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    Clinical Trial Results:
    A randomized, single dose, crossover study in healthy volunteers to investigate the relative bioavailability of linaprazan for a new oral tablet formulation of linaprazan glurate, and to assess the effect of food on the pharmacokinetics of linaprazan

    Summary
    EudraCT number
    		 2022-002273-29
    Trial protocol
    		 SI  
    Global end of trial date
    03 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 May 2025
    First version publication date
    30 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CX842A2106
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05627518
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cinclus Pharma Holding AB Publ.
    Sponsor organisation address
    World Trade Center, Kungsbron 1, Stockholm, Sweden, SE-111 22
    Public contact
    Gösta Hiller, Head of Project and Process Management, Cinclus Pharma Holding AB Publ., +46 723 72 59 58, gosta.hiller@cincluspharma.com
    Scientific contact
    Kajsa Larsson, CMO, Cinclus Pharma Holding AB Publ., +46 70 675 01 28, kajsa.larsson@cincluspharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jan 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this single-dose, randomized, 3-way cross-over study are to evaluate the relative bioavailability of linaprazan between the new test formulation of linaprazan glurate and the previously studied reference formulation of linaprazan glurate after the administration of single 100 mg doses in fasting conditions and to assess the effect of a high-fat, high-calorie meal on the PK of linaprazan after the administration of single 100 mg doses of the test formulation.
    Protection of trial subjects
    This study was conducted in compliance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E6 (Revision 2) Section 3, Institutional Review Board/Independent Ethics Committee guidelines, Good Clinical Practice regulations and guidelines, and all applicable local regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Nov 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovenia: 67
    Worldwide total number of subjects
    67
    EEA total number of subjects
    67
    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)
    67
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 67 Subjects were enrolled in the study. All subject were randomized and recieved treatment. Of the 67 subjects, 49 completed all three arms of the study. The main reasons for discontinuation were protocol violations (12 subjects), adverse event (3 subjects), and withdrawal by subject (3 subjects)

    Pre-assignment
    Screening details
    		 Key eligibility criteria: Medically healthy volunteers without clinically signifincant MedHis, aged 18-65, BMI 18.5-30.0 kg/m2 Adequate contraception or non-child bearing potential.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 TREATMENT A, 4 x 25mg reference formulation, fasted
    Arm description
    		 4 x 25 mg linaprazan glurate reference formulation in fasted condition
    Arm type
    		 Experimental

    Investigational medicinal product name
    4 x 25 mg linaprazan glurate reference formulation
    Investigational medicinal product code
    Other name
    CX842
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg (4 x 25mg) linaprazan glurate reference formulation

    Arm title
    		 TREATMENT B, 100 mg test formulation, fasted condition
    Arm description
    		 1 x 100 mg linaprazan glurate test formulation in fasted condition
    Arm type
    		 Experimental

    Investigational medicinal product name
    100 mg linaprazan glurate test formulation
    Investigational medicinal product code
    Other name
    CX842
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 x 100 mg linaprazan glurate test formulation

    Arm title
    		 TREATMENT C, 100 mg test formulation, fed condition
    Arm description
    		 1 x 100 mg linaprazan glurate test formulation in fed condition
    Arm type
    		 Experimental

    Investigational medicinal product name
    100 mg linaprazan glurate test formulation
    Investigational medicinal product code
    Other name
    CX842
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 x 100 mg linaprazan glurate test formulation

    Arm title
    		 Exploratory arm with underdosed subjects, 25 mg
    Arm description
    		 Subjects who were underdosed at treatment A with 1 x 25 mg linaprazan glurate in fed condition. PK results will not be presented from this arm, but they are part of the Safeyt analysis set.
    Arm type
    		 Experimental

    Investigational medicinal product name
    1 x 25 mg linaprazan glurate reference formulation
    Investigational medicinal product code
    Other name
    CX842
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg (1 x 25mg) linaprazan glurate reference formulation - erroneously underdosed with one instead of 4 tablets. The data from this group were kept because it would have been unethical to not utilize it.

    Number of subjects in period 1
    		TREATMENT A, 4 x 25mg reference formulation, fasted TREATMENT B, 100 mg test formulation, fasted condition TREATMENT C, 100 mg test formulation, fed condition Exploratory arm with underdosed subjects, 25 mg
    Started
    67
    53
    50
    13
    Completed
    51
    49
    49
    12
    Not completed
    16
    4
    1
    1
         Consent withdrawn by subject
    2
    2
    1
    -
         Adverse event, non-fatal
    2
    2
    -
    1
         Protocol deviation
    12
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Period Total
    Number of subjects
    		 67 67
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 67 67
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.1 ( 6.07 ) -
    Gender categorical
    Units: Subjects
        Female
    		 35 35
        Male
    		 32 32
    Subject analysis sets

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subject who were randomized, received at least one dose of linaprazan glurate, and who provided at least one post baseline assessment of data

    Subject analysis set title
    PK Analysis Set (PKAS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PK analysis set (PKAS) consisted of all subjects who received at least 1 dose of linaprazan glurate and provided an evaluable plasma concentration profile, and who had no AEs or protocol deviations judged to affect the PK analysis

    Subject analysis sets values
    		 Safety Analysis Set PK Analysis Set (PKAS)
    Number of subjects
    67
    54
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    67
    54
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    24.1 ( 6.07 )
    24.0 ( 6.54 )
    Gender categorical
    Units: Subjects
        Female
    35
    28
        Male
    32
    26

    End points

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    End points reporting groups
    Reporting group title
    TREATMENT A, 4 x 25mg reference formulation, fasted
    Reporting group description
    		 4 x 25 mg linaprazan glurate reference formulation in fasted condition

    Reporting group title
    TREATMENT B, 100 mg test formulation, fasted condition
    Reporting group description
    		 1 x 100 mg linaprazan glurate test formulation in fasted condition

    Reporting group title
    TREATMENT C, 100 mg test formulation, fed condition
    Reporting group description
    		 1 x 100 mg linaprazan glurate test formulation in fed condition

    Reporting group title
    Exploratory arm with underdosed subjects, 25 mg
    Reporting group description
    		 Subjects who were underdosed at treatment A with 1 x 25 mg linaprazan glurate in fed condition. PK results will not be presented from this arm, but they are part of the Safeyt analysis set.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subject who were randomized, received at least one dose of linaprazan glurate, and who provided at least one post baseline assessment of data

    Subject analysis set title
    PK Analysis Set (PKAS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PK analysis set (PKAS) consisted of all subjects who received at least 1 dose of linaprazan glurate and provided an evaluable plasma concentration profile, and who had no AEs or protocol deviations judged to affect the PK analysis

    Primary: Relative Bioavailability of linaprazan, Test vs Reference formulation AUCinf

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    End point title
    		 Relative Bioavailability of linaprazan, Test vs Reference formulation AUCinf [1]
    End point description
    Relative bioavailability of linaprazan, given linaprazan glurate test formulation vs. linaprazan glurate reference formulation. Cross-over.
    End point type
    Primary
    End point timeframe
    Start to End of Study
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic results for the under-dosed group (Exploratory arm) will not be presented here, only per protocol groups. The exploratory arm is however represented in the Safety anaylsis set.
    End point values
    		 TREATMENT A, 4 x 25mg reference formulation, fasted TREATMENT B, 100 mg test formulation, fasted condition
    Number of subjects analysed
    40
    51
    Units: nanomole(s)/litre * h
    geometric mean (standard deviation)
        AUCinf
    12341 ( 1.51 )
    25001 ( 1.32 )
    Statistical analysis title
    		 Ratio AUCinf Test vs Reference formulation
    Statistical analysis description
    A comparison of natural-log (ln)-transformed PK parameters to evaluate the relative bioavailability of Test vs. Reference, by a linear fixed effects model analysis using PROC MIXED of SAS® incl SEQUENCE, TREATMENT, PERIOD and SUBJECT as fixed effects, with SUBJECT nested within SEQUENCE. The inferential results (least-squares [LS] means, diff. between LS means, and 90% CIs of the diff.) were exponentiated to the original scale. Geometric LS means, geometric mean ratios and 90% CIs are presented.
    Comparison groups
    TREATMENT A, 4 x 25mg reference formulation, fasted v TREATMENT B, 100 mg test formulation, fasted condition
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric mean LS ratio
    Point estimate
    1.9954
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.8399
         upper limit
    		 2.1641
    Notes
    [2] - Due to limitations in the system, the "subjects in this analysis" figure given is incorrect as this is a cross-over study. For the true numbers, please see the "Subjects analysed" in the Reporting Groups. The Ratio between the comparison groups were as follows: Treatment B/Treatment A

    Primary: Relative Bioavailability of linaprazan, Test vs Reference Cmax

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    End point title
    		 Relative Bioavailability of linaprazan, Test vs Reference Cmax [3]
    End point description
    Ratio of linaprazan Cmax comparing Treatment A, linaprazan glurate test formulation 1 x 100 mg test formulaiton vs Treatment B, 4 x 25 mg reference formulation, in fed condition.
    End point type
    Primary
    End point timeframe
    From study start to study end
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic results for the under-dosed group (Exploratory arm) will not be presented here, only per protocol groups. The exploratory arm is however represented in the Safety anaylsis set.
    End point values
    		 TREATMENT A, 4 x 25mg reference formulation, fasted TREATMENT B, 100 mg test formulation, fasted condition
    Number of subjects analysed
    51
    53
    Units: nanomole(s)/litre
    geometric mean (standard deviation)
        Cmax
    1430.0 ( 1.83 )
    3462.2 ( 1.25 )
    Statistical analysis title
    		 Ratio Cmax Test vs Reference formulation
    Statistical analysis description
    A comparison of natural-log (ln)-transformed PK parameters to evaluate the relative bioavailability of Test vs. Reference, by a linear fixed effects model analysis using PROC MIXED of SAS® incl SEQUENCE, TREATMENT, PERIOD and SUBJECT as fixed effects, with SUBJECT nested within SEQUENCE. The inferential results (least-squares [LS] means, diff. between LS means, and 90% CIs of the diff.) were exponentiated to the original scale. Geometric LS means, geometric mean ratios and 90% CIs are presented.
    Comparison groups
    TREATMENT B, 100 mg test formulation, fasted condition v TREATMENT A, 4 x 25mg reference formulation, fasted
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric mean LS ratio
    Point estimate
    2.3167
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 2.0922
         upper limit
    		 2.5652
    Notes
    [4] - Due to limitations in the system, the "subjects in this analysis" figure given is incorrect as this is a cross-over study. For the true numbers, please see the "Subjects analysed" in the Reporting Groups. The Ratio between the comparison groups were as follows: Treatment B/Treatment A

    Primary: Relative Bioavailability of linaprazan, Fed vs Fasted AUCinf

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    End point title
    		 Relative Bioavailability of linaprazan, Fed vs Fasted AUCinf [5]
    End point description
    Relative bioavailability of linaprazan, given linaprazan glurate test formulation under fed or fasting conditions. Cross-over.
    End point type
    Primary
    End point timeframe
    Start to end of study
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic results for the under-dosed group (Exploratory arm) will not be presented here, only per protocol groups. The exploratory arm is however represented in the Safety anaylsis set.
    End point values
    		 TREATMENT B, 100 mg test formulation, fasted condition TREATMENT C, 100 mg test formulation, fed condition
    Number of subjects analysed
    51
    49
    Units: nanomole(s)/litre * h
    geometric mean (standard deviation)
        AUCinf
    25001 ( 1.32 )
    19448.9 ( 1.32 )
    Statistical analysis title
    		 Ratio AUCinf Fed vs Fasted
    Statistical analysis description
    A comparison of natural-log (ln)-transformed PK parameters to evaluate the relative bioavailability of Test vs. Reference, by a linear fixed effects model analysis using PROC MIXED of SAS® incl SEQUENCE, TREATMENT, PERIOD and SUBJECT as fixed effects, with SUBJECT nested within SEQUENCE. The inferential results (least-squares [LS] means, diff. between LS means, and 90% CIs of the diff.) were exponentiated to the original scale. Geometric LS means, geometric mean ratios and 90% CIs are presented.
    Comparison groups
    TREATMENT B, 100 mg test formulation, fasted condition v TREATMENT C, 100 mg test formulation, fed condition
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric mean LS ratio
    Point estimate
    0.757
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.7009
         upper limit
    		 0.8177
    Notes
    [6] - Due to limitations in the system, the "subjects in this analysis" figure given is incorrect as this is a cross-over study. For the true numbers, please see the "Subjects analysed" in the Reporting Groups. The Ratio between the comparison groups were as follows: Treatment C/Treatment B

    Primary: Relative Bioavailability of linaprazan, Fed vs Fasted Cmax

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    End point title
    		 Relative Bioavailability of linaprazan, Fed vs Fasted Cmax [7]
    End point description
    End point type
    Primary
    End point timeframe
    Start to end of study
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic results for the under-dosed group (Exploratory arm) will not be presented here, only per protocol groups. The exploratory arm is however represented in the Safety anaylsis set.
    End point values
    		 TREATMENT B, 100 mg test formulation, fasted condition TREATMENT C, 100 mg test formulation, fed condition
    Number of subjects analysed
    53
    50
    Units: nanomole(s)/litre
        geometric mean (standard deviation)
    3462.2 ( 1.25 )
    1608.2 ( 1.29 )
    Statistical analysis title
    		 Ratio Cmax Fed vs Fasted
    Statistical analysis description
    A comparison of natural-log (ln)-transformed PK parameters to evaluate the food effect by a linear fixed effects model analysis using PROC MIXED of SAS® including SEQUENCE, TREATMENT, PERIOD and SUBJECT as fixed effects, with SUBJECT nested within SEQUENCE. The inferential results (least-squares [LS] means, diff. between LS means, and 90% CIs of the diff.) were exponentiated to the original scale. Geometric LS means, geometric mean ratios and 90% CIs are presented.
    Comparison groups
    TREATMENT B, 100 mg test formulation, fasted condition v TREATMENT C, 100 mg test formulation, fed condition
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric mean LS ratio
    Point estimate
    0.454
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.4094
         upper limit
    		 0.5035
    Notes
    [8] - Due to limitations in the system, the "subjects in this analysis" figure given is incorrect as this is a cross-over study. For the true numbers, please see the "Subjects analysed" in the Reporting Groups. The Ratio between the comparison groups were as follows: Treatment C/Treatment B

    Primary: Relative Bioavailability of linaprazan, Test vs Reference formulation AUClast

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    End point title
    		 Relative Bioavailability of linaprazan, Test vs Reference formulation AUClast [9]
    End point description
    Relative bioavailability of linaprazan, given linaprazan glurate test formulation vs. linaprazan glurate reference formulation. Cross-over.
    End point type
    Primary
    End point timeframe
    Start to End of Study
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic results for the under-dosed group (Exploratory arm) will not be presented here, only per protocol groups. The exploratory arm is however represented in the Safety anaylsis set.
    End point values
    		 TREATMENT A, 4 x 25mg reference formulation, fasted TREATMENT B, 100 mg test formulation, fasted condition
    Number of subjects analysed
    51
    53
    Units: nanomole(s)/Litre * h
    geometric mean (standard deviation)
        AUClast
    10016.2 ( 2.78 )
    24175.8 ( 1.34 )
    Statistical analysis title
    		 Ratio AUClast Test vs Reference formulation
    Statistical analysis description
    A comparison of natural-log (ln)-transformed PK parameters to evaluate the relative bioavailability of Test vs. Reference, by a linear fixed effects model analysis using PROC MIXED of SAS® incl SEQUENCE, TREATMENT, PERIOD and SUBJECT as fixed effects, with SUBJECT nested within SEQUENCE. The inferential results (least-squares [LS] means, diff. between LS means, and 90% CIs of the diff.) were exponentiated to the original scale. Geometric LS means, geometric mean ratios and 90% CIs are presented.
    Comparison groups
    TREATMENT A, 4 x 25mg reference formulation, fasted v TREATMENT B, 100 mg test formulation, fasted condition
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Ratio
    Point estimate
    2.125
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.9664
         upper limit
    		 2.2963
    Notes
    [10] - Due to limitations in the system, the "subjects in this analysis" figure given is incorrect as this is a cross-over study. For the true numbers, please see the "Subjects analysed" in the Reporting Groups. The Ratio between the comparison groups were as follows: Treatment B/Treatment A

    Primary: Relative Bioavailability of linaprazan, Fed vs Fasted AUClast

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    End point title
    		 Relative Bioavailability of linaprazan, Fed vs Fasted AUClast [11]
    End point description
    Relative bioavailability of linaprazan, given linaprazan glurate test formulation under fed or fasting conditions. Cross-over.
    End point type
    Primary
    End point timeframe
    Start to end of study
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic results for the under-dosed group (Exploratory arm) will not be presented here, only per protocol groups. The exploratory arm is however represented in the Safety anaylsis set.
    End point values
    		 TREATMENT B, 100 mg test formulation, fasted condition TREATMENT C, 100 mg test formulation, fed condition
    Number of subjects analysed
    53
    50
    Units: nanomole(s)/Litre * h
    geometric mean (standard deviation)
        AUClast
    24175.8 ( 1.34 )
    19022.8 ( 1.32 )
    Statistical analysis title
    		 Ratio AUClast Fed vs Fasted
    Statistical analysis description
    A comparison of natural-log (ln)-transformed PK parameters to evaluate the relative bioavailability of Test vs. Reference, by a linear fixed effects model analysis using PROC MIXED of SAS® incl SEQUENCE, TREATMENT, PERIOD and SUBJECT as fixed effects, with SUBJECT nested within SEQUENCE. The inferential results (least-squares [LS] means, diff. between LS means, and 90% CIs of the diff.) were exponentiated to the original scale. Geometric LS means, geometric mean ratios and 90% CIs are presented.
    Comparison groups
    TREATMENT C, 100 mg test formulation, fed condition v TREATMENT B, 100 mg test formulation, fasted condition
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric mean LS ratio
    Point estimate
    0.7684
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.7102
         upper limit
    		 0.8313
    Notes
    [12] - Due to limitations in the system, the "subjects in this analysis" figure given is incorrect as this is a cross-over study. For the true numbers, please see the "Subjects analysed" in the Reporting Groups. The Ratio between the comparison groups were as follows: Treatment C/Treatment B

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for reporting is from time of being randomized until end of study.
    Adverse event reporting additional description
    During the study period, a total of 35 subjects experienced at least one TEAE for a total of 55 events. A total of 2 events, were considered by the Investigator as possibly related to study treatment. 1 event of Gastrointestinal disorder (Constipation) and 1 event of liver disorder (Mild hepatopathy). Overall there was 1 SAE.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    TEAE
    Reporting group description
    		 During the overall study period, 35 subjects (52.2%) experienced at least one TEAE for a total of 55 events. The most commonly reported TEAEs by MedDRA PTs were nasopharyngitis (7 subjects [10.4%]) and tachycardia (7 subjects [10.4%]), followed by headache (5 subjects [7.5%]), hypertension (3 subjects [4.5%]), phlebitis (3 subjects [4.5%]) and constipation (3 subjects [4.5%]). The TEAEs Papule, Blood Pressure Diastolic increased, Rhinitis, Diarrhea and Vomiting all occurred in 2 subjects (3%) each. All other TEAEs were unique events reported in single subjects.

    Serious adverse events
    		 TEAE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 67 (1.49%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Skin and subcutaneous tissue disorders
    Skin bacterial infection
    Additional description: The subject experienced a TEAE of phlebitis (verebatim: phlebitis of the left cubital vein after i.v. cannula post insertion). The PI considered event to be moderate, unlikely related to the IP, but possibly related to the study procedures.
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4.5%
    Non-serious adverse events
    		 TEAE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 67 (52.24%)
    Investigations
    Blood pressure diastolic decreased
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    Phlebitis
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    3
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    7 / 67 (10.45%)
         occurrences all number
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 67 (7.46%)
         occurrences all number
    6
    Sciatica
         subjects affected / exposed
    1 / 67 (1.49%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    3 / 67 (4.48%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Papule
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 67 (13.43%)
         occurrences all number
    10
    Rhinitis
         subjects affected / exposed
    2 / 67 (2.99%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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