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    Clinical Trial Results:
    An Open-Label, Two-Period, Randomized, Crossover Study to Assess the Relative Bioavailability of GSK1120212 Tablet Formulation and the GSK1120212 Pediatric Oral Solution Formulation Following Single-Dose Administration to Adult Subjects with Solid Tumors

    Summary
    EudraCT number
    		 2011-004901-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 Nov 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Mar 2016
    First version publication date
    24 Feb 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MEK115892
    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,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    26 Mar 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the relative bioavailability of 2mg GSK1120212 pediatric oral solution formulation to 2mg of the tablet formulation of GSK1120212 in fasted subjects.
    Protection of trial subjects
    The safety assessments included monitoring of adverse events (AEs) and SAEs, clinical laboratory tests, vital signs, electrocardiograms (ECGs), MUGA/ECHO, physical examinations, and ophthalmologic examinations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jul 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 States: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    0
    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)
    9
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study consisted of 2 treatment periods separated by an incomplete wash-out period of 7 days, and a follow-up period. Sixteen participants were randomized to one of the two treatment sequences in this crossover study.

    Period 1
    Period 1 title
    Period 1- 7 days with incomplete washout
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2
    Arm description
    		 In Period 1, following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 milligrams (mg) tablet formulation with 240 milliliters (ml) of water. Period 1 also consisted of a 7-day pharmacokinetic (PK) sampling/incomplete wash-out period following dosing. In Period 2, after an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric oral solution (OS) formulation administered with a graduated syringe and were required to drink 100 ml of water following dosing. Participants were required to fast an additional 4 hours after administration of GSK1120212 in either formulation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1120212 (trametinib)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single 2 mg tablet oral dose taken with 240 ml of water

    Investigational medicinal product name
    GSK1120212 (trametinib)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Single 2 mg solution oral dose

    Arm title
    		 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Arm description
    		 In Period 1, following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric solution formulation administered with a graduated syringe and were required to drink 100 ml of water. Period 1 also consisted of a 7-day PK sampling/incomplete wash-out period following dosing. In Period 2 participants received a single dose of GSK1120212 2 mg tablet formulation with 240 ml of water following an overnight fast of at least 8 hours. Participants were required to fast an additional 4 hours after administration of GSK1120212 in either formulation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1120212 (trametinib)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single 2 mg tablet oral dose taken with 240 ml of water

    Investigational medicinal product name
    GSK1120212 (trametinib)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Single 2 mg solution oral dose

    Number of subjects in period 1
    		GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Started
    8
    8
    Completed
    8
    8
    Period 2
    Period 2 title
    Period 2 (7 days)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2
    Arm description
    		 In Period 1, following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 milligrams (mg) tablet formulation with 240 milliliters (ml) of water. Period 1 also consisted of a 7-day pharmacokinetic (PK) sampling/incomplete wash-out period following dosing. In Period 2, after an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric oral solution (OS) formulation administered with a graduated syringe and were required to drink 100 ml of water following dosing. Participants were required to fast an additional 4 hours after administration of GSK1120212 in either formulation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1120212 (trametinib)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single 2 mg tablet oral dose taken with 240 ml of water

    Investigational medicinal product name
    GSK1120212 (trametinib)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Single 2 mg solution oral dose

    Arm title
    		 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Arm description
    		 In Period 1, following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric solution formulation administered with a graduated syringe and were required to drink 100 ml of water. Period 1 also consisted of a 7-day PK sampling/incomplete wash-out period following dosing. In Period 2 participants received a single dose of GSK1120212 2 mg tablet formulation with 240 ml of water following an overnight fast of at least 8 hours. Participants were required to fast an additional 4 hours after administration of GSK1120212 in either formulation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1120212 (trametinib)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single 2 mg tablet oral dose taken with 240 ml of water

    Investigational medicinal product name
    GSK1120212 (trametinib)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Single 2 mg solution oral dose

    Number of subjects in period 2
    		GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Started
    8
    8
    Completed
    8
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2
    Reporting group description
    		 In Period 1, following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 milligrams (mg) tablet formulation with 240 milliliters (ml) of water. Period 1 also consisted of a 7-day pharmacokinetic (PK) sampling/incomplete wash-out period following dosing. In Period 2, after an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric oral solution (OS) formulation administered with a graduated syringe and were required to drink 100 ml of water following dosing. Participants were required to fast an additional 4 hours after administration of GSK1120212 in either formulation.

    Reporting group title
    GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Reporting group description
    		 In Period 1, following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric solution formulation administered with a graduated syringe and were required to drink 100 ml of water. Period 1 also consisted of a 7-day PK sampling/incomplete wash-out period following dosing. In Period 2 participants received a single dose of GSK1120212 2 mg tablet formulation with 240 ml of water following an overnight fast of at least 8 hours. Participants were required to fast an additional 4 hours after administration of GSK1120212 in either formulation.

    Reporting group values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2 Total
    Number of subjects
    		 8 8 16
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.1 ( 13.07 ) 57.4 ( 16.66 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 5 9
        Male
    		 4 3 7
    Race
    Units: Subjects
        White - White/Caucasian/European Heritage
    		 8 8 16

    End points

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    End points reporting groups
    Reporting group title
    GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2
    Reporting group description
    		 In Period 1, following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 milligrams (mg) tablet formulation with 240 milliliters (ml) of water. Period 1 also consisted of a 7-day pharmacokinetic (PK) sampling/incomplete wash-out period following dosing. In Period 2, after an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric oral solution (OS) formulation administered with a graduated syringe and were required to drink 100 ml of water following dosing. Participants were required to fast an additional 4 hours after administration of GSK1120212 in either formulation.

    Reporting group title
    GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Reporting group description
    		 In Period 1, following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric solution formulation administered with a graduated syringe and were required to drink 100 ml of water. Period 1 also consisted of a 7-day PK sampling/incomplete wash-out period following dosing. In Period 2 participants received a single dose of GSK1120212 2 mg tablet formulation with 240 ml of water following an overnight fast of at least 8 hours. Participants were required to fast an additional 4 hours after administration of GSK1120212 in either formulation.
    Reporting group title
    GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2
    Reporting group description
    		 In Period 1, following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 milligrams (mg) tablet formulation with 240 milliliters (ml) of water. Period 1 also consisted of a 7-day pharmacokinetic (PK) sampling/incomplete wash-out period following dosing. In Period 2, after an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric oral solution (OS) formulation administered with a graduated syringe and were required to drink 100 ml of water following dosing. Participants were required to fast an additional 4 hours after administration of GSK1120212 in either formulation.

    Reporting group title
    GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Reporting group description
    		 In Period 1, following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric solution formulation administered with a graduated syringe and were required to drink 100 ml of water. Period 1 also consisted of a 7-day PK sampling/incomplete wash-out period following dosing. In Period 2 participants received a single dose of GSK1120212 2 mg tablet formulation with 240 ml of water following an overnight fast of at least 8 hours. Participants were required to fast an additional 4 hours after administration of GSK1120212 in either formulation.

    Subject analysis set title
    GSK1120212 tablet
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 milligrams (mg) tablet formulation with 240 milliliters (ml) of water. Period 1 also consisted of a 7-day pharmacokinetic (PK) sampling/incomplete wash-out period following dosing.

    Subject analysis set title
    GSK1120212 pediatric oral solution
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric solution formulation administered with a graduated syringe and were required to drink 100 ml of water. Period 1 also consisted of a 7-day PK sampling/incomplete wash-out period following dosing.

    Primary: Area under the plasma concentration-time curve from zero to 24 hours AUC(0-24) of plasma GSK1120212 following a single dose administration in Period 1, Period 2 and combined periods

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    End point title
    		 Area under the plasma concentration-time curve from zero to 24 hours AUC(0-24) of plasma GSK1120212 following a single dose administration in Period 1, Period 2 and combined periods [1]
    End point description
    AUC is defined as the area under the drug concentration-time curve and is a measure of drug concentration. Blood samples were collected at the following time points: pre-dose and 0, 0.25, 0.5, 1, 2, 2.5, 3, 4, 6, 6.5, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours in both Period 1 and Period 2. Pharmacokinetic (PK) Population is defined as all participants who received study medication, for whom a PK blood sample was obtained and analyzed.
    End point type
    Primary
    End point timeframe
    Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both treatment periods
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The Geometric Mean Ratio and the CI was not calculated for the uncorrected AUC.
    End point values
    		 GSK1120212 tablet GSK1120212 pediatric oral solution
    Number of subjects analysed
    8 [2]
    8 [3]
    Units: nanograms*hours/milliliter (ng*hr/mL)
    geometric mean (geometric coefficient of variation)
        AUC(0-24), Period 1
    49.542 ( 35.233 )
    64.7164 ( 67.275 )
        AUC(0-24), Period 2
    98.8235 ( 63.104 )
    100.5039 ( 35.545 )
        AUC(0-24), Combined
    69.9708 ( 63.435 )
    80.6489 ( 57.01 )
    Notes
    [2] - PK Population
    [3] - PK Population
    No statistical analyses for this end point

    Primary: Corrected AUC(0-24) (CorrAUC[0-24]) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods

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    End point title
    		 Corrected AUC(0-24) (CorrAUC[0-24]) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods
    End point description
    Corrected area under the plasma concentration-time curve CorrAUC(0-24) for P2 was calculated as corrAUC(0-24) = AUC(0-24)(P2) – extrapAUC(P1) where in extrapAUC(P1) was the extrapolated AUC from P1. ExtrapAUC(P1) was calculated as extrapAUC(P1) = AUC(0-infinity)(P1) - AUC(0-t)(P1), where the last time point was pre-dose from P2. Blood samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose in Period 1 (P1) and Period 2 (P2).
    End point type
    Primary
    End point timeframe
    Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both treatment periods
    End point values
    		 GSK1120212 tablet GSK1120212 pediatric oral solution
    Number of subjects analysed
    8 [4]
    8 [5]
    Units: ng*hr/mL
    geometric mean (geometric coefficient of variation)
        Period 1
    49.542 ( 35.233 )
    64.7164 ( 67.275 )
        Period 2
    78.5862 ( 68.192 )
    83.7081 ( 35.882 )
        Combined
    62.3965 ( 57.954 )
    73.6022 ( 53.102 )
    Notes
    [4] - PK Population
    [5] - PK Population
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    GSK1120212 tablet v GSK1120212 pediatric oral solution
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    Method
    Parameter type
    		 Mixed Effects Model
    Point estimate
    1.1796
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.0493
         upper limit
    		 1.3261
    Notes
    [6] - Corrected PK parameters were used for the statistical analysis

    Primary: AUC extrapolated to infinity (0-infinity) following a single dose administration of GSK1120212 in Period 1, Period 2 and combined periods

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    End point title
    		 AUC extrapolated to infinity (0-infinity) following a single dose administration of GSK1120212 in Period 1, Period 2 and combined periods [7]
    End point description
    AUC(0-infinity) was calculated as the sum of AUC(0-t) and Ct/lambda z, where Ct was the observed concentration obtained from the log-linear regression analysis of the last quantifiable time-point and lambda z was the terminal phase rate constant. Blood samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both P1 and P2.
    End point type
    Primary
    End point timeframe
    Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both treatment periods
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The Geometric Mean Ratio and the CI was not calculated for the uncorrected AUC.
    End point values
    		 GSK1120212 tablet GSK1120212 pediatric oral solution
    Number of subjects analysed
    8 [8]
    8 [9]
    Units: ng*hr/mL
    geometric mean (geometric coefficient of variation)
        Period 1
    364.3343 ( 34.105 )
    436.6415 ( 48.187 )
        Period 2
    597.7219 ( 48.463 )
    572.8397 ( 30.003 )
        Combined
    466.659 ( 48.995 )
    500.1256 ( 41.276 )
    Notes
    [8] - PK Population
    [9] - PK Population
    No statistical analyses for this end point

    Primary: CorrAUC(0-infinity) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods

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    End point title
    		 CorrAUC(0-infinity) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods
    End point description
    Corrected AUC(0-infinity) for Period 2 was calculated as corrAUC(0-infinity)=AUC(0-infinity), Period 2 - extrap AUC, Period 1 (extrapolated AUC from Period 1) where extrap AUC, Period 1=AUC(0-infinity), Period 1- AUC(0-last), Period 1 where last time point is predose from Period 2. Blood samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both P1 and P2.
    End point type
    Primary
    End point timeframe
    Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both treatment periods
    End point values
    		 GSK1120212 tablet GSK1120212 pediatric oral solution
    Number of subjects analysed
    8 [10]
    8 [11]
    Units: ng*hr/mL
    geometric mean (geometric coefficient of variation)
        Period 1
    364.3343 ( 34.105 )
    436.6415 ( 48.187 )
        Period 2
    394.665 ( 60.935 )
    409.9326 ( 27.342 )
        Combined
    379.1965 ( 47.107 )
    423.0763 ( 37.587 )
    Notes
    [10] - PK Population
    [11] - PK Population
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    GSK1120212 tablet v GSK1120212 pediatric oral solution
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    Method
    Parameter type
    		 Mixed Effects Model
    Point estimate
    1.1157
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.0043
         upper limit
    		 1.2394
    Notes
    [12] - Corrected PK parameters were used for the statistical analysis

    Primary: AUC to the last quantifiable concentration (0-last) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods

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    End point title
    		 AUC to the last quantifiable concentration (0-last) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods [13]
    End point description
    AUC(0-last) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both P1 and P2.
    End point type
    Primary
    End point timeframe
    Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both treatment periods
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The Geometric Mean Ratio and the CI was not calculated for the uncorrected AUC.
    End point values
    		 GSK1120212 tablet GSK1120212 pediatric oral solution
    Number of subjects analysed
    8 [14]
    8 [15]
    Units: ng*hr/mL
    geometric mean (geometric coefficient of variation)
        Period 1
    200.7343 ( 33.649 )
    238.6422 ( 60.676 )
        Period 2
    389.5295 ( 54.163 )
    379.9972 ( 33.682 )
        Combined
    279.6282 ( 57.692 )
    301.1368 ( 53.792 )
    Notes
    [14] - PK Population
    [15] - PK Population
    No statistical analyses for this end point

    Primary: CorrAUC(0-last) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods

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    End point title
    		 CorrAUC(0-last) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods
    End point description
    CorrAUC(0-last) for P2 was calculated as corrAUC(0- last ) = AUC(0- last)(P2) – extrapAUC(P1) where in extrapAUC(P1) was the extrapolated AUC from P1. ExtrapAUC(P1) was calculated as extrapAUC(P1) = AUC(0-infinity)(P1) - AUC(0-last)(P1), where the last time point is pre-dose from P2. Blood samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both P1 and P2.
    End point type
    Primary
    End point timeframe
    Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both treatment periods
    End point values
    		 GSK1120212 tablet GSK1120212 pediatric oral solution
    Number of subjects analysed
    8 [16]
    8 [17]
    Units: ng*hr/mL
    geometric mean (geometric coefficient of variation)
        Period 1
    200.7343 ( 33.649 )
    238.6422 ( 60.676 )
        Period 2
    288.8255 ( 57.874 )
    293.8191 ( 33.148 )
        Combined
    240.7845 ( 49.627 )
    264.7974 ( 47.889 )
    Notes
    [16] - PK Population
    [17] - PK Population
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    GSK1120212 tablet v GSK1120212 pediatric oral solution
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [18]
    Method
    Parameter type
    		 Mixed Effects Model
    Point estimate
    1.0997
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.0331
         upper limit
    		 1.1706
    Notes
    [18] - Corrected PK parameters were used for the statistical analysis

    Primary: First occurrence of the maximum observed concentration (Cmax) values following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods

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    End point title
    		 First occurrence of the maximum observed concentration (Cmax) values following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods [19]
    End point description
    Cmax was determined directly from the raw concentration-time data. Blood samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both P1 and P2.
    End point type
    Primary
    End point timeframe
    Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both treatment periods
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The Geometric Mean Ratio and the CI was not calculated for the uncorrected Cmax.
    End point values
    		 GSK1120212 tablet GSK1120212 pediatric oral solution
    Number of subjects analysed
    8 [20]
    8 [21]
    Units: nanograms/milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        Period 1
    6.0255 ( 81.291 )
    10.7118 ( 72.805 )
        Period 2
    8.8983 ( 67.572 )
    13.7994 ( 41.345 )
        Combined
    7.3224 ( 75.677 )
    12.158 ( 57.913 )
    Notes
    [20] - PK Population
    [21] - PK Population
    No statistical analyses for this end point

    Primary: Corrected Cmax (CorrCmax) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods

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    End point title
    		 Corrected Cmax (CorrCmax) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods
    End point description
    CorrCmax for P2 was calculated as, corrCmax = Cmax, observed, P2 - Cpred, tmax where Cpred, tmax (predicted concentration at tmax [P2]) was calculated as Cpred, tmax = C0, P2*exp(-lambda z[P1]*tmax [P2]), where C0 = pre-dose concentrations from P2, lambda z was the elimination rate constant from P1 and tmax was observed time of Cmax from P2. Blood samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both P1 and P2.
    End point type
    Primary
    End point timeframe
    Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both treatment periods
    End point values
    		 GSK1120212 tablet GSK1120212 pediatric oral solution
    Number of subjects analysed
    8 [22]
    8 [23]
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Period 1
    6.0255 ( 81.291 )
    10.7118 ( 72.805 )
        Period 2
    7.9531 ( 71.818 )
    13.0262 ( 42.625 )
        Combined
    6.9225 ( 75.531 )
    11.8124 ( 57.608 )
    Notes
    [22] - PK Population
    [23] - PK Population
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    GSK1120212 pediatric oral solution v GSK1120212 tablet
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [24]
    Method
    Parameter type
    		 Mixed Effects Model
    Point estimate
    1.7064
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.2278
         upper limit
    		 2.3715
    Notes
    [24] - Corrected PK parameters were used for the statistical analysis

    Secondary: Apparent terminal elimination half-life (t1/2) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods

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    End point title
    		 Apparent terminal elimination half-life (t1/2) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods
    End point description
    t1/2 was obtained as the ratio of log-linear regression analysis of the last quantifiable time-point and the terminal phase rate constant (ln2/lambda z). Blood samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both P1 and P2.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both treatment periods
    End point values
    		 GSK1120212 tablet GSK1120212 pediatric oral solution
    Number of subjects analysed
    8 [25]
    8 [26]
    Units: hour (hr)
    geometric mean (geometric coefficient of variation)
        Period 1
    152.2262 ( 15.906 )
    150.9817 ( 36.013 )
        Period 2
    109.7371 ( 21.946 )
    108.4432 ( 19.551 )
        Combined
    129.2473 ( 25.328 )
    127.9568 ( 33.042 )
    Notes
    [25] - PK Population
    [26] - PK Population
    No statistical analyses for this end point

    Secondary: Time at which Cmax is observed (Tmax) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods

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    End point title
    		 Time at which Cmax is observed (Tmax) following a single dose administration of GSK1120212 2 mg in Period 1, Period 2 and combined treatment periods
    End point description
    Tmax was determined directly from the raw concentration-time data. Blood samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both P1 and P2.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 96 and 168 hours post-dose in both treatment periods
    End point values
    		 GSK1120212 tablet GSK1120212 pediatric oral solution
    Number of subjects analysed
    8 [27]
    8 [28]
    Units: Hr
    geometric mean (geometric coefficient of variation)
        Period 1
    2.3627 ( 112.408 )
    0.8857 ( 55.566 )
        Period 2
    1.9805 ( 59.933 )
    0.8387 ( 30.76 )
        Combined
    2.1632 ( 83.882 )
    0.8619 ( 42.848 )
    Notes
    [27] - PK Population
    [28] - PK Population
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    GSK1120212 tablet v GSK1120212 pediatric oral solution
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -1.483325
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.77495
         upper limit
    		 -0.5333

    Secondary: Number of participants with any adverse event (AE) or serious adverse event (SAE)

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    End point title
    		 Number of participants with any adverse event (AE) or serious adverse event (SAE)
    End point description
    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an event of possible drug-induced liver injury. All-Treated Population is defined as all participants who received at least one dose of any study treatment.
    End point type
    Secondary
    End point timeframe
    From the start of study treatment until 30 days after the last dose of study treatment (up to approximately 40 days)
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [29]
    8 [30]
    Units: Participants
        Any AE
    4
    6
        Any SAE
    0
    0
    Notes
    [29] - All-Treated Population
    [30] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean basophils, eosinophils, lymphocytes, monocytes, total absolute neutrophil count (ANC) and white blood cell (WBC) count at Screening and Day 1 of each treatment period

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    End point title
    		 Mean basophils, eosinophils, lymphocytes, monocytes, total absolute neutrophil count (ANC) and white blood cell (WBC) count at Screening and Day 1 of each treatment period
    End point description
    Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, Total ANC and WBC at Screening and Day 1 of each treatment period. All-Treated Population: Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All-Treated Population
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [31]
    8 [32]
    Units: Giga (10^9) cells per liter
    arithmetic mean (standard deviation)
        Basophils, Screening, n=8, 8
    0.0393 ( 0.04345 )
    0.0933 ( 0.09513 )
        Basophils, Period 1, n=4,5
    0 ( 0 )
    0.0515 ( 0.05011 )
        Basophils, Period 2, n=7,7
    0.1005 ( 0.10715 )
    0.0851 ( 0.0948 )
        Eosinophils, Screening, n=8, 8
    0.2035 ( 0.03896 )
    0.2548 ( 0.32471 )
        Eosinophils, Period 1, n=4,5
    0.175 ( 0.09574 )
    0.1218 ( 0.16276 )
        Eosinophils, Period 2, n=7,7
    0.2167 ( 0.07304 )
    0.2253 ( 0.24651 )
        Lymphocytes, Screening, n=8, 8
    1.5122 ( 0.68398 )
    1.3858 ( 0.79946 )
        Lymphocytes, Period 1, n=4,5
    1.425 ( 0.80571 )
    1.4825 ( 0.87552 )
        Lymphocytes, Period 2, n=7,7
    1.4552 ( 0.83932 )
    1.3457 ( 0.59371 )
        Monocytes, Screening, n=8, 8
    0.5772 ( 0.18387 )
    0.6685 ( 0.20024 )
        Monocytes, Period 1, n=4,5
    0.55 ( 0.1291 )
    0.845 ( 0.30842 )
        Monocytes, Period 2, n=7,7
    0.4913 ( 0.19271 )
    0.542 ( 0.15878 )
        Platelet count, Screening, n=8, 8
    261.3 ( 88.49 )
    264.6 ( 80.23 )
        Platelet count, Period 1, n=4,5
    202 ( 29.64 )
    320 ( 74.4 )
        Platelet count, Period 2, n=7,7
    253.9 ( 79.71 )
    253.9 ( 73.33 )
        Total ANC, Screening, n=8, 8
    5.0948 ( 2.66263 )
    5.9603 ( 1.81951 )
        Total ANC, Period 1, n=4,5
    4 ( 1.95789 )
    7.2 ( 2.28145 )
        Total ANC, Period 2, n=7,7
    4.1288 ( 1.58216 )
    5.8857 ( 2.50171 )
        WBC, Screening, n=8, 8
    7.43 ( 2.989 )
    8.36 ( 2.292 )
        WBC, Period 1, n=4,5
    6.15 ( 2.042 )
    9.7 ( 2.511 )
        WBC, Period 2, n=7,7
    6.47 ( 2.26 )
    8.09 ( 2.822 )
    Notes
    [31] - All-Treated Population
    [32] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean hemoglobin and mean corpuscular hemoglobin concentration (MCHC) at Screening and Day 1 of each treatment period

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    End point title
    		 Mean hemoglobin and mean corpuscular hemoglobin concentration (MCHC) at Screening and Day 1 of each treatment period
    End point description
    Blood samples were collected for the measurement of hemoglobin and MCHC at Screening and Day 1 of each treatment period. The MCH concentration is the average concentration of hemoglobin in a red blood cell. Hemoglobin is the red pigment in the blood, and it is reponsible for carrying oxygen. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All-Treated Population.
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [33]
    8 [34]
    Units: Grams per liter (G/L)
    arithmetic mean (standard deviation)
        Hemoglobin, Screening, n=8, 8
    128.6 ( 15.98 )
    113 ( 11.81 )
        Hemoglobin, Period 1, n=4,5
    131.5 ( 15.93 )
    108 ( 14.78 )
        Hemoglobin, Period 2, n=7,7
    120 ( 16.34 )
    109.9 ( 9.34 )
        MCHC, Screening, n=8, 8
    329.4 ( 6.93 )
    328.9 ( 6.36 )
        MCHC, Period 1, n=4,5
    329 ( 3.56 )
    330.6 ( 6.69 )
        MCHC, Period 2, n=7,7
    331 ( 5.66 )
    327.1 ( 8.09 )
    Notes
    [33] - All-Treated Population
    [34] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean Corpuscle Hemoglobin (MCH) values at Screening and Day 1 of each treatment period

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    End point title
    		 Mean Corpuscle Hemoglobin (MCH) values at Screening and Day 1 of each treatment period
    End point description
    Blood samples were collected for the measurement of MCH values at Screening and Day 1 of each treatment period. MCH is the average mass or amount of hemoglobin per red blood cell in a sample of blood. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All-Treated Population .
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [35]
    8 [36]
    Units: Picograms (PG)
    arithmetic mean (standard deviation)
        MCH, Screening, n=8, 8
    29.81 ( 2.092 )
    28.9 ( 2.026 )
        MCH, Period 1, n=4,5
    31.43 ( 1.179 )
    28.28 ( 2.413 )
        MCH, Period 2, n=7,7
    29.69 ( 2.084 )
    28.84 ( 2.025 )
    Notes
    [35] - All-Treated Population
    [36] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean corpuscular volume (MCV) value at Screening and Day 1 of each treatment period

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    End point title
    		 Mean corpuscular volume (MCV) value at Screening and Day 1 of each treatment period
    End point description
    Blood samples were collected for the measurement of MCV values at Screening and Day 1 of each treatment period. MCV is a measure of the average red blood cell size that is reported as part of a standard complete blood count. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All-Treated Population.
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [37]
    8 [38]
    Units: Femtoliters (10^15Liter) (F/L)
    arithmetic mean (standard deviation)
        MCV, Screening, n=8, 8
    90.6 ( 6.102 )
    87.9 ( 5.955 )
        MCV, Period 1, n=4,5
    95.75 ( 3.775 )
    85.56 ( 6.178 )
        MCV, Period 2, n=7,7
    89.77 ( 6.219 )
    88.16 ( 6.097 )
    Notes
    [37] - All-Treated Population
    [38] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean hematocrit values at Screening and Day 1 of each treament period

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    End point title
    		 Mean hematocrit values at Screening and Day 1 of each treament period
    End point description
    Blood samples were collected for the measurement of hematocrit values at Screening and Day 1 of each treatment period. The hematocrit is the percentage of the RBCs in the blood. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All-Treated Population.
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [39]
    8 [40]
    Units: percentage of RBCs
    arithmetic mean (standard deviation)
        Hematocrit, Screening, n=8, 8
    0.3895 ( 0.04288 )
    0.3434 ( 0.03187 )
        Hematocrit, Period 1, n=4,5
    0.4 ( 0.05105 )
    0.3258 ( 0.041 )
        Hematocrit, Period 2, n=7,7
    0.3619 ( 0.04822 )
    0.3357 ( 0.0258 )
    Notes
    [39] - All-Treated Population
    [40] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean calcium, chloride, carbon dioxide content (CO2)/bicarbonate, glucose, potassium, magnesium, phosphorus, sodium and urea/blood urea nitrogen (BUN) values at Screening and Day 1 of each treatment period

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    End point title
    		 Mean calcium, chloride, carbon dioxide content (CO2)/bicarbonate, glucose, potassium, magnesium, phosphorus, sodium and urea/blood urea nitrogen (BUN) values at Screening and Day 1 of each treatment period
    End point description
    Samples were collected for the measurement of Calcium, Chloride, CO2/Bicarbonate, Glucose, Potassium, Magnesium, Phosphorus, Sodium and Urea/BUN values at Screening and Day 1 of each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All-Treated Population.
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [41]
    8 [42]
    Units: Millimoles per liter (MMOL/L)
    arithmetic mean (standard deviation)
        Calcium, Screening, n=8, 8
    2.3204 ( 0.11703 )
    2.2112 ( 0.2009 )
        Calcium, Period 1, n=4,5
    2.1457 ( 0.07345 )
    2.2006 ( 0.21993 )
        Calcium, Period 2, n=7,7
    2.2705 ( 0.08399 )
    2.1885 ( 0.09304 )
        CO2/Bicarbonate, Screening, n=8, 8
    27.5 ( 1.93 )
    26.8 ( 4.03 )
        CO2/Bicarbonate, Period 1, n=4,5
    27.3 ( 2.06 )
    27.6 ( 2.79 )
        CO2/Bicarbonate, Period 2, n=7,7
    27.1 ( 3.08 )
    27.4 ( 2.82 )
        Chloride, Screening, n=8, 8
    100.4 ( 3.46 )
    102 ( 4.75 )
        Chloride, Period 1, n=4,5
    103 ( 2.16 )
    101 ( 3.87 )
        Chloride, Period 2, n=7,7
    101.3 ( 3.5 )
    103.1 ( 4.74 )
        Glucose, Screening, n=8, 8
    5.5371 ( 1.13636 )
    6.4392 ( 2.12973 )
        Glucose, Period 1, n=4,5
    4.9959 ( 0.41292 )
    5.3845 ( 1.14235 )
        Glucose, Period 2, n=7,7
    5.0514 ( 0.31072 )
    6.4074 ( 3.17862 )
        Magnesium, Screening, n=8, 8
    0.7655 ( 0.06189 )
    0.7449 ( 0.06381 )
        Magnesium, Period 1, n=4,5
    0.7295 ( 0.06165 )
    0.7069 ( 0.11769 )
        Magnesium, Period 2, n=7,7
    0.7398 ( 0.0411 )
    0.7398 ( 0.10067 )
        Phosphorus, Screening, n=8, 8
    1.1947 ( 0.1802 )
    1.0736 ( 0.21401 )
        Phosphorus, Period 1, n=4,5
    1.0817 ( 0.24521 )
    1.072 ( 0.31588 )
        Phosphorus, Period 2, n=7,7
    1.2685 ( 0.14997 )
    1.0794 ( 0.23274 )
        Potassium, Screening, n=8, 8
    4.05 ( 0.689 )
    4.06 ( 0.58 )
        Potassium, Period 1, n=4,5
    4 ( 0.374 )
    3.72 ( 0.665 )
        Potassium, Period 2, n=7,7
    4.06 ( 0.58 )
    4.04 ( 0.395 )
        Sodium, Screening, n=8, 8
    138.8 ( 2.25 )
    137.4 ( 3.11 )
        Sodium, Period 1, n=4,5
    140 ( 2 )
    136.6 ( 1.82 )
        Sodium, Period 2, n=7,7
    138.3 ( 1.8 )
    138.6 ( 3.21 )
        Urea/BUN, Screening, n=8, 8
    6.2029 ( 2.05469 )
    4.5071 ( 1.8297 )
        Urea/BUN, Period 1, n=4,5
    6.5153 ( 1.94174 )
    5.355 ( 1.87212 )
        Urea/BUN, Period 2, n=7,7
    6.069 ( 1.69966 )
    4.539 ( 2.04785 )
    Notes
    [41] - All-Treated Population
    [42] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean total bilirubin, uric acid and creatinine values at Screening and Day 1 of each treatment period

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    End point title
    		 Mean total bilirubin, uric acid and creatinine values at Screening and Day 1 of each treatment period
    End point description
    Blood samples were collected for the measurement of total bilirubin, uric acid, creatinine values at screening and Day 1 of each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All-Treated Population.
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [43]
    8 [44]
    Units: micromoles per liter (UMOL/L)
    arithmetic mean (standard deviation)
        Creatinine, Screening, n=8, 8
    92.9305 ( 33.00339 )
    68.6205 ( 20.65577 )
        Creatinine, Period 1, n=4,5
    83.98 ( 21.04341 )
    69.6592 ( 11.08354 )
        Creatinine, Period 2, n=7,7
    86.1269 ( 26.80264 )
    64.4057 ( 12.95624 )
        Total bilirubin, Screening, n=8, 8
    11.756 ( 3.3506 )
    10.474 ( 3.473 )
        Total bilirubin, Period 1, n=4,5
    12.398 ( 4.4972 )
    11.286 ( 3.1064 )
        Total bilirubin, Period 2, n=7,7
    10.749 ( 3.9137 )
    8.794 ( 2.3003 )
        Uric acid, Screening, n=8, 8
    335.3185 ( 110.3161 )
    300.374 ( 64.92395 )
        Uric acid, Period 1, n=4,5
    336.062 ( 31.28595 )
    302.1584 ( 24.30688 )
        Uric acid, Period 2, n=7,7
    344.1343 ( 111.8808 )
    329.6891 ( 53.18469 )
    Notes
    [43] - All-Treated Population
    [44] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean albumin and total protein values at Screening and Day 1 of each treatment period

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    End point title
    		 Mean albumin and total protein values at Screening and Day 1 of each treatment period
    End point description
    Blood samples were collected for the measurement of albumin and total protein values at Screening and Day 1 of each treatment period . Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All-Treated Population.
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [45]
    8 [46]
    Units: Grams per liter (G/L)
    arithmetic mean (standard deviation)
        Albumin, Screening, n=8, 8
    40.9 ( 3.04 )
    36.4 ( 3.29 )
        Albumin, Period 1, n=4,5
    41.3 ( 1.26 )
    35.2 ( 3.11 )
        Albumin, Period 2, n=7,7
    38.9 ( 3.72 )
    34.4 ( 2.3 )
        Total Protein, Screening, n=8, 8
    66.3 ( 5.06 )
    62 ( 6.28 )
        Total Protein, Period 1, n=4,5
    62 ( 1.15 )
    59.4 ( 5.59 )
        Total Protein, Period 2, n=7,7
    64.4 ( 2.7 )
    59.6 ( 3.64 )
    Notes
    [45] - All-Treated Population
    [46] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean alkaline phosphatase (ALP), alanine amino transferase (ALT) and aspartate amino transferase (AST) values at Screening and Day 1 of each treatment period

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    End point title
    		 Mean alkaline phosphatase (ALP), alanine amino transferase (ALT) and aspartate amino transferase (AST) values at Screening and Day 1 of each treatment period
    End point description
    Blood samples were collected for the measurement of ALP, ALT and AST values at Screening and Day 1 of each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All-Treated Population.
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [47]
    8 [48]
    Units: International units per liter (IU/L)
    arithmetic mean (standard deviation)
        ALP, Screening, n=8, 8
    84.5 ( 18.63 )
    184.8 ( 161.56 )
        ALP, Period 1, n=4,5
    66.8 ( 11.5 )
    108.2 ( 46.5 )
        ALP, Period 2, n=7,7
    82.7 ( 18.14 )
    180.9 ( 130.94 )
        AST, Screening, n=8, 8
    22.9 ( 10.99 )
    33.6 ( 24.97 )
        AST, Period 1, n=4,5
    17 ( 2.58 )
    27 ( 18.53 )
        AST, Period 2, n=7,7
    26 ( 14.47 )
    37.7 ( 24.45 )
        ALT, Screening, n=8, 8
    21.6 ( 7.13 )
    29 ( 17.82 )
        ALT, Period 1, n=4,5
    16.3 ( 1.71 )
    27.6 ( 16.29 )
        ALT, Period 2, n=7,7
    22.3 ( 8.06 )
    24.9 ( 16.72 )
    Notes
    [47] - All-Treated Population
    [48] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean creatinine clearence values estimated using Cockcroft-Gault formula at Screening and Day 1 of each treatment period

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    End point title
    		 Mean creatinine clearence values estimated using Cockcroft-Gault formula at Screening and Day 1 of each treatment period
    End point description
    Creatinine Clearance was estimated using Cockcroft-Gault formula. The Cockcroft-Gault formula estimates creatinine clearance without correction for body surface area (BSA) and is based on predicting the daily urine creatinine excretion using the age, weight and sex of the participant. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All-Treated Population. A Standard Deviation = 0 is entered because there were were too few participants to provide the SD.
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [49]
    8 [50]
    Units: milliliters/minute (mL/min)
    arithmetic mean (standard deviation)
        Creatinine clearence, Screening, n=8,7
    75.715 ( 35.2201 )
    107.219 ( 46.1563 )
        Creatinine clearence, Period 1, n=1,3
    43.3 ( 0 )
    99.947 ( 32.2818 )
        Creatinine clearence, Period 2, n=4,5
    73.078 ( 36.9831 )
    67.234 ( 53.0275 )
    Notes
    [49] - All-Treated Population
    [50] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean systolic and diastolic blood pressure (BP) at Screening and Day 1 of each treatment period

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    End point title
    		 Mean systolic and diastolic blood pressure (BP) at Screening and Day 1 of each treatment period
    End point description
    Vital sign monitoring included systolic and diastolic BP measurements. BP measurements were taken in semi-supine position after 5 minutes (min) of rest. Measurements were taken at Screening and Day 1 of each treatment period.
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [51]
    8 [52]
    Units: Millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        Diastolic BP, Screening
    75.8 ( 11.87 )
    71.6 ( 8.53 )
        Diastolic BP, Period 1
    75.6 ( 8.98 )
    75.1 ( 9.7 )
        Diastolic BP, Period 2
    74 ( 9.12 )
    76.4 ( 10.95 )
        Systolic BP, Screening
    130.3 ( 13.34 )
    120.5 ( 14.4 )
        Systolic BP, Period 1
    129.6 ( 17.26 )
    123.4 ( 13.07 )
        Systolic BP, Period 2
    131.5 ( 16.42 )
    121 ( 12.02 )
    Notes
    [51] - All-Treated Population
    [52] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean heart rate at screening and Day 1 of each treatment period

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    End point title
    		 Mean heart rate at screening and Day 1 of each treatment period
    End point description
    Vital sign monitoring included heart rate measurements. Heart rate was measured in semi-supine position after 5 min of rest. Measurements were taken at Screening and Day 1 of each treatment period.
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [53]
    8 [54]
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Heart rate,Screening
    83.6 ( 13.1 )
    82.4 ( 6.8 )
        Heart rate, Period 1
    83.1 ( 18.94 )
    80 ( 7.25 )
        Heart rate, Period 2
    79.1 ( 12.54 )
    78.5 ( 7.78 )
    Notes
    [53] - All-Treated Population
    [54] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Mean electrocardiogram (ECG) values at Screening, and Day 1 of each treatment period

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    End point title
    		 Mean electrocardiogram (ECG) values at Screening, and Day 1 of each treatment period
    End point description
    ECG measurements were obtained using single 12-lead ECGs at Screening and Day 1 of each treatment period. The ECG machine automatically calculated heart rate and measured the ECG parameters: PR interval, QT interval, QRS duration, QT duration corrected by Bazett’s formula (QTcB), QT duration corrected by Fridericia's formula (QTcF) and RR intervals. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All-Treated Population .
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [55]
    8 [56]
    Units: Milliseconds (msec)
    arithmetic mean (standard deviation)
        PR Interval, Screening, n=7,8
    157.7 ( 23.73 )
    154.6 ( 39.01 )
        PR Interval, Period 1, n=4,5
    165 ( 22.54 )
    156.8 ( 15.14 )
        PR Interval, Period 2, n=7,8
    164 ( 20.46 )
    157 ( 29.8 )
        QRS duration, Screening, n=8, 8
    83.8 ( 11.18 )
    85 ( 9.2 )
        QRS duration, Period 1, n=5,5
    84.8 ( 12.85 )
    92.8 ( 6.72 )
        QRS duration, Period 2, n=8, 8
    85.3 ( 9.5 )
    87.5 ( 10.18 )
        QTcB interval, Screening, n=8, 8
    422.4008 ( 27.90254 )
    428.1997 ( 8.68665 )
        QTcB interval, Period 1, n=5,5
    408.6607 ( 20.91749 )
    425.338 ( 12.33659 )
        QTcB interval, Period 2, n=8, 8
    425.481 ( 17.71296 )
    427.3145 ( 19.58335 )
        QTcF interval, Screening, n=8, 8
    407.5738 ( 20.02514 )
    407.5161 ( 9.84641 )
        QTcF interval, Period 1, n=5,5
    394.745 ( 15.76832 )
    409.8421 ( 9.66519 )
        QTcF interval, Period 2, n=8, 8
    415.4359 ( 16.85693 )
    411.4918 ( 15.47495 )
        Uncorrected QT interval, Screening, n=8, 8
    380.3 ( 25.44 )
    369.5 ( 18.69 )
        Uncorrected QT interval, Period 1, n=5,5
    368 ( 25.06 )
    380.4 ( 16.15 )
        Uncorrected QT interval, Period 2, n=8, 8
    397 ( 32.32 )
    381.5 ( 16.17 )
    Notes
    [55] - All-Treated Population
    [56] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated electrocardiogram (ECG) findings

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    End point title
    		 Number of participants with the indicated electrocardiogram (ECG) findings
    End point description
    ECG measurements were obtained using single 12-lead ECGs at Screening and Day 1 of each treatment period. The ECG machine automatically calculated heart rate and measured the ECG parameters: PR interval, QT interval, QRS duration, QTcB, QTcF and RR intervals. ECG findings were categorized as: normal, abnormal - clinically significant (CS) and abnormal - not clinically significant (NCS). Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Treated Population.
    End point type
    Secondary
    End point timeframe
    Screening and Day 1 of each treatment period
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [57]
    8 [58]
    Units: Participants
        Screening, Normal, n=8, 8
    2
    3
        Screening, Abnormal, NCS, n=8, 8
    6
    5
        Screening, Abnormal, CS, n=8, 8
    0
    0
        Period 1, Normal, n=5,5
    1
    3
        Period 1, Abnormal, NCS, n=5,5
    4
    2
        Period 1, Abnormal, CS, n=5,5
    0
    0
        Period 2, Normal, n=8, 8
    1
    3
        Period 2, Abnormal, NCS, n=8, 8
    7
    5
        Period 2, Abnormal, CS, n=8, 8
    0
    0
        Any time post-baseline, Normal, n=8, 8
    1
    3
        Any time post-baseline, Abnormal, NCS, n=8, 8
    7
    5
        Any time post-baseline, Abnormal, CS, n=8, 8
    0
    0
    Notes
    [57] - All-Treated Population
    [58] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated change from Baseline in left ventricular ejection fraction (LVEF)

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    End point title
    		 Number of participants with the indicated change from Baseline in left ventricular ejection fraction (LVEF)
    End point description
    An echocardiography (ECHO) scan was performed to assess cardiac ejection fraction and cardiac valve morphology. Change from Baseline for LVEF was calculated as Baseline value minus Day 8 value. Baseline was defined as the value of last assessment prior to first dose in Period 1. Absolute change from Baseline for LVEF was summarized into the following categories: no change or any increase, any decrease, >0-<10 percent decrease, 10-19 % decrease, >=20% decrease, >=10% decrease and >= lower limit of normal (LLN), >=10 % decrease and below LLN, >=20 % decrease and >= LLN, >=20 decrease and below LLN.
    End point type
    Secondary
    End point timeframe
    Baseline (Screening) and Day 8 of Period 2
    End point values
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Number of subjects analysed
    8 [59]
    8 [60]
    Units: Participants
        No change or any increase
    5
    5
        >0-<10 decrease
    3
    3
        10-19 decrease
    0
    0
        >=20 decrease
    0
    0
        >=10 decrease and >= LLN
    0
    0
        >=10 decrease and below LLN
    0
    0
        >=20 decrease and >= LLN
    0
    0
        >=20 decrease and below LLN
    0
    0
    Notes
    [59] - All-Treated Population
    [60] - All-Treated Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated palatability ranking score of GSK1120212 pediatric oral solution formulation on Day 1 of Period 1 or 2

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    End point title
    		 Number of participants with the indicated palatability ranking score of GSK1120212 pediatric oral solution formulation on Day 1 of Period 1 or 2
    End point description
    Palatability was assessed by ranking bitterness, sweetness, aroma and overall taste on a four-point scale recorded in the electronic case report form. Bitterness and sweetness were ranked by participants on a scale of 1 to 4, with 1= barely detectable, 2= weak, 3= moderate and 4=strong. Overall taste and aroma were ranked by participants on a scale of 1 to 4, 1= bad, 2= neutral, 3= acceptable and 4=good.
    End point type
    Secondary
    End point timeframe
    Day 1 of each treatment Period
    End point values
    		 GSK1120212 pediatric oral solution
    Number of subjects analysed
    16 [61]
    Units: Scores on a scale
        Bitterness ranking, Barely detectable
    4
        Bitterness ranking, Weak
    3
        Bitterness ranking, Moderate
    7
        Bitterness ranking, Strong
    2
        Sweetness perceived, Barely detectable
    3
        Sweetness perceived, Weak
    1
        Sweetness perceived, Moderate
    10
        Sweetness perceived, Strong
    2
        Aroma perceived, Bad
    0
        Aroma perceived, Neutral
    5
        Aroma perceived, Acceptable
    5
        Aroma perceived, Good
    6
        Overall taste ranking, Bad
    2
        Overall taste ranking, Neutral
    4
        Overall taste ranking, Acceptable
    9
        Overall taste ranking, Good
    1
    Notes
    [61] - All-Treated Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment until 30 days after the last dose of study treatment. (up to approximately 40 days).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2
    Reporting group description
    		 In Period 1, following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 milligrams (mg) tablet formulation with 240 milliliters (ml) of water. Period 1 also consisted of a 7-day pharmacokinetic (PK) sampling/incomplete wash-out period following dosing. In Period 2, after an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric oral solution (OS) formulation administered with a graduated syringe and were required to drink 100 ml of water following dosing. Participants were required to fast an additional 4 hours after administration of GSK1120212 in either formulation.

    Reporting group title
    GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Reporting group description
    		 In Period 1, following an overnight fast of at least 8 hours, participants received a single dose of GSK1120212 2 mg pediatric solution formulation administered with a graduated syringe and were required to drink 100 ml of water. Period 1 also consisted of a 7-day PK sampling/incomplete wash-out period following dosing. In Period 2 participants received a single dose of GSK1120212 2 mg tablet formulation with 240 ml of water following an overnight fast of at least 8 hours. Participants were required to fast an additional 4 hours after administration of GSK1120212 in either formulation.

    Serious adverse events
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK1120212 tablet in Period 1; GSK1120212 OS in Period 2 GSK1120212 OS in Period 1; GSK1120212 tablet in Period 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 8 (50.00%)
    6 / 8 (75.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphoma
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Tumour pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Lymphoedema
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Mucosal inflammation
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 8 (25.00%)
         occurrences all number
    2
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Nasal discharge discolouration
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Memory impairment
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    2
    1
    Skin and subcutaneous tissue disorders
    Dermatitis acneiform
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Night sweats
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Muscular weakness
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Dehydration
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 8 (37.50%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jan 2012
    Section 3.6 Time & Events Table Corrections Section 1.2.3 Rationale for the Study Population; pg 8 Correction to the number of AEs of special interest (6 versus 4)
    23 Apr 2012
    Change in subject population from healthy male volunteers only to male and female subjects with solid tumors. Text revised throughout the protocol to incorporate additional safety assessments (including disease assessments and evaluation of ECOG performance status), revised period of PK blood sample collection from 4 weeks to 7 days and indicated availability of the rollover study, MEK114375 for eligible subjects who completed this study.

    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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