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    Clinical Trial Results:
    A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation.

    Summary
    EudraCT number
    		 2015-003291-77
    Trial protocol
    		 GB   DE   CZ   IE  
    Global end of trial date
    06 Oct 2016

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

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG1837-CL-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02707562
    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
    04 Apr 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2016
    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 multiple oral doses of GLPG1837 in subjects with CF and at least one copy of the G551D mutation. Secondary objectives: - To assess changes in sweat chloride from baseline (Day 1) as the biomarker of CFTR ion channel function. - To explore the changes in pulmonary function (FEV1) from baseline. - To assess the PK profile of GLPG1837.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization (ICH) Note for Guidance on Good Clinical Practice (GCP) (CPMP/ICH/135/95) and with applicable local requirements. Prior to the performance of any study-specific procedure, written informed consent was obtained from each subject. All subjects were informed about the nature and purpose of the study, as well as of its risks and benefits. It was explained that s/he could withdraw from the study at any time for any reason and that this would not have any effect on her/his potential future medical care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Feb 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 11
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Ireland: 2
    Worldwide total number of subjects
    26
    EEA total number of subjects
    15
    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)
    26
    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 23 February 2016 to 06 October 2016. Sixteen sites across five countries (Ireland, Czech Republic, Germany, United Kingdom, Australia) participated in the study; 15 sites actively enrolled subjects in the study.

    Pre-assignment
    Screening details
    		 In total, 34 subjects were screened of which 26 were eligible and enrolled.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open label study.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 GLPG1837 - 125 mg b.i.d
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG1837
    Investigational medicinal product code
    G510037
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral doses of GLPG1837 125 mg were administered as two tablets of 62.5 mg, twice daily (b.i.d) during 1 week period under fed conditions. The study drug GLPG1837 was presented as a tablet containing 62.5 mg G510037 (G510037 is the compound code for GLPG1837).

    Arm title
    		 GLPG1837 - 250 mg b.i.d
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG1837
    Investigational medicinal product code
    G510037
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral doses of GLPG1837 250 mg were administered as two tablets of 125 mg, twice daily (b.i.d) during 1 week period under fed conditions. The study drug GLPG1837 was presented as a tablet containing 125 mg G510037. Treatment GLPG1837 - 250 mg b.i.d succeeded treatment GLPG1837 - 125 mg b.i.d, without washout in between dosing periods.

    Arm title
    		 GLPG1837 - 500 mg b.i.d
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG1837
    Investigational medicinal product code
    G510037
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral doses of GLPG1837 500 mg were administered as two tablets of 250 mg, twice daily (b.i.d) during 2 week period under fed conditions. The study drug GLPG1837 was presented as a tablet containing 250 mg G510037. Treatment GLPG1837 - 500 mg b.i.d succeeded treatment GLPG1837 - 250 mg b.i.d, without washout in between dosing periods.

    Number of subjects in period 1
    		GLPG1837 - 125 mg b.i.d GLPG1837 - 250 mg b.i.d GLPG1837 - 500 mg b.i.d
    Started
    26
    26
    26
    Completed
    26
    26
    26

    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
    		 26 26
    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)
    		 26 26
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 29 (19 to 51) -
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 12 12
    Race
    Units: Subjects
        White
    		 26 26
    BMI
    Units: kg/m²
        median (full range (min-max))
    		 23.1 (18.9 to 33.9) -

    End points

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    End points reporting groups
    Reporting group title
    GLPG1837 - 125 mg b.i.d
    Reporting group description
    		 -

    Reporting group title
    GLPG1837 - 250 mg b.i.d
    Reporting group description
    		 -

    Reporting group title
    GLPG1837 - 500 mg b.i.d
    Reporting group description
    		 -

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

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    End point title
    		 Safety - TEAE (Treatment-Emergent Adverse Events) [1]
    End point description
    The number of subjects with treatment-emergent adverse events (TEAEs). An analysis of the treatment-emergent AEs (TEAEs) was performed. Laboratory assessments, 12-lead ECG, vital signs and oxygen saturation by pulse oximetry were analyzed descriptively.
    End point type
    Primary
    End point timeframe
    From first study drug administration until the last follow-up visit at multiple time points.
    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: Analysis descriptive only.
    End point values
    		 GLPG1837 - 125 mg b.i.d GLPG1837 - 250 mg b.i.d GLPG1837 - 500 mg b.i.d
    Number of subjects analysed
    26
    26
    26
    Units: Subjects
        Any TEAE
    14
    14
    20
        Severe TEAE
    1
    0
    3
        Serious TEAE
    0
    0
    2
        Treatment related TEAE
    9
    7
    12
        Discontinuation due to AE
    0
    1
    1
    No statistical analyses for this end point

    Secondary: Efficacy - change in sweat chloride concentration

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    End point title
    		 Efficacy - change in sweat chloride concentration
    End point description
    The changes from baseline (Day 1 pre-dose) in sweat chloride (SwCl) concentration for the intent-to-treat (ITT) population after sequential administration of GLPG1837 125 mg b.i.d. for 7 days (at Day 8; GLPG1837 - 125 mg b.i.d. group), GLPG1837 250 mg b.i.d. for 7 days (at Day 15; GLPG1837 - 250 mg b.i.d. group) and GLPG1837 500 mg for 14 days (at Day 29; GLPG1837 - 500 mg b.i.d. group).
    End point type
    Secondary
    End point timeframe
    Change from baseline at Day 8, Day 15 and Day 29.
    End point values
    		 GLPG1837 - 125 mg b.i.d GLPG1837 - 250 mg b.i.d GLPG1837 - 500 mg b.i.d
    Number of subjects analysed
    26
    21
    25
    Units: mmol/L
        arithmetic mean (confidence interval 95%)
    -11.6 (-17.9 to -5.2)
    -15.1 (-19.6 to -10.7)
    -28.8 (-39.1 to -18.4)
    No statistical analyses for this end point

    Secondary: Efficacy - change in %FEV1

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    End point title
    		 Efficacy - change in %FEV1
    End point description
    The changes from baseline (Day 1 pre-dose) in percent predicted forced expiratory volume in 1 second (%FEV1) for the ITT population after sequential administration of GLPG1837 125 mg b.i.d. for 7 days (at Day 8; GLPG1837 - 125 mg b.i.d. group), GLPG1837 250 mg b.i.d. for 7 days (at Day 15; GLPG1837 - 250 mg b.i.d. group) and GLPG1837 500 mg b.i.d. for 14 days (at Day 29; GLPG1837 - 500 mg b.i.d. group).
    End point type
    Secondary
    End point timeframe
    Change from baseline at Day 8, Day 15 and Day 29.
    End point values
    		 GLPG1837 - 125 mg b.i.d GLPG1837 - 250 mg b.i.d GLPG1837 - 500 mg b.i.d
    Number of subjects analysed
    25
    24
    21
    Units: percent
        arithmetic mean (confidence interval 95%)
    0.0 (-1.3 to 1.4)
    0.6 (-1.5 to 2.6)
    2.8 (0.2 to 5.3)
    No statistical analyses for this end point

    Secondary: Pharmacokinetics - plasma concentration

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    End point title
    		 Pharmacokinetics - plasma concentration
    End point description
    Geometric mean plasma concentrations of GLPG1837 in plasma of the entire PK population at pre-dose after sequential administration of GLPG1837 125 mg b.i.d. for 7 days (at Day 8; GLPG1837 - 125 mg b.i.d. group), GLPG1837 250 mg b.i.d. for 7 days (at Day 15; GLPG1837 - 250 mg b.i.d. group) and GLPG1837 500 mg b.i.d. for 14 days (at Day 29; GLPG1837 - 500 mg b.i.d. group).
    End point type
    Secondary
    End point timeframe
    PK blood samples were taken pre-dose at Day 8, Day 15 and Day 29
    End point values
    		 GLPG1837 - 125 mg b.i.d GLPG1837 - 250 mg b.i.d GLPG1837 - 500 mg b.i.d
    Number of subjects analysed
    25
    25
    22
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    27.3 ± 113
    47.2 ± 122
    107 ± 375
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs: from signing informed consent until the last follow-up visit at multiple time points. TEAEs: from first study drug administration until the last follow-up visit at multiple time points.
    Adverse event reporting additional description
    All TEAEs are presented. TEAEs are tabulated by System Organ Class and Preferred Term.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    GLPG1837 - 125 mg b.i.d
    Reporting group description
    		 -

    Reporting group title
    GLPG1837 - 250 mg b.i.d
    Reporting group description
    		 -

    Reporting group title
    GLPG1837 - 500 mg b.i.d
    Reporting group description
    		 -

    Serious adverse events
    		 GLPG1837 - 125 mg b.i.d GLPG1837 - 250 mg b.i.d GLPG1837 - 500 mg b.i.d
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    2 / 26 (7.69%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Cystic fibrosis
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         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
    		 GLPG1837 - 125 mg b.i.d GLPG1837 - 250 mg b.i.d GLPG1837 - 500 mg b.i.d
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 26 (53.85%)
    14 / 26 (53.85%)
    20 / 26 (76.92%)
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 26 (3.85%)
    2 / 26 (7.69%)
         occurrences all number
    2
    1
    2
    Fatigue
         subjects affected / exposed
    4 / 26 (15.38%)
    5 / 26 (19.23%)
    0 / 26 (0.00%)
         occurrences all number
    6
    5
    0
    Chest pain
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    2
    Chills
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Vaginal discharge
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Sputum increased
         subjects affected / exposed
    6 / 26 (23.08%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    6
    0
    2
    Cough
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 26 (3.85%)
    2 / 26 (7.69%)
         occurrences all number
    2
    1
    2
    Dyspnoea
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    0
    1
    Haemoptysis
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Wheezing
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Libido decreased
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    1
    0
    2
    Bacterial test
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Blood pressure systolic increased
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Heart rate increased
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary sediment present
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Urine analysis abnormal
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    White blood cells urine
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Concussion
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 26 (15.38%)
    6 / 26 (23.08%)
    6 / 26 (23.08%)
         occurrences all number
    4
    9
    9
    Migraine
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    0
    4
    Dizziness
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    1
    Lethargy
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Syncope
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Tinnitus
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
    2 / 26 (7.69%)
         occurrences all number
    1
    1
    4
    Abdominal pain upper
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 26 (3.85%)
    2 / 26 (7.69%)
         occurrences all number
    2
    1
    4
    Abdominal pain
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    2 / 26 (7.69%)
         occurrences all number
    0
    1
    3
    Diarrhoea
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    1
    1
    0
    Constipation
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Eructation
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Steatorrhoea
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Glycosuria
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Urine abnormality
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Back pain
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Rhinovirus infection
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    Sputum purulent
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 26 (3.85%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Dec 2015
    General Clinical Study Protocol Amendment 1, version 1.0. In response to recommendations and specific requests from Competent Authorities, clarifications were added to the protocol. - Revised description of contraceptive methods - Changed recommendation for spermicides - Added restrictions and recommendations related to drugs that are substrates for CYP2B6, P-gp and BRCP These updates are considered substantial.
    14 Mar 2016
    General Clinical Study Protocol Amendment 2, version 1.0. Based upon a re-evaluation of 1/ the study objectives and 2/ the patient recruitment projection, the sample size of this study was increased from at least 12 to 32 subjects.

    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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