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    Clinical Trial Results:
    A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation

    Summary
    EudraCT number
    		 2016-004477-40
    Trial protocol
    		 GB   NL   BE   ES  
    Global end of trial date
    19 Oct 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG2222-CL-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03119649
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Clinical trial information desk, Galapagos NV, +32 15 342 900, rd@glpg.com
    Scientific contact
    Clinical trial information desk, Galapagos NV, +32 15 342 900, rd@glpg.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
    30 Mar 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: - To evaluate the safety and tolerability of 4 different doses of GLPG2222 administered orally and q.d. for 29 days in adult subjects with CF who are homozygous for the F508del CFTR mutation. Secondary Objectives: - To assess changes in biomarkers of CFTR activity. - To assess changes in respiratory symptoms. - To assess the PK of GLPG2222.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 (R2) and with the applicable European and local regulatory requirements. Prior to the performance of any study-specific procedure, written informed consent was obtained from each subject. The subject was informed about the nature and purpose of the study, as well as of its risks and benefits. It was explained that participation was voluntary and that the subject could withdraw from the study at any time for any reason and that this would not have any effect on potential future medical care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Mar 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 14
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Belgium: 12
    Country: Number of subjects enrolled
    Serbia: 8
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    59
    EEA total number of subjects
    36
    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)
    59
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted from 18 March 2017 (date the first subject signed the ICF) to 19 October 2017 (date of last contact with the last subject). The study was conducted in 21 sites located in the United States of America (5), the Netherlands (4), Belgium (4), United Kingdom (4), Spain (3) and Serbia (1).

    Pre-assignment
    Screening details
    		 73 subjects were screened, 59 of which were enrolled and treated.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Pooled placebo from Cohort A and B
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The matching placebo was provided as a tablet for oral use (cohort A: batch number 2016200079 and cohort B: batch number 0088/2017) and was administered q.d. for 29 days.

    Arm title
    		 GLPG2222 50 mg q.d.
    Arm description
    		 Cohort A
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG2222
    Investigational medicinal product code
    G957389
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG2222 was provided as tablets for oral use, containing 50 mg (batch number 2016200080) or 100 mg (batch number 2016200081) active substance of G957389 (G957389 is the compound code for GLPG2222) and was administered q.d. for 29 days.

    Arm title
    		 GLPG2222 100 mg q.d.
    Arm description
    		 Cohort A
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG2222
    Investigational medicinal product code
    G957389
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG2222 was provided as tablets for oral use, containing 50 mg (batch number 2016200080) or 100 mg (batch number 2016200081) active substance of G957389 (G957389 is the compound code for GLPG2222) and was administered q.d. for 29 days.

    Arm title
    		 GLPG2222 200 mg q.d.
    Arm description
    		 Cohort B
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG2222
    Investigational medicinal product code
    G957389
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG2222 was provided as tablets for oral use, containing 100 mg (batch number 0089/2017) or 150 mg (batch number 0090/2017) active substance of G957389 (G957389 is the compound code for GLPG2222) and was administered q.d. for 29 days.

    Arm title
    		 GLPG2222 400 mg q.d.
    Arm description
    		 Cohort B
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG2222
    Investigational medicinal product code
    G957389
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG2222 was provided as tablets for oral use, containing 100 mg (batch number 0089/2017) or 150 mg (batch number 0090/2017) active substance of G957389 (G957389 is the compound code for GLPG2222) and was administered q.d. for 29 days.

    Number of subjects in period 1
    		Placebo GLPG2222 50 mg q.d. GLPG2222 100 mg q.d. GLPG2222 200 mg q.d. GLPG2222 400 mg q.d.
    Started
    11
    10
    10
    14
    14
    Completed
    11
    10
    10
    14
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Pooled placebo from Cohort A and B

    Reporting group title
    GLPG2222 50 mg q.d.
    Reporting group description
    		 Cohort A

    Reporting group title
    GLPG2222 100 mg q.d.
    Reporting group description
    		 Cohort A

    Reporting group title
    GLPG2222 200 mg q.d.
    Reporting group description
    		 Cohort B

    Reporting group title
    GLPG2222 400 mg q.d.
    Reporting group description
    		 Cohort B

    Reporting group values
    		 Placebo GLPG2222 50 mg q.d. GLPG2222 100 mg q.d. GLPG2222 200 mg q.d. GLPG2222 400 mg q.d. Total
    Number of subjects
    		 11 10 10 14 14 59
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 11 10 10 14 14 59
        From 65-84 years
    		 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 27 (21 to 58) 26 (20 to 37) 24 (18 to 35) 32 (19 to 47) 26 (19 to 59) -
    Gender categorical
    Units: Subjects
        Female
    		 4 3 6 7 5 25
        Male
    		 7 7 4 7 9 34
    Race
    Units: Subjects
        White
    		 11 9 10 13 13 56
        Not allowed to ask per local regulations
    		 0 1 0 1 1 3
    BMI
    Units: kg/m2
        median (full range (min-max))
    		 22.20 (16.3 to 25.7) 21.05 (18.7 to 25.1) 20.75 (14.1 to 23.3) 22.30 (18.5 to 26.8) 22.40 (18.3 to 23.7) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Pooled placebo from Cohort A and B

    Reporting group title
    GLPG2222 50 mg q.d.
    Reporting group description
    		 Cohort A

    Reporting group title
    GLPG2222 100 mg q.d.
    Reporting group description
    		 Cohort A

    Reporting group title
    GLPG2222 200 mg q.d.
    Reporting group description
    		 Cohort B

    Reporting group title
    GLPG2222 400 mg q.d.
    Reporting group description
    		 Cohort B

    Primary: Safety - incidence of TEAE (Treatment-Emergent Adverse Events)

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    End point title
    		 Safety - incidence of TEAE (Treatment-Emergent Adverse Events) [1]
    End point description
    Safety and tolerability, assessed by the incidence of adverse events (AEs), as well as changes over time in weight, vital signs, oxygen saturation by pulse oximetry, 12-lead ECG, spirometry, and clinical safety laboratory data (hematology, chemistry, coagulation, and urinalysis).
    End point type
    Primary
    End point timeframe
    From first study drug administration until the last follow-up visit.
    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: Descriptive analysis only.
    End point values
    		 Placebo GLPG2222 50 mg q.d. GLPG2222 100 mg q.d. GLPG2222 200 mg q.d. GLPG2222 400 mg q.d.
    Number of subjects analysed
    11
    10
    10
    14
    14
    Units: Subjects
        Any TEAE
    9
    8
    10
    11
    9
        Severe TEAE
    1
    0
    1
    1
    0
        Serious TEAE
    2
    0
    1
    0
    0
        Treatment related TEAE
    2
    2
    6
    5
    1
        Discontinuation due to AE
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Sweat Chloride Concentration by treatment group

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    End point title
    		 Sweat Chloride Concentration by treatment group
    End point description
    Change from baseline in sweat chloride concentration through 29 days.
    End point type
    Secondary
    End point timeframe
    Sweat was collected at screening and pre-dose on Day 29 or early discontinuation (if applicable) with Last Observation Carried Forward (LOCF) imputation method.
    End point values
    		 Placebo GLPG2222 50 mg q.d. GLPG2222 100 mg q.d. GLPG2222 200 mg q.d. GLPG2222 400 mg q.d.
    Number of subjects analysed
    11
    9
    8
    14
    14
    Units: mmol/L
    least squares mean (standard error)
        Day 29 (Change from Baseline)
    -2.54 ± 2.787
    -5.84 ± 3.079
    -6.64 ± 3.286
    -18.30 ± 2.494
    -8.84 ± 2.494
    Statistical analysis title
    		 GLPG2222 50 mg q.d. versus placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline at each time point, with treatment as factor and baseline value as covariate, was applied. Between-group comparisons was done for each GLPG2222 group versus the pooled placebo group with Last Observation Carried Forward (LOCF) imputation method.
    Comparison groups
    Placebo v GLPG2222 50 mg q.d.
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4291
    Method
    		 ANCOVA
    Parameter type
    		 Least Square mean difference
    Point estimate
    -3.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.63
         upper limit
    		 5.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.146
    Statistical analysis title
    		 GLPG2222 100 mg q.d. versus placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline at each time point, with treatment as factor and baseline value as covariate, was applied. Between-group comparisons was done for each GLPG2222 group versus the pooled placebo group with Last Observation Carried Forward (LOCF) imputation method.
    Comparison groups
    GLPG2222 100 mg q.d. v Placebo
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3477
    Method
    		 ANCOVA
    Parameter type
    		 Least Square mean difference
    Point estimate
    -4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.79
         upper limit
    		 4.59
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.324
    Statistical analysis title
    		 GLPG2222 200 mg q.d. versus placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline at each time point, with treatment as factor and baseline value as covariate, was applied. Between-group comparisons was done for each GLPG2222 group versus the pooled placebo group with Last Observation Carried Forward (LOCF) imputation method.
    Comparison groups
    Placebo v GLPG2222 200 mg q.d.
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Square mean difference
    Point estimate
    -15.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.24
         upper limit
    		 -8.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.723
    Statistical analysis title
    		 GLPG2222 400 mg q.d. versus placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline at each time point, with treatment as factor and baseline value as covariate, was applied. Between-group comparisons was done for each GLPG2222 group versus the pooled placebo group with Last Observation Carried Forward (LOCF) imputation method.
    Comparison groups
    Placebo v GLPG2222 400 mg q.d.
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0995
    Method
    		 ANCOVA
    Parameter type
    		 Least Square mean difference
    Point estimate
    -6.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.85
         upper limit
    		 1.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.757

    Secondary: Pulmonary function by treatment group (ppFEV1)

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    End point title
    		 Pulmonary function by treatment group (ppFEV1)
    End point description
    Change from baseline in percent predicted FEV1 through 29 days.
    End point type
    Secondary
    End point timeframe
    Between screening and pre-dose on Day 29 or early discontinuation (if applicable) with Last Observation Carried Forward (LOCF) imputation method.
    End point values
    		 Placebo GLPG2222 50 mg q.d. GLPG2222 100 mg q.d. GLPG2222 200 mg q.d. GLPG2222 400 mg q.d.
    Number of subjects analysed
    11
    10
    10
    14
    14
    Units: Percent Predicted FEV1 (%)
    least squares mean (standard error)
        Day 29 (Change from Baseline)
    -1.0 ± 1.45
    0.1 ± 1.50
    -0.3 ± 1.51
    0.0 ± 1.27
    1.3 ± 1.26
    Statistical analysis title
    		 GLPG2222 50 mg q.d versus placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline at each time point, with treatment as factor and baseline value as covariate, was applied. Between-group comparisons was done for each GLPG2222 group versus the pooled placebo group with Last Observation Carried Forward (LOCF) imputation method.
    Comparison groups
    Placebo v GLPG2222 50 mg q.d.
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.594
    Method
    		 ANCOVA
    Parameter type
    		 Least Square mean difference
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 5.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.11
    Statistical analysis title
    		 GLPG2222 100 mg q.d versus placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline at each time point, with treatment as factor and baseline value as covariate, was applied. Between-group comparisons was done for each GLPG2222 group versus the pooled placebo group with Last Observation Carried Forward (LOCF) imputation method.
    Comparison groups
    Placebo v GLPG2222 100 mg q.d.
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7553
    Method
    		 ANCOVA
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 4.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.06
    Statistical analysis title
    		 GLPG2222 200 mg q.d versus placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline at each time point, with treatment as factor and baseline value as covariate, was applied. Between-group comparisons was done for each GLPG2222 group versus the pooled placebo group with Last Observation Carried Forward (LOCF) imputation method.
    Comparison groups
    Placebo v GLPG2222 200 mg q.d.
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5958
    Method
    		 ANCOVA
    Parameter type
    		 Least Square mean difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 4.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.94
    Statistical analysis title
    		 GLPG2222 400 mg q.d versus placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline at each time point, with treatment as factor and baseline value as covariate, was applied. Between-group comparisons was done for each GLPG2222 group versus the pooled placebo group with Last Observation Carried Forward (LOCF) imputation method.
    Comparison groups
    Placebo v GLPG2222 400 mg q.d.
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2403
    Method
    		 ANCOVA
    Parameter type
    		 Least Square mean difference
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 6.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.94

    Secondary: Cystic Fibrosis Questionnaire revised respiratory domain (CFQ-R)

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    End point title
    		 Cystic Fibrosis Questionnaire revised respiratory domain (CFQ-R)
    End point description
    Change from baseline in the respiratory domain of the Cystic Fibrosis Questionnaire- Revised (CFQ-R) through 29 days.
    End point type
    Secondary
    End point timeframe
    Eligible subjects were asked to complete the adult version of the CFQ-R at screening, and Day 29 or at early discontinuation (if applicable) with Last Observation Carried Forward (LOCF) imputation method.
    End point values
    		 Placebo GLPG2222 50 mg q.d. GLPG2222 100 mg q.d. GLPG2222 200 mg q.d. GLPG2222 400 mg q.d.
    Number of subjects analysed
    11
    10
    10
    14
    14
    Units: CFQ-R Score change from Baseline
    least squares mean (standard error)
        Day 29 (Change from Baseline)
    -2.36 ± 3.318
    0.35 ± 3.469
    -0.74 ± 3.480
    4.48 ± 2.931
    -0.77 ± 2.931
    Statistical analysis title
    		 GLPG2222 50 mg q.d. versus placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline at each time point, with treatment as factor and baseline value as covariate,was applied. Between-group comparisons was done for each GLPG2222 group versus the pooled placebo group with Last Observation Carried Forward (LOCF) imputation method.
    Comparison groups
    Placebo v GLPG2222 50 mg q.d.
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5749
    Method
    		 ANCOVA
    Parameter type
    		 Least Square mean difference
    Point estimate
    2.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.93
         upper limit
    		 12.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.805
    Statistical analysis title
    		 GLPG2222 100 mg q.d. versus placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline at each time point, with treatment as factor and baseline value as covariate,was applied. Between-group comparisons was done for each GLPG2222 group versus the pooled placebo group with Last Observation Carried Forward (LOCF) imputation method.
    Comparison groups
    Placebo v GLPG2222 100 mg q.d.
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7381
    Method
    		 ANCOVA
    Parameter type
    		 Least Square mean difference
    Point estimate
    1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.06
         upper limit
    		 11.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.826
    Statistical analysis title
    		 GLPG2222 200 mg q.d. versus placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline at each time point, with treatment as factor and baseline value as covariate,was applied. Between-group comparisons was done for each GLPG2222 group versus the pooled placebo group with Last Observation Carried Forward (LOCF) imputation method.
    Comparison groups
    Placebo v GLPG2222 200 mg q.d.
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1282
    Method
    		 ANCOVA
    Parameter type
    		 Least Square mean difference
    Point estimate
    6.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.04
         upper limit
    		 15.71
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.425
    Statistical analysis title
    		 GLPG2222 400 mg q.d. versus placebo
    Statistical analysis description
    An analysis of covariance (ANCOVA) model on the changes from baseline at each time point, with treatment as factor and baseline value as covariate,was applied. Between-group comparisons was done for each GLPG2222 group versus the pooled placebo group with Last Observation Carried Forward (LOCF) imputation method.
    Comparison groups
    Placebo v GLPG2222 400 mg q.d.
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7212
    Method
    		 ANCOVA
    Parameter type
    		 Least Square mean difference
    Point estimate
    1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.29
         upper limit
    		 10.47
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.427

    Secondary: PK - Cmax

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    End point title
    		 PK - Cmax [2]
    End point description
    To assess the maximum observed plasma concentration of GLPG2222.
    End point type
    Secondary
    End point timeframe
    PK blood samples for GLPG2222 were taken pre-dose and 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15 (or on Day 29 if subject was not available for full PK profiling on Day 15), and pre-dose on Day 29.
    Notes
    [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: The pooled placebo arm has been excluded from PK analysis.
    End point values
    		 GLPG2222 50 mg q.d. GLPG2222 100 mg q.d. GLPG2222 200 mg q.d. GLPG2222 400 mg q.d.
    Number of subjects analysed
    10
    10
    14
    13
    Units: ng/mL
        arithmetic mean (standard deviation)
    478 ± 128
    1170 ± 395
    2490 ± 535
    5330 ± 2700
    No statistical analyses for this end point

    Secondary: PK - AUC0-t

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    End point title
    		 PK - AUC0-t [3]
    End point description
    To assess area under the plasma concentration-time curve from time zero till 24 hours following multiple dosing of GLPG2222
    End point type
    Secondary
    End point timeframe
    PK blood samples for GLPG2222 were taken pre-dose and 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15 (or on Day 29 if subject was not available for full PK profiling on Day 15), and pre-dose on Day 29.
    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: The pooled placebo arm has been excluded from PK analysis.
    End point values
    		 GLPG2222 50 mg q.d. GLPG2222 100 mg q.d. GLPG2222 200 mg q.d. GLPG2222 400 mg q.d.
    Number of subjects analysed
    10
    10
    14
    13
    Units: ng.h/mL
        arithmetic mean (standard deviation)
    3850 ± 1670
    9670 ± 3770
    22900 ± 7530
    46400 ± 25500
    No statistical analyses for this end point

    Secondary: PK - tmax

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    End point title
    		 PK - tmax [4]
    End point description
    To assess time to occurrence of Cmax of GLPG2222
    End point type
    Secondary
    End point timeframe
    PK blood samples for GLPG2222 were taken pre-dose and 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15 (or on Day 29 if subject was not available for full PK profiling on Day 15), and pre-dose on Day 29.
    Notes
    [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: The pooled placebo arm has been excluded from PK analysis.
    End point values
    		 GLPG2222 50 mg q.d. GLPG2222 100 mg q.d. GLPG2222 200 mg q.d. GLPG2222 400 mg q.d.
    Number of subjects analysed
    10
    10
    14
    13
    Units: hour
        median (full range (min-max))
    2.0 (1.0 to 6.0)
    2.0 (2.0 to 6.0)
    3.0 (2.0 to 4.0)
    2.0 (0.5 to 6.0)
    No statistical analyses for this end point

    Secondary: PK - CTrough

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    End point title
    		 PK - CTrough [5]
    End point description
    To assess plasma concentration observed at pre-dose of GLPG2222 on the full PK profiling day (either Day 15 or Day 29 depending on the subject)
    End point type
    Secondary
    End point timeframe
    PK blood samples for GLPG2222 were taken pre-dose and 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15 (or on Day 29 if subject was not available for full PK profiling on Day 15), and pre-dose on Day 29.
    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: The pooled placebo arm has been excluded from PK analysis.
    End point values
    		 GLPG2222 50 mg q.d. GLPG2222 100 mg q.d. GLPG2222 200 mg q.d. GLPG2222 400 mg q.d.
    Number of subjects analysed
    10
    10
    14
    14
    Units: ng/mL
        arithmetic mean (standard deviation)
    48.1 ± 33.7
    132 ± 87.2
    343 ± 204
    677 ± 659
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE: from the signature of ICF until the final follow-up visit. TEAE:from first study drug administration until the final follow-up visit.
    Adverse event reporting additional description
    No deaths or TEAEs leading to study drug discontinuation were reported during the study. A total of 4 (2 after GLPG2222, 2 after placebo) SAEs were reported in 2/11 (18.2%) and 1/10 (10.0%) subjects in the pooled placebo and GLPG2222 100 mg q.d. treatment groups, respectively.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    GLPG2222 50 mg q.d.
    Reporting group description
    		 -

    Reporting group title
    GLPG2222 100 mg q.d.
    Reporting group description
    		 -

    Reporting group title
    GLPG2222 200 mg q.d.
    Reporting group description
    		 -

    Reporting group title
    GLPG2222 400 mg q.d.
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo GLPG2222 50 mg q.d. GLPG2222 100 mg q.d. GLPG2222 200 mg q.d. GLPG2222 400 mg q.d.
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo GLPG2222 50 mg q.d. GLPG2222 100 mg q.d. GLPG2222 200 mg q.d. GLPG2222 400 mg q.d.
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 11 (81.82%)
    8 / 10 (80.00%)
    10 / 10 (100.00%)
    11 / 14 (78.57%)
    9 / 14 (64.29%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    2 / 10 (20.00%)
    1 / 14 (7.14%)
    2 / 14 (14.29%)
         occurrences all number
    1
    1
    2
    1
    3
    Pyrexia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    2 / 14 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    2
    2
    0
    Adverse drug reaction
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    Asthenia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Chest discomfort
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    1
    Catheter site related reaction
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Exercise tolerance increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Reproductive system and breast disorders
    Azoospermia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Menstruation irregular
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 11 (27.27%)
    5 / 10 (50.00%)
    0 / 10 (0.00%)
    3 / 14 (21.43%)
    4 / 14 (28.57%)
         occurrences all number
    3
    6
    0
    3
    4
    Sputum increased
         subjects affected / exposed
    1 / 11 (9.09%)
    5 / 10 (50.00%)
    1 / 10 (10.00%)
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    1
    7
    1
    1
    1
    Dyspnoea
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 10 (20.00%)
    1 / 10 (10.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    2
    1
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Haemoptysis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    1
    2
    Nasal congestion
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    1
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    0
    0
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Decreased bronchial secretion
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Dysphonia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pleuritic pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pulmonary congestion
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory depth decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Respiratory tract congestion
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Sputum decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Sputum discoloured
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood glucose decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood uric acid increased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Body temperature increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Neutrophil count increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Platelet count increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Red blood cells urine positive
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Thrombin time prolonged
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Urine leukocyte esterase positive
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    White blood cell count increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    White blood cells urine positive
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Wound
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 10 (30.00%)
    3 / 10 (30.00%)
    5 / 14 (35.71%)
    3 / 14 (21.43%)
         occurrences all number
    1
    3
    4
    12
    3
    Dizziness
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Lethargy
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Loss of consciousness
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Memory impairment
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Retrograde amnesia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Eye pruritus
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    3 / 10 (30.00%)
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    3
    1
    1
    Abdominal pain
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    0
    3
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    2 / 14 (14.29%)
         occurrences all number
    0
    1
    0
    1
    2
    Nausea
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    2 / 10 (20.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Tongue discolouration
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Renal colic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Arthritis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Neck pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 10 (20.00%)
    1 / 10 (10.00%)
    2 / 14 (14.29%)
    2 / 14 (14.29%)
         occurrences all number
    1
    2
    1
    2
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    3 / 14 (21.43%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    1
    3
    1
    Ear infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Enterovirus infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pseudomonas infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Purulent discharge
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin candida
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Tooth abscess
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tooth infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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