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    Clinical Trial Results:
    Gastrointestinal behavior of posaconazol in healthy human volunteers

    Summary
    EudraCT number
    		 2013-002836-26
    Trial protocol
    		 BE  
    Global end of trial date
    10 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2019
    First version publication date
    29 Dec 2019
    Other versions
    Summary report(s)
    		 Hens et al. - Supersaturation and precipitation of posaconazole in the human GI tract

    Trial information

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    Trial identification
    Sponsor protocol code
    DDD13POSA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Clinical Trial Center UZ Leuven: S
    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
    27 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Study of the gastrointestinal behavior of posaconazol in healthy volunteers by using a suspension of the drug and a solution. This will learn us more about the behaviour of the drug in the GI tract (supersaturation/ precipitation/ dissolution/ ...)
    Protection of trial subjects
    NA.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jan 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
    		 Subjects were recruited by email based on an existing database.

    Pre-assignment
    Screening details
    		 Exclusion criteria were checked during a medical examination and included gastrointestinal disorders, infection with hepatitis B, hepatitis C or HIV, use of medication, pregnancy and frequent X-ray exposure. All volunteers provided informed consent to participate in the clinical study.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Suspension pH 1.6 40 mg
    Arm description
    		 For the acidified suspension, 1 mL of Noxafil® (40 mg posaconazole as such, which corresponds to 10% of the typical therapeutic dose) was dispersed in 240 mL of tap water acidified to pH 1.6 with HCl (70% of posaconazole in solution). This suspension was intragastrically administered to healthy subjects.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Posaconazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    For the acidified suspension, 1 mL of Noxafil® (40 mg posaconazole as such, which corresponds to 10% of the typical therapeutic dose) was dispersed in 240 mL of tap water acidified to pH 1.6 with HCl (70% of posaconazole in solution). This suspension was intragastrically administered to healthy subjects.

    Arm title
    		 Suspension pH 7.1 40 mg
    Arm description
    		 For the neutral suspension, 1 mL of Noxafil® (40 mg posaconazole) was dispersed in 240 mL of tap water (pH 7.1; 2.3% of posaconazole in solution). After intragastric administration, antral and duodenal fluids were aspirated for 3 h; samples were taken at 2, 7, 15, 25, 35, 45, 55, and 60 min during the first hour and every 15 min for the next 2 h. The sampling volumewas kept as small as possible (<4mL per time point). Immediately after aspiration of fluids, pH was measured (Hamilton Knick Portamess®, Bonaduz, Switzerland) and the determination of dissolved and total posaconazole was initiated. Blood samples were collected in heparinized tubes (BD Vacutainer systems, Plymouth, UK) at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, and 24 h after intragastric administration. Blood samples were centrifuged (2880g, 10 min, 4°C) and the obtained plasma was stored at -26°C until analysis.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Posaconazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    For the neutral suspension, 1 mL of Noxafil® (40 mg posaconazole) was dispersed in 240 mL of tap water (pH 7.1; 2.3% of posaconazole in solution). After intragastric administration, antral and duodenal fluids were aspirated for 3 h; samples were taken at 2, 7, 15, 25, 35, 45, 55, and 60 min during the first hour and every 15 min for the next 2 h. The sampling volumewas kept as small as possible (<4mL per time point). Immediately after aspiration of fluids, pH was measured (Hamilton Knick Portamess®, Bonaduz, Switzerland) and the determination of dissolved and total posaconazole was initiated. Blood samples were collected in heparinized tubes (BD Vacutainer systems, Plymouth, UK) at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, and 24 h after intragastric administration. Blood samples were centrifuged (2880g, 10 min, 4°C) and the obtained plasma was stored at -26°C until analysis.

    Arm title
    		 Solution pH 1.6 20 mg
    Arm description
    		 In an additional condition (no blood sampling involved), posaconazole as such was intragastrically administered as a solution in order to assess intestinal posaconazole precipitation without the potential impact of accelerated nucleation due to the presence of solid particles from the suspensions. The solution was prepared by dissolving 0.5 mL of Noxafil® (20 mg posaconazole) in 240 mL of tap water acidified to pH 1.6. Analogous to previous test conditions, antral and duodenal fluids were aspirated for 3 h, followed by pH measurement (Hamilton Knick Portamess®) and determination of dissolved and total posaconazole concentrations. Blood samples were not collected.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Posaconazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    In an additional condition (no blood sampling involved), posaconazole as such was intragastrically administered as a solution in order to assess intestinal posaconazole precipitation without the potential impact of accelerated nucleation due to the presence of solid particles from the suspensions. The solution was prepared by dissolving 0.5 mL of Noxafil® (20 mg posaconazole) in 240 mL of tap water acidified to pH 1.6. Analogous to previous test conditions, antral and duodenal fluids were aspirated for 3 h, followed by pH measurement (Hamilton Knick Portamess®) and determination of dissolved and total posaconazole concentrations. Blood samples were not collected.

    Number of subjects in period 1
    		Suspension pH 1.6 40 mg Suspension pH 7.1 40 mg Solution pH 1.6 20 mg
    Started
    5
    5
    5
    Completed
    5
    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
    		 5 5
    Age categorical
    A cross-over study with three experimental conditions was performed in five healthy volunteers (HVs; three women and two men, aged between 23 and 25 years).
    Units: Subjects
        adults (0-65 years old)
    		 5 5
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Suspension pH 1.6 40 mg
    Reporting group description
    		 For the acidified suspension, 1 mL of Noxafil® (40 mg posaconazole as such, which corresponds to 10% of the typical therapeutic dose) was dispersed in 240 mL of tap water acidified to pH 1.6 with HCl (70% of posaconazole in solution). This suspension was intragastrically administered to healthy subjects.

    Reporting group title
    Suspension pH 7.1 40 mg
    Reporting group description
    		 For the neutral suspension, 1 mL of Noxafil® (40 mg posaconazole) was dispersed in 240 mL of tap water (pH 7.1; 2.3% of posaconazole in solution). After intragastric administration, antral and duodenal fluids were aspirated for 3 h; samples were taken at 2, 7, 15, 25, 35, 45, 55, and 60 min during the first hour and every 15 min for the next 2 h. The sampling volumewas kept as small as possible (<4mL per time point). Immediately after aspiration of fluids, pH was measured (Hamilton Knick Portamess®, Bonaduz, Switzerland) and the determination of dissolved and total posaconazole was initiated. Blood samples were collected in heparinized tubes (BD Vacutainer systems, Plymouth, UK) at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, and 24 h after intragastric administration. Blood samples were centrifuged (2880g, 10 min, 4°C) and the obtained plasma was stored at -26°C until analysis.

    Reporting group title
    Solution pH 1.6 20 mg
    Reporting group description
    		 In an additional condition (no blood sampling involved), posaconazole as such was intragastrically administered as a solution in order to assess intestinal posaconazole precipitation without the potential impact of accelerated nucleation due to the presence of solid particles from the suspensions. The solution was prepared by dissolving 0.5 mL of Noxafil® (20 mg posaconazole) in 240 mL of tap water acidified to pH 1.6. Analogous to previous test conditions, antral and duodenal fluids were aspirated for 3 h, followed by pH measurement (Hamilton Knick Portamess®) and determination of dissolved and total posaconazole concentrations. Blood samples were not collected.

    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
    End point type
    Primary
    End point timeframe
    GI samples were taken at 2, 7, 15, 25, 35, 45, 55, and 60 min during the first hour and every 15 min for the next 2 h. Blood samples were collected at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, and 24 h after intragastric administration.
    End point values
    		 Suspension pH 1.6 40 mg Suspension pH 7.1 40 mg Solution pH 1.6 20 mg
    Number of subjects analysed
    5
    5
    5
    Units: luminal and systemic Concentrations
        number (not applicable)
    5
    5
    5
    Statistical analysis title
    		 Data Presentation and Statistical Analysis
    Statistical analysis description
    Intraluminal concentration-time profiles are presented as mean ± standard error of the mean (SEM) for five subjects. Pharmacokinetic parameters (plasma and duodenal Cmax tmax, and area under the curve [AUC]) are reported as mean ± SD. Test conditions were compared using a paired t-test (after logarithmic transformation of Cmax and AUC); differences were considered statistically significant at p < 0.05.
    Comparison groups
    Suspension pH 1.6 40 mg v Suspension pH 7.1 40 mg v Solution pH 1.6 20 mg
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    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
    After each test condition, questions were asked to the subject about adverse events. No adverse events were reported.
    Assessment type
    		 Non-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 nor serious nor non-serious events that occurred during this clinical 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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