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    Clinical Trial Results:
    A multicenter, open-label, 8 day treatment study to assess the pharmacokinetics, safety and tolerability of fevipiprant delivered via a once daily chewable tablet in children aged 6 to <12 years with asthma

    Summary
    EudraCT number
    		 2018-003920-35
    Trial protocol
    		 ES  
    Global end of trial date
    22 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jul 2020
    First version publication date
    27 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CQAW039B2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03650400
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001315-PIP02-16
    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
    22 Jan 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jan 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the key pharmacokinetic parameters of fevipiprant at steady state (ss), after at least four consecutive days of dosing
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2019
    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
    United States: 11
    Worldwide total number of subjects
    11
    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)
    11
    Adolescents (12-17 years)
    0
    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
    		 Six US centers recruited 11 subjects in the study. A total of 19 subjects were screened to enroll 11 subjects in the study.

    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
    		 Cohort A Fevipiprant 75 mg
    Arm description
    		 QAW039 75 mg Chewable tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    fevipiprant
    Investigational medicinal product code
    QAW039
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg (cohort A) or 375 mg (cohort B).

    Arm title
    		 Cohort B Feviprant 375 mg
    Arm description
    		 QAW039 375 mg Chewable tablet
    Arm type
    		 Cohort

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Started
    6
    5
    Completed
    6
    0
    Not completed
    0
    5
         Study terminated by sponsor
    -
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A Fevipiprant 75 mg
    Reporting group description
    		 QAW039 75 mg Chewable tablet

    Reporting group title
    Cohort B Feviprant 375 mg
    Reporting group description
    		 QAW039 375 mg Chewable tablet

    Reporting group values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg Total
    Number of subjects
    		 6 5 11
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 6 5 11
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.2 ( 1.83 ) 9.4 ( 1.52 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 4 3 7
        Male
    		 2 2 4
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 6 4 10
        More than one race
    		 0 1 1
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cohort A Fevipiprant 75 mg
    Reporting group description
    		 QAW039 75 mg Chewable tablet

    Reporting group title
    Cohort B Feviprant 375 mg
    Reporting group description
    		 QAW039 375 mg Chewable tablet

    Primary: Pharmacokinetics of fevipiprant by area under the curve from 0 to 24 hours at steady state (AUC0-24h,ss), after at least four consecutive days of dosing

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    End point title
    		 Pharmacokinetics of fevipiprant by area under the curve from 0 to 24 hours at steady state (AUC0-24h,ss), after at least four consecutive days of dosing [1]
    End point description
    Area under the curve (AUC0-24h,ss), steady state following drug administration. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
    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: No statistical analysis performed for PK parameters and no PK samples were collected for PK analysis in Cohort B, because of early study termination.
    End point values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Number of subjects analysed
    6
    0 [2]
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    2380 ( 1880 )
    ( )
    Notes
    [2] - Study terminated early.
    No statistical analyses for this end point

    Primary: Pharmacokinetics of fevipiprant by maximum plasma concentration at steady state (Cmax,ss), after at least four consecutive days of dosing

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    End point title
    		 Pharmacokinetics of fevipiprant by maximum plasma concentration at steady state (Cmax,ss), after at least four consecutive days of dosing [3]
    End point description
    Maximum plasma concentration (Cmax,ss) steady state following drug administration. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
    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: No statistical analysis performed for PK parameters and no PK samples were collected for PK analysis in Cohort B, because of early study termination.
    End point values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Number of subjects analysed
    6
    0 [4]
    Units: ng/mL
        arithmetic mean (standard deviation)
    394 ( 286 )
    ( )
    Notes
    [4] - Study terminated early
    No statistical analyses for this end point

    Primary: Pharmacokinetics of fevipiprant by oral clearance at steady state (CL/F), after at least four consecutive days of dosing

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    End point title
    		 Pharmacokinetics of fevipiprant by oral clearance at steady state (CL/F), after at least four consecutive days of dosing [5]
    End point description
    Oral clearance (CL/F), steady state following drug administration. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
    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: No statistical analysis performed for PK parameters and no PK samples were collected for PK analysis in Cohort B, because of early study termination.
    End point values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Number of subjects analysed
    6
    0 [6]
    Units: L/h
        arithmetic mean (standard deviation)
    48.2 ( 32 )
    ( )
    Notes
    [6] - Study terminated early
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of fevipiprant by CL/F

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    End point title
    		 Pharmacokinetics of fevipiprant by CL/F
    End point description
    Pharmacokinetics of fevipiprant by oral clearance (CL/F) at steady state
    End point type
    Secondary
    End point timeframe
    End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.
    End point values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Number of subjects analysed
    6
    0 [7]
    Units: L/h
        arithmetic mean (standard deviation)
    48.2 ( 32.0 )
    ( )
    Notes
    [7] - Study terminated early
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of fevipiprant by Tmax,ss

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    End point title
    		 Pharmacokinetics of fevipiprant by Tmax,ss
    End point description
    Pharmacokinetics of fevipiprant by time of maximum plasma concentration (Tmax,ss) at steady state
    End point type
    Secondary
    End point timeframe
    End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
    End point values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Number of subjects analysed
    6
    0 [8]
    Units: hours
        arithmetic mean (standard deviation)
    1.42 ( 0.916 )
    ( )
    Notes
    [8] - Study terminated early
    No statistical analyses for this end point

    Secondary: Urinary excretion of fevipiprant

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    End point title
    		 Urinary excretion of fevipiprant
    End point description
    CLr, amount and fraction of dose excreted over the PK collection interval at steady state, of fevipiprant
    End point type
    Secondary
    End point timeframe
    End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.
    End point values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Number of subjects analysed
    6
    0 [9]
    Units: L/h
        arithmetic mean (standard deviation)
    6.61 ( 4.88 )
    ( )
    Notes
    [9] - Study terminated early
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of fevipiprant by Cmin,ss

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    End point title
    		 Pharmacokinetics of fevipiprant by Cmin,ss
    End point description
    Pharmacokinetics of fevipiprant by minimum plasma concentration (Cmin,ss) at steady state
    End point type
    Secondary
    End point timeframe
    End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
    End point values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Number of subjects analysed
    6
    0 [10]
    Units: ng/mL
        arithmetic mean (standard deviation)
    28.3 ( 13.8 )
    ( )
    Notes
    [10] - Study terminated early
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of the metabolite CCN362 by AUC0-24h,ss

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    End point title
    		 Pharmacokinetics of the metabolite CCN362 by AUC0-24h,ss
    End point description
    Pharmacokinetics of CCN362 metabolite of fevipiprant , area under the curve (AUC0-24h,ss) at steady state.
    End point type
    Secondary
    End point timeframe
    End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
    End point values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Number of subjects analysed
    6
    0 [11]
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    2760 ( 1210 )
    ( )
    Notes
    [11] - Study terminated early
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of the metabolite CCN362 by Cmax,ss

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    End point title
    		 Pharmacokinetics of the metabolite CCN362 by Cmax,ss
    End point description
    Pharmacokinetics of CCN362 metabolite of fevipiprant by maximum plasma concentration (Cmax,ss) at steady state
    End point type
    Secondary
    End point timeframe
    End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
    End point values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Number of subjects analysed
    6
    0 [12]
    Units: ng/mL
        arithmetic mean (standard deviation)
    302 ( 134 )
    ( )
    Notes
    [12] - Study terminated early
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of the metabolite CCN362 by Cmin,ss

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    End point title
    		 Pharmacokinetics of the metabolite CCN362 by Cmin,ss
    End point description
    Pharmacokinetics of CCN362 metabolite of fevipiprant by minimum plasma concentration (Cmin,ss) at steady state
    End point type
    Secondary
    End point timeframe
    End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
    End point values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Number of subjects analysed
    6
    0 [13]
    Units: ng/mL
        arithmetic mean (standard deviation)
    33.6 ( 22.6 )
    ( )
    Notes
    [13] - Study terminated early
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of the metabolite CCN362 by Tmax,ss

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    End point title
    		 Pharmacokinetics of the metabolite CCN362 by Tmax,ss
    End point description
    Pharmacokinetics of CCN362 metabolite of fevipiprant by time of maximum plasma concentration (Tmax,ss) at steady state
    End point type
    Secondary
    End point timeframe
    End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
    End point values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Number of subjects analysed
    6
    0 [14]
    Units: hours
        arithmetic mean (standard deviation)
    2.69 ( 1.20 )
    ( )
    Notes
    [14] - Study terminated early
    No statistical analyses for this end point

    Secondary: Urinary excretion of the metabolite, CCN362

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    End point title
    		 Urinary excretion of the metabolite, CCN362
    End point description
    CLr, amount and fraction of dose excreted over the PK collection interval at steady state, of the metabolite, CCN362
    End point type
    Secondary
    End point timeframe
    End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.
    End point values
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Number of subjects analysed
    6
    0 [15]
    Units: L/h
        arithmetic mean (standard deviation)
    5.10 ( 1.96 )
    ( )
    Notes
    [15] - Study terminated early
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Cohort A Fevipiprant 75 mg
    Reporting group description
    		 QAW039 75 mg Chewable tablet

    Reporting group title
    Cohort B Feviprant 375 mg
    Reporting group description
    		 QAW039 375 mg Chewable tablet

    Serious adverse events
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events were reported in this study

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Feb 2019
    This protocol was amended based on health authority feedback. Based on this feedback the following changes were implemented: Modified study protocol with regards to meal intake for all days to ensure that meal intake is consistent on all treatment days Cyclosporine has been added as a prohibited medication in the study.

    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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    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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