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    Clinical Trial Results:
    Phase IV, single centre, randomised, open-label, two-period, two-way crossover clinical trial to assess the efficacy of Bilastine 20mg in the suppression of wheal and flare induced by intradermal histamine in healthy volunteers under fasted and fed conditions.

    Summary
    EudraCT number
    		 2018-000913-19
    Trial protocol
    		 ES  
    Global end of trial date
    03 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jul 2022
    First version publication date
    02 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BILA-3818/PD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    FAES Farma, S.A.
    Sponsor organisation address
    Avda Autonomía, 10, Leioa, Spain, 48940
    Public contact
    Clinical Research Director, FAES FARMA, S.A., 0034 944818300, ccampo@faes.es
    Scientific contact
    Clinical Research Director, FAES FARMA, S.A., 0034 944818300, ccampo@faes.es
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Sep 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of Bilastine 20 mg administered orally under fasted and fed conditions (moderate-fat meal) in reduction of histamine-induced skin reactivity in healthy volunteers, taking into account the first treatment day (Day 1) and steady state (Day 4).
    Protection of trial subjects
    Healthy volunteers, study designed to minimize the number of study drug administrations. All study subjects had immediate medical care access if necessary.
    Background therapy
    		 Healthy volunteers, no additional therapies needed
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    17 May 2018
    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
    Spain: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    0
    Adults (18-64 years)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 41 subjects were screened for the trial and 29 subjects met the inclusion/exclusion criteria. Twenty-four subjects were randomized and 23 completed their participation on the clinical study.

    Pre-assignment
    Screening details
    		 The inclusion phase (four weeks before the beginning of experimental phase) was initiated and all subjects underwent a complete medical check-up in order to verify that they met all the inclusion criteria and none of the exclusion criteria.

    Period 1
    Period 1 title
    Fed condition
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Total population Fed
    Arm description
    		 Total population treated with bilastine once daily under fed conditions
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bilastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg once daily for 4 days under Fasting conditions

    Number of subjects in period 1
    		Total population Fed
    Started
    24
    Completed
    24
    Period 2
    Period 2 title
    Fasting condition
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Total population Fasting
    Arm description
    		 Total population treated with bilastine once daily under fasting conditions
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bilastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg once daily for 4 days under fed conditions

    Number of subjects in period 2
    		Total population Fasting
    Started
    24
    Completed
    23
    Not completed
    1
         Patient did not attend the fasting period
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fed condition
    Reporting group description
    		 -

    Reporting group values
    		 Fed condition Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 24 24
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 12 12
    Subject analysis sets

    Subject analysis set title
    Pharmacodynamic profile
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects who completed the clinical study without protocol deviations.

    Subject analysis sets values
    		 Pharmacodynamic profile
    Number of subjects
    23
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    23
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    12
        Male
    11

    End points

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    End points reporting groups
    Reporting group title
    Total population Fed
    Reporting group description
    		 Total population treated with bilastine once daily under fed conditions
    Reporting group title
    Total population Fasting
    Reporting group description
    		 Total population treated with bilastine once daily under fasting conditions

    Subject analysis set title
    Pharmacodynamic profile
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects who completed the clinical study without protocol deviations.

    Primary: Efficacy of bilastine 20 mg on 1st treatment day (Day 1)

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    End point title
    		 Efficacy of bilastine 20 mg on 1st treatment day (Day 1)
    End point description
    The primary objective of this study is to compare the efficacy of bilastine 20 mg administered orally under fasting and fed conditions (moderate-fat breakfast) in reduction of histamine-induced skin reactivity in healthy volunteers, taking into account the first treatment day (Day 1)
    End point type
    Primary
    End point timeframe
    Day 1
    End point values
    		 Total population Fed Total population Fasting
    Number of subjects analysed
    23
    23
    Units: ngh/mL
        arithmetic mean (standard deviation)
    1494.60 ± 256.14
    1423.45 ± 191.88
    Statistical analysis title
    		 IBM-SPSS 22.0.
    Comparison groups
    Total population Fed v Total population Fasting
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - Statistical analyses were performed using the program IBM-SPSS 22.0. In all the statistical analyses the level of significance was set at 5% (alpha value = 0.05), two-sided

    Primary: Efficacy of bilastine 20 mg on steady state (Day 4)

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    End point title
    		 Efficacy of bilastine 20 mg on steady state (Day 4)
    End point description
    efficacy of bilastine 20 mg administered orally under fasting and fed conditions (moderate-fat breakfast) in reduction of histamine-induced skin reactivity in healthy volunteers, taking into account steady state (Day 4).
    End point type
    Primary
    End point timeframe
    Day 4
    End point values
    		 Total population Fed Total population Fasting
    Number of subjects analysed
    23
    23
    Units: ngh/mL
        arithmetic mean (standard deviation)
    1523.48 ± 199.60
    1529.46 ± 242.35
    Statistical analysis title
    		 IBM-SPSS (v22.0)
    Comparison groups
    Total population Fed v Total population Fasting
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Safety and tolerability

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    End point title
    		 Safety and tolerability
    End point description
    To assess the safety and tolerability of bilastine after repeated (4 days) single daily oral dose (20 mg) administration in young male and female healthy volunteers
    End point type
    Secondary
    End point timeframe
    From informed consent signature till final visit
    End point values
    		 Pharmacodynamic profile
    Number of subjects analysed
    23
    Units: number
    23
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent signature till final visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Fasting
    Reporting group description
    		 -

    Reporting group title
    Fed condition
    Reporting group description
    		 -

    Serious adverse events
    		 Fasting Fed condition
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (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
    		 Fasting Fed condition
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 24 (8.33%)
    3 / 24 (12.50%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 24 (8.33%)
    2 / 24 (8.33%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1

    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 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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