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    Clinical Trial Results:
    Relative bioavailability study to investigate the pharmacokinetics, safety and tolerability of single oral doses of finerenone 1.25 mg and 5 X 0.25 mg oro-dispersible tablet (pediatric formulation) in comparison to 10 mg tablet (adult formulation) in the fasting condition and to investigate the effect of a high fat, high calorie meal on 1.25 mg oro-dispersible tablet in healthy male subjects in a randomized, open-label, four-fold crossover design

    Summary
    EudraCT number
    		 2016-002895-29
    Trial protocol
    		 DE  
    Global end of trial date
    17 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2017
    First version publication date
    25 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY94-8862/18290
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02956109
    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, +49 30 300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, 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
    17 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 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: • investigate the relative bioavailability of a single oral dose of 1.25 milligram (mg) finerenone (BAY94-8862) oro-dispersible tablet (ODT) and 5 X 0.25 mg ODTs (pediatric formulation) in comparison to 10 mg finerenone (adult formulation) tablet in the fasting condition, • investigate the effect of a high fat, high calorie meal on the pharmacokinetics after a single oral dose of 1.25 mg finerenone ODT, • investigate whether the finerenone ODTs 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
    16 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 16 November 2016 (first subject first visit) and 22 December 2016 (last subject last visit).

    Pre-assignment
    Screening details
    		 Overall, 33 subjects were screened, of these 17 subjects were not included in the study; 13 were screen failures, 1 subject was lost to follow-up and 3 subjects were qualified but not needed. A total of 16 subjects were randomized and treated in a cross-over fashion, during the respective intervention periods (1st, 2nd, 3rd and 4th).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment A-C-B-D
    Arm description
    		 Subjects who followed treatment sequence A-C-B-D were reported. Subjects received a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state (Treatment A) in the first intervention period; followed by a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state (Treatment C) in the second intervention period; followed by a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state (Treatment B) in the third intervention period; and then a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) (Treatment D) in the fourth intervention period. A wash-out phase of at least 72 hours was maintained between the finerenone administrations.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet, Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment A: Subjects received a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state. Treatment C: Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state. Treatment B: Subjects received a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state. Treatment D: Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state).

    Arm title
    		 Treatment B-A-D-C
    Arm description
    		 Subjects who followed treatment sequence B-A-D-C were reported. Subjects received a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state (Treatment B) in the first intervention period; followed by a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state (Treatment A) in the second intervention period; followed by a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) (Treatment D) in the third intervention period; and then a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state (Treatment C) in the fourth intervention period. A wash-out phase of at least 72 hours was maintained between the finerenone administrations.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet, Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment B: Subjects received a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state. Treatment A: Subjects received a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state. Treatment D: Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state). Treatment C: Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state.

    Arm title
    		 Treatment C-D-A-B
    Arm description
    		 Subjects who followed treatment sequence C-D-A-B were reported. Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state (Treatment C) in the first intervention period; followed by a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) (Treatment D) in the second intervention period; followed by a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state (Treatment A) in the third intervention period; and then a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state (Treatment B) in the fourth intervention period. A wash-out phase of at least 72 hours was maintained between the finerenone administrations.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet, Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment C: Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state. Treatment D: Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state). Treatment A: Subjects received a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state. Treatment B: Subjects received a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state.

    Arm title
    		 Treatment D-B-C-A
    Arm description
    		 Subjects who followed treatment sequence D-B-C-A were reported. Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) (Treatment D) in the first intervention period; followed by a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state (Treatment B) in the second intervention period; followed by a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state (Treatment C) in the third intervention period; and then a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state (Treatment A) in the fourth intervention period. A wash-out phase of at least 72 hours was maintained between the finerenone administrations.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Pharmaceutical forms
    Film-coated tablet, Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment D: Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state). Treatment B: Subjects received a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state. Treatment C: Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state. Treatment A: Subjects received a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state.

    Number of subjects in period 1
    		Treatment A-C-B-D Treatment B-A-D-C Treatment C-D-A-B Treatment D-B-C-A
    Started
    4
    4
    4
    4
    Completed
    3
    4
    4
    4
    Not completed
    1
    0
    0
    0
         Adverse event
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment A-C-B-D
    Reporting group description
    		 Subjects who followed treatment sequence A-C-B-D were reported. Subjects received a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state (Treatment A) in the first intervention period; followed by a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state (Treatment C) in the second intervention period; followed by a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state (Treatment B) in the third intervention period; and then a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) (Treatment D) in the fourth intervention period. A wash-out phase of at least 72 hours was maintained between the finerenone administrations.

    Reporting group title
    Treatment B-A-D-C
    Reporting group description
    		 Subjects who followed treatment sequence B-A-D-C were reported. Subjects received a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state (Treatment B) in the first intervention period; followed by a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state (Treatment A) in the second intervention period; followed by a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) (Treatment D) in the third intervention period; and then a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state (Treatment C) in the fourth intervention period. A wash-out phase of at least 72 hours was maintained between the finerenone administrations.

    Reporting group title
    Treatment C-D-A-B
    Reporting group description
    		 Subjects who followed treatment sequence C-D-A-B were reported. Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state (Treatment C) in the first intervention period; followed by a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) (Treatment D) in the second intervention period; followed by a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state (Treatment A) in the third intervention period; and then a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state (Treatment B) in the fourth intervention period. A wash-out phase of at least 72 hours was maintained between the finerenone administrations.

    Reporting group title
    Treatment D-B-C-A
    Reporting group description
    		 Subjects who followed treatment sequence D-B-C-A were reported. Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) (Treatment D) in the first intervention period; followed by a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state (Treatment B) in the second intervention period; followed by a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state (Treatment C) in the third intervention period; and then a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state (Treatment A) in the fourth intervention period. A wash-out phase of at least 72 hours was maintained between the finerenone administrations.

    Reporting group values
    		 Treatment A-C-B-D Treatment B-A-D-C Treatment C-D-A-B Treatment D-B-C-A Total
    Number of subjects
    		 4 4 4 4 16
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 27.8 ± 4.3 36.8 ± 7.7 31 ± 4.1 28.5 ± 3.3 -
    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-C-B-D
    Reporting group description
    		 Subjects who followed treatment sequence A-C-B-D were reported. Subjects received a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state (Treatment A) in the first intervention period; followed by a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state (Treatment C) in the second intervention period; followed by a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state (Treatment B) in the third intervention period; and then a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) (Treatment D) in the fourth intervention period. A wash-out phase of at least 72 hours was maintained between the finerenone administrations.

    Reporting group title
    Treatment B-A-D-C
    Reporting group description
    		 Subjects who followed treatment sequence B-A-D-C were reported. Subjects received a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state (Treatment B) in the first intervention period; followed by a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state (Treatment A) in the second intervention period; followed by a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) (Treatment D) in the third intervention period; and then a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state (Treatment C) in the fourth intervention period. A wash-out phase of at least 72 hours was maintained between the finerenone administrations.

    Reporting group title
    Treatment C-D-A-B
    Reporting group description
    		 Subjects who followed treatment sequence C-D-A-B were reported. Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state (Treatment C) in the first intervention period; followed by a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) (Treatment D) in the second intervention period; followed by a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state (Treatment A) in the third intervention period; and then a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state (Treatment B) in the fourth intervention period. A wash-out phase of at least 72 hours was maintained between the finerenone administrations.

    Reporting group title
    Treatment D-B-C-A
    Reporting group description
    		 Subjects who followed treatment sequence D-B-C-A were reported. Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) (Treatment D) in the first intervention period; followed by a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state (Treatment B) in the second intervention period; followed by a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state (Treatment C) in the third intervention period; and then a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state (Treatment A) in the fourth intervention period. A wash-out phase of at least 72 hours was maintained between the finerenone administrations.

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

    Subject analysis set title
    Pharmacokinetics Analysis Set (PKS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PKS included all subjects with valid pharmacokinetic profiles for at least two of the treatments relevant for comparison (that is treatment A and B or treatment A and C or treatment C and D or treatment B and C) were included (N= 16).

    Subject analysis set title
    Finerenone, 10 mg tablet, fasted
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received a single oral dose of 10 mg (1 X 10 mg) finerenone tablet in fasted state during any of the intervention periods (N= 16).

    Subject analysis set title
    Finerenone, 5 X 0.25 mg ODTs, fasted
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received a single oral dose of 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state during any of the intervention periods (N= 16).

    Subject analysis set title
    Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state during any of the intervention periods (N= 16).

    Subject analysis set title
    Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received a single oral dose of 1.25 mg (1 X 1.25 mg) finerenone ODT after a standardized high-fat, high-calorie American breakfast (fed state) during any of the intervention periods (N= 15).

    Primary: Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) After Single Dose of Finerenone in Plasma

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    End point title
    		 Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) After Single Dose of Finerenone in Plasma
    End point description
    Area under the concentration versus time curve from zero to infinity divided by dose in plasma after single dose of finerenone was calculated. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    End point type
    Primary
    End point timeframe
    0 hour (pre-dose) to 24 hours post-dose of finerenone
    End point values
    		 Finerenone, 10 mg tablet, fasted Finerenone, 5 X 0.25 mg ODTs, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Number of subjects analysed
    16 [1]
    16 [2]
    16 [3]
    14 [4]
    Units: hour per liter * 10^-3 (h/L*10^-3)
        geometric mean (geometric coefficient of variation)
    17.1 ± 29.9
    16 ± 28
    16.9 ± 30.8
    19.9 ± 31.5
    Notes
    [1] - PKS
    [2] - PKS
    [3] - PKS
    [4] - PKS with evaluable subjects for this endpoint
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Logarithms of AUC/D were analyzed using analysis of variance (ANOVA) including sequence, subject (sequence), period, and treatment effects. Least square (LS)-Means and exploratory 90 percent (%) confidence intervals (CIs) for ratio C/A (1.25 mg [1 X 1.25 mg] ODT fasted/10 mg tablet fasted) were calculated by re-transformation of logarithmic data by intra-individual standard deviation of the ANOVA. Database auto-calculates total number of subjects erroneously, analysed number of subjects were 16
    Comparison groups
    Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted v Finerenone, 10 mg tablet, fasted
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 LS-Mean
    Point estimate
    0.9888
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.9221
         upper limit
    		 1.0604
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Logarithms of AUC/D were analyzed using ANOVA including sequence, subject (sequence), period, and treatment effects. LS-Means and exploratory 90 % CIs for ratio B/A (1.25 mg [5 X 0.25 mg] ODT fasted/10 mg tablet fasted) were calculated by re-transformation of logarithmic data by intra-individual standard deviation of the ANOVA. Database auto-calculates total number of subjects erroneously, analysed number of subjects were 16.
    Comparison groups
    Finerenone, 5 X 0.25 mg ODTs, fasted v Finerenone, 10 mg tablet, fasted
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 LS-Mean
    Point estimate
    0.9388
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8755
         upper limit
    		 1.0068
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Logarithms of AUC/D were analyzed using ANOVA including sequence, subject (sequence), period, and treatment effects. LS-Means and exploratory 90 % CIs for ratio B/C (1.25 mg [5 X 0.25 mg] ODT fasted/1.25 mg [1 X 1.25 mg] ODT fasted) were calculated by re-transformation of logarithmic data by intra-individual standard deviation of the ANOVA. Database auto-calculates total number of subjects erroneously, analysed number of subjects were 16.
    Comparison groups
    Finerenone, 5 X 0.25 mg ODTs, fasted v Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 LS-Mean
    Point estimate
    0.9495
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8854
         upper limit
    		 1.0182
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Logarithms of AUC/D were analyzed using ANOVA including sequence, subject (sequence), period, and treatment effects. LS-Means and exploratory 90 % CIs for ratio D/C (1.25 mg [1 X 1.25 mg] ODT fed/1.25 mg [1 X 0.25 mg] ODT, fasted) were calculated by re-transformation of logarithmic data by intra-individual standard deviation of the ANOVA. Database auto-calculates total number of subjects erroneously, analysed number of subjects were 14.
    Comparison groups
    Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed v Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 LS-Mean
    Point estimate
    1.2075
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.1222
         upper limit
    		 1.2993

    Primary: Maximum Observed Finerenone Concentration in Measured Matrix Divided by Dose (Cmax/D) After Single Dose Administration of Finerenone

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    End point title
    		 Maximum Observed Finerenone Concentration in Measured Matrix Divided by Dose (Cmax/D) After Single Dose Administration of Finerenone
    End point description
    Maximum observed finerenone concentration in measured matrix divided by dose after single dose administration of finerenone was calculated. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    End point type
    Primary
    End point timeframe
    0 hour (pre-dose) to 24 hours post-dose of finerenone
    End point values
    		 Finerenone, 10 mg tablet, fasted Finerenone, 5 X 0.25 mg ODTs, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Number of subjects analysed
    16 [5]
    16 [6]
    16 [7]
    14 [8]
    Units: per liter * 10^-3 (/L*10^-3)
        geometric mean (geometric coefficient of variation)
    7.27 ± 31.1
    7.14 ± 29.8
    7.12 ± 29.2
    5.04 ± 50.1
    Notes
    [5] - PKS
    [6] - PKS
    [7] - PKS
    [8] - PKS with evaluable subjects for this endpoint
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Logarithms of Cmax/D were analyzed using ANOVA including sequence, subject (sequence), period, and treatment effects. LS-Means and exploratory 90 % CIs for ratio C/A (1.25 mg [1 X 1.25 mg] ODT fasted/10 mg tablet fasted) were calculated by re-transformation of logarithmic data by intra-individual standard deviation of the ANOVA. Database auto-calculates total number of subjects erroneously, analysed number of subjects were 16.
    Comparison groups
    Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted v Finerenone, 10 mg tablet, fasted
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 LS-Mean
    Point estimate
    0.979
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8492
         upper limit
    		 1.1286
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Logarithms of Cmax/D were analyzed using ANOVA including sequence, subject (sequence), period, and treatment effects. LS-Means and exploratory 90 % CIs for ratio B/A (1.25 mg [5 X 0.25 mg] ODT fasted/10 mg tablet fasted) were calculated by re-transformation of logarithmic data by intra-individual standard deviation of the ANOVA. Database auto-calculates total number of subjects erroneously, analysed number of subjects were 16.
    Comparison groups
    Finerenone, 5 X 0.25 mg ODTs, fasted v Finerenone, 10 mg tablet, fasted
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 LS-Mean
    Point estimate
    0.9822
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.852
         upper limit
    		 1.1322
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Logarithms of Cmax/D were analyzed using ANOVA including sequence, subject (sequence), period, and treatment effects. LS-Means and exploratory 90 % CIs for ratio B/C (1.25 mg [5 X 0.25 mg] ODT fasted/1.25 mg [1 X 1.25 mg] ODT fasted) were calculated by re-transformation of logarithmic data by intra-individual standard deviation of the ANOVA. Database auto-calculates total number of subjects erroneously, analysed number of subjects were 16.
    Comparison groups
    Finerenone, 5 X 0.25 mg ODTs, fasted v Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 LS-Mean
    Point estimate
    1.0032
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.873
         upper limit
    		 1.1565
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Logarithms of Cmax/D were analyzed using ANOVA including sequence, subject (sequence), period, and treatment effects. LS-Means and exploratory 90 % CIs for ratio D/C (1.25 mg [1 X 1.25 mg] ODT fed/1.25 mg [1 X 0.25 mg] ODT, fasted) were calculated by re-transformation of logarithmic data by intra-individual standard deviation of the ANOVA. Database auto-calculates total number of subjects erroneously, analysed number of subjects were 14.
    Comparison groups
    Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed v Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 ANOVA
    Parameter type
    		 LS-Mean
    Point estimate
    0.7155
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.6164
         upper limit
    		 0.8306

    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 a subject who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the 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 and another serious or important medical event as judged by the investigator. TEAEs were defined as AEs that started or worsened up to 3 days after the last finerenone dose administration.
    End point type
    Secondary
    End point timeframe
    From start of study treatment up to 3 days after the last finerenone dose administration
    End point values
    		 Finerenone, 10 mg tablet, fasted Finerenone, 5 X 0.25 mg ODTs, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Number of subjects analysed
    16 [9]
    16 [10]
    16 [11]
    15 [12]
    Units: subjects
        TEAE
    1
    1
    2
    0
        TESAE
    0
    0
    0
    0
    Notes
    [9] - SAF
    [10] - SAF
    [11] - SAF
    [12] - SAF
    No statistical analyses for this end point

    Other pre-specified: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) After Single Dose of Finerenone in Plasma

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    End point title
    		 Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) After Single Dose of Finerenone in Plasma
    End point description
    Area under the concentration versus time curve from zero to infinity after single dose of finerenone in plasma was calculated. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    End point type
    Other pre-specified
    End point timeframe
    0 hour (pre-dose) to 24 hours post-dose of finerenone
    End point values
    		 Finerenone, 10 mg tablet, fasted Finerenone, 5 X 0.25 mg ODTs, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Number of subjects analysed
    16 [13]
    16 [14]
    16 [15]
    14 [16]
    Units: microgram*hour per liter (mcg*h/L)
        geometric mean (geometric coefficient of variation)
    171 ± 29.9
    20 ± 28
    21.1 ± 30.8
    24.8 ± 31.5
    Notes
    [13] - PKS
    [14] - PKS
    [15] - PKS
    [16] - PKS with evaluable subjects for this endpoint
    No statistical analyses for this end point

    Other pre-specified: Maximum Observed Drug Concentration (Cmax) After Single Dose Administration of Finerenone in Plasma

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    End point title
    		 Maximum Observed Drug Concentration (Cmax) After Single Dose Administration of Finerenone in Plasma
    End point description
    Maximum observed drug concentration in plasma after single dose of finerenone was calculated. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    End point type
    Other pre-specified
    End point timeframe
    0 hour (pre-dose) to 24 hours post-dose of finerenone
    End point values
    		 Finerenone, 10 mg tablet, fasted Finerenone, 5 X 0.25 mg ODTs, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Number of subjects analysed
    16 [17]
    16 [18]
    16 [19]
    14 [20]
    Units: microgram per liter (mcg/L)
        geometric mean (geometric coefficient of variation)
    72.7 ± 31.1
    8.92 ± 29.8
    8.9 ± 29.2
    6.3 ± 50.1
    Notes
    [17] - PKS
    [18] - PKS
    [19] - PKS
    [20] - PKS with evaluable subjects for this endpoint
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Various Acceptance Regarding the Appearance of the Oro-dispersible Tablets Assessed by Questionnaire

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    End point title
    		 Number of Subjects With Various Acceptance Regarding the Appearance of the Oro-dispersible Tablets Assessed by Questionnaire
    End point description
    Subjects completed a questionnaire regarding the taste and palatability immediately after study drug administration. The questionnaire included statement judging the appearance, taste, smell, and overall impression. Subjects selected their response from one of the five options: ‘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". Number of subjects with various acceptance regarding appearance of oro-dispersible tablets were reported.
    End point type
    Other pre-specified
    End point timeframe
    immediately after study drug administration
    End point values
    		 Finerenone, 5 X 0.25 mg ODTs, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Number of subjects analysed
    16 [21]
    16 [22]
    15 [23]
    Units: subjects
        Disliked
    0
    1
    0
        Neutral
    2
    4
    4
        Liked
    14
    11
    11
    Notes
    [21] - SAF
    [22] - SAF
    [23] - SAF
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Various Acceptance Regarding the Taste of the Oro-dispersible Tablets Assessed by Questionnaire

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    End point title
    		 Number of Subjects With Various Acceptance Regarding the Taste of the Oro-dispersible Tablets Assessed by Questionnaire
    End point description
    Subjects completed a questionnaire regarding the taste and palatability immediately after study drug administration. The questionnaire included statement judging the appearance, taste, smell, and overall impression. Subjects selected their response from one of the five options: ‘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". Number of subjects with various acceptance regarding taste of oro-dispersible tablets were reported.
    End point type
    Other pre-specified
    End point timeframe
    immediately after study drug administration
    End point values
    		 Finerenone, 5 X 0.25 mg ODTs, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Number of subjects analysed
    16 [24]
    16 [25]
    15 [26]
    Units: subjects
        Taste: Disliked
    1
    1
    0
        Taste: Neutral
    11
    12
    10
        Taste: Liked
    4
    3
    5
        Aftertaste: Disliked
    0
    0
    1
        Aftertaste: Neutral
    15
    14
    12
        Aftertaste: Liked
    1
    2
    2
        Swallowability: Disliked
    2
    0
    0
        Swallowability: Neutral
    0
    0
    1
        Swallowability: Liked
    14
    16
    14
    Notes
    [24] - SAF
    [25] - SAF
    [26] - SAF
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Various Acceptance Regarding the Smell of the Oro-dispersible Tablets Assessed by Questionnaire

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    End point title
    		 Number of Subjects With Various Acceptance Regarding the Smell of the Oro-dispersible Tablets Assessed by Questionnaire
    End point description
    Subjects completed a questionnaire regarding the taste and palatability immediately after study drug administration. The questionnaire included statement judging the appearance, taste, smell, and overall impression. Subjects selected their response from one of the five options: ‘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". Number of subjects with various acceptance regarding smell of oro-dispersible tablets were reported.
    End point type
    Other pre-specified
    End point timeframe
    immediately after study drug administration
    End point values
    		 Finerenone, 5 X 0.25 mg ODTs, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Number of subjects analysed
    16 [27]
    16 [28]
    15 [29]
    Units: subjects
        Disliked
    1
    0
    0
        Neutral
    12
    15
    14
        Liked
    3
    1
    1
    Notes
    [27] - SAF
    [28] - SAF
    [29] - SAF
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Various Acceptance Regarding the Overall Impression of the Oro-dispersible Tablets Assessed by Questionnaire

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    End point title
    		 Number of Subjects With Various Acceptance Regarding the Overall Impression of the Oro-dispersible Tablets Assessed by Questionnaire
    End point description
    Subjects completed a questionnaire regarding the taste and palatability immediately after study drug administration. The questionnaire included statement judging the appearance, taste, smell, and overall impression. Subjects selected their response from one of the five options: ‘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". Number of subjects with various acceptance regarding overall impression of oro-dispersible tablets were reported.
    End point type
    Other pre-specified
    End point timeframe
    immediately after study drug administration
    End point values
    		 Finerenone, 5 X 0.25 mg ODTs, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Number of subjects analysed
    16 [30]
    16 [31]
    15 [32]
    Units: subjects
        Disliked
    1
    0
    0
        Neutral
    3
    4
    1
        Liked
    12
    12
    14
    Notes
    [30] - SAF
    [31] - SAF
    [32] - 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 treatment up to 3 days after the last dose of study drug
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Finerenone, 10 mg tablet fasted
    Reporting group description
    		 Subjects received a single oral dose 10 mg (1 X 10 mg) finerenone tablet in fasted state during any of the intervention periods.

    Reporting group title
    Finerenone, 5 X 0.25 mg ODTs, fasted
    Reporting group description
    		 Subjects received a single oral dose 1.25 mg (5 X 0.25 mg) finerenone ODTs in fasted state during any of the intervention periods.

    Reporting group title
    Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted
    Reporting group description
    		 Subjects received a single oral dose 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state during any of the intervention periods.

    Reporting group title
    Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Reporting group description
    		 Subjects received a single oral dose 1.25 mg (1 X 1.25 mg) finerenone ODT in fasted state during any of the intervention periods.

    Serious adverse events
    		 Finerenone, 10 mg tablet fasted Finerenone, 5 X 0.25 mg ODTs, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (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, 10 mg tablet fasted Finerenone, 5 X 0.25 mg ODTs, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fasted Finerenone, 1.25 mg (1 X 1.25 mg) ODT, fed
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    2 / 16 (12.50%)
    0 / 15 (0.00%)
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Dec 2016
    This amendment included the following changes: • Administrative changes: change of deputy investigator and role of the signatory on the signature page • Correction of number of overnight stays from 3 to 2 nights in each period for consistency • Change of one serum chemistry parameter: leucine aminopeptidase could not be determined any longer due to lack of CE-marked test. Alternatively, the bone-specific alkaline phosphatase (ostase) was determined if an increase in alkaline phosphatase was observed.

    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.
    For support, Contact us.
    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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