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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
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

A18116378

ISRCTN number

US NCT number

WHO universal trial number (UTN)

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,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

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?

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

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Spain: 37

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

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 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor

Are arms mutually exclusive

Yes

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.

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

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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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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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

Day 29; Placebo:GSK1070806 0.25 mg/kg

Comparison groups

Placebo v GSK1070806 0.25 mg/kg

Number of subjects included in analysis

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

Day 57; Placebo:GSK1070806 0.25 mg/kg

Comparison groups

Placebo v GSK1070806 0.25 mg/kg

Number of subjects included in analysis

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

Day 85; Placebo:GSK1070806 0.25 mg/kg

Comparison groups

Placebo v GSK1070806 0.25 mg/kg

Number of subjects included in analysis

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

Day 29; Placebo:GSK1070806 5 mg/kg

Comparison groups

Placebo v GSK1070806 5 mg/kg

Number of subjects included in analysis

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

Day 57; Placebo:GSK1070806 5 mg/kg

Comparison groups

Placebo v GSK1070806 5 mg/kg

Number of subjects included in analysis

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

Day 85; Placebo:GSK1070806 5 mg/kg

Comparison groups

Placebo v GSK1070806 5 mg/kg

Number of subjects included in analysis

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 1

Statistical analysis description

Day 29

Comparison groups

Placebo v GSK1070806 0.25 mg/kg

Number of subjects included in analysis

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 2

Statistical analysis description

Day 57

Comparison groups

Placebo v GSK1070806 0.25 mg/kg

Number of subjects included in analysis

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 3

Statistical analysis description

Day 85

Comparison groups

Placebo v GSK1070806 0.25 mg/kg

Number of subjects included in analysis

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 4

Statistical analysis description

Day 29

Comparison groups

Placebo v GSK1070806 5 mg/kg

Number of subjects included in analysis

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 5

Statistical analysis description

Day 57

Comparison groups

Placebo v GSK1070806 5 mg/kg

Number of subjects included in analysis

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 6

Statistical analysis description

Day 85

Comparison groups

Placebo v GSK1070806 5 mg/kg

Number of subjects included in analysis

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

Top of page

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 )	0.1 ( 0.174 )
HDL/LDL ratio, Day 32, n=11, 12, 12	0 ( 0.131 )	0.05 ( 0.05 )	0.02 ( 0.118 )
HDL/LDL ratio, Day 42, n=11, 12, 12	-0.02 ( 0.062 )	0.04 ( 0.072 )	0.03 ( 0.118 )
HDL/LDL ratio, Day 57, n=12, 12, 12	-0.05 ( 0.104 )	0.05 ( 0.099 )	0.09 ( 0.223 )
HDL/LDL ratio, Day 85, n=11, 11, 12	-0.02 ( 0.079 )	0.03 ( 0.072 )	0.07 ( 0.159 )
HDL/LDL ratio, Day 120, n=10, 12, 12	-0.03 ( 0.126 )	0.08 ( 0.078 )	0.04 ( 0.095 )
HDL/LDL ratio, Day 165, n=12, 11, 12	0.02 ( 0.097 )	0.05 ( 0.08 )	0.05 ( 0.246 )
HDL/LDL ratio, follow-up, n=12, 11, 12	0.01 ( 0.095 )	0.01 ( 0.068 )	0.1 ( 0.189 )

Notes
[118] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
[119] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
[120] - 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 waist circumference at Day 85

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End point title

Change from Baseline in waist circumference at Day 85

End point description

Summary statistics were not generated for these parameters.

End point type

Secondary

End point timeframe

Baseline; Day 85

End point values	Placebo	GSK1070806 0.25 mg/kg	GSK1070806 5 mg/kg
Number of subjects analysed	0 ^[121]	0 ^[122]	0 ^[123]
Units: centimeters
arithmetic mean (standard deviation)	( )	( )	( )

Notes
[121] - All Subject Population
[122] - All Subject Population
[123] - All Subject Population

No statistical analyses for this end point

Secondary: Number of participants with detectable levels of anti-GSK1070806 antibodies

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End point title

Number of participants with detectable levels of anti-GSK1070806 antibodies

End point description

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 ^[124]	13 ^[125]	12 ^[126]
Units: participants		0	0

Notes
[124] - All Subject Population
[125] - All Subject Population
[126] - All Subject Population

No statistical analyses for this end point

Secondary: Change from Baseline in body mass index (BMI) at Day 85

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End point title

Change from Baseline in body mass index (BMI) at Day 85

End point description

End point type

Secondary

End point timeframe

Baseline; Day 85

End point values	Placebo	GSK1070806 0.25 mg/kg	GSK1070806 5 mg/kg
Number of subjects analysed	0 ^[127]	0 ^[128]	0 ^[129]
Units: kilograms per meters squared (kg/m^2)
arithmetic mean (standard deviation)	( )	( )	( )

Notes
[127] - All Subject Population
[128] - All Subject Population
[129] - All Subject Population

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment until follow-up (assessed up to Study Day 210).

Adverse event reporting additional description

SAEs and non-serious AEs are reported for members of the All Subject Population, comprised of all participants who received study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.1

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.

Serious adverse events	Placebo	GSK1070806 0.25 mg/kg	GSK1070806 5 mg/kg
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	1 / 12 (8.33%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events
Nervous system disorders
VIIth nerve paralysis
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Diverticulitis
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Placebo	GSK1070806 0.25 mg/kg	GSK1070806 5 mg/kg
Total subjects affected by non serious adverse events
subjects affected / exposed	10 / 12 (83.33%)	12 / 13 (92.31%)	11 / 12 (91.67%)
Vascular disorders
Hypertension
subjects affected / exposed	0 / 12 (0.00%)	2 / 13 (15.38%)	3 / 12 (25.00%)
occurrences all number	0	2	3
Aortic stenosis
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Arterial disorder
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Hypotension
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Surgical and medical procedures
Tooth extraction
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 12 (0.00%)	1 / 13 (7.69%)	1 / 12 (8.33%)
occurrences all number	0	1	1
Pyrexia
subjects affected / exposed	1 / 12 (8.33%)	1 / 13 (7.69%)	0 / 12 (0.00%)
occurrences all number	1	1	0
Oedema peripheral
subjects affected / exposed	0 / 12 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)
occurrences all number	0	1	0
Reproductive system and breast disorders
Male sexual dysfunction
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	1 / 12 (8.33%)	1 / 13 (7.69%)	2 / 12 (16.67%)
occurrences all number	1	1	2
Acute respiratory failure
subjects affected / exposed	0 / 12 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)
occurrences all number	0	1	0
Epistaxis
subjects affected / exposed	0 / 12 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)
occurrences all number	0	1	0
Nasal obstruction
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Psychiatric disorders
Depression
subjects affected / exposed	1 / 12 (8.33%)	1 / 13 (7.69%)	1 / 12 (8.33%)
occurrences all number	1	1	1
Anxiety
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Insomnia
subjects affected / exposed	0 / 12 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)
occurrences all number	0	1	0
Injury, poisoning and procedural complications
Muscle rupture
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Cardiac disorders
Left ventricular hypertrophy
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Tachycardia
subjects affected / exposed	0 / 12 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)
occurrences all number	0	2	0
Nervous system disorders
Headache
subjects affected / exposed	1 / 12 (8.33%)	3 / 13 (23.08%)	1 / 12 (8.33%)
occurrences all number	1	4	1
Dizziness
subjects affected / exposed	0 / 12 (0.00%)	3 / 13 (23.08%)	0 / 12 (0.00%)
occurrences all number	0	3	0
Paraesthesia
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	1
Amnesia
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Hyperaesthesia
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Loss of consciousness
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Sciatica
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Blood and lymphatic system disorders
Lymphadenopathy
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Eye disorders
Vision blurred
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	3	0	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	2 / 12 (16.67%)	1 / 13 (7.69%)	2 / 12 (16.67%)
occurrences all number	2	2	2
Toothache
subjects affected / exposed	2 / 12 (16.67%)	1 / 13 (7.69%)	0 / 12 (0.00%)
occurrences all number	3	1	0
Constipation
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	1
Abdominal pain
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Abdominal pain upper
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 12 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)
occurrences all number	0	1	0
Haemorrhoids
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Stomatitis
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Vomiting
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Skin and subcutaneous tissue disorders
Erythema
subjects affected / exposed	0 / 12 (0.00%)	2 / 13 (15.38%)	0 / 12 (0.00%)
occurrences all number	0	3	0
Dermatitis
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Eczema
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Hangnail
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Ingrowing nail
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Pruritus
subjects affected / exposed	0 / 12 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)
occurrences all number	0	1	0
Renal and urinary disorders
Dysuria
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	0 / 12 (0.00%)	2 / 13 (15.38%)	2 / 12 (16.67%)
occurrences all number	0	2	3
Arthralgia
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	2 / 12 (16.67%)
occurrences all number	1	0	3
Lumbar spinal stenosis
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Muscle contracture
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Musculoskeletal chest pain
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Pain in extremity
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Rotator cuff syndrome
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Infections and infestations
Nasopharyngitis
subjects affected / exposed	4 / 12 (33.33%)	3 / 13 (23.08%)	4 / 12 (33.33%)
occurrences all number	5	4	8
Urinary tract infection
subjects affected / exposed	1 / 12 (8.33%)	1 / 13 (7.69%)	1 / 12 (8.33%)
occurrences all number	1	1	1
Gastroenteritis
subjects affected / exposed	0 / 12 (0.00%)	1 / 13 (7.69%)	1 / 12 (8.33%)
occurrences all number	0	1	1
Acute tonsillitis
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Bronchitis
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	2
Candida infection
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Onychomycosis
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1
Oral candidiasis
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Pharyngitis
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Pulpitis dental
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Respiratory tract infection
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Tonsillitis
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Tooth infection
subjects affected / exposed	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0
Metabolism and nutrition disorders
Gout
subjects affected / exposed	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

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.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

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

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

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

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

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

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

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)

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Secondary: Maximum observed concentration (Cmax)

Secondary: Maximum observed concentration (Cmax)

Secondary: Time of occurrence of Cmax (Tmax)

Secondary: Time of occurrence of Cmax (Tmax)

Secondary: Terminal phase rate constant

Secondary: Terminal phase rate constant

Secondary: Terminal half life (t1/2)

Secondary: Terminal half life (t1/2)

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

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

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

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

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

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

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

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

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.