Chronic Hepatitis B Atypical, Hepatitis B
Conditions
Keywords
Hepatitis, Chronic, HBV
Brief summary
To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive patients with chronic hepatitis B virus infection
Detailed description
This study examines the effects of IONIS-HBVRx or placebo (3:1 randomization) administered subcutaneously to treatment-naïve patients who are chronically infected with HBV and the effects of subsequent nucleos(t)ide analogue treatment on these patients.
Interventions
DRUGIONIS-HBVRx
Ascending multiple doses of IONIS-HBVRx by subcutaneous (SC) injection
DRUGPlacebo
Placebo
Sponsors
Ionis Pharmaceuticals, Inc.
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 70 years * Chronic HBV infection ≥6 months (e.g., positive for serum HBsAg ≥ 6 months) * Plasma HBV DNA ≥ 2 x 1000 IU/mL (HBV DNA adequately suppressed for exploratory nucleos(t)ide analogue experienced cohort) * Serum HBsAg ≥ 50 IU/mL * Exploratory nucleos(t)ide analogue experienced cohort only: currently taking and have been taking tenofovir or entecavir without changes in drug, dose level and/or frequency of administration for ≥ 12 months and expect to continue taking without change through to the end of their participation in this study
Exclusion criteria
* Current or prior receipt of anti-HBV nucleos(t)ide analogue therapy. Patients who have failed prior interferon treatment, greater than 6 months prior to Screening, may be evaluated for possible participation in the study (not applicable for exploratory nucleos(t)ide analogue experienced cohort) * History of liver cirrhosis and/or evidence of cirrhosis as determined by any of the following: 1. Liver biopsy (i.e., Metavir Score F4) within 2 years of Screening, or 2. Fibroscan \> 12 KPa, within 12 months of Screening, or 3. AST-to-Platelet Index (APRI) \> 2 and Fibrosure result \> 0.7 within 12 months of Screening For patients without a test for cirrhosis in the above timeframes, Fibroscan, or APRI and Fibrosure, may be performed during the screening period to rule out cirrhosis * History of liver failure as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal varices * History of liver disease other than Hepatitis B * Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV) * BMI \> 35 kg/m2 * History of, or suspected presence of vasculitis * Received solid organ or bone marrow transplant * Currently taking, or took within 3 months of Screening, any immunosuppressing drugs (e.g., prednisone) * Diagnosed hepatocellular carcinoma or suspected hepatocellular carcinoma as evidenced by screening alpha-fetoprotein ≥ 200 ng/mL. If the screening alpha-fetoprotein is ≥ 50 ng/mL and \< 200 ng/mL, the absence of liver mass must be documented by imaging within 6 months before randomization * Clinically-significant abnormalities aside from chronic HBV infection in medical history (e.g., previous acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening, uncontrolled diabetes) or physical examination * History of bleeding diathesis or coagulopathy * History of extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa) * History of excess alcohol consumption within 6 months of Screening * History of drug abuse or dependence, or recreational use of drugs: within 3 months of Screening for soft drugs (such as marijuana) and within 1-year of Screening for hard drugs (such as cocaine, phencyclidine \[PCP\])
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | Baseline (Day 1 pre-dose); Day1: 3 hours post-dose, 5 hours post-dose; Day 2; Day 22:pre-dose, 3 hours postdose, 5 hours post-dose; Days 23, 29 and 113 | Triplicate 12-lead Electrocardiograms (ECGs) were recorded at indicated timepoints. At each time point, ECG machine automatically measured QRS duration, uncorrected QT interval, QT corrected interval-Fredericia \[QTcF\] interval and QTc corrected by Bazett's formula (QTcB). Baseline ECG was the average of the triplicate taken on Day 1 Pre-dose, if only 1 or 2 assessments were available, the single assessment or average of the 2 assessments was used. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Number of Participants With Reported Pregnancy | Up to Day 211 | Female participants who were not surgically sterile or post-menopausal, underwent urine beta Human chorionic gonadotropin (Beta-HCG) pregnancy test. |
| Change From Baseline in Body Temperature | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Body temperature was measured at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline in Body Weight | Baseline (Day 1 pre-dose) and Days 29, 57, 211 | Body weight was measured at indicated time points. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) was measured at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline in Respiratory Rate | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Respiratory Rate was measured at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline in Pulse Rate | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Pulse Rate was measured at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Number of Participants With Abnormal Findings in Physical Examination | Up to Day 211 | Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. |
| Number of Participants Who Received Atleast One Concomitant Medication | Up to Day 211 | A concomitant medication is defined as any medication initiated after the first dose of study, or initiated prior to the first dose of study drug and continued after the first dose of study drug. |
| Change From Baseline in Electrocardiogram Mean Ventricular Rate | Baseline (Day 1 pre-dose); Day1: 3 hours post-dose, 5 hours post-dose; Day 2; Day 22:pre-dose, 3 hours postdose, 5 hours post-dose; Days 23, 29 and 113 | Triplicate 12-lead Electrocardiograms (ECGs) were recorded at indicated timepoints. At each time point, ECG machine automatically measured mean ventricular rate (VR). Baseline ECG was the average of the triplicate taken on Day 1 Pre-dose, if only 1 or 2 assessments were available, the single assessment or average of the 2 assessments was used. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%) | Up to Day 211 | An adverse event is any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. Any adverse event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any important medical event according to medical judgment were categorized as SAE. |
| Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Blood samples were collected for the analysis of clinical parameters including ALT, ALP, CK, GGT, LDH and AST. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Blood samples were collected for the analysis of clinical chemistry parameter-albumin and total protein. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Outcome Measure Timeframe: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Blood samples were collected for the analysis of clinical parameters including sodium, potassium, chloride, bicarbonate, calcium, magnesium, phosphate, glucose, blood urea nitrogen (BUN), cholesterol and urate. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Blood samples were collected for the analysis of clinical chemistry parameters: direct bilirubin, total bilirubin, indirect bilirubin and creatinine. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, WBC, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline for Hematology Parameters: Hemoglobin | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Blood samples were collected for the analysis of hematology parameters including hemoglobin at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline for Hematology Parameter: Hematocrit | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Blood samples were collected for the analysis of hematology parameter including hematocrit at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline Values in Urine Specific Gravity | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Urine samples were collected for the analysis of urine specific gravity. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. Urine specific gravity is measured as the ratio of urine density compared with water density. |
| Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Urine samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline Values in Urine Protein | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | Urine samples were collected for the analysis of urine protein. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | Baseline (Day 1 pre-dose) and Days 23, 57, 85, 211 | Blood samples were collected for the analysis of blood coagulation factors:activated partial thromboplastin time (aPTT) and Prothrombin Time (PT). Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Baseline (Day 1 pre-dose) and Days 23, 57, 85, 211 | Blood samples were collected for the analysis of blood coagulation factor: Prothrombin International normalized ratio. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change in Complement C3 Level at Worst Case Post Baseline Relative to Baseline | Baseline (Day 1 pre-dose) and up to Day 211 | Blood samples were collected from participants to evaluate change in complement C3 level at worst case post Baseline relative to Baseline. Worst case post Baseline in Complement C3 was the minimum post-Baseline level. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change in Complement C5a Level at Worst Case Post Baseline Relative to Baseline | Baseline (Day 1 pre-dose) and up to Day 211 | Blood samples were collected from participants to evaluate change in complement C5a level at worst case post Baseline relative to Baseline. Worst case post Baseline in Complement C5a was the maximum post-Baseline level. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change in Complement Bb Level at Worst Case Post Baseline Relative to Baseline | Baseline (Day 1 pre-dose) and up to Day 211 | Blood samples were collected from participants to evaluate change in complement Bb level at worst case post Baseline relative to Baseline. Worst case post Baseline in Complement Bb was the maximum post-Baseline level. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Week 31 | Baseline (Day 1 pre-dose) and Week 31 | Blood samples were collected from participants to assess HBV DNA viral load. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Change From Baseline in HBV Surface Antigen (HBsAg) Level in Serum at Day 29 | Baseline (Day 1 pre-dose) and Day 29 | Blood samples were collected from participants to assess HBsAg level. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. The LOCF method was used to impute missing values at Day 29 in this analysis. |
| Change From Baseline in HBsAg Level in Serum at Week 31 | Baseline (Day 1 pre-dose) and Week 31 | Blood samples were collected from participants to assess HBsAg level. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31 | At Day 29 and Week 31 | Blood samples were collected to evaluate the percentage of participants with HBsAg loss at Day 29 and Week 31. A 'Loss' of HBsAg means antigen is negative. HBsAg Loss percentage is defined as number of participants with HBsAg loss divided by total number of participants assessed multiplied by 100. Baseline is the last non-missing measurement prior to the first dose of study drug. |
| Percentage of Participants Who Achieved HBV e Antigen (HBeAg) Loss at Day 29 and Week 31 Who Were HBeAg Positive at Baseline | Baseline (Day 1, Pre dose) and at Day 29 and Week 31 | Blood samples were collected to evaluate the percentage of participants with HBeAg loss at Day 29 and Week 31. A 'Loss' of HBeAg means antigen is negative. HBeAg Loss percentage is defined as number of participants with HBeAg loss divided by number of participants with positive HBeAg at Baseline multiplied by 100. Baseline is the last non-missing measurement prior to the first dose of study drug. Participants was considered HBeAg positive at Baseline if the Baseline value\> 0.09 U/mL. |
| Change From Baseline in Serum HBeAg Concentration at Day 29 in Participants Who Were HBeAg Positive at Baseline | Baseline (Day 1, Pre dose) and at Day 29 | Blood samples were collected from participants to assess HBeAg level. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. Participant was considered HBeAg positive at Baseline if the Baseline value\> 0.09 International Units/milliliter (IU/mL). |
| Change From Baseline in Serum HBeAg Concentration at Week 31 in Participants Who Were HBeAg Positive at Baseline | Baseline (Day 1, Pre dose) and Week 31 | Blood samples were collected from participants to assess HBeAg level. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. Participant was considered HBeAg positive at Baseline if the Baseline value\> 0.09 U/mL. |
| Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1:pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose, Days 2 and 23: 24 hours post-dose, Day 4: 72 hours post-dose, Days 8 and 15: pre-dose, Day 22: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose, and Days 29, 36, 57, 85, 113, and 211 | Plasma samples were collected from participants with chronic HBV infection at indicated time points for pharmacokinetic analysis of GSK3228836. |
| Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Day 29 | Baseline (Day 1 pre-dose) and Day 29 | Blood samples were collected from participants to assess HBV DNA viral load. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. The last observation carried forward (LOCF) method was used to impute missing values at Day 29 in this analysis. |
Countries
Hong Kong, South Korea
Participant flow
Recruitment details
This study evaluated safety, tolerability, pharmacokinetics and antiviral activity of GSK3228836 in two population of participants with Chronic Hepatitis B (CHB) virus infection: treatment-naive participants (Cohorts 1, 2 and 3) and participants on stable nucleos(t)ide treatment (Cohort 4)
Pre-assignment details
A total of 31 participants were enrolled and received either GSK3228836 or placebo. In Cohort 3 participants were administered GSK3228836 300 milligram \[mg\] instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 GSK3228836 150 mg Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | 6 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | 12 |
| Cohorts 1-3 Placebo Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh. | 6 |
| Cohort 4 GSK3228836 300 mg Participants on stable nucleos(t)ide treatment were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | 5 |
| Cohort 4 Placebo Participants on stable nucleos(t)ide treatment were subcutaneously administered placebo on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | 2 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1 GSK3228836 150 mg | Cohort 2 and Cohort 3 GSK3228836 300 mg | Cohorts 1-3 Placebo | Cohort 4 GSK3228836 300 mg | Cohort 4 Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 42.5 Years STANDARD_DEVIATION 11.22 | 42.6 Years STANDARD_DEVIATION 14.12 | 49.3 Years STANDARD_DEVIATION 12.66 | 48.4 Years STANDARD_DEVIATION 7.4 | 37.0 Years STANDARD_DEVIATION 2.83 | 44.5 Years STANDARD_DEVIATION 11.9 |
| Race/Ethnicity, Customized Race Asian | 6 Participants | 12 Participants | 6 Participants | 5 Participants | 2 Participants | 31 Participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 2 Participants | 1 Participants | 1 Participants | 15 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 4 Participants | 4 Participants | 1 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 12 | 0 / 6 | 0 / 5 | 0 / 2 |
| other Total, other adverse events | 5 / 6 | 6 / 12 | 2 / 6 | 3 / 5 | 0 / 2 |
| serious Total, serious adverse events | 0 / 6 | 1 / 12 | 0 / 6 | 0 / 5 | 0 / 2 |
Outcome results
Primary
Change From Baseline for Hematology Parameter: Hematocrit
Blood samples were collected for the analysis of hematology parameter including hematocrit at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameter: Hematocrit | Day 29 | -2.47 Percentage of red blood cells in blood | Standard Deviation 1.15 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameter: Hematocrit | Day 57 | -1.17 Percentage of red blood cells in blood | Standard Deviation 2.63 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameter: Hematocrit | Day 85 | -1.33 Percentage of red blood cells in blood | Standard Deviation 3.043 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameter: Hematocrit | Day 211 | -0.37 Percentage of red blood cells in blood | Standard Deviation 4.065 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameter: Hematocrit | Day 29 | -2.39 Percentage of red blood cells in blood | Standard Deviation 2.858 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameter: Hematocrit | Day 211 | 1.53 Percentage of red blood cells in blood | Standard Deviation 4.799 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameter: Hematocrit | Day 57 | -1.04 Percentage of red blood cells in blood | Standard Deviation 3.089 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameter: Hematocrit | Day 85 | -0.98 Percentage of red blood cells in blood | Standard Deviation 3.698 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameter: Hematocrit | Day 211 | -1.83 Percentage of red blood cells in blood | Standard Deviation 2.066 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameter: Hematocrit | Day 57 | -2.17 Percentage of red blood cells in blood | Standard Deviation 3.08 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameter: Hematocrit | Day 85 | -3.13 Percentage of red blood cells in blood | Standard Deviation 2.501 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameter: Hematocrit | Day 29 | -4.20 Percentage of red blood cells in blood | Standard Deviation 2.577 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameter: Hematocrit | Day 29 | -2.23 Percentage of red blood cells in blood | Standard Deviation 2.089 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameter: Hematocrit | Day 57 | -1.10 Percentage of red blood cells in blood | Standard Deviation 2.482 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameter: Hematocrit | Day 211 | 1.40 Percentage of red blood cells in blood | Standard Deviation 1.93 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameter: Hematocrit | Day 85 | -0.28 Percentage of red blood cells in blood | Standard Deviation 1.646 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameter: Hematocrit | Day 211 | 1.05 Percentage of red blood cells in blood | Standard Deviation 1.768 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameter: Hematocrit | Day 85 | -1.65 Percentage of red blood cells in blood | Standard Deviation 3.748 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameter: Hematocrit | Day 57 | -0.80 Percentage of red blood cells in blood | Standard Deviation 2.546 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameter: Hematocrit | Day 29 | -3.30 Percentage of red blood cells in blood | Standard Deviation 0.283 |
Primary
Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets
Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, WBC, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 211 | -0.45 10^9 cells per liters | Standard Deviation 1.067 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 57 | -0.30 10^9 cells per liters | Standard Deviation 1.075 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 29 | -0.10 10^9 cells per liters | Standard Deviation 0.219 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 29 | 0.00 10^9 cells per liters | Standard Deviation 0 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 29 | -0.17 10^9 cells per liters | Standard Deviation 1.027 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes Day 57 | 0.00 10^9 cells per liters | Standard Deviation 0.2 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 211 | 0.17 10^9 cells per liters | Standard Deviation 0.301 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 85 | 0.17 10^9 cells per liters | Standard Deviation 0.288 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 57 | -2.5 10^9 cells per liters | Standard Deviation 26.76 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 211 | 0.00 10^9 cells per liters | Standard Deviation 0 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 29 | 0.03 10^9 cells per liters | Standard Deviation 0.103 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 211 | 12.3 10^9 cells per liters | Standard Deviation 22.81 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 29 | -0.5 10^9 cells per liters | Standard Deviation 23.87 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 57 | -0.02 10^9 cells per liters | Standard Deviation 0.098 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 57 | 0.00 10^9 cells per liters | Standard Deviation 0 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 211 | 0.07 10^9 cells per liters | Standard Deviation 0.103 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 85 | 0.08 10^9 cells per liters | Standard Deviation 0.172 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 85 | 0.08 10^9 cells per liters | Standard Deviation 0.075 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 211 | 0.10 10^9 cells per liters | Standard Deviation 0.11 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 57 | 0.00 10^9 cells per liters | Standard Deviation 0.089 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 29 | -0.18 10^9 cells per liters | Standard Deviation 1.206 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 29 | 0.08 10^9 cells per liters | Standard Deviation 0.117 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 57 | -0.33 10^9 cells per liters | Standard Deviation 1.172 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 85 | -5.2 10^9 cells per liters | Standard Deviation 31.92 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 211 | -0.75 10^9 cells per liters | Standard Deviation 0.873 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 85 | -0.58 10^9 cells per liters | Standard Deviation 1.177 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 85 | -0.02 10^9 cells per liters | Standard Deviation 0.041 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 85 | -0.95 10^9 cells per liters | Standard Deviation 0.812 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 85 | -0.45 10^9 cells per liters | Standard Deviation 1.026 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 85 | 0.00 10^9 cells per liters | Standard Deviation 0 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 85 | -0.04 10^9 cells per liters | Standard Deviation 0.124 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 29 | -0.36 10^9 cells per liters | Standard Deviation 0.945 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 211 | 0.18 10^9 cells per liters | Standard Deviation 0.725 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 29 | -0.27 10^9 cells per liters | Standard Deviation 0.293 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 85 | -0.03 10^9 cells per liters | Standard Deviation 0.115 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 57 | 0.00 10^9 cells per liters | Standard Deviation 0 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 211 | -0.11 10^9 cells per liters | Standard Deviation 0.334 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 211 | 0.01 10^9 cells per liters | Standard Deviation 0.696 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes Day 57 | -0.15 10^9 cells per liters | Standard Deviation 0.275 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 57 | -8.3 10^9 cells per liters | Standard Deviation 31.77 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 57 | -0.01 10^9 cells per liters | Standard Deviation 0.131 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 85 | -0.13 10^9 cells per liters | Standard Deviation 0.273 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 57 | -0.49 10^9 cells per liters | Standard Deviation 0.958 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 211 | -0.04 10^9 cells per liters | Standard Deviation 0.108 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 29 | 0.01 10^9 cells per liters | Standard Deviation 0.029 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 211 | 4.6 10^9 cells per liters | Standard Deviation 43.15 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 211 | 0.01 10^9 cells per liters | Standard Deviation 0.029 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 29 | -8.3 10^9 cells per liters | Standard Deviation 17.23 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 85 | -0.63 10^9 cells per liters | Standard Deviation 0.796 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 29 | -0.02 10^9 cells per liters | Standard Deviation 0.103 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 29 | -0.01 10^9 cells per liters | Standard Deviation 0.138 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 57 | -0.31 10^9 cells per liters | Standard Deviation 0.898 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 211 | -0.05 10^9 cells per liters | Standard Deviation 0.1 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 29 | -0.60 10^9 cells per liters | Standard Deviation 0.921 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 57 | -0.03 10^9 cells per liters | Standard Deviation 0.115 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 85 | -8.3 10^9 cells per liters | Standard Deviation 29.59 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 29 | 11.0 10^9 cells per liters | Standard Deviation 21.94 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 29 | 0.00 10^9 cells per liters | Standard Deviation 0 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 57 | 0.00 10^9 cells per liters | Standard Deviation 0 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 85 | 0.00 10^9 cells per liters | Standard Deviation 0 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 211 | 0.00 10^9 cells per liters | Standard Deviation 0 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 29 | 0.03 10^9 cells per liters | Standard Deviation 0.052 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 57 | 0.05 10^9 cells per liters | Standard Deviation 0.084 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 85 | 0.02 10^9 cells per liters | Standard Deviation 0.075 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 211 | 0.03 10^9 cells per liters | Standard Deviation 0.052 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 29 | -0.12 10^9 cells per liters | Standard Deviation 0.826 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 57 | -0.37 10^9 cells per liters | Standard Deviation 1.204 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 85 | -0.65 10^9 cells per liters | Standard Deviation 0.814 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 211 | 0.10 10^9 cells per liters | Standard Deviation 1.834 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 29 | -0.03 10^9 cells per liters | Standard Deviation 0.294 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes Day 57 | -0.10 10^9 cells per liters | Standard Deviation 0.456 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 85 | -0.03 10^9 cells per liters | Standard Deviation 0.258 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 211 | -0.07 10^9 cells per liters | Standard Deviation 0.234 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 29 | -0.17 10^9 cells per liters | Standard Deviation 0.706 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 57 | -0.32 10^9 cells per liters | Standard Deviation 1.301 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 85 | -0.67 10^9 cells per liters | Standard Deviation 0.585 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 211 | 0.08 10^9 cells per liters | Standard Deviation 1.967 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 29 | 0.02 10^9 cells per liters | Standard Deviation 0.098 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 57 | 0.00 10^9 cells per liters | Standard Deviation 0.167 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 85 | 0.03 10^9 cells per liters | Standard Deviation 0.082 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 211 | 0.02 10^9 cells per liters | Standard Deviation 0.075 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 57 | 9.7 10^9 cells per liters | Standard Deviation 37.08 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 85 | 22.2 10^9 cells per liters | Standard Deviation 27.95 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 211 | 25.8 10^9 cells per liters | Standard Deviation 20.49 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 211 | 0.48 10^9 cells per liters | Standard Deviation 0.377 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 85 | 0.03 10^9 cells per liters | Standard Deviation 0.05 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 57 | 0.13 10^9 cells per liters | Standard Deviation 0.275 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 57 | 0.00 10^9 cells per liters | Standard Deviation 0.082 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 29 | 0.28 10^9 cells per liters | Standard Deviation 0.624 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 29 | 0.0 10^9 cells per liters | Standard Deviation 0 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 211 | 0.10 10^9 cells per liters | Standard Deviation 0.115 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 57 | 0.0 10^9 cells per liters | Standard Deviation 0 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 29 | 0.00 10^9 cells per liters | Standard Deviation 0.082 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 85 | 1.5 10^9 cells per liters | Standard Deviation 7.14 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 211 | 0.0 10^9 cells per liters | Standard Deviation 0 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 29 | 18.0 10^9 cells per liters | Standard Deviation 32.28 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 29 | 0.08 10^9 cells per liters | Standard Deviation 0.05 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 85 | 0.35 10^9 cells per liters | Standard Deviation 0.342 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 85 | 0.0 10^9 cells per liters | Standard Deviation 0 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 211 | 0.05 10^9 cells per liters | Standard Deviation 0.058 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 211 | 0.70 10^9 cells per liters | Standard Deviation 0.589 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 85 | 0.10 10^9 cells per liters | Standard Deviation 0.294 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 57 | 0.08 10^9 cells per liters | Standard Deviation 0.222 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes Day 57 | -0.05 10^9 cells per liters | Standard Deviation 0.1 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 57 | 0.03 10^9 cells per liters | Standard Deviation 0.096 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 57 | -7.5 10^9 cells per liters | Standard Deviation 8.7 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 211 | 0.15 10^9 cells per liters | Standard Deviation 0.208 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 85 | 0.43 10^9 cells per liters | Standard Deviation 0.556 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 29 | -0.10 10^9 cells per liters | Standard Deviation 0.216 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 85 | -0.03 10^9 cells per liters | Standard Deviation 0.126 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 211 | 17.3 10^9 cells per liters | Standard Deviation 20.52 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 29 | 0.30 10^9 cells per liters | Standard Deviation 0.392 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 29 | 0.20 10^9 cells per liters | Standard Deviation 0.283 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 85 | -1.05 10^9 cells per liters | Standard Deviation 0.071 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 57 | 0.0 10^9 cells per liters | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 57 | -0.60 10^9 cells per liters | Standard Deviation 0.849 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 57 | -0.95 10^9 cells per liters | Standard Deviation 0.636 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 85 | -0.65 10^9 cells per liters | Standard Deviation 0.212 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 29 | -1.15 10^9 cells per liters | Standard Deviation 0.212 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 211 | -0.55 10^9 cells per liters | Standard Deviation 0.212 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 211 | 0.05 10^9 cells per liters | Standard Deviation 0.071 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 29 | -0.25 10^9 cells per liters | Standard Deviation 0.212 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 85 | -0.05 10^9 cells per liters | Standard Deviation 0.071 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 85 | 14.5 10^9 cells per liters | Standard Deviation 40.31 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 57 | -0.15 10^9 cells per liters | Standard Deviation 0.354 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 57 | -0.10 10^9 cells per liters | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 29 | 0.0 10^9 cells per liters | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 85 | -0.20 10^9 cells per liters | Standard Deviation 0.283 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Day 29 | 0.00 10^9 cells per liters | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Day 211 | -0.15 10^9 cells per liters | Standard Deviation 0.212 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 211 | 0.0 10^9 cells per liters | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 29 | 16.0 10^9 cells per liters | Standard Deviation 9.9 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Day 85 | 0.0 10^9 cells per liters | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes Day 57 | -0.05 10^9 cells per liters | Standard Deviation 0.071 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 211 | -4.5 10^9 cells per liters | Standard Deviation 44.55 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 85 | -0.10 10^9 cells per liters | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Day 29 | -1.05 10^9 cells per liters | Standard Deviation 0.212 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Day 211 | -0.10 10^9 cells per liters | Standard Deviation 0.141 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | WBC, Day 211 | -0.85 10^9 cells per liters | Standard Deviation 0.212 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Day 57 | 24.5 10^9 cells per liters | Standard Deviation 17.68 |
Primary
Change From Baseline for Hematology Parameters: Hemoglobin
Blood samples were collected for the analysis of hematology parameters including hemoglobin at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Hemoglobin | Day 29 | -7.3 Grams per liter | Standard Deviation 3.5 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Hemoglobin | Day 57 | -3.3 Grams per liter | Standard Deviation 10.25 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Hemoglobin | Day 85 | -4.0 Grams per liter | Standard Deviation 10.6 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline for Hematology Parameters: Hemoglobin | Day 211 | -0.7 Grams per liter | Standard Deviation 15.73 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Hemoglobin | Day 29 | -6.8 Grams per liter | Standard Deviation 8.74 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Hemoglobin | Day 211 | 1.8 Grams per liter | Standard Deviation 16.68 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Hemoglobin | Day 57 | -3.0 Grams per liter | Standard Deviation 10.79 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Hemoglobin | Day 85 | -4.8 Grams per liter | Standard Deviation 13.13 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Hemoglobin | Day 211 | -7.5 Grams per liter | Standard Deviation 6.47 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Hemoglobin | Day 57 | -5.8 Grams per liter | Standard Deviation 9.28 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Hemoglobin | Day 85 | -9.2 Grams per liter | Standard Deviation 10.07 |
| Cohorts 1-3 Placebo | Change From Baseline for Hematology Parameters: Hemoglobin | Day 29 | -11.3 Grams per liter | Standard Deviation 7.31 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Hemoglobin | Day 29 | -6.0 Grams per liter | Standard Deviation 6.48 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Hemoglobin | Day 57 | -3.8 Grams per liter | Standard Deviation 6.95 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Hemoglobin | Day 211 | 4.8 Grams per liter | Standard Deviation 5.19 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline for Hematology Parameters: Hemoglobin | Day 85 | -0.3 Grams per liter | Standard Deviation 3.86 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Hemoglobin | Day 211 | 0.0 Grams per liter | Standard Deviation 1.41 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Hemoglobin | Day 85 | -5.0 Grams per liter | Standard Deviation 9.9 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Hemoglobin | Day 57 | -3.5 Grams per liter | Standard Deviation 4.95 |
| Cohort 4 Placebo | Change From Baseline for Hematology Parameters: Hemoglobin | Day 29 | -11.5 Grams per liter | Standard Deviation 2.12 |
Primary
Change From Baseline in Body Temperature
Body temperature was measured at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Body Temperature | Day 85 | 0.05 Degrees Celsius | Standard Deviation 0.451 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Body Temperature | Day 57 | 0.03 Degrees Celsius | Standard Deviation 0.294 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Body Temperature | Day 211 | -0.20 Degrees Celsius | Standard Deviation 0.21 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Body Temperature | Day 29 | -0.05 Degrees Celsius | Standard Deviation 0.288 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Body Temperature | Day 85 | -0.18 Degrees Celsius | Standard Deviation 0.29 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Body Temperature | Day 29 | -0.09 Degrees Celsius | Standard Deviation 0.353 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Body Temperature | Day 57 | -0.16 Degrees Celsius | Standard Deviation 0.342 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Body Temperature | Day 211 | -0.19 Degrees Celsius | Standard Deviation 0.291 |
| Cohorts 1-3 Placebo | Change From Baseline in Body Temperature | Day 211 | -0.17 Degrees Celsius | Standard Deviation 0.216 |
| Cohorts 1-3 Placebo | Change From Baseline in Body Temperature | Day 85 | -0.13 Degrees Celsius | Standard Deviation 0.103 |
| Cohorts 1-3 Placebo | Change From Baseline in Body Temperature | Day 29 | -0.15 Degrees Celsius | Standard Deviation 0.164 |
| Cohorts 1-3 Placebo | Change From Baseline in Body Temperature | Day 57 | -0.18 Degrees Celsius | Standard Deviation 0.248 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Body Temperature | Day 29 | 0.08 Degrees Celsius | Standard Deviation 0.25 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Body Temperature | Day 57 | 0.48 Degrees Celsius | Standard Deviation 0.096 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Body Temperature | Day 85 | 0.10 Degrees Celsius | Standard Deviation 0.115 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Body Temperature | Day 211 | 0.23 Degrees Celsius | Standard Deviation 0.369 |
| Cohort 4 Placebo | Change From Baseline in Body Temperature | Day 57 | 0.20 Degrees Celsius | Standard Deviation 0.849 |
| Cohort 4 Placebo | Change From Baseline in Body Temperature | Day 29 | 0.30 Degrees Celsius | Standard Deviation 0.141 |
| Cohort 4 Placebo | Change From Baseline in Body Temperature | Day 211 | -0.10 Degrees Celsius | Standard Deviation 0.424 |
| Cohort 4 Placebo | Change From Baseline in Body Temperature | Day 85 | -0.20 Degrees Celsius | Standard Deviation 0.707 |
Primary
Change From Baseline in Body Weight
Body weight was measured at indicated time points. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 211
Population: Safety Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Body Weight | Day 29 | -0.48 Kilograms | Standard Deviation 3.406 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Body Weight | Day 211 | -0.15 Kilograms | Standard Deviation 3.627 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Body Weight | Day 57 | -0.40 Kilograms | Standard Deviation 3.992 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Body Weight | Day 57 | -0.10 Kilograms | Standard Deviation 1.834 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Body Weight | Day 29 | 0.20 Kilograms | Standard Deviation 0.802 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Body Weight | Day 211 | -0.40 Kilograms | Standard Deviation 2.721 |
| Cohorts 1-3 Placebo | Change From Baseline in Body Weight | Day 57 | -0.18 Kilograms | Standard Deviation 1.009 |
| Cohorts 1-3 Placebo | Change From Baseline in Body Weight | Day 29 | 0.52 Kilograms | Standard Deviation 0.786 |
| Cohorts 1-3 Placebo | Change From Baseline in Body Weight | Day 211 | -0.37 Kilograms | Standard Deviation 1.35 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Body Weight | Day 29 | 0.00 Kilograms | Standard Deviation 0.808 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Body Weight | Day 211 | 2.00 Kilograms | Standard Deviation 1.212 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Body Weight | Day 57 | 0.20 Kilograms | Standard Deviation 1.214 |
| Cohort 4 Placebo | Change From Baseline in Body Weight | Day 57 | -0.25 Kilograms | Standard Deviation 0.354 |
| Cohort 4 Placebo | Change From Baseline in Body Weight | Day 29 | -1.25 Kilograms | Standard Deviation 0.636 |
| Cohort 4 Placebo | Change From Baseline in Body Weight | Day 211 | 1.95 Kilograms | Standard Deviation 0.354 |
Primary
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time
Blood samples were collected for the analysis of clinical parameters including ALT, ALP, CK, GGT, LDH and AST. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day29, n= 6,12,6,4,2 | -3.2 Units per liter (U/L) | Standard Deviation 8.23 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day29, n= 6,12,6,4,2 | 15.7 Units per liter (U/L) | Standard Deviation 56.65 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day57, n= 5,12,6,4,2 | 45.6 Units per liter (U/L) | Standard Deviation 60.06 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day85, n= 6,12,6,4,2 | -10.5 Units per liter (U/L) | Standard Deviation 30.2 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day211, n= 6,12,6,4,2 | -24.3 Units per liter (U/L) | Standard Deviation 43.68 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day57, n= 5,12,6,4,2 | 7.8 Units per liter (U/L) | Standard Deviation 12.09 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day85, n= 6,12,6,4,2 | 7.2 Units per liter (U/L) | Standard Deviation 7.73 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day211, n= 6,12,6,4,2 | 18.2 Units per liter (U/L) | Standard Deviation 10.32 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day29, n= 6,12,6,4,2 | 17.7 Units per liter (U/L) | Standard Deviation 50.41 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day57, n= 5,12,6,4,2 | 22.8 Units per liter (U/L) | Standard Deviation 34.3 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day85, n= 6,12,6,4,2 | 3.0 Units per liter (U/L) | Standard Deviation 16.66 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day211, n= 6,12,6,4,2 | -9.3 Units per liter (U/L) | Standard Deviation 22.2 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day29, n= 6,12,6,4,2 | 35.5 Units per liter (U/L) | Standard Deviation 127.87 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day57, n= 5,12,6,4,2 | -9.6 Units per liter (U/L) | Standard Deviation 47.77 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day85, n= 6,12,6,4,2 | 26.2 Units per liter (U/L) | Standard Deviation 61.64 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day211, n= 6,12,6,4,2 | 29.2 Units per liter (U/L) | Standard Deviation 71.04 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day29, n= 6,12,6,4,2 | -2.3 Units per liter (U/L) | Standard Deviation 3.88 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day57, n= 5,12,6,4,2 | 1.4 Units per liter (U/L) | Standard Deviation 3.44 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day85, n= 6,12,6,4,2 | -0.5 Units per liter (U/L) | Standard Deviation 1.52 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day211, n= 6,12,6,4,2 | -7.7 Units per liter (U/L) | Standard Deviation 11.57 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day29, n= 6,12,6,4,2 | 12.0 Units per liter (U/L) | Standard Deviation 27.03 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day57, n= 5,12,6,4,2 | 4.4 Units per liter (U/L) | Standard Deviation 26.68 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day85, n= 6,12,6,4,2 | 9.5 Units per liter (U/L) | Standard Deviation 22.79 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day211, n= 6,12,6,4,2 | 7.0 Units per liter (U/L) | Standard Deviation 18.78 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day85, n= 6,12,6,4,2 | 3.2 Units per liter (U/L) | Standard Deviation 6.66 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day85, n= 6,12,6,4,2 | 8.8 Units per liter (U/L) | Standard Deviation 29.87 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day57, n= 5,12,6,4,2 | -4.7 Units per liter (U/L) | Standard Deviation 21.4 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day85, n= 6,12,6,4,2 | 4.6 Units per liter (U/L) | Standard Deviation 20.37 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day211, n= 6,12,6,4,2 | -1.1 Units per liter (U/L) | Standard Deviation 2.15 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day57, n= 5,12,6,4,2 | 6.5 Units per liter (U/L) | Standard Deviation 15.85 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day85, n= 6,12,6,4,2 | -12.3 Units per liter (U/L) | Standard Deviation 22.42 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day211, n= 6,12,6,4,2 | -16.2 Units per liter (U/L) | Standard Deviation 30.75 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day211, n= 6,12,6,4,2 | -6.5 Units per liter (U/L) | Standard Deviation 16.46 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day29, n= 6,12,6,4,2 | 31.0 Units per liter (U/L) | Standard Deviation 78.95 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day85, n= 6,12,6,4,2 | 9.9 Units per liter (U/L) | Standard Deviation 9.24 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day57, n= 5,12,6,4,2 | 37.5 Units per liter (U/L) | Standard Deviation 58.31 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day211, n= 6,12,6,4,2 | 24.2 Units per liter (U/L) | Standard Deviation 42.39 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day29, n= 6,12,6,4,2 | -17.6 Units per liter (U/L) | Standard Deviation 28.46 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day29, n= 6,12,6,4,2 | 3.1 Units per liter (U/L) | Standard Deviation 8.27 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day57, n= 5,12,6,4,2 | 13.3 Units per liter (U/L) | Standard Deviation 14.55 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day211, n= 6,12,6,4,2 | 3.3 Units per liter (U/L) | Standard Deviation 28.06 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day29, n= 6,12,6,4,2 | 52.5 Units per liter (U/L) | Standard Deviation 112.14 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day57, n= 5,12,6,4,2 | 9.8 Units per liter (U/L) | Standard Deviation 25.89 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day211, n= 6,12,6,4,2 | 11.3 Units per liter (U/L) | Standard Deviation 13.61 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day29, n= 6,12,6,4,2 | 5.2 Units per liter (U/L) | Standard Deviation 14.6 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day57, n= 5,12,6,4,2 | 23.3 Units per liter (U/L) | Standard Deviation 50.25 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day29, n= 6,12,6,4,2 | 1.7 Units per liter (U/L) | Standard Deviation 41.09 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day85, n= 6,12,6,4,2 | 16.8 Units per liter (U/L) | Standard Deviation 28.51 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day57, n= 5,12,6,4,2 | -2.2 Units per liter (U/L) | Standard Deviation 8.77 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day211, n= 6,12,6,4,2 | 77.2 Units per liter (U/L) | Standard Deviation 132.59 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day211, n= 6,12,6,4,2 | 9.3 Units per liter (U/L) | Standard Deviation 8.71 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day85, n= 6,12,6,4,2 | -17.5 Units per liter (U/L) | Standard Deviation 37.56 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day85, n= 6,12,6,4,2 | 29.2 Units per liter (U/L) | Standard Deviation 35.29 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day29, n= 6,12,6,4,2 | -11.7 Units per liter (U/L) | Standard Deviation 22.27 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day211, n= 6,12,6,4,2 | -3.2 Units per liter (U/L) | Standard Deviation 12.88 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day57, n= 5,12,6,4,2 | -17.0 Units per liter (U/L) | Standard Deviation 36.3 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day29, n= 6,12,6,4,2 | -0.5 Units per liter (U/L) | Standard Deviation 3.99 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day29, n= 6,12,6,4,2 | -0.7 Units per liter (U/L) | Standard Deviation 8.12 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day211, n= 6,12,6,4,2 | 55.0 Units per liter (U/L) | Standard Deviation 54.59 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day57, n= 5,12,6,4,2 | 2.3 Units per liter (U/L) | Standard Deviation 3.33 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day85, n= 6,12,6,4,2 | 0.5 Units per liter (U/L) | Standard Deviation 9.14 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day85, n= 6,12,6,4,2 | 1.5 Units per liter (U/L) | Standard Deviation 4.46 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day29, n= 6,12,6,4,2 | -1.5 Units per liter (U/L) | Standard Deviation 15 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day85, n= 6,12,6,4,2 | 5.0 Units per liter (U/L) | Standard Deviation 49.78 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day57, n= 5,12,6,4,2 | 22.0 Units per liter (U/L) | Standard Deviation 36.74 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day211, n= 6,12,6,4,2 | 3.8 Units per liter (U/L) | Standard Deviation 3.76 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day85, n= 6,12,6,4,2 | 7.7 Units per liter (U/L) | Standard Deviation 9.89 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day29, n= 6,12,6,4,2 | -13.2 Units per liter (U/L) | Standard Deviation 29.36 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day29, n= 6,12,6,4,2 | -0.7 Units per liter (U/L) | Standard Deviation 8.91 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day57, n= 5,12,6,4,2 | -0.5 Units per liter (U/L) | Standard Deviation 24.04 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day211, n= 6,12,6,4,2 | -17.8 Units per liter (U/L) | Standard Deviation 41.06 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day57, n= 5,12,6,4,2 | 8.0 Units per liter (U/L) | Standard Deviation 11.31 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day57, n= 5,12,6,4,2 | 18.3 Units per liter (U/L) | Standard Deviation 15.84 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day57, n= 5,12,6,4,2 | 1.3 Units per liter (U/L) | Standard Deviation 9.22 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day85, n= 6,12,6,4,2 | 0.0 Units per liter (U/L) | Standard Deviation 4.24 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day29, n= 6,12,6,4,2 | 46.8 Units per liter (U/L) | Standard Deviation 35.51 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day211, n= 6,12,6,4,2 | 1.5 Units per liter (U/L) | Standard Deviation 7.85 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day29, n= 6,12,6,4,2 | 27.5 Units per liter (U/L) | Standard Deviation 23.07 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day85, n= 6,12,6,4,2 | 5.5 Units per liter (U/L) | Standard Deviation 4.51 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day211, n= 6,12,6,4,2 | 5.3 Units per liter (U/L) | Standard Deviation 3.3 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day57, n= 5,12,6,4,2 | 4.8 Units per liter (U/L) | Standard Deviation 9.25 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day29, n= 6,12,6,4,2 | -6.8 Units per liter (U/L) | Standard Deviation 19.21 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day57, n= 5,12,6,4,2 | 57.0 Units per liter (U/L) | Standard Deviation 142.54 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day211, n= 6,12,6,4,2 | 25.3 Units per liter (U/L) | Standard Deviation 13.6 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day85, n= 6,12,6,4,2 | 178.8 Units per liter (U/L) | Standard Deviation 359.38 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day211, n= 6,12,6,4,2 | 53.8 Units per liter (U/L) | Standard Deviation 50.68 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day29, n= 6,12,6,4,2 | 5.3 Units per liter (U/L) | Standard Deviation 6.7 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day85, n= 6,12,6,4,2 | 3.8 Units per liter (U/L) | Standard Deviation 17.19 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day57, n= 5,12,6,4,2 | 9.0 Units per liter (U/L) | Standard Deviation 3.74 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day85, n= 6,12,6,4,2 | 5.3 Units per liter (U/L) | Standard Deviation 3.1 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day29, n= 6,12,6,4,2 | 45.3 Units per liter (U/L) | Standard Deviation 32.1 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day211, n= 6,12,6,4,2 | 4.3 Units per liter (U/L) | Standard Deviation 2.22 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day57, n= 5,12,6,4,2 | 46.0 Units per liter (U/L) | Standard Deviation 42.31 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day85, n= 6,12,6,4,2 | 7.5 Units per liter (U/L) | Standard Deviation 13.18 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day211, n= 6,12,6,4,2 | 6.5 Units per liter (U/L) | Standard Deviation 9.95 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day29, n= 6,12,6,4,2 | 9.8 Units per liter (U/L) | Standard Deviation 11.95 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day85, n= 6,12,6,4,2 | 26.5 Units per liter (U/L) | Standard Deviation 31.82 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day57, n= 5,12,6,4,2 | 111.0 Units per liter (U/L) | Standard Deviation 148.49 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day57, n= 5,12,6,4,2 | 11.0 Units per liter (U/L) | Standard Deviation 11.31 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day29, n= 6,12,6,4,2 | 49.0 Units per liter (U/L) | Standard Deviation 62.23 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day211, n= 6,12,6,4,2 | 5.0 Units per liter (U/L) | Standard Deviation 11.31 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day29, n= 6,12,6,4,2 | -0.5 Units per liter (U/L) | Standard Deviation 3.54 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day57, n= 5,12,6,4,2 | 4.0 Units per liter (U/L) | Standard Deviation 5.66 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day211, n= 6,12,6,4,2 | 4.5 Units per liter (U/L) | Standard Deviation 2.12 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day85, n= 6,12,6,4,2 | 3.0 Units per liter (U/L) | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day211, n= 6,12,6,4,2 | 5.5 Units per liter (U/L) | Standard Deviation 3.54 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day57, n= 5,12,6,4,2 | 1.0 Units per liter (U/L) | Standard Deviation 3.54 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day211, n= 6,12,6,4,2 | 2.0 Units per liter (U/L) | Standard Deviation 1.41 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day57, n= 5,12,6,4,2 | 4.5 Units per liter (U/L) | Standard Deviation 2.12 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day29, n= 6,12,6,4,2 | 0.0 Units per liter (U/L) | Standard Deviation 0.9 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALP, Day85, n= 6,12,6,4,2 | 6.0 Units per liter (U/L) | Standard Deviation 4.24 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | ALT, Day85, n= 6,12,6,4,2 | -0.5 Units per liter (U/L) | Standard Deviation 0.71 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | AST, Day29, n= 6,12,6,4,2 | 2.0 Units per liter (U/L) | Standard Deviation 1.41 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day57, n= 5,12,6,4,2 | 2.0 Units per liter (U/L) | Standard Deviation 2.83 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day85, n= 6,12,6,4,2 | 6.0 Units per liter (U/L) | Standard Deviation 8.49 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day29, n= 6,12,6,4,2 | -2.5 Units per liter (U/L) | Standard Deviation 2.12 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | CK, Day211, n= 6,12,6,4,2 | 94.0 Units per liter (U/L) | Standard Deviation 114.55 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day29, n= 6,12,6,4,2 | 12.5 Units per liter (U/L) | Standard Deviation 0.71 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | GGT, Day85, n= 6,12,6,4,2 | 1.0 Units per liter (U/L) | Standard Deviation 2.83 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | LDH, Day211, n= 6,12,6,4,2 | 24.0 Units per liter (U/L) | Standard Deviation 22.63 |
Primary
Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time
Blood samples were collected for the analysis of clinical chemistry parameter-albumin and total protein. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day57, n= 5,12,6,4,2 | 0.6 Grams per liter | Standard Deviation 1.67 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day211, n= 6,12,6,4,2 | 1.0 Grams per liter | Standard Deviation 2.28 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day211, n= 6,12,6,4,2 | 2.5 Grams per liter | Standard Deviation 4.81 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day57, n= 5,12,6,4,2 | 0.8 Grams per liter | Standard Deviation 3.49 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day29, n= 6,12,6,4,2 | -1.8 Grams per liter | Standard Deviation 2.64 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day85, n= 6,12,6,4,2 | 0.0 Grams per liter | Standard Deviation 2 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day29, n= 6,12,6,4,2 | -0.8 Grams per liter | Standard Deviation 1.47 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day85, n= 6,12,6,4,2 | 0.8 Grams per liter | Standard Deviation 3.54 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day211, n= 6,12,6,4,2 | 5.1 Grams per liter | Standard Deviation 4.23 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day211, n= 6,12,6,4,2 | 3.3 Grams per liter | Standard Deviation 2.26 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day85, n= 6,12,6,4,2 | 3.3 Grams per liter | Standard Deviation 5.03 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day57, n= 5,12,6,4,2 | 3.8 Grams per liter | Standard Deviation 4.27 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day57, n= 5,12,6,4,2 | 1.7 Grams per liter | Standard Deviation 2.57 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day29, n= 6,12,6,4,2 | 0.3 Grams per liter | Standard Deviation 2.23 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day85, n= 6,12,6,4,2 | 2.0 Grams per liter | Standard Deviation 3.28 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day29, n= 6,12,6,4,2 | 1.9 Grams per liter | Standard Deviation 3.18 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day85, n= 6,12,6,4,2 | 0.3 Grams per liter | Standard Deviation 4.97 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day211, n= 6,12,6,4,2 | 1.7 Grams per liter | Standard Deviation 3.33 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day57, n= 5,12,6,4,2 | 0.2 Grams per liter | Standard Deviation 3.25 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day57, n= 5,12,6,4,2 | 0.0 Grams per liter | Standard Deviation 1.55 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day85, n= 6,12,6,4,2 | -0.8 Grams per liter | Standard Deviation 3.19 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day211, n= 6,12,6,4,2 | 0.7 Grams per liter | Standard Deviation 3.01 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day29, n= 6,12,6,4,2 | -1.8 Grams per liter | Standard Deviation 4.75 |
| Cohorts 1-3 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day29, n= 6,12,6,4,2 | -1.3 Grams per liter | Standard Deviation 1.51 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day29, n= 6,12,6,4,2 | 3.0 Grams per liter | Standard Deviation 2.16 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day29, n= 6,12,6,4,2 | 6.5 Grams per liter | Standard Deviation 3.11 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day57, n= 5,12,6,4,2 | 3.0 Grams per liter | Standard Deviation 1.41 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day57, n= 5,12,6,4,2 | 1.8 Grams per liter | Standard Deviation 1.5 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day211, n= 6,12,6,4,2 | 8.0 Grams per liter | Standard Deviation 2.71 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day85, n= 6,12,6,4,2 | 3.5 Grams per liter | Standard Deviation 3.42 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day211, n= 6,12,6,4,2 | 4.3 Grams per liter | Standard Deviation 0.5 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day85, n= 6,12,6,4,2 | 1.3 Grams per liter | Standard Deviation 2.22 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day211, n= 6,12,6,4,2 | 4.5 Grams per liter | Standard Deviation 12.02 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day29, n= 6,12,6,4,2 | 1.5 Grams per liter | Standard Deviation 3.54 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day57, n= 5,12,6,4,2 | 5.5 Grams per liter | Standard Deviation 0.71 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day85, n= 6,12,6,4,2 | 3.0 Grams per liter | Standard Deviation 2.83 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day29, n= 6,12,6,4,2 | 1.5 Grams per liter | Standard Deviation 7.78 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day57, n= 5,12,6,4,2 | 6.0 Grams per liter | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Total Protein, Day85, n= 6,12,6,4,2 | 4.5 Grams per liter | Standard Deviation 2.12 |
| Cohort 4 Placebo | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Albumin, Day211, n= 6,12,6,4,2 | 3.0 Grams per liter | Standard Deviation 5.66 |
Primary
Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) was measured at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 85 | 2.2 Millimeters of Mercury (mmHg) | Standard Deviation 6.71 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 211 | 6.8 Millimeters of Mercury (mmHg) | Standard Deviation 6.37 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 85 | 3.0 Millimeters of Mercury (mmHg) | Standard Deviation 12.44 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 211 | 10.0 Millimeters of Mercury (mmHg) | Standard Deviation 13.49 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 29 | -4.0 Millimeters of Mercury (mmHg) | Standard Deviation 8.65 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 29 | -6.3 Millimeters of Mercury (mmHg) | Standard Deviation 13.76 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 57 | 1.0 Millimeters of Mercury (mmHg) | Standard Deviation 8.2 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 57 | 3.7 Millimeters of Mercury (mmHg) | Standard Deviation 11.33 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 57 | -0.2 Millimeters of Mercury (mmHg) | Standard Deviation 9.92 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 211 | -3.6 Millimeters of Mercury (mmHg) | Standard Deviation 15.21 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 29 | -8.8 Millimeters of Mercury (mmHg) | Standard Deviation 12.05 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 85 | 0.1 Millimeters of Mercury (mmHg) | Standard Deviation 12.43 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 85 | -5.4 Millimeters of Mercury (mmHg) | Standard Deviation 13.45 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 57 | -3.4 Millimeters of Mercury (mmHg) | Standard Deviation 13.98 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 29 | -2.2 Millimeters of Mercury (mmHg) | Standard Deviation 7.77 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 211 | 0.8 Millimeters of Mercury (mmHg) | Standard Deviation 9.88 |
| Cohorts 1-3 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 29 | -6.0 Millimeters of Mercury (mmHg) | Standard Deviation 5.73 |
| Cohorts 1-3 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 85 | -3.7 Millimeters of Mercury (mmHg) | Standard Deviation 6.65 |
| Cohorts 1-3 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 211 | -3.8 Millimeters of Mercury (mmHg) | Standard Deviation 9.56 |
| Cohorts 1-3 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 29 | -9.2 Millimeters of Mercury (mmHg) | Standard Deviation 10.11 |
| Cohorts 1-3 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 57 | -13.2 Millimeters of Mercury (mmHg) | Standard Deviation 5.31 |
| Cohorts 1-3 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 211 | -10.2 Millimeters of Mercury (mmHg) | Standard Deviation 5.19 |
| Cohorts 1-3 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 57 | -3.0 Millimeters of Mercury (mmHg) | Standard Deviation 11.06 |
| Cohorts 1-3 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 85 | -13.7 Millimeters of Mercury (mmHg) | Standard Deviation 7.99 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 57 | 0.0 Millimeters of Mercury (mmHg) | Standard Deviation 9.38 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 57 | 7.8 Millimeters of Mercury (mmHg) | Standard Deviation 7.93 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 85 | 4.3 Millimeters of Mercury (mmHg) | Standard Deviation 8.58 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 211 | 7.3 Millimeters of Mercury (mmHg) | Standard Deviation 10.21 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 29 | -3.0 Millimeters of Mercury (mmHg) | Standard Deviation 6.63 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 29 | -5.0 Millimeters of Mercury (mmHg) | Standard Deviation 7.26 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 85 | -1.8 Millimeters of Mercury (mmHg) | Standard Deviation 6.08 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 211 | 4.3 Millimeters of Mercury (mmHg) | Standard Deviation 6.95 |
| Cohort 4 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 211 | 8.0 Millimeters of Mercury (mmHg) | Standard Deviation 8.49 |
| Cohort 4 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 29 | 0.5 Millimeters of Mercury (mmHg) | Standard Deviation 9.19 |
| Cohort 4 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 57 | -2.0 Millimeters of Mercury (mmHg) | Standard Deviation 5.66 |
| Cohort 4 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 85 | 6.5 Millimeters of Mercury (mmHg) | Standard Deviation 13.44 |
| Cohort 4 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | SBP, Day 211 | 5.0 Millimeters of Mercury (mmHg) | Standard Deviation 9.9 |
| Cohort 4 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 29 | -0.5 Millimeters of Mercury (mmHg) | Standard Deviation 9.19 |
| Cohort 4 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 57 | 3.0 Millimeters of Mercury (mmHg) | Standard Deviation 4.24 |
| Cohort 4 Placebo | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | DBP, Day 85 | 4.5 Millimeters of Mercury (mmHg) | Standard Deviation 14.85 |
Primary
Change From Baseline in Electrocardiogram Mean Ventricular Rate
Triplicate 12-lead Electrocardiograms (ECGs) were recorded at indicated timepoints. At each time point, ECG machine automatically measured mean ventricular rate (VR). Baseline ECG was the average of the triplicate taken on Day 1 Pre-dose, if only 1 or 2 assessments were available, the single assessment or average of the 2 assessments was used. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose); Day1: 3 hours post-dose, 5 hours post-dose; Day 2; Day 22:pre-dose, 3 hours postdose, 5 hours post-dose; Days 23, 29 and 113
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day1, 3 hours Post-dose, n=6,12,6,5,2 | 4.3 Beats per minute | Standard Deviation 5.05 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | -1.4 Beats per minute | Standard Deviation 7.37 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | -1.8 Beats per minute | Standard Deviation 10.47 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 113, n=6,12,6,4,2 | -5.2 Beats per minute | Standard Deviation 9.75 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day1, 5 hours Post-dose, n=6,12,6,5,2 | 1.8 Beats per minute | Standard Deviation 6.52 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 29, n=6,12,6,4,2 | -1.3 Beats per minute | Standard Deviation 11.6 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 2, n=6,12,6,5,2 | -2.7 Beats per minute | Standard Deviation 10.27 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 23, n=5,12,6,4,2 | -2.4 Beats per minute | Standard Deviation 8.26 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, Pre-dose, n=5,12,6,4,2 | -3.6 Beats per minute | Standard Deviation 5.46 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, Pre-dose, n=5,12,6,4,2 | 0.4 Beats per minute | Standard Deviation 8.54 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | 3.4 Beats per minute | Standard Deviation 6.27 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 113, n=6,12,6,4,2 | 2.5 Beats per minute | Standard Deviation 10.6 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | 5.0 Beats per minute | Standard Deviation 7.24 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day1, 3 hours Post-dose, n=6,12,6,5,2 | 5.6 Beats per minute | Standard Deviation 8.85 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 2, n=6,12,6,5,2 | 10.1 Beats per minute | Standard Deviation 12.93 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day1, 5 hours Post-dose, n=6,12,6,5,2 | 2.0 Beats per minute | Standard Deviation 7.93 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 23, n=5,12,6,4,2 | 6.3 Beats per minute | Standard Deviation 3.65 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 29, n=6,12,6,4,2 | 2.8 Beats per minute | Standard Deviation 7.63 |
| Cohorts 1-3 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | -0.7 Beats per minute | Standard Deviation 5.82 |
| Cohorts 1-3 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day1, 5 hours Post-dose, n=6,12,6,5,2 | 4.7 Beats per minute | Standard Deviation 6.22 |
| Cohorts 1-3 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day1, 3 hours Post-dose, n=6,12,6,5,2 | 4.5 Beats per minute | Standard Deviation 4.93 |
| Cohorts 1-3 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 2, n=6,12,6,5,2 | 0.3 Beats per minute | Standard Deviation 2.66 |
| Cohorts 1-3 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, Pre-dose, n=5,12,6,4,2 | 1.0 Beats per minute | Standard Deviation 6.54 |
| Cohorts 1-3 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | 3.7 Beats per minute | Standard Deviation 5.47 |
| Cohorts 1-3 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 23, n=5,12,6,4,2 | 1.3 Beats per minute | Standard Deviation 4.76 |
| Cohorts 1-3 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 29, n=6,12,6,4,2 | 0.2 Beats per minute | Standard Deviation 4.45 |
| Cohorts 1-3 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 113, n=6,12,6,4,2 | -2.3 Beats per minute | Standard Deviation 6.06 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, Pre-dose, n=5,12,6,4,2 | 0.8 Beats per minute | Standard Deviation 4.86 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | 8.0 Beats per minute | Standard Deviation 6.22 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 2, n=6,12,6,5,2 | 22.8 Beats per minute | Standard Deviation 9.15 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 23, n=5,12,6,4,2 | 10.3 Beats per minute | Standard Deviation 4.92 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day1, 5 hours Post-dose, n=6,12,6,5,2 | 12.6 Beats per minute | Standard Deviation 6.88 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 113, n=6,12,6,4,2 | 8.3 Beats per minute | Standard Deviation 2.06 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 29, n=6,12,6,4,2 | 7.3 Beats per minute | Standard Deviation 6.13 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day1, 3 hours Post-dose, n=6,12,6,5,2 | 8.2 Beats per minute | Standard Deviation 4.6 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | 9.3 Beats per minute | Standard Deviation 4.92 |
| Cohort 4 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day1, 3 hours Post-dose, n=6,12,6,5,2 | 10.0 Beats per minute | Standard Deviation 2.83 |
| Cohort 4 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, Pre-dose, n=5,12,6,4,2 | -1.0 Beats per minute | Standard Deviation 5.66 |
| Cohort 4 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | 8.0 Beats per minute | Standard Deviation 2.83 |
| Cohort 4 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 2, n=6,12,6,5,2 | 5.5 Beats per minute | Standard Deviation 7.78 |
| Cohort 4 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | 8.5 Beats per minute | Standard Deviation 2.12 |
| Cohort 4 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 113, n=6,12,6,4,2 | 8.0 Beats per minute | Standard Deviation 9.9 |
| Cohort 4 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 29, n=6,12,6,4,2 | 3.5 Beats per minute | Standard Deviation 7.78 |
| Cohort 4 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day 23, n=5,12,6,4,2 | 0.0 Beats per minute | Standard Deviation 4.24 |
| Cohort 4 Placebo | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Mean VR, Day1, 5 hours Post-dose, n=6,12,6,5,2 | 8.0 Beats per minute | Standard Deviation 9.9 |
Primary
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula
Triplicate 12-lead Electrocardiograms (ECGs) were recorded at indicated timepoints. At each time point, ECG machine automatically measured QRS duration, uncorrected QT interval, QT corrected interval-Fredericia \[QTcF\] interval and QTc corrected by Bazett's formula (QTcB). Baseline ECG was the average of the triplicate taken on Day 1 Pre-dose, if only 1 or 2 assessments were available, the single assessment or average of the 2 assessments was used. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose); Day1: 3 hours post-dose, 5 hours post-dose; Day 2; Day 22:pre-dose, 3 hours postdose, 5 hours post-dose; Days 23, 29 and 113
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 23, n=5,12,6,4,2 | -0.4 Milliseconds | Standard Deviation 5.37 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day1, 5 hours Post-dose,n=6,12,6,5,2 | -0.8 Milliseconds | Standard Deviation 2.04 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 1, 5 hours Post-dose, n=6,12,6,5,2 | -11.3 Milliseconds | Standard Deviation 19.41 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 2, n=6,12,6,5,2 | 0.5 Milliseconds | Standard Deviation 3.94 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 23, n=4,8,4,4,2 | -0.8 Milliseconds | Standard Deviation 8.38 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 1, 3 hours Post-dose, n=6,12,6,5,2 | -11.8 Milliseconds | Standard Deviation 14.85 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, Pre-dose, n=5,12,6,4,2 | 0.2 Milliseconds | Standard Deviation 3.11 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 1,3 hours Post-dose, n=6,11,6,5,2 | -1.2 Milliseconds | Standard Deviation 8.42 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 113, n=6,12,6,4,2 | 0.3 Milliseconds | Standard Deviation 5.72 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | 1.6 Milliseconds | Standard Deviation 3.51 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 29, n=6,12,6,4,2 | 0.3 Milliseconds | Standard Deviation 4.18 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | 1.0 Milliseconds | Standard Deviation 5.15 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 2, n=6,12,6,5,2 | -0.3 Milliseconds | Standard Deviation 29.34 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 113, n=1,5,3,0,0 | 5.0 Milliseconds | — |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 29, n=5,8,4,4,2 | 4.0 Milliseconds | Standard Deviation 22.55 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 29, n=1,4,2,0,0 | 21.0 Milliseconds | — |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 113, n=6,12,6,4,2 | 7.7 Milliseconds | Standard Deviation 8.82 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 23, n=1,3,2,0,0 | 14.0 Milliseconds | — |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, 3 hours Post-dose, n=4,9,4,4,2 | 0.8 Milliseconds | Standard Deviation 10.08 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 22, 5 hours Post-dose, n=1,3,2,0,0 | 11.0 Milliseconds | — |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, 5 hours Post-dose, n=4,9,4,5,2 | -5.0 Milliseconds | Standard Deviation 7.66 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 22, 3 hours Post-dose, n=1,3,2,0,0 | 16.0 Milliseconds | — |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 113, n=5,6,3,4,2 | -1.08 Milliseconds | Standard Deviation 20.24 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 22, Pre-dose, n=1,3,2,0,0 | 27.0 Milliseconds | — |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 2, n=4,8,4,5,2 | -8.6 Milliseconds | Standard Deviation 13.5 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 2, n=1,3,2,0,0 | -3.0 Milliseconds | — |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 1, 5 hours Post-dose, n=6,11,6,5,2 | -1.7 Milliseconds | Standard Deviation 8.64 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 1, 5 hours Post-dose, n=1,3,2,0,0 | -9.0 Milliseconds | — |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 2, n=6,12,6,5,2 | 1.0 Milliseconds | Standard Deviation 4.65 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 1,3 hours Post-dose, n=1,3,2,0,0 | 5.0 Milliseconds | — |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, Pre-dose, n=5,12,6,4,2 | 7.0 Milliseconds | Standard Deviation 14.27 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 1,5 hours Post-dose, n=5,9,4,5,2 | -9.6 Milliseconds | Standard Deviation 10.67 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 113, n=6,12,6,4,2 | 13.7 Milliseconds | Standard Deviation 30.59 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | 2.0 Milliseconds | Standard Deviation 7.21 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 29, n=6,12,6,4,2 | 9.0 Milliseconds | Standard Deviation 31.92 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, 5 hours Post-dose, n=5,11,6,4,2 | -0.2 Milliseconds | Standard Deviation 10.03 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 23, n=5,12,6,4,2 | 8.0 Milliseconds | Standard Deviation 23.63 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 23, n=5,11,6,4,2 | 9.4 Milliseconds | Standard Deviation 12.03 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | 5.8 Milliseconds | Standard Deviation 29.71 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 29, n=6,12,6,4,2 | 4.8 Milliseconds | Standard Deviation 7.28 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 1,3 hours Post-dose, n=5,9,4,5,2 | -6.0 Milliseconds | Standard Deviation 6.28 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | 11.2 Milliseconds | Standard Deviation 30.6 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, Pre-dose, n=5,9,4,4,2 | -1.0 Milliseconds | Standard Deviation 2.94 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, Pre-dose, n=5,12,6,4,2 | 15.2 Milliseconds | Standard Deviation 12.91 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day1, 3 hours Post-dose,n=6,12,6,5,2 | 0.8 Milliseconds | Standard Deviation 3.97 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 113, n=5,6,3,4,2 | -1.0 Milliseconds | Standard Deviation 14.09 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 1, 5 hours Post-dose, n=6,12,6,5,2 | -10.3 Milliseconds | Standard Deviation 18.25 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 29, n=6,12,6,4,2 | -5.4 Milliseconds | Standard Deviation 20.97 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 113, n=1,5,3,0,0 | -1.8 Milliseconds | Standard Deviation 3.27 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 1,3 hours Post-dose, n=6,11,6,5,2 | 1.8 Milliseconds | Standard Deviation 9.99 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 1, 3 hours Post-dose, n=6,12,6,5,2 | -12.4 Milliseconds | Standard Deviation 17.3 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | -8.7 Milliseconds | Standard Deviation 21.05 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 2, n=6,12,6,5,2 | 0.8 Milliseconds | Standard Deviation 3.98 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 2, n=1,3,2,0,0 | 4.3 Milliseconds | Standard Deviation 7.57 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day1, 5 hours Post-dose,n=6,12,6,5,2 | -1.7 Milliseconds | Standard Deviation 4.38 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 113, n=6,12,6,4,2 | 0.0 Milliseconds | Standard Deviation 4.9 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, 5 hours Post-dose, n=5,11,6,4,2 | -2.3 Milliseconds | Standard Deviation 14.18 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, Pre-dose, n=5,12,6,4,2 | -3.6 Milliseconds | Standard Deviation 5.07 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 1, 5 hours Post-dose, n=6,11,6,5,2 | 1.3 Milliseconds | Standard Deviation 8.37 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | -8.0 Milliseconds | Standard Deviation 18.68 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 29, n=6,12,6,4,2 | 0.7 Milliseconds | Standard Deviation 4.91 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 1, 5 hours Post-dose, n=1,3,2,0,0 | -1.3 Milliseconds | Standard Deviation 11.02 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 113, n=6,12,6,4,2 | -1.6 Milliseconds | Standard Deviation 14.48 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 23, n=5,12,6,4,2 | 0.9 Milliseconds | Standard Deviation 3.09 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 23, n=5,12,6,4,2 | -13.9 Milliseconds | Standard Deviation 13.81 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | -1.0 Milliseconds | Standard Deviation 3.86 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 23, n=4,8,4,4,2 | -3.3 Milliseconds | Standard Deviation 9.82 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 2, n=6,12,6,5,2 | 0.7 Milliseconds | Standard Deviation 15.78 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | -1.2 Milliseconds | Standard Deviation 4.11 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 1,5 hours Post-dose, n=5,9,4,5,2 | -8.9 Milliseconds | Standard Deviation 8.49 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 29, n=1,4,2,0,0 | 3.0 Milliseconds | Standard Deviation 8.98 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 1,3 hours Post-dose, n=1,3,2,0,0 | 3.3 Milliseconds | Standard Deviation 3.06 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 29, n=5,8,4,4,2 | -0.1 Milliseconds | Standard Deviation 9.6 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 29, n=6,12,6,4,2 | -1.7 Milliseconds | Standard Deviation 11.67 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, Pre-dose, n=5,9,4,4,2 | 0.7 Milliseconds | Standard Deviation 12.19 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day1, 3 hours Post-dose,n=6,12,6,5,2 | -0.2 Milliseconds | Standard Deviation 5.08 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 2, n=6,12,6,5,2 | -25.5 Milliseconds | Standard Deviation 29.57 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 23, n=1,3,2,0,0 | 7.3 Milliseconds | Standard Deviation 8.62 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, Pre-dose, n=5,12,6,4,2 | -2.4 Milliseconds | Standard Deviation 11.7 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 23, n=5,11,6,4,2 | -1.6 Milliseconds | Standard Deviation 11.09 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, 3 hours Post-dose, n=4,9,4,4,2 | -1.0 Milliseconds | Standard Deviation 11.1 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 2, n=4,8,4,5,2 | -12.5 Milliseconds | Standard Deviation 9.01 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 22, 5 hours Post-dose, n=1,3,2,0,0 | 3.7 Milliseconds | Standard Deviation 2.31 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 113, n=6,12,6,4,2 | -15.4 Milliseconds | Standard Deviation 49.82 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 1,3 hours Post-dose, n=5,9,4,5,2 | -1.9 Milliseconds | Standard Deviation 8.16 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, 5 hours Post-dose, n=4,9,4,5,2 | -3.6 Milliseconds | Standard Deviation 12.97 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 22, 3 hours Post-dose, n=1,3,2,0,0 | 18.7 Milliseconds | Standard Deviation 16.77 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, Pre-dose, n=5,12,6,4,2 | 1.9 Milliseconds | Standard Deviation 17.05 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 22, Pre-dose, n=1,3,2,0,0 | 7.3 Milliseconds | Standard Deviation 6.43 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | 0.3 Milliseconds | Standard Deviation 14.51 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, Pre-dose, n=5,12,6,4,2 | 4.2 Milliseconds | Standard Deviation 3.19 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | 9.2 Milliseconds | Standard Deviation 21.51 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | 5.0 Milliseconds | Standard Deviation 6.99 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 1, 3 hours Post-dose, n=6,12,6,5,2 | -5.7 Milliseconds | Standard Deviation 8.21 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 2, n=4,8,4,5,2 | -1.0 Milliseconds | Standard Deviation 4.69 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, 5 hours Post-dose, n=4,9,4,5,2 | 5.8 Milliseconds | Standard Deviation 9.95 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 23, n=4,8,4,4,2 | -0.5 Milliseconds | Standard Deviation 7.05 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 29, n=5,8,4,4,2 | 3.0 Milliseconds | Standard Deviation 8.98 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 113, n=5,6,3,4,2 | 4.0 Milliseconds | Standard Deviation 12.29 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, Pre-dose, n=5,9,4,4,2 | 8.8 Milliseconds | Standard Deviation 8.88 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, 3 hours Post-dose, n=4,9,4,4,2 | 9.5 Milliseconds | Standard Deviation 10.47 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 1,3 hours Post-dose, n=6,11,6,5,2 | 3.5 Milliseconds | Standard Deviation 30.84 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 1, 5 hours Post-dose, n=6,11,6,5,2 | 10.8 Milliseconds | Standard Deviation 33.52 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 2, n=6,12,6,5,2 | 12.2 Milliseconds | Standard Deviation 21.45 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, Pre-dose, n=5,12,6,4,2 | 11.0 Milliseconds | Standard Deviation 19.84 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, 5 hours Post-dose, n=5,11,6,4,2 | 9.0 Milliseconds | Standard Deviation 22.82 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 23, n=5,11,6,4,2 | 11.2 Milliseconds | Standard Deviation 21.77 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 29, n=6,12,6,4,2 | 7.3 Milliseconds | Standard Deviation 17.64 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 113, n=6,12,6,4,2 | 14.3 Milliseconds | Standard Deviation 21.81 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day1, 3 hours Post-dose,n=6,12,6,5,2 | 2.2 Milliseconds | Standard Deviation 4.31 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day1, 5 hours Post-dose,n=6,12,6,5,2 | 6.0 Milliseconds | Standard Deviation 4.98 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 2, n=6,12,6,5,2 | 3.7 Milliseconds | Standard Deviation 8.07 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | 6.3 Milliseconds | Standard Deviation 5.28 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 23, n=5,12,6,4,2 | 0.3 Milliseconds | Standard Deviation 7 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 29, n=6,12,6,4,2 | 5.5 Milliseconds | Standard Deviation 7.5 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 113, n=6,12,6,4,2 | 4.7 Milliseconds | Standard Deviation 8.09 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 1, 5 hours Post-dose, n=6,12,6,5,2 | -7.3 Milliseconds | Standard Deviation 12.8 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 2, n=6,12,6,5,2 | 0.3 Milliseconds | Standard Deviation 6.41 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, Pre-dose, n=5,12,6,4,2 | 2.0 Milliseconds | Standard Deviation 19.65 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | -3.0 Milliseconds | Standard Deviation 17.31 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | 2.5 Milliseconds | Standard Deviation 16.31 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 23, n=5,12,6,4,2 | -5.2 Milliseconds | Standard Deviation 16.74 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 29, n=6,12,6,4,2 | 2.5 Milliseconds | Standard Deviation 15.45 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 113, n=6,12,6,4,2 | 4.2 Milliseconds | Standard Deviation 17.95 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 1,3 hours Post-dose, n=1,3,2,0,0 | 3.0 Milliseconds | Standard Deviation 1.41 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 1, 5 hours Post-dose, n=1,3,2,0,0 | 4.5 Milliseconds | Standard Deviation 0.71 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 2, n=1,3,2,0,0 | 2.5 Milliseconds | Standard Deviation 0.71 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 22, Pre-dose, n=1,3,2,0,0 | -0.5 Milliseconds | Standard Deviation 7.78 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 22, 3 hours Post-dose, n=1,3,2,0,0 | -2.0 Milliseconds | Standard Deviation 2.83 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 22, 5 hours Post-dose, n=1,3,2,0,0 | -14.5 Milliseconds | Standard Deviation 6.36 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 23, n=1,3,2,0,0 | -3.5 Milliseconds | Standard Deviation 7.78 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 29, n=1,4,2,0,0 | 6.5 Milliseconds | Standard Deviation 6.36 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcB, Day 113, n=1,5,3,0,0 | -13.0 Milliseconds | Standard Deviation 8.54 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 1,3 hours Post-dose, n=5,9,4,5,2 | 3.5 Milliseconds | Standard Deviation 7.05 |
| Cohorts 1-3 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 1,5 hours Post-dose, n=5,9,4,5,2 | 1.3 Milliseconds | Standard Deviation 5.32 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, Pre-dose, n=5,12,6,4,2 | -1.0 Milliseconds | Standard Deviation 12.68 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 29, n=6,12,6,4,2 | -1.8 Milliseconds | Standard Deviation 4.72 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 1, 5 hours Post-dose, n=6,11,6,5,2 | 1.4 Milliseconds | Standard Deviation 8.38 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 2, n=4,8,4,5,2 | -44.6 Milliseconds | Standard Deviation 65.5 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, 5 hours Post-dose, n=5,11,6,4,2 | -7.0 Milliseconds | Standard Deviation 9.42 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 1,3 hours Post-dose, n=6,11,6,5,2 | 0.8 Milliseconds | Standard Deviation 8.41 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 2, n=6,12,6,5,2 | -62.8 Milliseconds | Standard Deviation 19.38 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 113, n=5,6,3,4,2 | -6.5 Milliseconds | Standard Deviation 10.75 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 23, n=4,8,4,4,2 | -5.0 Milliseconds | Standard Deviation 9.2 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 23, n=5,12,6,4,2 | -30.5 Milliseconds | Standard Deviation 18.81 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 29, n=5,8,4,4,2 | -5.5 Milliseconds | Standard Deviation 10.08 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 1,5 hours Post-dose, n=5,9,4,5,2 | -9.0 Milliseconds | Standard Deviation 13.84 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 1,3 hours Post-dose, n=5,9,4,5,2 | -3.8 Milliseconds | Standard Deviation 13.88 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 113, n=6,12,6,4,2 | -2.0 Milliseconds | Standard Deviation 8.83 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | -6.5 Milliseconds | Standard Deviation 11.79 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | -0.3 Milliseconds | Standard Deviation 5.12 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, 5 hours Post-dose, n=4,9,4,5,2 | -5.8 Milliseconds | Standard Deviation 12.55 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, 3 hours Post-dose, n=4,9,4,4,2 | -4.5 Milliseconds | Standard Deviation 13.48 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 23, n=5,12,6,4,2 | -0.5 Milliseconds | Standard Deviation 4.12 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 29, n=6,12,6,4,2 | -23.0 Milliseconds | Standard Deviation 16.02 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | 2.5 Milliseconds | Standard Deviation 1.91 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | -27.3 Milliseconds | Standard Deviation 22.47 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 113, n=6,12,6,4,2 | -2.8 Milliseconds | Standard Deviation 5.19 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 29, n=6,12,6,4,2 | 3.0 Milliseconds | Standard Deviation 6.98 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day1, 3 hours Post-dose,n=6,12,6,5,2 | 1.0 Milliseconds | Standard Deviation 2 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, Pre-dose, n=5,12,6,4,2 | -0.8 Milliseconds | Standard Deviation 4.79 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, Pre-dose, n=5,12,6,4,2 | -2.8 Milliseconds | Standard Deviation 10.87 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 23, n=5,11,6,4,2 | -1.0 Milliseconds | Standard Deviation 7.79 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 113, n=6,12,6,4,2 | -28.3 Milliseconds | Standard Deviation 13.33 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 2, n=6,12,6,5,2 | -2.2 Milliseconds | Standard Deviation 4.87 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 1, 5 hours Post-dose, n=6,12,6,5,2 | -37.6 Milliseconds | Standard Deviation 19.89 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 1, 3 hours Post-dose, n=6,12,6,5,2 | -23.8 Milliseconds | Standard Deviation 9.55 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | -25.3 Milliseconds | Standard Deviation 23.73 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 2, n=6,12,6,5,2 | -2.4 Milliseconds | Standard Deviation 8.79 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day1, 5 hours Post-dose,n=6,12,6,5,2 | 0.4 Milliseconds | Standard Deviation 1.95 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, Pre-dose, n=5,9,4,4,2 | 1.3 Milliseconds | Standard Deviation 3.77 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day1, 3 hours Post-dose,n=6,12,6,5,2 | -1.5 Milliseconds | Standard Deviation 3.54 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 1, 5 hours Post-dose, n=6,12,6,5,2 | -21.0 Milliseconds | Standard Deviation 11.31 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 113, n=6,12,6,4,2 | 6.0 Milliseconds | Standard Deviation 7.07 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 29, n=6,12,6,4,2 | 10.0 Milliseconds | Standard Deviation 4.24 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 113, n=5,6,3,4,2 | -7.0 Milliseconds | Standard Deviation 5.66 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 23, n=5,11,6,4,2 | 4.5 Milliseconds | Standard Deviation 3.54 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 23, n=4,8,4,4,2 | -10.0 Milliseconds | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | -16.0 Milliseconds | Standard Deviation 12.73 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 1,5 hours Post-dose, n=5,9,4,5,2 | -7.5 Milliseconds | Standard Deviation 6.36 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | -17.5 Milliseconds | Standard Deviation 9.19 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, 5 hours Post-dose, n=5,11,6,4,2 | 5.5 Milliseconds | Standard Deviation 4.95 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 23, n=5,12,6,4,2 | -8.5 Milliseconds | Standard Deviation 6.36 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | 7.5 Milliseconds | Standard Deviation 6.36 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 29, n=6,12,6,4,2 | -4.0 Milliseconds | Standard Deviation 31.11 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 22, Pre-dose, n=5,12,6,4,2 | 8.0 Milliseconds | Standard Deviation 7.07 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 22, Pre-dose, n=5,12,6,4,2 | 3.0 Milliseconds | Standard Deviation 11.31 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 113, n=6,12,6,4,2 | -20.0 Milliseconds | Standard Deviation 22.63 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 2, n=6,12,6,5,2 | 5.5 Milliseconds | Standard Deviation 2.12 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 2, n=4,8,4,5,2 | -11.0 Milliseconds | Standard Deviation 5.66 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 1, 5 hours Post-dose, n=6,11,6,5,2 | -3.0 Milliseconds | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | PR, Day 1,3 hours Post-dose, n=6,11,6,5,2 | 7.0 Milliseconds | Standard Deviation 1.41 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 29, n=5,8,4,4,2 | -4.5 Milliseconds | Standard Deviation 10.61 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 1,3 hours Post-dose, n=5,9,4,5,2 | -4.5 Milliseconds | Standard Deviation 4.95 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, 5 hours Post-dose, n=4,9,4,5,2 | -4.5 Milliseconds | Standard Deviation 4.95 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, 3 hours Post-dose, n=4,9,4,4,2 | -1.5 Milliseconds | Standard Deviation 10.61 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, 5 hours Post-dose, n=5,12,6,4,2 | -2.0 Milliseconds | Standard Deviation 1.41 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, 3 hours Post-dose, n=5,12,6,4,2 | -1.0 Milliseconds | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 23, n=5,12,6,4,2 | 1.5 Milliseconds | Standard Deviation 3.54 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 22, Pre-dose, n=5,12,6,4,2 | -4.0 Milliseconds | Standard Deviation 2.83 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 29, n=6,12,6,4,2 | 0.5 Milliseconds | Standard Deviation 0.71 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 2, n=6,12,6,5,2 | -0.5 Milliseconds | Standard Deviation 0.71 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QTcF, Day 22, Pre-dose, n=5,9,4,4,2 | -1.5 Milliseconds | Standard Deviation 2.12 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day 113, n=6,12,6,4,2 | 1.0 Milliseconds | Standard Deviation 1.41 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QRS duration, Day1, 5 hours Post-dose,n=6,12,6,5,2 | -3.0 Milliseconds | Standard Deviation 4.24 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 1, 3 hours Post-dose, n=6,12,6,5,2 | -20.5 Milliseconds | Standard Deviation 0.71 |
| Cohort 4 Placebo | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | QT, Day 2, n=6,12,6,5,2 | 19.5 Milliseconds | Standard Deviation 19.09 |
Primary
Change From Baseline in Pulse Rate
Pulse Rate was measured at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Pulse Rate | Day 29 | -4.7 Beats/minute | Standard Deviation 13.63 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Pulse Rate | Day 57 | -1.5 Beats/minute | Standard Deviation 16.34 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Pulse Rate | Day 85 | 5.7 Beats/minute | Standard Deviation 19.96 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Pulse Rate | Day 211 | -0.3 Beats/minute | Standard Deviation 18.82 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Pulse Rate | Day 29 | 4.3 Beats/minute | Standard Deviation 8.14 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Pulse Rate | Day 211 | 2.9 Beats/minute | Standard Deviation 8.7 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Pulse Rate | Day 57 | 8.2 Beats/minute | Standard Deviation 14.33 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Pulse Rate | Day 85 | 2.3 Beats/minute | Standard Deviation 9.1 |
| Cohorts 1-3 Placebo | Change From Baseline in Pulse Rate | Day 211 | 1.8 Beats/minute | Standard Deviation 12.22 |
| Cohorts 1-3 Placebo | Change From Baseline in Pulse Rate | Day 57 | 6.5 Beats/minute | Standard Deviation 14.36 |
| Cohorts 1-3 Placebo | Change From Baseline in Pulse Rate | Day 85 | -1.7 Beats/minute | Standard Deviation 7.15 |
| Cohorts 1-3 Placebo | Change From Baseline in Pulse Rate | Day 29 | 1.5 Beats/minute | Standard Deviation 5.32 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Pulse Rate | Day 29 | 9.0 Beats/minute | Standard Deviation 6.63 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Pulse Rate | Day 57 | 16.0 Beats/minute | Standard Deviation 6.06 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Pulse Rate | Day 211 | 16.3 Beats/minute | Standard Deviation 8.42 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Pulse Rate | Day 85 | 16.8 Beats/minute | Standard Deviation 5.32 |
| Cohort 4 Placebo | Change From Baseline in Pulse Rate | Day 211 | 13.0 Beats/minute | Standard Deviation 2.83 |
| Cohort 4 Placebo | Change From Baseline in Pulse Rate | Day 85 | 3.5 Beats/minute | Standard Deviation 7.78 |
| Cohort 4 Placebo | Change From Baseline in Pulse Rate | Day 57 | 8.0 Beats/minute | Standard Deviation 4.24 |
| Cohort 4 Placebo | Change From Baseline in Pulse Rate | Day 29 | 1.0 Beats/minute | Standard Deviation 4.24 |
Primary
Change From Baseline in Respiratory Rate
Respiratory Rate was measured at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Respiratory Rate | Day 29 | 0.3 Breaths/minute | Standard Deviation 1.03 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Respiratory Rate | Day 57 | -0.5 Breaths/minute | Standard Deviation 1.87 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Respiratory Rate | Day 85 | -0.3 Breaths/minute | Standard Deviation 1.86 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Respiratory Rate | Day 211 | -0.5 Breaths/minute | Standard Deviation 1.97 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Respiratory Rate | Day 29 | 0.7 Breaths/minute | Standard Deviation 0.65 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Respiratory Rate | Day 211 | 0.7 Breaths/minute | Standard Deviation 0.78 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Respiratory Rate | Day 57 | 0.6 Breaths/minute | Standard Deviation 0.67 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Respiratory Rate | Day 85 | 0.5 Breaths/minute | Standard Deviation 0.52 |
| Cohorts 1-3 Placebo | Change From Baseline in Respiratory Rate | Day 211 | 0.0 Breaths/minute | Standard Deviation 0.1 |
| Cohorts 1-3 Placebo | Change From Baseline in Respiratory Rate | Day 57 | 0.2 Breaths/minute | Standard Deviation 1.33 |
| Cohorts 1-3 Placebo | Change From Baseline in Respiratory Rate | Day 85 | 0.2 Breaths/minute | Standard Deviation 0.41 |
| Cohorts 1-3 Placebo | Change From Baseline in Respiratory Rate | Day 29 | 0.3 Breaths/minute | Standard Deviation 0.52 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Respiratory Rate | Day 29 | -0.8 Breaths/minute | Standard Deviation 2.22 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Respiratory Rate | Day 57 | -0.8 Breaths/minute | Standard Deviation 2.22 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Respiratory Rate | Day 211 | -1.0 Breaths/minute | Standard Deviation 2 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Respiratory Rate | Day 85 | -0.8 Breaths/minute | Standard Deviation 2.22 |
| Cohort 4 Placebo | Change From Baseline in Respiratory Rate | Day 211 | -3.0 Breaths/minute | Standard Deviation 1.41 |
| Cohort 4 Placebo | Change From Baseline in Respiratory Rate | Day 85 | -3.0 Breaths/minute | Standard Deviation 1.41 |
| Cohort 4 Placebo | Change From Baseline in Respiratory Rate | Day 57 | -2.5 Breaths/minute | Standard Deviation 2.12 |
| Cohort 4 Placebo | Change From Baseline in Respiratory Rate | Day 29 | -2.5 Breaths/minute | Standard Deviation 2.12 |
Primary
Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio
Blood samples were collected for the analysis of blood coagulation factor: Prothrombin International normalized ratio. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 23, 57, 85, 211
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 57, n=6,12,5,4,2 | -0.02 Ratio | Standard Deviation 0.075 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 23, n=5,11,6,4,2 | -0.04 Ratio | Standard Deviation 0.055 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 211, n=5,11,6,2,2 | -0.06 Ratio | Standard Deviation 0.089 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 57, n=6,12,5,4,2 | -0.04 Ratio | Standard Deviation 0.079 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 23, n=5,11,6,4,2 | -0.04 Ratio | Standard Deviation 0.067 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 211, n=5,11,6,2,2 | -0.03 Ratio | Standard Deviation 0.079 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 57, n=6,12,5,4,2 | 0.02 Ratio | Standard Deviation 0.084 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 23, n=5,11,6,4,2 | 0.02 Ratio | Standard Deviation 0.041 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 211, n=5,11,6,2,2 | 0.02 Ratio | Standard Deviation 0.075 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 23, n=5,11,6,4,2 | 0.03 Ratio | Standard Deviation 0.096 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 85, n=0,0,0,1,0 | 0.00 Ratio | — |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 57, n=6,12,5,4,2 | 0.00 Ratio | Standard Deviation 0.082 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 211, n=5,11,6,2,2 | 0.05 Ratio | Standard Deviation 0.071 |
| Cohort 4 Placebo | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 57, n=6,12,5,4,2 | 0.00 Ratio | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 211, n=5,11,6,2,2 | 0.00 Ratio | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Day 23, n=5,11,6,4,2 | 0.00 Ratio | Standard Deviation 0 |
Primary
Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time
Blood samples were collected for the analysis of blood coagulation factors:activated partial thromboplastin time (aPTT) and Prothrombin Time (PT). Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 23, 57, 85, 211
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 23, n=5,11,6,4,2 | -2.44 Seconds | Standard Deviation 4.017 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 57, n=6,12,5,4,2 | 1.23 Seconds | Standard Deviation 3.518 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 211, n=5,11,6,2,2 | 1.28 Seconds | Standard Deviation 6.538 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day 23, n=5,11,6,4,2 | -0.42 Seconds | Standard Deviation 0.576 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day 57, n=6,12,5,4,2 | -0.10 Seconds | Standard Deviation 0.74 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day211, n=5,11,6,2,2 | -0.84 Seconds | Standard Deviation 0.623 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day 23, n=5,11,6,4,2 | -0.23 Seconds | Standard Deviation 0.71 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 57, n=6,12,5,4,2 | -3.03 Seconds | Standard Deviation 5.854 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day 57, n=6,12,5,4,2 | -0.50 Seconds | Standard Deviation 0.615 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day211, n=5,11,6,2,2 | -0.35 Seconds | Standard Deviation 0.726 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 211, n=5,11,6,2,2 | -1.01 Seconds | Standard Deviation 6.31 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 23, n=5,11,6,4,2 | -2.33 Seconds | Standard Deviation 6.46 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day211, n=5,11,6,2,2 | 0.42 Seconds | Standard Deviation 0.744 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 211, n=5,11,6,2,2 | 2.70 Seconds | Standard Deviation 3.046 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day 57, n=6,12,5,4,2 | 0.20 Seconds | Standard Deviation 0.869 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 57, n=6,12,5,4,2 | -0.18 Seconds | Standard Deviation 3.841 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 23, n=5,11,6,4,2 | -1.63 Seconds | Standard Deviation 1.715 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day 23, n=5,11,6,4,2 | 0.12 Seconds | Standard Deviation 0.483 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day 23, n=5,11,6,4,2 | 0.33 Seconds | Standard Deviation 0.585 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 57, n=6,12,5,4,2 | 0.13 Seconds | Standard Deviation 3.627 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 85, n=0,0,0,1,0 | 0.00 Seconds | — |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 211, n=5,11,6,2,2 | 1.30 Seconds | Standard Deviation 4.384 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day211, n=5,11,6,2,2 | 0.45 Seconds | Standard Deviation 0.919 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day 57, n=6,12,5,4,2 | -0.18 Seconds | Standard Deviation 0.78 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day85, n=0,0,0,1,0 | -0.80 Seconds | — |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 23, n=5,11,6,4,2 | -0.45 Seconds | Standard Deviation 1.808 |
| Cohort 4 Placebo | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 23, n=5,11,6,4,2 | 0.65 Seconds | Standard Deviation 0.778 |
| Cohort 4 Placebo | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 211, n=5,11,6,2,2 | 2.60 Seconds | Standard Deviation 3.394 |
| Cohort 4 Placebo | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | aPTT, Day 57, n=6,12,5,4,2 | -0.35 Seconds | Standard Deviation 1.344 |
| Cohort 4 Placebo | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day 23, n=5,11,6,4,2 | 0.60 Seconds | Standard Deviation 0.141 |
| Cohort 4 Placebo | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day211, n=5,11,6,2,2 | 0.70 Seconds | Standard Deviation 0.283 |
| Cohort 4 Placebo | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | PT, Day 57, n=6,12,5,4,2 | 0.40 Seconds | Standard Deviation 0.141 |
Primary
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate
Blood samples were collected for the analysis of clinical parameters including sodium, potassium, chloride, bicarbonate, calcium, magnesium, phosphate, glucose, blood urea nitrogen (BUN), cholesterol and urate. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Outcome Measure Timeframe: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day211, n= 6,12,6,4,2 | 0.023 Millimoles per liter | Standard Deviation 0.0528 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day85, n= 6,12,6,4,2 | 0.018 Millimoles per liter | Standard Deviation 0.3725 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day211, n= 6,12,6,4,2 | 2.8 Millimoles per liter | Standard Deviation 1.94 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day85, n= 6,12,6,4,2 | -0.020 Millimoles per liter | Standard Deviation 0.1942 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day211, n= 6,12,6,4,2 | 0.093 Millimoles per liter | Standard Deviation 0.4956 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day57, n= 5,12,6,4,2 | 0.052 Millimoles per liter | Standard Deviation 0.1657 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day29, n= 6,12,6,4,2 | -0.008 Millimoles per liter | Standard Deviation 0.0376 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day29, n= 6,12,6,4,2 | 0.3 Millimoles per liter | Standard Deviation 1.21 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day29, n= 6,12,6,4,2 | 0.052 Millimoles per liter | Standard Deviation 0.1488 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day57, n= 5,12,6,4,2 | 0.000 Millimoles per liter | Standard Deviation 0.05 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day29, n= 6,12,6,4,2 | 0.417 Millimoles per liter | Standard Deviation 1.0192 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day211, n= 6,12,6,4,2 | 0.008 Millimoles per liter | Standard Deviation 0.0585 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day85, n= 6,12,6,4,2 | -0.025 Millimoles per liter | Standard Deviation 0.0612 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day29, n= 6,12,6,4,2 | 0.012 Millimoles per liter | Standard Deviation 0.0811 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day211, n= 6,12,6,4,2 | 0.0012 Millimoles per liter | Standard Deviation 0.03783 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day57, n= 5,12,6,4,2 | 0.036 Millimoles per liter | Standard Deviation 0.0658 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day85, n= 6,12,6,4,2 | 0.0168 Millimoles per liter | Standard Deviation 0.04298 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day85, n= 6,12,6,4,2 | 0.020 Millimoles per liter | Standard Deviation 0.0672 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day211, n= 6,12,6,4,2 | 0.358 Millimoles per liter | Standard Deviation 1.258 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day57, n= 5,12,6,4,2 | 0.0192 Millimoles per liter | Standard Deviation 0.03713 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day211, n= 6,12,6,4,2 | 0.052 Millimoles per liter | Standard Deviation 0.0618 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day29, n= 6,12,6,4,2 | 0.0310 Millimoles per liter | Standard Deviation 0.05007 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day29, n= 6,12,6,4,2 | -0.8 Millimoles per liter | Standard Deviation 2.14 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day57, n= 5,12,6,4,2 | 1.0 Millimoles per liter | Standard Deviation 2.65 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day211, n= 6,12,6,4,2 | -0.5 Millimoles per liter | Standard Deviation 2.35 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day57, n= 5,12,6,4,2 | -1.2 Millimoles per liter | Standard Deviation 2.17 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day85, n= 6,12,6,4,2 | -0.3 Millimoles per liter | Standard Deviation 2.16 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day85, n= 6,12,6,4,2 | -1.0 Millimoles per liter | Standard Deviation 2.37 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day57, n= 5,12,6,4,2 | -1.0 Millimoles per liter | Standard Deviation 1.87 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day211, n= 6,12,6,4,2 | -0.8 Millimoles per liter | Standard Deviation 2.48 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day85, n= 6,12,6,4,2 | -0.177 Millimoles per liter | Standard Deviation 0.9241 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day29, n= 6,12,6,4,2 | 0.2 Millimoles per liter | Standard Deviation 0.75 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day29, n= 6,12,6,4,2 | -0.027 Millimoles per liter | Standard Deviation 0.2281 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day211, n= 6,12,6,4,2 | 0.03 Millimoles per liter | Standard Deviation 0.367 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day57, n= 5,12,6,4,2 | -0.422 Millimoles per liter | Standard Deviation 0.3739 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day85, n= 6,12,6,4,2 | 0.2 Millimoles per liter | Standard Deviation 3.92 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day85, n= 6,12,6,4,2 | 0.07 Millimoles per liter | Standard Deviation 0.151 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day85, n= 6,12,6,4,2 | -0.380 Millimoles per liter | Standard Deviation 0.5772 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day211, n= 6,12,6,4,2 | -0.110 Millimoles per liter | Standard Deviation 0.4369 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day57, n= 5,12,6,4,2 | 0.08 Millimoles per liter | Standard Deviation 0.335 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day29, n= 6,12,6,4,2 | 0.170 Millimoles per liter | Standard Deviation 0.7148 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day57, n= 5,12,6,4,2 | 0.788 Millimoles per liter | Standard Deviation 0.9903 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day29, n= 6,12,6,4,2 | 0.08 Millimoles per liter | Standard Deviation 0.248 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day57, n= 5,12,6,4,2 | 0.056 Millimoles per liter | Standard Deviation 0.4161 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day211, n= 6,12,6,4,2 | -0.121 Millimoles per liter | Standard Deviation 0.7581 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day85, n= 6,12,6,4,2 | -0.003 Millimoles per liter | Standard Deviation 0.1342 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day57, n= 5,12,6,4,2 | -0.110 Millimoles per liter | Standard Deviation 1.051 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day85, n= 6,12,6,4,2 | -0.218 Millimoles per liter | Standard Deviation 1.097 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day211, n= 6,12,6,4,2 | -0.3 Millimoles per liter | Standard Deviation 1.96 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day57, n= 5,12,6,4,2 | -0.328 Millimoles per liter | Standard Deviation 0.8109 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day57, n= 5,12,6,4,2 | -0.064 Millimoles per liter | Standard Deviation 0.1072 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day211, n= 6,12,6,4,2 | 0.056 Millimoles per liter | Standard Deviation 0.18 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day211, n= 6,12,6,4,2 | -0.205 Millimoles per liter | Standard Deviation 1.0796 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day211, n= 6,12,6,4,2 | -1.0 Millimoles per liter | Standard Deviation 1.81 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day57, n= 5,12,6,4,2 | -0.1 Millimoles per liter | Standard Deviation 2.02 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day29, n= 6,12,6,4,2 | -0.010 Millimoles per liter | Standard Deviation 0.1123 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day85, n= 6,12,6,4,2 | 0.5 Millimoles per liter | Standard Deviation 2.28 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day29, n= 6,12,6,4,2 | 0.013 Millimoles per liter | Standard Deviation 0.0377 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day85, n= 6,12,6,4,2 | 0.37 Millimoles per liter | Standard Deviation 0.183 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day29, n= 6,12,6,4,2 | 0.16 Millimoles per liter | Standard Deviation 0.215 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day211, n= 6,12,6,4,2 | 0.042 Millimoles per liter | Standard Deviation 0.0669 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day85, n= 6,12,6,4,2 | 0.8 Millimoles per liter | Standard Deviation 1.85 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day57, n= 5,12,6,4,2 | 0.038 Millimoles per liter | Standard Deviation 0.0483 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day211, n= 6,12,6,4,2 | -0.208 Millimoles per liter | Standard Deviation 1.0941 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day57, n= 5,12,6,4,2 | -0.2 Millimoles per liter | Standard Deviation 2.21 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day85, n= 6,12,6,4,2 | 0.029 Millimoles per liter | Standard Deviation 0.062 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day29, n= 6,12,6,4,2 | 0.356 Millimoles per liter | Standard Deviation 0.504 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day211, n= 6,12,6,4,2 | -0.0005 Millimoles per liter | Standard Deviation 0.05949 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day85, n= 6,12,6,4,2 | -0.211 Millimoles per liter | Standard Deviation 0.8659 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day29, n= 6,12,6,4,2 | 0.015 Millimoles per liter | Standard Deviation 0.0735 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day29, n= 6,12,6,4,2 | 0.2 Millimoles per liter | Standard Deviation 1.11 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day211, n= 6,12,6,4,2 | 0.0 Millimoles per liter | Standard Deviation 2.3 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day29, n= 6,12,6,4,2 | -0.3 Millimoles per liter | Standard Deviation 1.97 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day85, n= 6,12,6,4,2 | 0.5 Millimoles per liter | Standard Deviation 1.83 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day57, n= 5,12,6,4,2 | 0.029 Millimoles per liter | Standard Deviation 0.0899 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day57, n= 5,12,6,4,2 | 0.0 Millimoles per liter | Standard Deviation 1.86 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day85, n= 6,12,6,4,2 | -0.0061 Millimoles per liter | Standard Deviation 0.04391 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day29, n= 6,12,6,4,2 | 0.2 Millimoles per liter | Standard Deviation 2.33 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day57, n= 5,12,6,4,2 | 0.27 Millimoles per liter | Standard Deviation 0.161 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day85, n= 6,12,6,4,2 | 0.046 Millimoles per liter | Standard Deviation 0.0944 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day29, n= 6,12,6,4,2 | 0.009 Millimoles per liter | Standard Deviation 0.7782 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day57, n= 5,12,6,4,2 | 0.0119 Millimoles per liter | Standard Deviation 0.05856 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day29, n= 6,12,6,4,2 | -0.129 Millimoles per liter | Standard Deviation 0.4305 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day57, n= 5,12,6,4,2 | 0.238 Millimoles per liter | Standard Deviation 0.796 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day211, n= 6,12,6,4,2 | 0.056 Millimoles per liter | Standard Deviation 0.0745 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day85, n= 6,12,6,4,2 | -0.059 Millimoles per liter | Standard Deviation 0.8974 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day29, n= 6,12,6,4,2 | 0.0248 Millimoles per liter | Standard Deviation 0.04039 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day211, n= 6,12,6,4,2 | 0.31 Millimoles per liter | Standard Deviation 0.284 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day85, n= 6,12,6,4,2 | -0.0100 Millimoles per liter | Standard Deviation 0.02592 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day29, n= 6,12,6,4,2 | 1.0 Millimoles per liter | Standard Deviation 1.41 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day57, n= 5,12,6,4,2 | -0.2 Millimoles per liter | Standard Deviation 2.14 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day85, n= 6,12,6,4,2 | -0.8 Millimoles per liter | Standard Deviation 0.75 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day211, n= 6,12,6,4,2 | -0.8 Millimoles per liter | Standard Deviation 1.72 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day29, n= 6,12,6,4,2 | -0.040 Millimoles per liter | Standard Deviation 0.0506 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day57, n= 5,12,6,4,2 | -0.038 Millimoles per liter | Standard Deviation 0.0471 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day85, n= 6,12,6,4,2 | -0.028 Millimoles per liter | Standard Deviation 0.0679 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day211, n= 6,12,6,4,2 | -0.025 Millimoles per liter | Standard Deviation 0.0789 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day29, n= 6,12,6,4,2 | 0.8 Millimoles per liter | Standard Deviation 1.94 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day57, n= 5,12,6,4,2 | 0.7 Millimoles per liter | Standard Deviation 0.82 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day85, n= 6,12,6,4,2 | 1.5 Millimoles per liter | Standard Deviation 1.64 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day211, n= 6,12,6,4,2 | 1.7 Millimoles per liter | Standard Deviation 2.94 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day29, n= 6,12,6,4,2 | -0.252 Millimoles per liter | Standard Deviation 0.2044 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day57, n= 5,12,6,4,2 | -0.717 Millimoles per liter | Standard Deviation 0.5216 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day85, n= 6,12,6,4,2 | -0.812 Millimoles per liter | Standard Deviation 0.2704 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day211, n= 6,12,6,4,2 | -0.423 Millimoles per liter | Standard Deviation 0.698 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day29, n= 6,12,6,4,2 | 0.498 Millimoles per liter | Standard Deviation 1.3437 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day57, n= 5,12,6,4,2 | -0.157 Millimoles per liter | Standard Deviation 0.5147 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day85, n= 6,12,6,4,2 | -0.315 Millimoles per liter | Standard Deviation 0.2959 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day211, n= 6,12,6,4,2 | -0.223 Millimoles per liter | Standard Deviation 0.5205 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day29, n= 6,12,6,4,2 | -0.025 Millimoles per liter | Standard Deviation 0.0524 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day57, n= 5,12,6,4,2 | -0.033 Millimoles per liter | Standard Deviation 0.0516 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day85, n= 6,12,6,4,2 | -0.033 Millimoles per liter | Standard Deviation 0.0606 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day211, n= 6,12,6,4,2 | -0.008 Millimoles per liter | Standard Deviation 0.0492 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day29, n= 6,12,6,4,2 | 0.023 Millimoles per liter | Standard Deviation 0.1472 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day57, n= 5,12,6,4,2 | -0.025 Millimoles per liter | Standard Deviation 0.1088 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day85, n= 6,12,6,4,2 | 0.055 Millimoles per liter | Standard Deviation 0.1001 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day211, n= 6,12,6,4,2 | 0.005 Millimoles per liter | Standard Deviation 0.1401 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day29, n= 6,12,6,4,2 | 0.12 Millimoles per liter | Standard Deviation 0.458 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day57, n= 5,12,6,4,2 | 0.08 Millimoles per liter | Standard Deviation 0.293 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day85, n= 6,12,6,4,2 | 0.20 Millimoles per liter | Standard Deviation 0.21 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day211, n= 6,12,6,4,2 | 0.30 Millimoles per liter | Standard Deviation 0.228 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day29, n= 6,12,6,4,2 | 0.7 Millimoles per liter | Standard Deviation 2.42 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day57, n= 5,12,6,4,2 | -0.2 Millimoles per liter | Standard Deviation 1.47 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day85, n= 6,12,6,4,2 | 0.2 Millimoles per liter | Standard Deviation 1.72 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day211, n= 6,12,6,4,2 | 0.2 Millimoles per liter | Standard Deviation 1.94 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day29, n= 6,12,6,4,2 | -0.0127 Millimoles per liter | Standard Deviation 0.01127 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day57, n= 5,12,6,4,2 | -0.0158 Millimoles per liter | Standard Deviation 0.0226 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day211, n= 6,12,6,4,2 | -0.0128 Millimoles per liter | Standard Deviation 0.04086 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day29, n= 6,12,6,4,2 | 0.415 Millimoles per liter | Standard Deviation 0.6125 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day57, n= 5,12,6,4,2 | 0.535 Millimoles per liter | Standard Deviation 1.1451 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day85, n= 6,12,6,4,2 | 0.833 Millimoles per liter | Standard Deviation 0.7011 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day211, n= 6,12,6,4,2 | 0.713 Millimoles per liter | Standard Deviation 1.151 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day29, n= 6,12,6,4,2 | 0.180 Millimoles per liter | Standard Deviation 0.898 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day85, n= 6,12,6,4,2 | -0.008 Millimoles per liter | Standard Deviation 0.2017 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day57, n= 5,12,6,4,2 | 0.415 Millimoles per liter | Standard Deviation 1.4055 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day211, n= 6,12,6,4,2 | -0.018 Millimoles per liter | Standard Deviation 0.1231 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day29, n= 6,12,6,4,2 | -0.290 Millimoles per liter | Standard Deviation 0.1299 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day85, n= 6,12,6,4,2 | -0.8 Millimoles per liter | Standard Deviation 0.5 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day29, n= 6,12,6,4,2 | -0.05 Millimoles per liter | Standard Deviation 0.289 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day211, n= 6,12,6,4,2 | 0.960 Millimoles per liter | Standard Deviation 0.3982 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day57, n= 5,12,6,4,2 | 0.03 Millimoles per liter | Standard Deviation 0.206 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day57, n= 5,12,6,4,2 | 0.480 Millimoles per liter | Standard Deviation 0.7278 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day85, n= 6,12,6,4,2 | 0.00 Millimoles per liter | Standard Deviation 0.476 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day29, n= 6,12,6,4,2 | 0.123 Millimoles per liter | Standard Deviation 0.9238 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day57, n= 5,12,6,4,2 | 0.980 Millimoles per liter | Standard Deviation 1.5543 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day211, n= 6,12,6,4,2 | 0.23 Millimoles per liter | Standard Deviation 0.299 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day211, n= 6,12,6,4,2 | -0.5 Millimoles per liter | Standard Deviation 0.58 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day29, n= 6,12,6,4,2 | -1.0 Millimoles per liter | Standard Deviation 2.16 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day85, n= 6,12,6,4,2 | -0.3 Millimoles per liter | Standard Deviation 1.5 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day57, n= 5,12,6,4,2 | 0.3 Millimoles per liter | Standard Deviation 2.87 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day57, n= 5,12,6,4,2 | -0.5 Millimoles per liter | Standard Deviation 1.29 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day57, n= 5,12,6,4,2 | -1.0 Millimoles per liter | Standard Deviation 0 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day85, n= 6,12,6,4,2 | -0.8 Millimoles per liter | Standard Deviation 1.71 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day29, n= 6,12,6,4,2 | -2.0 Millimoles per liter | Standard Deviation 1.83 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day211, n= 6,12,6,4,2 | 0.893 Millimoles per liter | Standard Deviation 1.4463 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day211, n= 6,12,6,4,2 | 0.3 Millimoles per liter | Standard Deviation 0.5 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day211, n= 6,12,6,4,2 | 0.068 Millimoles per liter | Standard Deviation 0.0746 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day85, n= 6,12,6,4,2 | 0.000 Millimoles per liter | Standard Deviation 1.204 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day29, n= 6,12,6,4,2 | -0.0060 Millimoles per liter | Standard Deviation 0.02728 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day85, n= 6,12,6,4,2 | -0.013 Millimoles per liter | Standard Deviation 0.0675 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day57, n= 5,12,6,4,2 | -0.0043 Millimoles per liter | Standard Deviation 0.04377 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day57, n= 5,12,6,4,2 | 0.013 Millimoles per liter | Standard Deviation 0.015 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day85, n= 6,12,6,4,2 | -0.0078 Millimoles per liter | Standard Deviation 0.04984 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day29, n= 6,12,6,4,2 | 0.063 Millimoles per liter | Standard Deviation 0.0479 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day29, n= 6,12,6,4,2 | 0.0 Millimoles per liter | Standard Deviation 2.16 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day211, n= 6,12,6,4,2 | 0.0370 Millimoles per liter | Standard Deviation 0.02599 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day85, n= 6,12,6,4,2 | -0.038 Millimoles per liter | Standard Deviation 0.0479 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day57, n= 5,12,6,4,2 | 0.013 Millimoles per liter | Standard Deviation 0.0479 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day211, n= 6,12,6,4,2 | -0.8 Millimoles per liter | Standard Deviation 2.22 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day211, n= 6,12,6,4,2 | 0.050 Millimoles per liter | Standard Deviation 0.0577 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day29, n= 6,12,6,4,2 | 0.000 Millimoles per liter | Standard Deviation 0 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day29, n= 6,12,6,4,2 | -0.073 Millimoles per liter | Standard Deviation 0.0562 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day211, n= 6,12,6,4,2 | -0.373 Millimoles per liter | Standard Deviation 0.6375 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day85, n= 6,12,6,4,2 | 0.195 Millimoles per liter | Standard Deviation 0.5073 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day57, n= 5,12,6,4,2 | -0.058 Millimoles per liter | Standard Deviation 0.125 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day85, n= 6,12,6,4,2 | 0.073 Millimoles per liter | Standard Deviation 0.4524 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day85, n= 6,12,6,4,2 | -0.110 Millimoles per liter | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day211, n= 6,12,6,4,2 | -0.110 Millimoles per liter | Standard Deviation 0.3111 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day85, n= 6,12,6,4,2 | 0.080 Millimoles per liter | Standard Deviation 0.2546 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day57, n= 5,12,6,4,2 | 0.000 Millimoles per liter | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day29, n= 6,12,6,4,2 | 0.225 Millimoles per liter | Standard Deviation 0.0778 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day29, n= 6,12,6,4,2 | 0.355 Millimoles per liter | Standard Deviation 1.0112 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day211, n= 6,12,6,4,2 | -1.0 Millimoles per liter | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day211, n= 6,12,6,4,2 | -0.130 Millimoles per liter | Standard Deviation 0.1273 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day211, n= 6,12,6,4,2 | -0.025 Millimoles per liter | Standard Deviation 0.1344 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day211, n= 6,12,6,4,2 | 0.360 Millimoles per liter | Standard Deviation 0.7354 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day211, n= 6,12,6,4,2 | 0.0325 Millimoles per liter | Standard Deviation 0.02899 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day85, n= 6,12,6,4,2 | -2.0 Millimoles per liter | Standard Deviation 2.83 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day29, n= 6,12,6,4,2 | 0.00 Millimoles per liter | Standard Deviation 0.141 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day85, n= 6,12,6,4,2 | 0.000 Millimoles per liter | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day85, n= 6,12,6,4,2 | 0.390 Millimoles per liter | Standard Deviation 0.5091 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day57, n= 5,12,6,4,2 | -3.0 Millimoles per liter | Standard Deviation 2.83 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day29, n= 6,12,6,4,2 | 0.0355 Millimoles per liter | Standard Deviation 0.04172 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day57, n= 5,12,6,4,2 | -0.05 Millimoles per liter | Standard Deviation 0.354 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day57, n= 5,12,6,4,2 | 0.815 Millimoles per liter | Standard Deviation 0.5303 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day85, n= 6,12,6,4,2 | 0.050 Millimoles per liter | Standard Deviation 0.0707 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day211, n= 6,12,6,4,2 | 0.000 Millimoles per liter | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day57, n= 5,12,6,4,2 | -0.020 Millimoles per liter | Standard Deviation 0.1556 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day85, n= 6,12,6,4,2 | 0.00 Millimoles per liter | Standard Deviation 0.566 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Cholesterol, Day29, n= 6,12,6,4,2 | -0.155 Millimoles per liter | Standard Deviation 0.7 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day85, n= 6,12,6,4,2 | 0.000 Millimoles per liter | Standard Deviation 0.5091 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day29, n= 6,12,6,4,2 | 0.025 Millimoles per liter | Standard Deviation 0.0354 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day57, n= 5,12,6,4,2 | 0.0030 Millimoles per liter | Standard Deviation 0.00424 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Potassium, Day211, n= 6,12,6,4,2 | 0.05 Millimoles per liter | Standard Deviation 0.919 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day211, n= 6,12,6,4,2 | -1.0 Millimoles per liter | Standard Deviation 1.41 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day57, n= 5,12,6,4,2 | 0.010 Millimoles per liter | Standard Deviation 0.0566 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | BUN, Day57, n= 5,12,6,4,2 | 0.180 Millimoles per liter | Standard Deviation 0.2546 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Phosphate, Day29, n= 6,12,6,4,2 | -0.050 Millimoles per liter | Standard Deviation 0.1131 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day29, n= 6,12,6,4,2 | -1.5 Millimoles per liter | Standard Deviation 0.71 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day85, n= 6,12,6,4,2 | -1.5 Millimoles per liter | Standard Deviation 2.12 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Calcium, Day29, n= 6,12,6,4,2 | -0.030 Millimoles per liter | Standard Deviation 0.0707 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Glucose, Day57, n= 5,12,6,4,2 | -0.360 Millimoles per liter | Standard Deviation 0.198 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Urate, Day85, n= 6,12,6,4,2 | 0.0440 Millimoles per liter | Standard Deviation 0.02121 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day57, n= 5,12,6,4,2 | -1.0 Millimoles per liter | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day57, n= 5,12,6,4,2 | -1.5 Millimoles per liter | Standard Deviation 0.71 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Magnesium, Day211, n= 6,12,6,4,2 | 0.025 Millimoles per liter | Standard Deviation 0.0354 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day29, n= 6,12,6,4,2 | -2.0 Millimoles per liter | Standard Deviation 2.83 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Bicarbonate, Day211, n= 6,12,6,4,2 | -2.0 Millimoles per liter | Standard Deviation 4.24 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Sodium, Day85, n= 6,12,6,4,2 | -2.0 Millimoles per liter | Standard Deviation 1.41 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Chloride, Day29, n= 6,12,6,4,2 | -1.5 Millimoles per liter | Standard Deviation 0.71 |
Primary
Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine
Blood samples were collected for the analysis of clinical chemistry parameters: direct bilirubin, total bilirubin, indirect bilirubin and creatinine. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day211, n= 6,12,6,4,2 | 0.8 Micromoles per liter | Standard Deviation 6.62 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day211, n= 6,12,6,4,2 | 0.00 Micromoles per liter | Standard Deviation 0 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day57, n= 5,12,6,4,2 | 0.00 Micromoles per liter | Standard Deviation 0 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day85, n= 6,12,6,4,2 | 0.00 Micromoles per liter | Standard Deviation 0 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day57, n= 5,12,6,4,2 | -2.14 Micromoles per liter | Standard Deviation 2.105 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day29, n= 6,12,6,4,2 | -1.72 Micromoles per liter | Standard Deviation 2.699 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day85, n= 6,12,6,4,2 | 0.8 Micromoles per liter | Standard Deviation 8.73 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day85, n= 6,12,6,4,2 | -1.47 Micromoles per liter | Standard Deviation 2.151 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day57, n= 5,12,6,4,2 | 2.7 Micromoles per liter | Standard Deviation 5.13 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day211, n= 6,12,6,4,2 | -0.87 Micromoles per liter | Standard Deviation 2.608 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day29, n= 6,12,6,4,2 | 3.8 Micromoles per liter | Standard Deviation 3.39 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day29, n= 6,12,6,4,2 | 0.00 Micromoles per liter | Standard Deviation 0 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day29, n= 6,12,6,4,2 | -0.02 Micromoles per liter | Standard Deviation 0.061 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day29, n= 6,12,6,4,2 | -1.07 Micromoles per liter | Standard Deviation 2.529 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day211, n= 6,12,6,4,2 | 4.0 Micromoles per liter | Standard Deviation 8.82 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day57, n= 5,12,6,4,2 | -0.02 Micromoles per liter | Standard Deviation 0.061 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day85, n= 6,12,6,4,2 | 3.9 Micromoles per liter | Standard Deviation 6.46 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day85, n= 6,12,6,4,2 | -0.02 Micromoles per liter | Standard Deviation 0.061 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day29, n= 6,12,6,4,2 | 7.8 Micromoles per liter | Standard Deviation 4.37 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day211, n= 6,12,6,4,2 | -0.02 Micromoles per liter | Standard Deviation 0.061 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day57, n= 5,12,6,4,2 | -0.40 Micromoles per liter | Standard Deviation 3.93 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day211, n= 6,12,6,4,2 | -0.87 Micromoles per liter | Standard Deviation 3.538 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day85, n= 6,12,6,4,2 | -0.78 Micromoles per liter | Standard Deviation 2.84 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day57, n= 5,12,6,4,2 | 5.5 Micromoles per liter | Standard Deviation 6.53 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day211, n= 6,12,6,4,2 | 0.05 Micromoles per liter | Standard Deviation 0.122 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day29, n= 6,12,6,4,2 | -1.92 Micromoles per liter | Standard Deviation 2.497 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day57, n= 5,12,6,4,2 | -1.72 Micromoles per liter | Standard Deviation 1.216 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day85, n= 6,12,6,4,2 | -1.52 Micromoles per liter | Standard Deviation 3.411 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day211, n= 6,12,6,4,2 | 0.40 Micromoles per liter | Standard Deviation 5.907 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day29, n= 6,12,6,4,2 | 0.02 Micromoles per liter | Standard Deviation 0.041 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day57, n= 5,12,6,4,2 | -0.07 Micromoles per liter | Standard Deviation 0.167 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day85, n= 6,12,6,4,2 | -0.07 Micromoles per liter | Standard Deviation 0.167 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Indirect Bilirubin, Day29, n= 0,0,1,0,0 | -0.60 Micromoles per liter | — |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Indirect Bilirubin, Day211, n= 0,0,1,0,0 | 10.50 Micromoles per liter | — |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day29, n= 6,12,6,4,2 | -0.3 Micromoles per liter | Standard Deviation 7 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day57, n= 5,12,6,4,2 | 2.5 Micromoles per liter | Standard Deviation 5.08 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day85, n= 6,12,6,4,2 | 1.0 Micromoles per liter | Standard Deviation 5.67 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day211, n= 6,12,6,4,2 | 4.0 Micromoles per liter | Standard Deviation 6.82 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day85, n= 6,12,6,4,2 | 2.0 Micromoles per liter | Standard Deviation 5.43 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day57, n= 5,12,6,4,2 | 2.3 Micromoles per liter | Standard Deviation 12.18 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day29, n= 6,12,6,4,2 | -1.53 Micromoles per liter | Standard Deviation 3.497 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day57, n= 5,12,6,4,2 | -0.33 Micromoles per liter | Standard Deviation 3.802 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day29, n= 6,12,6,4,2 | 8.8 Micromoles per liter | Standard Deviation 5.89 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day211, n= 6,12,6,4,2 | 0.00 Micromoles per liter | Standard Deviation 0 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day57, n= 5,12,6,4,2 | 0.05 Micromoles per liter | Standard Deviation 0.105 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day211, n= 6,12,6,4,2 | 2.0 Micromoles per liter | Standard Deviation 5.43 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day85, n= 6,12,6,4,2 | 0.00 Micromoles per liter | Standard Deviation 0 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day85, n= 6,12,6,4,2 | -0.78 Micromoles per liter | Standard Deviation 2.29 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day211, n= 6,12,6,4,2 | 1.00 Micromoles per liter | Standard Deviation 2.432 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day29, n= 6,12,6,4,2 | 0.00 Micromoles per liter | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day211, n= 6,12,6,4,2 | 6.8 Micromoles per liter | Standard Deviation 3.18 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day211, n= 6,12,6,4,2 | 0.00 Micromoles per liter | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day85, n= 6,12,6,4,2 | 2.3 Micromoles per liter | Standard Deviation 3.18 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day85, n= 6,12,6,4,2 | 5.40 Micromoles per liter | Standard Deviation 7.071 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day29, n= 6,12,6,4,2 | 2.3 Micromoles per liter | Standard Deviation 3.18 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day57, n= 5,12,6,4,2 | 3.85 Micromoles per liter | Standard Deviation 6.576 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day211, n= 6,12,6,4,2 | 2.75 Micromoles per liter | Standard Deviation 4.738 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Creatinine, Day57, n= 5,12,6,4,2 | 2.3 Micromoles per liter | Standard Deviation 9.55 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Total Bilirubin, Day29, n= 6,12,6,4,2 | 1.40 Micromoles per liter | Standard Deviation 1.414 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day57, n= 5,12,6,4,2 | 0.00 Micromoles per liter | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day85, n= 6,12,6,4,2 | 0.00 Micromoles per liter | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Direct Bilirubin, Day29, n= 6,12,6,4,2 | 0.00 Micromoles per liter | Standard Deviation 0 |
Primary
Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio
Urine samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day85, n=6,8,4,3,2 | -0.003 Milligrams per millimole Creatinine | Standard Deviation 0.0554 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day211, n=4,8,4,3,1 | 0.003 Milligrams per millimole Creatinine | Standard Deviation 0.015 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day57, n=6,9,3,4,2 | -0.007 Milligrams per millimole Creatinine | Standard Deviation 0.0589 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day29, n=5,10,4,4,2 | 0.006 Milligrams per millimole Creatinine | Standard Deviation 0.0329 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day29, n=5,10,4,4,2 | -0.002 Milligrams per millimole Creatinine | Standard Deviation 0.1264 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine albumin/creatinine ratio, Day57,n=0,2,0,0,0 | -10.580 Milligrams per millimole Creatinine | Standard Deviation 10.9743 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine albumin/creatinine ratio, Day85,n=0,1,1,0,0 | -3.480 Milligrams per millimole Creatinine | — |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day57, n=6,9,3,4,2 | -0.043 Milligrams per millimole Creatinine | Standard Deviation 0.1168 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine albumin/creatinine ratio, Day29,n=0,1,0,0,0 | -3.340 Milligrams per millimole Creatinine | — |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day211, n=4,8,4,3,1 | -0.073 Milligrams per millimole Creatinine | Standard Deviation 0.1235 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day85, n=6,8,4,3,2 | -0.050 Milligrams per millimole Creatinine | Standard Deviation 0.1042 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day211, n=4,8,4,3,1 | -0.005 Milligrams per millimole Creatinine | Standard Deviation 0.0311 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine albumin/creatinine ratio, Day85,n=0,1,1,0,0 | 0.080 Milligrams per millimole Creatinine | — |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day29, n=5,10,4,4,2 | -0.005 Milligrams per millimole Creatinine | Standard Deviation 0.0058 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day85, n=6,8,4,3,2 | -0.005 Milligrams per millimole Creatinine | Standard Deviation 0.0129 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day57, n=6,9,3,4,2 | -0.003 Milligrams per millimole Creatinine | Standard Deviation 0.0058 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day57, n=6,9,3,4,2 | 0.020 Milligrams per millimole Creatinine | Standard Deviation 0 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day29, n=5,10,4,4,2 | 0.065 Milligrams per millimole Creatinine | Standard Deviation 0.0238 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day85, n=6,8,4,3,2 | 0.017 Milligrams per millimole Creatinine | Standard Deviation 0.0231 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day211, n=4,8,4,3,1 | 0.013 Milligrams per millimole Creatinine | Standard Deviation 0.0252 |
| Cohort 4 Placebo | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day57, n=6,9,3,4,2 | 0.010 Milligrams per millimole Creatinine | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day29, n=5,10,4,4,2 | 0.025 Milligrams per millimole Creatinine | Standard Deviation 0.0071 |
| Cohort 4 Placebo | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day211, n=4,8,4,3,1 | 0.000 Milligrams per millimole Creatinine | — |
| Cohort 4 Placebo | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio Day85, n=6,8,4,3,2 | 0.000 Milligrams per millimole Creatinine | Standard Deviation 0.0141 |
Primary
Change From Baseline Values in Urine Protein
Urine samples were collected for the analysis of urine protein. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Urine Protein | Day 85 | -2.07 Milligrams per deciliter | Standard Deviation 5.814 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Urine Protein | Day 211 | -2.29 Milligrams per deciliter | Standard Deviation 7.277 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Urine Protein | Day 57 | -2.57 Milligrams per deciliter | Standard Deviation 7.451 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Urine Protein | Day 29 | -1.08 Milligrams per deciliter | Standard Deviation 7.591 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Protein | Day 211 | 0.90 Milligrams per deciliter | Standard Deviation 2.832 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Protein | Day 29 | 7.06 Milligrams per deciliter | Standard Deviation 5.13 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Protein | Day 57 | 5.62 Milligrams per deciliter | Standard Deviation 7.91 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Protein | Day 85 | 1.45 Milligrams per deciliter | Standard Deviation 3.747 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Protein | Day 57 | 2.00 Milligrams per deciliter | Standard Deviation 5.903 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Protein | Day 211 | -0.46 Milligrams per deciliter | Standard Deviation 2.214 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Protein | Day 85 | 2.29 Milligrams per deciliter | Standard Deviation 2.267 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Protein | Day 29 | -0.51 Milligrams per deciliter | Standard Deviation 2.605 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Urine Protein | Day 85 | 2.48 Milligrams per deciliter | Standard Deviation 3.954 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Urine Protein | Day 57 | 4.48 Milligrams per deciliter | Standard Deviation 3.502 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Urine Protein | Day 211 | 0.90 Milligrams per deciliter | Standard Deviation 1.664 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Urine Protein | Day 29 | 11.13 Milligrams per deciliter | Standard Deviation 9.288 |
| Cohort 4 Placebo | Change From Baseline Values in Urine Protein | Day 211 | 2.71 Milligrams per deciliter | Standard Deviation 3.825 |
| Cohort 4 Placebo | Change From Baseline Values in Urine Protein | Day 29 | 3.76 Milligrams per deciliter | Standard Deviation 5.02 |
| Cohort 4 Placebo | Change From Baseline Values in Urine Protein | Day 57 | 5.56 Milligrams per deciliter | Standard Deviation 3.889 |
| Cohort 4 Placebo | Change From Baseline Values in Urine Protein | Day 85 | 4.01 Milligrams per deciliter | Standard Deviation 0.283 |
Primary
Change From Baseline Values in Urine Specific Gravity
Urine samples were collected for the analysis of urine specific gravity. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. Urine specific gravity is measured as the ratio of urine density compared with water density.
Time frame: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211
Population: Safety population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Urine Specific Gravity | Day 29 | -0.0017 Ratio of urine to water density | Standard Deviation 0.00703 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Urine Specific Gravity | Day 57 | 0.0000 Ratio of urine to water density | Standard Deviation 0.00832 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Urine Specific Gravity | Day 85 | -0.0007 Ratio of urine to water density | Standard Deviation 0.00653 |
| Cohort 1 GSK3228836 150 mg | Change From Baseline Values in Urine Specific Gravity | Day 211 | -0.0020 Ratio of urine to water density | Standard Deviation 0.00851 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Specific Gravity | Day 29 | 0.0033 Ratio of urine to water density | Standard Deviation 0.00585 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Specific Gravity | Day 211 | 0.0024 Ratio of urine to water density | Standard Deviation 0.00684 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Specific Gravity | Day 57 | 0.0059 Ratio of urine to water density | Standard Deviation 0.00763 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline Values in Urine Specific Gravity | Day 85 | 0.0020 Ratio of urine to water density | Standard Deviation 0.00481 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Specific Gravity | Day 211 | 0.0010 Ratio of urine to water density | Standard Deviation 0.00522 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Specific Gravity | Day 57 | 0.0028 Ratio of urine to water density | Standard Deviation 0.00519 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Specific Gravity | Day 85 | 0.0057 Ratio of urine to water density | Standard Deviation 0.00441 |
| Cohorts 1-3 Placebo | Change From Baseline Values in Urine Specific Gravity | Day 29 | 0.0032 Ratio of urine to water density | Standard Deviation 0.00523 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Urine Specific Gravity | Day 29 | 0.0028 Ratio of urine to water density | Standard Deviation 0.00427 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Urine Specific Gravity | Day 57 | 0.0038 Ratio of urine to water density | Standard Deviation 0.00457 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Urine Specific Gravity | Day 211 | -0.0005 Ratio of urine to water density | Standard Deviation 0.00387 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline Values in Urine Specific Gravity | Day 85 | 0.0013 Ratio of urine to water density | Standard Deviation 0.0045 |
| Cohort 4 Placebo | Change From Baseline Values in Urine Specific Gravity | Day 211 | 0.0060 Ratio of urine to water density | Standard Deviation 0.00849 |
| Cohort 4 Placebo | Change From Baseline Values in Urine Specific Gravity | Day 85 | 0.0130 Ratio of urine to water density | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline Values in Urine Specific Gravity | Day 57 | 0.0130 Ratio of urine to water density | Standard Deviation 0.00141 |
| Cohort 4 Placebo | Change From Baseline Values in Urine Specific Gravity | Day 29 | 0.0080 Ratio of urine to water density | Standard Deviation 0.00566 |
Primary
Change in Complement Bb Level at Worst Case Post Baseline Relative to Baseline
Blood samples were collected from participants to evaluate change in complement Bb level at worst case post Baseline relative to Baseline. Worst case post Baseline in Complement Bb was the maximum post-Baseline level. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and up to Day 211
Population: Safety Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change in Complement Bb Level at Worst Case Post Baseline Relative to Baseline | 0.355 Microgram per milliliter | Standard Deviation 0.1129 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change in Complement Bb Level at Worst Case Post Baseline Relative to Baseline | 0.365 Microgram per milliliter | Standard Deviation 0.4835 |
| Cohorts 1-3 Placebo | Change in Complement Bb Level at Worst Case Post Baseline Relative to Baseline | 0.240 Microgram per milliliter | Standard Deviation 0.3543 |
| Cohort 4 GSK3228836 300 mg | Change in Complement Bb Level at Worst Case Post Baseline Relative to Baseline | 0.472 Microgram per milliliter | Standard Deviation 0.1439 |
| Cohort 4 Placebo | Change in Complement Bb Level at Worst Case Post Baseline Relative to Baseline | 0.320 Microgram per milliliter | Standard Deviation 0.3677 |
Primary
Change in Complement C3 Level at Worst Case Post Baseline Relative to Baseline
Blood samples were collected from participants to evaluate change in complement C3 level at worst case post Baseline relative to Baseline. Worst case post Baseline in Complement C3 was the minimum post-Baseline level. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and up to Day 211
Population: Safety Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change in Complement C3 Level at Worst Case Post Baseline Relative to Baseline | -19.8 Milligram per deciliter | Standard Deviation 11.72 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change in Complement C3 Level at Worst Case Post Baseline Relative to Baseline | -22.3 Milligram per deciliter | Standard Deviation 12 |
| Cohorts 1-3 Placebo | Change in Complement C3 Level at Worst Case Post Baseline Relative to Baseline | -16.5 Milligram per deciliter | Standard Deviation 13.81 |
| Cohort 4 GSK3228836 300 mg | Change in Complement C3 Level at Worst Case Post Baseline Relative to Baseline | -12.4 Milligram per deciliter | Standard Deviation 3.78 |
| Cohort 4 Placebo | Change in Complement C3 Level at Worst Case Post Baseline Relative to Baseline | -25.5 Milligram per deciliter | Standard Deviation 16.26 |
Primary
Change in Complement C5a Level at Worst Case Post Baseline Relative to Baseline
Blood samples were collected from participants to evaluate change in complement C5a level at worst case post Baseline relative to Baseline. Worst case post Baseline in Complement C5a was the maximum post-Baseline level. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and up to Day 211
Population: Safety Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change in Complement C5a Level at Worst Case Post Baseline Relative to Baseline | 1.552 Nanogram per milliliter | Standard Deviation 1.3967 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change in Complement C5a Level at Worst Case Post Baseline Relative to Baseline | 3.778 Nanogram per milliliter | Standard Deviation 6.2062 |
| Cohorts 1-3 Placebo | Change in Complement C5a Level at Worst Case Post Baseline Relative to Baseline | 1.303 Nanogram per milliliter | Standard Deviation 0.8671 |
| Cohort 4 GSK3228836 300 mg | Change in Complement C5a Level at Worst Case Post Baseline Relative to Baseline | 2.232 Nanogram per milliliter | Standard Deviation 2.264 |
| Cohort 4 Placebo | Change in Complement C5a Level at Worst Case Post Baseline Relative to Baseline | 0.800 Nanogram per milliliter | Standard Deviation 0 |
Primary
Number of Participants Who Received Atleast One Concomitant Medication
A concomitant medication is defined as any medication initiated after the first dose of study, or initiated prior to the first dose of study drug and continued after the first dose of study drug.
Time frame: Up to Day 211
Population: Safety Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 GSK3228836 150 mg | Number of Participants Who Received Atleast One Concomitant Medication | 4 Participants |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Number of Participants Who Received Atleast One Concomitant Medication | 8 Participants |
| Cohorts 1-3 Placebo | Number of Participants Who Received Atleast One Concomitant Medication | 5 Participants |
| Cohort 4 GSK3228836 300 mg | Number of Participants Who Received Atleast One Concomitant Medication | 5 Participants |
| Cohort 4 Placebo | Number of Participants Who Received Atleast One Concomitant Medication | 2 Participants |
Primary
Number of Participants With Abnormal Findings in Physical Examination
Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems.
Time frame: Up to Day 211
Population: Safety Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 GSK3228836 150 mg | Number of Participants With Abnormal Findings in Physical Examination | 3 Participants |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Number of Participants With Abnormal Findings in Physical Examination | 1 Participants |
| Cohorts 1-3 Placebo | Number of Participants With Abnormal Findings in Physical Examination | 1 Participants |
| Cohort 4 GSK3228836 300 mg | Number of Participants With Abnormal Findings in Physical Examination | 0 Participants |
| Cohort 4 Placebo | Number of Participants With Abnormal Findings in Physical Examination | 0 Participants |
Primary
Number of Participants With Reported Pregnancy
Female participants who were not surgically sterile or post-menopausal, underwent urine beta Human chorionic gonadotropin (Beta-HCG) pregnancy test.
Time frame: Up to Day 211
Population: Safety Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 GSK3228836 150 mg | Number of Participants With Reported Pregnancy | 0 Participants |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Number of Participants With Reported Pregnancy | 0 Participants |
| Cohorts 1-3 Placebo | Number of Participants With Reported Pregnancy | 0 Participants |
| Cohort 4 GSK3228836 300 mg | Number of Participants With Reported Pregnancy | 0 Participants |
| Cohort 4 Placebo | Number of Participants With Reported Pregnancy | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%)
An adverse event is any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. Any adverse event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any important medical event according to medical judgment were categorized as SAE.
Time frame: Up to Day 211
Population: Safety Population includes all randomized participants who received at least 1 dose of GSK3228836 or placebo. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%) | Non-SAE (>=5%) | 5 Participants |
| Cohort 1 GSK3228836 150 mg | Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%) | SAE | 0 Participants |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%) | Non-SAE (>=5%) | 6 Participants |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%) | SAE | 1 Participants |
| Cohorts 1-3 Placebo | Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%) | Non-SAE (>=5%) | 2 Participants |
| Cohorts 1-3 Placebo | Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%) | SAE | 0 Participants |
| Cohort 4 GSK3228836 300 mg | Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%) | SAE | 0 Participants |
| Cohort 4 GSK3228836 300 mg | Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%) | Non-SAE (>=5%) | 3 Participants |
| Cohort 4 Placebo | Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%) | Non-SAE (>=5%) | 0 Participants |
| Cohort 4 Placebo | Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%) | SAE | 0 Participants |
Secondary
Change From Baseline in HBsAg Level in Serum at Week 31
Blood samples were collected from participants to assess HBsAg level. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Week 31
Population: Full Analysis Set Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in HBsAg Level in Serum at Week 31 | -0.523 Log10 (International Units/milliliter) | Standard Deviation 0.9299 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in HBsAg Level in Serum at Week 31 | -0.547 Log10 (International Units/milliliter) | Standard Deviation 0.6109 |
| Cohorts 1-3 Placebo | Change From Baseline in HBsAg Level in Serum at Week 31 | 0.059 Log10 (International Units/milliliter) | Standard Deviation 0.3859 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in HBsAg Level in Serum at Week 31 | -1.519 Log10 (International Units/milliliter) | Standard Deviation 1.4821 |
| Cohort 4 Placebo | Change From Baseline in HBsAg Level in Serum at Week 31 | -0.043 Log10 (International Units/milliliter) | Standard Deviation 0.0178 |
p-value: 0.141ANCOVA
p-value: 0.081ANCOVA
p-value: 0.616ANCOVA
Secondary
Change From Baseline in HBV Surface Antigen (HBsAg) Level in Serum at Day 29
Blood samples were collected from participants to assess HBsAg level. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. The LOCF method was used to impute missing values at Day 29 in this analysis.
Time frame: Baseline (Day 1 pre-dose) and Day 29
Population: Full Analysis Set Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in HBV Surface Antigen (HBsAg) Level in Serum at Day 29 | -0.504 Log10 (International Units/milliliter) | Standard Deviation 0.5656 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in HBV Surface Antigen (HBsAg) Level in Serum at Day 29 | -1.556 Log10 (International Units/milliliter) | Standard Deviation 1.3787 |
| Cohorts 1-3 Placebo | Change From Baseline in HBV Surface Antigen (HBsAg) Level in Serum at Day 29 | 0.000 Log10 (International Units/milliliter) | Standard Deviation 0.1116 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in HBV Surface Antigen (HBsAg) Level in Serum at Day 29 | -1.986 Log10 (International Units/milliliter) | Standard Deviation 1.7986 |
| Cohort 4 Placebo | Change From Baseline in HBV Surface Antigen (HBsAg) Level in Serum at Day 29 | -0.008 Log10 (International Units/milliliter) | Standard Deviation 0.039 |
p-value: 0.245ANCOVA
p-value: 0.001ANCOVA
p-value: 0.762ANCOVA
Secondary
Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Day 29
Blood samples were collected from participants to assess HBV DNA viral load. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. The last observation carried forward (LOCF) method was used to impute missing values at Day 29 in this analysis.
Time frame: Baseline (Day 1 pre-dose) and Day 29
Population: Full Analysis Set Population comprised of practically-feasible Intent-to-treat population, including subset of the Safety Set with a Baseline and at least 1 post-Baseline plasma HBV DNA concentration. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision,hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Day 29 | -0.384 Log10 (International Units/milliliter) | Standard Deviation 0.4199 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Day 29 | -1.655 Log10 (International Units/milliliter) | Standard Deviation 1.4791 |
| Cohorts 1-3 Placebo | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Day 29 | -0.001 Log10 (International Units/milliliter) | Standard Deviation 0.471 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Day 29 | 0.075 Log10 (International Units/milliliter) | Standard Deviation 0.1667 |
| Cohort 4 Placebo | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Day 29 | 0.000 Log10 (International Units/milliliter) | Standard Deviation 0 |
p-value: 0.116ANCOVA
p-value: <0.001ANCOVA
p-value: 0.573ANCOVA
Secondary
Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Week 31
Blood samples were collected from participants to assess HBV DNA viral load. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1 pre-dose) and Week 31
Population: Full Analysis Set Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Week 31 | -4.754 Log10 (International Units/milliliter) | Standard Deviation 0.8344 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Week 31 | -4.770 Log10 (International Units/milliliter) | Standard Deviation 1.2823 |
| Cohorts 1-3 Placebo | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Week 31 | -3.547 Log10 (International Units/milliliter) | Standard Deviation 1.2798 |
| Cohort 4 GSK3228836 300 mg | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Week 31 | 0.000 Log10 (International Units/milliliter) | Standard Deviation 0 |
| Cohort 4 Placebo | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Week 31 | 0.000 Log10 (International Units/milliliter) | — |
p-value: 0.609ANCOVA
p-value: 0.141ANCOVA
Secondary
Change From Baseline in Serum HBeAg Concentration at Day 29 in Participants Who Were HBeAg Positive at Baseline
Blood samples were collected from participants to assess HBeAg level. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. Participant was considered HBeAg positive at Baseline if the Baseline value\> 0.09 International Units/milliliter (IU/mL).
Time frame: Baseline (Day 1, Pre dose) and at Day 29
Population: Full Analysis Set Population. Only those participants with data available at the specified data points were analyzed. None of the participants were HBeAg positive at Baseline in Cohort 4, hence no data to report (N=0) for Cohort 4 arms. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Serum HBeAg Concentration at Day 29 in Participants Who Were HBeAg Positive at Baseline | -0.004 Log10 (IU/mL) | Standard Deviation 0.3967 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Serum HBeAg Concentration at Day 29 in Participants Who Were HBeAg Positive at Baseline | -0.052 Log10 (IU/mL) | Standard Deviation 0.6741 |
| Cohorts 1-3 Placebo | Change From Baseline in Serum HBeAg Concentration at Day 29 in Participants Who Were HBeAg Positive at Baseline | 0.133 Log10 (IU/mL) | Standard Deviation 0.2884 |
p-value: 0.763ANCOVA
p-value: 0.804ANCOVA
Secondary
Change From Baseline in Serum HBeAg Concentration at Week 31 in Participants Who Were HBeAg Positive at Baseline
Blood samples were collected from participants to assess HBeAg level. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. Participant was considered HBeAg positive at Baseline if the Baseline value\> 0.09 U/mL.
Time frame: Baseline (Day 1, Pre dose) and Week 31
Population: Full Analysis Set Population. Only those participants with data available at the specified data points were analyzed. None of the participants were HBeAg positive at Baseline in Cohort 4, hence no data to report (N=0) for Cohort 4 arms. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Change From Baseline in Serum HBeAg Concentration at Week 31 in Participants Who Were HBeAg Positive at Baseline | -0.577 Log10 IU/mL | Standard Deviation 1.3711 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Change From Baseline in Serum HBeAg Concentration at Week 31 in Participants Who Were HBeAg Positive at Baseline | -0.195 Log10 IU/mL | Standard Deviation 0.5047 |
| Cohorts 1-3 Placebo | Change From Baseline in Serum HBeAg Concentration at Week 31 in Participants Who Were HBeAg Positive at Baseline | 0.131 Log10 IU/mL | Standard Deviation 0.7477 |
p-value: 0.954ANCOVA
p-value: 0.372ANCOVA
Secondary
Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31
Blood samples were collected to evaluate the percentage of participants with HBsAg loss at Day 29 and Week 31. A 'Loss' of HBsAg means antigen is negative. HBsAg Loss percentage is defined as number of participants with HBsAg loss divided by total number of participants assessed multiplied by 100. Baseline is the last non-missing measurement prior to the first dose of study drug.
Time frame: At Day 29 and Week 31
Population: Full Analysis Set Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31 | Week 31 | 0 Percentage of Participants |
| Cohort 1 GSK3228836 150 mg | Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31 | Day 29 | 0 Percentage of Participants |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31 | Day 29 | 16.7 Percentage of Participants |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31 | Week 31 | 0 Percentage of Participants |
| Cohorts 1-3 Placebo | Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31 | Day 29 | 0 Percentage of Participants |
| Cohorts 1-3 Placebo | Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31 | Week 31 | 0 Percentage of Participants |
| Cohort 4 GSK3228836 300 mg | Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31 | Day 29 | 20.0 Percentage of Participants |
| Cohort 4 GSK3228836 300 mg | Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31 | Week 31 | 0 Percentage of Participants |
| Cohort 4 Placebo | Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31 | Week 31 | 0 Percentage of Participants |
| Cohort 4 Placebo | Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31 | Day 29 | 0 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved HBV e Antigen (HBeAg) Loss at Day 29 and Week 31 Who Were HBeAg Positive at Baseline
Blood samples were collected to evaluate the percentage of participants with HBeAg loss at Day 29 and Week 31. A 'Loss' of HBeAg means antigen is negative. HBeAg Loss percentage is defined as number of participants with HBeAg loss divided by number of participants with positive HBeAg at Baseline multiplied by 100. Baseline is the last non-missing measurement prior to the first dose of study drug. Participants was considered HBeAg positive at Baseline if the Baseline value\> 0.09 U/mL.
Time frame: Baseline (Day 1, Pre dose) and at Day 29 and Week 31
Population: Full Analysis Set Population. Only those participants with data available at the specified data points were analyzed. None of the participants were HBeAg positive at Baseline in Cohort 4, hence no data to report (N=0) for Cohort 4 arms. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Percentage of Participants Who Achieved HBV e Antigen (HBeAg) Loss at Day 29 and Week 31 Who Were HBeAg Positive at Baseline | Week 31 | 0 Percentage of Participants |
| Cohort 1 GSK3228836 150 mg | Percentage of Participants Who Achieved HBV e Antigen (HBeAg) Loss at Day 29 and Week 31 Who Were HBeAg Positive at Baseline | Day 29 | 0 Percentage of Participants |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Percentage of Participants Who Achieved HBV e Antigen (HBeAg) Loss at Day 29 and Week 31 Who Were HBeAg Positive at Baseline | Week 31 | 0 Percentage of Participants |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Percentage of Participants Who Achieved HBV e Antigen (HBeAg) Loss at Day 29 and Week 31 Who Were HBeAg Positive at Baseline | Day 29 | 0 Percentage of Participants |
| Cohorts 1-3 Placebo | Percentage of Participants Who Achieved HBV e Antigen (HBeAg) Loss at Day 29 and Week 31 Who Were HBeAg Positive at Baseline | Day 29 | 0 Percentage of Participants |
| Cohorts 1-3 Placebo | Percentage of Participants Who Achieved HBV e Antigen (HBeAg) Loss at Day 29 and Week 31 Who Were HBeAg Positive at Baseline | Week 31 | 0 Percentage of Participants |
Secondary
Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection
Plasma samples were collected from participants with chronic HBV infection at indicated time points for pharmacokinetic analysis of GSK3228836.
Time frame: Day 1:pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose, Days 2 and 23: 24 hours post-dose, Day 4: 72 hours post-dose, Days 8 and 15: pre-dose, Day 22: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose, and Days 29, 36, 57, 85, 113, and 211
Population: Pharmacokinetic Population consisted of participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid pharmacokinetic metric. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 3 hours post-dose, n=5,12,4 | 4070.00 Nanogram per milliliter | Standard Deviation 2146.742 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 4 hours post-dose, n=6,12,5 | 3340.00 Nanogram per milliliter | Standard Deviation 1223.781 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 3 hours post-dose, n=6,12,5 | 3360.00 Nanogram per milliliter | Standard Deviation 1614.955 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 2 hours post-dose, n=5,12,4 | 3466.00 Nanogram per milliliter | Standard Deviation 2033.158 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 5 hours post-dose, n=6,12,5 | 3210.00 Nanogram per milliliter | Standard Deviation 1156.962 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 36, n=5,12,4 | 5.32 Nanogram per milliliter | Standard Deviation 1.098 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 6 hours post-dose, n=6,12,5 | 2933.33 Nanogram per milliliter | Standard Deviation 986.097 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 57, n=5,12,4 | 1.91 Nanogram per milliliter | Standard Deviation 0.405 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 1.5 hours post-dose, n=5,12,4 | 2874.00 Nanogram per milliliter | Standard Deviation 1872.173 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 2, 24 hours post dose, n=6,12,5 | 112.22 Nanogram per milliliter | Standard Deviation 79.406 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, pre-dose, n=6,12,5 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 1 hour post-dose, n=5,12,4 | 2133.00 Nanogram per milliliter | Standard Deviation 1616.738 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 4 , 72 hours post-dose, n=6,12,5 | 6.77 Nanogram per milliliter | Standard Deviation 2.759 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 211, n=5,12,4 | 0.38 Nanogram per milliliter | Standard Deviation 0.845 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22 0.5 hour pre-dose, n=5,12,4 | 1315.40 Nanogram per milliliter | Standard Deviation 1064.38 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 8, pre-dose, n=6,12,4 | 7.69 Nanogram per milliliter | Standard Deviation 4.54 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 29, n=5,12,4 | 8.88 Nanogram per milliliter | Standard Deviation 1.68 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, pre-dose, n=5,12,4 | 9.38 Nanogram per milliliter | Standard Deviation 2.279 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 0.5 hour post-dose, n=6,12,5 | 1187.00 Nanogram per milliliter | Standard Deviation 1052.256 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 133, n=5,12,4 | 0.91 Nanogram per milliliter | Standard Deviation 1.273 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 23, 24 hours post-dose, n=5,12,4 | 152.90 Nanogram per milliliter | Standard Deviation 148.879 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 1 hour post-dose, n=6,11,5 | 1909.33 Nanogram per milliliter | Standard Deviation 1287.383 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 85, n=5,12,4 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 5 hours post-dose, n=5,12,4 | 3566.00 Nanogram per milliliter | Standard Deviation 1229.504 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 1.5 hours post-dose, n=6,12,5 | 2440.00 Nanogram per milliliter | Standard Deviation 1515.823 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 6 hours post-dose, n=5,12,4 | 2990.00 Nanogram per milliliter | Standard Deviation 817.099 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 4 hours post-dose, n=5,12,4 | 3760.00 Nanogram per milliliter | Standard Deviation 1572.26 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 2 hours post-dose, n=6,12,5 | 2976.67 Nanogram per milliliter | Standard Deviation 1444.793 |
| Cohort 1 GSK3228836 150 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 15, pre-dose, n=6,12,4 | 10.90 Nanogram per milliliter | Standard Deviation 4.989 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 57, n=5,12,4 | 3.80 Nanogram per milliliter | Standard Deviation 1.294 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 3 hours post-dose, n=6,12,5 | 9905.00 Nanogram per milliliter | Standard Deviation 3494.308 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 15, pre-dose, n=6,12,4 | 30.29 Nanogram per milliliter | Standard Deviation 12.598 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 1.5 hours post-dose, n=5,12,4 | 7094.17 Nanogram per milliliter | Standard Deviation 2862.178 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 3 hours post-dose, n=5,12,4 | 9137.50 Nanogram per milliliter | Standard Deviation 3303.139 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 6 hours post-dose, n=5,12,4 | 7769.17 Nanogram per milliliter | Standard Deviation 2295.697 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 36, n=5,12,4 | 12.58 Nanogram per milliliter | Standard Deviation 6.332 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, pre-dose, n=6,12,5 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 0.5 hour post-dose, n=6,12,5 | 2145.58 Nanogram per milliliter | Standard Deviation 1295.533 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 1 hour post-dose, n=6,11,5 | 4950.91 Nanogram per milliliter | Standard Deviation 2025.302 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 1.5 hours post-dose, n=6,12,5 | 6536.67 Nanogram per milliliter | Standard Deviation 2710.704 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 2 hours post-dose, n=6,12,5 | 8387.50 Nanogram per milliliter | Standard Deviation 3287.981 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 4 hours post-dose, n=6,12,5 | 9658.33 Nanogram per milliliter | Standard Deviation 3612.189 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 5 hours post-dose, n=6,12,5 | 9813.33 Nanogram per milliliter | Standard Deviation 3524.376 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 6 hours post-dose, n=6,12,5 | 9345.00 Nanogram per milliliter | Standard Deviation 3258.863 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 2, 24 hours post dose, n=6,12,5 | 336.88 Nanogram per milliliter | Standard Deviation 301.302 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 4 , 72 hours post-dose, n=6,12,5 | 12.92 Nanogram per milliliter | Standard Deviation 3.975 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 8, pre-dose, n=6,12,4 | 22.07 Nanogram per milliliter | Standard Deviation 7.715 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, pre-dose, n=5,12,4 | 22.85 Nanogram per milliliter | Standard Deviation 9.848 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22 0.5 hour pre-dose, n=5,12,4 | 2073.58 Nanogram per milliliter | Standard Deviation 883.806 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 1 hour post-dose, n=5,12,4 | 4815.83 Nanogram per milliliter | Standard Deviation 1835.595 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 2 hours post-dose, n=5,12,4 | 8351.67 Nanogram per milliliter | Standard Deviation 3274.596 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 4 hours post-dose, n=5,12,4 | 8650.00 Nanogram per milliliter | Standard Deviation 2913.339 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 5 hours post-dose, n=5,12,4 | 8072.50 Nanogram per milliliter | Standard Deviation 2748.322 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 23, 24 hours post-dose, n=5,12,4 | 387.88 Nanogram per milliliter | Standard Deviation 209.944 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 29, n=5,12,4 | 23.42 Nanogram per milliliter | Standard Deviation 9.358 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 85, n=5,12,4 | 1.32 Nanogram per milliliter | Standard Deviation 0.872 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 133, n=5,12,4 | 0.59 Nanogram per milliliter | Standard Deviation 0.619 |
| Cohort 2 and Cohort 3 GSK3228836 300 mg | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 211, n=5,12,4 | 1.04 Nanogram per milliliter | Standard Deviation 2.438 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 4 hours post-dose, n=6,12,5 | 9632.00 Nanogram per milliliter | Standard Deviation 2115.401 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 5 hours post-dose, n=6,12,5 | 9122.00 Nanogram per milliliter | Standard Deviation 2616.662 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 2 hours post-dose, n=5,12,4 | 6765.00 Nanogram per milliliter | Standard Deviation 3805.422 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 3 hours post-dose, n=6,12,5 | 8916.00 Nanogram per milliliter | Standard Deviation 2541.324 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 3 hours post-dose, n=5,12,4 | 8325.00 Nanogram per milliliter | Standard Deviation 5007.95 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 1.5 hours post-dose, n=6,12,5 | 6100.00 Nanogram per milliliter | Standard Deviation 1816.631 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 85, n=5,12,4 | 0.31 Nanogram per milliliter | Standard Deviation 0.625 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 4 hours post-dose, n=5,12,4 | 8690.00 Nanogram per milliliter | Standard Deviation 4808.791 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 1 hour post-dose, n=6,11,5 | 4074.00 Nanogram per milliliter | Standard Deviation 1314.565 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 8, pre-dose, n=6,12,4 | 21.80 Nanogram per milliliter | Standard Deviation 6.458 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 6 hours post-dose, n=5,12,4 | 7447.50 Nanogram per milliliter | Standard Deviation 3817.376 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 0.5 hour post-dose, n=6,12,5 | 1630.00 Nanogram per milliliter | Standard Deviation 539.583 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 211, n=5,12,4 | 0.37 Nanogram per milliliter | Standard Deviation 0.73 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 23, 24 hours post-dose, n=5,12,4 | 524.00 Nanogram per milliliter | Standard Deviation 372.305 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, pre-dose, n=6,12,5 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 133, n=5,12,4 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 29, n=5,12,4 | 21.50 Nanogram per milliliter | Standard Deviation 4.883 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 36, n=5,12,4 | 8.96 Nanogram per milliliter | Standard Deviation 3.246 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 15, pre-dose, n=6,12,4 | 33.33 Nanogram per milliliter | Standard Deviation 11.536 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 2 hours post-dose, n=6,12,5 | 7556.00 Nanogram per milliliter | Standard Deviation 2672.579 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, pre-dose, n=5,12,4 | 25.43 Nanogram per milliliter | Standard Deviation 7.63 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 4 , 72 hours post-dose, n=6,12,5 | 15.24 Nanogram per milliliter | Standard Deviation 3.138 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 57, n=5,12,4 | 1.90 Nanogram per milliliter | Standard Deviation 0.752 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22 0.5 hour pre-dose, n=5,12,4 | 1447.75 Nanogram per milliliter | Standard Deviation 850.592 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 2, 24 hours post dose, n=6,12,5 | 356.00 Nanogram per milliliter | Standard Deviation 140.49 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 5 hours post-dose, n=5,12,4 | 8027.50 Nanogram per milliliter | Standard Deviation 4274.166 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 1 hour post-dose, n=5,12,4 | 3477.50 Nanogram per milliliter | Standard Deviation 2009.766 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 1, 6 hours post-dose, n=6,12,5 | 8580.00 Nanogram per milliliter | Standard Deviation 2203.418 |
| Cohorts 1-3 Placebo | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Day 22, 1.5 hours post-dose, n=5,12,4 | 5235.00 Nanogram per milliliter | Standard Deviation 3036.341 |