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    Clinical Trial Results:
    A Phase IIa, randomised, double blind, placebo controlled, three way crossover study to assess the pharmacokinetics of RPL554 administered to adult patients with Cystic Fibrosis.

    Summary
    EudraCT number
    		 2015-004263-36
    Trial protocol
    		 GB   DE  
    Global end of trial date
    03 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Nov 2018
    First version publication date
    17 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RPL554-010-2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Verona Pharma Plc
    Sponsor organisation address
    3 More London Riverside, London, United Kingdom, SE1 2RE
    Public contact
    Brian Maurer, Verona Pharma plc, +44 2032834200, brian.maurer@veronapharma.com
    Scientific contact
    Brian Maurer, Verona Pharma plc, +44 2032834200, brian.maurer@veronapharma.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
    03 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate pharmacokinetics of single nebulised doses of RPL554 in patients with Cystic Fibrosis.
    Protection of trial subjects
    Standard procedures for emergency care were followed for any individual adverse events if clinically needed. Short acting bronchodilators could be used as rescue medication.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2017
    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
    United Kingdom: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Overall, 16 patients were screened for the study and 10 were treated. Patients received study treatment between 20 March 2017 and 30 October 2017. A total of nine patients completed the study and one was withdrawn

    Pre-assignment
    Screening details
    		 16 patients were screened. The reasons for screen failure were: (1) ECG/heart rate not meeting protocol ranges, (2) withdrew consent, (3) patient unwell, (4) prednisolone use, (5) spirometry <40% predicted normal and (6) chest infection

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 1.5 mg RPL554
    Arm description
    		 1.5 mg RPL554 administered with a nebuliser
    Arm type
    		 Experimental

    Investigational medicinal product name
    1.5 mg RPL554
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    1.5 mg RPL554 administered using a nebuliser

    Arm title
    		 6 mg RPL554
    Arm description
    		 6 mg RPL554
    Arm type
    		 Experimental

    Investigational medicinal product name
    6 mg RPL554
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    6 mg RPL554 administered using a nebuliser

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo administered using a nebuliser

    Number of subjects in period 1
    		1.5 mg RPL554 6 mg RPL554 Placebo
    Started
    10
    9
    10
    Completed
    10
    9
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 10 10
    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)
    		 10 10
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.6 ( 10.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    1.5 mg RPL554
    Reporting group description
    		 1.5 mg RPL554 administered with a nebuliser

    Reporting group title
    6 mg RPL554
    Reporting group description
    		 6 mg RPL554

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Plasma concentration area under the curve to time t

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    End point title
    		 Plasma concentration area under the curve to time t [1] [2]
    End point description
    AUC from time 0 to time t was estimated
    End point type
    Primary
    End point timeframe
    For 24 hours after each dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics by treatment group were applied
    [2] - 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: Pharmacokinetics were not applicable to the placebo arm
    End point values
    		 1.5 mg RPL554 6 mg RPL554
    Number of subjects analysed
    10
    9
    Units: pg.h/mL
        arithmetic mean (standard deviation)
    2342 ( 1029.9 )
    7699 ( 2965.7 )
    No statistical analyses for this end point

    Primary: Maximum plasma concentration

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    End point title
    		 Maximum plasma concentration [3] [4]
    End point description
    End point type
    Primary
    End point timeframe
    Over 24 hours after each dose
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics by treatment group were applied
    [4] - 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: Pharmacokinetics were not applicable to the placebo arm
    End point values
    		 1.5 mg RPL554 6 mg RPL554
    Number of subjects analysed
    10
    9
    Units: pg/mL
        arithmetic mean (standard deviation)
    270.1 ( 91.9 )
    828.3 ( 256.1 )
    No statistical analyses for this end point

    Primary: Time to maximum plasma concentration

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    End point title
    		 Time to maximum plasma concentration [5] [6]
    End point description
    End point type
    Primary
    End point timeframe
    Over 24 hours after each dose
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics by treatment group were applied
    [6] - 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: Pharmacokinetics were not applicable to the placebo arm
    End point values
    		 1.5 mg RPL554 6 mg RPL554
    Number of subjects analysed
    10
    9
    Units: hours
        median (full range (min-max))
    1.2 (0.4 to 2.2)
    1.3 (0.4 to 2.2)
    No statistical analyses for this end point

    Secondary: Peak forced expired volume in 1 second (FEV1)

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    End point title
    		 Peak forced expired volume in 1 second (FEV1)
    End point description
    End point type
    Secondary
    End point timeframe
    Over 4 hours after each dose
    End point values
    		 1.5 mg RPL554 6 mg RPL554 Placebo
    Number of subjects analysed
    10
    9
    10
    Units: Litres
        arithmetic mean (standard deviation)
    2.247 ( 0.72 )
    2.384 ( 0.73 )
    2.256 ( 0.71 )
    Statistical analysis title
    		 1.5 mg RPL554 versus placebo
    Comparison groups
    1.5 mg RPL554 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0196
    Method
    		 ANCOVA
    Parameter type
    		 Contrast ratio
    Point estimate
    1.038
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.007
         upper limit
    		 1.07
    Statistical analysis title
    		 6 mg RPL554 versus placebo
    Comparison groups
    6 mg RPL554 v Placebo
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0802
    Method
    		 ANCOVA
    Parameter type
    		 Contrast ratio
    Point estimate
    1.024
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.997
         upper limit
    		 1.052
    Statistical analysis title
    		 6 mg RPL554 versus 1.5 mg RPL554
    Comparison groups
    1.5 mg RPL554 v 6 mg RPL554
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3487
    Method
    		 ANCOVA
    Parameter type
    		 Contrast ratio
    Point estimate
    0.986
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.957
         upper limit
    		 1.017

    Secondary: Area under the curve for FEV1 over 4 hours

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    End point title
    		 Area under the curve for FEV1 over 4 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Over 4 hours after each dose
    End point values
    		 1.5 mg RPL554 6 mg RPL554 Placebo
    Number of subjects analysed
    10
    9
    10
    Units: Litres
        arithmetic mean (standard deviation)
    2.194 ( 0.72 )
    2.313 ( 0.73 )
    2.133 ( 0.73 )
    Statistical analysis title
    		 1.5 mg RPL554 versus placebo
    Comparison groups
    1.5 mg RPL554 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0043
    Method
    		 ANCOVA
    Parameter type
    		 Contrast ratio
    Point estimate
    1.072
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.026
         upper limit
    		 1.12
    Statistical analysis title
    		 6 mg RPL554 versus placebo
    Comparison groups
    6 mg RPL554 v Placebo
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0109
    Method
    		 ANCOVA
    Parameter type
    		 Contrast ratio
    Point estimate
    1.055
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.014
         upper limit
    		 1.096
    Statistical analysis title
    		 6 mg RPL554 versus 1.5 mg RPL554
    Comparison groups
    1.5 mg RPL554 v 6 mg RPL554
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4306
    Method
    		 ANCOVA
    Parameter type
    		 Contrast ratio
    Point estimate
    0.984
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.942
         upper limit
    		 1.027

    Secondary: Area under the curve for FEV1 over 6 hours

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    End point title
    		 Area under the curve for FEV1 over 6 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Over 6 hours after each dose
    End point values
    		 1.5 mg RPL554 6 mg RPL554 Placebo
    Number of subjects analysed
    10
    9
    10
    Units: Litres
        arithmetic mean (standard deviation)
    2.188 ( 0.73 )
    2.304 ( 0.74 )
    2.133 ( 0.73 )
    Statistical analysis title
    		 1.5 mg RPL554 versus placebo
    Comparison groups
    1.5 mg RPL554 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0064
    Method
    		 ANCOVA
    Parameter type
    		 Contrast ratio
    Point estimate
    1.065
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.021
         upper limit
    		 1.11
    Statistical analysis title
    		 6 mg RPL554 versus placebo
    Comparison groups
    6 mg RPL554 v Placebo
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0149
    Method
    		 ANCOVA
    Parameter type
    		 Contrast ratio
    Point estimate
    1.049
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.011
         upper limit
    		 1.089
    Statistical analysis title
    		 6 mg RPL554 versus 1.5 mg RPL554
    Comparison groups
    1.5 mg RPL554 v 6 mg RPL554
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.466
    Method
    		 ANCOVA
    Parameter type
    		 Contrast ratio
    Point estimate
    0.986
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.945
         upper limit
    		 1.027

    Secondary: Area under the curve for FEV1 over 8 hours

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    End point title
    		 Area under the curve for FEV1 over 8 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Over 8 hours after each dose
    End point values
    		 1.5 mg RPL554 6 mg RPL554 Placebo
    Number of subjects analysed
    10
    9
    10
    Units: Litres
        arithmetic mean (standard deviation)
    2.185 ( 0.74 )
    2.287 ( 0.75 )
    2.130 ( 0.74 )
    Statistical analysis title
    		 1.5 mg RPL554 versus placebo
    Comparison groups
    1.5 mg RPL554 v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0093
    Method
    		 ANCOVA
    Parameter type
    		 Contrast ratio
    Point estimate
    1.061
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.017
         upper limit
    		 1.107
    Statistical analysis title
    		 6 mg RPL554 versus placebo
    Comparison groups
    6 mg RPL554 v Placebo
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0333
    Method
    		 ANCOVA
    Parameter type
    		 Contrast ratio
    Point estimate
    1.042
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.004
         upper limit
    		 1.082
    Statistical analysis title
    		 6 mg RPL554 versus 1.5 mg RPL554
    Comparison groups
    1.5 mg RPL554 v 6 mg RPL554
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3693
    Method
    		 ANCOVA
    Parameter type
    		 Contrast ratio
    Point estimate
    0.982
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.941
         upper limit
    		 1.024

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent to the end of study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    1.5 mg RPL554
    Reporting group description
    		 1.5 mg RPL554 administered with a nebuliser

    Reporting group title
    6 mg RPL554
    Reporting group description
    		 6 mg RPL554

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 1.5 mg RPL554 6 mg RPL554 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 1.5 mg RPL554 6 mg RPL554 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 10 (60.00%)
    6 / 9 (66.67%)
    3 / 10 (30.00%)
    Investigations
    Forced expiratory volume decreased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary function test decreased
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 9 (22.22%)
    1 / 10 (10.00%)
         occurrences all number
    2
    2
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Syncope
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 9 (22.22%)
    0 / 10 (0.00%)
         occurrences all number
    2
    2
    0
    Nasal congestion
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Bak pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    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
    03 Mar 2017
    The range for ECG heart rate in inclusion criterion 3 was amended from 45 to 90 bpm to 45 to 100 bpm. In addition, the reference for predicted spirometry values was updated from Quanjer, 1993 to GLI Quanjer, 2012 and there was a change to the timeframe in which pharmacokinetic blood samples must be centrifuged after collection to within 30 minutes instead of 15 minutes. The address for the biomarker laboratory was also updated

    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
    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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