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    Clinical Trial Results:
    Intestinal disposition of mesalazine in healthy volunteers

    Summary
    EudraCT number
    		 2019-003728-19
    Trial protocol
    		 BE  
    Global end of trial date
    25 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2024
    First version publication date
    20 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DDD19IBDMES2
    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 box 921, Leuven, Belgium, 3000
    Public contact
    Patrick Augustijns, KU Leuven Drug Delivery & Disposition, patrick.augustijns@kuleuven.be
    Scientific contact
    Patrick Augustijns, KU Leuven Drug Delivery & Disposition, 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
    16 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    25 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the disposition of mesalazine at the level of the colon and systemic circulation
    Protection of trial subjects
    Standard procedures - no specific measures
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Feb 2021
    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: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy volunteers were recruited in Jan-May 2021 following a public announcement at the university campus (Leuven, Belgium).

    Pre-assignment
    Screening details
    		 Candidate participants were screened for in- and exclusion criteria. Inclusion: 18-35 years old, healthy Exclusion: illness at the time of study, allergy for salicylic derivatives, medication use (excluding contraceptives), history of acute/chronic gastrointestinal disease(s), (possible) pregnancy, infection with HIV, HBV, HCV

    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
    		 Pentasa
    Arm description
    		 Disposition of mesalazine following intake of 1 tablet of Pentasa (500 mg mesalazine) in fasted state.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mesalazine (Pentasa)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg of mesalazine administered as 1 tablet of Pentasa with 240 mL of water

    Arm title
    		 Claversal
    Arm description
    		 Disposition of mesalazine following intake of 1 tablet of Claversal (500 mg mesalazine) in fasted state.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mesalazine (Claversal)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg of mesalazine administered as 1 tablet of Claversal with 240 mL of water

    Arm title
    		 Claversal + PPI
    Arm description
    		 Disposition of mesalazine following intake of 1 tablet of Claversal (500 mg mesalazine) in fasted state and under treatment with the PPI Nexiam (esomeprazole 40 mg once-daily).
    Arm type
    		 Experimental

    Investigational medicinal product name
    mesalazine (Claversal)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg mesalazine administered as 1 tablet of Claversal with 240 mL of water

    Arm title
    		 Mezavant
    Arm description
    		 Disposition of mesalazine following intake of 1 tablet of Mezavant (1200 mg mesalazine) in fasted state.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mesalazine (Mezavant)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1200 mg of mesalazine administered as 1 tablet of Pentasa with 240 mL of water

    Number of subjects in period 1
    		Pentasa Claversal Claversal + PPI Mezavant
    Started
    5
    6
    5
    5
    Completed
    5
    6
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 23.5 (22 to 26) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Pentasa
    Reporting group description
    		 Disposition of mesalazine following intake of 1 tablet of Pentasa (500 mg mesalazine) in fasted state.

    Reporting group title
    Claversal
    Reporting group description
    		 Disposition of mesalazine following intake of 1 tablet of Claversal (500 mg mesalazine) in fasted state.

    Reporting group title
    Claversal + PPI
    Reporting group description
    		 Disposition of mesalazine following intake of 1 tablet of Claversal (500 mg mesalazine) in fasted state and under treatment with the PPI Nexiam (esomeprazole 40 mg once-daily).

    Reporting group title
    Mezavant
    Reporting group description
    		 Disposition of mesalazine following intake of 1 tablet of Mezavant (1200 mg mesalazine) in fasted state.

    Primary: Systemic AUC

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    End point title
    		 Systemic AUC [1]
    End point description
    Systemic AUC mesalazine + acetyl-mesalazine (combined)
    End point type
    Primary
    End point timeframe
    0-24 h after 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: The study was designed as exploratory without power to statistically test hypotheses.
    End point values
    		 Pentasa Claversal Claversal + PPI Mezavant
    Number of subjects analysed
    5
    5 [2]
    5
    5
    Units: µM*min
        arithmetic mean (standard deviation)
    3084 ( 976 )
    7343 ( 2182 )
    8650 ( 2362 )
    14594 ( 5395 )
    Notes
    [2] - The subject only participating in 1 arm of the study was excluded from the analyses.
    No statistical analyses for this end point

    Primary: Colonic tissue AUC

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    End point title
    		 Colonic tissue AUC [3]
    End point description
    AUC of mesalazine + acetyl-mesalazine (combined) in caecal tissue
    End point type
    Primary
    End point timeframe
    For arms 1-3: between 4,25 and 5,75 h after drug intake For arm 4 : between 9,75 and 11,15 h after drug intake
    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: The study was designed as exploratory without power to statistically test hypotheses.
    End point values
    		 Pentasa Claversal Claversal + PPI Mezavant
    Number of subjects analysed
    3 [4]
    3 [5]
    3 [6]
    5
    Units: min*nmol/mg
        arithmetic mean (standard deviation)
    166.4 ( 82.2 )
    526.6 ( 340.3 )
    590.0 ( 504.9 )
    1362.0 ( 807.4 )
    Notes
    [4] - Two outlier profiles were excluded from the mean.
    [5] - Two outlier profiles were excluded from the mean.
    [6] - Two outlier profiles were excluded from the mean.
    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 this 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.
    Exploratory, small scale study with no power to statistically test hypotheses.
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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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