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    Clinical Trial Results:
    A Multicentre, Open-label, Single Ascending Dose Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS Tablets in Pediatric Subjects from 5 to Less than 18 Years of Age with Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)

    Summary
    EudraCT number
    		 2014-000340-15
    Trial protocol
    		 DE   BE   NO   DK  
    Global end of trial date
    21 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Mar 2016
    First version publication date
    30 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    178-CL-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02211846
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe B.V.
    Sponsor organisation address
    Sylviusweg 62, Leiden, Netherlands, 2333 BE
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., astellas.resultsdisclosure@astellas.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000597-PIP10-04 EMEA-000597-PIP15-01
    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
    21 Sep 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the pharmacokinetics of mirabegron Oral Controlled Absorption System (OCAS) tablets after single-dose administration at different dose levels in children and adolescents with NDO or OAB.
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Sep 2014
    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
    Belgium: 1
    Country: Number of subjects enrolled
    Denmark: 11
    Country: Number of subjects enrolled
    Norway: 8
    Country: Number of subjects enrolled
    Poland: 14
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    19
    Adolescents (12-17 years)
    15
    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
    		 -

    Pre-assignment
    Screening details
    		 Children and adolescents with NDO or OAB, who consented to enter this study and fulfilled all the eligibility criteria were enrolled. A wash-out of prohibited medication for 5 half-lives was performed if a participant was using prohibited medication.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adolescents Low Dose (Fed)
    Arm description
    		 Adolescents aged 12 to less than 18 years received a single, weight-based dose of mirabegron after a light breakfast on day 1. Participants weighing 20.0 to < 55.0 kg received 25 mg mirabegron; participants ≥ 55.0 kg received 50 mg (both referred to as low dose, predicted to achieve the low exposure target).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirabegron
    Investigational medicinal product code
    YM178
    Other name
    Myrbetriq®, Betmiga™
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a single dose of mirabegron prolonged-release tablet/s (with strengths of 25 mg or 50 mg), with a glass of water on day 1.

    Arm title
    		 Children Low Dose (Fed)
    Arm description
    		 Children aged 5 to less than 12 years received a single, weight-based dose of mirabegron after a light breakfast on day 1. Participants weighing 20.0 to < 55.0 kg received 25 mg mirabegron; participants ≥ 55.0 kg received 50 mg (both referred to as low dose, predicted to achieve the low exposure target).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirabegron
    Investigational medicinal product code
    YM178
    Other name
    Myrbetriq®, Betmiga™
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a single dose of mirabegron prolonged-release tablet/s (with strengths of 25 mg or 50 mg), with a glass of water on day 1.

    Arm title
    		 Adolescents High Dose (Fed)
    Arm description
    		 Adolescents aged 12 to less than 18 years received a single, weight-based dose of mirabegron after a light breakfast on day 1. Participants weighing 20.0 to < 40.0 kg received 50 mg mirabegron; participants ≥ 40.0 kg received 75 mg (50 mg tablet + 25 mg tablet) (both referred to as high dose, predicted to achieve the high exposure target).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirabegron
    Investigational medicinal product code
    YM178
    Other name
    Myrbetriq®, Betmiga™
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a single dose of mirabegron prolonged-release tablet/s (with strengths of 25 mg or 50 mg), with a glass of water on day 1.

    Arm title
    		 Children High Dose (Fed)
    Arm description
    		 Children aged 5 to less than 12 years received a single, weight-based dose of mirabegron after a light breakfast on day 1. Participants weighing 20.0 to < 40.0 kg received 50 mg mirabegron; participants ≥ 40.0 kg received 75 mg (50 mg tablet + 25 mg tablet) (both referred to as high dose, predicted to achieve the high exposure target).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirabegron
    Investigational medicinal product code
    YM178
    Other name
    Myrbetriq®, Betmiga™
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a single dose of mirabegron prolonged-release tablet/s (with strengths of 25 mg or 50 mg), with a glass of water on day 1.

    Arm title
    		 Children High Dose (Fasted)
    Arm description
    		 Children aged 5 to less than 12 years received a single, weight-based dose of mirabegron under fasted conditions (fasted from at least midnight the day before before until 4 hours after dosing). Participants weighing 20.0 to < 40.0 kg received 50 mg mirabegron; participants ≥ 40.0 kg received 75 mg (50 mg tablet + 25 mg tablet) (both referred to as high dose, predicted to achieve the high exposure target).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirabegron
    Investigational medicinal product code
    YM178
    Other name
    Myrbetriq®, Betmiga™
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a single dose of mirabegron prolonged-release tablet/s (with strengths of 25 mg or 50 mg), with a glass of water on day 1.

    Number of subjects in period 1
    		Adolescents Low Dose (Fed) Children Low Dose (Fed) Adolescents High Dose (Fed) Children High Dose (Fed) Children High Dose (Fasted)
    Started
    7
    7
    8
    6
    6
    Safety Analysis Set (SAF)
    7
    7
    8
    6
    6
    Pharmacokinetic Analysis Set (PKAS)
    7
    7
    8
    6
    6
    Completed
    7
    7
    8
    6
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adolescents Low Dose (Fed)
    Reporting group description
    		 Adolescents aged 12 to less than 18 years received a single, weight-based dose of mirabegron after a light breakfast on day 1. Participants weighing 20.0 to < 55.0 kg received 25 mg mirabegron; participants ≥ 55.0 kg received 50 mg (both referred to as low dose, predicted to achieve the low exposure target).

    Reporting group title
    Children Low Dose (Fed)
    Reporting group description
    		 Children aged 5 to less than 12 years received a single, weight-based dose of mirabegron after a light breakfast on day 1. Participants weighing 20.0 to < 55.0 kg received 25 mg mirabegron; participants ≥ 55.0 kg received 50 mg (both referred to as low dose, predicted to achieve the low exposure target).

    Reporting group title
    Adolescents High Dose (Fed)
    Reporting group description
    		 Adolescents aged 12 to less than 18 years received a single, weight-based dose of mirabegron after a light breakfast on day 1. Participants weighing 20.0 to < 40.0 kg received 50 mg mirabegron; participants ≥ 40.0 kg received 75 mg (50 mg tablet + 25 mg tablet) (both referred to as high dose, predicted to achieve the high exposure target).

    Reporting group title
    Children High Dose (Fed)
    Reporting group description
    		 Children aged 5 to less than 12 years received a single, weight-based dose of mirabegron after a light breakfast on day 1. Participants weighing 20.0 to < 40.0 kg received 50 mg mirabegron; participants ≥ 40.0 kg received 75 mg (50 mg tablet + 25 mg tablet) (both referred to as high dose, predicted to achieve the high exposure target).

    Reporting group title
    Children High Dose (Fasted)
    Reporting group description
    		 Children aged 5 to less than 12 years received a single, weight-based dose of mirabegron under fasted conditions (fasted from at least midnight the day before before until 4 hours after dosing). Participants weighing 20.0 to < 40.0 kg received 50 mg mirabegron; participants ≥ 40.0 kg received 75 mg (50 mg tablet + 25 mg tablet) (both referred to as high dose, predicted to achieve the high exposure target).

    Reporting group values
    		 Adolescents Low Dose (Fed) Children Low Dose (Fed) Adolescents High Dose (Fed) Children High Dose (Fed) Children High Dose (Fasted) Total
    Number of subjects
    		 7 7 8 6 6
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.9 ± 1.6 8.1 ± 0.9 14.1 ± 1.6 8.2 ± 0.8 9.3 ± 0.8 -
    Gender categorical
    Units:
        Male
    		 2 2 2 2 3 11
        Female
    		 5 5 6 4 3 23
    Diagnosis at Screening
    Units: Subjects
        NDO
    		 2 2 3 2 2 11
        OAB
    		 5 5 5 4 4 23

    End points

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    End points reporting groups
    Reporting group title
    Adolescents Low Dose (Fed)
    Reporting group description
    		 Adolescents aged 12 to less than 18 years received a single, weight-based dose of mirabegron after a light breakfast on day 1. Participants weighing 20.0 to < 55.0 kg received 25 mg mirabegron; participants ≥ 55.0 kg received 50 mg (both referred to as low dose, predicted to achieve the low exposure target).

    Reporting group title
    Children Low Dose (Fed)
    Reporting group description
    		 Children aged 5 to less than 12 years received a single, weight-based dose of mirabegron after a light breakfast on day 1. Participants weighing 20.0 to < 55.0 kg received 25 mg mirabegron; participants ≥ 55.0 kg received 50 mg (both referred to as low dose, predicted to achieve the low exposure target).

    Reporting group title
    Adolescents High Dose (Fed)
    Reporting group description
    		 Adolescents aged 12 to less than 18 years received a single, weight-based dose of mirabegron after a light breakfast on day 1. Participants weighing 20.0 to < 40.0 kg received 50 mg mirabegron; participants ≥ 40.0 kg received 75 mg (50 mg tablet + 25 mg tablet) (both referred to as high dose, predicted to achieve the high exposure target).

    Reporting group title
    Children High Dose (Fed)
    Reporting group description
    		 Children aged 5 to less than 12 years received a single, weight-based dose of mirabegron after a light breakfast on day 1. Participants weighing 20.0 to < 40.0 kg received 50 mg mirabegron; participants ≥ 40.0 kg received 75 mg (50 mg tablet + 25 mg tablet) (both referred to as high dose, predicted to achieve the high exposure target).

    Reporting group title
    Children High Dose (Fasted)
    Reporting group description
    		 Children aged 5 to less than 12 years received a single, weight-based dose of mirabegron under fasted conditions (fasted from at least midnight the day before before until 4 hours after dosing). Participants weighing 20.0 to < 40.0 kg received 50 mg mirabegron; participants ≥ 40.0 kg received 75 mg (50 mg tablet + 25 mg tablet) (both referred to as high dose, predicted to achieve the high exposure target).

    Primary: Area Under the Concentration-Time Curve to Infinity (AUCinf) for Mirabegron

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    End point title
    		 Area Under the Concentration-Time Curve to Infinity (AUCinf) for Mirabegron [1]
    End point description
    The analysis population was the pharmacokinetic analysis set (PKAS), which consisted of all participants who received the dose of study drug and who had concentration values for a sufficient number of timepoints to reliably calculate at least 1 pharmacokinetic parameter.
    End point type
    Primary
    End point timeframe
    Days 1-7:Adolescents [5 samples on day 1&2]: 0.5-2, 3-4, 5-6, 7-8, 24-32 h postdose; Children [4 samples on day 1&2]: 0.5-2, 3-5, 6-8, 24-32 h post dose; All [2 samples from days 3-7]: 48-56, 72-80, or 96-104 h postdose/72-80,120-128 or 144–152 h postdose
    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: This study was written with no planned statistical analyses (inferential) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 Adolescents Low Dose (Fed) Children Low Dose (Fed) Adolescents High Dose (Fed) Children High Dose (Fed) Children High Dose (Fasted)
    Number of subjects analysed
    5 [2]
    7
    8
    5 [3]
    6
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    90.83 ± 25.56
    128.8 ± 65.48
    394.9 ± 205.5
    596.5 ± 385.5
    830.4 ± 384.8
    Notes
    [2] - Participants with available data.
    [3] - Participants with available data.
    No statistical analyses for this end point

    Primary: Maximum Concentration (Cmax) of Mirabegron

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    End point title
    		 Maximum Concentration (Cmax) of Mirabegron [4]
    End point description
    The analysis population was the PKAS.
    End point type
    Primary
    End point timeframe
    Days 1-7:Adolescents [5 samples on day 1&2]: 0.5-2, 3-4, 5-6, 7-8, 24-32 h postdose; Children [4 samples on day 1&2]: 0.5-2, 3-5, 6-8, 24-32 h post dose; All [2 samples from days 3-7]: 48-56, 72-80, or 96-104 h postdose/72-80,120-128 or 144–152 h postdose
    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: This study was written with no planned statistical analyses (inferential) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 Adolescents Low Dose (Fed) Children Low Dose (Fed) Adolescents High Dose (Fed) Children High Dose (Fed) Children High Dose (Fasted)
    Number of subjects analysed
    7
    7
    8
    6
    6
    Units: ng/mL
        arithmetic mean (standard deviation)
    4.73 ± 2.717
    6.909 ± 4.67
    31.98 ± 26.1
    43.99 ± 31.93
    56.42 ± 17.73
    No statistical analyses for this end point

    Primary: Time at Which Cmax Occurred (tmax) for Mirabegron

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    End point title
    		 Time at Which Cmax Occurred (tmax) for Mirabegron [5]
    End point description
    The analysis population was the PKAS.
    End point type
    Primary
    End point timeframe
    Days 1-7:Adolescents [5 samples on day 1&2]: 0.5-2, 3-4, 5-6, 7-8, 24-32 h postdose; Children [4 samples on day 1&2]: 0.5-2, 3-5, 6-8, 24-32 h post dose; All [2 samples from days 3-7]: 48-56, 72-80, or 96-104 h postdose/72-80,120-128 or 144–152 h postdose
    Notes
    [5] - 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: This study was written with no planned statistical analyses (inferential) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 Adolescents Low Dose (Fed) Children Low Dose (Fed) Adolescents High Dose (Fed) Children High Dose (Fed) Children High Dose (Fasted)
    Number of subjects analysed
    7
    7
    8
    6
    6
    Units: hours
        median (full range (min-max))
    5.03 (3.95 to 5.75)
    4.17 (2.55 to 6.37)
    4.475 (3.08 to 7.08)
    4.28 (3.88 to 4.42)
    3.95 (3.47 to 4.27)
    No statistical analyses for this end point

    Primary: Elimination Half Life (t1/2) of Mirabegron

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    End point title
    		 Elimination Half Life (t1/2) of Mirabegron [6]
    End point description
    The analysis population was the PKAS.
    End point type
    Primary
    End point timeframe
    Days 1-7:Adolescents [5 samples on day 1&2]: 0.5-2, 3-4, 5-6, 7-8, 24-32 h postdose; Children [4 samples on day 1&2]: 0.5-2, 3-5, 6-8, 24-32 h post dose; All [2 samples from days 3-7]: 48-56, 72-80, or 96-104 h postdose/72-80,120-128 or 144–152 h postdose
    Notes
    [6] - 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: This study was written with no planned statistical analyses (inferential) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 Adolescents Low Dose (Fed) Children Low Dose (Fed) Adolescents High Dose (Fed) Children High Dose (Fed) Children High Dose (Fasted)
    Number of subjects analysed
    5 [7]
    7
    8
    5 [8]
    6
    Units: hours
        arithmetic mean (standard deviation)
    27.16 ± 6.664
    30.76 ± 8.119
    29.2 ± 4.51
    28.97 ± 6.076
    26.16 ± 2.931
    Notes
    [7] - Participants with available data.
    [8] - Participants with available data.
    No statistical analyses for this end point

    Primary: Apparent Oral Clearance (CL/F) for Mirabegron

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    End point title
    		 Apparent Oral Clearance (CL/F) for Mirabegron [9]
    End point description
    The analysis population was the PKAS.
    End point type
    Primary
    End point timeframe
    Days 1-7:Adolescents [5 samples on day 1&2]: 0.5-2, 3-4, 5-6, 7-8, 24-32 h postdose; Children [4 samples on day 1&2]: 0.5-2, 3-5, 6-8, 24-32 h post dose; All [2 samples from days 3-7]: 48-56, 72-80, or 96-104 h postdose/72-80,120-128 or 144–152 h postdose
    Notes
    [9] - 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: This study was written with no planned statistical analyses (inferential) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 Adolescents Low Dose (Fed) Children Low Dose (Fed) Adolescents High Dose (Fed) Children High Dose (Fed) Children High Dose (Fasted)
    Number of subjects analysed
    5 [10]
    7
    8
    5 [11]
    6
    Units: L/h
        arithmetic mean (standard deviation)
    339.1 ± 97.54
    248.7 ± 132.5
    230.1 ± 137.4
    113 ± 62.89
    79.08 ± 45.64
    Notes
    [10] - Participants with available data.
    [11] - Participants with available data.
    No statistical analyses for this end point

    Primary: Apparent Volume of Distribution (Vz/F) of Mirabegron

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    End point title
    		 Apparent Volume of Distribution (Vz/F) of Mirabegron [12]
    End point description
    The analysis population was the PKAS.
    End point type
    Primary
    End point timeframe
    Days 1-7:Adolescents [5 samples on day 1&2]: 0.5-2, 3-4, 5-6, 7-8, 24-32 h postdose; Children [4 samples on day 1&2]: 0.5-2, 3-5, 6-8, 24-32 h post dose; All [2 samples from days 3-7]: 48-56, 72-80, or 96-104 h postdose/72-80,120-128 or 144–152 h postdose
    Notes
    [12] - 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: This study was written with no planned statistical analyses (inferential) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 Adolescents Low Dose (Fed) Children Low Dose (Fed) Adolescents High Dose (Fed) Children High Dose (Fed) Children High Dose (Fasted)
    Number of subjects analysed
    5 [13]
    7
    8
    5 [14]
    6
    Units: liters
        arithmetic mean (standard deviation)
    13063 ± 4569
    9959 ± 3639
    9918 ± 6702
    4895 ± 2921
    2866 ± 1438
    Notes
    [13] - Participants with available data.
    [14] - Participants with available data.
    No statistical analyses for this end point

    Primary: Area Under the Concentration-Time Curve to 24 Hours (AUC24) for Mirabegron

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    End point title
    		 Area Under the Concentration-Time Curve to 24 Hours (AUC24) for Mirabegron [15]
    End point description
    The analysis population was the PKAS.
    End point type
    Primary
    End point timeframe
    Time Frame: Days 1-2: Adolescents [5 samples on day 1&2]: 0.5-2, 3-4, 5-6, 7-8, 24-32 h postdose; Children [4 samples on day 1&2]: 0.5-2, 3-5, 6-8, 24-32 h post dose
    Notes
    [15] - 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: This study was written with no planned statistical analyses (inferential) to be performed for any end points due to the simple design and purpose of the study.
    End point values
    		 Adolescents Low Dose (Fed) Children Low Dose (Fed) Adolescents High Dose (Fed) Children High Dose (Fed) Children High Dose (Fasted)
    Number of subjects analysed
    7
    7
    8
    6
    6
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    47.9 ± 14.24
    66.33 ± 31.66
    230.7 ± 132.5
    336 ± 225.4
    508.6 ± 190.2
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events (AEs)

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    End point title
    		 Number of Participants with Adverse Events (AEs)
    End point description
    Safety was assessed by collecting AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital sign, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of study drug until 7 days after the last dose of study drug. A related SAE or TEAE was possible or probable, as assessed by the Investigator, or records where relationship is missing. The analysis population was the Safety Analysis Set (SAF) which consisted of all participants who took the dose of study drug.
    End point type
    Secondary
    End point timeframe
    From dosing up to 7 days postdose
    End point values
    		 Adolescents Low Dose (Fed) Children Low Dose (Fed) Adolescents High Dose (Fed) Children High Dose (Fed) Children High Dose (Fasted)
    Number of subjects analysed
    7
    7
    8
    6
    6
    Units: participants
        TEAE
    1
    1
    1
    0
    1
        Related TEAE
    0
    0
    1
    0
    0
        Death
    0
    0
    0
    0
    0
        SAE
    0
    0
    0
    0
    0
        Drug-related SAE
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From dosing up to 7 days postdose
    Adverse event reporting additional description
    SAF
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Adolescents Low Dose (Fed)
    Reporting group description
    		 Male and female adolescents aged 12 to less than 18 years) who received a low dose of mirabegron under fed conditons.

    Reporting group title
    Children Low Dose (Fed)
    Reporting group description
    		 Male and female children aged 5 to less than 12 years who received a low dose of mirabegron under fed conditons.

    Reporting group title
    Adolescents High Dose (Fed)
    Reporting group description
    		 Male and female adolescents aged 12 to less than 18 years) who received a high dose of mirabegron under fed conditons.

    Reporting group title
    Children High Dose (Fed)
    Reporting group description
    		 Male and female children aged 5 to less than 12 years who received a high dose of mirabegron under fed conditons.

    Reporting group title
    Children High Dose (Fasted)
    Reporting group description
    		 Male and female children aged 5 to less than 12 years who received a high dose of mirabegron under fasted conditons (fasted from at least midnight the day before before until 4 hours after dosing).

    Serious adverse events
    		 Adolescents Low Dose (Fed) Children Low Dose (Fed) Adolescents High Dose (Fed) Children High Dose (Fed) Children High Dose (Fasted)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adolescents Low Dose (Fed) Children Low Dose (Fed) Adolescents High Dose (Fed) Children High Dose (Fed) Children High Dose (Fasted)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    Investigations
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    0
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Sep 2014
    In this global amendment, changes include: (1) The United States was added as a study location; (2) The method for estimated glomerular filtration rate calculation was amended from the modification of diet in renal disease (MDRD) study equation method to the revised Schwartz method; (3) Cystatin C was added as a biochemistry parameter.
    06 Feb 2015
    In this global amendment, changes include: (1)The Investigator’s Brochure was listed as a source for contraindications or precautions to exclusion criterion 12; (2) The required wash-out period for mirabegron before the planned reference day (day -4 to day -1) was amended from 24 days to 12 days; (3) Current, untreated constipation (or fecal impaction for NDO participants) were added as an exclusion criterion at screening; (4) Use of botox within 4 months prior to screening was added as an exclusion criterion at screening; (5) Symptomatic Urinary tract infection (UTI) was added as a day 1 exclusion criterion; (6) Several sections were updated to allow preselected study visits to take place outside the clinic; (7) The pharmacokinetic-specific restrictions for dosing on Friday and weekend samplings were removed; (8) Assessments of palatability (taste) and acceptability (ease of swallowing) were included in the protocol as exploratory endpoints.

    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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