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    Clinical Trial Results:
    The influence of gastrointestinal lipid digestion on the intraluminal behavior of abiraterone (acetate) in healthy volunteers

    Summary
    EudraCT number
    		 2019-003460-50
    Trial protocol
    		 BE  
    Global end of trial date
    12 Aug 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
    DDD19ABI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 UZ Leuven Clinical Trial Center: S63186
    Sponsors
    Sponsor organisation name
    KU Leuven Drug Delivery and Disposition
    Sponsor organisation address
    Gasthuisberg ON2 | Herestraat 49 box 921, Leuven, Belgium, 3000
    Public contact
    Patrick Augustijns, KU Leuven Drug Delivery & Disposition, +32 16330301, patrick.augustijns@kuleuven.be
    Scientific contact
    Patrick Augustijns, KU Leuven Drug Delivery & Disposition, +32 16330301, 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
    03 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore the influence of lipid digestion on the gastrointestinal and systemic disposition of abiraterone (acetate) following oral intake of Zytiga in healthy, male volunteers.
    Protection of trial subjects
    Standard procedures for placement of nasogastric tubes to aspirate gastrointestinal fluids and a venous catheter to sample systemic blood.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Mar 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: 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 were recruited in March-August 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: male, 18-40 years old, healthy. Exclusion: female, illness at the time of study, medication use (in particular CYP3A4 inducers), history of acute/chronic gastrointestinal, liver or cardiovascular disease(s), 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
    		 Fasted state
    Arm description
    		 Disposition of abiraterone following oral intake of 1 tablet of Zytiga (abiraterone acetate 500 mg) in fasted state conditions.
    Arm type
    		 Experimental

    Investigational medicinal product name
    abiraterone acetate (Zytiga)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Abiraterone acetate (500 mg) was administered as 1 tablet of Zytiga with 240 mL of water.

    Arm title
    		 Fed state
    Arm description
    		 Disposition of abiraterone following oral intake of 1 tablet of Zytiga (abiraterone acetate 500 mg) in fed state conditions (intake of an Ensure Plus liquid meal).
    Arm type
    		 Experimental

    Investigational medicinal product name
    abiraterone acetate (Zytiga)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Abiraterone acetate (500 mg) was administered as 1 tablet of Zytiga with 240 mL of water, 20 min after intake of the liquid meal Ensure Plus.

    Arm title
    		 Fasted state + inhibition lipolysis
    Arm description
    		 Disposition of abiraterone following oral intake of 1 tablet of Zytiga (abiraterone acetate 500 mg) in fasted state conditions and upon administration of the lipase inhibitor orlistat (Xenical, 2x 120 mg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    abiraterone acetate (Zytiga)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Abiraterone acetate 500 mg was administered as 1 tablet of Zytiga with 240 mL of water, 20 min after intake of a capsule of Xenical (orlistat 120 mg). Two hours after intake of Zytiga, a second Xenical capsule was administered.

    Arm title
    		 Fed state + inhibition lipolysis
    Arm description
    		 Disposition of abiraterone following oral intake of 1 tablet of Zytiga (abiraterone acetate 500 mg) in fed state conditions and upon administration of the lipase inhibitor orlistat (Xenical, 2x 120 mg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    abiraterone acetate (Zytiga)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Abiraterone acetate 500 mg was administered as 1 tablet of Zytiga with 240 mL of water, 20 min after intake of the liquid meal Ensure Plus and a capsule of Xenical (orlistat 120 mg). Two hours after intake of Zytiga, a second Xenical capsule was administered.

    Number of subjects in period 1
    		Fasted state Fed state Fasted state + inhibition lipolysis Fed state + inhibition lipolysis
    Started
    4
    5
    4
    4
    Completed
    4
    5
    4
    4

    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
    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
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    Fasted state
    Reporting group description
    		 Disposition of abiraterone following oral intake of 1 tablet of Zytiga (abiraterone acetate 500 mg) in fasted state conditions.

    Reporting group title
    Fed state
    Reporting group description
    		 Disposition of abiraterone following oral intake of 1 tablet of Zytiga (abiraterone acetate 500 mg) in fed state conditions (intake of an Ensure Plus liquid meal).

    Reporting group title
    Fasted state + inhibition lipolysis
    Reporting group description
    		 Disposition of abiraterone following oral intake of 1 tablet of Zytiga (abiraterone acetate 500 mg) in fasted state conditions and upon administration of the lipase inhibitor orlistat (Xenical, 2x 120 mg)

    Reporting group title
    Fed state + inhibition lipolysis
    Reporting group description
    		 Disposition of abiraterone following oral intake of 1 tablet of Zytiga (abiraterone acetate 500 mg) in fed state conditions and upon administration of the lipase inhibitor orlistat (Xenical, 2x 120 mg)

    Primary: Systemic AUC abiraterone

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    End point title
    		 Systemic AUC abiraterone [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: The study was designed as exploratory without power to statistically test hypotheses.
    End point values
    		 Fasted state Fed state Fasted state + inhibition lipolysis Fed state + inhibition lipolysis
    Number of subjects analysed
    4
    4 [2]
    4
    4
    Units: nM*h
        arithmetic mean (standard deviation)
    803 ± 301
    2490 ± 373
    655 ± 477
    2405 ± 494
    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: Jejunal AUC abiraterone

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    End point title
    		 Jejunal AUC abiraterone [3]
    End point description
    End point type
    Primary
    End point timeframe
    0-5 h post 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
    		 Fasted state Fed state Fasted state + inhibition lipolysis Fed state + inhibition lipolysis
    Number of subjects analysed
    4
    4
    4
    4
    Units: µM*min
        arithmetic mean (standard deviation)
    9011 ± 5468
    16044 ± 3344
    7684 ± 2960
    10609 ± 2240
    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? Yes
    Date
    Amendment
    07 Jan 2021
    - Restart of clinical trial after outbreak of the COVID-19 pandemic, including specific measures to minimize the risk on COVID-19 transmission during positioning of the gastrointestinal catheters. - Use of an optimized catheter design, enabling positioning of the catheter at the day of the study (instead of the previous day).

    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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