Trial Outcomes & Findings for GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection (NCT NCT01209078)
NCT ID: NCT01209078
Last Updated: 2017-12-04
Results Overview
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) \>=3 x upper limit of normal (ULN), and total bilirubin \>=2 x ULN or international normalised ratio \>1.5.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Up to Follow-up (28 Day Follow-up, Day 40)
Results posted on
2017-12-04
Participant Flow
The study was planned on 75 male and female participants with Gram-positive acute bacterial skin and skin structure infection (ABSSSI) who were not receiving any antibacterial therapy, aged 18 years or older at eight study centers in the United States from 13 September 2010 to 20 December 2010.
A total of 84 participants were enrolled in the study; of which, 57 participants were randomized in a ratio of 2:1 to receive GSK1322322 1500 milligram (mg) twice a day (BID) and 27 were randomized to receive linezolid 600 mg BID for 10 days.
Participant milestones
| Measure |
GSK1322322 1500 mg BID
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 milliliter (mL) of water or liquid.
|
Linezolid 600 mg BID
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
27
|
|
Overall Study
COMPLETED
|
41
|
24
|
|
Overall Study
NOT COMPLETED
|
16
|
3
|
Reasons for withdrawal
| Measure |
GSK1322322 1500 mg BID
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 milliliter (mL) of water or liquid.
|
Linezolid 600 mg BID
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Physician Decision
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection
Baseline characteristics by cohort
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.4 Years
STANDARD_DEVIATION 11.87 • n=5 Participants
|
41.5 Years
STANDARD_DEVIATION 11.00 • n=7 Participants
|
43.5 Years
STANDARD_DEVIATION 11.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: Safety Population was defined as all participants who received at least one dose of study medication.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) \>=3 x upper limit of normal (ULN), and total bilirubin \>=2 x ULN or international normalised ratio \>1.5.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)
Any AE
|
49 Participants
|
20 Participants
|
|
Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)
Any SAE
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: Safety Population. Only those participants available at the specified time points were analyzed.
Blood samples were obtained for analysis of albumin and total protein at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Albumin, Day 1
|
39.9 Gram/Liter
Standard Deviation 3.41
|
40.3 Gram/Liter
Standard Deviation 3.47
|
|
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Albumin, Day 4
|
40.0 Gram/Liter
Standard Deviation 3.70
|
40.5 Gram/Liter
Standard Deviation 2.66
|
|
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Albumin, Day 8
|
40.3 Gram/Liter
Standard Deviation 4.04
|
40.4 Gram/Liter
Standard Deviation 3.35
|
|
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Albumin, Day 11
|
40.9 Gram/Liter
Standard Deviation 3.59
|
42.2 Gram/Liter
Standard Deviation 2.83
|
|
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Albumin, 7 Day Follow-up
|
41.4 Gram/Liter
Standard Deviation 4.03
|
42.8 Gram/Liter
Standard Deviation 3.02
|
|
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Albumin, 28 Day Follow-up
|
41.5 Gram/Liter
Standard Deviation 4.03
|
41.1 Gram/Liter
Standard Deviation 3.04
|
|
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Total protein, Day 1
|
72.6 Gram/Liter
Standard Deviation 5.86
|
72.2 Gram/Liter
Standard Deviation 6.86
|
|
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Total protein, Day 4
|
72.0 Gram/Liter
Standard Deviation 5.98
|
72.4 Gram/Liter
Standard Deviation 6.80
|
|
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Total protein, Day 8
|
72.8 Gram/Liter
Standard Deviation 5.94
|
71.3 Gram/Liter
Standard Deviation 4.46
|
|
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Total protein, Day 11
|
73.2 Gram/Liter
Standard Deviation 6.19
|
73.4 Gram/Liter
Standard Deviation 4.58
|
|
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Total protein, 7 Day Follow-up
|
73.5 Gram/Liter
Standard Deviation 5.79
|
74.3 Gram/Liter
Standard Deviation 6.44
|
|
Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points
Total protein, 28 Day Follow-up
|
73.2 Gram/Liter
Standard Deviation 6.35
|
72.6 Gram/Liter
Standard Deviation 4.42
|
PRIMARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: Safety Population. Only those participants available at the specified time points were analyzed.
Blood samples were obtained for analysis of ALT, ALP, AST, FSH, GGT, LDH and creatine kinase at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
ALP, Day 1
|
102.5 International units (IU)/Liter
Standard Deviation 39.65
|
97.7 International units (IU)/Liter
Standard Deviation 34.73
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
ALP, Day 4
|
95.0 International units (IU)/Liter
Standard Deviation 21.99
|
92.4 International units (IU)/Liter
Standard Deviation 26.32
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
ALP, Day 8
|
94.8 International units (IU)/Liter
Standard Deviation 21.26
|
88.2 International units (IU)/Liter
Standard Deviation 21.63
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
ALP, Day 11
|
95.4 International units (IU)/Liter
Standard Deviation 23.88
|
89.3 International units (IU)/Liter
Standard Deviation 19.06
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
ALP, 7 Day Follow-up
|
95.6 International units (IU)/Liter
Standard Deviation 27.45
|
90.9 International units (IU)/Liter
Standard Deviation 22.18
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
ALP, 28 Day Follow-up
|
95.2 International units (IU)/Liter
Standard Deviation 27.79
|
92.9 International units (IU)/Liter
Standard Deviation 29.85
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
ALT, Day 1
|
26.5 International units (IU)/Liter
Standard Deviation 18.55
|
27.3 International units (IU)/Liter
Standard Deviation 17.94
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
ALT, Day 4
|
30.1 International units (IU)/Liter
Standard Deviation 29.46
|
25.4 International units (IU)/Liter
Standard Deviation 12.11
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
ALT, Day 8
|
34.3 International units (IU)/Liter
Standard Deviation 30.90
|
34.0 International units (IU)/Liter
Standard Deviation 35.20
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
ALT, Day 11
|
39.4 International units (IU)/Liter
Standard Deviation 51.29
|
32.2 International units (IU)/Liter
Standard Deviation 30.22
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
ALT, 7 Day Follow-up
|
37.5 International units (IU)/Liter
Standard Deviation 35.13
|
32.6 International units (IU)/Liter
Standard Deviation 25.03
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
ALT, 28 Day Follow-up
|
28.4 International units (IU)/Liter
Standard Deviation 19.03
|
22.7 International units (IU)/Liter
Standard Deviation 10.66
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
AST, Day 1
|
25.9 International units (IU)/Liter
Standard Deviation 14.49
|
26.3 International units (IU)/Liter
Standard Deviation 14.66
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
AST, Day 4
|
27.3 International units (IU)/Liter
Standard Deviation 15.01
|
24.7 International units (IU)/Liter
Standard Deviation 7.69
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
AST, Day 8
|
32.0 International units (IU)/Liter
Standard Deviation 25.19
|
29.3 International units (IU)/Liter
Standard Deviation 18.97
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
AST, Day 11
|
34.6 International units (IU)/Liter
Standard Deviation 30.89
|
28.5 International units (IU)/Liter
Standard Deviation 15.97
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
AST, 7 Day Follow-up
|
35.5 International units (IU)/Liter
Standard Deviation 25.72
|
28.7 International units (IU)/Liter
Standard Deviation 11.37
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
AST, 28 Day Follow-up
|
30.2 International units (IU)/Liter
Standard Deviation 21.83
|
24.0 International units (IU)/Liter
Standard Deviation 10.11
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
Creatine kinase, Day 1
|
118.1 International units (IU)/Liter
Standard Deviation 187.13
|
191.1 International units (IU)/Liter
Standard Deviation 396.31
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
Creatine kinase, Day 4
|
135.2 International units (IU)/Liter
Standard Deviation 98.96
|
166.7 International units (IU)/Liter
Standard Deviation 209.06
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
Creatine kinase, Day 8
|
117.3 International units (IU)/Liter
Standard Deviation 71.14
|
120.3 International units (IU)/Liter
Standard Deviation 69.81
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
Creatine kinase, Day 11
|
135.8 International units (IU)/Liter
Standard Deviation 113.14
|
169.3 International units (IU)/Liter
Standard Deviation 200.90
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
Creatine kinase, 7 Day Follow-up
|
204.7 International units (IU)/Liter
Standard Deviation 561.92
|
189.1 International units (IU)/Liter
Standard Deviation 235.47
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
Creatine kinase, 28 Day Follow-up
|
155.3 International units (IU)/Liter
Standard Deviation 168.84
|
117.5 International units (IU)/Liter
Standard Deviation 64.86
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
FSH, Day 1
|
21.47 International units (IU)/Liter
Standard Deviation 14.585
|
16.05 International units (IU)/Liter
Standard Deviation 24.955
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
GGT, Day 1
|
52.9 International units (IU)/Liter
Standard Deviation 51.70
|
52.6 International units (IU)/Liter
Standard Deviation 52.17
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
GGT, Day 4
|
55.3 International units (IU)/Liter
Standard Deviation 56.17
|
53.4 International units (IU)/Liter
Standard Deviation 43.15
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
GGT, Day 8
|
57.7 International units (IU)/Liter
Standard Deviation 52.08
|
57.7 International units (IU)/Liter
Standard Deviation 45.20
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
GGT, Day 11
|
55.7 International units (IU)/Liter
Standard Deviation 57.22
|
53.5 International units (IU)/Liter
Standard Deviation 40.95
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
GGT, 7 Day Follow-up
|
65.1 International units (IU)/Liter
Standard Deviation 70.73
|
52.8 International units (IU)/Liter
Standard Deviation 39.12
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
GGT, 28 Day Follow-up
|
50.1 International units (IU)/Liter
Standard Deviation 57.09
|
42.1 International units (IU)/Liter
Standard Deviation 42.1
|
|
Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points
LDH, Day 1
|
172.0 International units (IU)/Liter
Standard Deviation NA
Only one participant was analyzed.
|
—
|
PRIMARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: Safety Population. Only those participants available at the specified time points were analyzed.
Blood samples were obtained for analysis of creatinine, uric acid, direct bilirubin and total bilirubin at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Creatinine, Day 1
|
68.73 Micromoles (µmol)/liter
Standard Deviation 18.911
|
66.99 Micromoles (µmol)/liter
Standard Deviation 13.567
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Creatinine, Day 4
|
71.48 Micromoles (µmol)/liter
Standard Deviation 14.307
|
72.35 Micromoles (µmol)/liter
Standard Deviation 13.123
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Creatinine, Day 8
|
74.85 Micromoles (µmol)/liter
Standard Deviation 16.204
|
73.42 Micromoles (µmol)/liter
Standard Deviation 13.159
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Creatinine, Day 11
|
74.19 Micromoles (µmol)/liter
Standard Deviation 16.223
|
72.07 Micromoles (µmol)/liter
Standard Deviation 12.370
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Creatinine, 7 Day Follow-up
|
70.84 Micromoles (µmol)/liter
Standard Deviation 15.601
|
75.06 Micromoles (µmol)/liter
Standard Deviation 21.598
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Creatinine, 28 Day Follow-up
|
72.77 Micromoles (µmol)/liter
Standard Deviation 20.980
|
72.49 Micromoles (µmol)/liter
Standard Deviation 13.537
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Uric acid, Day 1
|
322.5 Micromoles (µmol)/liter
Standard Deviation 88.53
|
293.3 Micromoles (µmol)/liter
Standard Deviation 84.03
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Uric acid, Day 4
|
282.2 Micromoles (µmol)/liter
Standard Deviation 78.77
|
346.4 Micromoles (µmol)/liter
Standard Deviation 74.21
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Uric acid, Day 8
|
323.2 Micromoles (µmol)/liter
Standard Deviation 73.92
|
360.4 Micromoles (µmol)/liter
Standard Deviation 71.96
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Uric acid, Day 11
|
370.5 Micromoles (µmol)/liter
Standard Deviation 88.00
|
367.4 Micromoles (µmol)/liter
Standard Deviation 84.86
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Uric acid, 7 Day Follow-up
|
386.0 Micromoles (µmol)/liter
Standard Deviation 105.60
|
363.8 Micromoles (µmol)/liter
Standard Deviation 97.17
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Uric acid, 28 Day Follow-up
|
358.3 Micromoles (µmol)/liter
Standard Deviation 89.30
|
332.6 Micromoles (µmol)/liter
Standard Deviation 79.96
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Direct bilirubin, Day 1
|
2.3 Micromoles (µmol)/liter
Standard Deviation 1.36
|
2.5 Micromoles (µmol)/liter
Standard Deviation 1.05
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Direct bilirubin, Day 4
|
2.4 Micromoles (µmol)/liter
Standard Deviation 1.39
|
2.0 Micromoles (µmol)/liter
Standard Deviation 1.00
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Direct bilirubin, Day 8
|
2.4 Micromoles (µmol)/liter
Standard Deviation 1.24
|
1.9 Micromoles (µmol)/liter
Standard Deviation 0.93
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Direct bilirubin, Day 11
|
2.5 Micromoles (µmol)/liter
Standard Deviation 1.32
|
2.1 Micromoles (µmol)/liter
Standard Deviation 0.95
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Direct bilirubin, 7 Day Follow-up
|
2.6 Micromoles (µmol)/liter
Standard Deviation 2.16
|
3.0 Micromoles (µmol)/liter
Standard Deviation 1.18
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Direct bilirubin, 28 Day Follow-up
|
2.3 Micromoles (µmol)/liter
Standard Deviation 1.16
|
2.3 Micromoles (µmol)/liter
Standard Deviation 0.92
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Total bilirubin, Day 1
|
8.7 Micromoles (µmol)/liter
Standard Deviation 3.87
|
8.4 Micromoles (µmol)/liter
Standard Deviation 4.31
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Total bilirubin, Day 4
|
7.3 Micromoles (µmol)/liter
Standard Deviation 2.66
|
6.6 Micromoles (µmol)/liter
Standard Deviation 1.87
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Total bilirubin, Day 8
|
7.6 Micromoles (µmol)/liter
Standard Deviation 3.15
|
6.6 Micromoles (µmol)/liter
Standard Deviation 1.91
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Total bilirubin, Day 11
|
8.1 Micromoles (µmol)/liter
Standard Deviation 3.07
|
7.6 Micromoles (µmol)/liter
Standard Deviation 2.17
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Total bilirubin, 7 Day Follow-up
|
8.1 Micromoles (µmol)/liter
Standard Deviation 4.13
|
8.9 Micromoles (µmol)/liter
Standard Deviation 4.04
|
|
Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points
Total bilirubin, 28 Day Follow-up
|
8.5 Micromoles (µmol)/liter
Standard Deviation 3.81
|
7.6 Micromoles (µmol)/liter
Standard Deviation 3.01
|
PRIMARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: Safety Population. Only those participants available at the specified time points were analyzed.
Blood samples were obtained for analysis of glucose, sodium, calcium, potassium, chloride, CO2 content /bicarbonate and urea/BUN at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Glucose, Day 1
|
6.21 Millimole (mmol)/Liter
Standard Deviation 2.385
|
6.63 Millimole (mmol)/Liter
Standard Deviation 5.652
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Glucose, Day 4
|
6.13 Millimole (mmol)/Liter
Standard Deviation 2.459
|
6.77 Millimole (mmol)/Liter
Standard Deviation 5.834
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Glucose, Day 8
|
5.94 Millimole (mmol)/Liter
Standard Deviation 1.473
|
5.77 Millimole (mmol)/Liter
Standard Deviation 1.618
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Glucose, Day 11
|
6.27 Millimole (mmol)/Liter
Standard Deviation 2.025
|
6.65 Millimole (mmol)/Liter
Standard Deviation 3.355
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Glucose, 7 Day Follow-up
|
5.96 Millimole (mmol)/Liter
Standard Deviation 1.607
|
6.40 Millimole (mmol)/Liter
Standard Deviation 2.212
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Glucose, 28 Day Follow-up
|
6.10 Millimole (mmol)/Liter
Standard Deviation 1.487
|
6.76 Millimole (mmol)/Liter
Standard Deviation 3.068
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Sodium, Day 1
|
138.3 Millimole (mmol)/Liter
Standard Deviation 2.49
|
138.3 Millimole (mmol)/Liter
Standard Deviation 3.17
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Sodium, Day 4
|
137.3 Millimole (mmol)/Liter
Standard Deviation 3.07
|
138.3 Millimole (mmol)/Liter
Standard Deviation 1.96
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Sodium, Day 8
|
137.8 Millimole (mmol)/Liter
Standard Deviation 1.99
|
138.4 Millimole (mmol)/Liter
Standard Deviation 3.11
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Sodium, Day 11
|
138.6 Millimole (mmol)/Liter
Standard Deviation 2.11
|
138.2 Millimole (mmol)/Liter
Standard Deviation 2.79
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Sodium, 7 Day Follow-up
|
139.2 Millimole (mmol)/Liter
Standard Deviation 2.27
|
138.5 Millimole (mmol)/Liter
Standard Deviation 2.26
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Sodium, 28 Day Follow-up
|
138.8 Millimole (mmol)/Liter
Standard Deviation 1.93
|
138.8 Millimole (mmol)/Liter
Standard Deviation 3.03
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Calcium, Day 1
|
2.264 Millimole (mmol)/Liter
Standard Deviation 0.1523
|
2.251 Millimole (mmol)/Liter
Standard Deviation 0.1169
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Calcium, Day 4
|
2.217 Millimole (mmol)/Liter
Standard Deviation 0.1094
|
2.257 Millimole (mmol)/Liter
Standard Deviation 0.0930
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Calcium, Day 8
|
2.267 Millimole (mmol)/Liter
Standard Deviation 0.1055
|
2.273 Millimole (mmol)/Liter
Standard Deviation 0.0719
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Calcium, Day 11
|
2.301 Millimole (mmol)/Liter
Standard Deviation 0.1070
|
2.282 Millimole (mmol)/Liter
Standard Deviation 0.0772
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Calcium, 7 Day Follow-up
|
2.315 Millimole (mmol)/Liter
Standard Deviation 0.1082
|
2.303 Millimole (mmol)/Liter
Standard Deviation 0.0959
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Calcium, 28 Day Follow-up
|
2.306 Millimole (mmol)/Liter
Standard Deviation 0.1268
|
2.263 Millimole (mmol)/Liter
Standard Deviation 0.0913
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Potassium, Day 1
|
4.18 Millimole (mmol)/Liter
Standard Deviation 0.373
|
4.08 Millimole (mmol)/Liter
Standard Deviation 0.297
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Potassium, Day 4
|
4.19 Millimole (mmol)/Liter
Standard Deviation 0.400
|
4.11 Millimole (mmol)/Liter
Standard Deviation 0.301
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Potassium, Day 8
|
4.18 Millimole (mmol)/Liter
Standard Deviation 0.288
|
4.13 Millimole (mmol)/Liter
Standard Deviation 0.303
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Potassium, Day 11
|
4.12 Millimole (mmol)/Liter
Standard Deviation 0.280
|
4.04 Millimole (mmol)/Liter
Standard Deviation 0.301
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Potassium, 7 Day Follow-up
|
4.16 Millimole (mmol)/Liter
Standard Deviation 0.331
|
4.06 Millimole (mmol)/Liter
Standard Deviation 0.357
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Potassium, 28 Day Follow-up
|
4.04 Millimole (mmol)/Liter
Standard Deviation 0.307
|
4.13 Millimole (mmol)/Liter
Standard Deviation 0.293
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Chloride, Day 1
|
102.3 Millimole (mmol)/Liter
Standard Deviation 3.12
|
102.4 Millimole (mmol)/Liter
Standard Deviation 3.55
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Chloride, Day 4
|
101.9 Millimole (mmol)/Liter
Standard Deviation 3.71
|
103.0 Millimole (mmol)/Liter
Standard Deviation 3.01
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Chloride, Day 8
|
102.9 Millimole (mmol)/Liter
Standard Deviation 2.57
|
103.8 Millimole (mmol)/Liter
Standard Deviation 2.95
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Chloride, Day 11
|
104.2 Millimole (mmol)/Liter
Standard Deviation 2.69
|
102.7 Millimole (mmol)/Liter
Standard Deviation 4.05
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Chloride, 7 Day Follow-up
|
104.7 Millimole (mmol)/Liter
Standard Deviation 2.14
|
102.6 Millimole (mmol)/Liter
Standard Deviation 3.85
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Chloride, 28 Day Follow-up
|
103.7 Millimole (mmol)/Liter
Standard Deviation 2.60
|
103.7 Millimole (mmol)/Liter
Standard Deviation 3.97
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
CO2 content/bicarbonate, Day 1
|
21.7 Millimole (mmol)/Liter
Standard Deviation 2.68
|
21.1 Millimole (mmol)/Liter
Standard Deviation 2.43
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
CO2 content/bicarbonate, Day 4
|
22.3 Millimole (mmol)/Liter
Standard Deviation 2.51
|
23.0 Millimole (mmol)/Liter
Standard Deviation 2.44
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
CO2 content/bicarbonate, Day 8
|
22.2 Millimole (mmol)/Liter
Standard Deviation 2.16
|
22.5 Millimole (mmol)/Liter
Standard Deviation 2.08
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
CO2 content/bicarbonate, Day 11
|
21.6 Millimole (mmol)/Liter
Standard Deviation 2.20
|
22.8 Millimole (mmol)/Liter
Standard Deviation 2.77
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
CO2 content/bicarbonate, 7 Day Follow-up
|
21.9 Millimole (mmol)/Liter
Standard Deviation 2.31
|
22.0 Millimole (mmol)/Liter
Standard Deviation 2.51
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
CO2 content/bicarbonate, 28 Day Follow-up
|
22.3 Millimole (mmol)/Liter
Standard Deviation 2.05
|
21.5 Millimole (mmol)/Liter
Standard Deviation 2.64
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Urea/BUN, Day 1
|
4.90 Millimole (mmol)/Liter
Standard Deviation 1.695
|
4.20 Millimole (mmol)/Liter
Standard Deviation 1.137
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Urea/BUN, Day 4
|
4.81 Millimole (mmol)/Liter
Standard Deviation 1.383
|
4.48 Millimole (mmol)/Liter
Standard Deviation 1.475
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Urea/BUN, Day 8
|
4.47 Millimole (mmol)/Liter
Standard Deviation 1.188
|
4.73 Millimole (mmol)/Liter
Standard Deviation 1.452
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Urea/BUN, Day 11
|
4.69 Millimole (mmol)/Liter
Standard Deviation 1.381
|
4.87 Millimole (mmol)/Liter
Standard Deviation 1.618
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Urea/BUN, 7 Day Follow-up
|
4.84 Millimole (mmol)/Liter
Standard Deviation 1.665
|
5.00 Millimole (mmol)/Liter
Standard Deviation 1.836
|
|
Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points
Urea/BUN, 28 Day Follow-up
|
4.88 Millimole (mmol)/Liter
Standard Deviation 1.526
|
4.85 Millimole (mmol)/Liter
Standard Deviation 0.947
|
PRIMARY outcome
Timeframe: Day 1Population: Safety Population. Only those participants available at the specified time points were analyzed.
Blood samples were obtained for analysis of estradiol at Day 1.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=6 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=3 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Clinical Chemistry Parameter of Estradiol at Indicated Time Point
|
261.8 Picomole (pmol)/Liter
Standard Deviation 218.20
|
61.3 Picomole (pmol)/Liter
Standard Deviation 22.37
|
PRIMARY outcome
Timeframe: Up to Follow-up (7 Day Follow-up, Day 19)Population: Safety Population. Only those participants available at the specified time points were analyzed.
Blood samples were obtained for analysis of high sensitivity C-Reactive protein at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11 and 7 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points
Day 1
|
38.39 mg/Liter
Standard Deviation 35.968
|
43.97 mg/Liter
Standard Deviation 42.829
|
|
Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points
Day 2
|
33.76 mg/Liter
Standard Deviation 36.759
|
40.72 mg/Liter
Standard Deviation 43.485
|
|
Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points
Day 3
|
27.13 mg/Liter
Standard Deviation 32.425
|
30.99 mg/Liter
Standard Deviation 42.930
|
|
Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points
Day 4
|
15.71 mg/Liter
Standard Deviation 23.564
|
21.82 mg/Liter
Standard Deviation 34.947
|
|
Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points
Day 8
|
6.87 mg/Liter
Standard Deviation 7.561
|
6.02 mg/Liter
Standard Deviation 5.280
|
|
Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points
Day 11
|
7.56 mg/Liter
Standard Deviation 9.711
|
4.74 mg/Liter
Standard Deviation 4.658
|
|
Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points
7 Day Follow-up
|
10.25 mg/Liter
Standard Deviation 16.299
|
7.29 mg/Liter
Standard Deviation 8.377
|
PRIMARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: Safety Population. Only those participants available at the specified time points were analyzed.
Blood samples were obtained for analysis of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, WBC and platelet count at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Basophils, Day 1
|
0.027 Giga cells/Liter
Standard Deviation 0.0146
|
0.035 Giga cells/Liter
Standard Deviation 0.0272
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Basophils, Day 4
|
0.030 Giga cells/Liter
Standard Deviation 0.0179
|
0.035 Giga cells/Liter
Standard Deviation 0.0247
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Basophils, Day 8
|
0.027 Giga cells/Liter
Standard Deviation 0.0125
|
0.035 Giga cells/Liter
Standard Deviation 0.0343
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Basophils, Day 11
|
0.030 Giga cells/Liter
Standard Deviation 0.0234
|
0.020 Giga cells/Liter
Standard Deviation 0.0088
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Basophils, 7 Day Follow-up
|
0.032 Giga cells/Liter
Standard Deviation 0.0162
|
0.027 Giga cells/Liter
Standard Deviation 0.0199
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Basophils, 28 Day Follow-up
|
0.024 Giga cells/Liter
Standard Deviation 0.0144
|
0.031 Giga cells/Liter
Standard Deviation 0.0187
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Eosinophils, Day 1
|
0.149 Giga cells/Liter
Standard Deviation 0.1116
|
0.140 Giga cells/Liter
Standard Deviation 0.1022
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Eosinophils, Day 4
|
0.149 Giga cells/Liter
Standard Deviation 0.1708
|
0.145 Giga cells/Liter
Standard Deviation 0.1018
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Eosinophils, Day 8
|
0.165 Giga cells/Liter
Standard Deviation 0.1347
|
0.155 Giga cells/Liter
Standard Deviation 0.1016
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Eosinophils, Day 11
|
0.175 Giga cells/Liter
Standard Deviation 0.1534
|
0.168 Giga cells/Liter
Standard Deviation 0.1155
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Eosinophils, 7 Day Follow-up
|
0.151 Giga cells/Liter
Standard Deviation 0.0870
|
0.128 Giga cells/Liter
Standard Deviation 0.0947
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Eosinophils, 28 Day Follow-up
|
0.141 Giga cells/Liter
Standard Deviation 0.1060
|
0.150 Giga cells/Liter
Standard Deviation 0.0959
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Monocytes, Day 1
|
0.432 Giga cells/Liter
Standard Deviation 0.2097
|
0.517 Giga cells/Liter
Standard Deviation 0.2131
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Monocytes, Day 4
|
0.354 Giga cells/Liter
Standard Deviation 0.1352
|
0.408 Giga cells/Liter
Standard Deviation 0.2819
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Monocytes, Day 8
|
0.370 Giga cells/Liter
Standard Deviation 0.1265
|
0.388 Giga cells/Liter
Standard Deviation 0.1826
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Monocytes, Day 11
|
0.320 Giga cells/Liter
Standard Deviation 0.1475
|
0.420 Giga cells/Liter
Standard Deviation 0.1800
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Monocytes, 7 Day Follow-up
|
0.345 Giga cells/Liter
Standard Deviation 0.1544
|
0.410 Giga cells/Liter
Standard Deviation 0.1677
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Monocytes, 28 Day Follow-up
|
0.384 Giga cells/Liter
Standard Deviation 0.1502
|
0.471 Giga cells/Liter
Standard Deviation 0.2175
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Total neutrophils, Day 1
|
6.533 Giga cells/Liter
Standard Deviation 3.0198
|
7.231 Giga cells/Liter
Standard Deviation 2.4074
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Total neutrophils, Day 4
|
4.757 Giga cells/Liter
Standard Deviation 2.1470
|
4.984 Giga cells/Liter
Standard Deviation 2.0237
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Total neutrophils, Day 8
|
4.371 Giga cells/Liter
Standard Deviation 1.6688
|
4.780 Giga cells/Liter
Standard Deviation 2.6362
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Total neutrophils, Day 11
|
4.495 Giga cells/Liter
Standard Deviation 2.0516
|
4.524 Giga cells/Liter
Standard Deviation 1.7753
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Total neutrophils, 7 Day Follow-up
|
4.111 Giga cells/Liter
Standard Deviation 1.5873
|
4.821 Giga cells/Liter
Standard Deviation 2.0453
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Total neutrophils, 28 Day Follow-up
|
4.709 Giga cells/Liter
Standard Deviation 1.9470
|
5.496 Giga cells/Liter
Standard Deviation 2.9618
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
WBC count, Day 1
|
9.15 Giga cells/Liter
Standard Deviation 3.420
|
9.87 Giga cells/Liter
Standard Deviation 2.673
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
WBC count, Day 4
|
7.35 Giga cells/Liter
Standard Deviation 2.551
|
7.54 Giga cells/Liter
Standard Deviation 2.462
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
WBC count, Day 8
|
6.82 Giga cells/Liter
Standard Deviation 1.997
|
7.30 Giga cells/Liter
Standard Deviation 2.895
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
WBC count, Day 11
|
6.77 Giga cells/Liter
Standard Deviation 2.209
|
7.06 Giga cells/Liter
Standard Deviation 2.172
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
WBC count, 7 Day Follow-up
|
6.44 Giga cells/Liter
Standard Deviation 2.077
|
7.48 Giga cells/Liter
Standard Deviation 2.432
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
WBC count, 28 Day Follow-up
|
7.16 Giga cells/Liter
Standard Deviation 2.415
|
8.10 Giga cells/Liter
Standard Deviation 3.268
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Platelet count, Day 1
|
285.5 Giga cells/Liter
Standard Deviation 91.48
|
255.0 Giga cells/Liter
Standard Deviation 72.48
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Platelet count, Day 4
|
296.5 Giga cells/Liter
Standard Deviation 93.96
|
273.2 Giga cells/Liter
Standard Deviation 74.68
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Platelet count, Day 8
|
293.0 Giga cells/Liter
Standard Deviation 79.28
|
268.3 Giga cells/Liter
Standard Deviation 56.90
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Platelet count, Day 11
|
280.2 Giga cells/Liter
Standard Deviation 78.24
|
253.9 Giga cells/Liter
Standard Deviation 62.44
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Platelet count, 7 Day Follow-up
|
264.0 Giga cells/Liter
Standard Deviation 71.40
|
249.8 Giga cells/Liter
Standard Deviation 58.68
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Platelet count, 28 Day Follow-up
|
279.3 Giga cells/Liter
Standard Deviation 74.61
|
240.5 Giga cells/Liter
Standard Deviation 69.81
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Lymphocytes, Day 1
|
2.012 Giga cells/Liter
Standard Deviation 0.7487
|
1.947 Giga cells/Liter
Standard Deviation 0.6455
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Lymphocytes, Day 4
|
2.057 Giga cells/Liter
Standard Deviation 0.8168
|
1.968 Giga cells/Liter
Standard Deviation 0.6718
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Lymphocytes, Day 8
|
1.890 Giga cells/Liter
Standard Deviation 0.7039
|
1.941 Giga cells/Liter
Standard Deviation 0.7312
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Lymphocytes, Day 11
|
1.749 Giga cells/Liter
Standard Deviation 0.6990
|
1.925 Giga cells/Liter
Standard Deviation 0.6202
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Lymphocytes, 7 Day Follow-up
|
1.806 Giga cells/Liter
Standard Deviation 0.7018
|
2.091 Giga cells/Liter
Standard Deviation 0.8427
|
|
Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points
Lymphocytes, 28 Day Follow-up
|
1.907 Giga cells/Liter
Standard Deviation 0.7745
|
1.955 Giga cells/Liter
Standard Deviation 0.4947
|
PRIMARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: Safety Population. Only those participants available at the specified time points were analyzed.
Blood samples were obtained for analysis of MCV at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points
Day 1
|
90.5 Femtoliter
Standard Deviation 5.24
|
91.1 Femtoliter
Standard Deviation 8.53
|
|
Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points
Day 4
|
89.8 Femtoliter
Standard Deviation 5.52
|
91.6 Femtoliter
Standard Deviation 7.13
|
|
Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points
Day 8
|
89.4 Femtoliter
Standard Deviation 5.88
|
91.2 Femtoliter
Standard Deviation 7.01
|
|
Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points
Day 11
|
89.7 Femtoliter
Standard Deviation 5.38
|
90.7 Femtoliter
Standard Deviation 6.96
|
|
Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points
7 Day Follow-up
|
89.1 Femtoliter
Standard Deviation 4.91
|
91.5 Femtoliter
Standard Deviation 7.00
|
|
Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points
28 Day Follow-up
|
90.1 Femtoliter
Standard Deviation 5.60
|
91.3 Femtoliter
Standard Deviation 7.63
|
PRIMARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: Safety Population. Only those participants available at the specified time points were analyzed.
Blood samples were obtained for analysis of MCHC at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
Hemoglobin, Day 1
|
136.7 Gram/Liter
Standard Deviation 15.67
|
134.2 Gram/Liter
Standard Deviation 19.49
|
|
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
Hemoglobin, Day 4
|
132.9 Gram/Liter
Standard Deviation 15.49
|
133.5 Gram/Liter
Standard Deviation 18.44
|
|
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
Hemoglobin, Day 8
|
135.8 Gram/Liter
Standard Deviation 16.47
|
134.0 Gram/Liter
Standard Deviation 19.03
|
|
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
Hemoglobin, Day 11
|
135.9 Gram/Liter
Standard Deviation 16.83
|
136.4 Gram/Liter
Standard Deviation 19.04
|
|
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
Hemoglobin, 7 Day Follow-up
|
137.7 Gram/Liter
Standard Deviation 19.71
|
135.8 Gram/Liter
Standard Deviation 19.08
|
|
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
Hemoglobin, 28 Day Follow-up
|
139.6 Gram/Liter
Standard Deviation 17.82
|
136.1 Gram/Liter
Standard Deviation 18.35
|
|
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
MCHC, Day 1
|
334.0 Gram/Liter
Standard Deviation 8.73
|
331.9 Gram/Liter
Standard Deviation 12.38
|
|
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
MCHC, Day 4
|
335.1 Gram/Liter
Standard Deviation 9.42
|
333.5 Gram/Liter
Standard Deviation 15.25
|
|
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
MCHC, Day 8
|
336.6 Gram/Liter
Standard Deviation 8.73
|
335.7 Gram/Liter
Standard Deviation 12.60
|
|
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
MCHC, Day 11
|
335.5 Gram/Liter
Standard Deviation 7.73
|
336.4 Gram/Liter
Standard Deviation 14.24
|
|
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
MCHC, 7 Day Follow-up
|
337.8 Gram/Liter
Standard Deviation 7.39
|
335.4 Gram/Liter
Standard Deviation 10.67
|
|
Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points
MCHC, 28 Day Follow-up
|
336.1 Gram/Liter
Standard Deviation 8.53
|
334.3 Gram/Liter
Standard Deviation 11.80
|
PRIMARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: Safety Population. Only those participants available at the specified time points were analyzed.
Blood samples were obtained for analysis of MCH at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points
Day 1
|
30.22 Picogram
Standard Deviation 1.970
|
30.24 Picogram
Standard Deviation 3.284
|
|
Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points
Day 4
|
30.08 Picogram
Standard Deviation 2.169
|
30.58 Picogram
Standard Deviation 2.957
|
|
Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points
Day 8
|
30.10 Picogram
Standard Deviation 2.165
|
30.63 Picogram
Standard Deviation 2.970
|
|
Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points
Day 11
|
30.06 Picogram
Standard Deviation 2.107
|
30.59 Picogram
Standard Deviation 3.014
|
|
Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points
7 Day Follow-up
|
30.14 Picogram
Standard Deviation 2.021
|
30.71 Picogram
Standard Deviation 2.845
|
|
Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points
28 Day Follow-up
|
30.26 Picogram
Standard Deviation 2.070
|
30.56 Picogram
Standard Deviation 3.002
|
PRIMARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: Safety Population. Only those participants available at the specified time points were analyzed.
Blood samples were obtained for analysis of RBC count and reticulocyte at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
Reticulocytes, Day 11
|
0.07 Trillion cells (TI)/Liter
Standard Deviation 0.031
|
0.07 Trillion cells (TI)/Liter
Standard Deviation 0.025
|
|
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
RBC count, Day 1
|
4.53 Trillion cells (TI)/Liter
Standard Deviation 0.413
|
4.43 Trillion cells (TI)/Liter
Standard Deviation 0.397
|
|
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
RBC count, Day 4
|
4.43 Trillion cells (TI)/Liter
Standard Deviation 0.370
|
4.36 Trillion cells (TI)/Liter
Standard Deviation 0.454
|
|
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
RBC count, Day 8
|
4.52 Trillion cells (TI)/Liter
Standard Deviation 0.430
|
4.37 Trillion cells (TI)/Liter
Standard Deviation 0.389
|
|
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
RBC count, Day 11
|
4.52 Trillion cells (TI)/Liter
Standard Deviation 0.410
|
4.46 Trillion cells (TI)/Liter
Standard Deviation 0.436
|
|
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
RBC count, 7 Day Follow-up
|
4.56 Trillion cells (TI)/Liter
Standard Deviation 0.489
|
4.42 Trillion cells (TI)/Liter
Standard Deviation 0.457
|
|
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
RBC count, 28 Day Follow-up
|
4.61 Trillion cells (TI)/Liter
Standard Deviation 0.430
|
4.44 Trillion cells (TI)/Liter
Standard Deviation 0.376
|
|
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
Reticulocytes, Day 1
|
0.07 Trillion cells (TI)/Liter
Standard Deviation 0.032
|
0.06 Trillion cells (TI)/Liter
Standard Deviation 0.021
|
|
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
Reticulocytes, Day 4
|
0.06 Trillion cells (TI)/Liter
Standard Deviation 0.024
|
0.05 Trillion cells (TI)/Liter
Standard Deviation 0.020
|
|
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
Reticulocytes, Day 8
|
0.07 Trillion cells (TI)/Liter
Standard Deviation 0.026
|
0.05 Trillion cells (TI)/Liter
Standard Deviation 0.023
|
|
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
Reticulocytes, 7 Day Follow-up
|
0.06 Trillion cells (TI)/Liter
Standard Deviation 0.029
|
0.08 Trillion cells (TI)/Liter
Standard Deviation 0.027
|
|
Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points
Reticulocytes, 28 Day Follow-up
|
0.07 Trillion cells (TI)/Liter
Standard Deviation 0.031
|
0.06 Trillion cells (TI)/Liter
Standard Deviation 0.023
|
PRIMARY outcome
Timeframe: Up to Day 11Population: Safety Population. Only those participants available at the specified time points were analyzed.
Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three BP measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single BP was obtained at all other time points during the study.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 1
|
78.1 Millimeters of mercury (mmHg)
Standard Deviation 10.39
|
74.5 Millimeters of mercury (mmHg)
Standard Deviation 10.46
|
|
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 2
|
76.0 Millimeters of mercury (mmHg)
Standard Deviation 10.81
|
76.7 Millimeters of mercury (mmHg)
Standard Deviation 9.70
|
|
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 3
|
73.6 Millimeters of mercury (mmHg)
Standard Deviation 10.92
|
77.3 Millimeters of mercury (mmHg)
Standard Deviation 11.01
|
|
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 4
|
69.7 Millimeters of mercury (mmHg)
Standard Deviation 9.63
|
76.8 Millimeters of mercury (mmHg)
Standard Deviation 12.02
|
|
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 8
|
73.5 Millimeters of mercury (mmHg)
Standard Deviation 10.77
|
72.1 Millimeters of mercury (mmHg)
Standard Deviation 11.23
|
|
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP, Day 11
|
73.6 Millimeters of mercury (mmHg)
Standard Deviation 9.75
|
72.8 Millimeters of mercury (mmHg)
Standard Deviation 10.97
|
|
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 1
|
125.6 Millimeters of mercury (mmHg)
Standard Deviation 14.21
|
123.1 Millimeters of mercury (mmHg)
Standard Deviation 12.72
|
|
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 2
|
119.2 Millimeters of mercury (mmHg)
Standard Deviation 13.78
|
125.1 Millimeters of mercury (mmHg)
Standard Deviation 12.74
|
|
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 3
|
120.0 Millimeters of mercury (mmHg)
Standard Deviation 14.52
|
126.9 Millimeters of mercury (mmHg)
Standard Deviation 15.96
|
|
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 4
|
119.3 Millimeters of mercury (mmHg)
Standard Deviation 13.56
|
126.1 Millimeters of mercury (mmHg)
Standard Deviation 14.83
|
|
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 8
|
122.7 Millimeters of mercury (mmHg)
Standard Deviation 14.78
|
121.2 Millimeters of mercury (mmHg)
Standard Deviation 16.02
|
|
Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP, Day 11
|
122.0 Millimeters of mercury (mmHg)
Standard Deviation 14.53
|
120.4 Millimeters of mercury (mmHg)
Standard Deviation 13.25
|
PRIMARY outcome
Timeframe: Up to Day 11Population: Safety Population. Only those participants available at the specified time points were analyzed.
Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three HR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single HR was obtained at all other time points during the study.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points
Day 1
|
74.9 Beats per minute
Standard Deviation 13.75
|
73.9 Beats per minute
Standard Deviation 14.11
|
|
Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points
Day 2
|
81.2 Beats per minute
Standard Deviation 14.54
|
76.2 Beats per minute
Standard Deviation 12.80
|
|
Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points
Day 3
|
77.6 Beats per minute
Standard Deviation 12.81
|
76.1 Beats per minute
Standard Deviation 11.70
|
|
Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points
Day 4
|
71.9 Beats per minute
Standard Deviation 11.21
|
74.6 Beats per minute
Standard Deviation 17.08
|
|
Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points
Day 8
|
69.9 Beats per minute
Standard Deviation 10.52
|
69.2 Beats per minute
Standard Deviation 12.07
|
|
Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points
Day 11
|
70.9 Beats per minute
Standard Deviation 12.86
|
74.0 Beats per minute
Standard Deviation 12.22
|
PRIMARY outcome
Timeframe: Up to Day 11Population: Safety Population. Only those participants available at the specified time points were analyzed.
Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three RR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single RR was obtained at all other time points during the study.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points
Day 1
|
17.1 Breaths per minute
Standard Deviation 1.95
|
17.9 Breaths per minute
Standard Deviation 1.70
|
|
Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points
Day 2
|
17.3 Breaths per minute
Standard Deviation 1.78
|
17.4 Breaths per minute
Standard Deviation 1.98
|
|
Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points
Day 3
|
17.4 Breaths per minute
Standard Deviation 2.08
|
17.3 Breaths per minute
Standard Deviation 1.85
|
|
Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points
Day 4
|
17.3 Breaths per minute
Standard Deviation 1.92
|
17.4 Breaths per minute
Standard Deviation 1.85
|
|
Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points
Day 8
|
17.1 Breaths per minute
Standard Deviation 1.66
|
17.2 Breaths per minute
Standard Deviation 1.76
|
|
Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points
Day 11
|
17.6 Breaths per minute
Standard Deviation 2.20
|
16.8 Breaths per minute
Standard Deviation 1.96
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) up to Day 11Population: Safety Population. Only those participants available at the specified time points were analyzed.
Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three BP measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single BP was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Change From Baseline in SBP and DBP at Indicated Time Points
SBP, Day 2
|
-6.5 mmHg
Standard Deviation 12.23
|
1.6 mmHg
Standard Deviation 15.35
|
|
Mean Change From Baseline in SBP and DBP at Indicated Time Points
SBP, Day 3
|
-5.2 mmHg
Standard Deviation 11.24
|
3.7 mmHg
Standard Deviation 18.64
|
|
Mean Change From Baseline in SBP and DBP at Indicated Time Points
SBP, Day 4
|
-6.5 mmHg
Standard Deviation 11.31
|
3.1 mmHg
Standard Deviation 15.21
|
|
Mean Change From Baseline in SBP and DBP at Indicated Time Points
SBP, Day 8
|
-2.5 mmHg
Standard Deviation 12.23
|
-2.7 mmHg
Standard Deviation 13.95
|
|
Mean Change From Baseline in SBP and DBP at Indicated Time Points
SBP, Day 11
|
-2.7 mmHg
Standard Deviation 12.70
|
-2.6 mmHg
Standard Deviation 15.44
|
|
Mean Change From Baseline in SBP and DBP at Indicated Time Points
DBP, Day 2
|
-2.6 mmHg
Standard Deviation 8.64
|
1.8 mmHg
Standard Deviation 6.46
|
|
Mean Change From Baseline in SBP and DBP at Indicated Time Points
DBP, Day 3
|
-4.8 mmHg
Standard Deviation 8.64
|
2.7 mmHg
Standard Deviation 13.59
|
|
Mean Change From Baseline in SBP and DBP at Indicated Time Points
DBP, Day 4
|
-8.7 mmHg
Standard Deviation 9.02
|
2.5 mmHg
Standard Deviation 12.10
|
|
Mean Change From Baseline in SBP and DBP at Indicated Time Points
DBP, Day 8
|
-4.7 mmHg
Standard Deviation 9.92
|
-2.8 mmHg
Standard Deviation 11.00
|
|
Mean Change From Baseline in SBP and DBP at Indicated Time Points
DBP, Day 11
|
-4.4 mmHg
Standard Deviation 7.61
|
-1.7 mmHg
Standard Deviation 9.53
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) up to Day 11Population: Safety Population. Only those participants available at the specified time points were analyzed.
Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three HR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single HR was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Change From Baseline in HR at Indicated Time Points
Day 2
|
6.5 Beats per minute
Standard Deviation 13.74
|
3.7 Beats per minute
Standard Deviation 11.93
|
|
Mean Change From Baseline in HR at Indicated Time Points
Day 3
|
2.2 Beats per minute
Standard Deviation 11.47
|
4.0 Beats per minute
Standard Deviation 11.48
|
|
Mean Change From Baseline in HR at Indicated Time Points
Day 4
|
-1.4 Beats per minute
Standard Deviation 10.28
|
2.5 Beats per minute
Standard Deviation 19.57
|
|
Mean Change From Baseline in HR at Indicated Time Points
Day 8
|
-3.0 Beats per minute
Standard Deviation 10.98
|
-2.7 Beats per minute
Standard Deviation 12.05
|
|
Mean Change From Baseline in HR at Indicated Time Points
Day 11
|
-2.5 Beats per minute
Standard Deviation 12.07
|
1.7 Beats per minute
Standard Deviation 12.28
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) up to Day 11Population: Safety Population. Only those participants available at the specified time points were analyzed.
Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three RR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single RR was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Change From Baseline in RR at Indicated Time Points
Day 2
|
0.4 Breaths per minute
Standard Deviation 1.80
|
-0.7 Breaths per minute
Standard Deviation 2.07
|
|
Mean Change From Baseline in RR at Indicated Time Points
Day 3
|
0.5 Breaths per minute
Standard Deviation 2.41
|
-0.7 Breaths per minute
Standard Deviation 1.43
|
|
Mean Change From Baseline in RR at Indicated Time Points
Day 4
|
0.4 Breaths per minute
Standard Deviation 2.35
|
-0.6 Breaths per minute
Standard Deviation 2.14
|
|
Mean Change From Baseline in RR at Indicated Time Points
Day 8
|
0.2 Breaths per minute
Standard Deviation 1.98
|
-0.8 Breaths per minute
Standard Deviation 1.75
|
|
Mean Change From Baseline in RR at Indicated Time Points
Day 11
|
0.6 Breaths per minute
Standard Deviation 2.11
|
-1.2 Breaths per minute
Standard Deviation 1.89
|
PRIMARY outcome
Timeframe: Up to Day 11Population: Safety Population. Only those participants available at the specified time points were analyzed.
12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). The mean value recorded pre-dose on Day 1 was classified as Baseline.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
PR interval, Day 1, mean pre-dose
|
158.0 Millisecond (msec)
Standard Deviation 15.88
|
155.0 Millisecond (msec)
Standard Deviation 20.17
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
PR interval, Day 1, 0.25-1.5 h post-dose
|
157.0 Millisecond (msec)
Standard Deviation 15.80
|
159.2 Millisecond (msec)
Standard Deviation 22.72
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
PR interval, Day 1,1.5-3 h post-dose
|
158.5 Millisecond (msec)
Standard Deviation 17.07
|
157.2 Millisecond (msec)
Standard Deviation 23.87
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
PR interval, Day 4, 4-12 h post-dose
|
165.8 Millisecond (msec)
Standard Deviation 18.35
|
159.2 Millisecond (msec)
Standard Deviation 21.39
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
PR interval, Day 8, pre morning dose
|
167.4 Millisecond (msec)
Standard Deviation 16.52
|
158.1 Millisecond (msec)
Standard Deviation 23.98
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
PR interval, Day 11, 0 h
|
158.6 Millisecond (msec)
Standard Deviation 19.72
|
159.3 Millisecond (msec)
Standard Deviation 19.37
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QRS duration, Day 1, mean pre-dose
|
94.0 Millisecond (msec)
Standard Deviation 8.94
|
95.9 Millisecond (msec)
Standard Deviation 6.67
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QRS duration, Day 1, 0.25-1.5 h post-dose
|
93.9 Millisecond (msec)
Standard Deviation 9.19
|
97.1 Millisecond (msec)
Standard Deviation 6.70
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QRS duration, Day 1,1.5-3 h post-dose
|
95.7 Millisecond (msec)
Standard Deviation 8.76
|
96.1 Millisecond (msec)
Standard Deviation 8.40
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QRS duration, Day 4, 4-12 h post-dose
|
95.7 Millisecond (msec)
Standard Deviation 8.91
|
93.7 Millisecond (msec)
Standard Deviation 6.76
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QRS duration, Day 8, pre morning dose
|
95.5 Millisecond (msec)
Standard Deviation 10.07
|
95.3 Millisecond (msec)
Standard Deviation 8.81
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QRS duration, Day 11, 0 h
|
95.2 Millisecond (msec)
Standard Deviation 8.41
|
96.2 Millisecond (msec)
Standard Deviation 8.22
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
UncQT interval, Day 1, mean pre-dose
|
376.7 Millisecond (msec)
Standard Deviation 36.76
|
378.2 Millisecond (msec)
Standard Deviation 39.50
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
UncQT interval, Day 1, 0.25-1.5 h post-dose
|
370.8 Millisecond (msec)
Standard Deviation 35.79
|
375.1 Millisecond (msec)
Standard Deviation 28.51
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
UncQT interval, Day 1,1.5-3 h post-dose
|
370.3 Millisecond (msec)
Standard Deviation 36.01
|
374.0 Millisecond (msec)
Standard Deviation 25.42
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
UncQT interval, Day 4, 4-12 h post-dose
|
392.6 Millisecond (msec)
Standard Deviation 32.26
|
378.4 Millisecond (msec)
Standard Deviation 37.77
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
UncQT interval, Day 8, pre morning dose
|
397.1 Millisecond (msec)
Standard Deviation 31.64
|
390.3 Millisecond (msec)
Standard Deviation 27.18
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
UncQT interval, Day 11, 0 h
|
385.3 Millisecond (msec)
Standard Deviation 32.05
|
382.2 Millisecond (msec)
Standard Deviation 41.47
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QTcB interval, Day 1, mean pre-dose
|
416.0 Millisecond (msec)
Standard Deviation 26.09
|
411.6 Millisecond (msec)
Standard Deviation 28.57
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QTcB interval, Day 1, 0.25-1.5 h post-dose
|
421.1 Millisecond (msec)
Standard Deviation 22.91
|
407.9 Millisecond (msec)
Standard Deviation 28.74
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QTcB interval, Day 1,1.5-3 h post-dose
|
424.1 Millisecond (msec)
Standard Deviation 24.89
|
412.7 Millisecond (msec)
Standard Deviation 25.40
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QTcB interval, Day 4, 4-12 h post-dose
|
422.9 Millisecond (msec)
Standard Deviation 23.65
|
413.2 Millisecond (msec)
Standard Deviation 22.61
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QTcB interval, Day 8, pre morning dose
|
420.1 Millisecond (msec)
Standard Deviation 22.82
|
411.0 Millisecond (msec)
Standard Deviation 26.94
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QTcB interval, Day 11, 0 h
|
414.5 Millisecond (msec)
Standard Deviation 17.76
|
413.1 Millisecond (msec)
Standard Deviation 22.21
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QTcF interval, Day 1, mean pre-dose
|
402.0 Millisecond (msec)
Standard Deviation 24.04
|
399.7 Millisecond (msec)
Standard Deviation 28.20
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QTcF interval, Day 1, 0.25-1.5 h post-dose
|
403.1 Millisecond (msec)
Standard Deviation 22.51
|
396.3 Millisecond (msec)
Standard Deviation 24.78
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QTcF interval, Day 1,1.5-3 h post-dose
|
405.0 Millisecond (msec)
Standard Deviation 24.14
|
399.2 Millisecond (msec)
Standard Deviation 22.47
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QTcF interval, Day 4, 4-12 h post-dose
|
412.3 Millisecond (msec)
Standard Deviation 22.76
|
400.9 Millisecond (msec)
Standard Deviation 21.28
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QTcF interval, Day 8, pre morning dose
|
412.0 Millisecond (msec)
Standard Deviation 21.87
|
403.7 Millisecond (msec)
Standard Deviation 21.54
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
QTcF interval, Day 11, 0 h
|
404.1 Millisecond (msec)
Standard Deviation 16.95
|
402.0 Millisecond (msec)
Standard Deviation 24.27
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
RR interval, Day 1, mean pre-dose
|
832.9 Millisecond (msec)
Standard Deviation 173.04
|
854.6 Millisecond (msec)
Standard Deviation 150.70
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
RR interval, Day 1, 0.25-1.5 h post-dose
|
783.8 Millisecond (msec)
Standard Deviation 148.25
|
855.0 Millisecond (msec)
Standard Deviation 126.77
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
RR interval, Day 1,1.5-3 h post-dose
|
770.7 Millisecond (msec)
Standard Deviation 149.27
|
825.8 Millisecond (msec)
Standard Deviation 101.01
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
RR interval, Day 4, 4-12 h post-dose
|
868.7 Millisecond (msec)
Standard Deviation 133.65
|
860.7 Millisecond (msec)
Standard Deviation 185.66
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
RR interval, Day 8, pre morning dose
|
900.4 Millisecond (msec)
Standard Deviation 134.96
|
918.6 Millisecond (msec)
Standard Deviation 150.00
|
|
Mean Electrocardiogram (ECG) Values at Indicated Time Points
RR interval, Day 11, 0 h
|
873.4 Millisecond (msec)
Standard Deviation 155.04
|
865.0 Millisecond (msec)
Standard Deviation 170.76
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, Baseline) up to Day 11Population: Safety Population. Only those participants available at the specified time points were analyzed.
12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). Mean value recorded pre-dose on Day 1 was classified as Baseline. Change from Baseline was calculated by subtracting the Baseline value from individual post-Baseline (Day 1 post-dose, Day 4, Day 8 and Day 11) values.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
PR interval, Day 1, 0.25-1.5 h post dose
|
-1.0 msec
Standard Deviation 9.64
|
4.2 msec
Standard Deviation 12.88
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
PR interval, Day 1, 1.5-3 h post dose
|
0.4 msec
Standard Deviation 12.09
|
1.3 msec
Standard Deviation 11.79
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
PR interval, Day 4, 4-12 h post dose
|
6.3 msec
Standard Deviation 11.03
|
2.2 msec
Standard Deviation 11.75
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
PR interval, Day 8, pre morning dose
|
7.1 msec
Standard Deviation 12.08
|
-0.0 msec
Standard Deviation 13.79
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
PR interval, Day 11, 0 h
|
-1.2 msec
Standard Deviation 13.86
|
1.5 msec
Standard Deviation 14.27
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QRS duration, Day 1, 0.25-1.5 h post dose
|
-0.2 msec
Standard Deviation 6.32
|
1.2 msec
Standard Deviation 5.52
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QRS duration, Day 1, 1.5-3 h post dose
|
1.6 msec
Standard Deviation 5.85
|
0.3 msec
Standard Deviation 6.84
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QRS duration, Day 4, 4-12 h post dose
|
1.6 msec
Standard Deviation 5.25
|
-2.2 msec
Standard Deviation 7.28
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QRS duration, Day 8, pre morning dose
|
1.0 msec
Standard Deviation 6.54
|
-0.2 msec
Standard Deviation 8.18
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QRS duration, Day 11, 0 h
|
1.2 msec
Standard Deviation 7.19
|
-0.2 msec
Standard Deviation 7.50
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
UncQT interval, Day 1, 0.25-1.5 h post dose
|
-6.0 msec
Standard Deviation 18.66
|
-3.1 msec
Standard Deviation 15.70
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
UncQT interval, Day 1, 1.5-3 h post dose
|
-7.1 msec
Standard Deviation 19.33
|
-7.2 msec
Standard Deviation 20.09
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
UncQT interval, Day 4, 4-12 h post dose
|
14.1 msec
Standard Deviation 24.16
|
0.5 msec
Standard Deviation 36.55
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
UncQT interval, Day 8, pre morning dose
|
17.6 msec
Standard Deviation 29.12
|
10.5 msec
Standard Deviation 26.68
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
UncQT interval, Day 11, 0 h
|
8.2 msec
Standard Deviation 30.04
|
1.5 msec
Standard Deviation 29.88
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QTcB interval, Day 1, 0.25-1.5 h post dose
|
5.1 msec
Standard Deviation 18.67
|
-3.8 msec
Standard Deviation 13.50
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QTcB interval, Day 1, 1.5-3 h post dose
|
8.5 msec
Standard Deviation 16.86
|
1.9 msec
Standard Deviation 17.59
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QTcB interval, Day 4, 4-12 h post dose
|
8.4 msec
Standard Deviation 21.55
|
7.3 msec
Standard Deviation 16.70
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QTcB interval, Day 8, pre morning dose
|
5.4 msec
Standard Deviation 23.19
|
3.3 msec
Standard Deviation 21.13
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QTcB interval, Day 11, 0 h
|
0.0 msec
Standard Deviation 19.45
|
3.0 msec
Standard Deviation 20.16
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QTcF interval, Day 1, 0.25-1.5 h post dose
|
1.1 msec
Standard Deviation 14.99
|
-3.4 msec
Standard Deviation 10.86
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QTcF interval, Day 1, 1.5-3 h post dose
|
3.0 msec
Standard Deviation 13.39
|
-1.2 msec
Standard Deviation 14.74
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QTcF interval, Day 4, 4-12 h post dose
|
10.6 msec
Standard Deviation 16.68
|
4.9 msec
Standard Deviation 16.57
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QTcF interval, Day 8, pre morning dose
|
9.8 msec
Standard Deviation 19.31
|
5.9 msec
Standard Deviation 17.99
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
QTcF interval, Day 11, 0 h
|
2.9 msec
Standard Deviation 18.09
|
2.3 msec
Standard Deviation 18.28
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
RR interval, Day 1, 0.25-1.5 h post dose
|
-49.2 msec
Standard Deviation 108.01
|
0.4 msec
Standard Deviation 88.51
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
RR interval, Day 1, 1.5-3 h post dose
|
-66.4 msec
Standard Deviation 104.58
|
-43.0 msec
Standard Deviation 102.48
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
RR interval, Day 4, 4-12 h post dose
|
23.7 msec
Standard Deviation 143.89
|
-12.2 msec
Standard Deviation 194.88
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
RR interval, Day 8, pre morning dose
|
51.6 msec
Standard Deviation 160.59
|
44.6 msec
Standard Deviation 146.43
|
|
Mean Change From Baseline in ECG Values at Indicated Time Points
RR interval, Day 11, 0 h
|
33.9 msec
Standard Deviation 142.01
|
-5.1 msec
Standard Deviation 153.97
|
PRIMARY outcome
Timeframe: Up to Day 11Population: Safety Population. Only those participants available at the specified time points were analyzed.
12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rhythm and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart and the mean of the three measurements was calculated. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour).
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean ECG Rhythms at Indicated Time Points
Day 1, mean pre-dose
|
75.0 Beats per minute
Standard Deviation 14.33
|
72.8 Beats per minute
Standard Deviation 15.01
|
|
Mean ECG Rhythms at Indicated Time Points
Day 1, 0.25-1.5 h post-dose
|
79.2 Beats per minute
Standard Deviation 14.34
|
72.0 Beats per minute
Standard Deviation 13.04
|
|
Mean ECG Rhythms at Indicated Time Points
Day 1,1.5-3 h post-dose
|
80.4 Beats per minute
Standard Deviation 14.22
|
73.7 Beats per minute
Standard Deviation 9.19
|
|
Mean ECG Rhythms at Indicated Time Points
Day 4, 4-12 h post-dose
|
70.6 Beats per minute
Standard Deviation 10.67
|
73.0 Beats per minute
Standard Deviation 16.39
|
|
Mean ECG Rhythms at Indicated Time Points
Day 8, pre-morning dose
|
68.2 Beats per minute
Standard Deviation 10.37
|
67.2 Beats per minute
Standard Deviation 12.28
|
|
Mean ECG Rhythms at Indicated Time Points
Day 11, 0 h
|
70.9 Beats per minute
Standard Deviation 13.15
|
72.0 Beats per minute
Standard Deviation 13.94
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, Baseline) up to Day 11Population: Safety Population. Only those participants available at the specified time points were analyzed.
12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rhythm and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart and the mean of the three measurements was calculated. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). The value recorded pre-dose on Day 1 was the Baseline. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1 post-dose, Day 4, Day 8 and Day 11) values.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Change From Baseline in ECG Rhythms at Indicated Time Points
Day 1, 0.25-1.5 h post-dose
|
4.2 Beats per minute
Standard Deviation 8.69
|
-0.9 Beats per minute
Standard Deviation 6.29
|
|
Mean Change From Baseline in ECG Rhythms at Indicated Time Points
Day 1, 1.5-3 h post-dose
|
5.9 Beats per minute
Standard Deviation 9.23
|
2.9 Beats per minute
Standard Deviation 8.35
|
|
Mean Change From Baseline in ECG Rhythms at Indicated Time Points
Day 4, 4-12 h post-dose
|
-3.1 Beats per minute
Standard Deviation 11.37
|
2.4 Beats per minute
Standard Deviation 16.48
|
|
Mean Change From Baseline in ECG Rhythms at Indicated Time Points
Day 8, pre morning dose
|
-5.2 Beats per minute
Standard Deviation 12.40
|
-3.5 Beats per minute
Standard Deviation 10.12
|
|
Mean Change From Baseline in ECG Rhythms at Indicated Time Points
Day 11, 0 h
|
-3.2 Beats per minute
Standard Deviation 11.94
|
1.1 Beats per minute
Standard Deviation 11.39
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, Baseline) up Follow-up (28 Day Follow-up, Day 40)Population: Safety Population. Only those participants available at the specified time points were analyzed.
The parameters of clinical chemistry included albumin, total protein, ALT, ALP, AST, GGT, LDH and creatine kinase, creatinine, uric acid, direct bilirubin, total bilirubin, glucose, sodium, calcium, potassium, chloride, CO2 content /bicarbonate and urea/BUN and high sensitivity C-Reactive protein. The assessments were done at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline was defined as the assessment done on Day 1 (pre-dose). Data is reported for number of participants with abnormal transition from Baseline 'to high' or 'to low' relative to normal range. Only those parameters for which at least one value of abnormal transition was reported are summarized.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, GGT, to high
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Glucose, to high
|
7 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Potassium, to low
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Sodium, to low
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Total protein, to low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Total protein, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Urea/BUN, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Uric acid, to low
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Uric acid, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, CO2/bicarbonate, to low
|
4 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 2, C-Reactive protein, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 3, C-Reactive protein, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, ALT, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, ALP, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, AST, to high
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, Calcium, to low
|
6 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, CO2/bicarbonate, to low
|
4 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, Chloride, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, Creatine kinase, to high
|
5 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, Creatinine, to low
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, GGT, to high
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, Glucose, to low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, Glucose, to high
|
7 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, Potassium, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, Sodium, to low
|
6 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, Total protein, to low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, Urea/BUN, to low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, Urea/BUN, to high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 4, Uric acid, to low
|
5 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, ALT, to high
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, Albumin, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, AST, to high
|
4 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, Calcium, to low
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, Chloride, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, Creatine kinase, to high
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, Creatinine, to low
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, GGT, to high
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, Glucose, to low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, Glucose, to high
|
7 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, Sodium, to low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, Urea/BUN, to low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 8, Uric acid, to low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, ALT, to high
|
3 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, AST, to high
|
5 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Calcium, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, CO2/bicarbonate, to low
|
5 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Chloride, to low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Chloride, to high
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Creatine kinase, to high
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Creatinine, to low
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, GGT, to high
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Glucose, to low
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Glucose, to high
|
8 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, C-Reactive protein, to high
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Potassium, to low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Sodium, to low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Total protein, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Urea/BUN, to low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Urea/BUN, to high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Uric acid, to low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
Day 11, Uric acid, to high
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, ALT, to high
|
6 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, AST, to high
|
6 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Calcium, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Calcium, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Chloride, to low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Chloride, to high
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Creatine kinase, to high
|
4 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Creatinine, to low
|
4 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Creatinine, to high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Direct bilirubin, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, GGT, to high
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Glucose, to high
|
4 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, C-Reactive protein, to high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Potassium, to low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Sodium, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Total bilirubin, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Total protein, to high
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Urea/BUN, to low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Urea/BUN, to high
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Uric acid, to low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
7 Day Follow-up, Uric acid, to high
|
5 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, ALT, to high
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, ALP, to high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, AST, to high
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Calcium, to low
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Calcium, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, CO2/bicarbonate, to low
|
1 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Chloride, to low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Chloride, to high
|
2 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Creatine kinase, to high
|
5 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Creatinine, to low
|
2 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range
28 Day Follow-up, Creatinine, to high
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, Baseline) up Follow-up (28 Day Follow-up, Day 40)Population: Safety Population. Only those participants available at the specified time points were analyzed.
The parameters of clinical chemistry included basophils, eosinophils, lymphocytes, monocytes, total neutrophils, WBC count, platelet count, MCV, hemoglobin, MCHC, MCH, RBC count and reticulocyte count. The assessments were done at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline was defined as the assessment done on Day 1 (pre-dose). Data is reported for number of participants with abnormal transition from Baseline 'to high' or 'to low' relative to normal range. Only those parameters for which at least one value of abnormal transition was reported are summarized.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, Eosinophils, to low
|
6 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, Eosinophils, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, Hemoglobin, to low
|
3 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, Lymphocytes, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, MCHC, to low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, Monocytes, to low
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, Monocytes, to high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, Platelet count, to high
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, RBC count, to low
|
2 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, Reticulocytes, to low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, Reticulocytes, to high
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, Total neutrophils, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, Total neutrophils, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, WBC count, to low
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 4, WBC count, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, Eosinophils, to low
|
3 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, Hemoglobin, to low
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, Lymphocytes, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, MCHC, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, MCV, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, Monocytes, to low
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, Platelet count, to high
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, RBC count, to low
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, Reticulocytes, to low
|
0 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, Reticulocytes, to high
|
5 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, Total neutrophils, to low
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, Total neutrophils, to high
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 8, WBC count, to low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, Eosinophils, to low
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, Hemoglobin, to low
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, Hemoglobin, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, Lymphocytes, to low
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, Monocytes, to low
|
5 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, Platelet count, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, RBC count, to low
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, Reticulocytes, to low
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, Reticulocytes, to high
|
3 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, Total neutrophils, to low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, Total neutrophils, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, WBC count, to low
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
Day 11, WBC count, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
7 Day Follow-up, Eosinophils, to low
|
0 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
7 Day Follow-up, Hemoglobin, to low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
7 Day Follow-up, Lymphocytes, to low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
7 Day Follow-up, Monocytes, to low
|
5 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
7 Day Follow-up, Platelet count, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
7 Day Follow-up, RBC count, to low
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
7 Day Follow-up, Reticulocytes, to low
|
4 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
7 Day Follow-up, Reticulocytes, to high
|
1 Participants
|
10 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
7 Day Follow-up, Total neutrophils, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
7 Day Follow-up, Total neutrophils, to high
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
7 Day Follow-up, WBC count, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
7 Day Follow-up, WBC count, to high
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, Eosinophils, to low
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, Hemoglobin, to low
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, Hemoglobin, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, Lymphocytes, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, Lymphocytes, to high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, MCHC, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, Monocytes, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, Platelet count, to low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, Platelet count, to high
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, RBC count, to low
|
0 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, Reticulocytes, to low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, Reticulocytes, to high
|
3 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, Total neutrophils, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, Total neutrophils, to high
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, WBC count, to low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range
28 Day Follow-up, WBC count, to high
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: Intent-to-Treat Clinical (ITTC) Population was defined as all randomized participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.
The clinical response was evaluated by the investigator at end of therapy (within 3 days post therapy; Day 12-14) and Follow-up (7 day Follow-up; Day 16 to 19 and 28 day Follow-up; Day 37 to 40). Clinical response was determined after clinical evaluation of reviewing clinical signs and symptoms. Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudate skin infection score (SIS) of 0.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Number of Participants With Clinical Success of Clinical Response
Day 11
|
38 Participants
|
24 Participants
|
|
Number of Participants With Clinical Success of Clinical Response
7 Day Follow-up
|
38 Participants
|
25 Participants
|
|
Number of Participants With Clinical Success of Clinical Response
28 Day Follow-up
|
37 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Day 11 (end of therapy) and Follow-up (7 Day Follow-up, Day 19)Population: ITTC Population.
The clinical response was determined by the investigator after clinical evaluation of reviewing clinical signs and symptoms at end of therapy (within 3 days post therapy; visit window of Day 12-14) and 7 day Follow-up ( visit window of Day 16 to 19), and the resulting clinical outcome was assigned, for each participant. Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudates SIS of 0.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Percentage of Participants With Clinical Success of Clinical Outcome
End of therapy
|
66.7 Percentage of participants
|
88.9 Percentage of participants
|
|
Percentage of Participants With Clinical Success of Clinical Outcome
Follow-up
|
64.9 Percentage of participants
|
88.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 11 (end of therapy)Population: Intent-to-Treat Bacteriology (ITTB) Population was defined as all randomized participants who received at least one dose of study medication and who had a pathogen isolated at Baseline.
The 'by pathogen' microbiological response was determined by comparing the Baseline (Day 1) culture results to the culture results at the end of therapy (visit window of Day 12-14), and the corresponding microbiological outcome (success or failure) by participant was then assigned. Microbiological success was defined as: elimination of Baseline pathogens (defined as microbiological eradication in microbiological response); clinical outcome was success such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and was documented in the electronic case report form (eCRF) (defined as presumed microbiological eradication in microbiological response); new pathogen not previously identified, was identified at end of therapy in a participant who was a 'clinical success' (defined as colonization in microbiological response).
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=37 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=18 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Percentage of Participants With Microbiological Success of Microbiological Outcome at End of Therapy
|
59.5 Percentage of participants
|
94.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Follow-up (7 Day Follow-up, Day 19)Population: ITTB Population.
The 'by pathogen' microbiological response was determined by comparing the Baseline (Day 1) culture results to culture results at Follow-up (Day 16-19), and corresponding microbiological outcome (success or failure) by participant was then assigned. Microbiological success was defined as: Baseline pathogen was eradicated or presumed eradicated at end of therapy, or Baseline pathogens were present at end of therapy and is absent at Follow-up (microbiological eradication in microbiological response); Baseline pathogen was eradicated or presumed eradicated at end of therapy, or the Baseline pathogens were present at end of therapy and, participant was a 'clinical success', such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and was documented in the eCRF (microbiological eradication); a new pathogen, not previously identified at Baseline, was identified at Follow-up in a participant who was a 'clinical success' (colonization)
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=37 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=18 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Percentage of Participants With Microbiological Success of Microbiological Outcome at Follow-up
|
59.5 Percentage of participants
|
94.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Follow-up (7 day Follow-up, Day 19)Population: Per Protocol Bacteriology (PPB) Population was defined as ITTB participants who adhered to protocol-specific criteria (i.e., no protocol violation ): taking 80% of medications and/or not missing more than 48 h in a row of study drug, and have both end of therapy and 7 day Follow-up to be evaluable and a documented pathogen cultured at Baseline.
Therapeutic outcome was combined clinical and microbiological outcome. Therapeutic outcome was a measure of the overall efficacy response, and a therapeutic success referred to participants who had been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic outcome. Therapeutic outcome was determined programmatically, obtained at 7 day Follow-up.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=22 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=17 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Percentage of Participants With Therapeutic Success of Therapeutic Outcome
|
0.8636 Percentage of participants
Interval 0.7202 to 1.0
|
1.0000 Percentage of participants
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Up to Follow-up (7 Day Follow up, Day 19)Population: ITTC Population. Only those participants available at the specified time points were analyzed.
SF-MPQ-2 is composed of 22 items that describes different quantities of pain and related symptoms. Sub-score of continuous pain represents mean of throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain and tender (mean of items 1, 5, 6, 8, 9 and 10). Sub-score of intermittent pain represents mean of shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain and piercing (mean of items 2, 3, 4, 11, 16 and 18). Sub-score of neuropathic pain represents mean of hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or pins and needles, numbness (mean of items 7, 17, 19, 20, 21 and 22). Sub-score of affective descriptors represents mean of tiring-exhaustive, sickening, fearful, punishing-cruel (mean of items 12, 13, 14 and 15). Scores ranged from 0 to 10, where 0 indicated absence of symptom and higher score indicated more severe symptoms. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11 and 7 Day Follow-up.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Continuous Pain, Day 1
|
4.459 Scores on scale
Standard Deviation 2.8567
|
4.889 Scores on scale
Standard Deviation 2.2773
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Continuous Pain, Day 2
|
3.407 Scores on scale
Standard Deviation 2.4454
|
3.533 Scores on scale
Standard Deviation 2.6745
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Continuous Pain, Day 3
|
2.826 Scores on scale
Standard Deviation 2.5509
|
2.744 Scores on scale
Standard Deviation 2.8477
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Continuous Pain, Day 4
|
2.645 Scores on scale
Standard Deviation 2.7701
|
2.067 Scores on scale
Standard Deviation 2.4462
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Continuous Pain, Day 8
|
1.420 Scores on scale
Standard Deviation 1.9653
|
1.389 Scores on scale
Standard Deviation 2.0534
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Continuous Pain, Day 11
|
0.882 Scores on scale
Standard Deviation 1.3387
|
0.806 Scores on scale
Standard Deviation 1.3976
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Continuous Pain, 7 Day Follow-up
|
0.733 Scores on scale
Standard Deviation 1.3018
|
0.533 Scores on scale
Standard Deviation 1.2342
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Intermittent Pain, Day 1
|
3.836 Scores on scale
Standard Deviation 3.1349
|
3.802 Scores on scale
Standard Deviation 2.9067
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Intermittent Pain, Day 2
|
2.337 Scores on scale
Standard Deviation 2.4214
|
2.693 Scores on scale
Standard Deviation 2.9867
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Intermittent Pain, Day 3
|
2.078 Scores on scale
Standard Deviation 2.4989
|
2.244 Scores on scale
Standard Deviation 2.7913
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Intermittent Pain, Day 4
|
1.906 Scores on scale
Standard Deviation 2.6239
|
1.620 Scores on scale
Standard Deviation 2.4188
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Intermittent Pain, Day 8
|
0.871 Scores on scale
Standard Deviation 1.8040
|
1.236 Scores on scale
Standard Deviation 1.9640
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Intermittent Pain, Day 11
|
0.504 Scores on scale
Standard Deviation 0.9927
|
0.688 Scores on scale
Standard Deviation 1.4902
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Intermittent Pain, 7 Day Follow-up
|
0.581 Scores on scale
Standard Deviation 1.3429
|
0.440 Scores on scale
Standard Deviation 1.1656
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Neuropathic Pain, Day 1
|
3.520 Scores on scale
Standard Deviation 2.5554
|
3.846 Scores on scale
Standard Deviation 2.3705
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Neuropathic Pain, Day 2
|
2.705 Scores on scale
Standard Deviation 2.0982
|
2.193 Scores on scale
Standard Deviation 2.2632
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Neuropathic Pain, Day 3
|
2.327 Scores on scale
Standard Deviation 2.0089
|
2.026 Scores on scale
Standard Deviation 2.3526
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Neuropathic Pain, Day 4
|
2.391 Scores on scale
Standard Deviation 2.3476
|
1.613 Scores on scale
Standard Deviation 2.0473
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Neuropathic Pain, Day 8
|
1.508 Scores on scale
Standard Deviation 1.7878
|
1.410 Scores on scale
Standard Deviation 2.0042
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Neuropathic Pain, Day 11
|
0.813 Scores on scale
Standard Deviation 1.1113
|
0.778 Scores on scale
Standard Deviation 1.2450
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Neuropathic Pain, 7 Day Follow-up
|
0.690 Scores on scale
Standard Deviation 1.1515
|
0.593 Scores on scale
Standard Deviation 1.1707
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Affective Descriptors, Day 1
|
3.360 Scores on scale
Standard Deviation 3.0063
|
2.806 Scores on scale
Standard Deviation 2.9000
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Affective Descriptors, Day 2
|
2.226 Scores on scale
Standard Deviation 2.5925
|
2.500 Scores on scale
Standard Deviation 2.9244
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Affective Descriptors, Day 3
|
1.929 Scores on scale
Standard Deviation 2.4088
|
1.692 Scores on scale
Standard Deviation 2.6517
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Affective Descriptors, Day 4
|
1.641 Scores on scale
Standard Deviation 2.4736
|
1.330 Scores on scale
Standard Deviation 2.2287
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Affective Descriptors, Day 8
|
0.852 Scores on scale
Standard Deviation 1.5970
|
1.021 Scores on scale
Standard Deviation 2.0811
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Affective Descriptors, Day 11
|
0.640 Scores on scale
Standard Deviation 1.1320
|
0.490 Scores on scale
Standard Deviation 1.2079
|
|
Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points
Affective Descriptors, 7 Day Follow-up
|
0.483 Scores on scale
Standard Deviation 1.0400
|
0.430 Scores on scale
Standard Deviation 1.1099
|
SECONDARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: ITTC Population. Only those participants available at the specified time points were analyzed.
The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The exudate or pus sub-score of SIS was rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Exudate or Pus Sub-score of SIS at Indicated Time Points
Day 1
|
3.2 Scores on scale
Standard Deviation 2.23
|
3.2 Scores on scale
Standard Deviation 2.39
|
|
Mean Exudate or Pus Sub-score of SIS at Indicated Time Points
Day 2
|
3.0 Scores on scale
Standard Deviation 1.81
|
2.8 Scores on scale
Standard Deviation 1.97
|
|
Mean Exudate or Pus Sub-score of SIS at Indicated Time Points
Day 3
|
2.1 Scores on scale
Standard Deviation 1.56
|
2.2 Scores on scale
Standard Deviation 1.86
|
|
Mean Exudate or Pus Sub-score of SIS at Indicated Time Points
Day 4
|
1.5 Scores on scale
Standard Deviation 1.60
|
1.7 Scores on scale
Standard Deviation 1.51
|
|
Mean Exudate or Pus Sub-score of SIS at Indicated Time Points
Day 8
|
0.8 Scores on scale
Standard Deviation 1.29
|
0.4 Scores on scale
Standard Deviation 0.71
|
|
Mean Exudate or Pus Sub-score of SIS at Indicated Time Points
Day 11
|
0.2 Scores on scale
Standard Deviation 0.70
|
0.0 Scores on scale
Standard Deviation 0.00
|
|
Mean Exudate or Pus Sub-score of SIS at Indicated Time Points
7 Day Follow-up
|
0.1 Scores on scale
Standard Deviation 0.37
|
0.0 Scores on scale
Standard Deviation 0.00
|
|
Mean Exudate or Pus Sub-score of SIS at Indicated Time Points
28 Day Follow-up
|
0.0 Scores on scale
Standard Deviation 0.00
|
0.0 Scores on scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: ITTC Population. Only those participants available at the specified time points were analyzed.
The investigator evaluated the infection by grading the infected lesion according to SIS. The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The items were rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. The total score ranged from 0 to 42, where 0 indicated absence of symptoms and higher score indicated more severe symptoms. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Total SIS at Indicated Time Points
Day 1
|
25.7 Scores on scale
Standard Deviation 5.44
|
26.0 Scores on scale
Standard Deviation 4.39
|
|
Mean Total SIS at Indicated Time Points
Day 2
|
22.2 Scores on scale
Standard Deviation 5.24
|
23.3 Scores on scale
Standard Deviation 5.01
|
|
Mean Total SIS at Indicated Time Points
Day 3
|
17.2 Scores on scale
Standard Deviation 6.09
|
18.1 Scores on scale
Standard Deviation 6.59
|
|
Mean Total SIS at Indicated Time Points
Day 4
|
14.6 Scores on scale
Standard Deviation 6.47
|
14.1 Scores on scale
Standard Deviation 6.19
|
|
Mean Total SIS at Indicated Time Points
Day 8
|
8.8 Scores on scale
Standard Deviation 5.52
|
6.9 Scores on scale
Standard Deviation 4.17
|
|
Mean Total SIS at Indicated Time Points
Day 11
|
3.7 Scores on scale
Standard Deviation 3.53
|
2.3 Scores on scale
Standard Deviation 2.11
|
|
Mean Total SIS at Indicated Time Points
7 Day Follow-up
|
2.4 Scores on scale
Standard Deviation 2.55
|
1.8 Scores on scale
Standard Deviation 2.07
|
|
Mean Total SIS at Indicated Time Points
28 Day Follow-up
|
0.3 Scores on scale
Standard Deviation 1.29
|
0.1 Scores on scale
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Day 1 (Baseline ) up to Follow-up (28 Day Follow-up, Day 40)Population: ITTC Population. Only those participants available at the specified time points were analyzed.
The investigator evaluated the infection by grading the infected lesion according to SIS. The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The items were rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. The total score ranged from 0 to 42, where 0 indicated absence of symptoms and higher score indicated more severe symptoms. Baseline was defined as the assessment value done on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Change From Baseline in Total SIS at Indicated Time Points
Day 2
|
-3.4 Scores on scale
Standard Deviation 4.83
|
-3.1 Scores on scale
Standard Deviation 4.98
|
|
Mean Change From Baseline in Total SIS at Indicated Time Points
Day 3
|
-8.4 Scores on scale
Standard Deviation 6.39
|
-8.0 Scores on scale
Standard Deviation 6.79
|
|
Mean Change From Baseline in Total SIS at Indicated Time Points
Day 4
|
-10.9 Scores on scale
Standard Deviation 6.98
|
-11.9 Scores on scale
Standard Deviation 6.84
|
|
Mean Change From Baseline in Total SIS at Indicated Time Points
Day 8
|
-16.8 Scores on scale
Standard Deviation 7.22
|
-19.0 Scores on scale
Standard Deviation 6.38
|
|
Mean Change From Baseline in Total SIS at Indicated Time Points
Day 11
|
-22.0 Scores on scale
Standard Deviation 6.06
|
-23.6 Scores on scale
Standard Deviation 4.82
|
|
Mean Change From Baseline in Total SIS at Indicated Time Points
7 Day Follow-up
|
-23.0 Scores on scale
Standard Deviation 5.91
|
-24.2 Scores on scale
Standard Deviation 4.75
|
|
Mean Change From Baseline in Total SIS at Indicated Time Points
28 Day Follow-up
|
-25.1 Scores on scale
Standard Deviation 5.54
|
-26.1 Scores on scale
Standard Deviation 3.98
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) up to Follow-up (28 Day Follow-up, Day 40)Population: ITTC Population. Only those participants available at the specified time points were analyzed.
The area of the infected lesion size was calculated as the product between the length (L) and width (W) of the lesion size. The wound was measured by the investigator in centimeters (cm), using a standard metric ruler. Baseline was defined as the assessment value done on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Mean Change From Baseline in Wound Area at Indicated Time Points
Day 2
|
-23.22 cm^2
Standard Deviation 52.486
|
-20.71 cm^2
Standard Deviation 88.184
|
|
Mean Change From Baseline in Wound Area at Indicated Time Points
Day 3
|
-67.69 cm^2
Standard Deviation 93.511
|
-124.27 cm^2
Standard Deviation 188.568
|
|
Mean Change From Baseline in Wound Area at Indicated Time Points
Day 4
|
-119.96 cm^2
Standard Deviation 86.544
|
-209.79 cm^2
Standard Deviation 224.125
|
|
Mean Change From Baseline in Wound Area at Indicated Time Points
Day 8
|
-192.92 cm^2
Standard Deviation 175.606
|
-291.86 cm^2
Standard Deviation 338.675
|
|
Mean Change From Baseline in Wound Area at Indicated Time Points
Day 11
|
-234.99 cm^2
Standard Deviation 276.801
|
-329.93 cm^2
Standard Deviation 362.831
|
|
Mean Change From Baseline in Wound Area at Indicated Time Points
7 Day Follow-up
|
-231.32 cm^2
Standard Deviation 273.285
|
-335.20 cm^2
Standard Deviation 363.233
|
|
Mean Change From Baseline in Wound Area at Indicated Time Points
28 Day Follow-up
|
-242.92 cm^2
Standard Deviation 277.312
|
-344.99 cm^2
Standard Deviation 383.444
|
SECONDARY outcome
Timeframe: Up to Follow-up (28 Day Follow-up, Day 40)Population: ITTC Population. Only those participants available at the specified time points were analyzed.
Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudates SIS of 0. The pathogens isolated at Baseline included staphylococcus aureus (methicillin-resistant staphylococcus aureus \[MRSA\] and methicillin-susceptible staphylococcus aureus \[MSSA\] as defined by susceptibility to cefoxitin or oxacilin), streptococcus pyogenes, other streptococcus species, other Gram-positive pathogens and Gram-negative pathogens. Data is categorized for the percentage of participants with clinical success for each of the pathogens, all pathogens and no pathogens.
Outcome measures
| Measure |
GSK1322322 1500 mg BID
n=57 Participants
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 Participants
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline
Staphylococcus aureus (all)
|
58.3 Percentage of participants
|
93.8 Percentage of participants
|
|
Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline
MRSA
|
50.0 Percentage of participants
|
87.5 Percentage of participants
|
|
Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline
MSSA
|
71.4 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline
Streptococcus pyogenes
|
33.3 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline
Other Streptococcus species
|
—
|
100.0 Percentage of participants
|
|
Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline
Other Gram-positive pathogens
|
—
|
100.0 Percentage of participants
|
|
Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline
Gram-negative pathogens
|
75.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline
All pathogens
|
58.1 Percentage of participants
|
95.7 Percentage of participants
|
|
Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline
No pathogens
|
80.0 Percentage of participants
|
77.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 (0.25-1.5 hours post-initial dose, 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose) and Day 8 (pre-morning dose)Population: Pharmacokinetic (PK) Concentration Population defined all Participants in the "Safety Population" who underwent plasma PK sampling during the study and from whom a measurable plasma concentration above the assay's limit of quantification were obtained for one of the treatment regimens. No participants were analyzed for this outcome measure.
Blood samples were planned to be collected on Day 1, 0.25-1.5 hours post-initial dose (corresponding to the safety laboratory and ECG timepoint), and 1.5-3 hours post-initial dose (corresponding to the safety laboratory and ECG timepoint), and Day 4, 4-12 hours post-morning dose (corresponding to the safety laboratory and ECG timepoint), and Day 8, pre-morning dose (corresponding to safety laboratory and ECG timepoint) during the outpatient visit. The data for this outcome measure was not collected and assessed.
Outcome measures
Outcome data not reported
Adverse Events
GSK1322322 1500 mg BID
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Linezolid 600 mg BID
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1322322 1500 mg BID
n=57 participants at risk
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 participants at risk
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
1.8%
1/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
0.00%
0/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
3.7%
1/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
3.7%
1/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
Other adverse events
| Measure |
GSK1322322 1500 mg BID
n=57 participants at risk
Participants received oral dose of GSK1322322 1500 mg as 3 tablets of 500 mg each, BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo capsules to linezoid in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
Linezolid 600 mg BID
n=27 participants at risk
Participants received oral dose of linezolid 600 mg tablet BID in the morning and evening for 10 days. Blinding was maintained by administration of matching placebo tablets to GSK1322322 in the morning and evening. The study medication was taken with 240 mL of water or liquid.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
24.6%
14/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
14.8%
4/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.0%
8/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
7.4%
2/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
9/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
3.7%
1/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
7.4%
2/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Investigations
Blood glucose increased
|
10.5%
6/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
11.1%
3/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Investigations
Alanine aminotransferase increased
|
7.0%
4/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
7.4%
2/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.8%
1/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
7.4%
2/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Investigations
Haemoglobin decreased
|
5.3%
3/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
0.00%
0/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Nervous system disorders
Headache
|
12.3%
7/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
7.4%
2/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Nervous system disorders
Dizziness
|
8.8%
5/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
3.7%
1/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
General disorders
Fatigue
|
5.3%
3/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
0.00%
0/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
General disorders
Pain
|
5.3%
3/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
0.00%
0/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
General disorders
Pyrexia
|
1.8%
1/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
7.4%
2/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
3/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
3.7%
1/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
3/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
0.00%
0/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Infections and infestations
Skin infection
|
1.8%
1/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
7.4%
2/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
3/57 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
0.00%
0/27 • AEs were collected up to Follow-up (28 Day Follow-up, Day 40)
Safety Population was used.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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