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    Clinical Trial Results:
    Relative bioavailability study to investigate the pharmacokinetics, safety and tolerability of a single oral dose of finerenone 20 mg as suspension (pediatric formulation), intact tablet and crushed tablet (adult formulation) in the fasting condition, and to investigate the effect of a high fat, high calorie meal on the suspension in healthy male subjects in a randomized, open-label, four-fold crossover design

    Summary
    EudraCT number
    		 2016-002813-24
    Trial protocol
    		 DE  
    Global end of trial date
    01 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jan 2018
    First version publication date
    25 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY94-8862/16538
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02957396
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, D-51368 Leverkusen, Germany,
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001623-PIP01-14
    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
    01 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to 1. investigate the relative bioavailability of a single oral dose of 20 milligram (mg) finerenone suspension and 20 mg crushed and re-suspended tablet in comparison to 20 mg finerenone tablet in the fasting condition; 2. investigate the effect of a high fat, high calorie meal on the pharmacokinetics (PK) of a single oral dose of 20 mg finerenone suspension; 3. investigate whether 20 mg finerenone suspension and 20 mg crushed and re-suspended tablet are palatable and swallowable by using a questionnaire regarding overall impression, appearance, smell, taste, texture, and swallowability.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 2016
    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
    Germany: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at one study center in Germany, between 17 November 2016 (first subject first visit) and 13 January 2017 (last subject last visit).

    Pre-assignment
    Screening details
    		 Overall, 36 subjects were enrolled, of them 20 subjects were not included into the study. A total of 16 subjects were randomized and received all the treatments in a four-fold cross-over fashion (A-D-C-B, B-C-D-A, C-A-B-D, or D-B-A-C) and completed the study.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment A-D-C-B
    Arm description
    		 Subjects who followed treatment sequence A-D-C-B in fasted and fed state were reported. Subjects received a single oral dose of 20 mg finerenone (BAY94-8862) intact film-coated tablet in fasted state (Treatment A) in the first intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 milliliter [mL]) after a standardized high-fat, high-calorie American breakfast in fed state (Treatment D) in the second intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state (Treatment C) in the third intervention period; followed by a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state (Treatment B) in the fourth intervention period. A wash-out period of at least 72 hours was maintained between finerenone administrations.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment A: Subjects received a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state. Treatment D: Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state. Treatment C: Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state. Treatment B: Subjects received a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state.

    Arm title
    		 Treatment B-C-D-A
    Arm description
    		 Subjects who followed treatment sequence B-C-D-A in fasted and fed state were reported. Subjects received a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state (Treatment B) in the first intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state (Treatment C) in the second intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state (Treatment D) in the third intervention period; followed by a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state (Treatment A) in the fourth intervention period. A wash-out period of at least 72 hours was maintained between finerenone administrations.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment B: Subjects received a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state. Treatment C: Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state. Treatment D: Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state. Treatment A: Subjects received a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state.

    Arm title
    		 Treatment C-A-B-D
    Arm description
    		 Subjects who followed treatment sequence C-A-B-D in fasted and fed state were reported. Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state (Treatment C) in the first intervention period; followed by a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state (Treatment A) in the second intervention period; followed by a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state (Treatment B) in the third intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state (Treatment D) in the fourth intervention period. A wash-out period of at least 72 hours was maintained between finerenone administrations.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment C: Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state. Treatment A: Subjects received a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state. Treatment B: Subjects received a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state. Treatment D: Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state.

    Arm title
    		 Treatment D-B-A-C
    Arm description
    		 Subjects who followed treatment sequence D-B-A-C in fed and fasted state were reported. Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state (Treatment D) in the first intervention period; followed by a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state (Treatment B) in the second intervention period; followed by a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state (Treatment A) in the third intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state (Treatment C) in the fourth intervention period. A wash-out period of at least 72 hours was maintained between finerenone administrations.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment D: Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state. Treatment B: Subjects received a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state. Treatment A: Subjects received a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state. Treatment C: Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state.

    Number of subjects in period 1
    		Treatment A-D-C-B Treatment B-C-D-A Treatment C-A-B-D Treatment D-B-A-C
    Started
    4
    4
    4
    4
    Completed
    4
    4
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment A-D-C-B
    Reporting group description
    		 Subjects who followed treatment sequence A-D-C-B in fasted and fed state were reported. Subjects received a single oral dose of 20 mg finerenone (BAY94-8862) intact film-coated tablet in fasted state (Treatment A) in the first intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 milliliter [mL]) after a standardized high-fat, high-calorie American breakfast in fed state (Treatment D) in the second intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state (Treatment C) in the third intervention period; followed by a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state (Treatment B) in the fourth intervention period. A wash-out period of at least 72 hours was maintained between finerenone administrations.

    Reporting group title
    Treatment B-C-D-A
    Reporting group description
    		 Subjects who followed treatment sequence B-C-D-A in fasted and fed state were reported. Subjects received a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state (Treatment B) in the first intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state (Treatment C) in the second intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state (Treatment D) in the third intervention period; followed by a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state (Treatment A) in the fourth intervention period. A wash-out period of at least 72 hours was maintained between finerenone administrations.

    Reporting group title
    Treatment C-A-B-D
    Reporting group description
    		 Subjects who followed treatment sequence C-A-B-D in fasted and fed state were reported. Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state (Treatment C) in the first intervention period; followed by a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state (Treatment A) in the second intervention period; followed by a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state (Treatment B) in the third intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state (Treatment D) in the fourth intervention period. A wash-out period of at least 72 hours was maintained between finerenone administrations.

    Reporting group title
    Treatment D-B-A-C
    Reporting group description
    		 Subjects who followed treatment sequence D-B-A-C in fed and fasted state were reported. Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state (Treatment D) in the first intervention period; followed by a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state (Treatment B) in the second intervention period; followed by a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state (Treatment A) in the third intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state (Treatment C) in the fourth intervention period. A wash-out period of at least 72 hours was maintained between finerenone administrations.

    Reporting group values
    		 Treatment A-D-C-B Treatment B-C-D-A Treatment C-A-B-D Treatment D-B-A-C Total
    Number of subjects
    		 4 4 4 4 16
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.3 ( 7.3 ) 35.3 ( 7.0 ) 36.8 ( 5.0 ) 36.8 ( 10.9 ) -
    Gender Categorical
    Units: Subjects
        Male
    		 4 4 4 4 16

    End points

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    End points reporting groups
    Reporting group title
    Treatment A-D-C-B
    Reporting group description
    		 Subjects who followed treatment sequence A-D-C-B in fasted and fed state were reported. Subjects received a single oral dose of 20 mg finerenone (BAY94-8862) intact film-coated tablet in fasted state (Treatment A) in the first intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 milliliter [mL]) after a standardized high-fat, high-calorie American breakfast in fed state (Treatment D) in the second intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state (Treatment C) in the third intervention period; followed by a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state (Treatment B) in the fourth intervention period. A wash-out period of at least 72 hours was maintained between finerenone administrations.

    Reporting group title
    Treatment B-C-D-A
    Reporting group description
    		 Subjects who followed treatment sequence B-C-D-A in fasted and fed state were reported. Subjects received a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state (Treatment B) in the first intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state (Treatment C) in the second intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state (Treatment D) in the third intervention period; followed by a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state (Treatment A) in the fourth intervention period. A wash-out period of at least 72 hours was maintained between finerenone administrations.

    Reporting group title
    Treatment C-A-B-D
    Reporting group description
    		 Subjects who followed treatment sequence C-A-B-D in fasted and fed state were reported. Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state (Treatment C) in the first intervention period; followed by a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state (Treatment A) in the second intervention period; followed by a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state (Treatment B) in the third intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state (Treatment D) in the fourth intervention period. A wash-out period of at least 72 hours was maintained between finerenone administrations.

    Reporting group title
    Treatment D-B-A-C
    Reporting group description
    		 Subjects who followed treatment sequence D-B-A-C in fed and fasted state were reported. Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state (Treatment D) in the first intervention period; followed by a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state (Treatment B) in the second intervention period; followed by a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state (Treatment A) in the third intervention period; followed by a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state (Treatment C) in the fourth intervention period. A wash-out period of at least 72 hours was maintained between finerenone administrations.

    Subject analysis set title
    Safety analysis set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SAF (N=16) included all subjects who received at least one dose of the study medication.

    Subject analysis set title
    Pharmacokinetic analysis set (PKS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PKS (N=16) included all subjects with a valid PK profile for at least two of the treatments relevant for comparison (Treatment A and B or Treatment A and C or Treatment C and D).

    Subject analysis set title
    Finerenone 20 mg Intact Tablet Fasted (Treatment A)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects (N=16) received a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state during any intervention period.

    Subject analysis set title
    Finerenone 20 mg Crushed Tablet Fasted (Treatment B)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects (N=16) received a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state during any intervention period.

    Subject analysis set title
    Finerenone 20 mg Suspension Fasted (Treatment C)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects (N=16) received a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state during any intervention period.

    Subject analysis set title
    Finerenone 20 mg Suspension Fed (Treatment D)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects (N=16) received a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state during any intervention period.

    Primary: Maximum Observed Concentration (Cmax) After Single Dose Administration of Finerenone in Plasma

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    End point title
    		 Maximum Observed Concentration (Cmax) After Single Dose Administration of Finerenone in Plasma
    End point description
    Maximum observed concentration of finerenone in plasma after single dose administration was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    End point type
    Primary
    End point timeframe
    Pre-dose to 24 hours post-dose
    End point values
    		 Finerenone 20 mg Intact Tablet Fasted (Treatment A) Finerenone 20 mg Crushed Tablet Fasted (Treatment B) Finerenone 20 mg Suspension Fasted (Treatment C) Finerenone 20 mg Suspension Fed (Treatment D)
    Number of subjects analysed
    16
    16
    16
    16
    Units: microgram per liter (mcg/L)
        geometric mean (geometric coefficient of variation)
    154 ( 29.9 )
    138 ( 35.9 )
    190 ( 32.3 )
    110 ( 27.3 )
    Statistical analysis title
    		 Statistical analysis: Treatment (C)/Treatment (A)
    Statistical analysis description
    Cmax of finerenone were analyzed using analysis of variance (ANOVA) including sequence, subject (sequence), period, and treatment effects. Based on these analysis point estimates (least squares (LS)-means) and exploratory 90 percent (%) confidence intervals (CIs) for the ratios “20 mg suspension fasted (C)/20 mg intact tablet fasted (A)” of Cmax were calculated. Database auto-calculate number of subjects analysed, but the actual number of subjects analysed was 16.
    Comparison groups
    Finerenone 20 mg Intact Tablet Fasted (Treatment A) v Finerenone 20 mg Suspension Fasted (Treatment C)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Estimated ratio in percent [%]
    Point estimate
    122.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 104.48
         upper limit
    		 144.56
    Statistical analysis title
    		 Statistical analysis: Treatment (D)/Treatment (C)
    Statistical analysis description
    Cmax of finerenone were analyzed using ANOVA including sequence, subject (sequence), period, and treatment effects. Based on these analysis point estimates (LS-means) and exploratory 90% CIs for the ratios “20 mg suspension fed (D)/20 mg suspension fasted (C)” of Cmax were calculated. Database auto-calculate number of subjects analysed, but the actual number of subjects analysed was 16.
    Comparison groups
    Finerenone 20 mg Suspension Fasted (Treatment C) v Finerenone 20 mg Suspension Fed (Treatment D)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Estimated ratio in %
    Point estimate
    58.02
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 49.32
         upper limit
    		 68.25
    Statistical analysis title
    		 Statistical analysis: Treatment (B)/Treatment (A)
    Statistical analysis description
    Cmax of finerenone were analyzed using ANOVA including sequence, subject (sequence), period, and treatment effects. Based on these analysis point estimates (LS-means) and exploratory 90% CIs for the ratios “20 mg crushed/re-suspended tablet fasted (B)/20 mg intact tablet fasted (A)” of Cmax were calculated. Database auto-calculate number of subjects analysed, but the actual number of subjects analysed was 16.
    Comparison groups
    Finerenone 20 mg Intact Tablet Fasted (Treatment A) v Finerenone 20 mg Crushed Tablet Fasted (Treatment B)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Estimated ratio in %
    Point estimate
    89.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 75.69
         upper limit
    		 104.74

    Primary: Area Under Concentration Versus Time Curve From Zero to Infinity (AUC) After Single Dose Administration of Finerenone in Plasma

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    End point title
    		 Area Under Concentration Versus Time Curve From Zero to Infinity (AUC) After Single Dose Administration of Finerenone in Plasma
    End point description
    Area under the concentration versus time curve from zero to infinity after single dose administration of finerenone in plasma was measured. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    End point type
    Primary
    End point timeframe
    Pre-dose to 24 hours post-dose
    End point values
    		 Finerenone 20 mg Intact Tablet Fasted (Treatment A) Finerenone 20 mg Crushed Tablet Fasted (Treatment B) Finerenone 20 mg Suspension Fasted (Treatment C) Finerenone 20 mg Suspension Fed (Treatment D)
    Number of subjects analysed
    16 [1]
    16 [2]
    16 [3]
    16 [4]
    Units: microgram * hour per liter (mcg*h/L)
        geometric mean (geometric coefficient of variation)
    432 ( 33.0 )
    352 ( 37.7 )
    451 ( 28.7 )
    453 ( 26.4 )
    Notes
    [1] - PKS
    [2] - PKS
    [3] - PKS
    [4] - PKS
    Statistical analysis title
    		 Statistical analysis: Treatment (C)/Treatment (A)
    Statistical analysis description
    AUC of finerenone were analyzed using ANOVA including sequence, subject (sequence), period, and treatment effects. Based on these analysis point estimates (LS-means) and exploratory 90% CIs for the ratios “20 mg suspension fasted (C)/20 mg intact tablet fasted (A)” of AUC were calculated. Database auto calculate number of subjects analyzed, but the actual number of subjects analyzed was 16.
    Comparison groups
    Finerenone 20 mg Intact Tablet Fasted (Treatment A) v Finerenone 20 mg Suspension Fasted (Treatment C)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Estimated ratio in %
    Point estimate
    104.55
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 95.85
         upper limit
    		 114.04
    Statistical analysis title
    		 Statistical analysis: Treatment (B)/Treatment (A)
    Statistical analysis description
    AUC of finerenone were analyzed using ANOVA including sequence, subject (sequence), period, and treatment effects. Based on these analysis point estimates (LS-means) and exploratory 90% CIs for the ratios “20 mg crushed/re-suspended tablet fasted (B)/20 mg intact tablet fasted (A)” of AUC were calculated. Database auto calculate number of subjects analyzed, but the actual number of subjects analyzed was 16.
    Comparison groups
    Finerenone 20 mg Intact Tablet Fasted (Treatment A) v Finerenone 20 mg Crushed Tablet Fasted (Treatment B)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Estimated ratio in %
    Point estimate
    81.61
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 74.82
         upper limit
    		 89.02
    Statistical analysis title
    		 Statistical analysis: Treatment (D)/Treatment (C)
    Statistical analysis description
    AUC of finerenone were analyzed using ANOVA including sequence, subject (sequence), period, and treatment effects. Based on these analysis point estimates (LS-means) and exploratory 90% CIs for the ratios “20 mg suspension fed (D)/20 mg suspension fasted (C)” of AUC were calculated. Database auto calculate number of subjects analyzed, but the actual number of subjects analyzed was 16.
    Comparison groups
    Finerenone 20 mg Suspension Fasted (Treatment C) v Finerenone 20 mg Suspension Fed (Treatment D)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 Estimated ratio in %
    Point estimate
    100.37
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 92.02
         upper limit
    		 109.48

    Secondary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect and another serious or important medical event as judged by the investigator. AE/SAEs that started or worsened after study drug treatment were recorded as TEAE/TESAEs.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 1 week after last drug administration (Day 16)
    End point values
    		 Finerenone 20 mg Intact Tablet Fasted (Treatment A) Finerenone 20 mg Crushed Tablet Fasted (Treatment B) Finerenone 20 mg Suspension Fasted (Treatment C) Finerenone 20 mg Suspension Fed (Treatment D)
    Number of subjects analysed
    16 [5]
    16 [6]
    16 [7]
    16 [8]
    Units: subjects
        TEAE
    2
    2
    3
    4
        TESAE
    0
    0
    0
    0
    Notes
    [5] - SAF
    [6] - SAF
    [7] - SAF
    [8] - SAF
    No statistical analyses for this end point

    Other pre-specified: Appearance of the Formulation Assessed by Questionnaire

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    End point title
    		 Appearance of the Formulation Assessed by Questionnaire
    End point description
    Subjects completed a questionnaire regarding appearance immediately after study drug administration. Subjects were asked the question as ‘I like the appearance of the medium’, where subjects were selected their response from one of the five items: ‘completely disagree’, ‘somewhat disagree’, ‘neutral’, ‘somewhat agree’ and ‘completely agree’. In the below table, the response for categories ‘completely disagree’, ‘somewhat disagree’ were summarized under "disliked" and response from categories ‘somewhat agree’ and ‘completely agree’ were summarized under "liked".
    End point type
    Other pre-specified
    End point timeframe
    Immediately after study drug administration
    End point values
    		 Finerenone 20 mg Crushed Tablet Fasted (Treatment B) Finerenone 20 mg Suspension Fasted (Treatment C) Finerenone 20 mg Suspension Fed (Treatment D)
    Number of subjects analysed
    16 [9]
    16 [10]
    16 [11]
    Units: subjects
        Disliked
    0
    3
    3
        Neutral
    6
    7
    8
        Liked
    10
    6
    5
    Notes
    [9] - SAF
    [10] - SAF
    [11] - SAF
    No statistical analyses for this end point

    Other pre-specified: Taste of the Formulation Assessed by Questionnaire

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    End point title
    		 Taste of the Formulation Assessed by Questionnaire
    End point description
    Subjects completed a questionnaire regarding taste immediately after study drug administration. Subjects were asked the question as ‘I like the taste after swallowing’, where subjects were selected their response from one of the five items: ‘completely disagree’, ‘somewhat disagree’, ‘neutral’, ‘somewhat agree’ and ‘completely agree’. In the below table, the response for categories ‘completely disagree’, ‘somewhat disagree’ were summarized under "disliked" and response from categories ‘somewhat agree’ and ‘completely agree’ were summarized under "liked".
    End point type
    Other pre-specified
    End point timeframe
    Immediately after study drug administration
    End point values
    		 Finerenone 20 mg Crushed Tablet Fasted (Treatment B) Finerenone 20 mg Suspension Fasted (Treatment C) Finerenone 20 mg Suspension Fed (Treatment D)
    Number of subjects analysed
    16 [12]
    16 [13]
    16 [14]
    Units: subjects
        Disliked
    1
    4
    3
        Neutral
    2
    8
    5
        Liked
    13
    4
    8
    Notes
    [12] - SAF
    [13] - SAF
    [14] - SAF
    No statistical analyses for this end point

    Other pre-specified: Smell of the Formulation Assessed by Questionnaire

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    End point title
    		 Smell of the Formulation Assessed by Questionnaire
    End point description
    Subjects completed a questionnaire regarding smell immediately after study drug administration. Subjects were asked the question as ‘I like the smell of the medium’, where subjects were selected their response from one of the five items: ‘completely disagree’, ‘somewhat disagree’, ‘neutral’, ‘somewhat agree’ and ‘completely agree’. In the below table, the response for categories ‘completely disagree’, ‘somewhat disagree’ were summarized under "disliked" and response from categories ‘somewhat agree’ and ‘completely agree’ were summarized under "liked".
    End point type
    Other pre-specified
    End point timeframe
    Immediately after study drug administration
    End point values
    		 Finerenone 20 mg Crushed Tablet Fasted (Treatment B) Finerenone 20 mg Suspension Fasted (Treatment C) Finerenone 20 mg Suspension Fed (Treatment D)
    Number of subjects analysed
    16 [15]
    16 [16]
    16 [17]
    Units: subjects
        Disliked
    0
    2
    2
        Neutral
    4
    12
    11
        Liked
    12
    1
    3
    Notes
    [15] - SAF
    [16] - SAF
    [17] - SAF
    No statistical analyses for this end point

    Other pre-specified: Overall Impression of the Formulation Assessed by Questionnaire

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    End point title
    		 Overall Impression of the Formulation Assessed by Questionnaire
    End point description
    Subjects completed a questionnaire regarding overall impression immediately after study drug administration. Subjects were asked the question as ‘I like the medium overall’, where subjects were selected their response from one of the five items: ‘completely disagree’, ‘somewhat disagree’, ‘neutral’, ‘somewhat agree’ and ‘completely agree’. In the below table, the response for categories ‘completely disagree’, ‘somewhat disagree’ were summarized under "disliked" and response from categories ‘somewhat agree’ and ‘completely agree’ were summarized under "liked".
    End point type
    Other pre-specified
    End point timeframe
    Immediately after study drug administration
    End point values
    		 Finerenone 20 mg Crushed Tablet Fasted (Treatment B) Finerenone 20 mg Suspension Fasted (Treatment C) Finerenone 20 mg Suspension Fed (Treatment D)
    Number of subjects analysed
    16 [18]
    16 [19]
    16 [20]
    Units: subjects
        Disliked
    0
    2
    1
        Neutral
    3
    5
    5
        Liked
    13
    9
    10
    Notes
    [18] - SAF
    [19] - SAF
    [20] - SAF
    No statistical analyses for this end point

    Other pre-specified: Texture of the Formulation Assessed by Questionnaire

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    End point title
    		 Texture of the Formulation Assessed by Questionnaire
    End point description
    Subjects completed a questionnaire regarding texture immediately after study drug administration. Subjects were asked the question as ‘texture like sand, sticky, dry, creamy and strange (unlike any of the above mentioned) or other feeling’, where subjects were selected their response from one of the five items: ‘completely disagree’, ‘somewhat disagree’, ‘neutral’, ‘somewhat agree’ and ‘completely agree’. In the below table, the response for categories ‘completely disagree’, ‘somewhat disagree’ were summarized under "disliked" and response from categories ‘somewhat agree’ and ‘completely agree’ were summarized under "liked".
    End point type
    Other pre-specified
    End point timeframe
    Immediately after study drug administration
    End point values
    		 Finerenone 20 mg Crushed Tablet Fasted (Treatment B) Finerenone 20 mg Suspension Fasted (Treatment C) Finerenone 20 mg Suspension Fed (Treatment D)
    Number of subjects analysed
    16 [21]
    16 [22]
    16 [23]
    Units: subjects
        Sand: Disliked
    16
    15
    16
        Sand: Neutral
    0
    0
    0
        Sand: Liked
    0
    1
    0
        Sticky: Disliked
    13
    11
    11
        Sticky: Neutral
    1
    1
    0
        Sticky: Liked
    2
    4
    5
        Dry: Disliked
    16
    15
    16
        Dry: Neutral
    0
    1
    0
        Dry: Liked
    0
    0
    0
        Creamy: Disliked  
    6
    2
    2
        Creamy: Neutral
    4
    4
    4
        Creamy: Liked  
    6
    10
    10
        Strange: Disliked 
    14
    15
    14
        Strange: Neutral
    1
    0
    1
        Strange: Liked 
    1
    1
    1
    Notes
    [21] - SAF
    [22] - SAF
    [23] - SAF
    No statistical analyses for this end point

    Other pre-specified: Whether Oro-dispersible Tablets are Palatable and Swallowable Assessed by Questionnaire

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    End point title
    		 Whether Oro-dispersible Tablets are Palatable and Swallowable Assessed by Questionnaire
    End point description
    Subjects completed a questionnaire regarding palatable and swallowable immediately after study drug administration. Subjects were asked the question as ‘It was easy for me to swallow’, where subjects were selected their response from one of the two items: ‘somewhat disagree’, and ‘completely agree’. In the below table, the response for category ‘somewhat disagree’ was summarized under "disliked" and response from category ‘completely agree’ was summarized under "liked".
    End point type
    Other pre-specified
    End point timeframe
    Immediately after study drug administration
    End point values
    		 Finerenone 20 mg Crushed Tablet Fasted (Treatment B) Finerenone 20 mg Suspension Fasted (Treatment C) Finerenone 20 mg Suspension Fed (Treatment D)
    Number of subjects analysed
    16 [24]
    16 [25]
    16 [26]
    Units: subjects
        Disliked
    0
    0
    0
        Neutral
    0
    0
    0
        Liked
    16
    16
    16
    Notes
    [24] - SAF
    [25] - SAF
    [26] - SAF
    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 study drug administration up to 1 week after the last drug administration (Day 16)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Finerenone, 20mg Intact Tablet Fasted
    Reporting group description
    		 Subjects received a single oral dose of 20 mg finerenone intact film-coated tablet in fasted state during any intervention period.

    Reporting group title
    Finerenone, 20mg Crushed Tablet Fasted
    Reporting group description
    		 Subjects received a single oral dose of 20 mg finerenone crushed and re-suspended film-coated tablet in fasted state during any intervention period.

    Reporting group title
    Finerenone, 20mg Suspension Fasted
    Reporting group description
    		 Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) in fasted state during any intervention period.

    Reporting group title
    Finerenone, 20mg Suspension Fed
    Reporting group description
    		 Subjects received a single oral dose of 20 mg finerenone suspension (10 mL) after a standardized high-fat, high-calorie American breakfast in fed state during any intervention period.

    Serious adverse events
    		 Finerenone, 20mg Intact Tablet Fasted Finerenone, 20mg Crushed Tablet Fasted Finerenone, 20mg Suspension Fasted Finerenone, 20mg Suspension Fed
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Finerenone, 20mg Intact Tablet Fasted Finerenone, 20mg Crushed Tablet Fasted Finerenone, 20mg Suspension Fasted Finerenone, 20mg Suspension Fed
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 16 (12.50%)
    2 / 16 (12.50%)
    3 / 16 (18.75%)
    4 / 16 (25.00%)
    Investigations
    Amylase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    0
    1
    Lipase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    2
    White blood cell count increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    0
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Rhinitis
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    0

    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.
    Occurrence of "±” in relation with geometric CV is auto-generated and cannot be deleted. Decimal places were automatically truncated if last decimal equals zero.
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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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