Cohort 3, Age group A Cohort 3, Age group B Cohort 3, Age group C
    Number of subjects analysed
    6
    6
    5
    6
    6
    6
    6
    6
    5
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Cariprazine
    4.39 ± 48.2
    4.33 ± 26.9
    3.91 ± 30
    8.43 ± 28.7
    9.12 ± 20.8
    7.65 ± 29.6
    16.02 ± 40.1
    18.67 ± 18.5
    16.6 ± 17.8
        Desmethyl-Cariprazine
    0.91 ± 47.6
    1.09 ± 59.2
    1.01 ± 43.3
    2.62 ± 75
    2.33 ± 57.5
    2.01 ± 5.6
    5.11 ± 39.8
    3.85 ± 30
    4.67 ± 34.7
        Didesmethyl-Cariprazine
    6.15 ± 54.9
    7.03 ± 57.8
    6.66 ± 40.4
    17.12 ± 61.9
    15 ± 30.8
    15.18 ± 29.9
    33.49 ± 51.1
    23.78 ± 81.9
    24.02 ± 50
    No statistical analyses for this end point

    Primary: Determination of AUC

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    End point title
    		 Determination of AUC [2]
    End point description
    End point type
    Primary
    End point timeframe
    at steady state on Day 28
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was provided for plasma concentrations and PK parameters.
    End point values
    		 Cohort 1, Age group A Cohort 1, Age group B Cohort 1, Age group C Cohort 2, Age group A Cohort 2, Age group B Cohort 2, Age group C Cohort 3, Age group A Cohort 3, Age group B Cohort 3, Age group C
    Number of subjects analysed
    6
    6
    5
    6
    6
    6
    6
    6
    5
    Units: ng*h/mL
    geometric mean (geometric coefficient of variation)
        Cariprazine
    70.4 ± 41.9
    67.7 ± 34.1
    68.2 ± 33.1
    123.1 ± 37.1
    143 ± 27.4
    124.6 ± 36.6
    242.3 ± 31.9
    318.1 ± 28.9
    262.7 ± 19.3
        Desmethyl-Cariprazine
    18.06 ± 45.3
    20.28 ± 55.5
    19.58 ± 34.4
    46.47 ± 75.9
    46.07 ± 54.1
    39.7 ± 4.7
    94.12 ± 31.4
    77.2 ± 27.1
    90.67 ± 40.2
        Didesmethyl-Cariprazine
    140.2 ± 51.8
    157.4 ± 59.5
    153.6 ± 39.3
    381.3 ± 64
    338.2 ± 33.2
    333.3 ± 30.3
    726.7 ± 52
    502.8 ± 85.2
    529.4 ± 50
    No statistical analyses for this end point

    Primary: Determination of CLss/F

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    End point title
    		 Determination of CLss/F [3]
    End point description
    apparent oral plasma clearence at steady state
    End point type
    Primary
    End point timeframe
    at steady state on Day 28
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was provided for plasma concentrations and PK parameters.
    End point values
    		 Cohort 1, Age group A Cohort 1, Age group B Cohort 1, Age group C Cohort 2, Age group A Cohort 2, Age group B Cohort 2, Age group C Cohort 3, Age group A Cohort 3, Age group B Cohort 3, Age group C
    Number of subjects analysed
    6
    6
    5
    6
    6
    6
    6
    6
    5
    Units: L/h
    geometric mean (geometric coefficient of variation)
        Cariprazine
    21.3 ± 41.9
    22.2 ± 34.1
    22 ± 33.1
    24.4 ± 37.1
    21 ± 27.4
    24.1 ± 36.6
    24.8 ± 31.9
    18.9 ± 28.9
    22.8 ± 19.3
        Desmethyl-Cariprazine
    83.1 ± 45.3
    74 ± 55.5
    76.6 ± 34.4
    64.6 ± 75.9
    65.1 ± 54.1
    75.6 ± 4.7
    63.7 ± 31.4
    77.7 ± 27.1
    66.2 ± 40.2
        Didesmethyl-Cariprazine
    10.7 ± 51.8
    9.53 ± 59.5
    9.77 ± 39.3
    7.87 ± 64
    8.87 ± 33.2
    9 ± 30.3
    8.26 ± 52
    11.93 ± 85.2
    11.33 ± 50
    No statistical analyses for this end point

    Primary: Determination of T1/2

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    End point title
    		 Determination of T1/2 [4]
    End point description
    apparent terminal half-life
    End point type
    Primary
    End point timeframe
    at steady state on Day 28
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was provided for plasma concentrations and PK parameters.
    End point values
    		 Cohort 1, Age group A Cohort 1, Age group B Cohort 1, Age group C Cohort 2, Age group A Cohort 2, Age group B Cohort 2, Age group C Cohort 3, Age group A Cohort 3, Age group B Cohort 3, Age group C
    Number of subjects analysed
    6
    6
    5
    6
    6
    6
    6
    6
    5
    Units: hour
    geometric mean (geometric coefficient of variation)
        Cariprazine
    41.3 ± 25.6
    38.8 ± 6.5
    50.8 ± 33.7
    40 ± 32
    37.4 ± 25.6
    32.2 ± 8.8
    31.9 ± 24.8
    32.8 ± 32.5
    27 ± 9.2
        Desmethyl-Cariprazine
    50.9 ± 32.5
    42.1 ± 35
    44.1 ± 50.9
    32.4 ± 0
    25 ± 43.8
    38.2 ± 55.9
    24.9 ± 0
    0 ± 0
    22.8 ± 46
        Didesmethyl-Cariprazine
    165 ± 24.3
    176 ± 23.6
    229 ± 35.1
    137 ± 23.1
    154 ± 25.6
    171 ± 21.6
    137 ± 32.3
    143 ± 14.6
    157 ± 22.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time points for adverse event assessment: -14 day, baseline, days 2, 3, 4, 5, 14, 21, 28, 29 (end of study), follow up visits on days 31, 35, 42.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Age group 13-<15 years, Cariprazine 1.5 mg - 6 mg
    Reporting group description
    		 -

    Reporting group title
    Age group 15-<18 years, Cariprazine 1.5 mg - 6 mg
    Reporting group description
    		 -

    Reporting group title
    Age group 18-40 years, Cariprazine 1.5 mg - 6 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Age group 13-<15 years, Cariprazine 1.5 mg - 6 mg Age group 15-<18 years, Cariprazine 1.5 mg - 6 mg Age group 18-40 years, Cariprazine 1.5 mg - 6 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Age group 13-<15 years, Cariprazine 1.5 mg - 6 mg Age group 15-<18 years, Cariprazine 1.5 mg - 6 mg Age group 18-40 years, Cariprazine 1.5 mg - 6 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 22 (50.00%)
    11 / 21 (52.38%)
    9 / 20 (45.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 21 (9.52%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    1
    Cardiac disorders
    Sinus arrhythmia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Sedation
         subjects affected / exposed
    3 / 22 (13.64%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
         occurrences all number
    3
    4
    0
    Akathisia
         subjects affected / exposed
    0 / 22 (0.00%)
    5 / 21 (23.81%)
    0 / 20 (0.00%)
         occurrences all number
    0
    7
    0
    Dizziness postural
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
         occurrences all number
    0
    2
    0
    Somnolence
         subjects affected / exposed
    0 / 22 (0.00%)
    5 / 21 (23.81%)
    2 / 20 (10.00%)
         occurrences all number
    0
    12
    3
    Tension headache
         subjects affected / exposed
    0 / 22 (0.00%)
    4 / 21 (19.05%)
    0 / 20 (0.00%)
         occurrences all number
    0
    10
    0
    Disturbance in attention
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Tremor
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
         occurrences all number
    0
    2
    0
    Asthenia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 22 (0.00%)
    3 / 21 (14.29%)
    1 / 20 (5.00%)
         occurrences all number
    0
    11
    1
    Constipation
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Dry mouth
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
         occurrences all number
    0
    3
    0
    Sleep disorder
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 21 (9.52%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    1
    Tension
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2017
    Modification of the following items was implemented during the global amandement of the final protocol: • ECG related exclusion criterion has been revised to implement age-specific and gender-specific values for bradycardia and tachycardia diagnosis • use of certain EPS medications has been allowed • involvement of at least one investigator into the interim data review meeting after completion of subgroup 2B and 2A • replacement procedures • list of Adverse Event of Special Interest has been modified • change in the definition of PK Analysis Population • protocol deviations and violations • Administrative changes, clarifications (central ECG lab procedures, use of catheter, nominal sampling time point with allowed time deviation for Day 31, Day 35 and Day 42 PK samples), correction of in-text discrepancies and spelling errors

    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 reported
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