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    Clinical Trial Results:
    A Phase I, Open Label, Randomised, Balanced, Single-dose, Two-period, Two-sequence Crossover-design Study to Evaluate Effects of Food on the Bioavailability of 80 mg Elafibranor (IPN60190) To-be-marketed Tablet Formulation after Single Oral Administration in Healthy Adult Participants.

    Summary
    EudraCT number
    		 2022-001883-91
    Trial protocol
    		 FR  
    Global end of trial date
    14 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2023
    First version publication date
    16 Dec 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLIN-60190-452
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05564208
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Bioscience, Inc.
    Sponsor organisation address
    One Main Street 7th Floor Cambridge, Massachusetts, United States, 02142
    Public contact
    Medical Director, Ipsen Bioscience Inc, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Ipsen Bioscience Inc, clinical.trials@ipsen.com
    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
    14 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the bioavailability of a single dose of the to-be-marketed tablet of elafibranor 80 milligrams (mg) administered in fasting and fed conditions and to assess the pharmacokinetic (PK) parameters of elafibranor for total exposure and peak exposure.
    Protection of trial subjects
    The study was conducted under the provisions of the Declaration of Helsinki, Version 2013 in accordance with the International Conference on Harmonisation Consolidated Guideline on Good Clinical Practice and in compliance with International Ethics Committees/Institutional Review Boards and informed consent regulations. In addition, this study adhered to all local regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Oct 2022
    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
    France: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    34
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This Phase I, randomized, single-dose, 2-period, 2-sequence crossover design study was conducted in healthy participants to evaluate effects of food on the bioavailability of elafibranor 80 mg. A total of 34 participants were randomized in this study in a 1:1 ratio (fed followed by fasting: fasting followed by fed).

    Pre-assignment
    Screening details
    		 This study consisted of a screening period (up to 4 weeks); 2 intervention periods (single doses in 2 periods [approximately 3 weeks] were separated by a washout phase [21-28 days]) and a final end-of-study (EOS) visit (21 days after last dose of study treatment). The maximum duration of the study was up to approximately 10 to 11 weeks.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Elafibranor 80 mg fed/Elafibranor 80 mg fasting
    Arm description
    		 Participants received 1 tablet of elafibranor 80 mg following an overnight fast of at least 10 hours and high-fat, high-calorie breakfast, on Day 1 of Period 1 followed by a washout period of at least 21 days up to a maximum of 28 days. On Day 1 of Period 2, those participants received 1 tablet of elafibranor 80 mg following an overnight fast of at least 10 hours.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elafibranor
    Investigational medicinal product code
    Other name
    GFT505, IPN60190
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Elafibranor was administered as 80 mg film-coated tablet with 240 milliliters (mL) of still water under fed and fasted conditions on Day 1 in each intervention period.

    Arm title
    		 Elafibranor 80 mg fasting/Elafibranor 80 mg fed
    Arm description
    		 Participants received 1 tablet of elafibranor 80 mg following an overnight fast of at least 10 hours on Day 1 of Period 1 followed by a washout period of at least 21 days up to a maximum of 28 days. On Day 1 of Period 2, those participants received 1 tablet of elafibranor 80 mg following an overnight fast of at least 10 hours and high-fat, high-calorie breakfast.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elafibranor
    Investigational medicinal product code
    Other name
    GFT505, IPN60190
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Elafibranor was administered as 80 mg film-coated tablet with 240 mL of still water under fed and fasted conditions on Day 1 in each intervention period.

    Number of subjects in period 1
    		Elafibranor 80 mg fed/Elafibranor 80 mg fasting Elafibranor 80 mg fasting/Elafibranor 80 mg fed
    Started
    17
    17
    Completed
    16
    17
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Elafibranor 80 mg fed/Elafibranor 80 mg fasting
    Reporting group description
    		 Participants received 1 tablet of elafibranor 80 mg following an overnight fast of at least 10 hours and high-fat, high-calorie breakfast, on Day 1 of Period 1 followed by a washout period of at least 21 days up to a maximum of 28 days. On Day 1 of Period 2, those participants received 1 tablet of elafibranor 80 mg following an overnight fast of at least 10 hours.

    Reporting group title
    Elafibranor 80 mg fasting/Elafibranor 80 mg fed
    Reporting group description
    		 Participants received 1 tablet of elafibranor 80 mg following an overnight fast of at least 10 hours on Day 1 of Period 1 followed by a washout period of at least 21 days up to a maximum of 28 days. On Day 1 of Period 2, those participants received 1 tablet of elafibranor 80 mg following an overnight fast of at least 10 hours and high-fat, high-calorie breakfast.

    Reporting group values
    		 Elafibranor 80 mg fed/Elafibranor 80 mg fasting Elafibranor 80 mg fasting/Elafibranor 80 mg fed Total
    Number of subjects
    		 17 17 34
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28.6 ( 6.6 ) 32.1 ( 8.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9 18
        Male
    		 8 8 16
    Race
    Units: Subjects
        Asian
    		 0 0 0
        Black or African American
    		 4 2 6
        White
    		 13 14 27
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        American Indian or Alaska Native
    		 0 1 1
        Not Reported
    		 0 0 0
        Other
    		 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 17 17 34
        Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Elafibranor 80 mg fed/Elafibranor 80 mg fasting
    Reporting group description
    		 Participants received 1 tablet of elafibranor 80 mg following an overnight fast of at least 10 hours and high-fat, high-calorie breakfast, on Day 1 of Period 1 followed by a washout period of at least 21 days up to a maximum of 28 days. On Day 1 of Period 2, those participants received 1 tablet of elafibranor 80 mg following an overnight fast of at least 10 hours.

    Reporting group title
    Elafibranor 80 mg fasting/Elafibranor 80 mg fed
    Reporting group description
    		 Participants received 1 tablet of elafibranor 80 mg following an overnight fast of at least 10 hours on Day 1 of Period 1 followed by a washout period of at least 21 days up to a maximum of 28 days. On Day 1 of Period 2, those participants received 1 tablet of elafibranor 80 mg following an overnight fast of at least 10 hours and high-fat, high-calorie breakfast.

    Subject analysis set title
    Elafibranor 80 mg fed cohort
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants who received elafibranor 80 mg following an overnight fast of at least 10 hours, and high-fat, high-calorie breakfast irrespective of intervention period were included in this set. The PK analysis set consisted of all participants who completed both periods and had sufficient data to calculate maximum observed plasma concentration (Cmax), area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUC0-t) and area under the plasma concentration-time curve from time zero to infinity (AUC0-∞). Participants were excluded from the PK set if they experienced emesis during the first 4 hours following any elafibranor administration.

    Subject analysis set title
    Elafibranor 80 mg fasting cohort
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants who received elafibranor 80 mg following an overnight fast of at least 10 hours irrespective of intervention period were included in this set. The PK analysis set consisted of all participants who completed both periods and had sufficient data to calculate Cmax, AUC0-t and AUC0-∞. Participants were excluded from the PK set if they experienced emesis during the first 4 hours following any elafibranor administration.

    Primary: AUC0-t of Elafibranor

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    End point title
    		 AUC0-t of Elafibranor
    End point description
    Plasma samples were collected for assessing AUC0-t by non-compartmental analysis (NCA). Participants were classified according to the actual treatment sequence/each condition of treatment administration.
    End point type
    Primary
    End point timeframe
    Pre-dose, 10, 20, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose
    End point values
    		 Elafibranor 80 mg fed cohort Elafibranor 80 mg fasting cohort
    Number of subjects analysed
    33
    33
    Units: hour*nanogram/milliliter (h*ng/mL)
        arithmetic mean (standard deviation)
    1374 ( 416 )
    1596 ( 488 )
    Statistical analysis title
    		 Geometric mean ratio between fed-fasting cohort
    Statistical analysis description
    It was calculated using a linear mixed model including treatment, sequence and period as fixed effects and participant within sequence as a random effect. The same 33 subjects contribute to both fed and fasting periods.
    Comparison groups
    Elafibranor 80 mg fed cohort v Elafibranor 80 mg fasting cohort
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0004 [1]
    Method
    		 ANOVA
    Parameter type
    		 geometric mean ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 0.92
    Notes
    [1] - p-value of treatment is considered.

    Primary: AUC0-∞ of Elafibranor

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    End point title
    		 AUC0-∞ of Elafibranor
    End point description
    Plasma samples were collected for assessing AUC0-∞ by NCA. Participants were classified according to the actual treatment sequence/each condition of treatment administration.
    End point type
    Primary
    End point timeframe
    Pre-dose, 10, 20, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose
    End point values
    		 Elafibranor 80 mg fed cohort Elafibranor 80 mg fasting cohort
    Number of subjects analysed
    33
    33
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    1531 ( 451 )
    1793 ( 564 )
    Statistical analysis title
    		 Geometric mean ratio between fed-fasting cohort
    Statistical analysis description
    It was calculated using a linear mixed model including treatment, sequence and period as fixed effects and participant within sequence as a random effect. The same 33 subjects contribute to both fed and fasting periods.
    Comparison groups
    Elafibranor 80 mg fed cohort v Elafibranor 80 mg fasting cohort
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0003 [2]
    Method
    		 ANOVA
    Parameter type
    		 geometric mean ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 0.91
    Notes
    [2] - p-value of treatment is considered.

    Primary: Cmax of Elafibranor

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    End point title
    		 Cmax of Elafibranor
    End point description
    Plasma samples were collected for assessing Cmax by NCA. Participants were classified according to the actual treatment sequence/each condition of treatment administration.
    End point type
    Primary
    End point timeframe
    Pre-dose, 10, 20, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose
    End point values
    		 Elafibranor 80 mg fed cohort Elafibranor 80 mg fasting cohort
    Number of subjects analysed
    33
    33
    Units: ng/mL
        arithmetic mean (standard deviation)
    195 ( 118 )
    352 ( 155 )
    Statistical analysis title
    		 Geometric mean ratio between fed-fasting cohort
    Statistical analysis description
    It was calculated using a linear mixed model including treatment, sequence and period as fixed effects and participant within sequence as a random effect. The same 33 subjects contribute to both fed and fasting periods.
    Comparison groups
    Elafibranor 80 mg fed cohort v Elafibranor 80 mg fasting cohort
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.0001 [3]
    Method
    		 ANOVA
    Parameter type
    		 geometric mean ratio
    Point estimate
    0.52
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 0.66
    Notes
    [3] - p-value of treatment is considered.

    Secondary: AUC0-t of GFT1007

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    End point title
    		 AUC0-t of GFT1007
    End point description
    Plasma samples were collected for assessing AUC0-t by NCA. Participants were classified according to the actual treatment sequence/each condition of treatment administration.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 10, 20, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, and 168 hours post-dose
    End point values
    		 Elafibranor 80 mg fed cohort Elafibranor 80 mg fasting cohort
    Number of subjects analysed
    33
    33
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    7040 ( 1403 )
    7024 ( 2119 )
    Statistical analysis title
    		 Geometric mean ratio between fed-fasting cohort
    Statistical analysis description
    It was calculated using a linear mixed model including treatment, sequence and period as fixed effects and participant within sequence as a random effect. The same 33 subjects contribute to both fed and fasting periods.
    Comparison groups
    Elafibranor 80 mg fed cohort v Elafibranor 80 mg fasting cohort
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.4379 [4]
    Method
    		 ANOVA
    Parameter type
    		 geometric mean ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.08
    Notes
    [4] - p-value of treatment is considered.

    Secondary: AUC0-∞ of GFT1007

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    End point title
    		 AUC0-∞ of GFT1007
    End point description
    Plasma samples were collected for the collection of AUC0-∞ by NCA. Participants were classified according to the actual treatment sequence/each condition of treatment administration. Only those participants with data available were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 10, 20, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, and 168 hours post-dose
    End point values
    		 Elafibranor 80 mg fed cohort Elafibranor 80 mg fasting cohort
    Number of subjects analysed
    30
    24
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    7374 ( 1425 )
    7506 ( 1786 )
    Statistical analysis title
    		 Geometric mean ratio between fed-fasting cohort
    Statistical analysis description
    It was calculated using a linear mixed model including treatment, sequence and period as fixed effects and participant within sequence as a random effect. The same 33 subjects contribute to both fed and fasting periods.
    Comparison groups
    Elafibranor 80 mg fed cohort v Elafibranor 80 mg fasting cohort
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6177
    Method
    		 ANOVA
    Parameter type
    		 geometric mean ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.03

    Secondary: Cmax of GFT1007

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    End point title
    		 Cmax of GFT1007
    End point description
    Plasma samples were collected for assessing Cmax by NCA. Participants were classified according to the actual treatment sequence/each condition of treatment administration.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 10, 20, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, and 168 hours post-dose
    End point values
    		 Elafibranor 80 mg fed cohort Elafibranor 80 mg fasting cohort
    Number of subjects analysed
    33
    33
    Units: ng/mL
        arithmetic mean (standard deviation)
    1383 ( 651 )
    1823 ( 576 )
    Statistical analysis title
    		 Geometric mean ratio between fed-fasting cohort
    Statistical analysis description
    It was calculated using a linear mixed model including treatment, sequence and period as fixed effects and participant within sequence as a random effect. The same 33 subjects contribute to both fed and fasting periods.
    Comparison groups
    Elafibranor 80 mg fed cohort v Elafibranor 80 mg fasting cohort
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.0001 [5]
    Method
    		 ANOVA
    Parameter type
    		 geometric mean ratio
    Point estimate
    0.72
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 0.81
    Notes
    [5] - p-value of treatment is considered.

    Secondary: Terminal Elimination Half-Life (t1/2) of Elafibranor and GFT1007

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    End point title
    		 Terminal Elimination Half-Life (t1/2) of Elafibranor and GFT1007
    End point description
    Plasma samples were collected for assessing t1/2 by NCA. Participants were classified according to the actual treatment sequence/each condition of treatment administration. Only those participants with data available were included in the analysis and denoted by 'n' in the categories.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 10, 20, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168 (GFT1007), and 216 hours post-dose (elafibranor)
    End point values
    		 Elafibranor 80 mg fed cohort Elafibranor 80 mg fasting cohort
    Number of subjects analysed
    33
    33
    Units: hours
    median (full range (min-max))
        Elafibranor (n= 33,33)
    66.3 (44.2 to 90.0)
    70.2 (37.1 to 92.2)
        GFT1007 (n=30, 24)
    11.1 (6.72 to 26.9)
    15.4 (9.39 to 21.7)
    No statistical analyses for this end point

    Secondary: Time to Maximum Observed Drug Concentration (Tmax) of Elafibranor and GFT1007

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    End point title
    		 Time to Maximum Observed Drug Concentration (Tmax) of Elafibranor and GFT1007
    End point description
    Plasma samples were collected for assessing Tmax by NCA. Participants were classified according to the actual treatment sequence/each condition of treatment administration.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 10, 20, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168 (GFT1007), 216 hours post-dose (elafibranor)
    End point values
    		 Elafibranor 80 mg fed cohort Elafibranor 80 mg fasting cohort
    Number of subjects analysed
    33
    33
    Units: hours
    median (full range (min-max))
        Elafibranor
    2.0 (0.33 to 8.0)
    1.5 (0.33 to 4.0)
        GFT1007
    2.5 (1.0 to 8.0)
    1.5 (0.50 to 5.0)
    No statistical analyses for this end point

    Secondary: Time of Observation Prior to the First Observation With a Measurable (Nonzero) Concentration (Tlag) of Elafibranor and GFT1007

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    End point title
    		 Time of Observation Prior to the First Observation With a Measurable (Nonzero) Concentration (Tlag) of Elafibranor and GFT1007
    End point description
    Plasma samples were collected for assessing Tlag by NCA. Participants were classified according to the actual treatment sequence/each condition of treatment administration.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 10, 20, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168 (GFT1007), 216 hours post-dose (elafibranor)
    End point values
    		 Elafibranor 80 mg fed cohort Elafibranor 80 mg fasting cohort
    Number of subjects analysed
    33
    33
    Units: hours
    median (full range (min-max))
        Elafibranor
    0.17 (0 to 2.0)
    0 (0 to 0.33)
        GFT1007
    0.17 (0 to 1.5)
    0.17 (0 to 0.33)
    No statistical analyses for this end point

    Secondary: Terminal Elimination Rate Constant (λz) of Elafibranor and GFT1007

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    End point title
    		 Terminal Elimination Rate Constant (λz) of Elafibranor and GFT1007
    End point description
    Plasma samples were collected for assessing λz by NCA. Participants were classified according to the actual treatment sequence/each condition of treatment administration. Only those participants with data available were included in the analysis denoted by 'n' in the categories.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 10, 20, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168 (GFT1007), 216 hours post-dose (elafibranor)
    End point values
    		 Elafibranor 80 mg fed cohort Elafibranor 80 mg fasting cohort
    Number of subjects analysed
    33
    33
    Units: per hour (/h)
    arithmetic mean (standard deviation)
        Elafibranor (n=33, 33)
    0.0108 ( 0.00194 )
    0.0106 ( 0.00245 )
        GFT1007 (n=30, 24)
    0.0605 ( 0.0189 )
    0.0477 ( 0.0124 )
    No statistical analyses for this end point

    Secondary: Total Body Clearance (Cl/F) of Elafibranor

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    End point title
    		 Total Body Clearance (Cl/F) of Elafibranor
    End point description
    Plasma samples were collected for assessing Cl/F by NCA. Participants were classified according to the actual treatment sequence/each condition of treatment administration.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 10, 20, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose
    End point values
    		 Elafibranor 80 mg fed cohort Elafibranor 80 mg fasting cohort
    Number of subjects analysed
    33
    33
    Units: liter/hour
        arithmetic mean (standard deviation)
    57.8 ( 21.0 )
    50.0 ( 19.2 )
    No statistical analyses for this end point

    Secondary: Volume of Distribution (Vd/F) of Elafibranor

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    End point title
    		 Volume of Distribution (Vd/F) of Elafibranor
    End point description
    Plasma samples were collected for assessing Vd/F by NCA. Participants were classified according to the actual treatment sequence/each condition of treatment administration.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 10, 20, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose
    End point values
    		 Elafibranor 80 mg fed cohort Elafibranor 80 mg fasting cohort
    Number of subjects analysed
    33
    33
    Units: liter
        arithmetic mean (standard deviation)
    5389 ( 1661 )
    4731 ( 1486 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of treatment administration up to end-of-study, approximately 3 months.
    Adverse event reporting additional description
    The Safety set consisted of all participants who received at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Elafibranor 80 mg fed
    Reporting group description
    		 All participants who received elafibranor 80 mg following an overnight fast of at least 10 hours, and high-fat, high-calorie breakfast irrespective of intervention period were included in this set.

    Reporting group title
    Elafibranor 80 mg fasting
    Reporting group description
    		 All participants who received elafibranor 80 mg following an overnight fast of at least 10 hours irrespective of intervention period were included in this set.

    Serious adverse events
    		 Elafibranor 80 mg fed Elafibranor 80 mg fasting
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Elafibranor 80 mg fed Elafibranor 80 mg fasting
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 34 (20.59%)
    8 / 33 (24.24%)
    Investigations
    SARS-CoV-2 test positive
         subjects affected / exposed
    3 / 34 (8.82%)
    1 / 33 (3.03%)
         occurrences all number
    3
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 34 (5.88%)
    4 / 33 (12.12%)
         occurrences all number
    2
    4
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Sep 2022
    Protocol was amended to implement the changes requested by the Competent Authority during the submission of the clinical trial application.

    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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