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    Clinical Trial Results:
    Gastrointestinal behavior of itraconazole in healthy volunteers

    Summary
    EudraCT number
    		 2011-005928-17
    Trial protocol
    		 BE  
    Global end of trial date
    04 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Apr 2021
    First version publication date
    28 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FTB-11-ITRA01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pharmacotechnology and Biopharmacy
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium,
    Public contact
    Pharmacotechnology and Biopharmacy, Katholieke Universiteit Leuven, 32 16330300, joachim.brouwers@pharm.kuleuven.be
    Scientific contact
    Pharmacotechnology and Biopharmacy, Katholieke Universiteit Leuven, 32 16330300, joachim.brouwers@pharm.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
    13 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the gastrointestinal behavior and absorption of itraconazole.
    Protection of trial subjects
    Identification of the trial subjects was replaced by study participant numbers.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Apr 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: 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 will be selected via a database that is available in the lab and via mouth to mouth recruitment.

    Pre-assignment
    Screening details
    		 xclusion criteria for participation were a history ofgastrointestinal disease(s), pregnancy, frequent exposure toionizing radiation during the previous year, and/or illness at thetime of the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 2 Sporanox capsules
    Arm description
    		 2 Sporanox capsules
    Arm type
    		 Experimental

    Investigational medicinal product name
    itraconazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200mg of itraconazole administerd in 2 Sporanox capsules

    Arm title
    		 20 mL Sporanox oral solution
    Arm description
    		 20 mL Sporanox oral solution
    Arm type
    		 Active comparator

    Investigational medicinal product name
    itraconazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral/rectal solution
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg of itraconazole administered via a 20 mL Sporanox oral solution

    Number of subjects in period 1
    		2 Sporanox capsules 20 mL Sporanox oral solution
    Started
    5
    5
    Completed
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 5 5
    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)
    		 5 5
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 25 (23 to 27) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    2 Sporanox capsules
    Reporting group description
    		 2 Sporanox capsules

    Reporting group title
    20 mL Sporanox oral solution
    Reporting group description
    		 20 mL Sporanox oral solution

    Subject analysis set title
    Sporanox capsules vs solution
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    5 HV who received 200mg of itraconazole delivered one time as 2 sporanox capsules and one time as a 20mL sporanox solution

    Primary: AUC

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    End point title
    		 AUC [1]
    End point description
    End point type
    Primary
    End point timeframe
    from drug administration until 8 hours after administraion
    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 p-value available in the article. Only the mean +- SD was mentioned.
    End point values
    		 2 Sporanox capsules 20 mL Sporanox oral solution
    Number of subjects analysed
    5
    5
    Units: nM x h
        arithmetic mean (standard deviation)
    1880 ± 543
    5708 ± 1006
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From start of visit 1 until the end of visit 2
    Assessment type
    		 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 happen in 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.
    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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