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    Clinical Trial Results:
    Fluconazole pharmacokinetics, including bioavailability, in Obese subjects after an Intravenous and oral Administration (FOLIA).

    Summary
    EudraCT number
    		 2018-002613-35
    Trial protocol
    		 NL  
    Global end of trial date
    21 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Sep 2023
    First version publication date
    01 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UMCN-AKF-18.07
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboud UMC
    Sponsor organisation address
    Geert Grooteplein 10, Nijmegen, Netherlands,
    Public contact
    Roger Brüggemann, Radboud university medical center, +31 243616405, roger.bruggemann@radboudumc.nl
    Scientific contact
    Roger Brüggemann, Radboud university medical center, +31 243616405, roger.bruggemann@radboudumc.nl
    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
    21 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the effect of obesity (BMI ≥35 kg/m2) and bariatric surgery on the pharmacokinetics, including oral bioavailability of fluconazole.
    Protection of trial subjects
    n.a.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 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
    Netherlands: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    25
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 a. obese groups: subject must have a BMI ≥35 kg/m2 at the time of inclusion or has undergone bariatric surgery; b. non-obese group: subject must have a BMI ≥18.5 and <30 kg/m2 at the time of inclusion; 2. Subject is at least 18 of age on the day of screening and not older than 65 years of age on the day of dosing

    Pre-assignment
    Screening details
    		 At screening, medical and surgical history, concomitant diseases, anthropomorphic data (weight, height, sex, month and year of birth), clinical diagnosis and concomitant drugs will be reported

    Period 1
    Period 1 title
    Screening + inclusion phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Individuals with obesity
    Arm description
    		 Patients scheduled for bariatric surgery with BMI >35
    Arm type
    		 Experimental

    Investigational medicinal product name
    fluconazole 400mg capsule
    Investigational medicinal product code
    Other name
    Diflucan
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral administration 400mg

    Investigational medicinal product name
    Fluconazole 400mg infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of 400mg administered over 20 minutes, starting 2h after the oral administration

    Arm title
    		 non-obese control patients
    Arm description
    		 Normal weight healthy volunteers
    Arm type
    		 Active comparator

    Investigational medicinal product name
    fluconazole 400mg capsule
    Investigational medicinal product code
    Other name
    Diflucan
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral administration 400mg

    Investigational medicinal product name
    Fluconazole 400mg infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of 400mg administered over 20 minutes, starting 2h after the oral administration

    Number of subjects in period 1
    		Individuals with obesity non-obese control patients
    Started
    17
    8
    completed
    17
    8
    Completed
    17
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Individuals with obesity
    Reporting group description
    		 Patients scheduled for bariatric surgery with BMI >35

    Reporting group title
    non-obese control patients
    Reporting group description
    		 Normal weight healthy volunteers

    Reporting group values
    		 Individuals with obesity non-obese control patients Total
    Number of subjects
    		 17 8 25
    Age categorical
    Age
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 17 8 25
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        obese
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 5 14
        Male
    		 8 3 11

    End points

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    End points reporting groups
    Reporting group title
    Individuals with obesity
    Reporting group description
    		 Patients scheduled for bariatric surgery with BMI >35

    Reporting group title
    non-obese control patients
    Reporting group description
    		 Normal weight healthy volunteers

    Primary: Influence of body weight on fluconazoel pharmacokinetics

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    End point title
    		 Influence of body weight on fluconazoel pharmacokinetics
    End point description
    A full PK-curve after oral and intravenous administration of fluconazole will be obtained in obese and non-obese individuals. Nonlinear mixed effects modelling will be employed to evaluate differences in PK parameters between obese and non-obese individuals
    End point type
    Primary
    End point timeframe
    n.a.
    End point values
    		 Individuals with obesity non-obese control patients
    Number of subjects analysed
    17
    8
    Units: mg/L
    number (not applicable)
        Clearance
    1.21
    0.94
        Volume of distribution
    58.8
    40.6
    Attachments
    		 Figure 1: individual concentration time profiles
    Statistical analysis title
    		 NONMEM
    Statistical analysis description
    nonlinear mixed effects modelling
    Comparison groups
    Individuals with obesity v non-obese control patients
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05 [2]
    Method
    		 Chi-squared
    Parameter type
    		 Log likelihood ratio
    Point estimate
    0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.214
         upper limit
    		 0.532
    Variability estimate
    Standard deviation
    Dispersion value
    30
    Notes
    [1] - Nonlinear mixed effects modelling
    [2] - n.a.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    <24 hours
    Adverse event reporting additional description
    Adverse events will be reported to the medical supervisor within 24 hours.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    Extravasation
    Reporting group description
    		 Extravasation of IMP

    Serious adverse events
    		 Extravasation
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Extravasation
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Product issues
    Extravasation
    Additional description: Extravasation of the IMP
    alternative dictionary used: MedDRA 26
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    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.
    n.a.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35613035
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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
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