Trial Outcomes & Findings for A Phase I, 2-part (Part 1 Being a Single Dose Escalation and Part 2, a Parallel Group) Study of Toll-like Receptor (TLR4) Agonist (GSK1795091) in Healthy Subjects (NCT NCT02798978)
NCT ID: NCT02798978
Last Updated: 2020-11-27
Results Overview
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All participants enrolled into the study who have received a dose of study medication (GSK1795091 or placebo) were included in the All Subjects Population. Participants with non-serious AEs (5 percentage threshold) and SAEs has been reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Up to Day 32
Results posted on
2020-11-27
Participant Flow
This study was planned to be conducted in 2-parts, however Part 2 was discontinued by the Sponsor prior to its scheduled start. Part 1 was single-dose escalation, sequential group evaluation of intravenously administered GSK1795091 to evaluate the safety and tolerability in healthy participants.
Forty two participants were randomized in Part 1 of which 2 did not receive dose due to abnormal findings during pre-dose examination. Participants were randomized in ratio of 3:1 to receive GSK1795091 or matching placebo.
Participant milestones
| Measure |
Part 1: Placebo
Participants in Part 1 were randomized to receive intravenous (IV) matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 nanogram (ng). Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
All Participants in Part 2
In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled.
|
|---|---|---|---|---|---|---|---|
|
Part 1 (30 Days)
STARTED
|
10
|
6
|
6
|
6
|
6
|
6
|
0
|
|
Part 1 (30 Days)
COMPLETED
|
10
|
6
|
6
|
6
|
6
|
6
|
0
|
|
Part 1 (30 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (45 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (45 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (45 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I, 2-part (Part 1 Being a Single Dose Escalation and Part 2, a Parallel Group) Study of Toll-like Receptor (TLR4) Agonist (GSK1795091) in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive intravenous (IV) matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 nanogram (ng). Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
All Participants in Part 2
In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.2 Years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
30.2 Years
STANDARD_DEVIATION 6.62 • n=7 Participants
|
40.5 Years
STANDARD_DEVIATION 7.64 • n=5 Participants
|
39.7 Years
STANDARD_DEVIATION 7.47 • n=4 Participants
|
43.3 Years
STANDARD_DEVIATION 8.43 • n=21 Participants
|
38.3 Years
STANDARD_DEVIATION 6.02 • n=8 Participants
|
—
|
37.6 Years
STANDARD_DEVIATION 8.21 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
1 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
—
|
39 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Row 2 · Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
2 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Row 2 · White/Caucasian/European Heritage
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
—
|
38 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to Day 32Population: All Subjects Population.
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All participants enrolled into the study who have received a dose of study medication (GSK1795091 or placebo) were included in the All Subjects Population. Participants with non-serious AEs (5 percentage threshold) and SAEs has been reported.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)
Non-SAE (>= 5%)
|
0 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.Population: All Subjects Population.
Body temperature was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Temperature Part 1
Day 3
|
-0.10 Celsius
Standard Deviation 0.221
|
0.07 Celsius
Standard Deviation 0.207
|
-0.17 Celsius
Standard Deviation 0.225
|
0.10 Celsius
Standard Deviation 0.179
|
-0.13 Celsius
Standard Deviation 0.250
|
-0.08 Celsius
Standard Deviation 0.204
|
|
Change From Baseline in Body Temperature Part 1
Day 4
|
0.01 Celsius
Standard Deviation 0.197
|
0.25 Celsius
Standard Deviation 0.259
|
-0.15 Celsius
Standard Deviation 0.217
|
0.05 Celsius
Standard Deviation 0.266
|
0.02 Celsius
Standard Deviation 0.223
|
-0.12 Celsius
Standard Deviation 0.204
|
|
Change From Baseline in Body Temperature Part 1
Day 5
|
0.14 Celsius
Standard Deviation 0.178
|
0.22 Celsius
Standard Deviation 0.147
|
-0.12 Celsius
Standard Deviation 0.194
|
0.17 Celsius
Standard Deviation 0.273
|
-0.13 Celsius
Standard Deviation 0.250
|
0.13 Celsius
Standard Deviation 0.234
|
|
Change From Baseline in Body Temperature Part 1
Day 1, 1 hour
|
0.14 Celsius
Standard Deviation 0.084
|
0.17 Celsius
Standard Deviation 0.163
|
0.08 Celsius
Standard Deviation 0.264
|
0.15 Celsius
Standard Deviation 0.187
|
0.15 Celsius
Standard Deviation 0.281
|
0.17 Celsius
Standard Deviation 0.327
|
|
Change From Baseline in Body Temperature Part 1
Day 1, 2 hour
|
0.17 Celsius
Standard Deviation 0.095
|
0.23 Celsius
Standard Deviation 0.163
|
0.32 Celsius
Standard Deviation 0.232
|
0.68 Celsius
Standard Deviation 0.354
|
0.40 Celsius
Standard Deviation 0.179
|
0.87 Celsius
Standard Deviation 0.367
|
|
Change From Baseline in Body Temperature Part 1
Day 1, 4 hour
|
0.26 Celsius
Standard Deviation 0.196
|
0.42 Celsius
Standard Deviation 0.147
|
0.55 Celsius
Standard Deviation 0.389
|
0.98 Celsius
Standard Deviation 0.556
|
0.63 Celsius
Standard Deviation 0.383
|
1.25 Celsius
Standard Deviation 0.295
|
|
Change From Baseline in Body Temperature Part 1
Day 1, 6 hour
|
0.43 Celsius
Standard Deviation 0.206
|
0.53 Celsius
Standard Deviation 0.301
|
0.45 Celsius
Standard Deviation 0.464
|
0.82 Celsius
Standard Deviation 0.665
|
0.38 Celsius
Standard Deviation 0.483
|
0.93 Celsius
Standard Deviation 0.163
|
|
Change From Baseline in Body Temperature Part 1
Day 1, 8 hour
|
0.41 Celsius
Standard Deviation 0.197
|
0.53 Celsius
Standard Deviation 0.273
|
0.43 Celsius
Standard Deviation 0.301
|
0.63 Celsius
Standard Deviation 0.432
|
0.57 Celsius
Standard Deviation 0.258
|
0.75 Celsius
Standard Deviation 0.389
|
|
Change From Baseline in Body Temperature Part 1
Day 1, 12 hour
|
0.14 Celsius
Standard Deviation 0.255
|
0.18 Celsius
Standard Deviation 0.337
|
0.28 Celsius
Standard Deviation 0.397
|
0.28 Celsius
Standard Deviation 0.397
|
0.23 Celsius
Standard Deviation 0.242
|
0.67 Celsius
Standard Deviation 0.294
|
|
Change From Baseline in Body Temperature Part 1
Day 1, 16 hour
|
0.03 Celsius
Standard Deviation 0.258
|
0.02 Celsius
Standard Deviation 0.223
|
-0.08 Celsius
Standard Deviation 0.319
|
0.03 Celsius
Standard Deviation 0.175
|
0.03 Celsius
Standard Deviation 0.225
|
0.32 Celsius
Standard Deviation 0.349
|
|
Change From Baseline in Body Temperature Part 1
Day 2
|
0.06 Celsius
Standard Deviation 0.190
|
-0.02 Celsius
Standard Deviation 0.172
|
-0.05 Celsius
Standard Deviation 0.226
|
0.12 Celsius
Standard Deviation 0.147
|
-0.08 Celsius
Standard Deviation 0.117
|
0.13 Celsius
Standard Deviation 0.186
|
|
Change From Baseline in Body Temperature Part 1
Day 7
|
0.02 Celsius
Standard Deviation 0.199
|
0.12 Celsius
Standard Deviation 0.204
|
-0.13 Celsius
Standard Deviation 0.314
|
0.08 Celsius
Standard Deviation 0.354
|
-0.20 Celsius
Standard Deviation 0.415
|
0.10 Celsius
Standard Deviation 0.228
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.Population: All Subjects Population.
Systolic and diastolic BP was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
DBP, Day 4
|
2.6 Millimeter of mercury (mmHg)
Standard Deviation 9.38
|
0.7 Millimeter of mercury (mmHg)
Standard Deviation 8.41
|
-6.2 Millimeter of mercury (mmHg)
Standard Deviation 11.29
|
-2.2 Millimeter of mercury (mmHg)
Standard Deviation 9.62
|
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 4.10
|
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 6.23
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
DBP, Day 5
|
2.4 Millimeter of mercury (mmHg)
Standard Deviation 5.02
|
4.2 Millimeter of mercury (mmHg)
Standard Deviation 4.54
|
-1.2 Millimeter of mercury (mmHg)
Standard Deviation 10.25
|
1.5 Millimeter of mercury (mmHg)
Standard Deviation 10.45
|
1.5 Millimeter of mercury (mmHg)
Standard Deviation 2.07
|
2.5 Millimeter of mercury (mmHg)
Standard Deviation 6.06
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
SBP, Day 1, 1 hour
|
6.5 Millimeter of mercury (mmHg)
Standard Deviation 5.78
|
4.7 Millimeter of mercury (mmHg)
Standard Deviation 8.89
|
1.5 Millimeter of mercury (mmHg)
Standard Deviation 9.05
|
8.8 Millimeter of mercury (mmHg)
Standard Deviation 8.16
|
3.3 Millimeter of mercury (mmHg)
Standard Deviation 6.12
|
-1.3 Millimeter of mercury (mmHg)
Standard Deviation 14.60
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
SBP, Day 1, 2 hour
|
-2.0 Millimeter of mercury (mmHg)
Standard Deviation 6.53
|
-1.2 Millimeter of mercury (mmHg)
Standard Deviation 5.56
|
-1.2 Millimeter of mercury (mmHg)
Standard Deviation 11.23
|
-3.7 Millimeter of mercury (mmHg)
Standard Deviation 8.52
|
1.2 Millimeter of mercury (mmHg)
Standard Deviation 7.08
|
0.8 Millimeter of mercury (mmHg)
Standard Deviation 6.05
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
SBP, Day 1, 6 hour
|
5.0 Millimeter of mercury (mmHg)
Standard Deviation 8.65
|
4.2 Millimeter of mercury (mmHg)
Standard Deviation 4.31
|
2.2 Millimeter of mercury (mmHg)
Standard Deviation 11.70
|
1.8 Millimeter of mercury (mmHg)
Standard Deviation 10.46
|
7.5 Millimeter of mercury (mmHg)
Standard Deviation 9.35
|
3.2 Millimeter of mercury (mmHg)
Standard Deviation 6.46
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
SBP, Day 1, 8 hour
|
0.7 Millimeter of mercury (mmHg)
Standard Deviation 8.04
|
2.3 Millimeter of mercury (mmHg)
Standard Deviation 5.68
|
0.8 Millimeter of mercury (mmHg)
Standard Deviation 17.78
|
-2.7 Millimeter of mercury (mmHg)
Standard Deviation 10.98
|
2.5 Millimeter of mercury (mmHg)
Standard Deviation 6.25
|
-2.3 Millimeter of mercury (mmHg)
Standard Deviation 4.72
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
SBP, Day 1, 12 hour
|
3.9 Millimeter of mercury (mmHg)
Standard Deviation 11.56
|
2.3 Millimeter of mercury (mmHg)
Standard Deviation 4.32
|
6.0 Millimeter of mercury (mmHg)
Standard Deviation 19.76
|
6.2 Millimeter of mercury (mmHg)
Standard Deviation 5.85
|
6.2 Millimeter of mercury (mmHg)
Standard Deviation 9.68
|
2.0 Millimeter of mercury (mmHg)
Standard Deviation 7.21
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
SBP, Day 1, 16 hour
|
-1.8 Millimeter of mercury (mmHg)
Standard Deviation 6.16
|
-6.8 Millimeter of mercury (mmHg)
Standard Deviation 6.43
|
-7.2 Millimeter of mercury (mmHg)
Standard Deviation 22.51
|
-6.8 Millimeter of mercury (mmHg)
Standard Deviation 8.11
|
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 14.10
|
0.8 Millimeter of mercury (mmHg)
Standard Deviation 13.29
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
SBP, Day 2
|
-3.2 Millimeter of mercury (mmHg)
Standard Deviation 7.15
|
-1.8 Millimeter of mercury (mmHg)
Standard Deviation 3.60
|
-5.0 Millimeter of mercury (mmHg)
Standard Deviation 17.44
|
-2.3 Millimeter of mercury (mmHg)
Standard Deviation 11.54
|
-0.7 Millimeter of mercury (mmHg)
Standard Deviation 5.16
|
2.2 Millimeter of mercury (mmHg)
Standard Deviation 6.85
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
SBP, Day 3
|
-2.0 Millimeter of mercury (mmHg)
Standard Deviation 10.09
|
-1.3 Millimeter of mercury (mmHg)
Standard Deviation 5.89
|
-7.8 Millimeter of mercury (mmHg)
Standard Deviation 15.94
|
5.0 Millimeter of mercury (mmHg)
Standard Deviation 8.39
|
1.8 Millimeter of mercury (mmHg)
Standard Deviation 5.12
|
1.0 Millimeter of mercury (mmHg)
Standard Deviation 8.81
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
SBP, Day 4
|
0.7 Millimeter of mercury (mmHg)
Standard Deviation 6.50
|
-1.7 Millimeter of mercury (mmHg)
Standard Deviation 8.38
|
-8.2 Millimeter of mercury (mmHg)
Standard Deviation 19.86
|
-1.8 Millimeter of mercury (mmHg)
Standard Deviation 12.88
|
-1.7 Millimeter of mercury (mmHg)
Standard Deviation 5.85
|
-0.3 Millimeter of mercury (mmHg)
Standard Deviation 2.66
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
SBP, Day 5
|
4.2 Millimeter of mercury (mmHg)
Standard Deviation 4.69
|
1.5 Millimeter of mercury (mmHg)
Standard Deviation 3.08
|
-2.5 Millimeter of mercury (mmHg)
Standard Deviation 17.76
|
9.5 Millimeter of mercury (mmHg)
Standard Deviation 13.43
|
5.0 Millimeter of mercury (mmHg)
Standard Deviation 4.65
|
4.0 Millimeter of mercury (mmHg)
Standard Deviation 5.37
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
SBP, Day 7
|
-0.1 Millimeter of mercury (mmHg)
Standard Deviation 6.81
|
5.3 Millimeter of mercury (mmHg)
Standard Deviation 8.91
|
-4.3 Millimeter of mercury (mmHg)
Standard Deviation 14.96
|
2.3 Millimeter of mercury (mmHg)
Standard Deviation 10.78
|
1.5 Millimeter of mercury (mmHg)
Standard Deviation 11.50
|
5.2 Millimeter of mercury (mmHg)
Standard Deviation 7.83
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
DBP, Day 1, 1 hour
|
-2.1 Millimeter of mercury (mmHg)
Standard Deviation 6.14
|
-3.8 Millimeter of mercury (mmHg)
Standard Deviation 2.79
|
-2.3 Millimeter of mercury (mmHg)
Standard Deviation 5.50
|
-1.3 Millimeter of mercury (mmHg)
Standard Deviation 4.27
|
-3.2 Millimeter of mercury (mmHg)
Standard Deviation 5.23
|
-3.3 Millimeter of mercury (mmHg)
Standard Deviation 4.18
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
DBP, Day 1, 2 hour
|
-4.3 Millimeter of mercury (mmHg)
Standard Deviation 4.00
|
-5.0 Millimeter of mercury (mmHg)
Standard Deviation 1.26
|
-5.0 Millimeter of mercury (mmHg)
Standard Deviation 10.06
|
-6.5 Millimeter of mercury (mmHg)
Standard Deviation 2.43
|
-4.8 Millimeter of mercury (mmHg)
Standard Deviation 3.43
|
-7.0 Millimeter of mercury (mmHg)
Standard Deviation 8.20
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
DBP, Day 1, 4 hour
|
-1.9 Millimeter of mercury (mmHg)
Standard Deviation 4.77
|
-3.8 Millimeter of mercury (mmHg)
Standard Deviation 3.54
|
-3.7 Millimeter of mercury (mmHg)
Standard Deviation 5.05
|
-3.7 Millimeter of mercury (mmHg)
Standard Deviation 5.82
|
-4.5 Millimeter of mercury (mmHg)
Standard Deviation 4.14
|
-4.2 Millimeter of mercury (mmHg)
Standard Deviation 4.88
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
DBP, Day 1, 6 hour
|
-0.5 Millimeter of mercury (mmHg)
Standard Deviation 4.86
|
-6.0 Millimeter of mercury (mmHg)
Standard Deviation 4.86
|
-3.5 Millimeter of mercury (mmHg)
Standard Deviation 6.09
|
-5.3 Millimeter of mercury (mmHg)
Standard Deviation 8.21
|
-0.8 Millimeter of mercury (mmHg)
Standard Deviation 6.34
|
-7.5 Millimeter of mercury (mmHg)
Standard Deviation 6.38
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
DBP, Day 1, 8 hour
|
0.9 Millimeter of mercury (mmHg)
Standard Deviation 5.17
|
-0.5 Millimeter of mercury (mmHg)
Standard Deviation 2.95
|
-2.3 Millimeter of mercury (mmHg)
Standard Deviation 5.47
|
-4.3 Millimeter of mercury (mmHg)
Standard Deviation 10.73
|
-0.8 Millimeter of mercury (mmHg)
Standard Deviation 5.23
|
-6.8 Millimeter of mercury (mmHg)
Standard Deviation 6.85
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
DBP, Day 1, 12 hour
|
-2.2 Millimeter of mercury (mmHg)
Standard Deviation 6.01
|
-0.3 Millimeter of mercury (mmHg)
Standard Deviation 6.25
|
-2.7 Millimeter of mercury (mmHg)
Standard Deviation 11.17
|
-2.8 Millimeter of mercury (mmHg)
Standard Deviation 5.27
|
-4.3 Millimeter of mercury (mmHg)
Standard Deviation 7.03
|
-2.0 Millimeter of mercury (mmHg)
Standard Deviation 8.32
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
DBP, Day 1, 16 hour
|
-3.2 Millimeter of mercury (mmHg)
Standard Deviation 6.00
|
-5.5 Millimeter of mercury (mmHg)
Standard Deviation 8.87
|
-5.8 Millimeter of mercury (mmHg)
Standard Deviation 15.22
|
-6.2 Millimeter of mercury (mmHg)
Standard Deviation 5.88
|
-3.8 Millimeter of mercury (mmHg)
Standard Deviation 5.04
|
-2.7 Millimeter of mercury (mmHg)
Standard Deviation 10.13
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
DBP, Day 2
|
0.0 Millimeter of mercury (mmHg)
Standard Deviation 5.40
|
1.0 Millimeter of mercury (mmHg)
Standard Deviation 6.10
|
-5.3 Millimeter of mercury (mmHg)
Standard Deviation 8.80
|
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 6.66
|
1.3 Millimeter of mercury (mmHg)
Standard Deviation 7.87
|
0.7 Millimeter of mercury (mmHg)
Standard Deviation 7.00
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
DBP, Day 3
|
0.1 Millimeter of mercury (mmHg)
Standard Deviation 6.30
|
-1.3 Millimeter of mercury (mmHg)
Standard Deviation 5.39
|
-5.0 Millimeter of mercury (mmHg)
Standard Deviation 8.99
|
4.3 Millimeter of mercury (mmHg)
Standard Deviation 10.89
|
1.0 Millimeter of mercury (mmHg)
Standard Deviation 6.51
|
0.8 Millimeter of mercury (mmHg)
Standard Deviation 7.08
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
DBP, Day 7
|
0.9 Millimeter of mercury (mmHg)
Standard Deviation 7.03
|
3.7 Millimeter of mercury (mmHg)
Standard Deviation 6.71
|
-1.8 Millimeter of mercury (mmHg)
Standard Deviation 7.86
|
4.7 Millimeter of mercury (mmHg)
Standard Deviation 9.22
|
1.3 Millimeter of mercury (mmHg)
Standard Deviation 6.31
|
3.2 Millimeter of mercury (mmHg)
Standard Deviation 9.43
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
SBP, Day 1, 4 hour
|
-1.6 Millimeter of mercury (mmHg)
Standard Deviation 4.25
|
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 7.56
|
-4.2 Millimeter of mercury (mmHg)
Standard Deviation 11.99
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 6.35
|
1.7 Millimeter of mercury (mmHg)
Standard Deviation 8.55
|
1.2 Millimeter of mercury (mmHg)
Standard Deviation 3.37
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.Population: All Subjects Population.
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Pulse Rate Part 1
Day 1, 1 hour
|
8.1 Beats per minute
Standard Deviation 6.92
|
8.2 Beats per minute
Standard Deviation 3.31
|
11.8 Beats per minute
Standard Deviation 7.65
|
16.7 Beats per minute
Standard Deviation 7.66
|
12.0 Beats per minute
Standard Deviation 5.10
|
10.2 Beats per minute
Standard Deviation 4.88
|
|
Change From Baseline in Pulse Rate Part 1
Day 1, 2 hour
|
5.9 Beats per minute
Standard Deviation 5.36
|
8.2 Beats per minute
Standard Deviation 8.57
|
11.3 Beats per minute
Standard Deviation 11.74
|
17.5 Beats per minute
Standard Deviation 8.60
|
14.8 Beats per minute
Standard Deviation 9.45
|
14.3 Beats per minute
Standard Deviation 7.45
|
|
Change From Baseline in Pulse Rate Part 1
Day 1, 4 hour
|
5.0 Beats per minute
Standard Deviation 7.67
|
2.8 Beats per minute
Standard Deviation 2.99
|
11.7 Beats per minute
Standard Deviation 15.12
|
17.8 Beats per minute
Standard Deviation 20.22
|
17.3 Beats per minute
Standard Deviation 9.79
|
20.8 Beats per minute
Standard Deviation 5.42
|
|
Change From Baseline in Pulse Rate Part 1
Day 1, 6 hour
|
8.7 Beats per minute
Standard Deviation 6.73
|
8.7 Beats per minute
Standard Deviation 3.98
|
10.8 Beats per minute
Standard Deviation 13.12
|
15.7 Beats per minute
Standard Deviation 17.07
|
17.7 Beats per minute
Standard Deviation 7.37
|
15.7 Beats per minute
Standard Deviation 5.09
|
|
Change From Baseline in Pulse Rate Part 1
Day 1, 8 hour
|
3.2 Beats per minute
Standard Deviation 6.49
|
1.7 Beats per minute
Standard Deviation 3.20
|
4.7 Beats per minute
Standard Deviation 6.15
|
4.7 Beats per minute
Standard Deviation 8.87
|
8.2 Beats per minute
Standard Deviation 5.74
|
6.3 Beats per minute
Standard Deviation 5.35
|
|
Change From Baseline in Pulse Rate Part 1
Day 1, 12 hour
|
4.6 Beats per minute
Standard Deviation 8.45
|
4.7 Beats per minute
Standard Deviation 5.99
|
5.2 Beats per minute
Standard Deviation 15.48
|
7.2 Beats per minute
Standard Deviation 4.07
|
10.5 Beats per minute
Standard Deviation 4.59
|
9.0 Beats per minute
Standard Deviation 6.57
|
|
Change From Baseline in Pulse Rate Part 1
Day 1, 16 hour
|
-1.9 Beats per minute
Standard Deviation 5.55
|
-2.0 Beats per minute
Standard Deviation 4.94
|
-0.8 Beats per minute
Standard Deviation 19.77
|
-0.7 Beats per minute
Standard Deviation 5.61
|
3.2 Beats per minute
Standard Deviation 2.64
|
2.8 Beats per minute
Standard Deviation 5.56
|
|
Change From Baseline in Pulse Rate Part 1
Day 2
|
0.3 Beats per minute
Standard Deviation 4.37
|
-0.3 Beats per minute
Standard Deviation 3.78
|
1.0 Beats per minute
Standard Deviation 7.64
|
4.3 Beats per minute
Standard Deviation 6.12
|
0.5 Beats per minute
Standard Deviation 4.04
|
1.7 Beats per minute
Standard Deviation 8.16
|
|
Change From Baseline in Pulse Rate Part 1
Day 3
|
1.4 Beats per minute
Standard Deviation 3.27
|
5.5 Beats per minute
Standard Deviation 4.37
|
-1.3 Beats per minute
Standard Deviation 12.71
|
7.0 Beats per minute
Standard Deviation 7.62
|
2.0 Beats per minute
Standard Deviation 3.16
|
-1.2 Beats per minute
Standard Deviation 5.71
|
|
Change From Baseline in Pulse Rate Part 1
Day 4
|
3.2 Beats per minute
Standard Deviation 7.69
|
4.8 Beats per minute
Standard Deviation 7.60
|
-1.3 Beats per minute
Standard Deviation 13.84
|
4.5 Beats per minute
Standard Deviation 4.97
|
2.2 Beats per minute
Standard Deviation 6.21
|
-2.3 Beats per minute
Standard Deviation 3.83
|
|
Change From Baseline in Pulse Rate Part 1
Day 5
|
7.3 Beats per minute
Standard Deviation 8.58
|
6.3 Beats per minute
Standard Deviation 6.41
|
2.2 Beats per minute
Standard Deviation 14.69
|
4.5 Beats per minute
Standard Deviation 5.24
|
4.5 Beats per minute
Standard Deviation 7.56
|
2.7 Beats per minute
Standard Deviation 3.01
|
|
Change From Baseline in Pulse Rate Part 1
Day 7
|
7.4 Beats per minute
Standard Deviation 5.50
|
7.0 Beats per minute
Standard Deviation 4.43
|
1.7 Beats per minute
Standard Deviation 10.46
|
3.8 Beats per minute
Standard Deviation 7.19
|
6.7 Beats per minute
Standard Deviation 13.41
|
3.8 Beats per minute
Standard Deviation 5.19
|
PRIMARY outcome
Timeframe: Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.Population: All Subjects Population.
Respiratory rate was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Respiratory Rate Part 1
Day 7
|
0.3 Breaths per minute
Standard Deviation 1.89
|
-0.3 Breaths per minute
Standard Deviation 1.21
|
-0.5 Breaths per minute
Standard Deviation 1.87
|
0.5 Breaths per minute
Standard Deviation 2.07
|
-0.3 Breaths per minute
Standard Deviation 1.86
|
0.5 Breaths per minute
Standard Deviation 2.07
|
|
Change From Baseline in Respiratory Rate Part 1
Day 1, 1 hour
|
0.2 Breaths per minute
Standard Deviation 1.03
|
1.2 Breaths per minute
Standard Deviation 0.41
|
-0.2 Breaths per minute
Standard Deviation 1.17
|
1.2 Breaths per minute
Standard Deviation 2.93
|
-0.2 Breaths per minute
Standard Deviation 1.60
|
-0.2 Breaths per minute
Standard Deviation 1.94
|
|
Change From Baseline in Respiratory Rate Part 1
Day 1, 2 hour
|
0.3 Breaths per minute
Standard Deviation 1.49
|
0.2 Breaths per minute
Standard Deviation 0.75
|
-0.2 Breaths per minute
Standard Deviation 0.75
|
1.3 Breaths per minute
Standard Deviation 3.08
|
1.0 Breaths per minute
Standard Deviation 0.89
|
0.2 Breaths per minute
Standard Deviation 1.94
|
|
Change From Baseline in Respiratory Rate Part 1
Day 1, 4 hour
|
0.2 Breaths per minute
Standard Deviation 1.14
|
0.0 Breaths per minute
Standard Deviation 1.79
|
-0.2 Breaths per minute
Standard Deviation 2.93
|
1.0 Breaths per minute
Standard Deviation 2.00
|
1.2 Breaths per minute
Standard Deviation 2.04
|
1.5 Breaths per minute
Standard Deviation 4.04
|
|
Change From Baseline in Respiratory Rate Part 1
Day 1, 6 hour
|
0.9 Breaths per minute
Standard Deviation 2.96
|
0.3 Breaths per minute
Standard Deviation 2.34
|
-0.7 Breaths per minute
Standard Deviation 1.51
|
-0.3 Breaths per minute
Standard Deviation 2.34
|
1.5 Breaths per minute
Standard Deviation 2.74
|
0.7 Breaths per minute
Standard Deviation 3.27
|
|
Change From Baseline in Respiratory Rate Part 1
Day 1, 8 hour
|
1.3 Breaths per minute
Standard Deviation 2.31
|
1.0 Breaths per minute
Standard Deviation 2.68
|
-0.3 Breaths per minute
Standard Deviation 1.97
|
0.8 Breaths per minute
Standard Deviation 4.36
|
0.8 Breaths per minute
Standard Deviation 1.72
|
-0.5 Breaths per minute
Standard Deviation 2.88
|
|
Change From Baseline in Respiratory Rate Part 1
Day 1, 12 hour
|
0.4 Breaths per minute
Standard Deviation 2.37
|
-0.5 Breaths per minute
Standard Deviation 1.76
|
0.0 Breaths per minute
Standard Deviation 3.22
|
0.8 Breaths per minute
Standard Deviation 2.40
|
0.8 Breaths per minute
Standard Deviation 1.72
|
0.5 Breaths per minute
Standard Deviation 3.56
|
|
Change From Baseline in Respiratory Rate Part 1
Day 1, 16 hour
|
-0.4 Breaths per minute
Standard Deviation 2.22
|
-1.8 Breaths per minute
Standard Deviation 2.14
|
-1.3 Breaths per minute
Standard Deviation 2.25
|
0.0 Breaths per minute
Standard Deviation 3.35
|
0.7 Breaths per minute
Standard Deviation 1.75
|
-0.8 Breaths per minute
Standard Deviation 2.23
|
|
Change From Baseline in Respiratory Rate Part 1
Day 2
|
-0.3 Breaths per minute
Standard Deviation 1.70
|
0.2 Breaths per minute
Standard Deviation 1.60
|
-0.3 Breaths per minute
Standard Deviation 0.82
|
-0.5 Breaths per minute
Standard Deviation 2.95
|
1.5 Breaths per minute
Standard Deviation 2.17
|
-0.3 Breaths per minute
Standard Deviation 3.01
|
|
Change From Baseline in Respiratory Rate Part 1
Day 3
|
0.4 Breaths per minute
Standard Deviation 1.90
|
-0.3 Breaths per minute
Standard Deviation 1.97
|
0.3 Breaths per minute
Standard Deviation 3.56
|
0.3 Breaths per minute
Standard Deviation 2.07
|
1.3 Breaths per minute
Standard Deviation 2.34
|
-0.2 Breaths per minute
Standard Deviation 2.40
|
|
Change From Baseline in Respiratory Rate Part 1
Day 4
|
0.6 Breaths per minute
Standard Deviation 2.01
|
-0.2 Breaths per minute
Standard Deviation 1.72
|
-0.5 Breaths per minute
Standard Deviation 2.26
|
-0.5 Breaths per minute
Standard Deviation 2.51
|
0.5 Breaths per minute
Standard Deviation 2.07
|
-0.2 Breaths per minute
Standard Deviation 2.56
|
|
Change From Baseline in Respiratory Rate Part 1
Day 5
|
0.4 Breaths per minute
Standard Deviation 0.97
|
-0.7 Breaths per minute
Standard Deviation 1.21
|
0.5 Breaths per minute
Standard Deviation 3.27
|
1.5 Breaths per minute
Standard Deviation 1.76
|
0.8 Breaths per minute
Standard Deviation 1.47
|
0.3 Breaths per minute
Standard Deviation 3.61
|
PRIMARY outcome
Timeframe: Up to Day 7Population: All Subjects Population.
Hematology parameters included hemoglobin (HGB), hematocrit (HCT), Red Blood Cell (RBC) count, White Blood Cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), platelet count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). Reference range for basophil was 0.01 - 0.07\*10\^9/Liters (L), eosinophils 0.03 - 0.5\*10\^9/L, HCT 0.38 - 0.48 proportion of RBC in blood, HGB 126 - 165\*gram (g)/L, lymphocytes 1.08 - 3\*10\^9/L, MCH 26.3 - 32.8\*picogram (pg), MCHC 324 - 359\*g/L, MCV 77 - 94.9\*femtoliter (fL), monocytes 0.3 - 0.92\*10\^9/L, neutrophils 1.46 - 5.85\*10\^9/L, platelets 155 - 342\*10\^9/L, erythrocytes 4.12 - 5.74\*10\^12/L, leukocytes 3.19 - 8.71\*10\^9/L. Values below these ranges were considered as low and above these ranges were considered as high (H). Data for participants from any visit post-screening with values \> reference range high and \< reference range low are report.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Monocytes,> reference range H
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Monocytes, < reference range low
|
4 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Neutrophils,> reference range H
|
0 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Basophil, > reference range H
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Basophil, < reference range low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Eosinophils, > reference range H
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Eosinophils, < reference range low
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Neutrophils, < reference range low
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Platelets,> reference range H
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Platelets, < reference range low
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
MCHC, > reference range H
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
MCHC,< reference range low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
MCH, > reference range H
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
MCH, < reference range low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
MCV, > reference range H
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
MCV, < reference range low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Erythrocytes, > reference range H
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Erythrocytes, < reference range low
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
HCT,> reference range H
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
HCT, < reference range low
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
HGB,> reference range H
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
HGB, < reference range low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Leukocytes,> reference range H
|
1 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Leukocytes, < reference range low
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Lymphocytes,> reference range H
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Lymphocytes, < reference range low
|
1 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7Population: All Subjects Population.
Clinical chemistry parameters with reference range were albumin 35-52\*g/L, Alkaline phosphatase (ALP) 30-120\*International units/L (IU/L), Alanine aminotransferase (ALT) 0-50 \* IU/L, Aspartate aminotransferase (AST) 0-50\*IU/L, direct bilirubin 0-3.4\* micromoles/L (µmol/L), bilirubin 5-21\*µmol/L, calcium 2.2-2.65\* millimoles/L (mmol/L), cholesterol 0-5.19\* mmol/L, creatinine 59-104\* µmol/L, C-reactive protein (CRP) 0-5\*milligram (mg)/L,Gamma Glutamyl Transferase (GGT) 4.1-5.9\*mmol/L, high density lipoproteins (HDL) cholesterol 0.99-2.32\*mmol/L, potassium 3.5-5.1\*mmol/L, low density lipoproteins (LDL) cholesterol 0-3.3\*mmol/L, protein 66-83\*g/L, sodium 136-146 \* mmol/L, triglycerides 0-2.25 \* mmol/L, glucose 4.1-5.9\*mmol/L, and urea 2.8-7.2\*mmol/L. Values below these ranges were considered as low and above these ranges were considered as high. Data for participants from any visit post-screening with values \> reference range high and \< reference range low are reported.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
ALT, < reference range low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Albumin, < reference range low
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
ALP, > reference range H
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Calcium,> reference range H
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Creatinine, < reference range low
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Direct Bilirubin,> reference range H
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
ALT, > reference range H
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Albumin, > reference range H
|
00 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
ALP,< reference range low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
AST, > reference range H
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
AST, < reference range low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Bilirubin, > reference range H
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Bilirubin, < reference range low
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
CRP, > reference range H
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
CRP, < reference range low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Calcium, < reference range low
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Creatinine,> reference range H
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Direct Bilirubin, < reference range low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Glucose,> reference range H
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Glucose, < reference range low
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Indirect bilirubin,> reference range H
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Indirect bilirubin, < reference range low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Potassium,> reference range H
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Potassium, < reference range low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Protein,> reference range H
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Protein, < reference range low
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Sodium,> reference range H
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Sodium, < reference range low
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Urea,> reference range H
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Urea, < reference range low
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7Population: All Subjects Population
Urinalysis included microscopic examination parameters like Casts, REC, SEC, Urine erythrocytes and Urine leukocytes. Data at indicated time points were reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Casts, Day -1 Pre-dose, n=1,0,2,1,0,1
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point.
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point.
|
—
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point.
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
REC, Day 7, n=4,0,2,2,0,0
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
—
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Urine Leukocytes,Day 1 Pre-dose, n=3,1,2,0,0,2
|
5.0 Cells per high power field
Standard Deviation 8.66
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.5 Cells per high power field
Standard Deviation 0.71
|
—
|
—
|
3.0 Cells per high power field
Standard Deviation 2.83
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Urine Leukocytes,Day 2 , n=1,0,3,1,1,2
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
4.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.5 Cells per high power field
Standard Deviation 0.71
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Urine Leukocytes,Day 4, n=3,0,1,2,0,0
|
1.0 Cells per high power field
Standard Deviation 1.73
|
—
|
3.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
42.0 Cells per high power field
Standard Deviation 59.40
|
—
|
—
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Urine Leukocytes,Day 7, n=4,0,2,2,0,0
|
0.3 Cells per high power field
Standard Deviation 0.50
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
40.5 Cells per high power field
Standard Deviation 55.86
|
—
|
—
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Casts, Day 1, Pre-dose, n=3,1,2,0,0,2
|
0.0 Cells per high power field
Standard Deviation 0.0
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point.
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Casts, Day 2, n=1,0,3,1,1,2
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point.
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point.
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point.
|
0.0 Cells per high power field
Standard Deviation 0.0
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Casts, Day 4, n=3,0,1,2,0,0
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point.
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
—
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Casts, Day 7, n=4,0,2,2,0,0
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
—
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
REC, Day -1 Pre-dose, n=1,0,2,1,0,1
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
—
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
REC, Day 1 Pre-dose, n=3,1,2,0,0,2
|
0.0 Cells per high power field
Standard Deviation 0.0
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
REC, Day 2 , n=1,0,3,1,1,2
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.0 Cells per high power field
Standard Deviation 0.0
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
REC, Day 4, n=3,0,1,2,0,0
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
—
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
SEC, Day -1 Pre-dose, n=1,0,2,1,0,1
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
—
|
4.0 Cells per high power field
Standard Deviation 5.66
|
8.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
—
|
3.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
SEC, Day 1 Pre-dose, n=3,1,2,0,0,2
|
1.0 Cells per high power field
Standard Deviation 1.73
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
2.0 Cells per high power field
Standard Deviation 2.83
|
—
|
—
|
1.5 Cells per high power field
Standard Deviation 0.71
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
SEC, Day 2 , n=1,0,3,1,1,2
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.0 Cells per high power field
Standard Deviation 0.0
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
SEC, Day 4, n=3,0,1,2,0,0
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
10.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
1.0 Cells per high power field
Standard Deviation 1.41
|
—
|
—
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
SEC, Day 7, n=4,0,2,2,0,0
|
1.5 Cells per high power field
Standard Deviation 3.00
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
11.0 Cells per high power field
Standard Deviation 12.73
|
—
|
—
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Urine Erythrocytes,Day -1 Pre-dose, n=1,0,2,1,0,1
|
5.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
—
|
0.5 Cells per high power field
Standard Deviation 0.71
|
3.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
—
|
1.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Urine Erythrocytes,Day 1 Pre-dose, n=3,1,2,0,0,2
|
2.3 Cells per high power field
Standard Deviation 4.04
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Urine Erythrocytes,Day 2 , n=1,0,3,1,1,2
|
1.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
7.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.5 Cells per high power field
Standard Deviation 0.71
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Urine Erythrocytes,Day 4, n=3,0,1,2,0,0
|
1.0 Cells per high power field
Standard Deviation 1.00
|
—
|
2.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
—
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Urine Erythrocytes,Day 7, n=4,0,2,2,0,0
|
0.5 Cells per high power field
Standard Deviation 1.00
|
—
|
0.0 Cells per high power field
Standard Deviation 0.0
|
0.0 Cells per high power field
Standard Deviation 0.0
|
—
|
—
|
|
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Urine Leukocytes,Day -1 Pre-dose, n=1,0,2,1,0,1
|
1.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
—
|
1.5 Cells per high power field
Standard Deviation 2.12
|
1.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
—
|
4.0 Cells per high power field
Standard Deviation NA
NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point
|
PRIMARY outcome
Timeframe: Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7Population: All Subjects Population
Urinalysis included parameters like ketones and urine glucose. Data at indicated time points were reported.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Ketones and Urine Glucose at Indicated Time Points
Ketones, Pre-dose Day -1
|
0.05 Millimoles per liter
Standard Deviation 0.158
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.08 Millimoles per liter
Standard Deviation 0.204
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.25 Millimoles per liter
Standard Deviation 0.612
|
|
Ketones and Urine Glucose at Indicated Time Points
Ketones, Pre-dose Day 1
|
0.05 Millimoles per liter
Standard Deviation 0.158
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.25 Millimoles per liter
Standard Deviation 0.612
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.08 Millimoles per liter
Standard Deviation 0.204
|
|
Ketones and Urine Glucose at Indicated Time Points
Ketones, Day 2
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.00 Millimoles per liter
Standard Deviation 0.00
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
1.75 Millimoles per liter
Standard Deviation 2.525
|
|
Ketones and Urine Glucose at Indicated Time Points
Ketones, Day 4
|
0.15 Millimoles per liter
Standard Deviation 0.242
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.08 Millimoles per liter
Standard Deviation 0.204
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.08 Millimoles per liter
Standard Deviation 0.204
|
|
Ketones and Urine Glucose at Indicated Time Points
Ketones, Day 7
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.08 Millimoles per liter
Standard Deviation 0.204
|
0.25 Millimoles per liter
Standard Deviation 0.612
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.08 Millimoles per liter
Standard Deviation 0.204
|
|
Ketones and Urine Glucose at Indicated Time Points
Urine glucose, Pre-dose Day -1
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
|
Ketones and Urine Glucose at Indicated Time Points
Urine glucose, Pre-dose Day 1
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
|
Ketones and Urine Glucose at Indicated Time Points
Urine glucose, Day 2
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
|
Ketones and Urine Glucose at Indicated Time Points
Urine glucose, Day 4
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
|
Ketones and Urine Glucose at Indicated Time Points
Urine glucose, Day 7
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
0.0 Millimoles per liter
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7Population: All Subjects Population
Urinalysis included parameter like Occult blood. Data at indicated time points were reported.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Occult Blood at Indicated Time Points
Pre-dose Day -1
|
2.5 10^9 cells per liter
Standard Deviation 7.91
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
5.8 10^9 cells per liter
Standard Deviation 10.21
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
|
Occult Blood at Indicated Time Points
Pre-dose Day 1
|
4.5 10^9 cells per liter
Standard Deviation 8.32
|
1.7 10^9 cells per liter
Standard Deviation 4.08
|
3.3 10^9 cells per liter
Standard Deviation 5.16
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
1.7 10^9 cells per liter
Standard Deviation 4.08
|
|
Occult Blood at Indicated Time Points
Day 2
|
2.5 10^9 cells per liter
Standard Deviation 7.91
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
5.0 10^9 cells per liter
Standard Deviation 5.48
|
4.2 10^9 cells per liter
Standard Deviation 10.21
|
1.7 10^9 cells per liter
Standard Deviation 4.08
|
5.8 10^9 cells per liter
Standard Deviation 10.21
|
|
Occult Blood at Indicated Time Points
Day 4
|
4.5 10^9 cells per liter
Standard Deviation 8.32
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
4.2 10^9 cells per liter
Standard Deviation 10.21
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
|
Occult Blood at Indicated Time Points
Day 7
|
4.0 10^9 cells per liter
Standard Deviation 5.16
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
8.3 10^9 cells per liter
Standard Deviation 12.91
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
0.0 10^9 cells per liter
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7Population: All Subjects Population
Urinalysis included parameter like Urine protein. Data at indicated time points were reported.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Urine Protein at Indicated Time Points
Pre-dose Day -1
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.042 Gram per liter
Standard Deviation 0.1021
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
|
Urine Protein at Indicated Time Points
Pre-dose Day 1
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
|
Urine Protein at Indicated Time Points
Day 2
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
|
Urine Protein at Indicated Time Points
Day 4
|
0.025 Gram per liter
Standard Deviation 0.0791
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.042 Gram per liter
Standard Deviation 0.1021
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
|
Urine Protein at Indicated Time Points
Day 7
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.042 Gram per liter
Standard Deviation 0.1021
|
0.042 Gram per liter
Standard Deviation 0.1021
|
0.000 Gram per liter
Standard Deviation 0.0000
|
0.000 Gram per liter
Standard Deviation 0.0000
|
PRIMARY outcome
Timeframe: Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7Population: All Subjects Population
Urinalysis included parameter like specific gravity. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Specific Gravity at Indicated Time Points
Pre-dose Day -1
|
1.018 Ratio
Standard Deviation 0.0065
|
1.008 Ratio
Standard Deviation 0.0053
|
1.017 Ratio
Standard Deviation 0.0091
|
1.015 Ratio
Standard Deviation 0.0019
|
1.008 Ratio
Standard Deviation 0.0030
|
1.019 Ratio
Standard Deviation 0.0047
|
|
Specific Gravity at Indicated Time Points
Pre-dose Day 1
|
1.014 Ratio
Standard Deviation 0.0072
|
1.011 Ratio
Standard Deviation 0.0048
|
1.015 Ratio
Standard Deviation 0.0083
|
1.013 Ratio
Standard Deviation 0.0063
|
1.008 Ratio
Standard Deviation 0.0031
|
1.014 Ratio
Standard Deviation 0.0060
|
|
Specific Gravity at Indicated Time Points
Day 2
|
1.017 Ratio
Standard Deviation 0.0049
|
1.013 Ratio
Standard Deviation 0.0055
|
1.017 Ratio
Standard Deviation 0.0041
|
1.016 Ratio
Standard Deviation 0.0044
|
1.014 Ratio
Standard Deviation 0.0048
|
1.017 Ratio
Standard Deviation 0.0072
|
|
Specific Gravity at Indicated Time Points
Day 4
|
1.019 Ratio
Standard Deviation 0.0069
|
1.014 Ratio
Standard Deviation 0.0041
|
1.018 Ratio
Standard Deviation 0.0072
|
1.016 Ratio
Standard Deviation 0.0038
|
1.014 Ratio
Standard Deviation 0.0061
|
1.016 Ratio
Standard Deviation 0.0059
|
|
Specific Gravity at Indicated Time Points
Day 7
|
1.016 Ratio
Standard Deviation 0.0082
|
1.006 Ratio
Standard Deviation 0.0025
|
1.015 Ratio
Standard Deviation 0.0117
|
1.015 Ratio
Standard Deviation 0.0090
|
1.010 Ratio
Standard Deviation 0.0079
|
1.013 Ratio
Standard Deviation 0.0058
|
PRIMARY outcome
Timeframe: Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7Population: All Subject Population
Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Urine Potential of Hydrogen (pH) at Indicated Time Points
Pre-dose Day -1
|
6.10 pH
Standard Deviation 0.843
|
6.42 pH
Standard Deviation 0.801
|
5.00 pH
Standard Deviation 0.000
|
5.83 pH
Standard Deviation 0.931
|
6.50 pH
Standard Deviation 0.775
|
5.67 pH
Standard Deviation 0.753
|
|
Urine Potential of Hydrogen (pH) at Indicated Time Points
Pre-dose Day 1
|
6.05 pH
Standard Deviation 0.926
|
5.83 pH
Standard Deviation 0.931
|
5.75 pH
Standard Deviation 0.822
|
5.50 pH
Standard Deviation 0.837
|
6.25 pH
Standard Deviation 0.758
|
5.33 pH
Standard Deviation 0.816
|
|
Urine Potential of Hydrogen (pH) at Indicated Time Points
Day 2
|
6.20 pH
Standard Deviation 0.753
|
5.83 pH
Standard Deviation 0.983
|
5.92 pH
Standard Deviation 0.801
|
6.25 pH
Standard Deviation 0.689
|
5.33 pH
Standard Deviation 0.516
|
5.50 pH
Standard Deviation 0.837
|
|
Urine Potential of Hydrogen (pH) at Indicated Time Points
Day 4
|
5.95 pH
Standard Deviation 0.725
|
5.67 pH
Standard Deviation 1.033
|
5.50 pH
Standard Deviation 0.775
|
5.92 pH
Standard Deviation 1.021
|
6.08 pH
Standard Deviation 0.917
|
5.67 pH
Standard Deviation 0.816
|
|
Urine Potential of Hydrogen (pH) at Indicated Time Points
Day 7
|
6.00 pH
Standard Deviation 0.882
|
5.58 pH
Standard Deviation 0.917
|
5.25 pH
Standard Deviation 0.612
|
5.75 pH
Standard Deviation 0.880
|
5.92 pH
Standard Deviation 0.801
|
6.08 pH
Standard Deviation 0.917
|
PRIMARY outcome
Timeframe: Up to Day 32Population: All Subjects Population.
Single measurements of 12-lead ECGs were obtained after 10 minutes of rest in a semi-supine position for the participant. Participants with abnormal ECG findings that are clinically not significant (NCS) and clinically significant (CS) data has been presented here. The data of worst case post-Baseline is presented here.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline
NCS
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline
CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification.
Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated for each participant using a non-compartmental method. All participants for whom, at least, one valid and evaluable pharmacokinetic parameter (AUC or Cmax) was derived were included in PK Parameter Population. Only those participants with data available at the specified data points were analyzed.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 1
|
NA Picogram/milliliter (pg/mL)
Geometric Coefficient of Variation NA
NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification.
|
3.78 Picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 15.9
|
10.1 Picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 13.0
|
9.45 Picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 25.5
|
23.7 Picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 6.69
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification.
Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1
t1/2
|
NA Hours
Standard Deviation NA
NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification.
|
25.2 Hours
Standard Deviation 9.51
|
45.7 Hours
Standard Deviation 12.5
|
67.1 Hours
Standard Deviation 33.9
|
69.4 Hours
Standard Deviation 9.24
|
—
|
|
Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1
tmax
|
NA Hours
Standard Deviation NA
NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification.
|
0.0950 Hours
Standard Deviation 0.0197
|
0.0833 Hours
Standard Deviation 0.00816
|
0.103 Hours
Standard Deviation 0.0755
|
0.0880 Hours
Standard Deviation 0.0110
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification.
Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. AUC (0-t) was used interchangeably with AUC to last time of quantifiable concentration (AUC\[0-last\]) .Only those participants with data available at the specified data points were analyzed.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1
AUC(0-t)
|
NA Hours*pg/mL
Geometric Coefficient of Variation NA
NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification.
|
21.1 Hours*pg/mL
Geometric Coefficient of Variation 89.7
|
233 Hours*pg/mL
Geometric Coefficient of Variation 56.4
|
264 Hours*pg/mL
Geometric Coefficient of Variation 33.3
|
1100 Hours*pg/mL
Geometric Coefficient of Variation 12.2
|
—
|
|
Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1
AUC(0-inf)
|
NA Hours*pg/mL
Geometric Coefficient of Variation NA
NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification.
|
104 Hours*pg/mL
Geometric Coefficient of Variation 52.2
|
417 Hours*pg/mL
Geometric Coefficient of Variation 40.0
|
532 Hours*pg/mL
Geometric Coefficient of Variation 26.3
|
1440 Hours*pg/mL
Geometric Coefficient of Variation 15.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification.
Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Clearance (CL) of GSK1795091 for Part 1
|
NA Liters per hour (L/h)
Geometric Coefficient of Variation NA
NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification.
|
0.202 Liters per hour (L/h)
Geometric Coefficient of Variation 52.2
|
0.144 Liters per hour (L/h)
Geometric Coefficient of Variation 40.0
|
0.113 Liters per hour (L/h)
Geometric Coefficient of Variation 26.3
|
0.0693 Liters per hour (L/h)
Geometric Coefficient of Variation 15.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification.
Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Volume of Distribution of GSK1795091 for Part 1
|
NA Liters (L)
Geometric Coefficient of Variation NA
NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification.
|
6.95 Liters (L)
Geometric Coefficient of Variation 10.1
|
9.46 Liters (L)
Geometric Coefficient of Variation 24.2
|
9.95 Liters (L)
Geometric Coefficient of Variation 25.7
|
6.75 Liters (L)
Geometric Coefficient of Variation 10.7
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population.
Blood samples were collected at indicated time points for the assessment of IL-6. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. All participants in the "All Subjects Population" for whom valid and evaluable pharmacodynamic parameters were derived are included in Pharmacodynamic (PD) Population. Data from multiplex immunoassay has been reported.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1
1 hour
|
40.17 Percent fold change
Standard Deviation 51.192
|
30.81 Percent fold change
Standard Deviation 33.517
|
193.49 Percent fold change
Standard Deviation 163.904
|
332.92 Percent fold change
Standard Deviation 310.845
|
588.11 Percent fold change
Standard Deviation 324.942
|
956.69 Percent fold change
Standard Deviation 763.404
|
|
Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1
2 hour
|
26.49 Percent fold change
Standard Deviation 39.212
|
239.27 Percent fold change
Standard Deviation 301.767
|
625.51 Percent fold change
Standard Deviation 547.296
|
1801.82 Percent fold change
Standard Deviation 1788.852
|
2171.25 Percent fold change
Standard Deviation 1363.074
|
7305.11 Percent fold change
Standard Deviation 6138.721
|
|
Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1
4 hour
|
169.63 Percent fold change
Standard Deviation 421.394
|
255.33 Percent fold change
Standard Deviation 254.874
|
513.81 Percent fold change
Standard Deviation 523.303
|
803.37 Percent fold change
Standard Deviation 1020.453
|
1244.12 Percent fold change
Standard Deviation 1759.562
|
1170.88 Percent fold change
Standard Deviation 767.439
|
|
Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1
8 hour
|
262.38 Percent fold change
Standard Deviation 339.956
|
161.33 Percent fold change
Standard Deviation 187.908
|
338.13 Percent fold change
Standard Deviation 317.030
|
166.86 Percent fold change
Standard Deviation 176.423
|
677.24 Percent fold change
Standard Deviation 903.777
|
190.07 Percent fold change
Standard Deviation 181.963
|
|
Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1
12 hour
|
267.01 Percent fold change
Standard Deviation 274.112
|
832.13 Percent fold change
Standard Deviation 965.345
|
938.35 Percent fold change
Standard Deviation 1585.370
|
500.75 Percent fold change
Standard Deviation 827.894
|
644.77 Percent fold change
Standard Deviation 311.661
|
363.91 Percent fold change
Standard Deviation 610.090
|
|
Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1
16 hour
|
284.52 Percent fold change
Standard Deviation 356.147
|
607.83 Percent fold change
Standard Deviation 986.760
|
249.04 Percent fold change
Standard Deviation 280.046
|
467.74 Percent fold change
Standard Deviation 620.968
|
326.81 Percent fold change
Standard Deviation 300.766
|
210.55 Percent fold change
Standard Deviation 425.106
|
|
Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1
24 hour
|
129.34 Percent fold change
Standard Deviation 110.041
|
200.07 Percent fold change
Standard Deviation 261.810
|
56.24 Percent fold change
Standard Deviation 157.132
|
182.47 Percent fold change
Standard Deviation 248.911
|
201.93 Percent fold change
Standard Deviation 375.976
|
160.58 Percent fold change
Standard Deviation 383.092
|
|
Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1
48 hour
|
-13.13 Percent fold change
Standard Deviation 46.097
|
-33.21 Percent fold change
Standard Deviation 30.172
|
-18.95 Percent fold change
Standard Deviation 45.030
|
-21.89 Percent fold change
Standard Deviation 30.042
|
-14.22 Percent fold change
Standard Deviation 42.014
|
-26.67 Percent fold change
Standard Deviation 21.931
|
|
Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1
144 hour
|
-12.48 Percent fold change
Standard Deviation 27.665
|
-29.63 Percent fold change
Standard Deviation 38.535
|
-19.58 Percent fold change
Standard Deviation 26.650
|
-4.52 Percent fold change
Standard Deviation 41.111
|
-10.87 Percent fold change
Standard Deviation 26.937
|
-6.59 Percent fold change
Standard Deviation 39.036
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population.
Blood samples were collected at indicated time points for the assessment of TNF-alpha. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. Data from multiplex immunoassay has been reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1
1 hour, n=8, 3, 5, 5, 4, 5
|
3.61 Percent fold change
Standard Deviation 28.753
|
12.51 Percent fold change
Standard Deviation 22.453
|
112.63 Percent fold change
Standard Deviation 185.111
|
130.88 Percent fold change
Standard Deviation 126.286
|
771.06 Percent fold change
Standard Deviation 579.613
|
1838.09 Percent fold change
Standard Deviation 2790.783
|
|
Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1
2 hour, n=8, 3, 5, 5, 4, 5
|
-1.26 Percent fold change
Standard Deviation 11.879
|
-6.42 Percent fold change
Standard Deviation 5.229
|
209.17 Percent fold change
Standard Deviation 437.355
|
51.85 Percent fold change
Standard Deviation 58.482
|
379.87 Percent fold change
Standard Deviation 299.578
|
661.61 Percent fold change
Standard Deviation 998.133
|
|
Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1
4 hour, n=8, 3, 5, 5, 4, 5
|
-4.38 Percent fold change
Standard Deviation 12.448
|
-5.82 Percent fold change
Standard Deviation 8.277
|
164.74 Percent fold change
Standard Deviation 402.327
|
12.90 Percent fold change
Standard Deviation 22.215
|
66.55 Percent fold change
Standard Deviation 76.017
|
18.87 Percent fold change
Standard Deviation 26.716
|
|
Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1
8 hour, n=8, 3, 5, 5, 4, 5
|
1.72 Percent fold change
Standard Deviation 8.690
|
-12.56 Percent fold change
Standard Deviation 13.872
|
75.34 Percent fold change
Standard Deviation 202.570
|
2.28 Percent fold change
Standard Deviation 4.332
|
11.12 Percent fold change
Standard Deviation 32.576
|
-7.87 Percent fold change
Standard Deviation 10.985
|
|
Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1
12 hour, n=8, 3, 5, 5, 4, 5
|
4.38 Percent fold change
Standard Deviation 19.376
|
-10.33 Percent fold change
Standard Deviation 26.632
|
54.30 Percent fold change
Standard Deviation 170.246
|
7.61 Percent fold change
Standard Deviation 10.968
|
24.14 Percent fold change
Standard Deviation 35.746
|
-4.21 Percent fold change
Standard Deviation 9.459
|
|
Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1
16 hour, n=8, 3, 5, 5, 4, 5
|
-1.81 Percent fold change
Standard Deviation 17.321
|
-11.77 Percent fold change
Standard Deviation 16.419
|
17.36 Percent fold change
Standard Deviation 92.732
|
-1.28 Percent fold change
Standard Deviation 9.826
|
43.11 Percent fold change
Standard Deviation 90.323
|
-11.41 Percent fold change
Standard Deviation 14.569
|
|
Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1
24 hour, n=8, 3, 5, 5, 4, 5
|
3.30 Percent fold change
Standard Deviation 30.223
|
-10.02 Percent fold change
Standard Deviation 21.221
|
17.39 Percent fold change
Standard Deviation 75.367
|
7.26 Percent fold change
Standard Deviation 13.568
|
34.79 Percent fold change
Standard Deviation 37.921
|
-6.04 Percent fold change
Standard Deviation 17.245
|
|
Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1
48 hour, n=8, 3, 5, 5, 3, 5
|
-2.56 Percent fold change
Standard Deviation 16.028
|
-7.18 Percent fold change
Standard Deviation 9.567
|
-10.99 Percent fold change
Standard Deviation 37.153
|
4.03 Percent fold change
Standard Deviation 23.030
|
-2.31 Percent fold change
Standard Deviation 45.586
|
-13.33 Percent fold change
Standard Deviation 14.853
|
|
Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1
144 hour, n=8, 3, 5, 5, 4, 5
|
-7.34 Percent fold change
Standard Deviation 15.006
|
-2.90 Percent fold change
Standard Deviation 20.283
|
-14.85 Percent fold change
Standard Deviation 27.169
|
-2.10 Percent fold change
Standard Deviation 37.702
|
5.46 Percent fold change
Standard Deviation 31.910
|
-5.16 Percent fold change
Standard Deviation 17.479
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population
Blood samples were collected at indicated time points for the assessment of IFN-gamma. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. Data from multiplex immunoassay has been reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1
2 hour, n=10, 5, 4, 6, 6, 5
|
5.04 Percent fold change
Standard Deviation 13.885
|
-7.35 Percent fold change
Standard Deviation 10.068
|
-0.81 Percent fold change
Standard Deviation 4.453
|
17.81 Percent fold change
Standard Deviation 56.864
|
72.02 Percent fold change
Standard Deviation 125.017
|
104.54 Percent fold change
Standard Deviation 208.806
|
|
Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1
1 hour, n=9, 5, 4, 6, 6, 5
|
-1.24 Percent fold change
Standard Deviation 7.942
|
-6.31 Percent fold change
Standard Deviation 7.547
|
-3.16 Percent fold change
Standard Deviation 6.918
|
-1.52 Percent fold change
Standard Deviation 3.299
|
-8.15 Percent fold change
Standard Deviation 9.430
|
14.42 Percent fold change
Standard Deviation 17.175
|
|
Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1
4 hour, n=10, 5, 4, 6, 6, 5
|
-2.39 Percent fold change
Standard Deviation 8.391
|
2.33 Percent fold change
Standard Deviation 6.932
|
49.66 Percent fold change
Standard Deviation 97.641
|
119.86 Percent fold change
Standard Deviation 211.426
|
247.58 Percent fold change
Standard Deviation 188.954
|
229.73 Percent fold change
Standard Deviation 352.909
|
|
Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1
8 hour, n=10, 5, 4, 6, 6, 5
|
0.05 Percent fold change
Standard Deviation 5.453
|
-0.10 Percent fold change
Standard Deviation 5.957
|
13.68 Percent fold change
Standard Deviation 39.549
|
36.75 Percent fold change
Standard Deviation 48.057
|
86.13 Percent fold change
Standard Deviation 63.258
|
66.69 Percent fold change
Standard Deviation 94.960
|
|
Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1
16 hour, n=10, 5, 4, 6, 6, 5
|
6.51 Percent fold change
Standard Deviation 24.803
|
-6.27 Percent fold change
Standard Deviation 29.923
|
-15.42 Percent fold change
Standard Deviation 22.050
|
20.62 Percent fold change
Standard Deviation 29.976
|
34.82 Percent fold change
Standard Deviation 46.979
|
12.75 Percent fold change
Standard Deviation 19.418
|
|
Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1
12 hour, n=10, 5, 4, 6, 6, 5
|
4.48 Percent fold change
Standard Deviation 14.140
|
-7.01 Percent fold change
Standard Deviation 27.233
|
-9.18 Percent fold change
Standard Deviation 10.540
|
20.90 Percent fold change
Standard Deviation 32.530
|
38.35 Percent fold change
Standard Deviation 48.687
|
31.00 Percent fold change
Standard Deviation 37.179
|
|
Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1
48 hour, n=10, 4, 4, 6, 6, 5
|
4.21 Percent fold change
Standard Deviation 22.768
|
1.41 Percent fold change
Standard Deviation 6.871
|
-19.82 Percent fold change
Standard Deviation 34.669
|
-3.63 Percent fold change
Standard Deviation 13.448
|
0.39 Percent fold change
Standard Deviation 20.837
|
2.43 Percent fold change
Standard Deviation 5.216
|
|
Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1
24 hour, n=10, 4, 4, 6, 6, 5
|
3.96 Percent fold change
Standard Deviation 17.217
|
6.57 Percent fold change
Standard Deviation 16.853
|
-19.32 Percent fold change
Standard Deviation 32.943
|
2.48 Percent fold change
Standard Deviation 8.071
|
-3.08 Percent fold change
Standard Deviation 14.045
|
6.46 Percent fold change
Standard Deviation 8.403
|
|
Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1
144 hour, n=10, 4, 3, 6, 6, 5
|
33.01 Percent fold change
Standard Deviation 107.893
|
4.96 Percent fold change
Standard Deviation 8.947
|
-2.15 Percent fold change
Standard Deviation 13.149
|
-4.16 Percent fold change
Standard Deviation 14.851
|
6.81 Percent fold change
Standard Deviation 21.544
|
-1.26 Percent fold change
Standard Deviation 5.652
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population
Blood samples were collected at indicated time points for the assessment of IP-10. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1
1 hour
|
-17.09 Percent fold change
Standard Deviation 11.676
|
-22.96 Percent fold change
Standard Deviation 9.621
|
-10.99 Percent fold change
Standard Deviation 11.237
|
-21.97 Percent fold change
Standard Deviation 10.771
|
-6.50 Percent fold change
Standard Deviation 12.551
|
14.49 Percent fold change
Standard Deviation 35.063
|
|
Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1
2 hour
|
-15.30 Percent fold change
Standard Deviation 9.675
|
-8.75 Percent fold change
Standard Deviation 16.126
|
39.93 Percent fold change
Standard Deviation 26.514
|
54.49 Percent fold change
Standard Deviation 58.967
|
112.79 Percent fold change
Standard Deviation 66.958
|
312.12 Percent fold change
Standard Deviation 121.798
|
|
Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1
4 hour
|
-14.34 Percent fold change
Standard Deviation 11.025
|
25.43 Percent fold change
Standard Deviation 42.934
|
351.07 Percent fold change
Standard Deviation 286.393
|
1672.77 Percent fold change
Standard Deviation 1676.676
|
2045.12 Percent fold change
Standard Deviation 1937.378
|
6740.10 Percent fold change
Standard Deviation 1888.455
|
|
Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1
8 hour
|
-11.97 Percent fold change
Standard Deviation 10.564
|
4.07 Percent fold change
Standard Deviation 29.521
|
119.48 Percent fold change
Standard Deviation 103.465
|
338.47 Percent fold change
Standard Deviation 349.007
|
538.99 Percent fold change
Standard Deviation 614.669
|
2367.11 Percent fold change
Standard Deviation 1067.103
|
|
Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1
12 hour
|
-22.97 Percent fold change
Standard Deviation 8.906
|
-9.76 Percent fold change
Standard Deviation 17.265
|
46.78 Percent fold change
Standard Deviation 40.980
|
133.47 Percent fold change
Standard Deviation 128.186
|
337.37 Percent fold change
Standard Deviation 416.181
|
802.21 Percent fold change
Standard Deviation 272.436
|
|
Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1
16 hour
|
-14.51 Percent fold change
Standard Deviation 14.185
|
-6.75 Percent fold change
Standard Deviation 20.215
|
52.55 Percent fold change
Standard Deviation 32.122
|
99.47 Percent fold change
Standard Deviation 114.305
|
238.17 Percent fold change
Standard Deviation 321.382
|
394.46 Percent fold change
Standard Deviation 171.075
|
|
Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1
24 hour
|
-2.89 Percent fold change
Standard Deviation 20.587
|
25.65 Percent fold change
Standard Deviation 38.100
|
46.42 Percent fold change
Standard Deviation 25.692
|
67.34 Percent fold change
Standard Deviation 34.573
|
137.55 Percent fold change
Standard Deviation 128.045
|
186.87 Percent fold change
Standard Deviation 57.860
|
|
Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1
48 hour
|
6.24 Percent fold change
Standard Deviation 28.068
|
37.30 Percent fold change
Standard Deviation 78.673
|
31.98 Percent fold change
Standard Deviation 40.635
|
35.61 Percent fold change
Standard Deviation 26.802
|
41.03 Percent fold change
Standard Deviation 42.609
|
57.44 Percent fold change
Standard Deviation 28.805
|
|
Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1
144 hour
|
5.97 Percent fold change
Standard Deviation 35.519
|
20.56 Percent fold change
Standard Deviation 41.682
|
16.66 Percent fold change
Standard Deviation 39.635
|
15.62 Percent fold change
Standard Deviation 50.973
|
24.18 Percent fold change
Standard Deviation 21.117
|
29.64 Percent fold change
Standard Deviation 21.330
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population
Blood samples were collected at indicated time points for the assessment of MCP-1. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1
1 hour
|
0.39 Percent fold change
Standard Deviation 9.459
|
-1.15 Percent fold change
Standard Deviation 10.591
|
4.50 Percent fold change
Standard Deviation 12.165
|
18.59 Percent fold change
Standard Deviation 24.366
|
21.31 Percent fold change
Standard Deviation 30.421
|
119.24 Percent fold change
Standard Deviation 58.836
|
|
Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1
2 hour
|
0.73 Percent fold change
Standard Deviation 9.124
|
76.83 Percent fold change
Standard Deviation 60.093
|
481.09 Percent fold change
Standard Deviation 255.487
|
1097.31 Percent fold change
Standard Deviation 743.475
|
2604.72 Percent fold change
Standard Deviation 1691.082
|
5883.27 Percent fold change
Standard Deviation 2461.263
|
|
Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1
4 hour
|
-3.44 Percent fold change
Standard Deviation 14.828
|
64.60 Percent fold change
Standard Deviation 54.045
|
315.88 Percent fold change
Standard Deviation 237.902
|
907.01 Percent fold change
Standard Deviation 928.980
|
1241.68 Percent fold change
Standard Deviation 1744.836
|
5290.85 Percent fold change
Standard Deviation 2834.623
|
|
Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1
8 hour
|
1.97 Percent fold change
Standard Deviation 14.914
|
7.94 Percent fold change
Standard Deviation 17.127
|
35.25 Percent fold change
Standard Deviation 25.294
|
51.16 Percent fold change
Standard Deviation 29.055
|
70.82 Percent fold change
Standard Deviation 58.048
|
223.95 Percent fold change
Standard Deviation 113.142
|
|
Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1
12 hour
|
6.99 Percent fold change
Standard Deviation 16.748
|
16.17 Percent fold change
Standard Deviation 18.245
|
29.60 Percent fold change
Standard Deviation 25.748
|
32.76 Percent fold change
Standard Deviation 23.618
|
56.45 Percent fold change
Standard Deviation 56.466
|
111.19 Percent fold change
Standard Deviation 67.497
|
|
Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1
16 hour
|
11.29 Percent fold change
Standard Deviation 17.046
|
29.40 Percent fold change
Standard Deviation 25.521
|
26.43 Percent fold change
Standard Deviation 9.956
|
35.30 Percent fold change
Standard Deviation 25.461
|
39.71 Percent fold change
Standard Deviation 40.794
|
45.49 Percent fold change
Standard Deviation 18.571
|
|
Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1
24 hour
|
-6.26 Percent fold change
Standard Deviation 9.139
|
-1.42 Percent fold change
Standard Deviation 9.045
|
4.06 Percent fold change
Standard Deviation 7.179
|
-7.95 Percent fold change
Standard Deviation 11.240
|
3.90 Percent fold change
Standard Deviation 14.549
|
10.69 Percent fold change
Standard Deviation 16.458
|
|
Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1
48 hour
|
-3.16 Percent fold change
Standard Deviation 12.267
|
-1.40 Percent fold change
Standard Deviation 9.991
|
-1.51 Percent fold change
Standard Deviation 9.848
|
-8.02 Percent fold change
Standard Deviation 15.104
|
-7.40 Percent fold change
Standard Deviation 10.834
|
-3.58 Percent fold change
Standard Deviation 10.363
|
|
Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1
144 hour
|
13.23 Percent fold change
Standard Deviation 20.203
|
24.53 Percent fold change
Standard Deviation 11.806
|
22.01 Percent fold change
Standard Deviation 11.379
|
8.74 Percent fold change
Standard Deviation 24.846
|
14.97 Percent fold change
Standard Deviation 16.939
|
15.23 Percent fold change
Standard Deviation 12.460
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population
Blood samples were collected at indicated time points for the assessment of GCSF. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1
1 hour
|
-0.99 Percent fold change
Standard Deviation 5.692
|
-4.68 Percent fold change
Standard Deviation 10.515
|
2.58 Percent fold change
Standard Deviation 7.662
|
2.91 Percent fold change
Standard Deviation 16.607
|
5.83 Percent fold change
Standard Deviation 8.244
|
25.99 Percent fold change
Standard Deviation 11.220
|
|
Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1
2 hour
|
2.91 Percent fold change
Standard Deviation 6.204
|
2.69 Percent fold change
Standard Deviation 12.149
|
11.12 Percent fold change
Standard Deviation 11.405
|
162.85 Percent fold change
Standard Deviation 247.315
|
105.64 Percent fold change
Standard Deviation 96.885
|
1365.60 Percent fold change
Standard Deviation 893.674
|
|
Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1
4 hour
|
10.78 Percent fold change
Standard Deviation 18.117
|
4.38 Percent fold change
Standard Deviation 9.022
|
13.23 Percent fold change
Standard Deviation 15.291
|
933.31 Percent fold change
Standard Deviation 1826.357
|
390.62 Percent fold change
Standard Deviation 541.504
|
3754.71 Percent fold change
Standard Deviation 2439.913
|
|
Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1
8 hour
|
19.67 Percent fold change
Standard Deviation 23.987
|
16.22 Percent fold change
Standard Deviation 12.747
|
9.78 Percent fold change
Standard Deviation 24.467
|
150.61 Percent fold change
Standard Deviation 232.289
|
96.07 Percent fold change
Standard Deviation 123.200
|
595.98 Percent fold change
Standard Deviation 316.686
|
|
Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1
12 hour
|
16.42 Percent fold change
Standard Deviation 20.532
|
13.85 Percent fold change
Standard Deviation 17.900
|
8.85 Percent fold change
Standard Deviation 20.773
|
71.44 Percent fold change
Standard Deviation 71.786
|
59.51 Percent fold change
Standard Deviation 72.401
|
265.40 Percent fold change
Standard Deviation 166.832
|
|
Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1
16 hour
|
5.83 Percent fold change
Standard Deviation 13.164
|
10.84 Percent fold change
Standard Deviation 18.000
|
-2.49 Percent fold change
Standard Deviation 17.532
|
30.82 Percent fold change
Standard Deviation 39.981
|
22.29 Percent fold change
Standard Deviation 55.206
|
162.78 Percent fold change
Standard Deviation 121.912
|
|
Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1
24 hour
|
6.67 Percent fold change
Standard Deviation 9.270
|
4.50 Percent fold change
Standard Deviation 13.016
|
1.23 Percent fold change
Standard Deviation 10.457
|
23.82 Percent fold change
Standard Deviation 29.497
|
15.76 Percent fold change
Standard Deviation 36.063
|
96.88 Percent fold change
Standard Deviation 87.031
|
|
Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1
48 hour
|
6.29 Percent fold change
Standard Deviation 12.038
|
2.52 Percent fold change
Standard Deviation 10.170
|
-1.26 Percent fold change
Standard Deviation 10.068
|
19.14 Percent fold change
Standard Deviation 17.687
|
3.08 Percent fold change
Standard Deviation 25.153
|
17.08 Percent fold change
Standard Deviation 32.119
|
|
Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1
144 hour
|
4.74 Percent fold change
Standard Deviation 19.231
|
-10.01 Percent fold change
Standard Deviation 13.393
|
7.06 Percent fold change
Standard Deviation 23.343
|
-4.23 Percent fold change
Standard Deviation 16.821
|
-5.25 Percent fold change
Standard Deviation 21.081
|
-4.94 Percent fold change
Standard Deviation 23.010
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population
Blood samples were collected at indicated time points for the assessment of IL-1Ra. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1
1 hour
|
4.06 Percent fold change
Standard Deviation 12.046
|
-1.63 Percent fold change
Standard Deviation 15.193
|
11.49 Percent fold change
Standard Deviation 8.978
|
19.88 Percent fold change
Standard Deviation 23.137
|
38.00 Percent fold change
Standard Deviation 20.565
|
111.99 Percent fold change
Standard Deviation 25.295
|
|
Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1
2 hour
|
5.26 Percent fold change
Standard Deviation 17.249
|
26.95 Percent fold change
Standard Deviation 19.100
|
149.20 Percent fold change
Standard Deviation 53.633
|
607.17 Percent fold change
Standard Deviation 611.511
|
803.47 Percent fold change
Standard Deviation 486.468
|
7054.40 Percent fold change
Standard Deviation 1029.027
|
|
Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1
4 hour
|
13.43 Percent fold change
Standard Deviation 24.391
|
196.62 Percent fold change
Standard Deviation 186.603
|
1716.81 Percent fold change
Standard Deviation 1046.690
|
12062.23 Percent fold change
Standard Deviation 13307.136
|
13359.29 Percent fold change
Standard Deviation 9271.512
|
105032.57 Percent fold change
Standard Deviation 61423.988
|
|
Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1
8 hour
|
20.78 Percent fold change
Standard Deviation 28.762
|
103.59 Percent fold change
Standard Deviation 63.317
|
818.24 Percent fold change
Standard Deviation 578.438
|
3136.61 Percent fold change
Standard Deviation 3429.187
|
2788.30 Percent fold change
Standard Deviation 2101.015
|
16830.47 Percent fold change
Standard Deviation 7106.072
|
|
Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1
12 hour
|
21.64 Percent fold change
Standard Deviation 23.580
|
99.49 Percent fold change
Standard Deviation 75.059
|
360.87 Percent fold change
Standard Deviation 233.664
|
1207.18 Percent fold change
Standard Deviation 1324.133
|
1422.66 Percent fold change
Standard Deviation 1254.465
|
7055.35 Percent fold change
Standard Deviation 3496.863
|
|
Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1
16 hour
|
29.17 Percent fold change
Standard Deviation 28.404
|
61.72 Percent fold change
Standard Deviation 38.867
|
217.81 Percent fold change
Standard Deviation 154.263
|
524.89 Percent fold change
Standard Deviation 652.117
|
723.30 Percent fold change
Standard Deviation 718.195
|
2273.75 Percent fold change
Standard Deviation 783.885
|
|
Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1
24 hour
|
35.02 Percent fold change
Standard Deviation 51.217
|
19.31 Percent fold change
Standard Deviation 36.307
|
75.80 Percent fold change
Standard Deviation 64.742
|
124.90 Percent fold change
Standard Deviation 154.983
|
195.35 Percent fold change
Standard Deviation 136.345
|
400.73 Percent fold change
Standard Deviation 98.553
|
|
Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1
48 hour
|
-11.07 Percent fold change
Standard Deviation 23.224
|
-3.86 Percent fold change
Standard Deviation 13.848
|
10.45 Percent fold change
Standard Deviation 25.851
|
7.64 Percent fold change
Standard Deviation 28.049
|
15.71 Percent fold change
Standard Deviation 18.469
|
37.51 Percent fold change
Standard Deviation 17.058
|
|
Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1
144 hour
|
-2.00 Percent fold change
Standard Deviation 35.912
|
-0.95 Percent fold change
Standard Deviation 19.617
|
-2.03 Percent fold change
Standard Deviation 19.870
|
3.17 Percent fold change
Standard Deviation 33.828
|
3.26 Percent fold change
Standard Deviation 14.855
|
2.75 Percent fold change
Standard Deviation 13.556
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population
Blood samples were collected at indicated time points for the assessment of IL-10. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=5 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1
1 hour
|
4.18 Percent fold change
Standard Deviation 2.923
|
36.13 Percent fold change
Standard Deviation 50.565
|
131.03 Percent fold change
Standard Deviation 167.082
|
170.79 Percent fold change
Standard Deviation 130.626
|
320.02 Percent fold change
Standard Deviation 171.738
|
590.82 Percent fold change
Standard Deviation 378.761
|
|
Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1
2 hour
|
3.89 Percent fold change
Standard Deviation 5.943
|
138.05 Percent fold change
Standard Deviation 233.654
|
496.20 Percent fold change
Standard Deviation 746.150
|
437.92 Percent fold change
Standard Deviation 436.690
|
587.14 Percent fold change
Standard Deviation 327.563
|
2985.38 Percent fold change
Standard Deviation 2768.658
|
|
Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1
4 hour
|
7.66 Percent fold change
Standard Deviation 9.351
|
35.74 Percent fold change
Standard Deviation 39.419
|
72.32 Percent fold change
Standard Deviation 81.429
|
75.74 Percent fold change
Standard Deviation 75.003
|
104.81 Percent fold change
Standard Deviation 83.542
|
166.23 Percent fold change
Standard Deviation 149.184
|
|
Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1
8 hour
|
1.45 Percent fold change
Standard Deviation 9.681
|
13.56 Percent fold change
Standard Deviation 22.309
|
44.31 Percent fold change
Standard Deviation 54.738
|
38.31 Percent fold change
Standard Deviation 30.005
|
98.31 Percent fold change
Standard Deviation 80.140
|
152.84 Percent fold change
Standard Deviation 125.207
|
|
Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1
12 hour
|
-0.94 Percent fold change
Standard Deviation 11.658
|
4.52 Percent fold change
Standard Deviation 18.393
|
22.10 Percent fold change
Standard Deviation 30.976
|
18.10 Percent fold change
Standard Deviation 20.319
|
39.32 Percent fold change
Standard Deviation 35.208
|
46.01 Percent fold change
Standard Deviation 29.984
|
|
Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1
16 hour
|
8.81 Percent fold change
Standard Deviation 23.057
|
13.70 Percent fold change
Standard Deviation 20.597
|
23.52 Percent fold change
Standard Deviation 32.664
|
25.13 Percent fold change
Standard Deviation 19.212
|
48.07 Percent fold change
Standard Deviation 34.705
|
36.84 Percent fold change
Standard Deviation 22.787
|
|
Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1
24 hour
|
14.43 Percent fold change
Standard Deviation 24.246
|
6.07 Percent fold change
Standard Deviation 9.298
|
11.37 Percent fold change
Standard Deviation 17.257
|
16.47 Percent fold change
Standard Deviation 10.573
|
24.70 Percent fold change
Standard Deviation 25.961
|
21.83 Percent fold change
Standard Deviation 17.997
|
|
Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1
48 hour
|
13.20 Percent fold change
Standard Deviation 45.366
|
4.98 Percent fold change
Standard Deviation 5.925
|
-1.41 Percent fold change
Standard Deviation 11.832
|
9.63 Percent fold change
Standard Deviation 5.995
|
-0.10 Percent fold change
Standard Deviation 8.984
|
2.73 Percent fold change
Standard Deviation 10.103
|
|
Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1
144 hour
|
17.99 Percent fold change
Standard Deviation 38.910
|
15.53 Percent fold change
Standard Deviation 13.540
|
10.35 Percent fold change
Standard Deviation 12.876
|
11.73 Percent fold change
Standard Deviation 4.742
|
14.73 Percent fold change
Standard Deviation 19.170
|
7.28 Percent fold change
Standard Deviation 10.035
|
SECONDARY outcome
Timeframe: Baseline, 4, 24 and 144 hoursPopulation: All Subjects Population
WBC differential included Lymphocytes Count, Monocytes Count, Granulocytes Count including neutrophils and eosinophil. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in WBC Differential for Part 1
Monocytes count, 4 hour, n=10, 6, 6, 5, 6, 6
|
0.012 10^9 cells per liter
Standard Deviation 0.0543
|
0.156 10^9 cells per liter
Standard Deviation 0.1228
|
0.253 10^9 cells per liter
Standard Deviation 0.0759
|
0.129 10^9 cells per liter
Standard Deviation 0.2242
|
0.169 10^9 cells per liter
Standard Deviation 0.1512
|
-0.061 10^9 cells per liter
Standard Deviation 0.1629
|
|
Change From Baseline in WBC Differential for Part 1
Monocytes count, 24 hour, n=10, 6, 6, 6, 4, 6
|
0.072 10^9 cells per liter
Standard Deviation 0.1631
|
-0.038 10^9 cells per liter
Standard Deviation 0.1411
|
0.018 10^9 cells per liter
Standard Deviation 0.0807
|
0.035 10^9 cells per liter
Standard Deviation 0.1415
|
0.004 10^9 cells per liter
Standard Deviation 0.0800
|
0.104 10^9 cells per liter
Standard Deviation 0.3037
|
|
Change From Baseline in WBC Differential for Part 1
Monocytes count, 144 hour, n=10, 6, 6, 6, 6, 6
|
0.002 10^9 cells per liter
Standard Deviation 0.0959
|
0.013 10^9 cells per liter
Standard Deviation 0.1454
|
-0.054 10^9 cells per liter
Standard Deviation 0.0746
|
0.040 10^9 cells per liter
Standard Deviation 0.1065
|
-0.012 10^9 cells per liter
Standard Deviation 0.0861
|
-0.038 10^9 cells per liter
Standard Deviation 0.0321
|
|
Change From Baseline in WBC Differential for Part 1
Granulocytes Count, 4 hour, n=10, 6, 6, 5, 6, 6
|
0.076 10^9 cells per liter
Standard Deviation 0.2703
|
1.548 10^9 cells per liter
Standard Deviation 0.8217
|
3.708 10^9 cells per liter
Standard Deviation 0.8286
|
3.747 10^9 cells per liter
Standard Deviation 2.3033
|
3.856 10^9 cells per liter
Standard Deviation 0.8005
|
4.018 10^9 cells per liter
Standard Deviation 4.9360
|
|
Change From Baseline in WBC Differential for Part 1
Granulocytes Count, 24 hour, n=10, 6, 6, 6, 4, 6
|
0.400 10^9 cells per liter
Standard Deviation 0.5482
|
0.062 10^9 cells per liter
Standard Deviation 0.7474
|
-0.691 10^9 cells per liter
Standard Deviation 0.8687
|
-0.122 10^9 cells per liter
Standard Deviation 0.6265
|
-0.176 10^9 cells per liter
Standard Deviation 0.3004
|
-0.940 10^9 cells per liter
Standard Deviation 2.3939
|
|
Change From Baseline in WBC Differential for Part 1
Granulocytes Count, 144 hour, n=10, 6, 6, 6, 6, 6
|
-0.067 10^9 cells per liter
Standard Deviation 0.9350
|
0.292 10^9 cells per liter
Standard Deviation 0.6764
|
-0.669 10^9 cells per liter
Standard Deviation 1.1381
|
0.245 10^9 cells per liter
Standard Deviation 0.9796
|
-0.073 10^9 cells per liter
Standard Deviation 1.0629
|
-0.974 10^9 cells per liter
Standard Deviation 1.9877
|
|
Change From Baseline in WBC Differential for Part 1
Lymphocytes count, 4 hour, n=10, 6, 6, 5, 6, 6
|
0.082 10^9 cells per liter
Standard Deviation 0.2017
|
-0.118 10^9 cells per liter
Standard Deviation 0.3070
|
-0.603 10^9 cells per liter
Standard Deviation 0.2988
|
-0.393 10^9 cells per liter
Standard Deviation 0.7111
|
-0.997 10^9 cells per liter
Standard Deviation 0.4404
|
-1.419 10^9 cells per liter
Standard Deviation 1.3685
|
|
Change From Baseline in WBC Differential for Part 1
Lymphocytes count, 24 hour, n=10, 6, 6, 6, 4, 6
|
0.135 10^9 cells per liter
Standard Deviation 0.2034
|
-0.045 10^9 cells per liter
Standard Deviation 0.2957
|
-0.051 10^9 cells per liter
Standard Deviation 0.2327
|
0.042 10^9 cells per liter
Standard Deviation 0.5468
|
-0.247 10^9 cells per liter
Standard Deviation 0.2634
|
-0.489 10^9 cells per liter
Standard Deviation 0.7405
|
|
Change From Baseline in WBC Differential for Part 1
Lymphocytes count, 144 hour, n=10, 6, 6, 6, 6, 6
|
-0.080 10^9 cells per liter
Standard Deviation 0.3950
|
-0.107 10^9 cells per liter
Standard Deviation 0.1786
|
-0.030 10^9 cells per liter
Standard Deviation 0.2490
|
0.060 10^9 cells per liter
Standard Deviation 0.6556
|
-0.175 10^9 cells per liter
Standard Deviation 0.5181
|
-0.266 10^9 cells per liter
Standard Deviation 0.6911
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 4 and 7Population: All Subjects Population
Blood samples were collected at indicated time points for the assessment of CRP. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.
Outcome measures
| Measure |
Part 1: Placebo
n=10 Participants
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 Participants
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in CRP for Part 1
Day 7
|
0.468 mg/L
Standard Deviation 1.3130
|
0.338 mg/L
Standard Deviation 0.3712
|
0.128 mg/L
Standard Deviation 0.3022
|
4.802 mg/L
Standard Deviation 9.2888
|
1.305 mg/L
Standard Deviation 0.8481
|
1.428 mg/L
Standard Deviation 1.0400
|
|
Change From Baseline in CRP for Part 1
Day 2
|
-0.074 mg/L
Standard Deviation 0.1852
|
0.448 mg/L
Standard Deviation 0.7342
|
4.550 mg/L
Standard Deviation 3.8044
|
10.413 mg/L
Standard Deviation 10.7622
|
11.900 mg/L
Standard Deviation 6.1323
|
19.442 mg/L
Standard Deviation 1.9676
|
|
Change From Baseline in CRP for Part 1
Day 4
|
-0.101 mg/L
Standard Deviation 0.3839
|
0.098 mg/L
Standard Deviation 0.1480
|
0.748 mg/L
Standard Deviation 0.5974
|
2.430 mg/L
Standard Deviation 2.3835
|
2.362 mg/L
Standard Deviation 1.4852
|
3.760 mg/L
Standard Deviation 1.2465
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Cmax assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of Adverse events (AEs) of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Tmax and t1/2 assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
AUC (0-t) and AUC (0-inf) assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
AUC (0-tau) and AUC (0-last) assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
CL assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Volume of distribution assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. Data were not collected for part 2 as none of the participant was enrolled into Part 2 of the study.
Accumulation ratio assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dosePopulation: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Time invariance assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
IL-6 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
TNF-alpha assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
IFN-gamma assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population. The data was not collected for Part 2 because no Par. were enrolled into this part of the study.
IP-10 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
MCP-1 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
GCSF assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population. The data was not collected for Part 2 because no Par. were enrolled into this part of the study.
IL-1Ra assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hoursPopulation: PD Population. The data was not collected for Part 2 because no Par. were enrolled into this part of the study.
IL-10 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 2, 24 and 144 hoursPopulation: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
WBC differential assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 7Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Urinalysis as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 7Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Hematology as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 7Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Clinical chemistry as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Pre-dose, 1, 2, 4, 8, 12, 16, 24, and 48 hours post dosePopulation: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
CRP assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to Day 7Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Body temperature was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to Day 7Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
SBP and DBP was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to Day 7Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Respiratory rate was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to Day 7Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Pulse rate was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Outcome measures
Outcome data not reported
Adverse Events
Part 1: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: GSK1795091 7 ng
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: GSK1795091 21 ng
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: GSK1795091 60 ng
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1: GSK1795091 Repeated 60 ng
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: GSK1795091 100 ng
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
All Participants in Part 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Placebo
n=10 participants at risk
Participants in Part 1 were randomized to receive IV matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 7 ng
n=6 participants at risk
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 21 ng
n=6 participants at risk
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 60 ng
n=6 participants at risk
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 Repeated 60 ng
n=6 participants at risk
In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5.
|
Part 1: GSK1795091 100 ng
n=6 participants at risk
In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5.
|
All Participants in Part 2
In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Influenza like illness
|
0.00%
0/10 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
66.7%
4/6 • Number of events 4 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
83.3%
5/6 • Number of events 5 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
—
0/0 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
—
0/0 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
—
0/0 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
33.3%
2/6 • Number of events 2 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
—
0/0 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
|
Investigations
Body temperature increased
|
0.00%
0/10 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
66.7%
4/6 • Number of events 6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
—
0/0 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
|
Investigations
Heart rate increased
|
0.00%
0/10 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 4 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
—
0/0 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
33.3%
2/6 • Number of events 2 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
—
0/0 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
—
0/0 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/10 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
—
0/0 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
16.7%
1/6 • Number of events 1 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
0.00%
0/6 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
—
0/0 • Up to 102 days
Non-serious AEs and SAE for All Subjects Population in Part 1 was reported. Non-serious AEs and SAE data was not collected for Part 2 as none of the participants were enrolled into Part 2 of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER