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    Clinical Trial Results:
    A placebo-controlled, double-blind (sponsor open), randomised, crossover study to assess the efficacy, safety, and tolerability of GSK2798745 in participants with chronic cough

    Summary
    EudraCT number
    2017-002265-21
    Trial protocol
    GB  
    Global end of trial date
    08 Oct 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Sep 2019
    First version publication date
    22 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    207702
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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
    22 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the efficacy of 7 days dosing of GSK2798745 with placebo in participants with idiopathic or treatment-resistant chronic cough.
    Protection of trial subjects
    Not Applicable
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Apr 2018
    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: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    10
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study was conducted at 4 centers in the United Kingdom. Participants who met eligibility criteria entered a 2-period crossover study. Participants were randomized to either placebo or GSK2798745 in each Treatment Period (each 7 days, with a 14-21 day washout). Total duration of participation was 10.5 weeks. Study terminated on grounds of futility

    Pre-assignment
    Screening details
    A total of 34 participants were screened of which 17 failed screening and 17 participants were included in the study.

    Period 1
    Period 1 title
    Treatment Period 1 (Up to 7 days)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/GSK2798745
    Arm description
    Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of 2.4 milligrams (mg) GSK2798745 each on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive two tablets of placebo on Day 1 and one tablet on Days 2 to 7, via the oral route with a glass of water.

    Investigational medicinal product name
    2.4 mg GSK2798745
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive two tablets of 2.4 mg GSK2798748 on Day 1 and one tablet on Days 2 to 7, via the oral route with a glass of water.

    Arm title
    GSK2798745/Placebo
    Arm description
    Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
    Arm type
    Experimental

    Investigational medicinal product name
    2.4 mg GSK2798745
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive two tablets of 2.4 mg GSK2798748 on Day 1 and one tablet on Days 2 to 7, via the oral route with a glass of water.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive two tablets of placebo on Day 1 and one tablet on Days 2 to 7, via the oral route with a glass of water.

    Number of subjects in period 1
    Placebo/GSK2798745 GSK2798745/Placebo
    Started
    9
    8
    Completed
    9
    8
    Period 2
    Period 2 title
    Wash-out period (14-21 days)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/GSK2798745
    Arm description
    Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of 2.4 milligrams (mg) GSK2798745 each on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive two tablets of placebo on Day 1 and one tablet on Days 2 to 7, via the oral route with a glass of water.

    Investigational medicinal product name
    2.4 mg GSK2798745
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive two tablets of 2.4 mg GSK2798748 on Day 1 and one tablet on Days 2 to 7, via the oral route with a glass of water.

    Arm title
    GSK2798745/Placebo
    Arm description
    Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive two tablets of placebo on Day 1 and one tablet on Days 2 to 7, via the oral route with a glass of water.

    Investigational medicinal product name
    2.4 mg GSK2798745
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive two tablets of 2.4 mg GSK2798748 on Day 1 and one tablet on Days 2 to 7, via the oral route with a glass of water.

    Number of subjects in period 2
    Placebo/GSK2798745 GSK2798745/Placebo
    Started
    9
    8
    Completed
    8
    8
    Not completed
    1
    0
         Sponsor terminated study treatment
    1
    -
    Period 3
    Period 3 title
    Treatment Period 2 (Up to 7 days)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/GSK2798745
    Arm description
    Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of 2.4 milligrams (mg) GSK2798745 each on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive two tablets of placebo on Day 1 and one tablet on Days 2 to 7, via the oral route with a glass of water.

    Investigational medicinal product name
    2.4 mg GSK2798745
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive two tablets of 2.4 mg GSK2798748 on Day 1 and one tablet on Days 2 to 7, via the oral route with a glass of water.

    Arm title
    GSK2798745/Placebo
    Arm description
    Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
    Arm type
    Experimental

    Investigational medicinal product name
    2.4 mg GSK2798745
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive two tablets of 2.4 mg GSK2798748 on Day 1 and one tablet on Days 2 to 7, via the oral route with a glass of water.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were randomized to receive two tablets of placebo on Day 1 and one tablet on Days 2 to 7, via the oral route with a glass of water.

    Number of subjects in period 3
    Placebo/GSK2798745 GSK2798745/Placebo
    Started
    8
    8
    Completed
    7
    8
    Not completed
    1
    0
         Study closed/Terminated
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo/GSK2798745
    Reporting group description
    Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of 2.4 milligrams (mg) GSK2798745 each on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Reporting group title
    GSK2798745/Placebo
    Reporting group description
    Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Reporting group values
    Placebo/GSK2798745 GSK2798745/Placebo Total
    Number of subjects
    9 8 17
    Age categorical
    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)
    5 5 10
        From 65-84 years
    4 3 7
        85 years and over
    0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    0 ± 0 0 ± 0 -
    Sex: Female, Male
    Units: Subjects
        Female
    8 7 15
        Male
    1 1 2
    Race/Ethnicity, Customized
    Units: Subjects
        Asian-Japanese/East Asian (EA)/South EA Heritage
    1 0 1
        White
    8 8 16
    Subject analysis sets

    Subject analysis set title
    All study participants
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All participants who were randomized to either of the two treatment sequences Placebo/GSK2798745 and GSK2798745/Placebo and received GSK2798745 and placebo in either Treatment period 1 or 2 were included. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Subject analysis set title
    GSK2798745
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Subject analysis sets values
    All study participants Placebo GSK2798745
    Number of subjects
    17
    17
    16
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    61.0 ± 9.85
    ±
    ±
    Sex: Female, Male
    Units: Subjects
        Female
    15
        Male
    2
    Race/Ethnicity, Customized
    Units: Subjects
        Asian-Japanese/East Asian (EA)/South EA Heritage
    1
        White
    16

    End points

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    End points reporting groups
    Reporting group title
    Placebo/GSK2798745
    Reporting group description
    Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of 2.4 milligrams (mg) GSK2798745 each on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Reporting group title
    GSK2798745/Placebo
    Reporting group description
    Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
    Reporting group title
    Placebo/GSK2798745
    Reporting group description
    Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of 2.4 milligrams (mg) GSK2798745 each on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Reporting group title
    GSK2798745/Placebo
    Reporting group description
    Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.
    Reporting group title
    Placebo/GSK2798745
    Reporting group description
    Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of 2.4 milligrams (mg) GSK2798745 each on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Reporting group title
    GSK2798745/Placebo
    Reporting group description
    Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Subject analysis set title
    All study participants
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All participants who were randomized to either of the two treatment sequences Placebo/GSK2798745 and GSK2798745/Placebo and received GSK2798745 and placebo in either Treatment period 1 or 2 were included. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Subject analysis set title
    GSK2798745
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Primary: Total cough counts during day time hours following 7-days of dosing

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    End point title
    Total cough counts during day time hours following 7-days of dosing
    End point description
    Coughs were monitored using the VitaloJAK cough monitor. Total cough counts during day-time (10 hours) was calculated from the time of monitor being attached i.e. immediately after dosing on Day 7 to 10 hours past the time of monitoring. Total cough counts were log-transformed prior to analysis. A non-informative prior was used. Analysis was performed using a Bayesian mixed model adjusting for subject-level and period-adjusted baselines, treatment and period. Subject-level baseline is defined as the mean of two period-specific baselines. Period-adjusted baseline is defined as difference between the period-specific baseline and subject-level baseline for each period. Posterior median and 95% credible interval is reported. All Subjects Population included all randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to treatment they actually received. Only those participants with data available at specified data points were analyzed.
    End point type
    Primary
    End point timeframe
    Up to 10 hours post-dose on Day 7 of each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    15
    Units: Cough counts
        median (confidence interval 95%)
    180.570 (137.852 to 235.446)
    241.105 (181.383 to 320.600)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v GSK2798745
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    Method
    Parameter type
    Ratio
    Point estimate
    1.336
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.965
         upper limit
    1.847
    Notes
    [1] - Treatment comparison ratio of GSK2798745 and placebo using posterior median ratio and 90% credible interval is presented.

    Secondary: Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment.
    End point type
    Secondary
    End point timeframe
    Up to 45 days
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    16
    Units: Participants
        Any AE
    9
    11
        Any SAE
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline values for clinical chemistry parameters: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate amino transferase (AST) and creatinine kinase (CK)

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    End point title
    Change from Baseline values for clinical chemistry parameters: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate amino transferase (AST) and creatinine kinase (CK)
    End point description
    Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT, AST and CK. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Day 8 of each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    14
    Units: International units per liter
    arithmetic mean (standard deviation)
        ALP
    1.8 ± 9.28
    -3.1 ± 6.75
        ALT
    0.2 ± 2.31
    -0.2 ± 5.32
        AST
    -0.6 ± 3.69
    -0.5 ± 2.65
        CK
    -3.0 ± 21.71
    -12.1 ± 52.12
    No statistical analyses for this end point

    Secondary: Change from Baseline values for clinical chemistry parameter: direct bilirubin, total bilirubin and creatinine

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    End point title
    Change from Baseline values for clinical chemistry parameter: direct bilirubin, total bilirubin and creatinine
    End point description
    Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Day 8 for each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    14
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        Direct bilirubin
    0.1 ± 1.11
    0.0 ± 0.78
        Total bilirubin
    -0.4 ± 3.41
    -0.4 ± 3.25
        Creatinine
    0.31 ± 6.458
    1.70 ± 4.031
    No statistical analyses for this end point

    Secondary: Change from Baseline values for clinical chemistry parameters: calcium, glucose, potassium, sodium and urea

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    End point title
    Change from Baseline values for clinical chemistry parameters: calcium, glucose, potassium, sodium and urea
    End point description
    Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium, sodium and urea/blood urea nitrogen (BUN). Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Day 8 of each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    14
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        Calcium
    0.011 ± 0.0588
    0.019 ± 0.0782
        Glucose
    -0.22 ± 1.234
    -0.06 ± 0.956
        Potassium
    0.09 ± 0.299
    0.09 ± 0.270
        Sodium
    0.2 ± 1.44
    -0.1 ± 1.46
        Urea
    0.18 ± 0.683
    -0.36 ± 0.908
    No statistical analyses for this end point

    Secondary: Change from Baseline values for clinical chemistry parameter: Total protein

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    End point title
    Change from Baseline values for clinical chemistry parameter: Total protein
    End point description
    Blood samples were collected for the analysis of clinical chemistry parameter total protein. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Day 8 of each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    14
    Units: Grams per liter
        arithmetic mean (standard deviation)
    1.2 ± 2.65
    0.9 ± 2.53
    No statistical analyses for this end point

    Secondary: Number of participants with abnormal values of cardiac troponin

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    End point title
    Number of participants with abnormal values of cardiac troponin
    End point description
    Cardiac troponin values was measured in participants.
    End point type
    Secondary
    End point timeframe
    Up to 45 days
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    16
    Units: Participants
    99999
    99999
    No statistical analyses for this end point

    Secondary: Change from Baseline values for hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell (WBC) count

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    End point title
    Change from Baseline values for hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell (WBC) count
    End point description
    Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Day 8 of each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    15
    Units: Giga units per liter
    arithmetic mean (standard deviation)
        Basophils
    0.005 ± 0.0250
    -0.005 ± 0.0316
        Eosinophils
    -0.005 ± 0.0400
    -0.007 ± 0.0758
        Lymphocytes
    0.019 ± 0.3065
    -0.002 ± 0.2608
        Monocytes
    -0.012 ± 0.1110
    0.027 ± 0.1012
        Total neutrophils
    0.186 ± 0.5817
    0.064 ± 1.0102
        Platelet count
    6.8 ± 13.57
    6.9 ± 19.76
        WBC count
    0.20 ± 0.614
    0.09 ± 1.276
    No statistical analyses for this end point

    Secondary: Change from Baseline values for hematology parameter: hemoglobin

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    End point title
    Change from Baseline values for hematology parameter: hemoglobin
    End point description
    Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Day 8 for each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    15
    Units: Grams per liter
        arithmetic mean (standard deviation)
    0.5 ± 2.29
    0.5 ± 3.52
    No statistical analyses for this end point

    Secondary: Change from Baseline values for hematology parameter: hematocrit

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    End point title
    Change from Baseline values for hematology parameter: hematocrit
    End point description
    Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Day 8 of each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    15
    Units: Percentage of red blood cells in blood
        arithmetic mean (standard deviation)
    0.0020 ± 0.01009
    0.0029 ± 0.00979
    No statistical analyses for this end point

    Secondary: Change from Baseline values for hematology parameter: Mean corpuscular hemoglobin (MCH)

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    End point title
    Change from Baseline values for hematology parameter: Mean corpuscular hemoglobin (MCH)
    End point description
    Blood samples were collected for the analysis of hematology parameter: MCH. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Day 8 for each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    15
    Units: Picograms
        arithmetic mean (standard deviation)
    -0.07 ± 0.377
    -0.09 ± 0.442
    No statistical analyses for this end point

    Secondary: Change from Baseline values for hematology parameter: Mean corpuscular volume (MCV)

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    End point title
    Change from Baseline values for hematology parameter: Mean corpuscular volume (MCV)
    End point description
    Blood samples were collected for the analysis of hematology parameter: MCV. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Day 8 of each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    15
    Units: Femtoliters
        arithmetic mean (standard deviation)
    -0.1 ± 2.01
    -0.1 ± 1.53
    No statistical analyses for this end point

    Secondary: Change from Baseline values for hematology parameter: Red blood cell (RBC) count

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    End point title
    Change from Baseline values for hematology parameter: Red blood cell (RBC) count
    End point description
    Blood samples were collected for the analysis of hematology parameter: RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Day 8 for each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    15
    Units: Tera units per liter
        arithmetic mean (standard deviation)
    0.04 ± 0.112
    0.03 ± 0.103
    No statistical analyses for this end point

    Secondary: Change from Baseline values for hematology parameter: reticulocytes

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    End point title
    Change from Baseline values for hematology parameter: reticulocytes
    End point description
    Blood samples were collected for the analysis of hematology parameter: reticulocytes. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Day 8 for each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    15
    Units: Percentage of reticulocytes in blood
        arithmetic mean (standard deviation)
    -0.0002 ± 0.00300
    -0.0002 ± 0.00260
    No statistical analyses for this end point

    Secondary: Number of participants with abnormal urinalysis data

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    End point title
    Number of participants with abnormal urinalysis data
    End point description
    Urine samples were collected for analysis of urinalysis data by dipstick method. Number of participants with abnormal urinalysis data has been presented. Abnormality was defined as value of potential clinical importance (PCI). PCI was flagged when a result changed from negative on Day 1 (pre-dose) to positive on Day 8. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Day 8
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    15
    Units: Participants
        number (not applicable)
    4
    2
    No statistical analyses for this end point

    Secondary: Change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP)

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    End point title
    Change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP)
    End point description
    Blood pressure was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose on Day 1) and Day 8 of each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    15
    Units: Millimeters of mercury
    arithmetic mean (standard deviation)
        DBP
    -0.2 ± 8.59
    -0.5 ± 13.07
        SBP
    1.6 ± 12.65
    0.9 ± 20.10
    No statistical analyses for this end point

    Secondary: Change from Baseline in temperature

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    End point title
    Change from Baseline in temperature
    End point description
    Temperature was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose on Day 1) and Day 8 of each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    15
    Units: Degrees Celsius
        arithmetic mean (standard deviation)
    0.02 ± 0.635
    -0.05 ± 0.331
    No statistical analyses for this end point

    Secondary: Change from Baseline in heart rate

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    End point title
    Change from Baseline in heart rate
    End point description
    Heart rate was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose on Day 1) and Day 8 of each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    15
    Units: Beats per minute
        arithmetic mean (standard deviation)
    0.6 ± 8.65
    -1.3 ± 12.09
    No statistical analyses for this end point

    Secondary: Number of participants with abnormal electrocardiogram (ECG) findings

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    End point title
    Number of participants with abnormal electrocardiogram (ECG) findings
    End point description
    Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with abnormal-clinically significant and abnormal-not clinically significant values has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category title).
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose on Day 1) and Day 8 of each treatment period
    End point values
    Placebo GSK2798745
    Number of subjects analysed
    17
    16
    Units: Participants
        Day 1 pre-dose, not clinically significant,n=17,16
    2
    1
        Day 1 pre-dose, clinically significant, n=17,16
    0
    0
        Day 8, not clinically significant, n=17,15
    2
    1
        Day 8, clinically significant, n=17,15
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs and SAEs were collected from the start of the treatment up to 45 days
    Adverse event reporting additional description
    AEs and SAEs were collected for All Subjects population
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of 2.4 milligrams (mg) GSK2798745 each on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Reporting group title
    GSK2798745
    Reporting group description
    Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.

    Serious adverse events
    Placebo GSK2798745
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo GSK2798745
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 17 (52.94%)
    11 / 16 (68.75%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal pruritus
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Productive cough
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Sneezing
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 17 (17.65%)
    7 / 16 (43.75%)
         occurrences all number
    3
    7
    Lethargy
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Visual impairment
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    Feeling cold
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Suprapubic pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Ear pruritus
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hypoacusis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Tinnitus
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Oct 2017
    Amendment No.01: The primary reason for amending the protocol was the removal of the Simplified Nutritional Appetite Questionnaire (SNAQ).
    22 Nov 2017
    Amendment No.02: Medicines and Healthcare Products Regulatory Agency (MHRA) requested: • Addition of the Columbia Suicidality Severity Rating Scale (CSSRS) at Follow-up. • That in case of an emergency, the investigator has the sole responsibility for determining if unblinding of a participant’s treatment assignment is warranted. • Addition of adverse event stopping criteria.
    25 Jun 2018
    Amendment No.03: A non-substantial protocol amendment was made to clarify the inclusion criteria and make administrative corrections.

    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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