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    Clinical Trial Results:
    A Single Blind (Sponsor-unblinded), Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of GSK1070806 in the Treatment of Obese Subjects with T2DM.

    Summary
    EudraCT number
    2012-000126-22
    Trial protocol
    GB   ES  
    Global end of trial date
    03 Jan 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    A18116378
    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 8664357343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, +1 8664357343,
    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
    20 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of two repeat intravenous dose administrations of GSK1070806 in subjects with T2DM.
    Protection of trial subjects
    The study design allowed for a long observational period following the first dose to monitor any adverse events (AEs) prior to administration of a second dose. Based on the half-life of the molecule, significant accumulation of drug following the administration of a second dose was not expected. The study had a long follow-up (out to Day 210) to monitor for the appearance of treatment-related AEs. All participants were rigorously screened by clinical examination for ongoing or potentially emergent infections by a physician at the screening visit, prior to dosing, and during the course of the study. Viral screening methods were employed at screening. Participants who tested positive for any of the following were excluded from the study: Hepatitis B, Hepatitis C, human immunodeficiency virus (HIV). Participants with current evidence of acute or ongoing infection and a history of repeated, chronic, or opportunistic infections (viral, bacterial, or fungal) were excluded. Where possible, inactivated flu vaccine was administered at screening prior to starting treatment with study medication and in accordance with local practices. Given the hypothetical role of IL-18 in the potentiation of immune surveillance of nascent tumours, participants with a history of malignancy were excluded from the study. Eligible women of childbearing potential were allowed to participate in the trial at study sites where regulation allows for their inclusion. They were requied to use contraception for approximately 30 weeks after the first dose or up to Study Day 210. Participants were advised to refrain from travelling to countries where there is a high incidence of infectious diseases until the study follow-up visit on Day 210. By Day 210, the effects on IFNinhibition in the obese population was predicted to be minimal; therefore, little or no impact on the participants’ immunity to infection would be anticipated after this time period.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Aug 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
    Spain: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    29
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study consisted of screening and a 4-week treatment period (sponsor-unblinded, placebo-controlled). Obese participants with Type 2 Diabetes Mellitus who remained on their current diet and dose of metformin were enrolled.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo via intravenous (IV) infusion on the Day 1 and Day 29 study visits.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosing on Days 1 and 29, by 60 minute infusion. Volume matched to active treatment.

    Arm title
    GSK1070806 0.25 mg/kg
    Arm description
    Participants received GSK1070806 0.25 milligrams per kilogram (mg/kg) via IV infusion on the Day 1 and Day 29 study visits.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK1070806
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosing on Days 1 and 29, at 0.25 mg/kg, by 60 minute infusion

    Arm title
    GSK1070806 5 mg/kg
    Arm description
    Participants received GSK1070806 5 mg/kg via IV infusion on the Day 1 and Day 29 study visits.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK1070806
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosing on Days 1 and 29, at 5 mg/kg, by 60 minute infusion

    Number of subjects in period 1
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Started
    12
    13
    12
    Completed
    12
    13
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo via intravenous (IV) infusion on the Day 1 and Day 29 study visits.

    Reporting group title
    GSK1070806 0.25 mg/kg
    Reporting group description
    Participants received GSK1070806 0.25 milligrams per kilogram (mg/kg) via IV infusion on the Day 1 and Day 29 study visits.

    Reporting group title
    GSK1070806 5 mg/kg
    Reporting group description
    Participants received GSK1070806 5 mg/kg via IV infusion on the Day 1 and Day 29 study visits.

    Reporting group values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg Total
    Number of subjects
    12 13 12 37
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    55.1 ± 9.61 58 ± 9.57 58.7 ± 7.97 -
    Gender categorical
    Units: Subjects
        Female
    2 4 3 9
        Male
    10 9 9 28
    Race, customized
    Units: Subjects
        White
    12 13 12 37

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo via intravenous (IV) infusion on the Day 1 and Day 29 study visits.

    Reporting group title
    GSK1070806 0.25 mg/kg
    Reporting group description
    Participants received GSK1070806 0.25 milligrams per kilogram (mg/kg) via IV infusion on the Day 1 and Day 29 study visits.

    Reporting group title
    GSK1070806 5 mg/kg
    Reporting group description
    Participants received GSK1070806 5 mg/kg via IV infusion on the Day 1 and Day 29 study visits.

    Primary: Change from Baseline in fasting plasma glucose (FPG) level on Days 29, 57, and 85

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    End point title
    Change from Baseline in fasting plasma glucose (FPG) level on Days 29, 57, and 85
    End point description
    The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. Change from Baseline in FPG was compared between treatment groups using repeated measures analysis with fixed effects for Baseline, visit, and Baseline by visit. The Baseline FPG value is defined as the value at Day 1. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. If pre-dose FPG values (labortory data) were missing, then values were imputed using pre-mixed meal test (MMT) glucose values (biomarker data).
    End point type
    Primary
    End point timeframe
    Baseline; Days 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [1]
    13 [2]
    12 [3]
    Units: Millimoles per liter (mmol/L)
    least squares mean (standard error)
        Day 29
    -0.047 ± 0.3851
    -0.471 ± 0.3689
    -0.05 ± 0.3799
        Day 57
    -0.755 ± 0.4645
    -0.409 ± 0.4454
    -1.133 ± 0.4603
        Day 85
    -0.555 ± 0.584
    -0.024 ± 0.5604
    -0.591 ± 0.5806
    Notes
    [1] - All Subject Population: all participants who received study drug
    [2] - All Subject Population: all participants who received study drug
    [3] - All Subject Population: all participants who received study drug
    Statistical analysis title
    Day 29; Placebo:GSK1070806 0.25 mg/kg
    Comparison groups
    Placebo v GSK1070806 0.25 mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4376
    Method
    Mixed Model Repeated Measures Analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.424
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.519
         upper limit
    0.672
    Statistical analysis title
    Day 57; Placebo:GSK1070806 0.25 mg/kg
    Comparison groups
    Placebo v GSK1070806 0.25 mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5973
    Method
    Mixed Model Repeated Measures Analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.346
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.975
         upper limit
    1.667
    Statistical analysis title
    Day 85; Placebo:GSK1070806 0.25 mg/kg
    Comparison groups
    Placebo v GSK1070806 0.25 mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5186
    Method
    Mixed Model Repeated Measures Analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.531
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.125
         upper limit
    2.186
    Statistical analysis title
    Day 29; Placebo:GSK1070806 5 mg/kg
    Comparison groups
    Placebo v GSK1070806 5 mg/kg
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.996
    Method
    Mixed Model Repeated Measures Analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.003
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.103
         upper limit
    1.097
    Statistical analysis title
    Day 57; Placebo:GSK1070806 5 mg/kg
    Comparison groups
    Placebo v GSK1070806 5 mg/kg
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5677
    Method
    Mixed Model Repeated Measures Analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.378
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.711
         upper limit
    0.956
    Statistical analysis title
    Day 85; Placebo:GSK1070806 5 mg/kg
    Comparison groups
    Placebo v GSK1070806 5 mg/kg
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9653
    Method
    Mixed Model Repeated Measures Analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.036
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.713
         upper limit
    1.641

    Primary: Change from Baseline in weighted mean glucose area under the concentration-time curve from time zero (pre-dose) to 4 hours (AUC[0 4hrs]) post-Mixed Meal Test (MMT) on Days 29, 57, and 85

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    End point title
    Change from Baseline in weighted mean glucose area under the concentration-time curve from time zero (pre-dose) to 4 hours (AUC[0 4hrs]) post-Mixed Meal Test (MMT) on Days 29, 57, and 85
    End point description
    The weighted mean parameters were derived by calculating the area under the curve (AUC, which reflects the actual body exposure to drug after administration of a dose of the drug) using the trapezoidal rule, and then dividing by the actual relevant time interval (i.e., actual time point [hrs] of the first non-missing observation [in planned time tf=0 hour] minus the actual time point [hrs] of the last non-missing observation [e.g., in planned time for glucose, tl=240 minutes]). Change from Baseline in weighted mean AUC(0-4hrs) post-MMT profiles for glucose was compared between treatment groups using repeated measures analysis with fixed effects for Baseline, visit, and Baseline by visit. The Baseline weighted mean glucose value is defined as the value at Day 1. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. If pre-MMT glucose values (biomarker data) were missing, then values were imputed using pre-dose FPG values (laboratory data).
    End point type
    Primary
    End point timeframe
    Baseline; Days 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [4]
    13 [5]
    12 [6]
    Units: mmol/L
    least squares mean (standard error)
        Day 29
    0.09 ± 0.42
    -0.43 ± 0.407
    -0.43 ± 0.407
        Day 57
    -0.47 ± 0.518
    -0.43 ± 0.5
    -1.28 ± 0.508
        Day 85
    -0.48 ± 0.588
    -0.3 ± 0.567
    -0.76 ± 0.579
    Notes
    [4] - All Subject Population
    [5] - All Subject Population
    [6] - All Subject Population
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Day 29
    Comparison groups
    Placebo v GSK1070806 0.25 mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.52
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.75
         upper limit
    0.71
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Day 57
    Comparison groups
    Placebo v GSK1070806 0.25 mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.46
         upper limit
    1.53
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    Day 85
    Comparison groups
    Placebo v GSK1070806 0.25 mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.5
         upper limit
    1.87
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    Day 29
    Comparison groups
    Placebo v GSK1070806 5 mg/kg
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.52
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    0.67
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    Day 57
    Comparison groups
    Placebo v GSK1070806 5 mg/kg
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.28
         upper limit
    0.66
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    Day 85
    Comparison groups
    Placebo v GSK1070806 5 mg/kg
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.95
         upper limit
    1.39

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

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    End point title
    Number of participants with any adverse event (AE) and any serious adverse event (SAE)
    End point description
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.
    End point type
    Secondary
    End point timeframe
    From Baseline until follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [7]
    13 [8]
    12 [9]
    Units: Participants
    number (not applicable)
        Any AE
    11
    12
    11
        Any SAE
    1
    0
    1
    Notes
    [7] - All Subject Population (ASP)
    [8] - All Subject Population (ASP)
    [9] - All Subject Population (ASP)
    No statistical analyses for this end point

    Secondary: Albumin and total protein values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Albumin and total protein values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    Albumin and total protein values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [10]
    13 [11]
    12 [12]
    Units: Grams per liter (G/L)
    arithmetic mean (standard deviation)
        Albumin, Screening, n=12, 13, 12
    47.1 ± 4.62
    45.9 ± 3.33
    45.4 ± 2.64
        Albumin, Day 1: pre-dose, n=12, 12, 12
    44.7 ± 3.42
    43.3 ± 3.14
    45 ± 2.59
        Albumin, Day 1: 4 hr, n=11, 12, 11
    42 ± 4.98
    42.5 ± 3.68
    42.4 ± 2.25
        Albumin, Day 4, n=11, 12, 11
    46.8 ± 3.31
    44.9 ± 2.06
    45.6 ± 2.87
        Albumin, Day 9, n=12, 13, 12
    46.4 ± 3.53
    45.2 ± 2.13
    44.8 ± 3.17
        Albumin, Day 14, n=12, 13, 12
    47.1 ± 4.29
    44.7 ± 2.78
    44.8 ± 2.69
        Albumin, Day 21, n=12, 13, 12
    45.9 ± 4.19
    44.6 ± 2.57
    45.3 ± 2.93
        Albumin, Day 29: pre-dose, n=11, 13, 12
    44.6 ± 4.25
    44 ± 4.22
    44.9 ± 2.97
        Albumin, Day 29: 4 hr, n=12, 10, 11
    42.5 ± 3.18
    42.3 ± 5.6
    42.2 ± 2.86
        Albumin, Day 32: n=11, 13, 12
    46.5 ± 2.91
    45.5 ± 2.85
    45.3 ± 2.86
        Albumin, Day 42: n=12, 13, 12
    46.7 ± 2.81
    44.8 ± 2.42
    46 ± 2.63
        Albumin, Day 57: n=12, 13, 12
    45.7 ± 2.53
    44.2 ± 3.89
    45.7 ± 2.19
        Albumin, Day 85: n=11, 12, 12
    45.4 ± 3.29
    45.8 ± 3.01
    45.3 ± 2.56
        Albumin, Day 120: n=11, 13, 12
    46 ± 2.9
    44.5 ± 2.96
    45 ± 3.3
        Albumin, Day 165: n=12, 12, 12
    45.5 ± 3.06
    44.8 ± 2.49
    44.1 ± 3.5
        Albumin, follow-up: n=12, 12, 12
    45.6 ± 3.4
    44.1 ± 3.12
    44.3 ± 1.86
        Total protein, Screening: n=12, 13, 12
    73.3 ± 4.79
    72.3 ± 4.4
    72.1 ± 4.96
        Total protein, Day 1: pre-dose, n=12, 12, 12
    69.8 ± 4.3
    69.4 ± 5.04
    70.6 ± 3.99
        Total protein, Day 1: 4 hr, n=11, 12, 11
    66.3 ± 7.77
    67.8 ± 3.79
    67.5 ± 3.56
        Total protein, Day 4: n=11, 13, 11
    73.5 ± 4.82
    70.2 ± 2.48
    71.2 ± 4.9
        Total protein, Day 9: n=12, 13, 12
    72.7 ± 4.5
    70.3 ± 2.9
    71.7 ± 5.14
        Total protein, Day 14: n=12, 13, 12
    73.6 ± 4.85
    70.2 ± 3.35
    71.7 ± 5.79
        Total protein, Day 21: n=12, 13, 12
    71.7 ± 4.03
    70.2 ± 3.06
    71.3 ± 4.52
        Total protein, Day 29: pre-dose, n=11, 13, 12
    70 ± 6.87
    68.5 ± 5.98
    70.3 ± 5
        Total protein, Day 29: 4 hr, n=12, 10, 11
    67.1 ± 5.68
    67.3 ± 6
    65.9 ± 4.93
        Total protein, Day 32: n=11, 13, 12
    72.4 ± 3.64
    71.5 ± 2.44
    71.3 ± 3.82
        Total protein, Day 42: n=12, 13, 12
    72.8 ± 4.15
    70.2 ± 2.45
    70.9 ± 4.38
        Total protein, Day 57: n=12, 13, 12
    72 ± 2.73
    68.5 ± 5.58
    71.1 ± 4.25
        Total protein, Day 85: n=11, 12, 12
    72.1 ± 2.91
    71.3 ± 5.3
    70.3 ± 4.96
        Total protein, Day 120: n=11, 13, 12
    73.3 ± 4.47
    70.2 ± 3.21
    71 ± 5.44
        Total protein, Day 165: n=12, 12, 12
    72.3 ± 2.96
    70.8 ± 3.36
    70.5 ± 5.14
        Total protein, follow-up: n=12, 11, 12
    73.2 ± 4.11
    69.9 ± 3.59
    70.8 ± 3.67
    Notes
    [10] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [11] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [12] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: ALP, ALT, AST, and GGT values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (FU)

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    End point title
    ALP, ALT, AST, and GGT values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (FU)
    End point description
    Alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [13]
    13 [14]
    12 [15]
    Units: International Units per liter (IU/L)
    arithmetic mean (standard deviation)
        ALP, Screening, n=12, 13, 12
    78.5 ± 23.65
    66.8 ± 13.39
    76.6 ± 25.72
        ALP, Day 1: pre-dose, n= 12, 12, 12
    74.5 ± 22.15
    63.7 ± 17.03
    69.9 ± 20.08
        ALP, Day 1: 4 hr, n=11, 12, 11
    71.4 ± 22.01
    62.9 ± 12.67
    68.5 ± 23.11
        ALP, Day 4, n=11, 13, 11
    83.4 ± 27.58
    64.2 ± 14.29
    73.6 ± 21.64
        ALP, Day 9, n=12, 13, 12
    79.6 ± 25.45
    66.2 ± 14.28
    70.2 ± 18.5
        ALP, Day 14, n=12, 13, 12
    79.3 ± 23.26
    62.1 ± 14.74
    71.9 ± 19.72
        ALP, Day 21, n=12, 13, 12
    77.1 ± 22.92
    63.7 ± 12.4
    74.9 ± 23.38
        ALP, Day 29: pre-dose, n=11, 13, 12
    74 ± 25.25
    63.5 ± 16.61
    74.3 ± 24.73
        ALP, Day 29: 4 hr, n=12, 10, 11
    72.8 ± 20.77
    57.1 ± 12.93
    71.7 ± 25.78
        ALP, Day 32, n=11, 13, 12
    83.4 ± 24.43
    64.2 ± 12.84
    75.5 ± 26.22
        ALP, Day 42, n=12, 13, 12
    80.4 ± 22.91
    61.3 ± 12.05
    71.7 ± 23
        ALP, Day 57, n=12, 13, 12
    78.1 ± 23.54
    59.8 ± 12.07
    70 ± 17.66
        ALP, Day 85, n=11,12, 12
    79.8 ± 20.85
    66.7 ± 12.46
    69.7 ± 19.12
        ALP, Day 120, n=11, 13, 12
    75 ± 21.67
    65.8 ± 13.86
    72.8 ± 20.97
        ALP, Day 165, n=12, 12, 12
    79.5 ± 23.73
    62.1 ± 13.12
    69.7 ± 20.22
        ALP, follow-up, n=12, 12, 12
    81.8 ± 22.68
    64.3 ± 16.74
    74.1 ± 18.88
        ALT, Screening, n=12, 13, 12
    34.3 ± 21.24
    27.9 ± 20.73
    28.4 ± 13.14
        ALT, Day 1: pre-dose, n=12, 12, 12
    30.7 ± 19.78
    26.3 ± 13.14
    26.2 ± 12.68
        ALT, Day 1: 4 hr, n=11, 12, 11
    29.4 ± 20.58
    28.6 ± 18.56
    26.5 ± 11.83
        ALT, Day 4, n=11, 13, 11
    32.2 ± 24.06
    29.6 ± 18.04
    27.4 ± 14.32
        ALT, Day 9, n=12, 13, 12
    31.8 ± 22.03
    26.3 ± 18.21
    25.7 ± 11.26
        ALT, Day 14, n=12, 13, 12
    30.3 ± 17.57
    25.5 ± 14.23
    29.9 ± 16.47
        ALT, Day 21, n=12, 13, 12
    29.3 ± 15.51
    25.7 ± 15.62
    31.3 ± 20.44
        ALT, Day 29: pre-dose, n=11, 13, 12
    26.7 ± 15.25
    25.4 ± 15.44
    28 ± 20.1
        ALT, Day 29: 4 hr, n=12, 10, 11
    25.8 ± 15
    24.5 ± 15.15
    26 ± 19.88
        ALT, Day 32, n=11, 13, 12
    29.2 ± 17.53
    26.2 ± 15.36
    27.7 ± 16.14
        ALT, Day 42, n=12, 13, 12
    26.3 ± 12.91
    25.2 ± 16.05
    21.6 ± 9.95
        ALT, Day 57, n=12, 13, 12
    27.8 ± 16.27
    27.1 ± 23.17
    24.1 ± 12.09
        ALT, Day 85, n=11, 12, 12
    23.6 ± 13.97
    28.3 ± 19.11
    22.3 ± 12.14
        ALT, Day 120, n=11, 13, 12
    28.3 ± 17.23
    27.2 ± 20
    24.1 ± 11.45
        ALT, Day 165, n=12, 12, 12
    25.8 ± 15.01
    28.3 ± 16.74
    29.8 ± 16.82
        ALT, follow-up, n=12, 12, 12
    28.8 ± 20.26
    27.7 ± 16.29
    26.2 ± 19.69
        AST, Screening, n=12, 13, 12
    28.3 ± 15.52
    23.1 ± 7.64
    30.3 ± 22.34
        AST, Day 1: pre-dose, n=12, 12, 12
    24.3 ± 11.24
    23.4 ± 6.57
    32.3 ± 22.5
        AST, Day 1: 4 hr, n= 11, 12, 11
    23.5 ± 12.19
    25.5 ± 11.71
    32.1 ± 20.6
        AST, Day 4, n=11, 13, 11
    26.9 ± 15.48
    28 ± 12.32
    29.3 ± 16.55
        AST, Day 9, n=12, 13, 12
    25.1 ± 11.58
    24.1 ± 11.15
    26.8 ± 12.74
        AST, Day 14, n=12, 13, 12
    23.8 ± 9.04
    23.4 ± 7.26
    31.3 ± 14.26
        AST, Day 21, n=12, 13, 12
    24 ± 8.34
    24.1 ± 11.51
    30.3 ± 15.99
        AST, Day 29: pre-dose, n=11, 13, 12
    23.9 ± 10.82
    24.5 ± 8.88
    26.8 ± 11.17
        AST, Day 29: 4 hr, n=12, 10, 11
    23.3 ± 10.69
    25.6 ± 10.89
    24.3 ± 12.55
        AST, Day 32, n=11, 13, 12
    25.6 ± 12.08
    26.5 ± 15.15
    26.1 ± 11.16
        AST, Day 42, n=12, 13, 12
    23.5 ± 8.57
    24.8 ± 11.04
    23.1 ± 7.22
        AST, Day 57, n=12, 13, 12
    23.5 ± 8.03
    27.2 ± 16.27
    26.4 ± 10.79
        AST, Day 85, n=11, 12, 12
    22 ± 7.04
    27.2 ± 12.3
    25.3 ± 9.39
        AST, Day 120, n=11, 13, 12
    24.7 ± 10.2
    27.8 ± 14.05
    25.5 ± 8.12
        AST, Day 165, n=12, 12, 11
    21.8 ± 7.31
    27.7 ± 16.04
    29.3 ± 15.43
        AST, follow-up, n=12, 12, 12
    23 ± 9.89
    30.2 ± 26.01
    30.6 ± 20.18
        GGT, Screening, n=12, 13, 12
    82.4 ± 91.07
    54.5 ± 44.72
    67.1 ± 78.69
        GGT, Day 1: pre-dose, n=12, 12, 12
    77.4 ± 93.11
    51.3 ± 49.89
    56.6 ± 63.91
        GGT, Day 1: 4 hr, n=11, 12, 11
    75.1 ± 92.04
    51.5 ± 40.97
    58.1 ± 64.05
        GGT, Day 4, n=11, 13, 11
    83.3 ± 114.1
    49.3 ± 39.21
    59.4 ± 59.95
        GGT, Day 9, n=12, 13, 12
    79.3 ± 98.99
    47.3 ± 37.47
    53.8 ± 54.12
        GGT, Day 14, n=12, 13, 12
    81.3 ± 104.94
    45.3 ± 34.15
    58.8 ± 70.41
        GGT, Day 21, n=12, 13, 12
    78.4 ± 102.85
    46.8 ± 34.7
    60.6 ± 76.89
        GGT, Day 29: pre-dose, n=11, 13, 12
    77.4 ± 86.33
    45.4 ± 34.77
    61.8 ± 78.46
        GGT, Day 29: 4 hr, n=12, 10, 11
    67.4 ± 79.37
    38.5 ± 30.31
    61.9 ± 86.34
        GGT, Day 32, n=11, 13, 12
    79.1 ± 87.28
    45.5 ± 33.09
    63.6 ± 80.35
        GGT, Day 42, n=12, 13, 12
    74.1 ± 87.81
    43.2 ± 30.1
    58.8 ± 69.92
        GGT, Day 57, n=12, 13, 12
    74.8 ± 84.94
    43 ± 30.35
    63.9 ± 87.39
        GGT, Day 85, n=11, 12,12
    76 ± 78.73
    50.7 ± 36.28
    54.8 ± 58.61
        GGT, Day 120, n=11, 13, 12
    76.5 ± 99.72
    51.8 ± 45.21
    55 ± 45.87
        GGT, Day 165, n=12, 12, 12
    68.1 ± 72.82
    54.2 ± 46.06
    54.3 ± 36.98
        GGT, follow-up, n=12, 12, 12
    81.5 ± 113.46
    52.4 ± 44.69
    51.5 ± 44.76
    Notes
    [13] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [14] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [15] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Total bilirubin (TB), direct bilirubin (DB), uric acid, and creatinine values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Total bilirubin (TB), direct bilirubin (DB), uric acid, and creatinine values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    TB, DB, uric acid, and creatinine were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [16]
    13 [17]
    12 [18]
    Units: Micromoles per liter (µmol/L)
    arithmetic mean (standard deviation)
        TB, Screening, n=12, 13, 12
    11.4 ± 5.18
    12.3 ± 9.45
    12.5 ± 4.91
        TB, Day 1: pre-dose, n=12, 12, 12
    10.6 ± 3.63
    12 ± 10.13
    10.6 ± 4.5
        TB, Day 1: 4 hr, n= 11, 12, 11
    10.4 ± 4.7
    12.8 ± 9.29
    11.5 ± 6.41
        TB, Day 4, n=11, 13, 11
    9.7 ± 3.41
    13.1 ± 8.87
    10.8 ± 4.94
        TB, Day 9, n=12, 13, 12
    11.1 ± 4.62
    11.6 ± 7.63
    11.4 ± 6.43
        TB, Day 14, n=12, 13, 12
    9.8 ± 3.89
    9.5 ± 4.98
    9.3 ± 3.42
        TB, Day 21, n=12, 13, 12
    10.6 ± 4.06
    11.2 ± 6.79
    9.1 ± 4.19
        TB, Day 29: pre-dose, n=11, 13, 12
    10.5 ± 4.74
    9.8 ± 6.92
    8 ± 3.72
        TB, Day 29: 4 hr, n=12, 10, 11
    9.3 ± 4.67
    11.2 ± 6.56
    9 ± 3.46
        TB, Day 32, n=11, 13, 12
    10.8 ± 4.62
    10.2 ± 5.51
    10.4 ± 3.96
        TB, Day 42, n=12, 13, 12
    9.4 ± 2.61
    10.6 ± 5.42
    9.7 ± 3.94
        TB, Day 57, n=12, 13, 12
    9.7 ± 4.25
    9.4 ± 5.84
    10.3 ± 4.9
        TB, Day 85, n=11, 12, 12
    10.4 ± 4.13
    10.3 ± 8.55
    9.2 ± 3.86
        TB, Day 120, n=11, 13, 12
    9.9 ± 4.87
    11.1 ± 7.86
    10.3 ± 3.52
        TB, Day 165, n=12, 12, 12
    12.3 ± 5.12
    12.4 ± 10.08
    9.6 ± 4.17
        TB, follow-up, n=12, 11, 12
    10.5 ± 3.9
    9.7 ± 5.88
    11.4 ± 5.37
        DB, Screening, n=12, 13, 12
    2.3 ± 1.14
    2.4 ± 1.39
    2.5 ± 1.09
        DB, Day 1: pre-dose, n=12, 12, 12
    2.2 ± 0.94
    2.2 ± 1.47
    2.3 ± 1.07
        DB, Day 1: 4 hr, n=11, 12 ,11
    2.3 ± 1.1
    2.3 ± 0.97
    2.4 ± 1.12
        DB, Day 4, n=11, 13, 11
    2.1 ± 0.7
    2.5 ± 1.33
    2.4 ± 1.12
        DB, Day 9, n=12, 13, 12
    2.3 ± 1.14
    2.5 ± 1.33
    2.5 ± 1.45
        DB, Day 14, n=12, 13, 12
    2.2 ± 1.03
    1.8 ± 1.07
    2.3 ± 0.89
        DB, Day 21, n=12, 13, 12
    2.1 ± 1.08
    2.3 ± 1.11
    1.9 ± 0.79
        DB, Day 29: pre-dose, n=11, 13, 12
    2.3 ± 1.01
    2 ± 1.29
    1.6 ± 0.79
        DB, Day 29: 4 hr, n=12, 10 ,11
    1.8 ± 0.83
    2.5 ± 0.97
    1.8 ± 0.98
        DB, Day 32, n=11, 13, 12
    2.4 ± 1.03
    2.1 ± 0.95
    2.1 ± 0.9
        DB, Day 42, n=12, 13, 12
    1.9 ± 0.79
    2.4 ± 1.19
    2.1 ± 0.79
        DB, Day 57, n=12, 13, 12
    1.8 ± 0.97
    1.9 ± 1.04
    2.2 ± 0.94
        DB, Day 85, n=11, 12, 12
    2.1 ± 0.83
    1.9 ± 1.44
    1.9 ± 1
        DB, Day 120, n=11, 13, 12
    2.1 ± 1.22
    2.3 ± 1.44
    2.2 ± 0.94
        DB, Day 165, n=12, 12, 12
    2.2 ± 1.19
    2.3 ± 1.72
    2.2 ± 1.19
        DB, follow-up, n=12, 12, 12
    2.2 ± 0.94
    1.8 ± 1.14
    2.5 ± 1.45
        Uric acid, Screening, n=12, 13, 12
    383.4 ± 90.22
    343.2 ± 45.25
    403.7 ± 141.38
        Uric acid, Day 1: pre-dose, n=12, 12, 12
    354.6 ± 69.19
    317.3 ± 48.27
    367.3 ± 115.15
        Uric acid, Day 1: 4 hr, n=11, 12, 11
    345.1 ± 76.77
    337.1 ± 44.8
    374.6 ± 113.7
        Uric acid, Day 4, n=11, 13, 11
    378.9 ± 73.68
    339.2 ± 53.7
    342.5 ± 70.47
        Uric acid, Day 9, n=12, 13, 12
    394.8 ± 72.25
    327.5 ± 54.67
    362.1 ± 113.01
        Uric acid, Day 14, n=12, 13, 12
    371.5 ± 73.76
    329.7 ± 38.12
    359.3 ± 106.74
        Uric acid, Day 21, n=12, 13,12
    377.4 ± 86.41
    349.4 ± 51.24
    369.9 ± 96.93
        Uric acid, Day 29: pre-dose, n=11, 13, 12
    373.8 ± 73.15
    318.2 ± 65.52
    351.3 ± 71.56
        Uric acid, Day 29: 4 hr, n=12, 10, 11
    377.7 ± 70.13
    335.2 ± 72.78
    369.2 ± 74.77
        Uric acid, Day 32, n=11, 13, 12
    363.9 ± 61.45
    338.5 ± 49.29
    360 ± 98.91
        Uric acid, Day 42, n=12, 13,1 2
    360.3 ± 66.93
    339.1 ± 49.42
    375.1 ± 107.18
        Uric acid, Day 57, n=12, 13, 12
    378.5 ± 70.18
    342.3 ± 72.58
    368.2 ± 97.41
        Uric acid, Day 85, n=11, 12, 12
    389.6 ± 75.62
    360.3 ± 57.89
    382.2 ± 86.89
        Uric acid, Day 120, n=11, 13, 12
    387.1 ± 73.72
    348.7 ± 60.3
    408.2 ± 133.75
        Uric acid, Day 165, n=12, 12, 12
    389.3 ± 92.6
    336 ± 52.75
    388.9 ± 118.78
        Uric acid, follow-up, n=12, 12, 12,
    375.3 ± 69.54
    351.7 ± 58.99
    400.3 ± 96.21
        Creatinine, Screening, n=12, 13, 12
    79.25 ± 12.629
    66.7 ± 22.865
    84.45 ± 36.172
        Creatinine, Day 1: pre-dose, n=12, 12, 12
    72.76 ± 9.329
    58.76 ± 21.306
    74.5 ± 29.48
        Creatinine, Day 1: 4 hr, n=11, 12, 11
    73.75 ± 13.953
    70.83 ± 20.913
    86.65 ± 36.271
        Creatinine, Day 4, n=11, 13, 11
    80.42 ± 13.807
    65.68 ± 21.55
    73.27 ± 23.152
        Creatinine, Day 9, n=12, 13, 12
    78.53 ± 9.959
    67.18 ± 27.883
    81.54 ± 38.35
        Creatinine, Day 14, n=12, 13, 12
    78.38 ± 8.858
    68.25 ± 22.215
    76.5 ± 30.091
        Creatinine, Day 21, n=12, 13, 12
    78.79 ± 11.323
    67.54 ± 23.637
    76.13 ± 23.563
        Creatinine, Day 29: pre-dose, n=11, 13 12
    75.26 ± 14.326
    63.05 ± 23.346
    70.58 ± 18.802
        Creatinine, Day 29: 4 hr, n=12, 10, 11
    80.6 ± 11.768
    64.69 ± 13.575
    83.14 ± 24.275
        Creatinine, Day 32, n=11, 13, 12
    78.19 ± 13.893
    69.72 ± 21.132
    73.79 ± 23.517
        Creatinine, Day 42, n=12, 13, 12
    79.58 ± 11.309
    67.9 ± 21.074
    76.68 ± 21.286
        Creatinine, Day 57, n=12, 13, 12
    79.43 ± 12.603
    62.82 ± 21.557
    72.2 ± 20.543
        Creatinine, Day 85, n=12, 12, 12
    77.98 ± 9.552
    65.96 ± 23.705
    73.3 ± 19.516
        Creatinine, Day 120, n=11, 13, 12
    81.96 ± 11.361
    68.87 ± 22.896
    77.58 ± 20.079
        Creatinine, Day 165, n=12, 12, 12
    83.46 ± 10.87
    71.09 ± 31.678
    76.02 ± 19.963
        Creatinine, follow-up, n=12, 12, 12
    82.77 ± 11.985
    72.35 ± 29.601
    80.14 ± 22.997
    Notes
    [16] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [17] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [18] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Potassium, glucose, calcium, cholesterol, HDL, LDL, chloride, creatinine, sodium, triglycerides, and urea/BUN values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and FU

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    End point title
    Potassium, glucose, calcium, cholesterol, HDL, LDL, chloride, creatinine, sodium, triglycerides, and urea/BUN values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and FU
    End point description
    Potassium, glucose, calcium, cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, chloride, creatinine, sodium, triglycerides, and urea/BUN values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [19]
    13 [20]
    12 [21]
    Units: Millimoles/liter (mmol/L)
    arithmetic mean (standard deviation)
        Potassium, Screening, n=12, 13, 12
    4.41 ± 0.494
    4.32 ± 0.377
    4.37 ± 0.41
        Potassium, Day 1: pre-dose, n=12, 12, 12
    4.3 ± 0.349
    4.27 ± 0.331
    4.28 ± 0.351
        Potassium, Day 1: 4 hr, n= 11, 12, 11
    4 ± 0.654
    4.18 ± 0.374
    4.42 ± 0.506
        Potassium, Day 4, n=11, 13, 11
    4.35 ± 0.281
    4.42 ± 0.637
    4.46 ± 0.266
        Potassium, Day 9, n=12, 13,12
    4.37 ± 0.308
    4.28 ± 0.359
    4.54 ± 0.37
        Potassium, Day 14, n=12, 13, 12
    4.51 ± 0.468
    4.5 ± 0.497
    4.66 ± 0.613
        Potassium, Day 21, n=12, 13, 12
    4.42 ± 0.371
    4.51 ± 0.388
    4.56 ± 0.466
        Potassium, Day 29: pre-dose, n=11, 13, 12
    4.27 ± 0.561
    4.19 ± 0.366
    4.3 ± 0.388
        Potassium, Day 29: 4 hr, n=12, 10, 11
    4.32 ± 0.6
    4 ± 0.478
    4.25 ± 0.468
        Potassium, Day 32, n=11, 13, 12
    4.48 ± 0.343
    4.59 ± 0.689
    4.51 ± 0.442
        Potassium, Day 42, n=12, 13, 12
    4.51 ± 0.219
    4.48 ± 0.511
    4.66 ± 0.558
        Potassium, Day 57, n=12, 13, 12
    4.48 ± 0.515
    4.28 ± 0.277
    4.25 ± 0.355
        Potassium, Day 85, n=11, 12, 12
    4.37 ± 0.358
    4.4 ± 0.451
    4.38 ± 0.51
        Potassium, Day 120, n=11, 13, 12
    4.51 ± 0.308
    4.56 ± 0.686
    4.4 ± 0.437
        Potassium, Day 165, n=12, 12, 11
    4.52 ± 0.609
    4.38 ± 0.411
    4.19 ± 0.532
        Potassium, follow-up, n=12, 12, 12
    4.5 ± 0.499
    4.42 ± 0.465
    4.52 ± 0.371
        Glucose, Day 1: pre-dose, n=12, 13, 12
    10.04 ± 2.545
    8.64 ± 1.532
    9.26 ± 1.89
        Glucose, Day 1: 4 hr, n= 12, 13, 12
    12.45 ± 4.058
    9.33 ± 1.7
    11.65 ± 3.087
        Glucose, Day 4, n=11, 13, 11
    9.91 ± 2.117
    8.41 ± 1.317
    9.33 ± 1.939
        Glucose, Day 9, n=12, 13, 12
    9.72 ± 1.799
    8.32 ± 1.445
    9.08 ± 1.173
        Glucose, Day 14, n=11, 13, 12
    9.76 ± 1.691
    8.7 ± 1.942
    8.88 ± 1.633
        Glucose, Day 21, n=12, 13, 12
    9.77 ± 1.308
    8.86 ± 2.042
    9.08 ± 1.904
        Glucose, Day 29: pre-dose, n=12, 13, 12
    9.76 ± 1.898
    8.37 ± 1.758
    9.22 ± 1.736
        Glucose, Day 29: 4 hr, n=12, 13, 12
    11.55 ± 3.987
    10.01 ± 2.761
    10.73 ± 2.776
        Glucose, Day 32, n=12, 13, 12
    9.58 ± 1.436
    8.64 ± 1.877
    9.15 ± 1.868
        Glucose, Day 42, n=12, 13, 12
    9.84 ± 1.829
    8.22 ± 1.438
    9.68 ± 3.568
        Glucose, Day 57, n=12, 13, 12
    9.05 ± 1.652
    8.43 ± 1.849
    8.13 ± 1.659
        Glucose, Day 85, n=12, 13, 12
    9.25 ± 1.71
    8.82 ± 2.127
    8.68 ± 2.146
        Glucose, Day 120, n=11, 13, 12
    8.73 ± 1.716
    9.62 ± 2.533
    9.01 ± 1.714
        Glucose, Day 165, n=12, 13, 12
    8.84 ± 1.388
    8.98 ± 2.318
    8.94 ± 1.713
        Glucose, follow-up, n=12, 13, 12
    9.81 ± 2.475
    8.67 ± 2.322
    9.55 ± 3.499
        Calcium, Screening, n=12, 13, 12
    2.467 ± 0.0931
    2.445 ± 0.0723
    2.416 ± 0.0742
        Calcium, Day 1: pre-dose, n=12, 12, 12
    2.35 ± 0.1681
    2.361 ± 0.1423
    2.405 ± 0.0888
        Calcium, Day 1: 4 hr, n= 11, 12, 11
    2.322 ± 0.2997
    2.4 ± 0.1135
    2.401 ± 0.1018
        Calcium, Day 4, n=11, 13, 11
    2.45 ± 0.0647
    2.382 ± 0.0941
    2.424 ± 0.1083
        Calcium, Day 9, n=12, 13, 12
    2.473 ± 0.0913
    2.406 ± 0.0749
    2.428 ± 0.1194
        Calcium, Day 14, n=12, 13, 12
    2.465 ± 0.0657
    2.396 ± 0.0947
    2.341 ± 0.1847
        Calcium, Day 21, n=12, 13, 12
    2.453 ± 0.0729
    2.423 ± 0.0774
    2.377 ± 0.0986
        Calcium, Day 29: pre-dose, n=11, 13,12
    2.394 ± 0.2223
    2.335 ± 0.1815
    2.392 ± 0.079
        Calcium, Day 29: 4 hr, n=12, 10, 11
    2.351 ± 0.2092
    2.301 ± 0.2548
    2.355 ± 0.1026
        Calcium, Day 32, n=11, 13, 12
    2.425 ± 0.0505
    2.392 ± 0.1129
    2.399 ± 0.0762
        Calcium, Day 42, n=12, 13, 12
    2.456 ± 0.0784
    2.404 ± 0.0636
    2.397 ± 0.1367
        Calcium, Day 57, n=12, 13, 12
    2.411 ± 0.1108
    2.319 ± 0.1689
    2.383 ± 0.1041
        Calcium, Day 85, n=11, 12, 12
    2.455 ± 0.0792
    2.413 ± 0.1013
    2.423 ± 0.1314
        Calcium, Day 120, n=11, 13, 12
    2.448 ± 0.1002
    2.365 ± 0.1761
    2.407 ± 0.0579
        Calcium, Day 165, n=12, 12, 11
    2.459 ± 0.1145
    2.426 ± 0.0915
    2.396 ± 0.1068
        Calcium, follow-up, n=12, 11, 12
    2.453 ± 0.0758
    2.37 ± 0.0952
    2.412 ± 0.0992
        Cholesterol, Screening, n=12, 13, 12
    4.691 ± 0.9451
    4.616 ± 0.9833
    4.93 ± 1.135
        Cholesterol, Day 1: pre-dose, n= 12, 12, 12
    4.445 ± 0.7338
    4.442 ± 1.0774
    4.501 ± 1.2156
        Cholesterol, Day 1: 4 hr, n=11, 12, 11
    4.189 ± 0.8437
    4.361 ± 0.7929
    4.307 ± 1.2554
        Cholesterol, Day 4, n=11, 13, 11
    4.489 ± 0.7969
    4.465 ± 0.9046
    4.38 ± 1.2766
        Cholesterol, Day 9, n=12, 13, 12
    4.454 ± 0.8224
    4.365 ± 0.8639
    4.325 ± 1.1791
        Cholesterol, Day 14, n=12, 13, 12
    4.428 ± 0.9009
    4.37 ± 0.875
    4.4 ± 1.1531
        Cholesterol, Day 21, n=12, 13, 12
    4.434 ± 0.9178
    4.528 ± 0.8273
    4.452 ± 1.2251
        Cholesterol, Day 29: pre-dose, n=11, 13, 12
    4.221 ± 0.8373
    4.281 ± 1.0434
    4.562 ± 1.0764
        Cholesterol, Day 29: 4 hr, n=12, 10, 11
    4.236 ± 0.9041
    4.009 ± 0.8938
    4.265 ± 1.1512
        Cholesterol, Day 32, n=11, 13, 12
    4.542 ± 0.8357
    4.305 ± 0.8342
    4.462 ± 1.0283
        Cholesterol, Day 42, n=12, 13, 12
    4.698 ± 0.6961
    4.312 ± 0.7405
    4.531 ± 1.1809
        Cholesterol, Day 57, n=12, 13, 12
    4.785 ± 1.0829
    4.292 ± 0.829
    4.763 ± 1.5079
        Cholesterol, Day 85, n=11, 12, 12
    4.936 ± 1.2475
    4.582 ± 0.9766
    4.585 ± 1.2112
        Cholesterol, Day 120, n=11, 13, 12
    4.56 ± 0.9324
    4.364 ± 1.0527
    4.778 ± 1.2748
        Cholesterol, Day 165, n=12, 12, 12
    4.691 ± 1.0977
    4.345 ± 0.7629
    4.748 ± 1.0543
        Cholesterol, follow-up, n=12, 12, 12
    4.944 ± 1.1249
    4.64 ± 0.8404
    4.32 ± 1.2699
        HCD, Screening, n=12, 13, 12
    1.038 ± 0.2031
    1.068 ± 0.2076
    1.103 ± 0.3764
        HCD, Day 1: pre-dose, n=12, 12, 12
    0.987 ± 0.1997
    1.021 ± 0.1821
    1.028 ± 0.3983
        HCD, Day 1: 4 hr, n= 11, 12, 11
    0.882 ± 0.2371
    0.905 ± 0.1766
    0.908 ± 0.3601
        HCD, Day 4, n=11, 13, 11
    1.016 ± 0.1767
    1.018 ± 0.1763
    1.059 ± 0.4174
        HCD, Day 9, n=12, 13, 12
    1.044 ± 0.2095
    1.052 ± 0.2055
    1.092 ± 0.4131
        HCD, Day 14, n=12, 13, 12
    1.031 ± 0.2288
    1.058 ± 0.231
    1.128 ± 0.4724
        HCD, Day 21, n=12, 13, 12
    1.059 ± 0.2206
    1.086 ± 0.2239
    1.15 ± 0.5763
        HCD, Day 29: pre-dose, n=11, 13,12
    0.979 ± 0.2402
    1.035 ± 0.1966
    1.144 ± 0.5198
        HCD, Day 29: 4 hr, n=12, 10, 11
    0.89 ± 0.1842
    0.945 ± 0.2067
    1.035 ± 0.5248
        HCD, Day 32, n=11, 13, 12
    1.056 ± 0.2792
    1.049 ± 0.2238
    1.128 ± 0.4264
        HCD, Day 42, n=12, 13, 12
    1.05 ± 0.2429
    1.061 ± 0.2222
    1.147 ± 0.4933
        HCD, Day 57, n=12, 13, 12
    1.008 ± 0.2057
    1.066 ± 0.2412
    1.143 ± 0.4881
        HCD, Day 85, n=11, 12, 12
    1.034 ± 0.2695
    1.071 ± 0.2734
    1.147 ± 0.4588
        HCD, Day 120, n=11, 13, 12
    1.043 ± 0.2749
    1.111 ± 0.3225
    1.143 ± 0.4692
        HCD, Day 165, n=12, 12, 12
    1.04 ± 0.2663
    1.123 ± 0.2947
    1.115 ± 0.3964
        HCD, follow-up, n=12, 12, 12
    1.118 ± 0.2713
    1.103 ± 0.2074
    1.101 ± 0.4437
        LCC, Screening, n=12, 13, 12
    2.554 ± 0.808
    2.669 ± 0.8961
    2.937 ± 1.131
        LCC, Day 1: pre-dose, n=12, 12, 12
    2.361 ± 0.8784
    2.624 ± 0.9658
    2.564 ± 1.1659
        LCC, Day 1: 4 hr, n=11, 12, 10
    1.907 ± 0.7812
    2.228 ± 0.7441
    2.228 ± 1.1966
        LCC, Day 4, n=11, 13, 11
    2.373 ± 0.8578
    2.684 ± 0.8231
    2.605 ± 1.2231
        LCC, Day 9, n=12, 13, 12
    2.304 ± 0.7187
    2.523 ± 0.8824
    2.449 ± 1.1501
        LCC, Day 14, n=12, 13, 12
    2.273 ± 0.7569
    2.497 ± 0.7612
    2.484 ± 1.0383
        LCC, Day 21, n=12, 13, 12
    2.346 ± 0.9068
    2.577 ± 0.8484
    2.468 ± 0.9989
        LCC, Day 29: pre-dose, n=11, 13, 12
    2.185 ± 0.8694
    2.522 ± 1.0284
    2.521 ± 0.9772
        LCC, Day 29: 4 hr, n=12, 10, 11
    1.998 ± 0.8793
    2.067 ± 0.8523
    2.105 ± 1.0604
        LCC, Day 32, n=11, 13, 12
    2.482 ± 0.6992
    2.45 ± 0.7498
    2.583 ± 0.9974
        LCC, Day 42, n=11, 13, 12
    2.693 ± 0.6449
    2.505 ± 0.7698
    2.563 ± 1.0248
        LCC, Day 57, n=12, 13, 12
    2.587 ± 1.0039
    2.474 ± 0.8736
    2.693 ± 1.3943
        LCC, Day 85, n=11, 12, 12
    2.738 ± 1.1679
    2.598 ± 0.885
    2.587 ± 1.1567
        LCC, Day 120, n=10, 13, 12
    2.591 ± 0.8264
    2.435 ± 0.9239
    2.639 ± 1.138
        LCC, Day 165, n=12, 12, 12
    2.556 ± 1.2146
    2.453 ± 0.6825
    2.718 ± 1.119
        LCC, follow-up, n=12, 12, 12
    2.672 ± 1.224
    2.736 ± 0.7792
    2.366 ± 1.2395
        Chloride, Screening, n=12, 13, 12
    103.6 ± 2.39
    101.7 ± 2.98
    103.1 ± 3.45
        Chloride, Day 1: pre-dose, n=12, 12, 12
    104.2 ± 2.92
    103.2 ± 3.71
    103.2 ± 3.59
        Chloride, Day 1: 4 hr, n= 11, 12, 11
    103.3 ± 5.14
    101.8 ± 3.16
    102.7 ± 3.38
        Chloride, Day 4, n=11, 13, 11
    102.3 ± 3.13
    102.1 ± 2.5
    103.9 ± 4.44
        Chloride, Day 9, n=12, 13, 12
    102.8 ± 1.82
    102 ± 2.24
    103.9 ± 3.15
        Chloride, Day 14, n=12, 13, 12
    102.1 ± 2.5
    102.8 ± 3.05
    103.7 ± 4.23
        Chloride, Day 21, n=12, 13, 12
    103.2 ± 2.59
    102.2 ± 3.48
    104 ± 2.76
        Chloride, Day 29: pre-dose, n=11, 13, 12
    104.5 ± 3.21
    103.2 ± 1.86
    103.2 ± 3.24
        Chloride, Day 29: 4 hr, n=12, 10, 11
    102.6 ± 4.21
    103.2 ± 5.12
    103.9 ± 2.84
        Chloride, Day 32, n=11, 13, 12
    103.5 ± 3.24
    102.4 ± 2.53
    103.7 ± 3.45
        Chloride, Day 42, n=12, 13, 12
    102.8 ± 2.34
    102.7 ± 2.98
    102.8 ± 2.59
        Chloride, Day 57, n=12, 13, 12
    103.4 ± 1.83
    104.1 ± 3.95
    104.1 ± 3
        Chloride, Day 85, n=11, 12, 12
    103.5 ± 2.88
    102.7 ± 2.57
    103.8 ± 3.44
        Chloride, Day 120, n=11, 13, 12
    102.8 ± 1.94
    102.5 ± 2.88
    103 ± 3.19
        Chloride, Day 165, n=12, 12,1 2
    103.3 ± 2.34
    103.1 ± 2.94
    102.7 ± 3.65
        Chloride, follow-up, n=12, 12,12
    103.3 ± 2.53
    102.1 ± 2.91
    103.4 ± 3.37
        Sodium, Screening, n=12, 13, 12
    140.3 ± 1.96
    138.5 ± 2.15
    138.8 ± 1.19
        Sodium, Day 1: pre-dose, n=12, 12, 12
    139.4 ± 2.15
    138.5 ± 3.03
    139.2 ± 1.47
        Sodium, Day 1: 4 hr, n=11, 12, 11
    138 ± 2.83
    138.3 ± 2.38
    137.7 ± 1.9
        Sodium, Day 4, n=11, 13, 11
    138.9 ± 2.07
    139.3 ± 2.36
    139.2 ± 1.89
        Sodium, Day 9, n=12, 13, 12
    138.8 ± 2.04
    138 ± 1.78
    139.3 ± 1.54
        Sodium, Day 14, n=12, 13, 12
    139.5 ± 1.17
    139.6 ± 2.43
    139.9 ± 2.19
        Sodium, Day 21, n=12, 13, 12
    139.3 ± 1.61
    138.5 ± 2.37
    139.7 ± 1.56
        Sodium, Day 29: pre-dose, n=11, 13, 12
    139.5 ± 1.69
    138.5 ± 1.9
    139.2 ± 2.29
        Sodium, Day 29: 4 hr, n=12, 10, 11
    137.9 ± 2.87
    139.2 ± 3.08
    138.1 ± 1.58
        Sodium, Day 32, n=11, 13, 12
    139.6 ± 1.69
    139.5 ± 2.07
    139 ± 1.71
        Sodium, Day 42, n=12, 13, 12
    139.2 ± 2.29
    139.2 ± 1.77
    138.5 ± 1.78
        Sodium, Day 57, n=12, 13, 12
    140.1 ± 1.73
    138.5 ± 2.54
    140.1 ± 1.98
        Sodium, Day 85, n=11, 12, 12
    139.1 ± 2.21
    138.5 ± 1.45
    139.4 ± 1.38
        Sodium, Day 120, n=11, 13, 12
    139.4 ± 2.2
    138.7 ± 3.2
    139.6 ± 1.38
        Sodium, Day 165, n=12, 12, 12
    139.3 ± 1.48
    138.6 ± 2.61
    138.4 ± 1.38
        Sodium, follow-up, n=12, 12, 12
    139.7 ± 1.97
    139.1 ± 2.39
    139.5 ± 2.68
        Triglyceride, Screening, n=12, 13, 12
    2.398 ± 0.9159
    1.915 ± 0.8348
    1.941 ± 0.6399
        Triglyceride, Day 1: pre-dose, n=12, 12, 12
    2.394 ± 0.802
    1.736 ± 0.8439
    1.988 ± 0.7275
        Triglyceride, Day 1: 4 hr, n=11, 12, 11
    3.055 ± 0.6153
    2.676 ± 0.9959
    2.575 ± 1.0535
        Triglyceride, Day 4, n=11, 13, 11
    2.396 ± 1.1058
    1.663 ± 0.6341
    1.554 ± 0.4501
        Triglyceride, Day 9, n=12, 13, 12
    2.41 ± 0.7973
    1.722 ± 0.8948
    1.707 ± 0.8005
        Triglyceride, Day 14, n=12, 13, 12
    2.448 ± 0.8671
    1.774 ± 0.8668
    1.718 ± 0.6216
        Triglyceride, Day 21, n=12, 13, 12
    2.243 ± 0.739
    1.887 ± 0.8812
    1.818 ± 0.8204
        Triglyceride, Day 29: pre-dose, n=11, 13, 12
    2.305 ± 0.785
    1.582 ± 0.7214
    1.953 ± 0.733
        Triglyceride, Day 29: 4 hr, n=12, 10, 11
    2.941 ± 0.5848
    2.172 ± 1.0823
    2.454 ± 0.8392
        Triglyceride, Day 32, n=11, 13, 12
    2.186 ± 0.8153
    1.755 ± 0.8522
    1.64 ± 0.4573
        Triglyceride, Day 42, n=12, 13, 12
    2.598 ± 1.5567
    1.625 ± 0.5765
    1.787 ± 0.5062
        Triglyceride, Day 57, n=12, 13, 12
    2.597 ± 0.8576
    1.642 ± 0.687
    2.019 ± 0.7403
        Triglyceride, Day 85, n=11, 12, 12
    2.54 ± 0.8901
    1.987 ± 0.6512
    1.856 ± 0.5816
        Triglyceride, Day 120, n=11, 13, 12
    2.522 ± 1.4038
    1.785 ± 1.012
    2.174 ± 0.6871
        Triglyceride, Day 165, n=12, 12, 12
    2.387 ± 1.0518
    1.675 ± 0.866
    1.998 ± 0.7234
        Triglyceride, follow-up, n=12, 12, 12
    2.516 ± 1.0983
    1.748 ± 0.7628
    1.858 ± 0.6771
        Urea/BUN, Screening, n=12, 13, 12
    7.56 ± 2.65
    5.52 ± 1.357
    6.15 ± 2.388
        Urea/BUN, Day 1: pre-dose, n=12, 12, 12
    6.33 ± 1.866
    5.53 ± 1.281
    6.76 ± 4.384
        Urea/BUN, Day 1: 4 hr, n=11, 12, 11
    6.3 ± 1.581
    6.01 ± 1.178
    7.32 ± 4.064
        Urea/BUN, Day 4, n=11, 13, 11
    6.76 ± 1.397
    5.75 ± 0.759
    6.58 ± 2.923
        Urea/BUN, Day 9, n=12, 13, 12
    6.41 ± 1.005
    5.35 ± 1.087
    6.98 ± 3.595
        Urea/BUN, Day 14, n=12, 13, 12
    6.48 ± 1.434
    5.99 ± 1.495
    6.7 ± 3.821
        Urea/BUN, Day 21, n=12, 13, 12
    6.86 ± 1.685
    5.75 ± 1.222
    6.36 ± 1.846
        Urea/BUN, Day 29: pre-dose, n=11, 13, 12
    6.97 ± 2.039
    5.54 ± 1.309
    5.85 ± 1.633
        Urea/BUN, Day 29: 4 hr, n=12, 10, 11
    7.13 ± 1.697
    5.73 ± 0.906
    6.55 ± 1.929
        Urea/BUN, Day 32, n=11, 13, 12
    6.86 ± 1.604
    5.78 ± 1.118
    6.38 ± 2.173
        Urea/BUN, Day 42, n=12, 13, 12
    6.53 ± 1.224
    5.67 ± 1.005
    6.4 ± 1.744
        Urea/BUN, Day 57, n=12, 13, 12
    6.68 ± 1.805
    5.65 ± 1.335
    6.27 ± 2.163
        Urea/BUN, Day 85, n=11, 12, 12
    6.72 ± 1.211
    5.76 ± 1.835
    6.33 ± 2.106
        Urea/BUN, Day 120, n=11, 13, 12
    7.46 ± 1.751
    5.92 ± 1.101
    6.19 ± 1.771
        Urea/BUN, Day 165, n=12, 12, 12
    6.93 ± 2.355
    6.03 ± 1.463
    6.25 ± 2.058
        Urea/BUN, follow-up, n=12, 12, 12
    7.04 ± 1.929
    6.03 ± 1.069
    6.38 ± 2.086
    Notes
    [19] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [20] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [21] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Total cholesterol/HDL ratio (TC/HDL ratio), HDL/LDL ratio, and triglyceride/HDL ratio (TG/HDL ratio) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Total cholesterol/HDL ratio (TC/HDL ratio), HDL/LDL ratio, and triglyceride/HDL ratio (TG/HDL ratio) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    TC/HDL ratio, HDL/LDL ratio, and triglyceride/HDL ratio values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [22]
    13 [23]
    12 [24]
    Units: Ratio
    arithmetic mean (standard deviation)
        TC/HDL ratio, Screening, n=12, 13, 12
    4.5517 ± 0.67139
    4.4335 ± 1.16277
    4.8275 ± 1.61827
        TC/HDL ratio, Day 1: pre-dose, n=12, 12, 12
    4.5833 ± 0.75575
    4.4437 ± 1.3486
    4.8528 ± 1.98221
        TC/HDL ratio, Day 1: 4 hr, n= 11, 12, 11
    4.8928 ± 0.95411
    4.9908 ± 1.40456
    5.2906 ± 2.31631
        TC/HDL ratio, Day 4, n=11, 13, 11
    4.4785 ± 0.79579
    4.4726 ± 1.16211
    4.539 ± 1.81475
        TC/HDL ratio, Day 9, n=12, 13, 12
    4.3908 ± 1.05287
    4.2825 ± 1.21595
    4.3225 ± 1.66246
        TC/HDL ratio, Day 14, n=12, 13, 12
    4.3954 ± 0.93858
    4.266 ± 1.16649
    4.2618 ± 1.56118
        TC/HDL ratio, Day 21, n=12, 13, 12
    4.264 ± 0.81159
    4.3206 ± 1.22274
    4.3941 ± 1.90723
        TC/HDL ratio, Day 29: pre-dose, n=11, 13, 12
    4.3882 ± 0.73541
    4.2708 ± 1.36303
    4.544 ± 2.02278
        TC/HDL ratio, Day 29: 4 hr, n=12, 10, 11
    4.8172 ± 0.92837
    4.4191 ± 1.45277
    4.7201 ± 2.12839
        TC/HDL ratio, Day 32, n=11, 13, 12
    4.4461 ± 0.87461
    4.3118 ± 1.51533
    4.323 ± 1.6147
        TC/HDL ratio, Day 42, n=12, 13, 12
    4.6364 ± 1.06085
    4.2224 ± 1.14198
    4.3167 ± 1.59367
        TC/HDL ratio, Day 57, n=12, 13, 12
    4.8836 ± 1.42324
    4.221 ± 1.29056
    4.5542 ± 1.97068
        TC/HDL ratio, Day 85, n=11, 12, 12
    4.97 ± 1.58565
    4.5079 ± 1.43704
    4.421 ± 1.9158
        TC/HDL ratio, Day 120, n=11, 13, 12
    4.4824 ± 0.67007
    4.2153 ± 1.71395
    4.6894 ± 2.096
        TC/HDL ratio, Day 165, n=12, 12, 12
    4.6683 ± 1.2241
    4.1097 ± 1.38627
    4.7094 ± 1.87947
        TC/HDL ratio, follow-up, n=12, 12, 12
    4.5717 ± 1.11481
    4.3414 ± 1.13258
    4.258 ± 1.43006
        HDL/LDL ratio, Screening, n=12, 13, 12
    0.4322 ± 0.11034
    0.4349 ± 0.14208
    0.4299 ± 0.21361
        HDL/LDL ratio, Day 1: pre-dose, n=12, 12, 12
    0.489 ± 0.2366
    0.4271 ± 0.13
    0.4816 ± 0.28547
        HDL/LDL ratio, Day 1: 4 hr, n=11, 12, 10
    0.571 ± 0.31912
    0.4393 ± 0.12977
    0.5166 ± 0.29093
        HDL/LDL ratio, Day 4, n=11, 13, 11
    0.4904 ± 0.2106
    0.409 ± 0.12033
    0.4879 ± 0.27487
        HDL/LDL ratio, Day 9, n=12, 13, 12
    0.4962 ± 0.1882
    0.4571 ± 0.15287
    0.5602 ± 0.33874
        HDL/LDL ratio, Day 14, n=12, 13, 12
    0.4958 ± 0.18073
    0.4536 ± 0.13598
    0.5247 ± 0.2519
        HDL/LDL ratio, Day 21, n=12, 13, 12
    0.5028 ± 0.17479
    0.4568 ± 0.14559
    0.5263 ± 0.2703
        HDL/LDL ratio, Day 29: pre-dose, n=11, 13, 12
    0.5429 ± 0.29396
    0.4583 ± 0.15254
    0.5254 ± 0.32512
        HDL/LDL ratio, Day 29: 4 hr, n=11, 10, 11
    0.569 ± 0.33723
    0.511 ± 0.17463
    0.5969 ± 0.32829
        HDL/LDL ratio, Day 32, n=11, 13, 12
    0.4463 ± 0.12702
    0.4682 ± 0.16788
    0.5001 ± 0.25773
        HDL/LDL ratio, Day 42, n=11, 13, 12
    0.4219 ± 0.14536
    0.4587 ± 0.15812
    0.5164 ± 0.25657
        HDL/LDL ratio, Day 57, n=12, 13, 12
    0.4418 ± 0.17798
    0.4759 ± 0.18751
    0.5732 ± 0.41531
        HDL/LDL ratio, Day 85, n=11, 12, 12
    0.4347 ± 0.17966
    0.4483 ± 0.16274
    0.5525 ± 0.38936
        HDL/LDL ratio, Day 120, n=10, 13, 12
    0.4365 ± 0.10934
    0.4966 ± 0.17561
    0.5176 ± 0.3155
        HDL/LDL ratio, Day 165, n=12, 12, 12
    0.5048 ± 0.27435
    0.4811 ± 0.15581
    0.5289 ± 0.44948
        HDL/LDL ratio, follow-up, n=12, 12, 12
    0.4963 ± 0.2287
    0.4322 ± 0.14335
    0.581 ± 0.37442
        TG/HDL ratio, Screening, n=12, 13, 12
    2.3782 ± 0.97356
    1.9368 ± 1.10017
    2.0276 ± 1.1114
        TG/HDL ratio, Day 1: pre-dose, n=12, 12, 12
    2.5398 ± 1.09229
    1.7328 ± 0.81922
    2.2982 ± 1.40144
        TG/HDL ratio, Day 1: 4 hr, n=11, 12, 11
    3.7321 ± 1.34144
    3.1181 ± 1.41296
    3.3154 ± 1.89189
        TG/HDL ratio, Day 4, n=11, 13, 11
    2.5015 ± 1.33091
    1.6556 ± 0.59018
    1.7557 ± 1.0279
        TG/HDL ratio, Day 9, n=12, 13, 12
    2.4587 ± 1.08718
    1.7316 ± 0.94072
    1.8978 ± 1.26276
        TG/HDL ratio, Day 14, n=12, 13, 12
    2.5216 ± 1.13514
    1.8014 ± 1.0782
    1.8224 ± 1.15332
        TG/HDL ratio, Day 21, n=12, 13, 12
    2.2854 ± 1.11024
    1.9121 ± 1.22395
    1.965 ± 1.25287
        TG/HDL ratio, Day 29: pre-dose, n=11, 13, 12
    2.5333 ± 1.26093
    1.6627 ± 1.04388
    2.1053 ± 1.38927
        TG/HDL ratio, Day 29: 4 hr, n=12, 10, 11
    3.4249 ± 1.02583
    2.4966 ± 1.45071
    2.8369 ± 1.54468
        TG/HDL ratio, Day 32, n=11, 13, 12
    2.2721 ± 1.07761
    1.8371 ± 1.25628
    1.6781 ± 0.79591
        TG/HDL ratio, Day 42, n=12, 13, 12
    2.7965 ± 2.27015
    1.6805 ± 0.89388
    1.8026 ± 0.87202
        TG/HDL ratio, Day 57, n=12, 13, 12
    2.7234 ± 1.12785
    1.7039 ± 1.04513
    1.9699 ± 0.99277
        TG/HDL ratio, Day 85, n=11, 12, 12
    2.7858 ± 1.62412
    2.0578 ± 1.04219
    1.827 ± 0.91655
        TG/HDL ratio, Day 120, n=11, 13, 12
    2.781 ± 2.29533
    1.9532 ± 1.78872
    2.2421 ± 1.27475
        TG/HDL ratio, Day 165, n=12, 12, 12
    2.5915 ± 1.63262
    1.7162 ± 1.37165
    2.0827 ± 1.22584
        TG/HDL ratio, follow-up, n=12, 12, 12
    2.512 ± 1.49353
    1.675 ± 0.83953
    1.9843 ± 1.18512
    Notes
    [22] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [23] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [24] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Glomerular filtration rate (GFR) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Glomerular filtration rate (GFR) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    GFR values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [25]
    13 [26]
    12 [27]
    Units: mL/second/1.73 meters squared (m^2)
    arithmetic mean (standard deviation)
        GFR, Day 1: pre-dose, n=12, 12, 12
    1.58511 ± 0.277574
    2.02627 ± 0.46816
    1.67696 ± 0.608263
        GFR, Day 1: 4 hr, n= 11, 11, 11
    1.59561 ± 0.4595
    1.63205 ± 0.416637
    1.40432 ± 0.491131
        GFR, Day 4, n=11, 13, 11
    1.41343 ± 0.288603
    1.78818 ± 0.405897
    1.63053 ± 0.503625
        GFR, Day 9, n=12, 13, 12
    1.44594 ± 0.226133
    1.79975 ± 0.455115
    1.54058 ± 0.531265
        GFR, Day 14, n=12, 13, 12
    1.44316 ± 0.21988
    1.71753 ± 0.436966
    1.60877 ± 0.538198
        GFR, Day 21, n=12, 13, 12
    1.44316 ± 0.226469
    1.75093 ± 0.429564
    1.54893 ± 0.430925
        GFR, Day 29: pre-dose, n=11, 13, 12
    1.54551 ± 0.347694
    1.90508 ± 0.475019
    1.66443 ± 0.455756
        GFR, Day 29: 4 hr, n=12, 9, 11
    1.4195 ± 0.295839
    1.66258 ± 0.314443
    1.37395 ± 0.359659
        GFR, Day 32, n=11, 13, 12
    1.46353 ± 0.280965
    1.65844 ± 0.379313
    1.62547 ± 0.509746
        GFR, Day 42, n=12, 13, 12
    1.42646 ± 0.227363
    1.71239 ± 0.37693
    1.5197 ± 0.443158
        GFR, Day 57, n=12, 13, 12
    1.44316 ± 0.280753
    1.89481 ± 0.491664
    1.63799 ± 0.479404
        GFR, Day 85, n=12, 12, 12
    1.45568 ± 0.227182
    1.78551 ± 0.428052
    1.59068 ± 0.427914
        GFR, Day 120, n=11, 13, 12
    1.36636 ± 0.231621
    1.70725 ± 0.44379
    1.48491 ± 0.390837
        GFR, Day 165, n=12, 12, 12
    1.34157 ± 0.158323
    1.77855 ± 0.601052
    1.52527 ± 0.417065
        GFR, follow-up, n=12, 12, 12
    1.35966 ± 0.219071
    1.71036 ± 0.533234
    1.46821 ± 0.4867
    Notes
    [25] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [26] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [27] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Basophil, eosinophil, lymphocyte, monocyte, segmented neutrophil (SN), TN, platelet count, and WBC count values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Basophil, eosinophil, lymphocyte, monocyte, segmented neutrophil (SN), TN, platelet count, and WBC count values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    Basophil, eosinophil, lymphocyte, monocyte, SN, total neutrophil (TN), platelet count, and white blood cell (WBC) count values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [28]
    13 [29]
    12 [30]
    Units: 10^9 cells per liter (GI/L)
    arithmetic mean (standard deviation)
        Basophils, Screening, n=12, 12, 11
    0.035 ± 0.0109
    0.026 ± 0.0156
    0.024 ± 0.0121
        Basophils, Day 1: pre-dose, n=12, 13, 11
    0.031 ± 0.009
    0.028 ± 0.0109
    0.026 ± 0.0175
        Basophils, Day 1: 4 hr, n=12, 12, 11
    0.027 ± 0.0115
    0.027 ± 0.0115
    0.028 ± 0.0154
        Basophils, Day 4, n=11, 12, 11
    0.037 ± 0.0149
    0.038 ± 0.0269
    0.032 ± 0.0125
        Basophils, Day 9, n=12, 13, 12
    0.029 ± 0.0067
    0.028 ± 0.0121
    0.035 ± 0.0183
        Basophils, Day 14, n=12, 12, 12
    0.039 ± 0.0116
    0.035 ± 0.0157
    0.032 ± 0.014
        Basophils, Day 21, n=12, 13, 12
    0.036 ± 0.0151
    0.032 ± 0.0128
    0.031 ± 0.0183
        Basophils, Day 29: pre-dose, n=12, 13, 12
    0.038 ± 0.0164
    0.025 ± 0.012
    0.027 ± 0.0161
        Basophils, Day 29: 4 hr, n=12, 13, 11
    0.032 ± 0.0103
    0.028 ± 0.0215
    0.027 ± 0.0127
        Basophils, Day 32, n=12, 13, 10
    0.038 ± 0.0094
    0.026 ± 0.0119
    0.031 ± 0.0238
        Basophils, Day 42, n=12, 13, 12
    0.037 ± 0.0167
    0.026 ± 0.0145
    0.033 ± 0.0166
        Basophils, Day 57, n=12, 13, 12
    0.028 ± 0.0111
    0.025 ± 0.0105
    0.03 ± 0.0154
        Basophils, Day 85, n=12, 13, 12
    0.03 ± 0.0121
    0.025 ± 0.0156
    0.028 ± 0.0111
        Basophils, Day 120, n=10, 13, 12
    0.031 ± 0.012
    0.035 ± 0.0181
    0.031 ± 0.0151
        Basophils, Day 165, n=12, 13, 12
    0.035 ± 0.0162
    0.037 ± 0.017
    0.032 ± 0.0185
        Basophils, follow-up, n=12, 13, 12
    0.032 ± 0.0119
    0.032 ± 0.0099
    0.028 ± 0.019
        Eosinophils, Screening, n=12, 12, 11
    0.193 ± 0.1046
    0.139 ± 0.0728
    0.211 ± 0.1612
        Eosinophils, Day 1: pre-dose, n=12, 13, 11
    0.21 ± 0.1648
    0.206 ± 0.1295
    0.234 ± 0.1539
        Eosinophils, Day 1: 4 hr, 12, 12, 11
    0.157 ± 0.13
    0.216 ± 0.2164
    0.206 ± 0.1496
        Eosinophils, Day 4, n=11, 12, 11
    0.216 ± 0.1214
    0.143 ± 0.0862
    0.226 ± 0.1364
        Eosinophils, Day 9, n=12, 13, 12
    0.188 ± 0.106
    0.188 ± 0.1166
    0.288 ± 0.2169
        Eosinophils, Day 14, n=12, 12, 12
    0.228 ± 0.141
    0.185 ± 0.0834
    0.246 ± 0.1154
        Eosinophils, Day 21, n=12, 13, 12
    0.234 ± 0.1725
    0.202 ± 0.1057
    0.258 ± 0.1638
        Eosinophils, Day 29: pre-dose, n=12, 13, 12
    0.232 ± 0.218
    0.198 ± 0.1514
    0.209 ± 0.1396
        Eosinophils, Day 29: 4 hr, n=12, 13, 11
    0.205 ± 0.2068
    0.211 ± 0.1413
    0.18 ± 0.1096
        Eosinophils, Day 32, n=12, 13, 10
    0.193 ± 0.1321
    0.204 ± 0.1183
    0.254 ± 0.1767
        Eosinophils, Day 42, n=12, 13, 12
    0.219 ± 0.1439
    0.18 ± 0.124
    0.247 ± 0.1942
        Eosinophils, Day 57, n=12, 13, 12
    0.216 ± 0.1323
    0.168 ± 0.115
    0.239 ± 0.1647
        Eosinophils, Day 85, n=12, 13, 12
    0.226 ± 0.1479
    0.161 ± 0.0867
    0.242 ± 0.1591
        Eosinophils, Day 120, n=10, 13, 12
    0.252 ± 0.1578
    0.185 ± 0.126
    0.275 ± 0.2013
        Eosinophils, Day 165, n=12, 13, 12
    0.193 ± 0.124
    0.178 ± 0.1133
    0.235 ± 0.1278
        Eosinophils, follow-up, n=12, 13, 12
    0.184 ± 0.0738
    0.219 ± 0.1547
    0.233 ± 0.1667
        Lymphocytes, Screening, n=12, 12, 11
    2.317 ± 0.5927
    1.953 ± 0.4253
    2.091 ± 0.6873
        Lymphocytes, Day 1: pre-dose, n=12, 13, 11
    2.343 ± 0.6072
    2.001 ± 0.5459
    2.138 ± 0.5642
        Lymphocytes, Day 1: 4 hr, n=12, 12, 11
    2.518 ± 0.7608
    2.204 ± 0.4915
    2.525 ± 0.7586
        Lymphocytes, Day 4, n=11, 12, 11
    2.648 ± 0.7298
    2.114 ± 0.471
    2.466 ± 0.7101
        Lymphocytes, Day 9, n=12, 13, 12
    2.598 ± 0.6504
    2.251 ± 0.5491
    2.513 ± 0.9688
        Lymphocytes, Day 14, n=12, 12, 12
    2.527 ± 0.5543
    2.185 ± 0.6946
    2.554 ± 0.8373
        Lymphocytes, Day 21, n=12, 13, 12
    2.443 ± 0.6599
    2.225 ± 0.5516
    2.559 ± 0.8931
        Lymphocytes, Day 29: pre-dose, n=12, 13, 12
    2.291 ± 0.6079
    1.948 ± 0.5789
    2.204 ± 0.6951
        Lymphocytes, Day 29: 4 hr, n=12, 13, 11
    2.534 ± 0.919
    2.446 ± 0.6275
    2.535 ± 0.8419
        Lymphocytes, Day 32, n=12, 13, 10
    2.428 ± 0.5944
    2.102 ± 0.656
    2.625 ± 0.6761
        Lymphocytes, Day 42, n=12, 13, 12
    2.28 ± 0.5761
    2.063 ± 0.5239
    2.384 ± 0.7138
        Lymphocytes, Day 57, n=12, 13, 12
    2.503 ± 0.5448
    2.211 ± 0.5601
    2.349 ± 0.8857
        Lymphocytes, Day 85, n=12, 13, 12
    2.324 ± 0.4915
    2.126 ± 0.6184
    2.413 ± 0.7779
        Lymphocytes, Day 120, n=10, 13, 12
    2.406 ± 0.3655
    2.122 ± 0.6655
    2.431 ± 0.6785
        Lymphocytes, Day 165, n=12, 13, 12
    2.481 ± 0.608
    2.277 ± 0.6019
    2.639 ± 0.965
        Lymphocytes, follow-up, n=12, 13, 12
    2.487 ± 0.5731
    2.182 ± 0.5712
    2.395 ± 0.9368
        Monocytes, Screening, n=12, 12, 11
    0.468 ± 0.1902
    0.444 ± 0.1418
    0.529 ± 0.1316
        Monocytes, Day 1: pre-dose, n=12, 13, 11
    0.452 ± 0.2115
    0.41 ± 0.1112
    0.591 ± 0.1929
        Monocytes, Day 1: 4 hr, n=12, 12, 11
    0.486 ± 0.2782
    0.464 ± 0.1623
    0.578 ± 0.2161
        Monocytes, Day 4, n=11, 12, 11
    0.564 ± 0.2131
    0.451 ± 0.1527
    0.553 ± 0.156
        Monocytes, Day 9, n=12, 13, 12
    0.551 ± 0.1814
    0.445 ± 0.1359
    0.601 ± 0.1812
        Monocytes, Day 14, n=12, 12, 12
    0.53 ± 0.153
    0.412 ± 0.1216
    0.567 ± 0.1654
        Monocytes, Day 21, n=12, 13, 12
    0.495 ± 0.2371
    0.439 ± 0.1556
    0.579 ± 0.1896
        Monocytes, Day 29: pre-dose, n=12, 13, 12
    0.52 ± 0.2108
    0.412 ± 0.2101
    0.483 ± 0.1345
        Monocytes, Day 29: 4 hr, n=12, 13, 11
    0.46 ± 0.2046
    0.481 ± 0.2329
    0.467 ± 0.1995
        Monocytes, Day 32, n=12, 13, 10
    0.524 ± 0.1996
    0.427 ± 0.161
    0.542 ± 0.1701
        Monocytes, Day 42, n=12, 13, 12
    0.508 ± 0.1889
    0.437 ± 0.1413
    0.526 ± 0.1477
        Monocytes, Day 57, n=12, 13, 12
    0.47 ± 0.1399
    0.414 ± 0.1281
    0.499 ± 0.1303
        Monocytes, Day 85, n=12, 13, 12
    0.503 ± 0.2007
    0.412 ± 0.0966
    0.505 ± 0.142
        Monocytes, Day 120, n=10, 13, 12
    0.503 ± 0.1905
    0.451 ± 0.1327
    0.561 ± 0.1402
        Monocytes, Day 165, n=12, 13, 12
    0.501 ± 0.1996
    0.457 ± 0.1375
    0.581 ± 0.1507
        Monocytes, follow-up, n=12, 13, 12
    0.518 ± 0.1865
    0.437 ± 0.1496
    0.562 ± 0.1711
        SN, Screening, n=12, 12, 11
    5.658 ± 1.3836
    4.668 ± 0.6027
    4.772 ± 0.9135
        SN, Day 1: pre-dose, n=12, 13, 11
    4.954 ± 1.4938
    4.72 ± 0.6397
    5.231 ± 1.0358
        SN, Day 1: 4 hr, n=12, 12, 11
    5.373 ± 1.3816
    4.793 ± 1.0974
    4.85 ± 1.1057
        SN, Day 4, n=11, 12, 11
    5.729 ± 2.5059
    5.228 ± 2.6104
    4.43 ± 1.0647
        SN, Day 9, n=12, 13, 12
    5.368 ± 1.9487
    4.686 ± 0.8311
    5.444 ± 2.7529
        SN, Day 14, n=12, 12, 12
    4.639 ± 1.524
    4.373 ± 0.6839
    4.836 ± 1.4616
        SN, Day 21, n=12, 13, 12
    5.059 ± 1.3648
    4.536 ± 0.813
    4.655 ± 1.9044
        SN, Day 29: pre-dose, n=12, 13, 12
    4.863 ± 1.2799
    4.545 ± 1.3399
    4.265 ± 0.9905
        SN, Day 29: 4 hr, n=12, 13, 11
    4.793 ± 1.692
    4.93 ± 1.7753
    4.43 ± 0.8664
        SN, Day 32, n=12, 13, 10
    4.951 ± 1.2533
    4.165 ± 0.776
    4.642 ± 1.3905
        SN, Day 42, n=12, 13, 12
    4.608 ± 1.148
    4.312 ± 1.4833
    4.745 ± 2.1018
        SN, Day 57, n=12, 13, 12
    4.852 ± 1.6242
    4.294 ± 0.7175
    4.654 ± 1.0599
        SN, Day 85, n=12, 13, 12
    4.706 ± 1.5539
    4.673 ± 1.0079
    4.43 ± 1.1635
        SN, Day 120, n=10, 13, 12
    4.507 ± 1.1009
    4.198 ± 0.9874
    4.753 ± 1.7489
        SN, Day 165, n=12, 13, 12
    5.13 ± 2.0136
    4.512 ± 0.9273
    4.999 ± 2.0022
        SN, follow-up, n=12, 13, 12
    4.866 ± 1.4912
    4.525 ± 0.6462
    4.787 ± 1.592
        TN, Screening, n=12, 12, 11
    5.658 ± 1.3836
    4.668 ± 0.6027
    4.772 ± 0.9135
        TN, Day 1: pre-dose, n=12, 13, 11
    4.954 ± 1.4938
    4.72 ± 0.6397
    5.231 ± 1.0358
        TN, Day 1: 4 hr, n=12, 12, 11
    5.373 ± 1.3816
    4.793 ± 1.0974
    4.85 ± 1.1057
        TN, Day 4, n=11, 12, 11
    5.729 ± 2.5059
    5.228 ± 2.6104
    4.43 ± 1.0647
        TN, Day 9, n=12, 13, 12
    5.368 ± 1.9487
    4.686 ± 0.8311
    5.444 ± 2.7529
        TN, Day 14, n=12, 12, 12
    4.639 ± 1.524
    4.373 ± 0.6839
    4.836 ± 1.4616
        TN, Day 21, n=12, 13, 12
    5.059 ± 1.3648
    4.536 ± 0.813
    4.655 ± 1.9044
        TN, Day 29: pre-dose, n=12, 13, 12
    4.863 ± 1.2799
    4.545 ± 1.3399
    4.265 ± 0.9905
        TN, Day 29: 4 hr, n=12, 13, 11
    4.793 ± 1.692
    4.93 ± 1.7753
    4.43 ± 0.8664
        TN, Day 32, n=12, 13, 10
    4.951 ± 1.2533
    4.165 ± 0.776
    4.642 ± 1.3905
        TN, Day 42, n=12, 13, 12
    4.608 ± 1.148
    4.312 ± 1.4833
    4.745 ± 2.1018
        TN, Day 57, n=12, 13, 12
    4.852 ± 1.6242
    4.294 ± 0.7175
    4.654 ± 1.0599
        TN, Day 85, n=12, 13, 12
    4.706 ± 1.5539
    4.673 ± 1.0079
    4.43 ± 1.1635
        TN, Day 120, n=10, 13, 12
    4.507 ± 1.1009
    4.198 ± 0.9874
    4.753 ± 1.7489
        TN, Day 165, n=12, 13, 12
    5.13 ± 2.0136
    4.512 ± 0.9273
    4.999 ± 2.0022
        TN, follow-up, n=12, 13, 12
    4.866 ± 1.4912
    4.525 ± 0.6462
    4.787 ± 1.592
        Platelet count, Screening, n=12, 12, 11
    227.2 ± 75.31
    242.3 ± 47.09
    195.4 ± 43.98
        Platelet count, Day 1: pre-dose, n=12, 13, 11
    226.6 ± 60.08
    234.2 ± 46.94
    196.5 ± 46.74
        Platelet count, Day 1: 4 hr, n=11, 12, 11
    225.8 ± 56.85
    235 ± 56.47
    205.6 ± 37.71
        Platelet count, Day 4, n=11, 12, 11
    233.6 ± 48.43
    258.7 ± 48.85
    214.8 ± 51.29
        Platelet count, Day 9, n=12, 13, 12
    228 ± 58.56
    249.2 ± 47.53
    209 ± 53.27
        Platelet count, Day 14, n=12, 13, 12
    236.1 ± 59.29
    238.5 ± 46.69
    222.8 ± 61.53
        Platelet count, Day 21, n=12, 13, 12
    238.2 ± 61.79
    244.2 ± 43.88
    199.9 ± 63.66
        Platelet count, Day 29: pre-dose, n=12, 12, 12
    224.6 ± 57.84
    237 ± 62.61
    185.8 ± 50.99
        Platelet count, Day 29: 4 hr, n=12, 13, 11
    221.4 ± 64.4
    237.8 ± 47.91
    180.9 ± 55.12
        Platelet count, Day 32, n=12, 13, 10
    240.6 ± 63.98
    249.2 ± 50.03
    209.4 ± 53.34
        Platelet count, Day 42, n=12, 13, 12
    234 ± 62.46
    251.8 ± 49.72
    201.9 ± 41.39
        Platelet count, Day 57, n=12, 12, 12
    225.7 ± 67.79
    237.1 ± 60.1
    192.3 ± 35.73
        Platelet count, Day 85, n=12, 12, 11
    221.8 ± 56.57
    244.2 ± 60.92
    200.2 ± 44.46
        Platelet count, Day 120, n=10, 13, 12
    235.2 ± 54.93
    241.5 ± 52.38
    203.4 ± 54.48
        Platelet count, Day 165, n=12, 13, 12
    232.5 ± 57.26
    255.6 ± 59.77
    204.3 ± 58
        Platelet count, follow-up, n=12, 13, 12
    244.5 ± 56.29
    249.5 ± 51.44
    212.2 ± 57.93
        WBC count, Screening, n=12, 12, 11
    8.67 ± 1.815
    7.23 ± 0.757
    7.62 ± 1.494
        WBC count, Day 1: pre-dose, n=12, 13, 11
    8 ± 1.982
    7.36 ± 0.991
    8.21 ± 1.662
        WBC count, Day 1: 4 hr, n=12, 12, 11
    8.58 ± 1.863
    7.7 ± 1.149
    8.17 ± 1.532
        WBC count, Day 4, n=11, 12, 11
    9.21 ± 2.841
    7.98 ± 2.817
    7.71 ± 1.624
        WBC count, Day 9, n=12, 12, 12
    8.74 ± 2.499
    7.6 ± 1.211
    8.88 ± 3.038
        WBC count, Day 14, n=12, 13, 12
    7.97 ± 1.835
    7.18 ± 1.257
    8.23 ± 1.855
        WBC count, Day 21, n=12, 13, 12
    8.26 ± 1.856
    7.45 ± 1.2
    8.08 ± 2.369
        WBC count, Day 29: pre-dose, n=12, 13, 12
    7.94 ± 1.681
    7.13 ± 1.66
    7.2 ± 1.591
        WBC count, Day 29: 4 hr, n=12, 13, 11
    8.02 ± 1.794
    8.1 ± 1.626
    7.65 ± 1.457
        WBC count, Day 32, n=12, 13, 10
    8.13 ± 1.766
    6.92 ± 1.114
    8.11 ± 2.221
        WBC count, Day 42, n=12, 13, 12
    7.65 ± 1.645
    7.02 ± 1.81
    7.94 ± 2.696
        WBC count, Day 57, n=12, 13, 12
    8.08 ± 2.065
    7.12 ± 1.094
    7.78 ± 1.796
        WBC count, Day 85, n=12, 13, 11
    7.79 ± 1.891
    7.38 ± 1.409
    7.62 ± 1.823
        WBC count, Day 120, n=10, 13, 12
    7.69 ± 1.339
    7 ± 1.348
    8.06 ± 2.21
        WBC count, Day 165, n=12, 13, 12
    8.34 ± 2.567
    7.47 ± 1.386
    8.48 ± 2.975
        WBC count, follow-up, n=12, 13, 12
    8.08 ± 1.875
    7.39 ± 1.054
    8.01 ± 2.012
    Notes
    [28] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [29] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [30] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Hemoglobin and mean corpuscle hemoglobin concentration (MCHC) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Hemoglobin and mean corpuscle hemoglobin concentration (MCHC) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    Hemoglobin and MCHC values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [31]
    13 [32]
    12 [33]
    Units: Grams per liter (G/L)
    arithmetic mean (standard deviation)
        Hemoglobin, Screening, n=12, 12, 11
    156.8 ± 17.52
    149.6 ± 18.31
    149.1 ± 9.98
        Hemoglobin, Day 1: pre-dose, n=12, 13, 11
    150.8 ± 14.28
    145.3 ± 17.72
    144.7 ± 9.1
        Hemoglobin, Day 1: 4 hr, n=12, 12, 11
    145.3 ± 12.11
    139.1 ± 12.65
    137.5 ± 7.57
        Hemoglobin, Day 4, n=11, 12, 11
    152.8 ± 16.33
    142.8 ± 16.26
    143 ± 8.41
        Hemoglobin, Day 9, n=12, 13, 12
    152.7 ± 14.12
    143.2 ± 17.2
    141.4 ± 10.18
        Hemoglobin, Day 14, n=12, 13, 12
    152.8 ± 13.74
    143.2 ± 16.47
    142.1 ± 9.34
        Hemoglobin, Day 21, n=12, 13, 12
    152 ± 13.75
    144.3 ± 16.99
    142.4 ± 11.07
        Hemoglobin, Day 29: pre-dose, n=12, 13, 12
    148.4 ± 13.63
    139.8 ± 17.51
    139.8 ± 11.69
        Hemoglobin, Day 29: 4 hr, n=12, 13, 11
    145.3 ± 14.12
    139.7 ± 17.14
    135.6 ± 8.63
        Hemoglobin, Day 32, n=12, 13, 10
    148.5 ± 12.52
    140.9 ± 17.26
    141.5 ± 11.34
        Hemoglobin, Day 42, n=12, 13, 12
    149.4 ± 12.65
    140.9 ± 17.07
    140.4 ± 11.08
        Hemoglobin, Day 57, n=12, 13, 12
    149.9 ± 13.7
    140.2 ± 17.51
    141 ± 11.95
        Hemoglobin, Day 85, n=12, 13, 12
    150.5 ± 16.28
    142.5 ± 16.57
    139 ± 11.1
        Hemoglobin, Day 120, n=10, 13, 12
    151.4 ± 17.37
    142.3 ± 20.33
    141.9 ± 13.96
        Hemoglobin, Day 165, n=12, 13, 12
    150.6 ± 15.62
    142.5 ± 20.28
    140.3 ± 13.72
        Hemoglobin, follow-up, n=12, 13, 12
    151.3 ± 14.69
    142.1 ± 22.08
    139.8 ± 12.63
        MCHC, Screening, n=12, 12, 11
    326.6 ± 9.06
    324.4 ± 7.86
    327.4 ± 11.29
        MCHC, Day 1: pre-dose, n=12, 13, 11
    326.6 ± 7.69
    322.8 ± 10.43
    327.6 ± 10.06
        MCHC, Day 1: 4 hr, n=12, 12, 11
    325 ± 6.52
    320.8 ± 11.26
    326.5 ± 7.83
        MCHC, Day 4, n=11, 12, 11
    326.4 ± 10.54
    325.8 ± 8.08
    327.4 ± 6.44
        MCHC, Day 9, n=12, 13, 12
    328.5 ± 11.21
    323.3 ± 6.51
    327.7 ± 11.48
        MCHC, Day 14, n=12, 13, 12
    325.2 ± 8.39
    325.1 ± 9.73
    328.8 ± 7.69
        MCHC, Day 21, n=12, 13, 12
    325.3 ± 8.76
    324.3 ± 6.34
    326.5 ± 6.74
        MCHC, Day 29: pre-dose, n=12, 13, 12
    326 ± 11.1
    320.1 ± 11.75
    320.8 ± 13.04
        MCHC, Day 29: 4 hr, n=12, 13, 11
    323 ± 7.16
    318.6 ± 10.34
    323.1 ± 11.67
        MCHC, Day 32, n=12, 13, 10
    326.9 ± 11.47
    323.2 ± 8.98
    325.1 ± 6.3
        MCHC, Day 42, n=12, 13, 12
    324.8 ± 9.61
    321.5 ± 10.96
    322.6 ± 9.1
        MCHC, Day 57, n=12, 13, 12
    323.8 ± 11.34
    321.2 ± 9.55
    323.2 ± 6.45
        MCHC, Day 85, n=12, 13, 12
    323.2 ± 10.22
    317.8 ± 8.27
    320.2 ± 7.4
        MCHC, Day 120, n=10, 13, 12
    321.3 ± 7.59
    319 ± 9.49
    319.8 ± 7.85
        MCHC, Day 165, n=12, 13, 12
    322.4 ± 9.77
    318.9 ± 7.24
    319 ± 6.81
        MCHC, follow-up, n=12, 13, 12
    319.3 ± 11.52
    318.8 ± 8.86
    319 ± 9.12
    Notes
    [31] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [32] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [33] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Hematocrit values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Hematocrit values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    Hematocrit values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [34]
    13 [35]
    12 [36]
    Units: Proportion of red blood cells in blood
    arithmetic mean (standard deviation)
        Screening, n=12, 12, 11
    0.4799 ± 0.05006
    0.461 ± 0.05737
    0.4555 ± 0.03407
        Day 1: pre-dose, n=12, 13, 11
    0.4607 ± 0.03855
    0.4504 ± 0.05399
    0.4419 ± 0.03158
        Day 1: 4 hr, n=12, 12, 11
    0.4468 ± 0.03652
    0.4341 ± 0.04154
    0.4214 ± 0.02543
        Day 4, n=11, 12, 11
    0.4682 ± 0.05106
    0.4387 ± 0.05038
    0.4371 ± 0.02468
        Day 9, n=12, 13, 12
    0.4649 ± 0.04146
    0.4432 ± 0.05507
    0.4315 ± 0.03044
        Day 14, n=12, 13, 12
    0.4701 ± 0.03889
    0.4408 ± 0.05164
    0.4321 ± 0.02489
        Day 21, n=12, 13, 12
    0.4673 ± 0.04176
    0.4454 ± 0.05511
    0.4364 ± 0.03362
        Day 29: pre-dose, n=12, 13, 12
    0.4551 ± 0.03785
    0.4368 ± 0.04971
    0.4361 ± 0.03512
        Day 29: 4 hr, n=12, 13, 11
    0.45 ± 0.04137
    0.4385 ± 0.05347
    0.4197 ± 0.02605
        Day 32, n=12, 13, 10
    0.4547 ± 0.03776
    0.4361 ± 0.05536
    0.4354 ± 0.03389
        Day 42, n=12, 13, 12
    0.4609 ± 0.04166
    0.4387 ± 0.0532
    0.4353 ± 0.03217
        Day 57, n=12, 13, 12
    0.4628 ± 0.03985
    0.4368 ± 0.05354
    0.4366 ± 0.03679
        Day 85, n=12, 13, 12
    0.4653 ± 0.04823
    0.4483 ± 0.05264
    0.4345 ± 0.0368
        Day 120, n=10, 13, 12
    0.4717 ± 0.05091
    0.4457 ± 0.06294
    0.4442 ± 0.04487
        Day 165, n=12, 13, 12
    0.4676 ± 0.04512
    0.4458 ± 0.05822
    0.4394 ± 0.04186
        Follow-up, n=12, 13, 12
    0.4733 ± 0.03656
    0.4454 ± 0.06752
    0.4381 ± 0.03863
    Notes
    [34] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [35] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [36] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Mean corpuscle hemoglobin (MCH) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Mean corpuscle hemoglobin (MCH) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    MCH values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [37]
    13 [38]
    12 [39]
    Units: Picograms
    arithmetic mean (standard deviation)
        Screening, n=12, 12, 11
    30.46 ± 1.743
    29.58 ± 1.736
    31.35 ± 2.23
        Day 1: pre-dose, n=12, 13, 11
    30.67 ± 1.793
    29.76 ± 1.531
    31.1 ± 2.385
        Day 1: 4 hr, n=12, 12, 11
    30.78 ± 1.88
    29.53 ± 1.555
    30.64 ± 1.967
        Day 4, n=11, 12, 11
    30.74 ± 1.989
    29.68 ± 1.73
    31.02 ± 2.101
        Day 9, n=12, 13, 12
    30.8 ± 1.805
    29.57 ± 1.625
    31.05 ± 2.345
        Day 14, n=12, 13, 12
    30.52 ± 1.7
    29.83 ± 1.666
    31.03 ± 2.214
        Day 21, n=12, 13, 12
    30.58 ± 1.693
    29.68 ± 1.496
    30.89 ± 2.381
        Day 29: pre-dose, n=12, 13, 12
    30.74 ± 1.931
    29.5 ± 1.694
    30.58 ± 2.482
        Day 29: 4 hr, n=12, 13, 11
    30.62 ± 1.712
    29.58 ± 1.585
    31.05 ± 2.649
        Day 32, n=12, 13, 10
    30.69 ± 1.834
    29.6 ± 1.759
    30.59 ± 2.227
        Day 42, n=12, 13, 12
    30.48 ± 1.698
    29.42 ± 1.672
    30.68 ± 2.51
        Day 57, n=12, 13, 12
    30.37 ± 1.861
    29.42 ± 1.912
    30.63 ± 2.623
        Day 85, n=12, 13, 12
    30.15 ± 1.822
    28.98 ± 1.983
    30.33 ± 2.5
        Day 120, n=10, 13, 12
    29.72 ± 2.059
    28.93 ± 2.197
    29.94 ± 2.405
        Day 165, n=12, 13, 12
    29.67 ± 2.195
    28.62 ± 2.378
    29.27 ± 2.597
        Follow-up, n=12, 13 12
    29.49 ± 2.198
    28.62 ± 2.3
    29.51 ± 2.652
    Notes
    [37] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [38] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [39] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Mean corpuscle volume (MCV) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Mean corpuscle volume (MCV) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    MCV values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [40]
    13 [41]
    12 [42]
    Units: Femtoliters
    arithmetic mean (standard deviation)
        Screening, n=12, 12, 11
    93.3 ± 4.74
    91.3 ± 4.25
    95.7 ± 5.22
        Day 1: pre-dose, n=12, 13, 11
    94 ± 4.67
    92.3 ± 4.48
    95 ± 5.8
        Day 1: 4 hr, n=12, 12, 11
    94.7 ± 4.83
    92 ± 4.11
    94 ± 4.2
        Day 4, n=11, 12, 11
    94 ± 4.6
    91.3 ± 4.59
    94.7 ± 6.21
        Day 9, n=12, 13, 12
    93.6 ± 4.74
    91.4 ± 3.91
    94.8 ± 5.72
        Day 14, n=12, 13, 12
    94 ± 4.39
    91.8 ± 4.52
    94.4 ± 6.87
        Day 21, n=12, 13, 12
    94.2 ± 3.97
    91.6 ± 4.65
    94.7 ± 6.5
        Day 29: pre-dose, n=12, 13, 12
    94.3 ± 4.44
    92.2 ± 5.32
    95.4 ± 6.89
        Day 29: 4 hr, n=12, 13, 11
    94.8 ± 4.81
    93 ± 5.12
    96.1 ± 6.88
        Day 32, n=12, 13, 10
    93.9 ± 4.25
    91.6 ± 4.21
    94.1 ± 7.13
        Day 42, n=12, 13, 12
    93.8 ± 3.93
    91.5 ± 4.99
    95.2 ± 7.23
        Day 57, n=12, 13, 12
    93.8 ± 4.11
    91.6 ± 4.84
    94.9 ± 7.46
        Day 85, n=12, 13, 12
    93.3 ± 3.87
    91.2 ± 5.12
    94.8 ± 6.98
        Day 120, n=10, 13, 12
    92.6 ± 5.04
    90.8 ± 5.82
    93.7 ± 6.17
        Day 165, n=12, 13, 12
    92 ± 5.67
    89.8 ± 5.85
    91.8 ± 6.63
        Follow-up, n=12, 13, 12
    92.3 ± 5.61
    89.8 ± 5.6
    92.3 ± 6.77
    Notes
    [40] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [41] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [42] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Red blood cell (RBC) count values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Red blood cell (RBC) count values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    RBC count values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [43]
    13 [44]
    12 [45]
    Units: 10^12 cells per liter (TI/L)
    arithmetic mean (standard deviation)
        Screening, n=12, 12, 11
    5.16 ± 0.568
    5.06 ± 0.661
    4.77 ± 0.473
        Day 1: pre-dose, n=12, 13, 11
    4.92 ± 0.449
    4.89 ± 0.595
    4.68 ± 0.5
        Day 1: 4 hr, n=12, 12, 11
    4.72 ± 0.404
    4.73 ± 0.449
    4.5 ± 0.412
        Day 4, n=11, 12, 11
    4.97 ± 0.471
    4.83 ± 0.583
    4.64 ± 0.437
        Day 9, n=12, 13, 12
    4.98 ± 0.411
    4.85 ± 0.613
    4.59 ± 0.523
        Day 14, n=12, 13, 12
    5.01 ± 0.365
    4.8 ± 0.564
    4.61 ± 0.542
        Day 21, n=12, 13, 12
    4.97 ± 0.384
    4.88 ± 0.596
    4.66 ± 0.611
        Day 29: pre-dose, n=12, 13, 12
    4.85 ± 0.368
    4.74 ± 0.55
    4.61 ± 0.598
        Day 29: 4 hr, n=12, 13, 11
    4.76 ± 0.378
    4.73 ± 0.545
    4.4 ± 0.506
        Day 32, n=10, 13, 10
    4.85 ± 0.361
    4.76 ± 0.605
    4.66 ± 0.572
        Day 42, n=12, 13, 12
    4.92 ± 0.404
    4.8 ± 0.557
    4.63 ± 0.645
        Day 57, n=12, 13, 12
    4.96 ± 0.408
    4.78 ± 0.564
    4.65 ± 0.664
        Day 85, n=12, 13, 12
    4.98 ± 0.427
    4.92 ± 0.537
    4.62 ± 0.608
        Day 120, n=10, 13, 12
    5.1 ± 0.478
    4.93 ± 0.612
    4.77 ± 0.679
        Day 165, n=12, 13, 12
    5.09 ± 0.36
    4.98 ± 0.554
    4.82 ± 0.671
        Follow-up, n=12, 13, 12
    5.15 ± 0.34
    4.97 ± 0.687
    4.79 ± 0.637
    Notes
    [43] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [44] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [45] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Systolic blood pressure (SBP) and diastolic blood pressure (DBP) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Systolic blood pressure (SBP) and diastolic blood pressure (DBP) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    SBP and DBP values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [46]
    13 [47]
    12 [48]
    Units: Millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        SBP, Screening
    141.9 ± 14.12
    139.7 ± 15.11
    145.5 ± 14.37
        SBP, Day 1: pre-dose
    141.5 ± 6.78
    139.2 ± 11.68
    140.9 ± 16.41
        SBP, Day 1: 4 hr
    139.7 ± 16.09
    139.8 ± 8.8
    138 ± 16.14
        SBP, Day 4
    140 ± 12.99
    137.5 ± 18.45
    141.5 ± 10.94
        SBP, Day 9
    136.3 ± 14.33
    137.3 ± 20.86
    140.4 ± 18.66
        SBP, Day 14
    139.2 ± 12.43
    136.9 ± 15.12
    135.9 ± 21
        SBP, Day 21
    133.1 ± 16.03
    142.3 ± 14.99
    139.9 ± 11.67
        SBP, Day 29: pre-dose
    133.9 ± 13.94
    139 ± 17
    140.7 ± 9.73
        SBP, Day 29: 4 hr
    132.6 ± 11.98
    141.2 ± 17.39
    146.5 ± 12.7
        SBP, Day 32
    137.4 ± 14.11
    136.1 ± 13.02
    143.5 ± 13.86
        SBP, Day 42
    134.8 ± 15.46
    137.4 ± 16.48
    135.3 ± 18.4
        SBP, Day 57
    136.7 ± 12.99
    134.8 ± 15.59
    133.3 ± 12.15
        SBP, Day 85
    133.8 ± 14.54
    138.3 ± 11.56
    140 ± 11.69
        SBP, Day 120
    132.1 ± 15.68
    134.2 ± 13.47
    147.2 ± 11.27
        SBP, Day 165
    131.7 ± 17.33
    136.2 ± 13.53
    137.9 ± 17.05
        SBP, follow-up
    131.9 ± 14.2
    139.3 ± 14.44
    137.3 ± 13.36
        DBP, Screening
    85.3 ± 5.37
    84.5 ± 8.38
    85.4 ± 7.45
        DBP, Day 1: pre-dose
    84.3 ± 8.85
    81.8 ± 6.31
    80.4 ± 8.73
        DBP, Day 1: 4 hr
    80.8 ± 7.09
    80.5 ± 5.01
    77.7 ± 11.08
        DBP, Day 4
    82.6 ± 8.01
    77.6 ± 9.42
    82.7 ± 6.83
        DBP, Day 9
    80.5 ± 7.27
    80.5 ± 8.81
    81.8 ± 7.44
        DBP, Day 14
    84.3 ± 7.33
    79.9 ± 6.75
    76.5 ± 14.81
        DBP, Day 21
    80.8 ± 6.04
    81.4 ± 6.13
    77.2 ± 9.28
        DBP, Day 29: pre-dose
    80.1 ± 9.55
    83.1 ± 11
    81.8 ± 8.44
        DBP, Day 29: 4 hr
    77.4 ± 7.66
    80.3 ± 7.38
    79.2 ± 8.55
        DBP, Day 32
    80.8 ± 8.62
    80.2 ± 6.26
    80 ± 12.67
        DBP, Day 42
    79.3 ± 4.85
    79.2 ± 8.02
    77.3 ± 10.25
        DBP, Day 57
    81.3 ± 8.09
    77.5 ± 7.08
    79.2 ± 9.72
        DBP, Day 85
    77.8 ± 8.09
    81.6 ± 8.44
    76 ± 7.45
        DBP, Day 120
    81.5 ± 7.15
    78.9 ± 5.17
    85.6 ± 7.28
        DBP, Day 165
    79.1 ± 9.73
    79.8 ± 9.33
    80.3 ± 9.38
        DBP, follow-up
    81.2 ± 9.25
    81 ± 7.31
    80.1 ± 8.66
    Notes
    [46] - All Subject Population
    [47] - All Subject Population
    [48] - All Subject Population
    No statistical analyses for this end point

    Secondary: Heart rate (HR) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Heart rate (HR) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    HR values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [49]
    13 [50]
    12 [51]
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Screening
    71.5 ± 9.49
    77.8 ± 12.62
    74.8 ± 9.18
        Day 1: pre-dose
    72.8 ± 6.73
    79.9 ± 10.7
    72.3 ± 7.63
        Day 1: 4 hr
    74.1 ± 11.37
    79.2 ± 10.64
    74.2 ± 10.03
        Day 4
    73.6 ± 8.27
    78.9 ± 15.53
    72.9 ± 8.26
        Day 9
    69.7 ± 9.26
    76.3 ± 11.24
    74.8 ± 14.45
        Day 14
    71.2 ± 11.64
    77.4 ± 9.63
    74.8 ± 9.2
        Day 21
    69 ± 9.17
    77.6 ± 9.25
    72.7 ± 11.04
        Day 29: pre-dose
    70.3 ± 9.19
    78.3 ± 11.13
    69.5 ± 7
        Day 29: 4 hr
    72.4 ± 10.23
    82.2 ± 12.05
    72.1 ± 10.44
        Day 32
    69.6 ± 10.19
    78 ± 10.52
    71.7 ± 11.06
        Day 42
    69.4 ± 11.29
    75.2 ± 11.63
    72.8 ± 14.48
        Day 57
    70.5 ± 9.44
    76.3 ± 11.66
    71.3 ± 10.03
        Day 85
    70.1 ± 8.86
    78.5 ± 10.32
    70.3 ± 4.83
        Day 120
    67.3 ± 9.72
    76.5 ± 10.07
    74 ± 13.1
        Day 165
    70.1 ± 10.32
    77.1 ± 11.21
    73.8 ± 9.37
        Follow-up
    69.2 ± 10.85
    75.5 ± 12.37
    71.4 ± 10.5
    Notes
    [49] - All Subject Population
    [50] - All Subject Population
    [51] - All Subject Population
    No statistical analyses for this end point

    Secondary: Respiration rate (RR) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Respiration rate (RR) values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    RR values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [52]
    13 [53]
    12 [54]
    Units: breaths per minute
    arithmetic mean (standard deviation)
        Screening
    16 ± 2.52
    16.3 ± 3.22
    17.2 ± 2.41
        Day 1: pre-dose
    16 ± 2.34
    15.8 ± 2.51
    17.2 ± 2.44
        Day 1: 4 hr
    17.8 ± 3.05
    15.9 ± 3.9
    18.2 ± 3.83
        Day 4
    15.5 ± 1.83
    15.5 ± 2.63
    17.3 ± 2.96
        Day 9
    16.6 ± 2.91
    15.6 ± 2.53
    16.7 ± 2.15
        Day 14
    16.3 ± 2.42
    15.1 ± 3.09
    16.7 ± 2.1
        Day 21
    15.6 ± 2.8
    15.2 ± 2.73
    16.9 ± 2.39
        Day 29: pre-dose
    16.7 ± 2.71
    15.4 ± 2.53
    17.7 ± 3.31
        Day 29: 4 hr
    16.9 ± 3.63
    15.9 ± 4.25
    18.7 ± 3.68
        Day 32
    15.9 ± 2.5
    14.8 ± 3.08
    16.8 ± 2.45
        Day 42
    15.6 ± 2.75
    15 ± 2.94
    17.8 ± 3.07
        Day 57
    15.8 ± 2.08
    15.3 ± 2.75
    17.2 ± 2.41
        Day 85
    16.2 ± 1.9
    15 ± 2.08
    17 ± 2.09
        Day 120
    16.3 ± 1.71
    15.5 ± 2.47
    16.5 ± 2.43
        Day 165
    16.3 ± 1.87
    15.4 ± 2.06
    16.2 ± 2.21
        Follow-up
    16.1 ± 1.98
    14.6 ± 2.18
    16.3 ± 1.54
    Notes
    [52] - All Subject Population
    [53] - All Subject Population
    [54] - All Subject Population
    No statistical analyses for this end point

    Secondary: Body temperature values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Body temperature values at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    Body temperature values were assessed at Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up.
    End point type
    Secondary
    End point timeframe
    Screening; Days 1 (pre-dose and 4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [55]
    13 [56]
    12 [57]
    Units: Degrees centigrade
    arithmetic mean (standard deviation)
        Screening
    35.98 ± 0.449
    36.22 ± 0.436
    35.87 ± 0.764
        Day 1: pre-dose
    35.85 ± 0.403
    35.93 ± 0.501
    35.9 ± 0.558
        Day 1: 4 hr
    36.33 ± 0.374
    36.06 ± 0.415
    36.07 ± 0.733
        Day 4
    35.91 ± 0.287
    36.07 ± 0.494
    35.98 ± 0.583
        Day 9
    35.74 ± 0.511
    36.06 ± 0.715
    35.96 ± 0.673
        Day 14
    35.83 ± 0.566
    35.82 ± 0.483
    35.93 ± 0.409
        Day 21
    35.94 ± 0.329
    35.83 ± 0.545
    35.98 ± 0.447
        Day 29: pre-dose
    35.89 ± 0.378
    35.81 ± 0.386
    36 ± 0.531
        Day 29: 4 hr
    36.13 ± 0.611
    36.09 ± 0.448
    35.92 ± 0.517
        Day 32
    35.71 ± 0.32
    35.88 ± 0.554
    35.78 ± 0.546
        Day 42
    35.82 ± 0.379
    35.91 ± 0.206
    36.01 ± 0.507
        Day 57
    35.81 ± 0.454
    35.97 ± 0.473
    35.83 ± 0.697
        Day 85
    35.77 ± 0.274
    35.65 ± 0.448
    35.84 ± 0.56
        Day 120
    35.93 ± 0.293
    35.97 ± 0.312
    35.58 ± 0.636
        Day 165
    35.78 ± 0.331
    36.01 ± 0.441
    35.6 ± 0.673
        Follow-up
    35.8 ± 0.313
    36.03 ± 0.357
    35.74 ± 0.611
    Notes
    [55] - All Subject Population
    [56] - All Subject Population
    [57] - All Subject Population
    No statistical analyses for this end point

    Secondary: Electrocardiogram (ECG) measurements at Screening, Day 1 (pre-dose and 1 hr and 4 hr post-dose), and Day 29 (pre-dose and 1 hr and 4 hr post-dose)

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    End point title
    Electrocardiogram (ECG) measurements at Screening, Day 1 (pre-dose and 1 hr and 4 hr post-dose), and Day 29 (pre-dose and 1 hr and 4 hr post-dose)
    End point description
    ECG measurements included PR interval, QRS duration, QT interval, corrected QT (QTc) interval, corrected QT by Bazett’s formula (QTcB) interval, corrected QT by Fridericia’s formula (QTcF) interval, and RR interval.
    End point type
    Secondary
    End point timeframe
    Screening, Day 1 (pre-dose; 1 and 4 hr post-dose), and Day 29 (pre-dose; 1 hr and 4 hr post-dose)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [58]
    13 [59]
    12 [60]
    Units: milliseconds
    arithmetic mean (standard deviation)
        PR Interval, Screening, n=12, 13, 11
    160.1 ± 32.8
    162.7 ± 19.55
    163.7 ± 19.84
        PR Interval, Day 1: pre-dose, n=12, 13, 11
    167.9 ± 25.29
    170.4 ± 16.16
    160.5 ± 19.23
        PR Interval, Day 1: 1 hr, n=12, 13, 11
    166.2 ± 27.83
    169.5 ± 18.96
    162.6 ± 17.38
        PR Interval, Day 1: 4 hr, n=12, 13, 11
    167 ± 32.19
    164.9 ± 18.2
    164.5 ± 22.11
        PR Interval, Day 29, pre-dose, n=12, 13, 11
    167.1 ± 35.51
    163.4 ± 15.22
    159.8 ± 30.41
        PR Interval, Day 29: 1 hr, n=12, 13, 11
    156.8 ± 35.19
    171.8 ± 15.58
    159.3 ± 31.05
        PR Interval, Day 29: 4 hr, n=12, 13, 11
    162.2 ± 37.64
    167.7 ± 20.36
    159.4 ± 32.06
        QRS duration, Screening, n=12, 13, 12
    105.8 ± 28.17
    94.2 ± 24.15
    102.9 ± 18.66
        QRS duration, Day 1: pre-dose, n=12, 13, 12
    101.6 ± 27.56
    93.5 ± 23.99
    103.6 ± 15.04
        QRS duration, Day 1: 1 hr, n=12, 13, 12
    105.5 ± 29.18
    94.2 ± 23.5
    98.9 ± 15.83
        QRS duration, Day 1: 4 hr, n=12, 13, 12
    104.4 ± 28.81
    92.3 ± 26.7
    103.9 ± 15.13
        QRS duration, Day 29, pre-dose, n=12, 12, 12
    103.2 ± 28.9
    92.8 ± 24.08
    101.8 ± 12.76
        QRS duration, Day 29: 1 hr, n=12, 13, 12
    103.1 ± 27.87
    96.4 ± 22.34
    101.3 ± 19.14
        QRS duration, Day 29: 4 hr, n=12, 13, 12
    104.5 ± 26.06
    95.8 ± 23.96
    102.5 ± 16.19
        QT interval, Screening, n=12, 13, 12
    377.6 ± 41.54
    365.2 ± 32.26
    385.6 ± 28.38
        QT interval, Day 1: pre-dose, n=12, 13, 12
    390.8 ± 31.12
    356.7 ± 28.42
    380.8 ± 24.44
        QT interval, Day 1: 1 hr, n=12, 13, 12
    389.1 ± 33.1
    362.8 ± 34.09
    386 ± 27.82
        QT interval, Day 1: 4 hr, n=12, 13, 12
    374.6 ± 43.03
    345.5 ± 30.49
    374.6 ± 28.88
        QT interval, Day 29, pre-dose, n=12, 12, 12
    379.9 ± 35.08
    353.8 ± 20.36
    382.2 ± 23.59
        QT interval, Day 29: 1 hr, n=12, 13, 12
    393.4 ± 36.63
    368.1 ± 32.66
    386.1 ± 33.29
        QT interval, Day 29: 4 hr, n=12, 13, 12
    378.8 ± 33.13
    356.2 ± 29.24
    375.4 ± 30.34
        QTc interval, Screening, n=5, 8, 5
    396.6 ± 43.69
    401.1 ± 24.31
    402.4 ± 24.69
        QTc interval, Day 1: pre-dose, n=5, 9, 5
    415 ± 22.46
    401 ± 26.37
    399.6 ± 25.99
        QTc interval, Day 1: 1 hr, n=5, 9, 5
    409 ± 31.71
    402.7 ± 32.39
    373 ± 21.83
        QTc interval, Day 1: 4 hr, n=5, 9, 6
    414.6 ± 23.33
    392.3 ± 25.5
    391.8 ± 23.03
        QTc interval, Day 29, pre-dose, n=5, 8, 5
    408.5 ± 26.41
    395 ± 27.81
    394.8 ± 26.11
        QTc interval, Day 29: 1 hr, n=5, 8, 4
    405 ± 29.26
    406.4 ± 29.18
    391 ± 21.69
        QTc interval, Day 29: 4 hr, n=5, 8, 5
    415.4 ± 20.47
    401.3 ± 27.59
    396.8 ± 26.53
        QTcB interval, Screening, n=7, 5, 7
    428.9 ± 66.45
    438.2 ± 73.43
    458.7 ± 82.52
        QTcB interval, Day 1: pre-dose, n=7, 4, 7
    446.4 ± 87.83
    444.5 ± 83
    450.6 ± 82.8
        QTcB interval, Day 1: 1 hr
    425.6 ± 69.63
    435.8 ± 89.82
    440 ± 89.05
        QTcB interval, Day 1: 4 hr, n=7, 4, 7
    422.1 ± 69.64
    441.5 ± 87.44
    451.5 ± 90.65
        QTcB interval, Day 29, pre-dose, n=7, 4, 6
    429.4 ± 70.44
    441.5 ± 87.64
    435.9 ± 87.94
        QTcB interval, Day 29: 1 hr, n=7, 5, 8
    428.4 ± 94.13
    425 ± 81.65
    440.6 ± 79.75
        QTcB interval, Day 29: 4 hr, n=7, 5, 7
    422 ± 69.14
    427.2 ± 80.83
    441 ± 87.06
        QTcF interval, Screening, n=7, 5, 7
    413.7 ± 44.18
    416 ± 41.6
    434.6 ± 54.29
        QTcF interval, Day 1: pre-dose, n=7, 4, 7
    427.9 ± 60.53
    416.8 ± 48.73
    427.9 ± 54.86
        QTcF interval, Day 1: 1 hr, n=7, 4, 7
    412.3 ± 45.59
    415.3 ± 49.45
    423.3 ± 59.13
        QTcF interval, Day 1: 4 hr, n=7, 4, 6
    408 ± 47.9
    415 ± 49.99
    425 ± 61.7
        QTcF interval, Day 29, pre-dose, n=7, 4, 7
    412.4 ± 47.74
    411.8 ± 54.02
    415.7 ± 58.11
        QTcF interval, Day 29: 1 hr, n=7, 5, 8
    417.7 ± 63.81
    408.4 ± 45.69
    421.4 ± 53.3
        QTcF interval, Day 29: 4 hr, n=7, 5, 7
    408.7 ± 44.66
    406.6 ± 46.65
    416.6 ± 59.57
        RR interval, Screening, n=7, 5, 7
    865.7 ± 243.54
    806.2 ± 285.39
    778.7 ± 208.89
        RR interval, Day 1: pre-dose, n=7, 4, 7
    834.9 ± 210.7
    746.8 ± 250.85
    783.3 ± 197.1
        RR interval, Day 1: 1 hr, n=7, 4, 7
    883.3 ± 230.65
    851.8 ± 347.73
    865 ± 235.3
        RR interval, Day 1: 4 hr, n=7, 4, 6
    873.7 ± 239.34
    771.5 ± 304.19
    747 ± 188.66
        RR interval, Day 29, pre-dose, n=7, 4, 7
    842.6 ± 217.13
    718 ± 219.91
    813.7 ± 210.22
        RR interval, Day 29: 1 hr, n=7, 5, 8
    942.9 ± 257.89
    893 ± 366.89
    823.3 ± 223.16
        RR interval, Day 29: 4 hr, n=7, 5, 7
    888.1 ± 237.25
    825.6 ± 296.3
    764.4 ± 204.75
    Notes
    [58] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [59] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [60] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Change from Baseline in glycohemoglobin A1c (% HbA1c) at Days 29, 57, and 85

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    End point title
    Change from Baseline in glycohemoglobin A1c (% HbA1c) at Days 29, 57, and 85
    End point description
    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a period of time. The Baseline HbA1c value is defined as the value at Day 1. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; Days 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [61]
    13 [62]
    12 [63]
    Units: Percentage of HbA1c in the blood
    arithmetic mean (standard deviation)
        Day 29, n=12, 12, 12
    -0.34 ± 0.281
    -0.2 ± 0.266
    -0.42 ± 0.469
        Day 57, n=11, 13, 12
    -0.6 ± 0.642
    -0.37 ± 0.411
    -0.61 ± 0.768
        Day 85, n=12, 12, 11
    -0.51 ± 0.847
    -0.3 ± 0.541
    -0.86 ± 0.717
    Notes
    [61] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [62] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [63] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Change from Baseline in fasting blood insulin from the post-mixed meal test (MMT) at pre-meal and 15, 30, 60, 90, 120, 180, and 250 minutes post-meal at Days 29, 57, and 85

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    End point title
    Change from Baseline in fasting blood insulin from the post-mixed meal test (MMT) at pre-meal and 15, 30, 60, 90, 120, 180, and 250 minutes post-meal at Days 29, 57, and 85
    End point description
    The Baseline fasting blood insulin value is defined as the value at Day 1. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; pre-meal; and 15, 30, 60, 90, 120, 180, and 250 post-meal at Days 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [64]
    13 [65]
    12 [66]
    Units: Picomoles per liter
    arithmetic mean (standard deviation)
        Day 29: pre-meal, n=12, 13, 11
    -4 ± 35.017
    26.31 ± 86.065
    21.27 ± 51.5
        Day 29: 15 minutes (min), n=12, 13, 11
    62.5 ± 104.377
    119.08 ± 123.665
    176.73 ± 220.933
        Day 29: 30 min, n=12, 13, 11
    120.5 ± 145.435
    222.46 ± 286.302
    181.09 ± 166.186
        Day 29: 60 min, n=11, 13, 11
    204.55 ± 121.089
    246 ± 279.971
    272.18 ± 207.174
        Day 29: 90 min, n=11, 13, 11
    153.27 ± 74.62
    192.92 ± 267.733
    160.36 ± 131.839
        Day 29: 120 min, n=11, 13, 11
    97.64 ± 82.447
    131.08 ± 182.382
    91.09 ± 110.921
        Day 29: 180 min, n=12, 13, 11
    55 ± 58.387
    36 ± 88.657
    8.18 ± 68.897
        Day 29: 240 min, n=12, 13, 11
    22 ± 46.92
    5.54 ± 63.708
    -21.27 ± 69.11
        Day 57: pre-meal, n=12, 13, 11
    2.5 ± 21.928
    12.46 ± 46.699
    -15.82 ± 57.941
        Day 57: 15 min, n=12, 13, 11
    44 ± 88.896
    176.77 ± 334.035
    105.27 ± 94.654
        Day 57: 30 min, n=12, 13, 11
    156.5 ± 136.329
    266.31 ± 456.641
    147.27 ± 141.131
        Day 57: 60 min, n=12, 13, 11
    211.5 ± 115.586
    243.69 ± 163.044
    247.64 ± 212.439
        Day 57: 90 min, n=11, 13, 11
    168 ± 49.332
    214.62 ± 128.058
    205.09 ± 187.116
        Day 57: 120 min, n=12, 13, 11
    125.5 ± 73.282
    109.38 ± 104.216
    131.45 ± 126.156
        Day 57: 180 min, n=12, 13, 11
    27 ± 58.481
    21.69 ± 39.462
    23.45 ± 50.447
        Day 57: 240 min, n=12, 13, 10
    2.5 ± 33.008
    -18.92 ± 70.605
    -5.4 ± 55.169
        Day 85: pre-meal, n=12, 13, 10
    1 ± 33.439
    17.08 ± 60.441
    10.2 ± 70.316
        Day 85: 15 min, n=12, 13, 11
    29 ± 39.372
    94.15 ± 129.901
    140.73 ± 224.906
        Day 85: 30 min, n=12, 13, 11
    194 ± 240.223
    194.77 ± 174.389
    176.18 ± 221.046
        Day 85: 60 min, n=12, 13, 11
    174.5 ± 102.479
    271.85 ± 334.096
    250.36 ± 180.122
        Day 85: 90 min, n=12, 13, 11
    151.5 ± 69.036
    218.31 ± 153.803
    197.45 ± 131.356
        Day 85: 120 min, n=12, 13, 11
    140 ± 73.187
    175.85 ± 206.461
    129.27 ± 148.076
        Day 85: 180 min, n=12, 13, 11
    32 ± 60.831
    28.15 ± 58.654
    32.73 ± 53.286
        Day 85: 240 min, 12, 12, 11
    0.5 ± 32.609
    0 ± 31.955
    9.82 ± 69.417
    Notes
    [64] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [65] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [66] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Change from Baseline in C-peptide levels from the post-MMT (MMT) at pre-meal and 15, 30, 60, 90, 120, 180, and 250 minutes post-meal at Days 29, 57, and 85

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    End point title
    Change from Baseline in C-peptide levels from the post-MMT (MMT) at pre-meal and 15, 30, 60, 90, 120, 180, and 250 minutes post-meal at Days 29, 57, and 85
    End point description
    The Baseline C-peptide value is defined as the value at Day 1. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; pre-meal; and 15, 30, 60, 90, 120, 180, and 250 post-meal at Days 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [67]
    13 [68]
    12 [69]
    Units: Nanomoles per liter
    arithmetic mean (standard deviation)
        Day 29: pre-meal, n=12, 12, 11
    0 ± 0.342
    0.13 ± 0.307
    0.07 ± 0.45
        Day 29: 15 min, n=12, 12, 11
    0.34 ± 0.436
    0.45 ± 0.397
    0.51 ± 0.757
        Day 29: 30 min, n=12, 12, 10
    0.68 ± 0.595
    0.89 ± 0.634
    0.92 ± 0.86
        Day 29: 60 min, n=11, 12, 11
    1.14 ± 0.617
    1.08 ± 0.693
    1.33 ± 0.97
        Day 29: 90 min, n=11, 12, 11
    1.05 ± 0.284
    1.15 ± 0.573
    1.11 ± 0.844
        Day 29: 120 min, n=11, 12, 10
    0.92 ± 0.37
    1.09 ± 0.527
    1.03 ± 0.672
        Day 29: 180 min, n=12, 12, 10
    0.81 ± 0.438
    0.6 ± 0.323
    0.59 ± 0.46
        Day 29: 240 min, n=12, 12, 11
    0.5 ± 0.463
    0.27 ± 0.329
    0.31 ± 0.355
        Day 57: pre-meal, n=12, 12, 12
    -0.07 ± 0.314
    0.07 ± 0.341
    -0.23 ± 0.244
        Day 57: 15 min, n=12, 12, 11
    0.21 ± 0.213
    0.61 ± 0.941
    0.29 ± 0.349
        Day 57: 30 min n=12, 12, 11
    0.56 ± 0.369
    0.85 ± 0.973
    0.45 ± 0.543
        Day 57: 60 min, n=12, 12, 11
    1.04 ± 0.591
    1.25 ± 0.583
    0.92 ± 0.821
        Day 57: 90 min, n=12, 12, 11
    1.1 ± 0.371
    1.38 ± 0.653
    1.02 ± 0.89
        Day 57: 120 min, n=12, 12, 11
    1.06 ± 0.435
    1.09 ± 0.524
    1.02 ± 0.837
        Day 57: 180 min, n=12, 12, 11
    0.59 ± 0.332
    0.6 ± 0.43
    0.53 ± 0.482
        Day 57: 240 min, n=11, 12, 10
    0.29 ± 0.48
    0.31 ± 0.395
    0.2 ± 0.41
        Day 85: pre-meal, n=12, 12, 11
    -0.01 ± 0.412
    0.09 ± 0.325
    0.02 ± 0.422
        Day 85: 15 min, n=12, 12, 11
    0.17 ± 0.413
    0.45 ± 0.475
    0.45 ± 0.721
        Day 85: 30 min, n=12, 12, 11
    0.78 ± 0.832
    0.98 ± 0.725
    0.65 ± 0.742
        Day 85: 60 min, n=12, 12, 11
    0.96 ± 0.518
    1.38 ± 0.683
    1.03 ± 0.624
        Day 85: 90 min, n=12, 12, 11
    1.01 ± 0.499
    1.48 ± 0.738
    1.11 ± 0.55
        Day 85: 120 min, n=12, 12, 11
    1.05 ± 0.404
    1.43 ± 0.856
    1.08 ± 0.566
        Day 85: 180 min, n=11, 12, 11
    0.6 ± 0.427
    0.75 ± 0.436
    0.6 ± 0.361
        Day 85: 240 min, n=12, 12, 10
    0.28 ± 0.358
    0.33 ± 0.234
    0.26 ± 0.416
    Notes
    [67] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [68] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [69] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Change from Baseline in weighted mean insulin level (AUC[0-4hrs]) post-MMT on Days 29, 57, and 85

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    End point title
    Change from Baseline in weighted mean insulin level (AUC[0-4hrs]) post-MMT on Days 29, 57, and 85
    End point description
    The weighted mean parameters were derived by calculating the area under the curve (AUC, which reflects the actual body exposure to drug after administration of a dose of the drug) using the trapezoidal rule, and then dividing by the actual relevant time interval (i.e., actual time point [hrs] of the first non-missing observation [in planned time tf=0 hour] minus the actual time point [hrs] of the last non-missing observation [e.g., in planned time for insulin, tl=240 minutes]). Change from Baseline in weighted mean AUC(0-4hrs) post-MMT profiles for insulin was compared between treatment groups using repeated measures analysis with fixed effects for Baseline, visit, and Baseline by visit. The Baseline weighted mean insulin value is defined as the value at Day 1. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; Days 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [70]
    13 [71]
    12 [72]
    Units: Picomoles per liter
    arithmetic mean (standard deviation)
        Day 29
    10.3 ± 39.145
    -1.13 ± 103.423
    4.89 ± 68.334
        Day 57
    12.52 ± 56.021
    -2.11 ± 56.314
    21.55 ± 68.549
        Day 85
    12.26 ± 37.965
    13.16 ± 78.556
    9.14 ± 61.995
    Notes
    [70] - All Subject Population
    [71] - All Subject Population
    [72] - All Subject Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in weighted mean C-peptide levels (AUC[0-4hrs]) post-MMT on Days 29, 57, and 85

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    End point title
    Change from Baseline in weighted mean C-peptide levels (AUC[0-4hrs]) post-MMT on Days 29, 57, and 85
    End point description
    The weighted mean parameters were derived by calculating the area under the curve (AUC, which reflects the actual body exposure to drug after administration of a dose of the drug) using the trapezoidal rule, and then dividing by the actual relevant time interval (i.e., actual time point [hrs] of the first non-missing observation [in planned time tf=0 hour] minus the actual time point [hrs] of the last non-missing observation [e.g., in planned time for C-peptide levels, tl=240 minutes]). Change from Baseline in weighted mean AUC(0-4hrs) post-MMT profiles for C-peptide was compared between treatment groups using repeated measures analysis with fixed effects for Baseline, visit, and Baseline by visit. The Baseline weighted mean C-peptide value is defined as the value at Day 1. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; Days 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [73]
    13 [74]
    12 [75]
    Units: Nanomoles per liter (nmol/L)
    arithmetic mean (standard deviation)
        Day 29
    0.19 ± 0.365
    -0.1 ± 0.302
    -0.09 ± 0.592
        Day 57
    0.1 ± 0.234
    -0.06 ± 0.327
    -0.24 ± 0.661
        Day 85
    0.1 ± 0.247
    0.09 ± 0.374
    -0.16 ± 0.521
    Notes
    [73] - All Subject Population
    [74] - All Subject Population
    [75] - All Subject Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in derived measures of insulin sensitivity (homeostasis model assessment [HOMA]-%S) and beta cell function (HOMA-%B) for insulin and C-peptide at Days 29, 57, and 85

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    End point title
    Change from Baseline in derived measures of insulin sensitivity (homeostasis model assessment [HOMA]-%S) and beta cell function (HOMA-%B) for insulin and C-peptide at Days 29, 57, and 85
    End point description
    The HOMA estimated steady-state beta cell function (%B) and insulin sensitivity (%S), as a percentages of a normal reference population. The HOMA2 Model was developed for insulin sensitivity (HOMA2-%S), where 100% was normal, which is the reciprocal of insulin resistance (100/S%). The Baseline value is defined as the value at Day 1. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. Note: In cases in which no participants were analyzed at a particular timepoint/for a paricular parameter, "99999" is used to indicate that data are not available. In cases, in which only one participant was analyzed at a particular timepoint/for a particular parameter, "99999" has been used to indicate that no dispersion data (standard deviation of the mean) are available for this single participant.
    End point type
    Secondary
    End point timeframe
    Baseline; Days 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [76]
    13 [77]
    12 [78]
    Units: Percentage
    arithmetic mean (standard deviation)
        Insulin HOMA2-%S, Day 29, n=12, 12, 12
    9.42 ± 35.88
    -10.03 ± 29.411
    -5.33 ± 27.589
        Insulin HOMA2-%S, Day 57, n=12, 12, 12
    0.39 ± 12.438
    -8.21 ± 41.853
    4.45 ± 33.226
        Insulin HOMA2-%S, Day 85, n=12, 12, 11
    -3 ± 15.088
    -15.46 ± 54.893
    -6.81 ± 28.723
        Insulin HOMA2-%B, Day 29, n=12, 12, 12
    -1.82 ± 12.091
    5.42 ± 10.715
    3.31 ± 18.961
        Insulin HOMA2-%B, Day 57, n=12, 12, 12
    5.9 ± 21.891
    6.63 ± 18.161
    7.5 ± 31.909
        Insulin HOMA2-%B, Day 85, n=12, 12, 11
    4.24 ± 23.204
    7.77 ± 24.274
    7.45 ± 29.459
        C-peptide, HOMA2-%S, Day 29, n=0, 1, 0
    99999 ± 99999
    -4.6 ± 99999
    99999 ± 99999
        C-peptide, HOMA2-%S, Day 57, n=0, 1, 0
    99999 ± 99999
    -3.8 ± 99999
    99999 ± 99999
        C-peptide, HOMA2-%S, Day 85, n=0, 1, 0
    99999 ± 99999
    -1.8 ± 99999
    99999 ± 99999
        C-peptide, HOMA2-%B, Day 29, n=0, 1, 0
    99999 ± 99999
    33.7 ± 99999
    99999 ± 99999
        C-peptide, HOMA2-%B, Day 57, n=0, 1, 0
    99999 ± 99999
    20 ± 99999
    99999 ± 99999
        C-peptide, HOMA2-%B, Day 85, n=0, 1, 0
    99999 ± 99999
    -33.5 ± 99999
    99999 ± 99999
    Notes
    [76] - All Subject Population
    [77] - All Subject Population
    [78] - All Subject Population
    No statistical analyses for this end point

    Secondary: Area under the concentration-time curve over the dosing interval (AUC[0-tau])

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    End point title
    Area under the concentration-time curve over the dosing interval (AUC[0-tau])
    End point description
    AUC(0-tau) is derived as a log-transformed plasma GSK1070806 pharmacokinetic (PK) Parameter and was measured after dose 1 and dose 2 of GSK1070806 0.25 mg/kg and GSK1070806 5 mg/kg. AUC reflects the actual body exposure to drug after administration of a dose of the drug. The PK Population is comprised of participants for whom a PK sample was obtained and analyzed.
    End point type
    Secondary
    End point timeframe
    From Day 1 until follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    0 [79]
    13 [80]
    12 [81]
    Units: ng*hr/mL
    geometric mean (geometric coefficient of variation)
        Dose 1, n=0, 11, 12
    ±
    1840725 ± 32.5
    25415627 ± 62.5
        Dose 2, n=0, 13, 12
    ±
    2483463 ± 31.3
    44281604 ± 22.8
    Notes
    [79] - PK Population. Only participants available at the specified time points were analyzed (n=X, X, X).
    [80] - PK Population. Only participants available at the specified time points were analyzed (n=X, X, X).
    [81] - PK Population. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Maximum observed concentration (Cmax)

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    End point title
    Maximum observed concentration (Cmax)
    End point description
    Cmax was measured after dose 1 and dose 2 of GSK1070806 0.25 mg/kg and GSK1070806 5 mg/kg.
    End point type
    Secondary
    End point timeframe
    From Day 1 until follow-up (up to Study Day 210/average of X study days)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    0 [82]
    13 [83]
    12 [84]
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Dose 1, n=0, 11, 12
    ±
    8361.1 ± 26.8
    95179.3 ± 69
        Dose 2, n=0, 13, 12
    ±
    9692.1 ± 21.9
    152972 ± 22
    Notes
    [82] - PK Population. Only participants available at the specified time points were analyzed (n=X, X, X).
    [83] - PK Population. Only participants available at the specified time points were analyzed (n=X, X, X).
    [84] - PK Population. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Time of occurrence of Cmax (Tmax)

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    End point title
    Time of occurrence of Cmax (Tmax)
    End point description
    Tmax was measured after dose 1 and dose 2 of GSK1070806 0.25 mg/kg and GSK1070806 5 mg/kg.
    End point type
    Secondary
    End point timeframe
    From Day 1 until follow-up (up to Study Day 210/average of X study days)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    0 [85]
    13 [86]
    12 [87]
    Units: Hours
    median (full range (min-max))
        Dose 1, n=0, 11, 12
    ( to )
    1.05 (1 to 67.75)
    1.055 (1 to 4.03)
        Dose 2, n=0, 13, 12
    ( to )
    1.07 (1 to 68.5)
    1.05 (1 to 4)
    Notes
    [85] - PK Population. Only participants available at the specified time points were analyzed (n=X, X, X).
    [86] - PK Population. Only participants available at the specified time points were analyzed (n=X, X, X).
    [87] - PK Population. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Terminal phase rate constant

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    End point title
    Terminal phase rate constant
    End point description
    The terminal rate constant is the rate at which the compound disappears more slowly during the terminal phase. The terminal phase rate constant was measured after the second dose of GSK1070806 0.25 mg/kg and GSK1070806 5 mg/kg. Summary statistics are not generated for this parameter as it is utilized for the calculation of other parameters.
    End point type
    Secondary
    End point timeframe
    From Day 1 until follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    0 [88]
    0 [89]
    0 [90]
    Units: 1/hr
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [88] - PK Population
    [89] - PK Population
    [90] - PK Population
    No statistical analyses for this end point

    Secondary: Terminal half life (t1/2)

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    End point title
    Terminal half life (t1/2)
    End point description
    t1/2 was measured after the second dose of GSK1070806 0.25 mg/kg and GSK1070806 5 mg/kg.
    End point type
    Secondary
    End point timeframe
    From Day 1 until follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    0 [91]
    12 [92]
    12 [93]
    Units: Hours
        geometric mean (geometric coefficient of variation)
    ±
    554.721 ± 22.7
    730.386 ± 21.3
    Notes
    [91] - PK Population. Only participants available at the specified time points were analyzed.
    [92] - PK Population. Only participants available at the specified time points were analyzed.
    [93] - PK Population. Only participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Serum levels of free IL-18 and drug-bound IL-18

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    End point title
    Serum levels of free IL-18 and drug-bound IL-18
    End point description
    Summary statistics were not generated for this parameter.
    End point type
    Secondary
    End point timeframe
    From Day 1 until follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    0 [94]
    0 [95]
    0 [96]
    Units: picograms per milliliter (pg/ml)
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [94] - Summary statistics were not generated for this parameter.
    [95] - Summary statistics were not generated for this parameter.
    [96] - Summary statistics were not generated for this parameter.
    No statistical analyses for this end point

    Secondary: Change from Baseline in adiponectin and high-sensitivity C-reactive protein (hsCRP) levels at Days 29, 57, and 85

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    End point title
    Change from Baseline in adiponectin and high-sensitivity C-reactive protein (hsCRP) levels at Days 29, 57, and 85
    End point description
    Serum samples were collected for the estimation of adiponectin and hsCRP biomarker levels. Adiponectin is a protein hormone that modulates a number of metabolic processes, including glucose regulation and fatty acid catabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value, where Day 1 is defined as Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; Day 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [97]
    13 [98]
    12 [99]
    Units: mg/L
    arithmetic mean (standard deviation)
        Adiponectin, Day 29, n=12, 13, 12
    0.08 ± 2.021
    -0.62 ± 2.567
    -1.58 ± 5.534
        Adiponectin, Day 57, n=12, 13, 12
    -0.08 ± 2.275
    -0.54 ± 2.933
    0.25 ± 2.896
        Adiponectin, Day 85, n=12, 13, 12
    0.67 ± 1.875
    0 ± 2.236
    0.42 ± 1.621
        hsCRP, Day 29, n=12, 11, 12
    3.04 ± 6.577
    13.96 ± 49.633
    -8.08 ± 20.237
        hsCRP, Day 57, n=12, 11, 12
    3.47 ± 7.662
    -0.55 ± 1.226
    -8.1 ± 19.414
        hsCRP, Day 85, n=12, 11, 12
    0.54 ± 2.137
    -0.17 ± 2.311
    -8.06 ± 19.995
    Notes
    [97] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [98] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [99] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Change from Baseline in HDL cholesterol, LDL cholesterol, and non-esterified fatty acid levels at Days 1 (4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Change from Baseline in HDL cholesterol, LDL cholesterol, and non-esterified fatty acid levels at Days 1 (4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    Serum samples were collected for the estimation of HDL cholesterol direct, LDL cholesterol calculation, and non-esterified fatty acids biomarker levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value, where Day 1 is defined as Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; Days 1 (4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [100]
    13 [101]
    12 [102]
    Units: mmol/L
    arithmetic mean (standard deviation)
        HDL cholesterol, Day 1: 4 hr, n=11, 11, 11
    -0.1 ± 0.096
    -0.1 ± 0.116
    -0.11 ± 0.07
        HDL cholesterol, Day 4, n=11, 12, 11
    0.07 ± 0.074
    0.01 ± 0.077
    0.02 ± 0.119
        HDL cholesterol, Day 9, n=12, 12, 12
    0.06 ± 0.117
    0.05 ± 0.134
    0.06 ± 0.087
        HDL cholesterol, Day 14, n=12, 12, 12
    0.04 ± 0.118
    0.06 ± 0.121
    0.1 ± 0.116
        HDL cholesterol, Day 21, n=12, 12, 12
    0.07 ± 0.153
    0.09 ± 0.146
    0.12 ± 0.215
        HDL cholesterol, Day 29 pre-dose, n=11, 12, 12
    -0.01 ± 0.13
    0.04 ± 0.106
    0.12 ± 0.197
        HDL cholesterol, Day 29: 4 hr, n=12, 10, 11
    -0.1 ± 0.134
    -0.01 ± 0.154
    0.01 ± 0.216
        HDL cholesterol, Day 32, n=11, 12, 12
    0.06 ± 0.174
    0.05 ± 0.145
    0.1 ± 0.129
        HDL cholesterol, Day 42, n=12, 12, 12
    0.06 ± 0.167
    0.06 ± 0.122
    0.12 ± 0.204
        HDL cholesterol, Day 57, n=12, 12, 12
    0.02 ± 0.114
    0.08 ± 0.204
    0.12 ± 0.207
        HDL cholesterol, Day 85, n=11, 11, 12
    0.03 ± 0.19
    0.08 ± 0.19
    0.12 ± 0.195
        HDL cholesterol, Day 120, n=11, 12, 12
    0.04 ± 0.164
    0.12 ± 0.228
    0.12 ± 0.211
        HDL cholesterol, Day 165, n=12, 11, 12
    0.05 ± 0.191
    0.12 ± 0.171
    0.09 ± 0.123
        HDL cholesterol, follow-up, n=12, 11, 12
    0.13 ± 0.161
    0.09 ± 0.171
    0.07 ± 0.129
        LDL cholesterol, Day 1: 4 hr, n=11, 11, 10
    -0.35 ± 0.217
    -0.36 ± 0.351
    -0.23 ± 0.159
        LDL cholesterol, Day 4, n=11, 12, 11
    0.02 ± 0.268
    0.1 ± 0.226
    0.06 ± 0.28
        LDL cholesterol, Day 9, n=12, 12, 12
    -0.06 ± 0.426
    -0.08 ± 0.342
    -0.12 ± 0.274
        LDL cholesterol, Day 14, n=12, 12, 12
    -0.09 ± 0.564
    -0.09 ± 0.35
    -0.08 ± 0.391
        LDL cholesterol, Day 21, n=12, 12, 12
    -0.01 ± 0.58
    0.02 ± 0.506
    -0.1 ± 0.394
        LDL cholesterol, Day 29 pre-dose, n=11, 12, 12
    -0.05 ± 0.389
    -0.06 ± 0.484
    -0.04 ± 0.413
        LDL cholesterol, Day 29: 4 hr, n=12, 10, 11
    -0.36 ± 0.508
    -0.37 ± 0.583
    -0.39 ± 0.611
        LDL cholesterol, Day 32, n=11, 12, 12
    -0.01 ± 0.553
    -0.16 ± 0.379
    0.02 ± 0.3
        LDL cholesterol, Day 42, n=11, 12, 12
    0.2 ± 0.357
    -0.1 ± 0.542
    0 ± 0.325
        LDL cholesterol, Day 57, n=12, 12, 12
    0.23 ± 0.542
    -0.08 ± 0.356
    0.13 ± 0.407
        LDL cholesterol, Day 85, n=11, 11, 12
    0.25 ± 0.784
    0.02 ± 0.406
    0.02 ± 0.507
        LDL cholesterol, Day 120, n=10, 12, 12
    0.14 ± 0.493
    -0.14 ± 0.61
    0.07 ± 0.475
        LDL cholesterol, Day 165, n=12, 11, 12
    0.2 ± 0.836
    -0.1 ± 0.624
    0.15 ± 0.613
        LDL cholesterol, follow-up, n=12, 11, 12
    0.31 ± 0.844
    0.13 ± 0.417
    -0.2 ± 0.967
        Non-esterfied fatty acids, Day 29, n=12, 13, 10
    -0.04 ± 0.135
    -0.02 ± 0.177
    0.01 ± 0.277
        Non-esterfied fatty acids, Day 57, n=12, 13, 10
    0.04 ± 0.212
    0.07 ± 0.189
    0.06 ± 0.311
        Non-esterfied fatty acids, Day 85, n=12, 13, 10
    -0.01 ± 0.144
    0.02 ± 0.187
    -0.05 ± 0.35
    Notes
    [100] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [101] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [102] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Change from Baseline in fructosamine level at Days 29, 57, and 85

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    End point title
    Change from Baseline in fructosamine level at Days 29, 57, and 85
    End point description
    Serum samples were collected for the estimation of fructosamine levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value, where Day 1 is defined as Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; Day 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    11 [103]
    12 [104]
    10 [105]
    Units: µmol/L
    arithmetic mean (standard deviation)
        Day 29
    -7.36 ± 25.26
    -10.25 ± 18.489
    -9 ± 19.402
        Day 57
    -4.18 ± 45.751
    -10.17 ± 30.68
    -6.7 ± 23.66
        Day 85
    -1 ± 43.428
    -6.83 ± 23.053
    -8.1 ± 29.622
    Notes
    [103] - All Subject Population. Only participants available at the specified time points were analyzed.
    [104] - All Subject Population. Only participants available at the specified time points were analyzed.
    [105] - All Subject Population. Only participants available at the specified time points were analyzed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in glomerular filtration rate (GFR) at Days 1 (4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Change from Baseline in glomerular filtration rate (GFR) at Days 1 (4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    Change from Baseline was calculated as the post-Baseline value minus the Baseline value, where Day 1 is defined as Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; Days 1 (4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [106]
    13 [107]
    12 [108]
    Units: mL/min/1.73 m^2
    arithmetic mean (standard deviation)
        Day 1: 4 hr, n=11, 10, 11
    -1.18 ± 14.972
    -24.4 ± 19.693
    -18.45 ± 24.411
        Day 4, n=11, 12, 11
    -10.55 ± 13.419
    -12.5 ± 11.39
    -4.18 ± 10.196
        Day 9, n=12, 12, 12
    -8.33 ± 11.484
    -10.83 ± 10.911
    -8.17 ± 12.597
        Day 14, n=12, 12, 12
    -8.5 ± 11.642
    -16.75 ± 10.593
    -4.08 ± 9.307
        Day 21, n=12, 12, 12
    -8.5 ± 12.147
    -14 ± 10.796
    -7.67 ± 13.68
        Day 29 pre-dose, n=11, 12, 12
    -3 ± 12.61
    -4.5 ± 12.236
    -0.75 ± 13.844
        Day 29: 4 hr, n=12, 9, 11
    -9.92 ± 14.494
    -25.89 ± 20.521
    -15.18 ± 21.706
        Day 32, n=11, 12, 12
    -4.64 ± 11.227
    -19.92 ± 8.49
    -3.08 ± 16.082
        Day 42, n=12, 12, 12
    -9.5 ± 12.895
    -16.83 ± 10.223
    -9.42 ± 15.359
        Day 57, n=12, 12, 12
    -8.5 ± 9.968
    -5.08 ± 10.149
    -2.33 ± 11.284
        Day 85, n=12, 11, 12
    -7.75 ± 8.508
    -14.18 ± 9.453
    -5.17 ± 16.297
        Day 120, n=11, 12, 12
    -11.73 ± 13.001
    -17 ± 13.981
    -11.5 ± 17.578
        Day 165, n=12, 11, 12
    -14.58 ± 12.831
    -10.91 ± 13.262
    -9.08 ± 14.669
        Follow-up, n=12, 11, 12
    -13.5 ± 10.975
    -11.91 ± 11.97
    -12.5 ± 17.381
    Notes
    [106] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [107] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [108] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Change from Baseline in interleukin-6 (IL-6), inducible protein-10 (IP-10), matrix metalloproteinase-9 (MMP-9), intercellular adhesion molecule-1 (IAM-1), and plasminogen activator inhibitor-1 (PAI-1) levels at Days 29, 57, and 85

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    End point title
    Change from Baseline in interleukin-6 (IL-6), inducible protein-10 (IP-10), matrix metalloproteinase-9 (MMP-9), intercellular adhesion molecule-1 (IAM-1), and plasminogen activator inhibitor-1 (PAI-1) levels at Days 29, 57, and 85
    End point description
    Serum samples were collected to estimate IL-6, IP-10, MMP-9, IAM-1 levels, and plasma samples were collected for the estimation of PAI-1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value, where Day 1 is defined as Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; Day 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [109]
    13 [110]
    12 [111]
    Units: ng/L
    arithmetic mean (standard deviation)
        IL-6, Day 29
    0.83 ± 2.392
    0.57 ± 2.149
    -1.03 ± 3.034
        IL-6, Day 57
    -0.24 ± 0.934
    0.42 ± 0.959
    -1.21 ± 2.71
        IL-6, Day 85
    -0.04 ± 1.362
    -0.17 ± 1.002
    -0.93 ± 2.819
        Inducible protein 10, Day 29
    9.34 ± 153.643
    25.93 ± 137.181
    -71.82 ± 109.09
        Inducible protein 10, Day 57
    -39.36 ± 122.103
    5.75 ± 135.903
    -57.63 ± 122.93
        Inducible protein 10, Day 85
    -1.29 ± 92.374
    -4.61 ± 115.887
    -80.62 ± 100.406
        MMP-9, Day 29
    -90583.7 ± 237918.2
    -12523.3 ± 292929
    -155023 ± 295290.1
        MMP-9, Day 57
    -13157.9 ± 261712.8
    -83140.8 ± 124294.1
    -108312 ± 315259.2
        MMP-9, Day 85
    11328.1 ± 148277.1
    33993.3 ± 272533.5
    -143274 ± 324839.2
        PAI-1, Day 29
    32889.5 ± 56971.2
    2692 ± 65526.9
    -15486.5 ± 37095.97
        PAI-1, Day 57
    14470.7 ± 39216.4
    5161.77 ± 55823.3
    -14603.6 ± 88836.85
        PAI-1, Day 85
    13992.3 ± 38433.2
    24970.6 ± 96291.6
    -14082.4 ± 75656.88
        IAM-1, Day 29
    -648.1 ± 100568.4
    15984.15 ± 109324.5
    -18708.7 ± 67939.63
        IAM-1, Day 57
    -31678.9 ± 114736.3
    21330.63 ± 137433.9
    -36358.3 ± 99707.46
        IAM-1, Day 85
    -60516.9 ± 120963.1
    -1197.05 ± 78516.41
    -75448.8 ± 101530.3
    Notes
    [109] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [110] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [111] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Change from Baseline in lymphocytes biomarker levels at Days 1 (4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up

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    End point title
    Change from Baseline in lymphocytes biomarker levels at Days 1 (4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up
    End point description
    Change from Baseline is defined as the post-Baseline value minus the Baseline value, where Day 1 is defined as Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; Days 1 (4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [112]
    13 [113]
    12 [114]
    Units: GI/L
    arithmetic mean (standard deviation)
        Day 1: 4 hr, n=12, 12, 10
    0.18 ± 0.311
    0.28 ± 0.357
    0.36 ± 0.436
        Day 4, n=11, 12, 10
    0.24 ± 0.403
    0.17 ± 0.281
    0.31 ± 0.487
        Day 9, n=12, 13, 11
    0.26 ± 0.364
    0.25 ± 0.324
    0.33 ± 0.734
        Day 14, n=12, 12, 11
    0.18 ± 0.599
    0.16 ± 0.43
    0.31 ± 0.951
        Day 21, n=12, 13, 11
    0.1 ± 0.429
    0.22 ± 0.359
    0.44 ± 0.541
        Day 29 pre-dose, n=12, 13, 11
    -0.05 ± 0.458
    -0.05 ± 0.421
    0.03 ± 0.365
        Day 29: 4 hr, n=12, 13, 11
    0.19 ± 0.467
    0.45 ± 0.582
    0.4 ± 0.579
        Day 32, n=12, 13, 9
    0.09 ± 0.498
    0.1 ± 0.532
    0.44 ± 0.269
        Day 42, n=12, 13, 11
    -0.06 ± 0.528
    0.06 ± 0.276
    0.29 ± 0.553
        Day 57, n=12, 13, 11
    0.16 ± 0.549
    0.21 ± 0.269
    0.28 ± 0.496
        Day 85, n=12, 13, 11
    -0.02 ± 0.497
    0.13 ± 0.319
    0.25 ± 0.536
        Day 120, n=10, 13, 11
    0.22 ± 0.394
    0.12 ± 0.377
    0.27 ± 0.448
        Day 165, n=12, 13, 11
    0.14 ± 0.602
    0.28 ± 0.304
    0.47 ± 0.712
        Follow-up, n=12, 13, 11
    0.14 ± 0.478
    0.18 ± 0.359
    0.27 ± 0.649
    Notes
    [112] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [113] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [114] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Change from Baseline in resistin biomarker levels at Days 29, 57, and 85

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    End point title
    Change from Baseline in resistin biomarker levels at Days 29, 57, and 85
    End point description
    Serum samples were collected to estimate resistin levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value, where Day 1 is defined as Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; Day 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [115]
    13 [116]
    11 [117]
    Units: micrograms per liter (µg/L)
    arithmetic mean (standard deviation)
        Day 29
    -0.17 ± 3.114
    -0.03 ± 2.045
    -2.22 ± 2.127
        Day 57
    -0.6 ± 1.67
    -0.23 ± 1.383
    -0.36 ± 2.071
        Day 85
    1.44 ± 4.065
    0.22 ± 1.308
    -0.45 ± 2.07
    Notes
    [115] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [116] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    [117] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
    No statistical analyses for this end point

    Secondary: Change from Baseline in Albumin/Creatinine Ratio, MCP1/Creatinine Ratio, and HDL/LDL Ratio at Days 29, 57, and 85

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    End point title
    Change from Baseline in Albumin/Creatinine Ratio, MCP1/Creatinine Ratio, and HDL/LDL Ratio at Days 29, 57, and 85
    End point description
    Change from Baseline was calculated as the post-Baseline value minus the Baseline value, where Day 1 is defined as Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline; Day 29, 57, and 85
    End point values
    Placebo GSK1070806 0.25 mg/kg GSK1070806 5 mg/kg
    Number of subjects analysed
    12 [118]
    13 [119]
    12 [120]
    Units: Ratio
    arithmetic mean (standard deviation)
        Albumin/Creatinine Ratio, Day 29, n=11, 13, 9
    -21.55 ± 44.239
    -14.88 ± 34.18
    -3.65 ± 9.827
        Albumin/Creatinine Ratio, Day 57, n=12, 13, 10
    -20 ± 49.537
    -13.89 ± 41.526
    5.49 ± 12.835
        Albumin/Creatinine Ratio, Day 85, n=12, 13, 11
    -16.1 ± 36.231
    -15.68 ± 38.938
    1.94 ± 12.017
        MCP1/Creatinine Ratio, Day 29, n=11, 13, 9
    9.07 ± 22.821
    -21.78 ± 32.329
    -1.02 ± 25.843
        MCP1/Creatinine Ratio, Day 57, n=12, 13, 11
    2.81 ± 15.518
    -1.4 ± 28.885
    0.91 ± 18.641
        MCP1/Creatinine Ratio, Day 85, n=12, 12, 11
    -4.48 ± 18.868
    -17.13 ± 11.408
    0.37 ± 21.605
        HDL/LDL ratio, Day 1:4H, n=11, 11, 10
    0.07 ± 0.088
    0.01 ± 0.044
    0 ± 0.052
        HDL/LDL ratio, Day 4, n=11, 12, 11
    0.01 ± 0.063
    -0.02 ± 0.029
    -0.01 ± 0.068
        HDL/LDL ratio, Day 9, n=12, 12, 12
    0.01 ± 0.084
    0.04 ± 0.039
    0.08 ± 0.131
        HDL/LDL ratio, Day 14, n=12, 12, 12
    0.01 ± 0.116
    0.03 ± 0.051
    0.04 ± 0.12
        HDL/LDL ratio, Day 21, n=12, 12, 12
    0.01 ± 0.107
    0.03 ± 0.065
    0.04 ± 0.114
        HDL/LDL ratio, Day 29 predose, n=11, 12, 12
    0.03 ± 0.091
    0.04 ± 0.067
    0.04 ± 0.11
        HDL/LDL ratio, Day 29:4H, n=12, 10, 11
    0.08 ± 0.124
    0.08 ± 0.087