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    Clinical Trial Results:
    Gastrointestinal Behavior of Posaconazole in Healthy Volunteers

    Summary
    EudraCT number
    		 2015-002703-28
    Trial protocol
    		 BE  
    Global end of trial date
    28 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Feb 2020
    First version publication date
    12 Feb 2020
    Other versions
    Summary report(s)
    		 Posaconazole - Tablet - Article

    Trial information

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    Trial identification
    Sponsor protocol code
    DDD15POSA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    KU Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Drug Delivery & Disposition, KU Leuven, +32 16330302, bart.hens@pharm.kuleuven.be
    Scientific contact
    Drug Delivery & Disposition, KU Leuven, +32 16330302, bart.hens@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
    28 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Study of the gastrointestinal (GI) behavior of posaconazol in healthy volunteers by administerting the Noxafil tablet (posaconazole, 100 mg) in fasted and fed state conditions to five healthy subjects. The obtained data will learn us more about the luminal behavior of posaconazole and the impact of different GI in the GI tract after being administered as a solid dispersion tablet (supersaturation/ precipitation/ dissolution/ ...).
    Protection of trial subjects
    Not applicable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2015
    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
    		 -

    Pre-assignment
    Screening details
    		 Exclusion criteria for this clinical study were gastrointestinal disorders, infection with hepatitis B, hepatitis C, or HIV, use of medication, pregnancy, and frequent X-ray exposure. These criteria were checked for every volunteer during a medical examination.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Fasted state conditions
    Arm description
    		 In the first test condition, one tablet of 100 mg posaconazole was taken orally with 240 mL of water.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Posaconazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the first test condition, one tablet of 100 mg posaconazole was taken orally with 240 mL of water. In the second test condition, volunteers were asked to drink 400 mL of Ensure Plus® nutrient shake (Abbott Laboratories B.V., Zwolle, The Netherlands), 20 min prior to oral intake of the tablet with 240 mL of water.

    Arm title
    		 Fed state conditions
    Arm description
    		 In the second test condition, volunteers were asked to drink 400 mL of Ensure Plus® nutrient shake (Abbott Laboratories B.V., Zwolle, The Netherlands), 20 min prior to oral intake of the tablet with 240 mL of water.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Posaconazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the second test condition, volunteers were asked to drink 400 mL of Ensure Plus® nutrient shake (Abbott Laboratories B.V., Zwolle, The Netherlands), 20 min prior to oral intake of the tablet (100 mg) with 240 mL of water.

    Number of subjects in period 1
    		Fasted state conditions Fed state conditions
    Started
    5
    4
    Completed
    5
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fasted state conditions
    Reporting group description
    		 In the first test condition, one tablet of 100 mg posaconazole was taken orally with 240 mL of water.

    Reporting group title
    Fed state conditions
    Reporting group description
    		 In the second test condition, volunteers were asked to drink 400 mL of Ensure Plus® nutrient shake (Abbott Laboratories B.V., Zwolle, The Netherlands), 20 min prior to oral intake of the tablet with 240 mL of water.

    Reporting group values
    		 Fasted state conditions Fed state conditions Total
    Number of subjects
    		 5 4
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 23 (21 to 26) 23 (21 to 26) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1 2
        Male
    		 4 3 7

    End points

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    End points reporting groups
    Reporting group title
    Fasted state conditions
    Reporting group description
    		 In the first test condition, one tablet of 100 mg posaconazole was taken orally with 240 mL of water.

    Reporting group title
    Fed state conditions
    Reporting group description
    		 In the second test condition, volunteers were asked to drink 400 mL of Ensure Plus® nutrient shake (Abbott Laboratories B.V., Zwolle, The Netherlands), 20 min prior to oral intake of the tablet with 240 mL of water.

    Primary: Gastrointestinal and plasma AUC, Cmax and Tmax

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    End point title
    		 Gastrointestinal and plasma AUC, Cmax and Tmax
    End point description
    In order to determine dissolved concentrations of posaconazole in gastrointestinal fluids, aspirates were immediately centrifuged (20,817 g, 5 min) and the supernatant was 20-fold diluted in mobile phase (methanol: 25 mM acetic acid buffer pH 3.5 [85:15 vol/vol]). To determine the total posaconazole content (i.e., solute + solid), aspirates were directly diluted 20-fold in mobile phase. In both cases, precipitated proteins were separated with an additional centrifugation step (20,817 g, 5 min, 37°C). Samples were analyzed by HPLC-FLUO.
    End point type
    Primary
    End point timeframe
    GI concentrations up to 4 h and plasma samples up to 24 h
    End point values
    		 Fasted state conditions Fed state conditions
    Number of subjects analysed
    5
    4
    Units: micromolar (concentration)
        number (not applicable)
    5
    4
    Statistical analysis title
    		 Data Presentation and Statistical Analysis
    Comparison groups
    Fed state conditions v Fasted state conditions
    Number of subjects included in analysis
    9
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    No adverse events were noted during or after this study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Excel file
    Dictionary version
    office 365
    Frequency threshold for reporting non-serious adverse events: 0%
    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: There were no adverse events noted.

    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.
    Not applicable.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27178739
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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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