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    Clinical Trial Results:
    Gastrointestinal behavior of atazanavir in healthy volunteers

    Summary
    EudraCT number
    		 2017-004579-29
    Trial protocol
    		 BE  
    Global end of trial date
    20 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 May 2020
    First version publication date
    02 May 2020
    Other versions
    Summary report(s)
    		 Atazanavir-Hens-2020

    Trial information

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    Trial identification
    Sponsor protocol code
    DDD17ATZ
    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
    Patrick Augustijns, KU Leuven, 0032 16330301, patrick.augustijns@kuleuven.be
    Scientific contact
    Patrick Augustijns, KU Leuven, 0032 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
    20 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study aims to investigatie principles of supersaturation and precipitation of a weakly basic drug atazanavir along the gastrointestinal tract in healthy human volunteers. The influence of acidic and calory-containing beverages will also be investigated.
    Protection of trial subjects
    NA; no stress or pain was examined for the subjects during this trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2018
    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: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 performed with three experimental conditions. Three women and two men participated in this study, aged between 24 and 49 years old. Exclusion criteria (i.e., GI disorders, infection with hepatitis B, hepatitis C or HIV, use of medication, pregnancy and frequent X-ray exposure) were checked during a medical examination. All volunteers provided

    Period 1
    Period 1 title
    water condition (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 water
    Arm description
    		 atazanavir was given with a glass of water
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    one capsule of atazanavir was given with a glass of water

    Arm title
    		 PPI condition
    Arm description
    		 atazanavir was given under achlorhydric conditions
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    one capsule of atazanavir was given with a glass of water

    Investigational medicinal product name
    esomeprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    esomeprazole was given 3 days before the start of the study on each day.

    Arm title
    		 Coca Cola
    Arm description
    		 Atazanavir was given with a glass of Coca Cola
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    one capsule of atazanavir was given with a glass of coca cola

    Number of subjects in period 1
    		water PPI condition Coca Cola
    Started
    5
    5
    5
    Completed
    5
    5
    5

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    water
    Reporting group description
    		 atazanavir was given with a glass of water

    Reporting group title
    PPI condition
    Reporting group description
    		 atazanavir was given under achlorhydric conditions

    Reporting group title
    Coca Cola
    Reporting group description
    		 Atazanavir was given with a glass of Coca Cola

    Primary: GI and plasma AUC, Cmax and Tmax

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    End point title
    		 GI and plasma AUC, Cmax and Tmax
    End point description
    End point type
    Primary
    End point timeframe
    The intake of the capsule was done randomly and not during a specific phase of the MMC cycle. After administration, antral and duodenal fluids were aspirated for 4 h; samples were taken each 15 min.
    End point values
    		 water PPI condition Coca Cola
    Number of subjects analysed
    5
    5
    5
    Units: Concentration
        number (not applicable)
    5
    5
    5
    Statistical analysis title
    		 Data Presentation and Statistical Analysis
    Comparison groups
    water v PPI condition v Coca Cola
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    before, during or after the study, adverse events can be reported
    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: 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 were reported. This is not applicable for our 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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