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    Clinical Trial Results:
    Intestinal disposition of budesonide in healthy volunteers

    Summary
    EudraCT number
    		 2019-003271-19
    Trial protocol
    		 BE  
    Global end of trial date
    31 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Sep 2024
    First version publication date
    27 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DDD19IBDBUD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    KU Leuven Drug Delivery and Disposition
    Sponsor organisation address
    ON2 / Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Drug Delivery & Disposition - Patrick Augustijns, KU Leuven, patrick.augustijns@kuleuven.be
    Scientific contact
    Drug Delivery & Disposition - Patrick Augustijns, KU Leuven, patrick.augustijns@kuleuven.be
    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
    12 Feb 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the disposition and bioavailability of Budesonide at the level of the colon and blood
    Protection of trial subjects
    xylocaine spray/gel during positioning and removal of nasogastric catheter
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Feb 2020
    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: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 healthy volunteers

    Pre-assignment
    Screening details
    		 Candidate participants were screened for in- and exclusion criteria.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Entocort budesonide
    Arm description
    		 Entocort budesonide
    Arm type
    		 Experimental

    Investigational medicinal product name
    budesonide (Entocort)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Entocort budesonide 3 mg administered with 240 ml water in fasted state

    Arm title
    		 Budenofalk budesonide
    Arm description
    		 Budenofalk budesonide
    Arm type
    		 Experimental

    Investigational medicinal product name
    budesonide (Budenofalk)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Budenofalk budesonide 3 mg administered with 240 ml water in fasted state

    Arm title
    		 Ferring budesonide
    Arm description
    		 Ferring budesonide
    Arm type
    		 Experimental

    Investigational medicinal product name
    budesonide (Ferring)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Ferring budesonide 9 mg administered with 240 ml water in fasted state

    Arm title
    		 budesonide + nexiam
    Arm description
    		 Budenofalk (3 mg budesonide) following 3-day Nexiam treatment (1x 40 mg esomeprazole / day)
    Arm type
    		 Experimental

    Investigational medicinal product name
    budesonide (Budenofalk)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Budenofalk budesonide 3 mg administered with 240 ml water in fasted state

    Investigational medicinal product name
    nexiam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    For the PPI test condition, subjects were asked to take one tablet of Nexiam® 40 mg once-daily (before breakfast), starting two days prior to the day of the trial (i.e., final dose taken in the morning of the day of the trial).

    Number of subjects in period 1
    		Entocort budesonide Budenofalk budesonide Ferring budesonide budesonide + nexiam
    Started
    5
    5
    5
    5
    Completed
    5
    5
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Entocort budesonide
    Reporting group description
    		 Entocort budesonide

    Reporting group title
    Budenofalk budesonide
    Reporting group description
    		 Budenofalk budesonide

    Reporting group title
    Ferring budesonide
    Reporting group description
    		 Ferring budesonide

    Reporting group title
    budesonide + nexiam
    Reporting group description
    		 Budenofalk (3 mg budesonide) following 3-day Nexiam treatment (1x 40 mg esomeprazole / day)

    Reporting group values
    		 Entocort budesonide Budenofalk budesonide Ferring budesonide budesonide + nexiam Total
    Number of subjects
    		 5 5 5 5 5
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 5 5 5 5 5
    Age continuous
    Units: years
        median (full range (min-max))
    		 23 (21 to 25) 23 (21 to 25) 23 (21 to 25) 23 (21 to 25) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1 1 1 1
        Male
    		 4 4 4 4 4

    End points

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    End points reporting groups
    Reporting group title
    Entocort budesonide
    Reporting group description
    		 Entocort budesonide

    Reporting group title
    Budenofalk budesonide
    Reporting group description
    		 Budenofalk budesonide

    Reporting group title
    Ferring budesonide
    Reporting group description
    		 Ferring budesonide

    Reporting group title
    budesonide + nexiam
    Reporting group description
    		 Budenofalk (3 mg budesonide) following 3-day Nexiam treatment (1x 40 mg esomeprazole / day)

    Primary: Systemic exposure to budesonide

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    End point title
    		 Systemic exposure to budesonide [1]
    End point description
    End point type
    Primary
    End point timeframe
    0-24 h post drug intake
    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 designed as exploratory, i.e. without the intention to formally test hypotheses. As such, the data obtained are descriptive in nature and do not allow statistical comparison.
    End point values
    		 Entocort budesonide Budenofalk budesonide Ferring budesonide budesonide + nexiam
    Number of subjects analysed
    5
    5
    5
    5
    Units: ng/mL*h
        arithmetic mean (full range (min-max))
    6.74 (3.78 to 8.76)
    6.17 (4.31 to 13.05)
    7.76 (5.37 to 15.54)
    4.15 (2.41 to 8.82)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From first visit of first subject till last visit of last subject.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 5%
    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 happened during the study.

    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.
    This study was designed as exploratory, i.e. without the intention to formally test hypotheses. As such, the data obtained are descriptive in nature and do not allow statistical comparison.
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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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