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    Clinical Trial Results:
    An integrated Phase I/IIa study to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of inhaled GRC 17536 in healthy adult volunteers and multiple ascending doses in patients with mild asthma; and randomised, double-blind, placebo controlled, cross-over study to evaluate the effects of multiple doses of inhaled GRC 17536 on late phase asthmatic response to allergen challenge in patients with mild asthma.

    Summary
    EudraCT number
    		 2012-002567-99
    Trial protocol
    		 GB  
    Global end of trial date
    15 Oct 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    12 Mar 2016
    First version publication date
    05 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • New data added to full data set
    Public contact name changed to Amol Pendse (Amol.Pendse@glenmarkpharma.com)

    Trial information

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    Trial identification
    Sponsor protocol code
    GRC17536-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Glenmark Pharmaceuticals SA
    Sponsor organisation address
    Chemin de la Combeta 5, 2300 La Chaux-de-Fonds, Switzerland,
    Public contact
    Amol Pendse, Glenmark Pharmaceuticals SA, +91 22 6772 0000, Amol.Pendse@glenmarkpharma.com
    Scientific contact
    Dr. Monika Tandon, Glenmark Pharmaceuticals SA, +91 22 6772 0000, Monika.Tandon@glenmarkpharma.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 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part 1 (single ascending dose [SAD]) - To evaluate the safety and tolerability of single ascending inhaled doses (SAD) of GRC 17536 in healthy male subjects. Part 2 (multiple ascending dose [MAD]) - To evaluate the safety and tolerability of twice daily multiple ascending inhaled doses (MAD) of GRC 17536 at three dose levels (highest safe once daily doses identified in SAD) in subjects with mild asthma. Part 3 (Allergen Challenge) - To evaluate the allergen-induced early and late phase asthmatic response (LAR) as measured by maximal percent decrease in the forced expiratory volume in 1 second (FEV1) and area under the effect curve (AUEC) from the baseline (pre-allergen challenge) to the period beginning 3 hours and ending 8 hours after allergen challenge at the two highest identified doses of GRC 17536 and placebo.
    Protection of trial subjects
    In the interests of subject safety and acceptable standards of medical care the Investigator was permitted to prescribe treatment(s) at his/her discretion. All treatments taken by the subjects during the study were recorded in the subjects’ CRF (medication, dose, treatment duration and indication).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Oct 2012
    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: 83
    Worldwide total number of subjects
    83
    EEA total number of subjects
    83
    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)
    83
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of first patient enrollment: 04 October 2012 Date of last patient completed: 15 October 2013 Country: United Kingdom

    Pre-assignment
    Screening details
    		 Screening Period: 28 days Inclusion Criteria: Healthy Volunteers, Mild Asthma Patients

    Period 1
    Period 1 title
    Part I (SAD) Study
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part I (SAD) study: GRC 17536
    Arm description
    		 GRC 17536 A total of 36 healthy adult male subjects participated in 6 cohorts (Cohorts A to F). Four subjects were randomised to GRC 17536 or placebo (3 GRC 17536 and 1 placebo) in Cohorts A and B, 6 subjects (4 GRC 17536 and 2 placebo) in Cohorts C and D and 8 subjects (6 GRC 17536 and 2 placebo) in Cohorts E and F. The dose of GRC 17536 administered was increased sequentially; 0.1, 0.5, 1.5, 3, 6 or 10 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GRC 17536
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Each capsule for Inhalation of GRC 17536

    Arm title
    		 Part I (SAD) study: Placebo
    Arm description
    		 Placebo: A total of 36 healthy adult male subjects participated in 6 cohorts (Cohorts A to F). Four subjects were randomised to GRC 17536 or placebo (3 GRC 17536 and 1 placebo) in Cohorts A and B, 6 subjects (4 GRC 17536 and 2 placebo) in Cohorts C and D and 8 subjects (6 GRC 17536 and 2 placebo) in Cohorts E and F. The dose of GRC 17536 administered was increased sequentially; 0.1, 0.5, 1.5, 3, 6 or 10 mg.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Capsule for inhalation

    Number of subjects in period 1 [1]
    		Part I (SAD) study: GRC 17536 Part I (SAD) study: Placebo
    Started
    26
    10
    Completed
    26
    10
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: There are three separate parts (Part I - SAD study, Part II - MAD study, and Part III - Allergen Challenge) in this study protocol and all the three parts are independent to each other.
    Period 2
    Period 2 title
    Part II (MAD) study
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part II (MAD) Study: GRC 17536
    Arm description
    		 GRC 17536 A total of 23 subjects were enrolled in 3 cohorts received 3 highest doses 3 mg, 6 mg and 10 mg GRC 17536 twice daily.Eight subjects were randomised to GRC 17536 or placebo in each cohort (6 subjects received GRC 17536 and 2 subjects received placebo).
    Arm type
    		 Experimental

    Investigational medicinal product name
    GRC 17536
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Each capsule for Inhalation of GRC 17536

    Arm title
    		 Part II (MAD) Study: Placebo
    Arm description
    		 Placebo A total of 23 subjects were enrolled in 3 cohorts received 3 highest doses 3 mg, 6 mg and 10 mg GRC 17536 twice daily.Eight subjects were randomised to GRC 17536 or placebo in each cohort (6 subjects received GRC 17536 and 2 subjects received placebo).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    placebo capsule for Inhalation use

    Number of subjects in period 2 [2]
    		Part II (MAD) Study: GRC 17536 Part II (MAD) Study: Placebo
    Started
    17
    6
    Completed
    16
    6
    Not completed
    1
    0
         Adverse event, non-fatal
    1
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: There are three separate parts (Part I - SAD study, Part II - MAD study, and Part III - Allergen Challenge) in this study protocol and all the three parts are independent to each other.
    Period 3
    Period 3 title
    Part III (Allergen Challenge)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Part III (Allergen Challenge): GRC 17536 6 mg
    Arm description
    		 This was a randomised, placebo-controlled, double-blind, 3-period cross-over, proof of concept study. A total of 24 subjects were randomised to one of 6 treatment sequences to receive 3 treatments (10 mg, 6 mg and placebo) in 3 treatment periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GRC 17536 6 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    GRC 17536 6 mg capsules for oral Inhalation use twice daily

    Arm title
    		 Part III (Allergen Challenge): GRC 17536 10 mg
    Arm description
    		 This was a randomised, placebo-controlled, double-blind, 3-period cross-over, proof of concept study. A total of 24 subjects were randomised to one of 6 treatment sequences to receive 3 treatments (10 mg, 6 mg and placebo) in 3 treatment periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GRC 17536 10 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    GRC 17536 10 mg capsules for oral Inhalation twice daily

    Arm title
    		 Part III (Allergen Challenge): Placebo
    Arm description
    		 This was a randomised, placebo-controlled, double-blind, 3-period cross-over, proof of concept study. A total of 24 subjects were randomised to one of 6 treatment sequences to receive 3 treatments (10 mg, 6 mg and placebo) in 3 treatment periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo capsules for oral inahalation use

    Number of subjects in period 3
    		Part III (Allergen Challenge): GRC 17536 6 mg Part III (Allergen Challenge): GRC 17536 10 mg Part III (Allergen Challenge): Placebo
    Started
    21
    23
    21
    Completed
    21
    20
    20
    Not completed
    0
    3
    1
         Consent withdrawn by subject
    -
    1
    -
         Exclusion criteria not met
    -
    1
    -
         Adverse event, non-fatal
    -
    1
    -
         Protocol deviation
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part I (SAD) study: GRC 17536
    Reporting group description
    		 GRC 17536 A total of 36 healthy adult male subjects participated in 6 cohorts (Cohorts A to F). Four subjects were randomised to GRC 17536 or placebo (3 GRC 17536 and 1 placebo) in Cohorts A and B, 6 subjects (4 GRC 17536 and 2 placebo) in Cohorts C and D and 8 subjects (6 GRC 17536 and 2 placebo) in Cohorts E and F. The dose of GRC 17536 administered was increased sequentially; 0.1, 0.5, 1.5, 3, 6 or 10 mg.

    Reporting group title
    Part I (SAD) study: Placebo
    Reporting group description
    		 Placebo: A total of 36 healthy adult male subjects participated in 6 cohorts (Cohorts A to F). Four subjects were randomised to GRC 17536 or placebo (3 GRC 17536 and 1 placebo) in Cohorts A and B, 6 subjects (4 GRC 17536 and 2 placebo) in Cohorts C and D and 8 subjects (6 GRC 17536 and 2 placebo) in Cohorts E and F. The dose of GRC 17536 administered was increased sequentially; 0.1, 0.5, 1.5, 3, 6 or 10 mg.

    Reporting group values
    		 Part I (SAD) study: GRC 17536 Part I (SAD) study: Placebo Total
    Number of subjects
    		 26 10 36
    Age categorical
    Part 1 (SAD): Healthy Male subjects aged 18 to 50 years
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        Age 18 to 65 years
    		 0 0 0
        Age 18 to 50 years
    		 26 10 36
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31 ( 7 ) 32 ( 9 ) -
    Gender categorical
    Units: Subjects
        Male
    		 26 10 36
        Female
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    GRC 17536 (SAD, Part I)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Healthy male subjects who were randomised to receive a single inhaled dose of GRC 17536

    Subject analysis set title
    Placebo (SAD, Part I)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Healthy male subjects were randomised to receive a single inhaled dose of placebo

    Subject analysis set title
    GRC 17536 (MAD, Part II)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Male subjects with mild asthma were enrolled to receive GRC 17536

    Subject analysis set title
    Placebo (MAD, Part II)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Male subjects with mild asthma were enrolled to receive Placebo

    Subject analysis set title
    GRC 17536 6mg (Allergen Challenge, Part III)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Male subjects with mild asthma were enrolled to receive 6 mg

    Subject analysis set title
    GRC 17536 10 mg (Allergen Challenge, Part III)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Male subjects with mild asthma were enrolled to receive 10 mg

    Subject analysis set title
    Placebo (Allergen Challenge, Part III)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Male subjects with mild asthma were enrolled and were randomised to receive placebo

    Subject analysis sets values
    		 GRC 17536 (SAD, Part I) Placebo (SAD, Part I) GRC 17536 (MAD, Part II) Placebo (MAD, Part II) GRC 17536 6mg (Allergen Challenge, Part III) GRC 17536 10 mg (Allergen Challenge, Part III) Placebo (Allergen Challenge, Part III)
    Number of subjects
    26
    10
    17
    6
    21
    23
    21
    Age categorical
    Part 1 (SAD): Healthy Male subjects aged 18 to 50 years
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    0
    0
    0
    0
    0
    0
    0
        From 65-84 years
    0
    0
    0
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    0
    0
    0
        Age 18 to 65 years
    0
    0
    17
    6
    21
    23
    21
        Age 18 to 50 years
    26
    10
    0
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    31 ( 7 )
    32 ( 9 )
    33 ( 13 )
    37 ( 13 )
    34.23 ( 7.95 )
    33.56 ( 8.07 )
    34.38 ( 8.01 )
    Gender categorical
    Units: Subjects
        Male
    26
    10
    17
    6
    21
    23
    21
        Female
    0
    0
    0
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Part I (SAD) study: GRC 17536
    Reporting group description
    		 GRC 17536 A total of 36 healthy adult male subjects participated in 6 cohorts (Cohorts A to F). Four subjects were randomised to GRC 17536 or placebo (3 GRC 17536 and 1 placebo) in Cohorts A and B, 6 subjects (4 GRC 17536 and 2 placebo) in Cohorts C and D and 8 subjects (6 GRC 17536 and 2 placebo) in Cohorts E and F. The dose of GRC 17536 administered was increased sequentially; 0.1, 0.5, 1.5, 3, 6 or 10 mg.

    Reporting group title
    Part I (SAD) study: Placebo
    Reporting group description
    		 Placebo: A total of 36 healthy adult male subjects participated in 6 cohorts (Cohorts A to F). Four subjects were randomised to GRC 17536 or placebo (3 GRC 17536 and 1 placebo) in Cohorts A and B, 6 subjects (4 GRC 17536 and 2 placebo) in Cohorts C and D and 8 subjects (6 GRC 17536 and 2 placebo) in Cohorts E and F. The dose of GRC 17536 administered was increased sequentially; 0.1, 0.5, 1.5, 3, 6 or 10 mg.
    Reporting group title
    Part II (MAD) Study: GRC 17536
    Reporting group description
    		 GRC 17536 A total of 23 subjects were enrolled in 3 cohorts received 3 highest doses 3 mg, 6 mg and 10 mg GRC 17536 twice daily.Eight subjects were randomised to GRC 17536 or placebo in each cohort (6 subjects received GRC 17536 and 2 subjects received placebo).

    Reporting group title
    Part II (MAD) Study: Placebo
    Reporting group description
    		 Placebo A total of 23 subjects were enrolled in 3 cohorts received 3 highest doses 3 mg, 6 mg and 10 mg GRC 17536 twice daily.Eight subjects were randomised to GRC 17536 or placebo in each cohort (6 subjects received GRC 17536 and 2 subjects received placebo).
    Reporting group title
    Part III (Allergen Challenge): GRC 17536 6 mg
    Reporting group description
    		 This was a randomised, placebo-controlled, double-blind, 3-period cross-over, proof of concept study. A total of 24 subjects were randomised to one of 6 treatment sequences to receive 3 treatments (10 mg, 6 mg and placebo) in 3 treatment periods.

    Reporting group title
    Part III (Allergen Challenge): GRC 17536 10 mg
    Reporting group description
    		 This was a randomised, placebo-controlled, double-blind, 3-period cross-over, proof of concept study. A total of 24 subjects were randomised to one of 6 treatment sequences to receive 3 treatments (10 mg, 6 mg and placebo) in 3 treatment periods.

    Reporting group title
    Part III (Allergen Challenge): Placebo
    Reporting group description
    		 This was a randomised, placebo-controlled, double-blind, 3-period cross-over, proof of concept study. A total of 24 subjects were randomised to one of 6 treatment sequences to receive 3 treatments (10 mg, 6 mg and placebo) in 3 treatment periods.

    Subject analysis set title
    GRC 17536 (SAD, Part I)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Healthy male subjects who were randomised to receive a single inhaled dose of GRC 17536

    Subject analysis set title
    Placebo (SAD, Part I)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Healthy male subjects were randomised to receive a single inhaled dose of placebo

    Subject analysis set title
    GRC 17536 (MAD, Part II)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Male subjects with mild asthma were enrolled to receive GRC 17536

    Subject analysis set title
    Placebo (MAD, Part II)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Male subjects with mild asthma were enrolled to receive Placebo

    Subject analysis set title
    GRC 17536 6mg (Allergen Challenge, Part III)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Male subjects with mild asthma were enrolled to receive 6 mg

    Subject analysis set title
    GRC 17536 10 mg (Allergen Challenge, Part III)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Male subjects with mild asthma were enrolled to receive 10 mg

    Subject analysis set title
    Placebo (Allergen Challenge, Part III)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Male subjects with mild asthma were enrolled and were randomised to receive placebo

    Primary: Safety (SAD, Part I)

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    End point title
    		 Safety (SAD, Part I)
    End point description
    End point type
    Primary
    End point timeframe
    1 week
    End point values
    		 GRC 17536 (SAD, Part I) Placebo (SAD, Part I)
    Number of subjects analysed
    26
    10
    Units: Number
    26
    10
    Statistical analysis title
    		 Summary of TEAE
    Comparison groups
    Placebo (SAD, Part I) v GRC 17536 (SAD, Part I)
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 not applicable
    Parameter type
    		 parameter estimate is not applicable
    Confidence interval
    Notes
    [1] - The overall incidence of TEAEs was 40 % in subjects receiving placebo and 26.9% in the subjects receiving GRC 17536.
    [2] - p value is not applicable as it safety analysis

    Primary: Safety (MAD, Part II)

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    End point title
    		 Safety (MAD, Part II)
    End point description
    End point type
    Primary
    End point timeframe
    2 Weeks
    End point values
    		 GRC 17536 (MAD, Part II) Placebo (MAD, Part II)
    Number of subjects analysed
    17
    6
    Units: Numbers
    17
    6
    Statistical analysis title
    		 Summary of TEAE
    Comparison groups
    GRC 17536 (MAD, Part II) v Placebo (MAD, Part II)
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0 [4]
    Method
    		 not applicable
    Parameter type
    		 Parameter estimate is not applicable
    Confidence interval
    Notes
    [3] - The overall incidence of TEAEs was 88.2% in GRC 17536 BID and 66.7% in placebo reported.
    [4] - p value is not applicable as it safety analysis.

    Primary: Max % decrease in FEV1 (Allergen Challenge, Part III)

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    End point title
    		 Max % decrease in FEV1 (Allergen Challenge, Part III)
    End point description
    End point type
    Primary
    End point timeframe
    8 hours
    End point values
    		 GRC 17536 6mg (Allergen Challenge, Part III) GRC 17536 10 mg (Allergen Challenge, Part III) Placebo (Allergen Challenge, Part III)
    Number of subjects analysed
    20
    22
    19
    Units: ml
        least squares mean (confidence interval 95%)
    -31 (-39.15 to -22.85)
    -34.94 (-42.99 to -26.89)
    -31.62 (-39.77 to -23.48)
    Statistical analysis title
    		 Statistics of FEV1 (GRC 17536 10 mg Vs Placebo)
    Comparison groups
    GRC 17536 10 mg (Allergen Challenge, Part III) v Placebo (Allergen Challenge, Part III)
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1337 [5]
    Method
    		 ANCOVA
    Parameter type
    		 parameter estimate is not applicable
    Confidence interval
    Notes
    [5] - GRC 17536 10 mg vs Placebo
    Statistical analysis title
    		 Statistics of FEV1 (GRC 17536 6 mg Vs Placebo)
    Comparison groups
    GRC 17536 6mg (Allergen Challenge, Part III) v Placebo (Allergen Challenge, Part III)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7803 [6]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [6] - GRC 17536 6 mg Vs placebo

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 week, 2 week & 3 weeks
    Adverse event reporting additional description
    There were no deaths or SAEs reported in the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    GRC 17536 0.1 mg (SAD, Part I)
    Reporting group description
    		 -

    Reporting group title
    GRC 17536 0.5 mg (SAD, Part I)
    Reporting group description
    		 -

    Reporting group title
    GRC 17536 1.5 mg (SAD, Part I)
    Reporting group description
    		 -

    Reporting group title
    GRC 17536 3 mg (SAD, Part I)
    Reporting group description
    		 -

    Reporting group title
    GRC 17536 6 mg (SAD, Part I)
    Reporting group description
    		 -

    Reporting group title
    GRC 17536 10 mg (SAD, Part I)
    Reporting group description
    		 -

    Reporting group title
    Placebo (SAD, Part I)
    Reporting group description
    		 -

    Reporting group title
    GRC 17536 3 mg (MAD, Part II)
    Reporting group description
    		 -

    Reporting group title
    GRC 17536 6 mg (MAD, Part II)
    Reporting group description
    		 -

    Reporting group title
    GRC 17536 10 mg (MAD, Part II)
    Reporting group description
    		 -

    Reporting group title
    Placebo (MAD, Part II)
    Reporting group description
    		 -

    Reporting group title
    GRC 17536 6 mg (Allergen Challenge, Part III)
    Reporting group description
    		 -

    Reporting group title
    GRC 17536 10 mg (Allergen Challenge, Part III)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Allergen Challenge, Part III)
    Reporting group description
    		 -

    Serious adverse events
    		 GRC 17536 0.1 mg (SAD, Part I) GRC 17536 0.5 mg (SAD, Part I) GRC 17536 1.5 mg (SAD, Part I) GRC 17536 3 mg (SAD, Part I) GRC 17536 6 mg (SAD, Part I) GRC 17536 10 mg (SAD, Part I) Placebo (SAD, Part I) GRC 17536 3 mg (MAD, Part II) GRC 17536 6 mg (MAD, Part II) GRC 17536 10 mg (MAD, Part II) Placebo (MAD, Part II) GRC 17536 6 mg (Allergen Challenge, Part III) GRC 17536 10 mg (Allergen Challenge, Part III) Placebo (Allergen Challenge, Part III)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GRC 17536 0.1 mg (SAD, Part I) GRC 17536 0.5 mg (SAD, Part I) GRC 17536 1.5 mg (SAD, Part I) GRC 17536 3 mg (SAD, Part I) GRC 17536 6 mg (SAD, Part I) GRC 17536 10 mg (SAD, Part I) Placebo (SAD, Part I) GRC 17536 3 mg (MAD, Part II) GRC 17536 6 mg (MAD, Part II) GRC 17536 10 mg (MAD, Part II) Placebo (MAD, Part II) GRC 17536 6 mg (Allergen Challenge, Part III) GRC 17536 10 mg (Allergen Challenge, Part III) Placebo (Allergen Challenge, Part III)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    2 / 4 (50.00%)
    2 / 4 (50.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    4 / 10 (40.00%)
    6 / 6 (100.00%)
    5 / 5 (100.00%)
    4 / 6 (66.67%)
    4 / 6 (66.67%)
    11 / 21 (52.38%)
    11 / 23 (47.83%)
    10 / 21 (47.62%)
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 21 (4.76%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    2
    1
    0
    Application Site reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Catheter site hematoma
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Irritability
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    1 / 23 (4.35%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    2
    Wheezing
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    Bronchospasm
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    Asthma
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    1 / 23 (4.35%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    Investigations
    Allergy test positive
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Muscle strain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    2 / 4 (50.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    3 / 6 (50.00%)
    1 / 5 (20.00%)
    2 / 6 (33.33%)
    3 / 6 (50.00%)
    2 / 21 (9.52%)
    4 / 23 (17.39%)
    5 / 21 (23.81%)
         occurrences all number
    0
    0
    1
    3
    1
    0
    0
    5
    1
    2
    3
    2
    5
    6
    Presyncope
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    Dizziness postural
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    1
    Flatulence
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Diarrhea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    2
    0
    0
    Blister
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Heat rash
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Sunburn
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Renal and urinary disorders
    Urine odour abnormal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Limb discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Muscle twitching
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Otitis externa
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Oral Herpes
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Feb 2013
    The following changes were made in Protocol Version 3.0: There was a change in the study design of Part 3 of the study with removal of Day 7 and incorporation of Day 5 and Day 9 and due to this an additional safety assessment were performed.

    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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