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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

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End point title

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

End point description

Change from Baseline is defined as the post-Baseline value minus the Baseline value, where Day 1 is defined as Baseline.

End point type

Secondary

End point timeframe

Baseline; Days 1 (4 hr post-dose), 4, 9, 14, 21, 29 (pre-dose and 4 hr post-dose), 32, 42, 57, 85, 120, and 165; and follow-up (up to Study Day 210)

End point values	Placebo	GSK1070806 0.25 mg/kg	GSK1070806 5 mg/kg
Number of subjects analysed	12 ^[112]	13 ^[113]	12 ^[114]
Units: GI/L
arithmetic mean (standard deviation)
Day 1: 4 hr, n=12, 12, 10	0.18 ± 0.311	0.28 ± 0.357	0.36 ± 0.436
Day 4, n=11, 12, 10	0.24 ± 0.403	0.17 ± 0.281	0.31 ± 0.487
Day 9, n=12, 13, 11	0.26 ± 0.364	0.25 ± 0.324	0.33 ± 0.734
Day 14, n=12, 12, 11	0.18 ± 0.599	0.16 ± 0.43	0.31 ± 0.951
Day 21, n=12, 13, 11	0.1 ± 0.429	0.22 ± 0.359	0.44 ± 0.541
Day 29 pre-dose, n=12, 13, 11	-0.05 ± 0.458	-0.05 ± 0.421	0.03 ± 0.365
Day 29: 4 hr, n=12, 13, 11	0.19 ± 0.467	0.45 ± 0.582	0.4 ± 0.579
Day 32, n=12, 13, 9	0.09 ± 0.498	0.1 ± 0.532	0.44 ± 0.269
Day 42, n=12, 13, 11	-0.06 ± 0.528	0.06 ± 0.276	0.29 ± 0.553
Day 57, n=12, 13, 11	0.16 ± 0.549	0.21 ± 0.269	0.28 ± 0.496
Day 85, n=12, 13, 11	-0.02 ± 0.497	0.13 ± 0.319	0.25 ± 0.536
Day 120, n=10, 13, 11	0.22 ± 0.394	0.12 ± 0.377	0.27 ± 0.448
Day 165, n=12, 13, 11	0.14 ± 0.602	0.28 ± 0.304	0.47 ± 0.712
Follow-up, n=12, 13, 11	0.14 ± 0.478	0.18 ± 0.359	0.27 ± 0.649

Notes
[112] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
[113] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
[114] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).

No statistical analyses for this end point

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

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End point title

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

End point description

Serum samples were collected to estimate resistin levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value, where Day 1 is defined as Baseline.

End point type

Secondary

End point timeframe

Baseline; Day 29, 57, and 85

End point values	Placebo	GSK1070806 0.25 mg/kg	GSK1070806 5 mg/kg
Number of subjects analysed	12 ^[115]	13 ^[116]	11 ^[117]
Units: micrograms per liter (µg/L)
arithmetic mean (standard deviation)
Day 29	-0.17 ± 3.114	-0.03 ± 2.045	-2.22 ± 2.127
Day 57	-0.6 ± 1.67	-0.23 ± 1.383	-0.36 ± 2.071
Day 85	1.44 ± 4.065	0.22 ± 1.308	-0.45 ± 2.07

Notes
[115] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
[116] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).
[117] - ASP. Only participants available at the specified time points were analyzed (n=X, X, X).

No statistical analyses for this end point

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

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End point title

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

End point description

Change from Baseline was calculated as the post-Baseline value minus the Baseline value, where Day 1 is defined as Baseline.

End point type

Secondary

End point timeframe

Baseline; Day 29, 57, and 85

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

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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.