Scleroderma, Systemic
Conditions
Keywords
Systemic Sclerosis, Repeat-dose, Phase IIA, GSK2330811, Pharmacodynamics, Pharmacokinetics, Proof of mechanism study
Brief summary
GSK2330811 is a humanized monoclonal antibody which is in development for systemic sclerosis (SSc), a rare autoimmune disease with high morbidity and mortality. Currently, there are no approved disease modifying therapies and it is an area of high unmet medical need. GSK2330811 has been shown to bind and neutralize Oncostatin M (OSM) that has been associated with fibrosis, vasculopathy and inflammation in a number of diseases. This multi-center, randomized, double-blind (sponsor open), placebo controlled, proof of mechanism study will be the first study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeat subcutaneous (SC) doses of GSK2330811 in male and female participants with diffuse cutaneous SSc (dcSSc). Participants with active disease and a disease duration of \<= 60 months will be enrolled. Approximately 24 to 40 participants will be randomized across two sequential cohorts. Cohort 1 will evaluate a repeat-dose predicted to provide sub-maximal inhibition of OSM, leading to a dose escalation decision. Cohort 1 is planned to consist of at least 4 participants, randomized such that 3 participants will receive GSK2330811 100 milligram (mg) and 1 will receive placebo. Cohort 2 is planned to consist of at least 20 participants, randomized such that participants will receive GSK2330811 300 mg and placebo in a 3:1 ratio respectively. The duration of the study is up to 34 weeks including a screening period of up to 6 weeks, treatment period of 12 weeks and follow-up period of 16 weeks.
Interventions
DRUGGSK2330811
GSK2330811 will be provided in vials and packed in 1 vial per carton. Each vial will contain 1.2 mL fill with 1 mL extractable volume at 100 mg/mL.
DRUGPlacebo
Normal saline (0.9 percent weight per volume sodium chloride).
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants of 18 years or over, at the time of signing the informed consent. * Documented diagnosis of systemic sclerosis with diffuse cutaneous involvement. * Modified rodnan skin score (mRSS) \>=10 and \<=35 at screening. * In all cases, a disease duration of \<=60 months at screening, defined as time from onset of the first non-Raynaud's phenomenon manifestation. * Active disease defined by at least one of the following criteria at screening: * C-Reactive Protein (CRP) \>=6 mg/liter (L) (0.6 mg/deciliter \[dL\]), that in the opinion of the investigator is due to SSc. * Disease duration \<=18 months at screening, defined as time from the first non-Raynaud's phenomenon manifestation. * Increase of \>=3 mRSS units, compared with an assessment performed within the previous 6 months. * Involvement of one new body area and an increase of \>=2 mRSS units compared with an assessment performed within the previous 6 months. * Involvement of two new body areas within the previous 6 months. * An area of uninvolved or mildly thickened skin that in the opinion of the investigator would allow subcutaneous injection either at abdomen, front or middle region of the thigh or at outer area of the upper arm. * An area of involved skin (mRSS \>=1) on the forearm suitable for repeated skin biopsies to be collected. * Participants who are taking mycophenolate mofetil (\<=3,000 mg/day) or equivalent mycophenolate sodium (\<=2160 mg/day) are permitted in the study if the participant has been on a stable dose for \>=3 months at the first dosing day (Day 1) and participant and investigator are willing to continue this dose until at least completion of the Day 85 (Week 12) visit. If mycophenolate was recently ceased, there must be \>=3 months between the date mycophenolate was ceased and the first dosing day (Day 1). * Participants who are taking oral corticosteroids (\<=10 mg/day of prednisone or equivalent) are permitted in the study if the participant has been receiving a dose no greater than 10 mg/day for at least 4 weeks at the first dosing day (Day 1) and the investigator does not anticipate increasing the dose above 10 mg/day during the study. * Participants who are taking phosphodiesterase 5 (PDE5) inhibitors and endothelin receptor antagonists (including bosentan) are permitted in the study if the participant has been on a stable dose for at least 4 weeks for PDE5 inhibitors and for at least 3 months for endothelin antagonists at the first dosing day (Day 1) and participant and investigator are willing to continue this dose until at least completion of the Day 85 (Week 12) visit. * Participants who are taking non-immunosuppressive medications are permitted in the study (e.g. hydroxychloroquine, angiotensin converting enzyme (ACE) inhibitors/angiotensin II receptor (AR) blockers, calcium-channel blockers and proton-pump inhibitors). However no new long-term medications and no dose-changes to existing long term medications are permitted during the two weeks prior to the first dosing day (Day 1). * Male participants must agree to use contraception during the dosing period and for at least 126 days (18 weeks) after the last dose of study treatment and refrain from donating sperm during this period. * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either she is not a woman of childbearing potential (WOCBP) or she is a WOCBP who agrees to use contraceptives from 28 days prior to first dosing day (Day 1), during the dosing period and for at least 126 days (18 weeks) after the last dose of study treatment. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions for this study.
Exclusion criteria
* Participants classified to the limited cutaneous SSc subset, as determined by the investigator. * Rheumatic autoimmune disease other than dcSSc including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, dermatomyositis, systemic vasculitis and primary Sjogren's syndrome, as determined by the investigator. * Forced vital capacity (FVC) \<=50 percentage of predicted, or a diffusing capacity of the lung for carbon dioxide (DLCO) (corrected for hemoglobin) \<=40 percentage of predicted at screening. * Pulmonary arterial hypertension, as determined by the investigator. * Clinically significant inflammatory myositis (related to SSc), as determined by the investigator. * SSc renal crisis within 6 months of the first day of dosing (Day 1). * History of clinically significant or uncontrolled cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease at screening not related to SSc and that in the opinion of the investigator would prevent participation in the study. * Known bleeding or coagulation disorder. * Major surgery (including joint surgery) within 3 months prior to screening, or planned during the duration of the study. * Clinically significant multiple or severe drug allergies (including to humanized monoclonal antibodies), intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A \[IgA\] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis). * An active infection, or a history of infections as follows: * History of opportunistic infections that have not resolved by 6 months prior to the first day of dosing (Day1) or recurrent infection as determined by the investigator. This does not include infections that may occur in immunocompetent individuals, such as fungal nail infections or vaginal candidiasis, unless it is of an unusual severity or frequency. * A serious infection requiring treatment with intravenous antibiotics and/or hospitalization, if the last dose of antibiotics or the hospital discharge date was within 3 months of the first day of dosing (Day1). * An acute or chronic infection requiring treatment with oral antibiotics or antiviral medications, if the last dose was received within 4 weeks of the first day of dosing (Day1). * Any active or unresolved bacterial, viral or fungal infection present on the first day of dosing (Day1), whether requiring treatment or not. This does not include fungal nail infections. * Active or past osteomyelitis, unless fully resolved in the opinion of the investigator. * Symptomatic herpes zoster that has not resolved by 3 months prior to the first day of dosing (Day1). * History of Tuberculosis (TB) or a positive QuantiFERON-TB Gold test or QuantiFERON-TB Gold PLUS test at screening. * If the QuantiFERON-TB Gold test or QuantiFERON-TB Gold PLUS test is indeterminate, it can be repeated once. A participant will not be eligible unless the second test is negative or they have a negative tuberculin skin test (defined as skin induration \<5 mm at 48 to 72 hours, regardless of Bacillus Calmette-Guerin or other vaccination history). * There must be no other clinical evidence of TB on physical examination of the participant (screening examination). * Alanine transferase (ALT) \>2 times upper limit of normal (ULN) at screening. * Bilirubin \>1.5 times ULN at screening (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percentage). * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones). Participants with evidence of liver fat on imaging but who are otherwise eligible for the study criteria may be enrolled. * QTc \>480 milliseconds (msec) or QTc \>500 msec in participants with bundle branch block at screening. * A history of carcinoma in situ and malignant disease, with the exception of basal cell carcinoma that has been completely excised prior to the study. * Treatment with methotrexate within 3 months prior to the first dosing day (Day 1). * Previous or planned bone marrow transplant (e.g. autologous stem cell transplant). * Treatment with a biologic within the following timeframes: * Tocilizumab, abatacept or anti- tumor necrosis factor (including etanercept, infliximab, certolizumab, golimumab or adalimumab) within 3 months prior to the first dosing day (Day 1). * Rituximab within 12 months prior to the first dosing day (Day 1). * For any other biologic consult the medical monitor. * Treatment with oral or intravenous cyclophosphamide within 6 months prior to the first dosing day (Day 1). * Treatment with any other non-biologic systemic immunosuppressive medication (e.g. azathioprine, tacrolimus, ciclosporin) not mentioned above within 4 weeks prior to the first dosing day (Day 1), with the exception of mycophenolate and permitted oral corticosteroid. * Treatment with topical immunosuppressive medications (e.g. topical corticosteroids, tacrolimus) within 1 week prior to the first dosing day (Day 1). * Treatment with intravenous prostanoids (e.g. iloprost) within 2 weeks prior to the first dosing day (Day 1) or planned treatment before the Day 85 (Week 12) visit. * Treatment with anti-fibrotic medications including tyrosine kinase inhibitors (e.g. nintedinib and imatinib) and pirfenidone within 3 months prior to the first dosing day (Day 1). * Live vaccine(s) within 4 weeks prior to the first dosing day (Day 1), or plans to receive such vaccines during the study. * Treatment with anti-coagulant medications, including warfarin, heparin, thrombin inhibitors, and factor Xa inhibitors within 2 weeks prior to the first dosing day (Day 1). * Treatment with anti-platelet medications (e.g. clopidogrel, prasugrel, ticagrelor and dipyridamole) within 2 weeks prior to first dosing day (Day 1). This does not include aspirin at doses of 150 mg or less, or non-steroidal anti-inflammatory drugs, which are permitted. * Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study treatment. * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day (Day 1). * Any of the following at screening: * Hemoglobin \<110 gram (g)/L * Platelet count \<150x10\^9/L * Estimated glomerular filtration rate (GFR) (modification of diet in renal disease \[MDRD\] calculation) of \<45 mL/minute/1.73m\^2 * A positive human immunodeficiency virus (HIV) antibody test at screening. * Presence of hepatitis B surface antigen (HBsAg) at screening. * Positive hepatitis B core antibody (HBcAb) test at screening. * Positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment. * Positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment. * Sensitivity to any of the study treatments or components thereof, or other allergy that in the opinion of the investigator, contraindicates participation in the study. * Where participation in the study would result in donation of blood or blood products in excess of a volume of 500 mL during the study. * A history of drug and alcohol misuse that could interfere with participation in the trial according to the protocol, or in the opinion of the investigator impacts on the physical or mental wellbeing of the participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Up to Day 57 | Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT intervals. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented. |
| Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze chemistry parameters: total bilirubin and direct bilirubin. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | Baseline (Day 1: Pre-dose) and Day 85 | Blood samples were collected to analyze chemistry parameters: cholesterol, direct HDL cholesterol, LDL cholesterol and triglycerides. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from post-dose visit value. |
| Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze chemistry parameters: corrected calcium and urea. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze chemistry parameter: estimated glomerular filtration rate. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Up to Day 197 | Urine samples were collected for the assessment of potential of hydrogen, specific gravity, glucose, ketones, occult blood and protein by dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters: potential of hydrogen, specific gravity, glucose, ketones, occult blood and protein were categorized as 'any increase from Baseline', which imply any increase in their concentrations in the urine sample. Only participants with emergent worst case any increase from Baseline values are presented. |
| Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | Baseline (Day 1: Pre-dose) and up to Day 197 | Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured in a seated or semi-supine position after 5 minutes of rest using a completely automated device. PCI ranges were: SBP (increase or decrease from Baseline of \>=40 millimeter of mercury \[mmHg\]), DBP (increase or decrease from Baseline of \>=20 mmHg), and HR (increase or decrease from Baseline of \>=30 beats per minute). Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. |
| Change From Baseline in Body Temperature | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Body temperature was measured in a seated or semi-supine position after 5 minutes of rest. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Up to Day 197, but protocol allowed for additional events to be collected; up to Day 603 post first dose | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. SAEs were collected up to Day 197, but the protocol also allowed investigators to report SAEs occurring after participants had completed the study. This outcome measure includes two SAEs reported after participants had completed the study, occurring on Day 306 and Day 603 following first dose. Safety Population consisted of all randomized participants who have taken at least 1 dose of study treatment. |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and WBC count. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze the hematology parameters: hemoglobin and MCHC. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze the hematology parameter: MCH. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze the hematology parameters: MCV and MPV. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze the hematology parameters: RBC count and reticulocyte count. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze the hematology parameter: RDW. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Reticulocyte Production Index | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze the hematology parameter: Reticulocyte Production Index. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Reticulocyte Production Index (RPI) was calculated as 'Reticulocyte Production Index = Reticulocyte Count (percent \[%\]) multiply by (x) (hematocrit \[%\] divided by \[/\] 45) x 1/ reticulocyte maturation time'. |
| Change From Baseline Hematology Parameter: Reticulocytes | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze the hematology parameter: reticulocytes. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Up to Day 197 | Blood samples were collected for analysis of clinical chemistry parameters. PCI ranges were low: \<30 grams per liter (g/L) (albumin), high: \>44.2 micromoles per liter (µmol/L) increase from Baseline (creatinine), low: \<3 or high: \>9 mmol/L (glucose), low: \<3 or high: \>5.5 mmol/L (potassium), and low: \<130 or high: \>150 mmol/L (sodium). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there was no change in their category. Participants whose laboratory value category was unchanged (e.g. High to High), or whose value became within range, were recorded in the To within Range or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add up to 100%. |
| Change From Baseline in Chemistry Parameter: Total Protein | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze chemistry parameter: total protein. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197 | Blood samples were collected to analyze chemistry parameters: ALP, ALT, AST and LDH. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration at the End of the Dosing Interval (Ctrough) of GSK2330811 | Days 1, 15, 29, 57, 85, 113, 155 and 197 | Blood samples were collected at the indicated time points for PK analysis of GSK2330811. |
| Apparent Clearance (CL/F) of GSK2330811 | Days 1, 15, 29, 57, 85, 113, 155 and 197 | Blood samples were collected at the indicated time points for PK analysis of GSK2330811. Data was analyzed by population pharmacokinetic methods using a non-linear mixed-effects modelling approach. |
| Apparent Volume of Distribution (Vss/F) of GSK2330811 | Days 1, 15, 29, 57, 85, 113, 155 and 197 | Blood samples were collected at the indicated time points for PK analysis of GSK2330811. Data was analyzed by population pharmacokinetic methods using a non-linear mixed-effects modelling approach. |
| Serum Level of Total Oncostatin M (OSM) | Days 1, 15, 29, 57, 85, 113, 155 and 197 | Blood samples were collected at indicated timepoints for analysis of total OSM levels in serum. Per Protocol Population comprised of participants in the 'Safety' population who complied with the protocol. |
| Serum Level of Free OSM | Days 1, 15, 29, 57, 85, 113, 155 and 197 | Blood samples were collected at indicated timepoints for analysis of free OSM levels in serum. |
| Number of Participants With Positive Anti-GSK2330811 Antibodies | Days 1, 15, 57, 85 and 197 | Serum samples were collected for the determination of anti-GSK2330811 antibodies (ADA) using a binding antibody detection assay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that were confirmed positive in the confirmation assay were reported as 'positive'. |
| Plasma Concentrations of GSK2330811 | Days 1, 15, 29, 57, 85, 113, 155 and 197 | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK2330811. Pharmacokinetic (PK) Population was defined as participants in the 'Safety' population who received an active dose and for whom a PK sample was obtained and analyzed. |
Countries
Canada, Netherlands, United Kingdom, United States
Participant flow
Recruitment details
This was a randomized, double-blind (sponsor open), proof of mechanism study of GSK2330811 in participants with diffuse cutaneous systemic sclerosis. This study was conducted in Canada, Netherlands, United Kingdom and United States.
Pre-assignment details
A total of 35 participants were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received subcutaneous injection of placebo on Day 1 and then every other week until the final dose on Day 71 (Week 10). | 8 |
| GSK2330811 100 mg Participants received subcutaneous injection of GSK2330811 100 milligrams (mg) on Day 1 and then every other week until the final dose on Day 71 (Week 10). | 3 |
| GSK2330811 300 mg Participants received subcutaneous injection of GSK2330811 300 mg on Day 1 and then every other week until the final dose on Day 71 (Week 10). | 24 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | GSK2330811 100 mg | GSK2330811 300 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 50.8 Years STANDARD_DEVIATION 15.42 | 66.7 Years STANDARD_DEVIATION 4.73 | 52.6 Years STANDARD_DEVIATION 12.59 | 53.4 Years STANDARD_DEVIATION 13.24 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 7 Participants | 3 Participants | 20 Participants | 30 Participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 19 Participants | 26 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 3 | 0 / 24 |
| other Total, other adverse events | 8 / 8 | 3 / 3 | 24 / 24 |
| serious Total, serious adverse events | 1 / 8 | 0 / 3 | 2 / 24 |
Outcome results
Primary
Change From Baseline Hematology Parameter: Reticulocytes
Blood samples were collected to analyze the hematology parameter: reticulocytes. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Hematology Parameter: Reticulocytes | Day 15: n=8,3,23 | 0.0026 Percentage of reticulocytes | Standard Deviation 0.00534 |
| Placebo | Change From Baseline Hematology Parameter: Reticulocytes | Day 57: n=6,3,22 | -0.0012 Percentage of reticulocytes | Standard Deviation 0.00214 |
| Placebo | Change From Baseline Hematology Parameter: Reticulocytes | Day 43: n=8,3,22 | -0.0008 Percentage of reticulocytes | Standard Deviation 0.00128 |
| Placebo | Change From Baseline Hematology Parameter: Reticulocytes | Day 29: n=8,3,23 | 0.0001 Percentage of reticulocytes | Standard Deviation 0.00155 |
| Placebo | Change From Baseline Hematology Parameter: Reticulocytes | Day 71: n=8,3,19 | 0.0014 Percentage of reticulocytes | Standard Deviation 0.00325 |
| Placebo | Change From Baseline Hematology Parameter: Reticulocytes | Day 197: n=7,3,15 | 0.0001 Percentage of reticulocytes | Standard Deviation 0.00157 |
| Placebo | Change From Baseline Hematology Parameter: Reticulocytes | Day 155: n=7,3,17 | 0.0006 Percentage of reticulocytes | Standard Deviation 0.00162 |
| Placebo | Change From Baseline Hematology Parameter: Reticulocytes | Day 85: n=7,3,22 | -0.0007 Percentage of reticulocytes | Standard Deviation 0.00138 |
| Placebo | Change From Baseline Hematology Parameter: Reticulocytes | Day 113: n=7,3,20 | -0.0011 Percentage of reticulocytes | Standard Deviation 0.00219 |
| GSK2330811 100 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 85: n=7,3,22 | -0.0043 Percentage of reticulocytes | Standard Deviation 0.00651 |
| GSK2330811 100 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 113: n=7,3,20 | 0.0013 Percentage of reticulocytes | Standard Deviation 0.00702 |
| GSK2330811 100 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 155: n=7,3,17 | -0.0027 Percentage of reticulocytes | Standard Deviation 0.00603 |
| GSK2330811 100 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 197: n=7,3,15 | -0.0063 Percentage of reticulocytes | Standard Deviation 0.00924 |
| GSK2330811 100 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 43: n=8,3,22 | -0.0057 Percentage of reticulocytes | Standard Deviation 0.00611 |
| GSK2330811 100 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 57: n=6,3,22 | -0.0023 Percentage of reticulocytes | Standard Deviation 0.00551 |
| GSK2330811 100 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 71: n=8,3,19 | -0.0027 Percentage of reticulocytes | Standard Deviation 0.00551 |
| GSK2330811 100 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 29: n=8,3,23 | -0.0040 Percentage of reticulocytes | Standard Deviation 0.00265 |
| GSK2330811 100 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 15: n=8,3,23 | -0.0053 Percentage of reticulocytes | Standard Deviation 0.00551 |
| GSK2330811 300 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 197: n=7,3,15 | 0.0005 Percentage of reticulocytes | Standard Deviation 0.00233 |
| GSK2330811 300 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 15: n=8,3,23 | -0.0037 Percentage of reticulocytes | Standard Deviation 0.00236 |
| GSK2330811 300 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 29: n=8,3,23 | -0.0030 Percentage of reticulocytes | Standard Deviation 0.00423 |
| GSK2330811 300 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 43: n=8,3,22 | -0.0021 Percentage of reticulocytes | Standard Deviation 0.00389 |
| GSK2330811 300 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 57: n=6,3,22 | 0.0004 Percentage of reticulocytes | Standard Deviation 0.00422 |
| GSK2330811 300 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 71: n=8,3,19 | 0.0037 Percentage of reticulocytes | Standard Deviation 0.00625 |
| GSK2330811 300 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 85: n=7,3,22 | 0.0065 Percentage of reticulocytes | Standard Deviation 0.00647 |
| GSK2330811 300 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 155: n=7,3,17 | 0.0054 Percentage of reticulocytes | Standard Deviation 0.00405 |
| GSK2330811 300 mg | Change From Baseline Hematology Parameter: Reticulocytes | Day 113: n=7,3,20 | 0.0121 Percentage of reticulocytes | Standard Deviation 0.00704 |
Primary
Change From Baseline in Body Temperature
Body temperature was measured in a seated or semi-supine position after 5 minutes of rest. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Body Temperature | Day 85: n=8,3,22 | 0.012 Degrees Celsius | Standard Deviation 0.3563 |
| Placebo | Change From Baseline in Body Temperature | Day 57: n=7,3,22 | 0.100 Degrees Celsius | Standard Deviation 0.2449 |
| Placebo | Change From Baseline in Body Temperature | Day 155: n=7,3,17 | -0.257 Degrees Celsius | Standard Deviation 0.3409 |
| Placebo | Change From Baseline in Body Temperature | Day 71: n=8,3,21 | -0.112 Degrees Celsius | Standard Deviation 0.5303 |
| Placebo | Change From Baseline in Body Temperature | Day 197: n=7,3,17 | -0.143 Degrees Celsius | Standard Deviation 0.486 |
| Placebo | Change From Baseline in Body Temperature | Day 113: n=7,3,20 | -0.257 Degrees Celsius | Standard Deviation 0.3505 |
| Placebo | Change From Baseline in Body Temperature | Day 43: n=8,3,23 | 0.012 Degrees Celsius | Standard Deviation 0.4121 |
| Placebo | Change From Baseline in Body Temperature | Day 15: n=8,3,23 | 0.037 Degrees Celsius | Standard Deviation 0.4689 |
| Placebo | Change From Baseline in Body Temperature | Day 29: n=8,3,23 | 0.037 Degrees Celsius | Standard Deviation 0.3889 |
| GSK2330811 100 mg | Change From Baseline in Body Temperature | Day 197: n=7,3,17 | 0.267 Degrees Celsius | Standard Deviation 0.4933 |
| GSK2330811 100 mg | Change From Baseline in Body Temperature | Day 29: n=8,3,23 | 0.467 Degrees Celsius | Standard Deviation 0.6807 |
| GSK2330811 100 mg | Change From Baseline in Body Temperature | Day 43: n=8,3,23 | 0.033 Degrees Celsius | Standard Deviation 0.4163 |
| GSK2330811 100 mg | Change From Baseline in Body Temperature | Day 57: n=7,3,22 | 0.133 Degrees Celsius | Standard Deviation 0.3215 |
| GSK2330811 100 mg | Change From Baseline in Body Temperature | Day 71: n=8,3,21 | 0.267 Degrees Celsius | Standard Deviation 0.5132 |
| GSK2330811 100 mg | Change From Baseline in Body Temperature | Day 85: n=8,3,22 | 0.467 Degrees Celsius | Standard Deviation 0.5859 |
| GSK2330811 100 mg | Change From Baseline in Body Temperature | Day 113: n=7,3,20 | 0.400 Degrees Celsius | Standard Deviation 0.6245 |
| GSK2330811 100 mg | Change From Baseline in Body Temperature | Day 155: n=7,3,17 | 0.167 Degrees Celsius | Standard Deviation 0.5033 |
| GSK2330811 100 mg | Change From Baseline in Body Temperature | Day 15: n=8,3,23 | 0.400 Degrees Celsius | Standard Deviation 0.4359 |
| GSK2330811 300 mg | Change From Baseline in Body Temperature | Day 85: n=8,3,22 | -0.023 Degrees Celsius | Standard Deviation 0.3854 |
| GSK2330811 300 mg | Change From Baseline in Body Temperature | Day 29: n=8,3,23 | 0.130 Degrees Celsius | Standard Deviation 0.347 |
| GSK2330811 300 mg | Change From Baseline in Body Temperature | Day 155: n=7,3,17 | 0.118 Degrees Celsius | Standard Deviation 0.6054 |
| GSK2330811 300 mg | Change From Baseline in Body Temperature | Day 113: n=7,3,20 | 0.100 Degrees Celsius | Standard Deviation 0.4952 |
| GSK2330811 300 mg | Change From Baseline in Body Temperature | Day 57: n=7,3,22 | 0.177 Degrees Celsius | Standard Deviation 0.4253 |
| GSK2330811 300 mg | Change From Baseline in Body Temperature | Day 197: n=7,3,17 | 0.212 Degrees Celsius | Standard Deviation 0.5122 |
| GSK2330811 300 mg | Change From Baseline in Body Temperature | Day 71: n=8,3,21 | 0.186 Degrees Celsius | Standard Deviation 0.4328 |
| GSK2330811 300 mg | Change From Baseline in Body Temperature | Day 43: n=8,3,23 | 0.039 Degrees Celsius | Standard Deviation 0.4197 |
| GSK2330811 300 mg | Change From Baseline in Body Temperature | Day 15: n=8,3,23 | 0.117 Degrees Celsius | Standard Deviation 0.3833 |
Primary
Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea
Blood samples were collected to analyze chemistry parameters: corrected calcium and urea. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 85: Corrected calcium, n=8,3,22 | -0.043 Millimoles per liter | Standard Deviation 0.0599 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 43: Corrected calcium, n=8,3,22 | -0.003 Millimoles per liter | Standard Deviation 0.0483 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 29: Urea, n=8,2,23 | 0.0000 Millimoles per liter | Standard Deviation 1.13389 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 113: Corrected calcium, n=7,3,20 | -0.026 Millimoles per liter | Standard Deviation 0.0746 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 155: Urea, n=7,3,18 | 0.2857 Millimoles per liter | Standard Deviation 1.75255 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 15: Urea, n=7,2,23 | 0.0714 Millimoles per liter | Standard Deviation 1.13389 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 155: Corrected calcium, n=7,3,18 | -0.037 Millimoles per liter | Standard Deviation 0.0678 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 29: Corrected calcium, n=8,2,23 | -0.035 Millimoles per liter | Standard Deviation 0.0563 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 197: Corrected calcium, n=7,3,19 | 0.014 Millimoles per liter | Standard Deviation 0.0862 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 57: Corrected calcium, n=7,3,22 | -0.003 Millimoles per liter | Standard Deviation 0.0509 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 85: Urea, n=8,3,22 | -0.1875 Millimoles per liter | Standard Deviation 1.25178 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 113: Urea, n=7,3,20 | 0.2857 Millimoles per liter | Standard Deviation 1.70434 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 71: Urea, n=8,3,21 | -0.1875 Millimoles per liter | Standard Deviation 1.3076 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 197: Urea, n=7,3,19 | -0.0714 Millimoles per liter | Standard Deviation 2.11007 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 57: Urea, n=7,3,22 | -0.1429 Millimoles per liter | Standard Deviation 1.14434 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 71: Corrected calcium, n=8,3,21 | -0.023 Millimoles per liter | Standard Deviation 0.0362 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 15: Corrected calcium, n=7,2,23 | 0.011 Millimoles per liter | Standard Deviation 0.054 |
| Placebo | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 43: Urea, n=8,3,22 | 0.4375 Millimoles per liter | Standard Deviation 1.08356 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 15: Corrected calcium, n=7,2,23 | -0.020 Millimoles per liter | Standard Deviation 0.0566 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 71: Urea, n=8,3,21 | -0.5000 Millimoles per liter | Standard Deviation 0.5 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 29: Corrected calcium, n=8,2,23 | -0.070 Millimoles per liter | Standard Deviation 0.0424 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 43: Corrected calcium, n=8,3,22 | -0.060 Millimoles per liter | Standard Deviation 0.02 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 57: Corrected calcium, n=7,3,22 | -0.060 Millimoles per liter | Standard Deviation 0.0721 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 71: Corrected calcium, n=8,3,21 | -0.020 Millimoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 85: Corrected calcium, n=8,3,22 | -0.027 Millimoles per liter | Standard Deviation 0.0808 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 113: Corrected calcium, n=7,3,20 | 0.000 Millimoles per liter | Standard Deviation 0.0346 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 155: Corrected calcium, n=7,3,18 | 0.000 Millimoles per liter | Standard Deviation 0.0346 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 197: Corrected calcium, n=7,3,19 | -0.020 Millimoles per liter | Standard Deviation 0.06 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 15: Urea, n=7,2,23 | -2.0000 Millimoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 29: Urea, n=8,2,23 | -0.7500 Millimoles per liter | Standard Deviation 0.35355 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 43: Urea, n=8,3,22 | -0.8333 Millimoles per liter | Standard Deviation 0.28868 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 57: Urea, n=7,3,22 | -0.8333 Millimoles per liter | Standard Deviation 0.76376 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 85: Urea, n=8,3,22 | -0.1667 Millimoles per liter | Standard Deviation 0.76376 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 113: Urea, n=7,3,20 | -0.8333 Millimoles per liter | Standard Deviation 0.28868 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 155: Urea, n=7,3,18 | -0.8333 Millimoles per liter | Standard Deviation 1.1547 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 197: Urea, n=7,3,19 | -1.0000 Millimoles per liter | Standard Deviation 0.5 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 15: Corrected calcium, n=7,2,23 | -0.013 Millimoles per liter | Standard Deviation 0.0725 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 43: Urea, n=8,3,22 | 0.3182 Millimoles per liter | Standard Deviation 1.34116 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 57: Corrected calcium, n=7,3,22 | -0.069 Millimoles per liter | Standard Deviation 0.0827 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 197: Urea, n=7,3,19 | 0.1510 Millimoles per liter | Standard Deviation 1.7645 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 57: Urea, n=7,3,22 | 0.5682 Millimoles per liter | Standard Deviation 1.30289 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 43: Corrected calcium, n=8,3,22 | -0.061 Millimoles per liter | Standard Deviation 0.0737 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 71: Urea, n=8,3,21 | 0.0952 Millimoles per liter | Standard Deviation 1.50515 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 29: Corrected calcium, n=8,2,23 | -0.036 Millimoles per liter | Standard Deviation 0.0809 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 155: Urea, n=7,3,18 | 0.0912 Millimoles per liter | Standard Deviation 1.5254 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 85: Urea, n=8,3,22 | 0.4091 Millimoles per liter | Standard Deviation 1.40269 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 197: Corrected calcium, n=7,3,19 | -0.020 Millimoles per liter | Standard Deviation 0.0629 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 113: Corrected calcium, n=7,3,20 | -0.035 Millimoles per liter | Standard Deviation 0.055 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 155: Corrected calcium, n=7,3,18 | -0.034 Millimoles per liter | Standard Deviation 0.0508 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 15: Urea, n=7,2,23 | 0.3043 Millimoles per liter | Standard Deviation 1.56481 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 85: Corrected calcium, n=8,3,22 | -0.049 Millimoles per liter | Standard Deviation 0.0689 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 113: Urea, n=7,3,20 | 0.4000 Millimoles per liter | Standard Deviation 1.47434 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 29: Urea, n=8,2,23 | 0.3043 Millimoles per liter | Standard Deviation 1.67698 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Corrected Calcium, Urea | Day 71: Corrected calcium, n=8,3,21 | -0.066 Millimoles per liter | Standard Deviation 0.0705 |
Primary
Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate
Blood samples were collected to analyze chemistry parameter: estimated glomerular filtration rate. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 29: n=8,2,23 | -4.3085 Milliliter/minute/1.73 square meter | Standard Deviation 8.34077 |
| Placebo | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 113: n=7,3,20 | -2.7351 Milliliter/minute/1.73 square meter | Standard Deviation 12.23546 |
| Placebo | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 197: n=7,3,21 | -4.2733 Milliliter/minute/1.73 square meter | Standard Deviation 15.3664 |
| Placebo | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 15: n=7,2,23 | -6.4180 Milliliter/minute/1.73 square meter | Standard Deviation 10.28099 |
| Placebo | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 43: n=8,3,22 | -0.4780 Milliliter/minute/1.73 square meter | Standard Deviation 9.34592 |
| Placebo | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 57: n=7,3,22 | 1.3446 Milliliter/minute/1.73 square meter | Standard Deviation 7.121 |
| Placebo | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 155: n=7,3,20 | -0.9239 Milliliter/minute/1.73 square meter | Standard Deviation 13.25672 |
| Placebo | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 71: n=8,3,21 | -0.4405 Milliliter/minute/1.73 square meter | Standard Deviation 12.50899 |
| Placebo | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 85: n=8,3,22 | -1.0010 Milliliter/minute/1.73 square meter | Standard Deviation 8.15284 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 57: n=7,3,22 | 2.6893 Milliliter/minute/1.73 square meter | Standard Deviation 5.61068 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 85: n=8,3,22 | -7.1513 Milliliter/minute/1.73 square meter | Standard Deviation 6.77426 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 29: n=8,2,23 | -2.7765 Milliliter/minute/1.73 square meter | Standard Deviation 9.78424 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 43: n=8,3,22 | -4.3223 Milliliter/minute/1.73 square meter | Standard Deviation 3.88914 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 113: n=7,3,20 | -0.2900 Milliliter/minute/1.73 square meter | Standard Deviation 6.1999 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 155: n=7,3,20 | -3.9510 Milliliter/minute/1.73 square meter | Standard Deviation 5.74 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 15: n=7,2,23 | 1.7630 Milliliter/minute/1.73 square meter | Standard Deviation 1.28693 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 197: n=7,3,21 | -7.7100 Milliliter/minute/1.73 square meter | Standard Deviation 8.47159 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 71: n=8,3,21 | -0.9993 Milliliter/minute/1.73 square meter | Standard Deviation 5.98467 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 197: n=7,3,21 | -2.7185 Milliliter/minute/1.73 square meter | Standard Deviation 8.91665 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 155: n=7,3,20 | -4.2795 Milliliter/minute/1.73 square meter | Standard Deviation 9.19612 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 15: n=7,2,23 | -0.7528 Milliliter/minute/1.73 square meter | Standard Deviation 9.25789 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 29: n=8,2,23 | -1.5543 Milliliter/minute/1.73 square meter | Standard Deviation 9.55847 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 43: n=8,3,22 | -3.4266 Milliliter/minute/1.73 square meter | Standard Deviation 6.99189 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 57: n=7,3,22 | -5.1256 Milliliter/minute/1.73 square meter | Standard Deviation 7.41957 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 71: n=8,3,21 | -2.5432 Milliliter/minute/1.73 square meter | Standard Deviation 7.12712 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 85: n=8,3,22 | -5.1038 Milliliter/minute/1.73 square meter | Standard Deviation 8.90164 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate | Day 113: n=7,3,20 | -8.5267 Milliliter/minute/1.73 square meter | Standard Deviation 7.71222 |
Primary
Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH)
Blood samples were collected to analyze chemistry parameters: ALP, ALT, AST and LDH. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 197: LDH, n=7,3,19 | -10.9 International units per liter | Standard Deviation 27.97 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 113: AST, n=7,3,20 | -2.7 International units per liter | Standard Deviation 4.39 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 113: ALT, n=7,3,20 | -1.4 International units per liter | Standard Deviation 5.13 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 15: ALP, n=7,2,23 | -1.3 International units per liter | Standard Deviation 10.53 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 85: ALT, n=8,3,22 | -1.5 International units per liter | Standard Deviation 3.89 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 85: ALP, n=8,3,22 | -2.4 International units per liter | Standard Deviation 11.96 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 29: LDH, n=8,2,23 | -7.0 International units per liter | Standard Deviation 14.95 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 71: ALT, n=8,3,21 | 0.3 International units per liter | Standard Deviation 2.82 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 113: ALP, n=7,3,20 | -1.3 International units per liter | Standard Deviation 4.99 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 85: AST, n=8,3,22 | -0.8 International units per liter | Standard Deviation 4.37 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 57: ALT, n=7,3,22 | -1.6 International units per liter | Standard Deviation 1.27 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 155: ALP, n=7,3,19 | -8.4 International units per liter | Standard Deviation 15.88 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 29: ALP, n=8,2,23 | -2.3 International units per liter | Standard Deviation 7.89 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 43: ALT, n=8,3,22 | 1.3 International units per liter | Standard Deviation 3.15 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 197: ALP, n=7,3,19 | -3.6 International units per liter | Standard Deviation 12.16 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 71: AST, n=8,3,21 | 1.9 International units per liter | Standard Deviation 5 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 29: ALT, n=8,2,23 | 0.6 International units per liter | Standard Deviation 1.85 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 15: ALT, n=7,2,23 | -0.4 International units per liter | Standard Deviation 2.7 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 57: AST, n=7,3,22 | -0.6 International units per liter | Standard Deviation 2.82 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 43: ALP, n=8,3,22 | -4.4 International units per liter | Standard Deviation 12.36 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 197: AST, n=7,3,19 | 0.1 International units per liter | Standard Deviation 4.91 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 43: AST, n=8,3,22 | 1.6 International units per liter | Standard Deviation 6.74 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 57: ALP, n=7,3,22 | -5.0 International units per liter | Standard Deviation 13.23 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 43: LDH, n=8,3,22 | 12.1 International units per liter | Standard Deviation 11.54 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 29: AST, n=8,2,23 | 1.8 International units per liter | Standard Deviation 7.11 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 71: ALP, n=8,3,21 | -3.5 International units per liter | Standard Deviation 10.94 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 71: LDH, n=8,3,21 | 10.5 International units per liter | Standard Deviation 29.62 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 155: AST, n=7,3,18 | -5.0 International units per liter | Standard Deviation 7.7 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 15: AST, n=7,2,23 | -0.1 International units per liter | Standard Deviation 1.77 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 85: LDH, n=8,3,22 | -2.5 International units per liter | Standard Deviation 26.26 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 57: LDH, n=7,3,22 | -5.1 International units per liter | Standard Deviation 19.36 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 197: ALT, n=7,3,21 | 3.6 International units per liter | Standard Deviation 3.87 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 113: LDH, n=7,3,20 | -17.6 International units per liter | Standard Deviation 17.89 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 155: LDH, n=7,3,17 | -20.4 International units per liter | Standard Deviation 32.67 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 15: LDH, n=7,2,23 | 4.1 International units per liter | Standard Deviation 28.54 |
| Placebo | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 155: ALT, n=7,3,18 | -2.6 International units per liter | Standard Deviation 6.65 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 15: LDH, n=7,2,23 | -3.5 International units per liter | Standard Deviation 51.62 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 43: LDH, n=8,3,22 | 2.7 International units per liter | Standard Deviation 30.62 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 113: LDH, n=7,3,20 | 6.3 International units per liter | Standard Deviation 25.5 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 29: LDH, n=8,2,23 | 11.0 International units per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 57: LDH, n=7,3,22 | 15.3 International units per liter | Standard Deviation 31.02 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 15: ALP, n=7,2,23 | -1.0 International units per liter | Standard Deviation 4.24 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 29: ALP, n=8,2,23 | 4.5 International units per liter | Standard Deviation 6.36 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 43: ALP, n=8,3,22 | 0.7 International units per liter | Standard Deviation 7.51 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 57: ALP, n=7,3,22 | 3.3 International units per liter | Standard Deviation 9.07 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 71: LDH, n=8,3,21 | 13.3 International units per liter | Standard Deviation 26.95 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 85: LDH, n=8,3,22 | 3.0 International units per liter | Standard Deviation 11.53 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 155: LDH, n=7,3,17 | 1.0 International units per liter | Standard Deviation 16 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 197: LDH, n=7,3,19 | 0.3 International units per liter | Standard Deviation 20.6 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 71: ALP, n=8,3,21 | 1.3 International units per liter | Standard Deviation 1.53 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 85: ALP, n=8,3,22 | -2.3 International units per liter | Standard Deviation 4.93 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 113: ALP, n=7,3,20 | -2.3 International units per liter | Standard Deviation 4.93 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 155: ALP, n=7,3,19 | -3.3 International units per liter | Standard Deviation 5.69 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 197: ALP, n=7,3,19 | -4.0 International units per liter | Standard Deviation 6.93 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 15: ALT, n=7,2,23 | 0.0 International units per liter | Standard Deviation 1.41 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 29: ALT, n=8,2,23 | -2.0 International units per liter | Standard Deviation 2.83 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 43: ALT, n=8,3,22 | 4.0 International units per liter | Standard Deviation 6.08 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 57: ALT, n=7,3,22 | 2.0 International units per liter | Standard Deviation 4.58 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 71: ALT, n=8,3,21 | 3.0 International units per liter | Standard Deviation 6.24 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 85: ALT, n=8,3,22 | -0.3 International units per liter | Standard Deviation 2.52 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 113: ALT, n=7,3,20 | 4.7 International units per liter | Standard Deviation 8.14 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 155: ALT, n=7,3,18 | 1.0 International units per liter | Standard Deviation 1 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 197: ALT, n=7,3,21 | -0.3 International units per liter | Standard Deviation 2.52 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 15: AST, n=7,2,23 | 0.5 International units per liter | Standard Deviation 0.71 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 29: AST, n=8,2,23 | 1.0 International units per liter | Standard Deviation 1.41 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 43: AST, n=8,3,22 | 2.0 International units per liter | Standard Deviation 3.61 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 57: AST, n=7,3,22 | 2.3 International units per liter | Standard Deviation 3.06 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 71: AST, n=8,3,21 | 3.3 International units per liter | Standard Deviation 4.93 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 85: AST, n=8,3,22 | 0.3 International units per liter | Standard Deviation 2.31 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 113: AST, n=7,3,20 | 1.3 International units per liter | Standard Deviation 4.04 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 155: AST, n=7,3,18 | 2.3 International units per liter | Standard Deviation 0.58 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 197: AST, n=7,3,19 | 2.7 International units per liter | Standard Deviation 0.58 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 85: AST, n=8,3,22 | -0.2 International units per liter | Standard Deviation 2.2 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 113: ALT, n=7,3,20 | 0.2 International units per liter | Standard Deviation 3.18 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 155: LDH, n=7,3,17 | 13.4 International units per liter | Standard Deviation 12.63 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 57: LDH, n=7,3,22 | 22.4 International units per liter | Standard Deviation 23.71 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 155: ALT, n=7,3,18 | 0.9 International units per liter | Standard Deviation 3.95 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 85: LDH, n=8,3,22 | 24.9 International units per liter | Standard Deviation 28.66 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 197: AST, n=7,3,19 | 1.2 International units per liter | Standard Deviation 3.32 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 197: ALT, n=7,3,21 | 2.4 International units per liter | Standard Deviation 4.69 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 71: LDH, n=8,3,21 | 32.7 International units per liter | Standard Deviation 29.9 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 113: AST, n=7,3,20 | -0.9 International units per liter | Standard Deviation 2.5 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 15: AST, n=7,2,23 | 1.7 International units per liter | Standard Deviation 5.11 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 57: ALP, n=7,3,22 | 1.0 International units per liter | Standard Deviation 7.55 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 43: LDH, n=8,3,22 | 27.2 International units per liter | Standard Deviation 34.69 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 29: AST, n=8,2,23 | 2.0 International units per liter | Standard Deviation 5.42 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 43: ALP, n=8,3,22 | -1.1 International units per liter | Standard Deviation 9 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 15: LDH, n=7,2,23 | 18.4 International units per liter | Standard Deviation 32.34 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 43: AST, n=8,3,22 | 0.9 International units per liter | Standard Deviation 4.14 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 29: ALP, n=8,2,23 | -1.1 International units per liter | Standard Deviation 10.94 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 155: AST, n=7,3,18 | -0.6 International units per liter | Standard Deviation 2.66 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 15: ALT, n=7,2,23 | 1.6 International units per liter | Standard Deviation 3.85 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 197: ALP, n=7,3,19 | -2.1 International units per liter | Standard Deviation 11.03 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 57: AST, n=7,3,22 | 2.0 International units per liter | Standard Deviation 5.34 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 29: ALT, n=8,2,23 | 3.3 International units per liter | Standard Deviation 9.58 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 155: ALP, n=7,3,19 | -5.4 International units per liter | Standard Deviation 9.84 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 29: LDH, n=8,2,23 | 20.9 International units per liter | Standard Deviation 22.9 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 43: ALT, n=8,3,22 | 3.1 International units per liter | Standard Deviation 10.7 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 113: ALP, n=7,3,20 | -6.3 International units per liter | Standard Deviation 8.15 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 71: AST, n=8,3,21 | -0.3 International units per liter | Standard Deviation 1.98 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 57: ALT, n=7,3,22 | 3.7 International units per liter | Standard Deviation 10.03 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 85: ALP, n=8,3,22 | -3.0 International units per liter | Standard Deviation 11.65 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 15: ALP, n=7,2,23 | 0.6 International units per liter | Standard Deviation 5.67 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 71: ALT, n=8,3,21 | 0.0 International units per liter | Standard Deviation 2.67 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 71: ALP, n=8,3,21 | -3.0 International units per liter | Standard Deviation 11.52 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 113: LDH, n=7,3,20 | 14.2 International units per liter | Standard Deviation 26.43 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 85: ALT, n=8,3,22 | 0.4 International units per liter | Standard Deviation 4.27 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) | Day 197: LDH, n=7,3,19 | 16.1 International units per liter | Standard Deviation 21.91 |
Primary
Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides
Blood samples were collected to analyze chemistry parameters: cholesterol, direct HDL cholesterol, LDL cholesterol and triglycerides. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose) and Day 85
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | Cholesterol: n=8,3,22 | -0.125 Millimoles per liter | Standard Deviation 0.7474 |
| Placebo | Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | Direct HDL Cholesterol: n=7,3,22 | -0.093 Millimoles per liter | Standard Deviation 0.1718 |
| Placebo | Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | LDL Cholesterol: n=7,3,21 | -0.091 Millimoles per liter | Standard Deviation 0.7376 |
| Placebo | Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | Triglycerides: n=8,3,22 | 0.025 Millimoles per liter | Standard Deviation 0.3427 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | Triglycerides: n=8,3,22 | -0.020 Millimoles per liter | Standard Deviation 0.08 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | Cholesterol: n=8,3,22 | 0.067 Millimoles per liter | Standard Deviation 0.1258 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | LDL Cholesterol: n=7,3,21 | 0.110 Millimoles per liter | Standard Deviation 0.12 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | Direct HDL Cholesterol: n=7,3,22 | -0.033 Millimoles per liter | Standard Deviation 0.0289 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | Triglycerides: n=8,3,22 | 0.535 Millimoles per liter | Standard Deviation 0.8036 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | Direct HDL Cholesterol: n=7,3,22 | -0.036 Millimoles per liter | Standard Deviation 0.2989 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | LDL Cholesterol: n=7,3,21 | 0.274 Millimoles per liter | Standard Deviation 0.5011 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Cholesterol, Direct High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides | Cholesterol: n=8,3,22 | 0.450 Millimoles per liter | Standard Deviation 0.578 |
Primary
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin
Blood samples were collected to analyze chemistry parameters: total bilirubin and direct bilirubin. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 57: Direct bilirubin, n=7,3,22 | 0.0 Micromoles per liter | Standard Deviation 0 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 57: Total bilirubin, n=7,3,22 | -0.286 Micromoles per liter | Standard Deviation 1.3801 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 71: Direct bilirubin, n=8,3,21 | -0.3 Micromoles per liter | Standard Deviation 0.71 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 85: Direct bilirubin, n=8,3,22 | -0.3 Micromoles per liter | Standard Deviation 0.71 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 113: Direct bilirubin, n=7,3,20 | 0.0 Micromoles per liter | Standard Deviation 1.15 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 71: Total bilirubin, n=8,3,21 | 0.250 Micromoles per liter | Standard Deviation 1.9821 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 155: Direct bilirubin, n=7,3,17 | -0.3 Micromoles per liter | Standard Deviation 0.76 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 85: Total bilirubin, n=8,3,22 | 0.250 Micromoles per liter | Standard Deviation 2.7124 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 197: Direct bilirubin, n=7,3,17 | 0.0 Micromoles per liter | Standard Deviation 0 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 113: Total bilirubin, n=7,3,20 | 0.000 Micromoles per liter | Standard Deviation 3.266 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 29: Total bilirubin, n=8,2,23 | -1.000 Micromoles per liter | Standard Deviation 2.8284 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 155: Total bilirubin, n=7,3,18 | -1.143 Micromoles per liter | Standard Deviation 3.0237 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 197: Total bilirubin, n=7,3,20 | 0.571 Micromoles per liter | Standard Deviation 2.7603 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 15: Total bilirubin, n=7,2,23 | 0.571 Micromoles per liter | Standard Deviation 2.2254 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 15: Direct bilirubin, n=7,2,23 | 0.0 Micromoles per liter | Standard Deviation 0 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 43: Total bilirubin, n=8,3,22 | -1.500 Micromoles per liter | Standard Deviation 1.4142 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 29: Direct bilirubin, n=8,2,23 | -0.3 Micromoles per liter | Standard Deviation 0.71 |
| Placebo | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 43: Direct bilirubin, n=8,3,22 | -0.3 Micromoles per liter | Standard Deviation 0.71 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 43: Total bilirubin, n=8,3,22 | -2.000 Micromoles per liter | Standard Deviation 2 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 57: Direct bilirubin, n=7,3,22 | 0.0 Micromoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 113: Total bilirubin, n=7,3,20 | -1.333 Micromoles per liter | Standard Deviation 1.1547 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 15: Direct bilirubin, n=7,2,23 | 0.0 Micromoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 71: Direct bilirubin, n=8,3,21 | 0.0 Micromoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 57: Total bilirubin, n=7,3,22 | -2.000 Micromoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 15: Total bilirubin, n=7,2,23 | 2.000 Micromoles per liter | Standard Deviation 2.8284 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 85: Direct bilirubin, n=8,3,22 | 0.0 Micromoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 85: Total bilirubin, n=8,3,22 | -2.000 Micromoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 155: Total bilirubin, n=7,3,18 | -3.333 Micromoles per liter | Standard Deviation 1.1547 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 113: Direct bilirubin, n=7,3,20 | -0.7 Micromoles per liter | Standard Deviation 1.15 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 29: Total bilirubin, n=8,2,23 | -3.000 Micromoles per liter | Standard Deviation 1.4142 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 43: Direct bilirubin, n=8,3,22 | 0.0 Micromoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 155: Direct bilirubin, n=7,3,17 | 0.0 Micromoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 197: Total bilirubin, n=7,3,20 | -4.000 Micromoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 29: Direct bilirubin, n=8,2,23 | 0.0 Micromoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 197: Direct bilirubin, n=7,3,17 | 0.0 Micromoles per liter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 71: Total bilirubin, n=8,3,21 | -1.333 Micromoles per liter | Standard Deviation 1.1547 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 197: Direct bilirubin, n=7,3,17 | -0.1 Micromoles per liter | Standard Deviation 1.11 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 71: Total bilirubin, n=8,3,21 | -0.095 Micromoles per liter | Standard Deviation 2.1425 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 85: Total bilirubin, n=8,3,22 | -0.364 Micromoles per liter | Standard Deviation 1.8138 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 15: Total bilirubin, n=7,2,23 | -0.957 Micromoles per liter | Standard Deviation 1.8944 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 29: Total bilirubin, n=8,2,23 | -0.087 Micromoles per liter | Standard Deviation 1.8565 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 43: Total bilirubin, n=8,3,22 | -0.364 Micromoles per liter | Standard Deviation 1.4653 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 57: Total bilirubin, n=7,3,22 | -0.636 Micromoles per liter | Standard Deviation 2.0827 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 113: Total bilirubin, n=7,3,20 | 0.100 Micromoles per liter | Standard Deviation 1.5183 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 155: Total bilirubin, n=7,3,18 | -1.604 Micromoles per liter | Standard Deviation 2.4901 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 197: Total bilirubin, n=7,3,20 | -1.416 Micromoles per liter | Standard Deviation 1.6976 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 15: Direct bilirubin, n=7,2,23 | -0.4 Micromoles per liter | Standard Deviation 1.59 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 29: Direct bilirubin, n=8,2,23 | 0.0 Micromoles per liter | Standard Deviation 1.21 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 43: Direct bilirubin, n=8,3,22 | -0.2 Micromoles per liter | Standard Deviation 1.05 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 57: Direct bilirubin, n=7,3,22 | -0.4 Micromoles per liter | Standard Deviation 1.18 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 71: Direct bilirubin, n=8,3,21 | -0.1 Micromoles per liter | Standard Deviation 1.18 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 85: Direct bilirubin, n=8,3,22 | -0.2 Micromoles per liter | Standard Deviation 1.05 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 113: Direct bilirubin, n=7,3,20 | -0.3 Micromoles per liter | Standard Deviation 0.98 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin | Day 155: Direct bilirubin, n=7,3,17 | -0.2 Micromoles per liter | Standard Deviation 0.97 |
Primary
Change From Baseline in Chemistry Parameter: Total Protein
Blood samples were collected to analyze chemistry parameter: total protein. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chemistry Parameter: Total Protein | Day 57: n=7,3,22 | 1.3 Grams per liter | Standard Deviation 2.29 |
| Placebo | Change From Baseline in Chemistry Parameter: Total Protein | Day 197: n=7,3,19 | 2.3 Grams per liter | Standard Deviation 3.9 |
| Placebo | Change From Baseline in Chemistry Parameter: Total Protein | Day 85: n=8,3,22 | 0.3 Grams per liter | Standard Deviation 1.39 |
| Placebo | Change From Baseline in Chemistry Parameter: Total Protein | Day 71: n=8,3,21 | -0.1 Grams per liter | Standard Deviation 3.56 |
| Placebo | Change From Baseline in Chemistry Parameter: Total Protein | Day 15: n=7,2,23 | 1.0 Grams per liter | Standard Deviation 3.06 |
| Placebo | Change From Baseline in Chemistry Parameter: Total Protein | Day 155: n=7,3,18 | -1.3 Grams per liter | Standard Deviation 1.25 |
| Placebo | Change From Baseline in Chemistry Parameter: Total Protein | Day 43: n=8,3,22 | -0.1 Grams per liter | Standard Deviation 2.36 |
| Placebo | Change From Baseline in Chemistry Parameter: Total Protein | Day 29: n=8,2,23 | -0.1 Grams per liter | Standard Deviation 3.14 |
| Placebo | Change From Baseline in Chemistry Parameter: Total Protein | Day 113: n=7,3,20 | -0.9 Grams per liter | Standard Deviation 2.61 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 71: n=8,3,21 | 0.7 Grams per liter | Standard Deviation 1.15 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 15: n=7,2,23 | 0.5 Grams per liter | Standard Deviation 4.95 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 29: n=8,2,23 | -1.0 Grams per liter | Standard Deviation 5.66 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 43: n=8,3,22 | -0.3 Grams per liter | Standard Deviation 2.08 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 57: n=7,3,22 | 1.3 Grams per liter | Standard Deviation 2.08 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 85: n=8,3,22 | 0.0 Grams per liter | Standard Deviation 2 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 113: n=7,3,20 | 1.7 Grams per liter | Standard Deviation 0.58 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 155: n=7,3,18 | 3.0 Grams per liter | Standard Deviation 7.21 |
| GSK2330811 100 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 197: n=7,3,19 | 2.3 Grams per liter | Standard Deviation 3.51 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 43: n=8,3,22 | -0.5 Grams per liter | Standard Deviation 3.52 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 15: n=7,2,23 | 0.4 Grams per liter | Standard Deviation 3.56 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 113: n=7,3,20 | 0.2 Grams per liter | Standard Deviation 4.06 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 29: n=8,2,23 | 0.7 Grams per liter | Standard Deviation 2.86 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 197: n=7,3,19 | 1.5 Grams per liter | Standard Deviation 5 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 71: n=8,3,21 | -1.1 Grams per liter | Standard Deviation 4.44 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 57: n=7,3,22 | -0.5 Grams per liter | Standard Deviation 3.65 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 155: n=7,3,18 | -0.1 Grams per liter | Standard Deviation 4.59 |
| GSK2330811 300 mg | Change From Baseline in Chemistry Parameter: Total Protein | Day 85: n=8,3,22 | 0.3 Grams per liter | Standard Deviation 3.71 |
Primary
Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit | Day 57: n=6,3,22 | -0.0092 Proportion of red blood cells in blood | Standard Deviation 0.025 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit | Day 197: n=7,3,15 | -0.0111 Proportion of red blood cells in blood | Standard Deviation 0.02634 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit | Day 85: n=7,3,22 | -0.0151 Proportion of red blood cells in blood | Standard Deviation 0.02591 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit | Day 71: n=8,3,20 | -0.0146 Proportion of red blood cells in blood | Standard Deviation 0.0287 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit | Day 15: n=8,3,23 | -0.0089 Proportion of red blood cells in blood | Standard Deviation 0.02744 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit | Day 155: n=7,3,17 | -0.0164 Proportion of red blood cells in blood | Standard Deviation 0.03169 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit | Day 43: n=8,3,22 | -0.0049 Proportion of red blood cells in blood | Standard Deviation 0.01788 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit | Day 29: n=8,3,23 | -0.0023 Proportion of red blood cells in blood | Standard Deviation 0.01955 |
| Placebo | Change From Baseline in Hematology Parameter: Hematocrit | Day 113: n=7,3,20 | -0.0141 Proportion of red blood cells in blood | Standard Deviation 0.03007 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 71: n=8,3,20 | -0.0217 Proportion of red blood cells in blood | Standard Deviation 0.02329 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 15: n=8,3,23 | 0.0127 Proportion of red blood cells in blood | Standard Deviation 0.02203 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 29: n=8,3,23 | -0.0027 Proportion of red blood cells in blood | Standard Deviation 0.04234 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 43: n=8,3,22 | -0.0057 Proportion of red blood cells in blood | Standard Deviation 0.03564 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 57: n=6,3,22 | -0.0120 Proportion of red blood cells in blood | Standard Deviation 0.03274 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 85: n=7,3,22 | -0.0300 Proportion of red blood cells in blood | Standard Deviation 0.01803 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 113: n=7,3,20 | -0.0323 Proportion of red blood cells in blood | Standard Deviation 0.02822 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 155: n=7,3,17 | -0.0263 Proportion of red blood cells in blood | Standard Deviation 0.01626 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 197: n=7,3,15 | -0.0193 Proportion of red blood cells in blood | Standard Deviation 0.00981 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 43: n=8,3,22 | -0.0271 Proportion of red blood cells in blood | Standard Deviation 0.03187 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 15: n=8,3,23 | -0.0035 Proportion of red blood cells in blood | Standard Deviation 0.01771 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 113: n=7,3,20 | -0.0602 Proportion of red blood cells in blood | Standard Deviation 0.02839 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 29: n=8,3,23 | -0.0141 Proportion of red blood cells in blood | Standard Deviation 0.02486 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 197: n=7,3,15 | -0.0125 Proportion of red blood cells in blood | Standard Deviation 0.02252 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 71: n=8,3,20 | -0.0637 Proportion of red blood cells in blood | Standard Deviation 0.03983 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 57: n=6,3,22 | -0.0444 Proportion of red blood cells in blood | Standard Deviation 0.04224 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 155: n=7,3,17 | -0.0349 Proportion of red blood cells in blood | Standard Deviation 0.02482 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 85: n=7,3,22 | -0.0688 Proportion of red blood cells in blood | Standard Deviation 0.03265 |
Primary
Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH)
Blood samples were collected to analyze the hematology parameter: MCH. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 15: n=8,3,23 | -0.08 Picogram | Standard Deviation 0.711 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 43: n=8,3,22 | -0.23 Picogram | Standard Deviation 0.807 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 57: n=6,3,22 | -0.25 Picogram | Standard Deviation 0.75 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 197: n=7,3,15 | -0.44 Picogram | Standard Deviation 1.015 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 155: n=7,3,17 | -0.16 Picogram | Standard Deviation 0.637 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 71: n=8,3,20 | 0.18 Picogram | Standard Deviation 0.945 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 85: n=7,3,22 | 0.07 Picogram | Standard Deviation 1.034 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 29: n=8,3,23 | -0.24 Picogram | Standard Deviation 0.616 |
| Placebo | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 113: n=7,3,20 | -0.06 Picogram | Standard Deviation 0.808 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 29: n=8,3,23 | 0.37 Picogram | Standard Deviation 0.709 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 113: n=7,3,20 | 0.87 Picogram | Standard Deviation 0.513 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 155: n=7,3,17 | 0.90 Picogram | Standard Deviation 0.2 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 197: n=7,3,15 | 0.33 Picogram | Standard Deviation 0.208 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 43: n=8,3,22 | -0.10 Picogram | Standard Deviation 0.173 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 15: n=8,3,23 | 0.03 Picogram | Standard Deviation 0.493 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 57: n=6,3,22 | 0.10 Picogram | Standard Deviation 0.361 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 85: n=7,3,22 | -0.30 Picogram | Standard Deviation 0.755 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 71: n=8,3,20 | 0.17 Picogram | Standard Deviation 0.379 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 197: n=7,3,15 | -0.23 Picogram | Standard Deviation 1.285 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 15: n=8,3,23 | 0.04 Picogram | Standard Deviation 0.503 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 29: n=8,3,23 | -0.23 Picogram | Standard Deviation 0.437 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 43: n=8,3,22 | -0.41 Picogram | Standard Deviation 0.45 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 57: n=6,3,22 | -0.39 Picogram | Standard Deviation 0.493 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 71: n=8,3,20 | -0.50 Picogram | Standard Deviation 0.503 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 85: n=7,3,22 | -0.45 Picogram | Standard Deviation 0.709 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 113: n=7,3,20 | -0.27 Picogram | Standard Deviation 0.873 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin (MCH) | Day 155: n=7,3,17 | 0.04 Picogram | Standard Deviation 1.18 |
Primary
Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW)
Blood samples were collected to analyze the hematology parameter: RDW. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 113: n=7,3,20 | 0.26 Percentage of width | Standard Deviation 0.748 |
| Placebo | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 155: n=7,3,17 | -0.09 Percentage of width | Standard Deviation 0.771 |
| Placebo | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 43: n=8,3,22 | 0.25 Percentage of width | Standard Deviation 0.583 |
| Placebo | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 197: n=7,3,15 | -0.16 Percentage of width | Standard Deviation 1.286 |
| Placebo | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 15: n=8,3,23 | 0.04 Percentage of width | Standard Deviation 0.711 |
| Placebo | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 57: n=6,3,22 | -0.02 Percentage of width | Standard Deviation 0.578 |
| Placebo | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 29: n=8,3,23 | 0.24 Percentage of width | Standard Deviation 0.417 |
| Placebo | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 71: n=8,3,20 | 0.04 Percentage of width | Standard Deviation 0.725 |
| Placebo | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 85: n=7,3,22 | -0.04 Percentage of width | Standard Deviation 0.663 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 85: n=7,3,22 | -0.20 Percentage of width | Standard Deviation 2.307 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 113: n=7,3,20 | 0.73 Percentage of width | Standard Deviation 1.95 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 15: n=8,3,23 | -0.27 Percentage of width | Standard Deviation 1.05 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 71: n=8,3,20 | -0.23 Percentage of width | Standard Deviation 2.57 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 155: n=7,3,17 | 0.10 Percentage of width | Standard Deviation 1.916 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 57: n=6,3,22 | -0.83 Percentage of width | Standard Deviation 2.248 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 29: n=8,3,23 | -0.53 Percentage of width | Standard Deviation 1.704 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 197: n=7,3,15 | -0.57 Percentage of width | Standard Deviation 1.872 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 43: n=8,3,22 | -0.97 Percentage of width | Standard Deviation 1.65 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 197: n=7,3,15 | 1.06 Percentage of width | Standard Deviation 1.375 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 15: n=8,3,23 | -0.26 Percentage of width | Standard Deviation 0.667 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 29: n=8,3,23 | -0.47 Percentage of width | Standard Deviation 1.036 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 43: n=8,3,22 | -0.47 Percentage of width | Standard Deviation 1.049 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 57: n=6,3,22 | 0.15 Percentage of width | Standard Deviation 1.331 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 71: n=8,3,20 | 0.96 Percentage of width | Standard Deviation 2.04 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 113: n=7,3,20 | 4.24 Percentage of width | Standard Deviation 2.737 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 155: n=7,3,17 | 2.86 Percentage of width | Standard Deviation 1.636 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) | Day 85: n=7,3,22 | 1.67 Percentage of width | Standard Deviation 1.792 |
Primary
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and WBC count. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Lymphocytes, n=6,3,22 | -0.043 Giga cells per liter | Standard Deviation 0.3732 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: WBC count, n=7,3,21 | 0.47 Giga cells per liter | Standard Deviation 1.138 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Total neutrophils, n=7,3,20 | 0.680 Giga cells per liter | Standard Deviation 1.2472 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Lymphocytes, n=8,3,20 | -0.060 Giga cells per liter | Standard Deviation 0.2384 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: WBC count, n=8,3,23 | 0.28 Giga cells per liter | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Total neutrophils, n=7,2,22 | -0.139 Giga cells per liter | Standard Deviation 1.1995 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Lymphocytes, n=7,2,22 | -0.109 Giga cells per liter | Standard Deviation 0.2202 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Basophils, n=7,3,18 | -0.006 Giga cells per liter | Standard Deviation 0.0399 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Total neutrophils, n=8,3,20 | 0.789 Giga cells per liter | Standard Deviation 2.1739 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Lymphocytes, n=7,3,21 | -0.297 Giga cells per liter | Standard Deviation 0.5087 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Basophils, n=6,3,22 | -0.010 Giga cells per liter | Standard Deviation 0.0167 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Total neutrophils, n=6,3,22 | 0.538 Giga cells per liter | Standard Deviation 0.9156 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Lymphocytes, n=7,3,20 | -0.046 Giga cells per liter | Standard Deviation 0.2327 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: WBC count, n=8,3,23 | 0.20 Giga cells per liter | Standard Deviation 1.546 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Total neutrophils, n=8,3,22 | 0.315 Giga cells per liter | Standard Deviation 1.3403 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Lymphocytes, n=7,3,18 | -0.066 Giga cells per liter | Standard Deviation 0.4108 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Eosinophils, n=8,3,23 | 0.016 Giga cells per liter | Standard Deviation 0.0616 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Total neutrophils, n=8,3,23 | 0.318 Giga cells per liter | Standard Deviation 1.4309 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Monocytes, n=8,3,23 | 0.096 Giga cells per liter | Standard Deviation 0.1507 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: WBC count, n=7,3,19 | 0.31 Giga cells per liter | Standard Deviation 1.469 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Total neutrophils, n=8,3,23 | 0.228 Giga cells per liter | Standard Deviation 1.324 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Monocytes, n=8,3,23 | 0.006 Giga cells per liter | Standard Deviation 0.0578 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Platelet count, n=7,3,19 | -10.1 Giga cells per liter | Standard Deviation 30.3 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Monocytes, n=7,3,18 | 0.051 Giga cells per liter | Standard Deviation 0.2242 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Monocytes, n=8,3,22 | 0.103 Giga cells per liter | Standard Deviation 0.2093 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Eosinophils, n=8,3,23 | 0.036 Giga cells per liter | Standard Deviation 0.0901 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Monocytes, n=7,3,20 | 0.064 Giga cells per liter | Standard Deviation 0.1229 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Monocytes, n=6,3,22 | -0.037 Giga cells per liter | Standard Deviation 0.0698 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: WBC count, n=7,3,22 | -0.29 Giga cells per liter | Standard Deviation 1.182 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Monocytes, n=7,3,21 | 0.070 Giga cells per liter | Standard Deviation 0.1494 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Monocytes, n=8,3,20 | 0.050 Giga cells per liter | Standard Deviation 0.1414 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Platelet count, n=6,3,20 | -26.7 Giga cells per liter | Standard Deviation 19.62 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Monocytes, n=7,2,22 | -0.007 Giga cells per liter | Standard Deviation 0.0652 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Eosinophils, n=8,3,22 | 0.019 Giga cells per liter | Standard Deviation 0.05 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Basophils, n=8,3,20 | -0.010 Giga cells per liter | Standard Deviation 0.0267 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Platelet count, n=7,3,20 | -14.4 Giga cells per liter | Standard Deviation 25.53 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Eosinophils, n=6,3,22 | 0.010 Giga cells per liter | Standard Deviation 0.0473 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: WBC count, n=7,3,20 | 0.07 Giga cells per liter | Standard Deviation 1.228 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Platelet count, n=7,3,22 | -18.0 Giga cells per liter | Standard Deviation 25.89 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Eosinophils, n=8,3,20 | 0.018 Giga cells per liter | Standard Deviation 0.044 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: WBC count, n=8,3,20 | 0.76 Giga cells per liter | Standard Deviation 2.191 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Platelet count, n=7,3,20 | -12.3 Giga cells per liter | Standard Deviation 17.67 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Eosinophils, n=7,2,22 | 0.001 Giga cells per liter | Standard Deviation 0.0406 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Basophils, n=7,2,22 | -0.020 Giga cells per liter | Standard Deviation 0.0294 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Platelet count, n=6,3,22 | -4.2 Giga cells per liter | Standard Deviation 20.4 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Eosinophils, n=7,3,21 | 0.056 Giga cells per liter | Standard Deviation 0.1005 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Basophils, n=8,3,22 | -0.005 Giga cells per liter | Standard Deviation 0.0169 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Basophils, n=8,3,23 | -0.006 Giga cells per liter | Standard Deviation 0.0262 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Eosinophils, n=7,3,20 | 0.003 Giga cells per liter | Standard Deviation 0.0403 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: WBC count, n=6,3,22 | 0.43 Giga cells per liter | Standard Deviation 0.774 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Platelet count, n=8,3,23 | -16.1 Giga cells per liter | Standard Deviation 14.56 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Eosinophils, n=7,3,18 | 0.069 Giga cells per liter | Standard Deviation 0.1426 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Basophils, n=7,3,21 | -0.006 Giga cells per liter | Standard Deviation 0.0237 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Platelet count, n=7,3,23 | -5.9 Giga cells per liter | Standard Deviation 20.38 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Lymphocytes, n=8,3,23 | -0.116 Giga cells per liter | Standard Deviation 0.3926 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Basophils, n=8,3,23 | -0.005 Giga cells per liter | Standard Deviation 0.0288 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Platelet count, n=8,3,23 | -1.5 Giga cells per liter | Standard Deviation 24.02 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Lymphocytes, n=8,3,23 | -0.064 Giga cells per liter | Standard Deviation 0.2539 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: WBC count, n=8,3,22 | 0.46 Giga cells per liter | Standard Deviation 1.418 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Total neutrophils, n=7,3,18 | 0.317 Giga cells per liter | Standard Deviation 1.3578 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Lymphocytes, n=8,3,22 | 0.020 Giga cells per liter | Standard Deviation 0.2891 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Basophils, n=7,3,20 | 0.004 Giga cells per liter | Standard Deviation 0.027 |
| Placebo | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Total neutrophils, n=7,3,20 | 0.027 Giga cells per liter | Standard Deviation 1.2229 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Platelet count, n=8,3,23 | -49.0 Giga cells per liter | Standard Deviation 22.27 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Basophils, n=8,3,23 | 0.013 Giga cells per liter | Standard Deviation 0.0252 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Basophils, n=8,3,23 | -0.003 Giga cells per liter | Standard Deviation 0.0252 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Basophils, n=8,3,22 | 0.027 Giga cells per liter | Standard Deviation 0.0635 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Basophils, n=6,3,22 | 0.013 Giga cells per liter | Standard Deviation 0.0404 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Basophils, n=8,3,20 | -0.003 Giga cells per liter | Standard Deviation 0.0208 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Basophils, n=7,2,22 | 0.045 Giga cells per liter | Standard Deviation 0.0636 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Basophils, n=7,3,21 | 0.040 Giga cells per liter | Standard Deviation 0.0693 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Basophils, n=7,3,20 | 0.060 Giga cells per liter | Standard Deviation 0.0721 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Basophils, n=7,3,18 | 0.033 Giga cells per liter | Standard Deviation 0.0208 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Eosinophils, n=8,3,23 | 0.070 Giga cells per liter | Standard Deviation 0.07 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Eosinophils, n=8,3,23 | 0.060 Giga cells per liter | Standard Deviation 0.2007 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Eosinophils, n=8,3,22 | 0.103 Giga cells per liter | Standard Deviation 0.1026 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Eosinophils, n=6,3,22 | 0.113 Giga cells per liter | Standard Deviation 0.1795 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Eosinophils, n=8,3,20 | 0.137 Giga cells per liter | Standard Deviation 0.2344 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Eosinophils, n=7,2,22 | 0.130 Giga cells per liter | Standard Deviation 0.3111 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Eosinophils, n=7,3,21 | 0.070 Giga cells per liter | Standard Deviation 0.0872 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Eosinophils, n=7,3,20 | 0.080 Giga cells per liter | Standard Deviation 0.03 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Eosinophils, n=7,3,18 | 0.170 Giga cells per liter | Standard Deviation 0.1323 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Lymphocytes, n=8,3,23 | 0.103 Giga cells per liter | Standard Deviation 0.3955 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Lymphocytes, n=8,3,23 | 0.477 Giga cells per liter | Standard Deviation 0.4177 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Lymphocytes, n=8,3,22 | 0.530 Giga cells per liter | Standard Deviation 0.327 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Lymphocytes, n=6,3,22 | 0.563 Giga cells per liter | Standard Deviation 0.3798 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Lymphocytes, n=8,3,20 | 0.430 Giga cells per liter | Standard Deviation 0.3601 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Lymphocytes, n=7,2,22 | 0.580 Giga cells per liter | Standard Deviation 0.4667 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Lymphocytes, n=7,3,21 | 0.383 Giga cells per liter | Standard Deviation 0.3907 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Lymphocytes, n=7,3,20 | 0.160 Giga cells per liter | Standard Deviation 0.26 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Lymphocytes, n=7,3,18 | -0.010 Giga cells per liter | Standard Deviation 0.4419 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Monocytes, n=8,3,23 | -0.017 Giga cells per liter | Standard Deviation 0.1102 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Monocytes, n=8,3,23 | -0.030 Giga cells per liter | Standard Deviation 0.3959 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Monocytes, n=8,3,22 | 0.047 Giga cells per liter | Standard Deviation 0.1069 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Monocytes, n=6,3,22 | -0.120 Giga cells per liter | Standard Deviation 0.16 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Monocytes, n=8,3,20 | -0.003 Giga cells per liter | Standard Deviation 0.0404 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Monocytes, n=7,2,22 | 0.140 Giga cells per liter | Standard Deviation 0.1697 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Monocytes, n=7,3,21 | 0.030 Giga cells per liter | Standard Deviation 0.1735 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Monocytes, n=7,3,20 | 0.167 Giga cells per liter | Standard Deviation 0.125 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Monocytes, n=7,3,18 | -0.043 Giga cells per liter | Standard Deviation 0.1266 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Total neutrophils, n=8,3,23 | 1.060 Giga cells per liter | Standard Deviation 3.0143 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Total neutrophils, n=8,3,23 | 0.323 Giga cells per liter | Standard Deviation 1.8591 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Total neutrophils, n=8,3,22 | -0.350 Giga cells per liter | Standard Deviation 1.4731 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Total neutrophils, n=6,3,22 | -0.517 Giga cells per liter | Standard Deviation 1.9998 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Total neutrophils, n=8,3,20 | -0.223 Giga cells per liter | Standard Deviation 1.8928 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Total neutrophils, n=7,2,22 | -0.990 Giga cells per liter | Standard Deviation 2.9698 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Total neutrophils, n=7,3,20 | -0.263 Giga cells per liter | Standard Deviation 1.0384 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Total neutrophils, n=7,3,20 | -0.673 Giga cells per liter | Standard Deviation 2.1324 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Total neutrophils, n=7,3,18 | -1.603 Giga cells per liter | Standard Deviation 4.0868 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Platelet count, n=8,3,23 | -42.0 Giga cells per liter | Standard Deviation 32.7 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Platelet count, n=7,3,23 | -39.7 Giga cells per liter | Standard Deviation 29.28 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Platelet count, n=6,3,22 | -66.0 Giga cells per liter | Standard Deviation 42.04 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Platelet count, n=7,3,20 | -41.7 Giga cells per liter | Standard Deviation 45.21 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Platelet count, n=7,3,22 | -48.0 Giga cells per liter | Standard Deviation 29.1 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Platelet count, n=7,3,20 | -20.3 Giga cells per liter | Standard Deviation 42.52 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Platelet count, n=6,3,20 | 15.0 Giga cells per liter | Standard Deviation 31.24 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Platelet count, n=7,3,19 | -20.7 Giga cells per liter | Standard Deviation 71.53 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: WBC count, n=8,3,23 | 1.20 Giga cells per liter | Standard Deviation 2.685 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: WBC count, n=8,3,23 | 0.80 Giga cells per liter | Standard Deviation 1.212 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: WBC count, n=8,3,22 | 0.33 Giga cells per liter | Standard Deviation 0.95 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: WBC count, n=6,3,22 | 0.03 Giga cells per liter | Standard Deviation 1.617 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: WBC count, n=8,3,20 | 0.33 Giga cells per liter | Standard Deviation 1.258 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: WBC count, n=7,3,22 | -0.10 Giga cells per liter | Standard Deviation 1.4 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: WBC count, n=7,3,21 | 0.27 Giga cells per liter | Standard Deviation 0.473 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: WBC count, n=7,3,20 | -0.20 Giga cells per liter | Standard Deviation 1.778 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: WBC count, n=7,3,19 | -1.50 Giga cells per liter | Standard Deviation 4.444 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Lymphocytes, n=6,3,22 | 0.105 Giga cells per liter | Standard Deviation 0.5853 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: WBC count, n=7,3,21 | -0.61 Giga cells per liter | Standard Deviation 1.913 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Total neutrophils, n=7,3,20 | -1.002 Giga cells per liter | Standard Deviation 1.5195 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Lymphocytes, n=8,3,22 | -0.078 Giga cells per liter | Standard Deviation 0.6156 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: WBC count, n=8,3,22 | -1.60 Giga cells per liter | Standard Deviation 2.039 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Total neutrophils, n=7,3,20 | -0.183 Giga cells per liter | Standard Deviation 1.2208 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Lymphocytes, n=8,3,23 | -0.102 Giga cells per liter | Standard Deviation 0.6071 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Basophils, n=7,2,22 | 0.000 Giga cells per liter | Standard Deviation 0.0344 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Total neutrophils, n=7,3,18 | -0.001 Giga cells per liter | Standard Deviation 1.4937 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Lymphocytes, n=8,3,23 | -0.125 Giga cells per liter | Standard Deviation 0.411 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Basophils, n=8,3,23 | 0.003 Giga cells per liter | Standard Deviation 0.035 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Platelet count, n=8,3,23 | -124.6 Giga cells per liter | Standard Deviation 87.57 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Eosinophils, n=7,3,18 | 0.056 Giga cells per liter | Standard Deviation 0.1302 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: WBC count, n=6,3,22 | -1.46 Giga cells per liter | Standard Deviation 1.947 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Platelet count, n=7,3,23 | -145.7 Giga cells per liter | Standard Deviation 94.01 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Eosinophils, n=7,3,20 | 0.005 Giga cells per liter | Standard Deviation 0.1695 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Eosinophils, n=7,3,21 | 0.087 Giga cells per liter | Standard Deviation 0.2873 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Platelet count, n=8,3,23 | -150.2 Giga cells per liter | Standard Deviation 90.41 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Eosinophils, n=7,2,22 | -0.035 Giga cells per liter | Standard Deviation 0.1773 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Basophils, n=8,3,20 | -0.008 Giga cells per liter | Standard Deviation 0.0341 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Platelet count, n=6,3,22 | -148.6 Giga cells per liter | Standard Deviation 90.99 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Eosinophils, n=8,3,20 | 0.012 Giga cells per liter | Standard Deviation 0.1241 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: WBC count, n=7,3,19 | -0.01 Giga cells per liter | Standard Deviation 1.948 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Platelet count, n=7,3,20 | -129.4 Giga cells per liter | Standard Deviation 90.54 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Eosinophils, n=6,3,22 | -0.034 Giga cells per liter | Standard Deviation 0.1797 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: WBC count, n=8,3,20 | -1.29 Giga cells per liter | Standard Deviation 1.953 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Platelet count, n=7,3,22 | -97.4 Giga cells per liter | Standard Deviation 73.99 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Eosinophils, n=8,3,22 | -0.015 Giga cells per liter | Standard Deviation 0.1954 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Basophils, n=6,3,22 | -0.004 Giga cells per liter | Standard Deviation 0.0333 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Platelet count, n=7,3,20 | -61.2 Giga cells per liter | Standard Deviation 96.89 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Eosinophils, n=8,3,23 | 0.001 Giga cells per liter | Standard Deviation 0.1633 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: WBC count, n=7,3,20 | 0.01 Giga cells per liter | Standard Deviation 1.571 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Platelet count, n=6,3,20 | -6.9 Giga cells per liter | Standard Deviation 60 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Monocytes, n=8,3,20 | -0.070 Giga cells per liter | Standard Deviation 0.1838 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Eosinophils, n=8,3,23 | 0.084 Giga cells per liter | Standard Deviation 0.2934 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Monocytes, n=7,2,22 | -0.127 Giga cells per liter | Standard Deviation 0.2495 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Monocytes, n=6,3,22 | -0.130 Giga cells per liter | Standard Deviation 0.2216 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: WBC count, n=7,3,22 | -1.27 Giga cells per liter | Standard Deviation 2.509 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Monocytes, n=7,3,21 | -0.028 Giga cells per liter | Standard Deviation 0.2246 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Monocytes, n=8,3,22 | -0.106 Giga cells per liter | Standard Deviation 0.2045 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Platelet count, n=7,3,19 | -10.3 Giga cells per liter | Standard Deviation 42.86 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Monocytes, n=7,3,20 | -0.022 Giga cells per liter | Standard Deviation 0.1414 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Monocytes, n=8,3,23 | -0.120 Giga cells per liter | Standard Deviation 0.2175 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Basophils, n=7,3,18 | 0.015 Giga cells per liter | Standard Deviation 0.0517 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Monocytes, n=7,3,18 | -0.053 Giga cells per liter | Standard Deviation 0.2234 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Monocytes, n=8,3,23 | -0.051 Giga cells per liter | Standard Deviation 0.1659 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Basophils, n=8,3,22 | -0.005 Giga cells per liter | Standard Deviation 0.0323 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Total neutrophils, n=8,3,23 | -0.917 Giga cells per liter | Standard Deviation 1.4114 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 197: Lymphocytes, n=7,3,18 | 0.039 Giga cells per liter | Standard Deviation 0.778 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: WBC count, n=8,3,23 | -1.00 Giga cells per liter | Standard Deviation 1.487 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: Total neutrophils, n=8,3,23 | -1.104 Giga cells per liter | Standard Deviation 1.4251 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Lymphocytes, n=7,3,20 | 0.202 Giga cells per liter | Standard Deviation 0.4504 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 155: Basophils, n=7,3,20 | 0.000 Giga cells per liter | Standard Deviation 0.04 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 43: Total neutrophils, n=8,3,22 | -1.406 Giga cells per liter | Standard Deviation 1.4631 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Lymphocytes, n=7,3,21 | 0.287 Giga cells per liter | Standard Deviation 0.6783 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 15: Basophils, n=8,3,23 | 0.007 Giga cells per liter | Standard Deviation 0.0325 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 57: Total neutrophils, n=6,3,22 | -1.387 Giga cells per liter | Standard Deviation 1.4428 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Lymphocytes, n=7,2,22 | 0.313 Giga cells per liter | Standard Deviation 0.5521 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 29: WBC count, n=8,3,23 | -1.33 Giga cells per liter | Standard Deviation 1.927 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Total neutrophils, n=8,3,20 | -1.369 Giga cells per liter | Standard Deviation 1.6361 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 71: Lymphocytes, n=8,3,20 | 0.155 Giga cells per liter | Standard Deviation 0.5169 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 113: Basophils, n=7,3,21 | -0.002 Giga cells per liter | Standard Deviation 0.039 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count | Day 85: Total neutrophils, n=7,2,22 | -1.424 Giga cells per liter | Standard Deviation 2.3949 |
Primary
Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)
Blood samples were collected to analyze the hematology parameters: hemoglobin and MCHC. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 71: Hemoglobin, n=8,3,20 | -4.1 Grams per liter | Standard Deviation 10.38 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 29: Hemoglobin, n=8,3,23 | -2.5 Grams per liter | Standard Deviation 6.55 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 43: Hemoglobin, n=8,3,23 | -2.5 Grams per liter | Standard Deviation 6.39 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 57: Hemoglobin, n=6,3,22 | -3.8 Grams per liter | Standard Deviation 8.47 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 15: Hemoglobin, n=8,3,23 | -2.8 Grams per liter | Standard Deviation 8.89 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 85: Hemoglobin, n=7,3,22 | -3.9 Grams per liter | Standard Deviation 7.58 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 113: Hemoglobin, n=7,3,21 | -5.0 Grams per liter | Standard Deviation 8.43 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 155: Hemoglobin, n=7,3,20 | -6.3 Grams per liter | Standard Deviation 9.41 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 197: Hemoglobin, n=7,3,19 | -4.1 Grams per liter | Standard Deviation 8.88 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 15: MCHC, n=8,3,23 | 0.9 Grams per liter | Standard Deviation 8.53 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 29: MCHC, n=8,3,23 | -3.6 Grams per liter | Standard Deviation 6.39 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 43: MCHC, n=8,3,22 | -1.3 Grams per liter | Standard Deviation 9.27 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 57: MCHC, n=6,3,22 | -1.2 Grams per liter | Standard Deviation 10.11 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 71: MCHC, n=8,3,20 | 2.3 Grams per liter | Standard Deviation 12.87 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 85: MCHC, n=7,3,22 | 3.3 Grams per liter | Standard Deviation 10.53 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 113: MCHC, n=7,3,20 | -0.4 Grams per liter | Standard Deviation 7.18 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 155: MCHC, n=7,3,17 | -1.4 Grams per liter | Standard Deviation 5.26 |
| Placebo | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 197: MCHC, n=7,3,15 | -0.4 Grams per liter | Standard Deviation 8.58 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 197: MCHC, n=7,3,15 | -0.3 Grams per liter | Standard Deviation 7.02 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 15: Hemoglobin, n=8,3,23 | 2.0 Grams per liter | Standard Deviation 7 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 15: MCHC, n=8,3,23 | -5.0 Grams per liter | Standard Deviation 3 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 57: MCHC, n=6,3,22 | 3.7 Grams per liter | Standard Deviation 4.93 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 29: Hemoglobin, n=8,3,23 | -0.7 Grams per liter | Standard Deviation 11.06 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 85: MCHC, n=7,3,22 | -1.7 Grams per liter | Standard Deviation 9.5 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 113: MCHC, n=7,3,20 | 5.0 Grams per liter | Standard Deviation 8.19 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 43: Hemoglobin, n=8,3,23 | -1.7 Grams per liter | Standard Deviation 8.5 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 29: MCHC, n=8,3,23 | 2.0 Grams per liter | Standard Deviation 13.11 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 155: MCHC, n=7,3,17 | 3.7 Grams per liter | Standard Deviation 4.16 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 57: Hemoglobin, n=6,3,22 | -2.7 Grams per liter | Standard Deviation 11.15 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 197: Hemoglobin, n=7,3,19 | -6.7 Grams per liter | Standard Deviation 2.08 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 71: MCHC, n=8,3,20 | 2.7 Grams per liter | Standard Deviation 6.81 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 71: Hemoglobin, n=8,3,20 | -6.3 Grams per liter | Standard Deviation 4.73 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 155: Hemoglobin, n=7,3,20 | -7.3 Grams per liter | Standard Deviation 6.03 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 43: MCHC, n=8,3,22 | 1.0 Grams per liter | Standard Deviation 7.55 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 85: Hemoglobin, n=7,3,22 | -10.7 Grams per liter | Standard Deviation 6.11 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 113: Hemoglobin, n=7,3,21 | -9.0 Grams per liter | Standard Deviation 7.55 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 85: Hemoglobin, n=7,3,22 | -22.0 Grams per liter | Standard Deviation 10.05 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 113: Hemoglobin, n=7,3,21 | -21.3 Grams per liter | Standard Deviation 10.49 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 155: Hemoglobin, n=7,3,20 | -14.3 Grams per liter | Standard Deviation 8.62 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 85: MCHC, n=7,3,22 | 2.8 Grams per liter | Standard Deviation 6.68 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 197: Hemoglobin, n=7,3,19 | -5.8 Grams per liter | Standard Deviation 6.58 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 197: MCHC, n=7,3,15 | -3.5 Grams per liter | Standard Deviation 8.18 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 15: MCHC, n=8,3,23 | 2.4 Grams per liter | Standard Deviation 7.83 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 29: MCHC, n=8,3,23 | 2.0 Grams per liter | Standard Deviation 8.3 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 113: MCHC, n=7,3,20 | -3.3 Grams per liter | Standard Deviation 8.16 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 43: MCHC, n=8,3,22 | 2.5 Grams per liter | Standard Deviation 4.86 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 15: Hemoglobin, n=8,3,23 | -0.2 Grams per liter | Standard Deviation 5.31 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 29: Hemoglobin, n=8,3,23 | -3.7 Grams per liter | Standard Deviation 7.45 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 57: MCHC, n=6,3,22 | 2.8 Grams per liter | Standard Deviation 8.42 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 43: Hemoglobin, n=8,3,23 | -7.7 Grams per liter | Standard Deviation 9.06 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 57: Hemoglobin, n=6,3,22 | -13.7 Grams per liter | Standard Deviation 12.32 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 71: Hemoglobin, n=8,3,20 | -21.2 Grams per liter | Standard Deviation 11.61 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 71: MCHC, n=8,3,20 | 0.5 Grams per liter | Standard Deviation 8.62 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 155: MCHC, n=7,3,17 | -4.2 Grams per liter | Standard Deviation 9.35 |
Primary
Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV)
Blood samples were collected to analyze the hematology parameters: MCV and MPV. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 71: MCV, n=8,3,20 | -0.13 Femtoliter | Standard Deviation 3.441 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 29: MCV, n=8,3,23 | 0.38 Femtoliter | Standard Deviation 1.188 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 43: MCV, n=8,3,22 | -0.38 Femtoliter | Standard Deviation 2.326 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 57: MCV, n=6,3,22 | -0.17 Femtoliter | Standard Deviation 2.787 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 15: MCV, n=8,3,23 | -0.63 Femtoliter | Standard Deviation 1.188 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 85: MCV, n=7,3,22 | -0.71 Femtoliter | Standard Deviation 1.113 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 113: MCV, n=7,3,21 | -0.29 Femtoliter | Standard Deviation 2.563 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 155: MCV, n=7,3,20 | -0.14 Femtoliter | Standard Deviation 1.215 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 197: MCV, n=7,3,18 | -1.29 Femtoliter | Standard Deviation 1.799 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 15: MPV, n=8,3,23 | 0.04 Femtoliter | Standard Deviation 0.256 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 29: MPV, n=8,3,23 | -0.04 Femtoliter | Standard Deviation 0.378 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 43: MPV, n=7,3,22 | -0.14 Femtoliter | Standard Deviation 0.276 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 57: MPV, n=6,3,21 | 0.23 Femtoliter | Standard Deviation 0.446 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 71: MPV, n=7,3,20 | -0.21 Femtoliter | Standard Deviation 0.393 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 85: MPV, n=7,3,22 | 0.00 Femtoliter | Standard Deviation 0.356 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 113: MPV, n=7,3,19 | -0.04 Femtoliter | Standard Deviation 0.443 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 155: MPV, n=6,3,17 | 0.17 Femtoliter | Standard Deviation 0.565 |
| Placebo | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 197: MPV, n=7,3,15 | -0.11 Femtoliter | Standard Deviation 0.385 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 197: MPV, n=7,3,15 | 0.10 Femtoliter | Standard Deviation 0.781 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 15: MCV, n=8,3,23 | 1.33 Femtoliter | Standard Deviation 1.528 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 15: MPV, n=8,3,23 | 0.20 Femtoliter | Standard Deviation 0.361 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 57: MPV, n=6,3,21 | 0.47 Femtoliter | Standard Deviation 0.416 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 29: MCV, n=8,3,23 | 0.33 Femtoliter | Standard Deviation 1.155 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 85: MPV, n=7,3,22 | 0.43 Femtoliter | Standard Deviation 0.808 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 113: MPV, n=7,3,19 | 0.30 Femtoliter | Standard Deviation 0.781 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 43: MCV, n=8,3,22 | -0.67 Femtoliter | Standard Deviation 1.528 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 29: MPV, n=8,3,23 | 0.47 Femtoliter | Standard Deviation 0.764 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 155: MPV, n=6,3,17 | 0.10 Femtoliter | Standard Deviation 0.872 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 57: MCV, n=6,3,22 | -1.00 Femtoliter | Standard Deviation 0 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 197: MCV, n=7,3,18 | 0.67 Femtoliter | Standard Deviation 2.082 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 71: MPV, n=7,3,20 | 0.23 Femtoliter | Standard Deviation 0.231 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 71: MCV, n=8,3,20 | -0.67 Femtoliter | Standard Deviation 1.528 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 155: MCV, n=7,3,20 | 1.67 Femtoliter | Standard Deviation 0.577 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 43: MPV, n=7,3,22 | 0.23 Femtoliter | Standard Deviation 0.737 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 85: MCV, n=7,3,22 | -0.67 Femtoliter | Standard Deviation 0.577 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 113: MCV, n=7,3,21 | 1.00 Femtoliter | Standard Deviation 1.732 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 85: MCV, n=7,3,22 | -2.05 Femtoliter | Standard Deviation 2.478 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 113: MCV, n=7,3,21 | 0.00 Femtoliter | Standard Deviation 3.225 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 155: MCV, n=7,3,20 | 1.26 Femtoliter | Standard Deviation 4.584 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 85: MPV, n=7,3,22 | -0.11 Femtoliter | Standard Deviation 0.462 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 197: MCV, n=7,3,18 | -0.02 Femtoliter | Standard Deviation 3.575 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 197: MPV, n=7,3,15 | 0.07 Femtoliter | Standard Deviation 0.58 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 15: MPV, n=8,3,23 | 0.45 Femtoliter | Standard Deviation 0.46 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 29: MPV, n=8,3,23 | 0.29 Femtoliter | Standard Deviation 0.63 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 113: MPV, n=7,3,19 | 0.03 Femtoliter | Standard Deviation 0.622 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 43: MPV, n=7,3,22 | 0.07 Femtoliter | Standard Deviation 0.594 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 15: MCV, n=8,3,23 | -0.39 Femtoliter | Standard Deviation 1.725 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 29: MCV, n=8,3,23 | -1.17 Femtoliter | Standard Deviation 2.188 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 57: MPV, n=6,3,21 | 0.12 Femtoliter | Standard Deviation 0.599 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 43: MCV, n=8,3,22 | -1.86 Femtoliter | Standard Deviation 1.583 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 57: MCV, n=6,3,22 | -1.77 Femtoliter | Standard Deviation 2.308 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 71: MCV, n=8,3,20 | -1.60 Femtoliter | Standard Deviation 2.722 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 71: MPV, n=7,3,20 | -0.15 Femtoliter | Standard Deviation 0.516 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume (MCV), Mean Platelet Volume (MPV) | Day 155: MPV, n=6,3,17 | 0.01 Femtoliter | Standard Deviation 0.448 |
Primary
Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count
Blood samples were collected to analyze the hematology parameters: RBC count and reticulocyte count. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 71: RBC count, n=8,3,20 | -0.13 Tera cells per liter | Standard Deviation 0.396 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 29: RBC count, n=8,3,23 | -0.03 Tera cells per liter | Standard Deviation 0.225 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 43: RBC count, n=8,3,22 | -0.03 Tera cells per liter | Standard Deviation 0.238 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 57: RBC count, n=6,3,22 | -0.07 Tera cells per liter | Standard Deviation 0.288 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 15: RBC count, n=8,3,23 | -0.05 Tera cells per liter | Standard Deviation 0.321 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 85: RBC count, n=7,3,22 | -0.10 Tera cells per liter | Standard Deviation 0.311 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 113: RBC count, n=7,3,20 | -0.13 Tera cells per liter | Standard Deviation 0.35 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 155: RBC count, n=7,3,17 | -0.17 Tera cells per liter | Standard Deviation 0.33 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 197: RBC count, n=7,3,15 | -0.04 Tera cells per liter | Standard Deviation 0.282 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 15: Reticulocyte count, n=8,3,23 | 0.0109 Tera cells per liter | Standard Deviation 0.02401 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 29: Reticulocyte count, n=8,3,23 | -0.0001 Tera cells per liter | Standard Deviation 0.00543 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 43: Reticulocyte count, n=8,3,22 | -0.0032 Tera cells per liter | Standard Deviation 0.00554 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 57: Reticulocyte count, n=6,3,22 | -0.0058 Tera cells per liter | Standard Deviation 0.00638 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 71: Reticulocyte count, n=8,3,19 | 0.0026 Tera cells per liter | Standard Deviation 0.01261 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 85: Reticulocyte count, n=7,3,22 | -0.0044 Tera cells per liter | Standard Deviation 0.00539 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 113: Reticulocyte count, n=7,3,20 | -0.0064 Tera cells per liter | Standard Deviation 0.0103 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 155: Reticulocyte count, n=7,3,17 | 0.0006 Tera cells per liter | Standard Deviation 0.00623 |
| Placebo | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 197: Reticulocyte count, n=7,3,16 | 0.0003 Tera cells per liter | Standard Deviation 0.0055 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 197: Reticulocyte count, n=7,3,16 | -0.0285 Tera cells per liter | Standard Deviation 0.03458 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 15: RBC count, n=8,3,23 | 0.07 Tera cells per liter | Standard Deviation 0.208 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 15: Reticulocyte count, n=8,3,23 | -0.0207 Tera cells per liter | Standard Deviation 0.02463 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 57: Reticulocyte count, n=6,3,22 | -0.0091 Tera cells per liter | Standard Deviation 0.02177 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 29: RBC count, n=8,3,23 | -0.07 Tera cells per liter | Standard Deviation 0.404 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 85: Reticulocyte count, n=7,3,22 | -0.0209 Tera cells per liter | Standard Deviation 0.02471 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 113: Reticulocyte count, n=7,3,20 | 0.0012 Tera cells per liter | Standard Deviation 0.02944 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 43: RBC count, n=8,3,22 | -0.07 Tera cells per liter | Standard Deviation 0.321 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 29: Reticulocyte count, n=8,3,23 | -0.0169 Tera cells per liter | Standard Deviation 0.00911 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 155: Reticulocyte count, n=7,3,17 | -0.0157 Tera cells per liter | Standard Deviation 0.02263 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 57: RBC count, n=6,3,22 | -0.10 Tera cells per liter | Standard Deviation 0.361 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 197: RBC count, n=7,3,15 | -0.23 Tera cells per liter | Standard Deviation 0.058 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 71: Reticulocyte count, n=8,3,19 | -0.0125 Tera cells per liter | Standard Deviation 0.01878 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 71: RBC count, n=8,3,20 | -0.23 Tera cells per liter | Standard Deviation 0.208 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 155: RBC count, n=7,3,17 | -0.37 Tera cells per liter | Standard Deviation 0.252 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 43: Reticulocyte count, n=8,3,22 | -0.0228 Tera cells per liter | Standard Deviation 0.02303 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 85: RBC count, n=7,3,22 | -0.33 Tera cells per liter | Standard Deviation 0.208 |
| GSK2330811 100 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 113: RBC count, n=7,3,20 | -0.40 Tera cells per liter | Standard Deviation 0.265 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 85: RBC count, n=7,3,22 | -0.68 Tera cells per liter | Standard Deviation 0.343 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 113: RBC count, n=7,3,20 | -0.68 Tera cells per liter | Standard Deviation 0.361 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 155: RBC count, n=7,3,17 | -0.47 Tera cells per liter | Standard Deviation 0.264 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 85: Reticulocyte count, n=7,3,22 | 0.0152 Tera cells per liter | Standard Deviation 0.02006 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 197: RBC count, n=7,3,15 | -0.15 Tera cells per liter | Standard Deviation 0.16 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 197: Reticulocyte count, n=7,3,16 | 0.0017 Tera cells per liter | Standard Deviation 0.01003 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 15: Reticulocyte count, n=8,3,23 | -0.0160 Tera cells per liter | Standard Deviation 0.00964 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 29: Reticulocyte count, n=8,3,23 | -0.0132 Tera cells per liter | Standard Deviation 0.01784 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 113: Reticulocyte count, n=7,3,20 | 0.0356 Tera cells per liter | Standard Deviation 0.02009 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 43: Reticulocyte count, n=8,3,22 | -0.0109 Tera cells per liter | Standard Deviation 0.01699 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 15: RBC count, n=8,3,23 | -0.01 Tera cells per liter | Standard Deviation 0.205 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 29: RBC count, n=8,3,23 | -0.11 Tera cells per liter | Standard Deviation 0.275 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 57: Reticulocyte count, n=6,3,22 | -0.0031 Tera cells per liter | Standard Deviation 0.01656 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 43: RBC count, n=8,3,22 | -0.22 Tera cells per liter | Standard Deviation 0.331 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 57: RBC count, n=6,3,22 | -0.42 Tera cells per liter | Standard Deviation 0.464 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 71: RBC count, n=8,3,20 | -0.66 Tera cells per liter | Standard Deviation 0.406 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 71: Reticulocyte count, n=8,3,19 | 0.0065 Tera cells per liter | Standard Deviation 0.01934 |
| GSK2330811 300 mg | Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count, Reticulocyte Count | Day 155: Reticulocyte count, n=7,3,17 | 0.0158 Tera cells per liter | Standard Deviation 0.0134 |
Primary
Change From Baseline in Reticulocyte Production Index
Blood samples were collected to analyze the hematology parameter: Reticulocyte Production Index. Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Reticulocyte Production Index (RPI) was calculated as 'Reticulocyte Production Index = Reticulocyte Count (percent \[%\]) multiply by (x) (hematocrit \[%\] divided by \[/\] 45) x 1/ reticulocyte maturation time'.
Time frame: Baseline (Day 1: Pre-dose), Days 15, 29, 43, 57, 71, 85, 113, 155 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Reticulocyte Production Index | Day 71: n=8,3,19 | 0.0154 Unitless | Standard Deviation 0.2456 |
| Placebo | Change From Baseline in Reticulocyte Production Index | Day 29: n=8,3,23 | 0.0391 Unitless | Standard Deviation 0.09687 |
| Placebo | Change From Baseline in Reticulocyte Production Index | Day 155: n=7,3,17 | -0.0033 Unitless | Standard Deviation 0.24087 |
| Placebo | Change From Baseline in Reticulocyte Production Index | Day 197: n=7,3,15 | -0.0296 Unitless | Standard Deviation 0.11222 |
| Placebo | Change From Baseline in Reticulocyte Production Index | Day 43: n=8,3,22 | -0.0691 Unitless | Standard Deviation 0.11447 |
| Placebo | Change From Baseline in Reticulocyte Production Index | Day 15: n=8,3,23 | 0.2009 Unitless | Standard Deviation 0.49644 |
| Placebo | Change From Baseline in Reticulocyte Production Index | Day 57: n=6,3,22 | -0.0763 Unitless | Standard Deviation 0.13476 |
| Placebo | Change From Baseline in Reticulocyte Production Index | Day 85: n=7,3,22 | -0.0831 Unitless | Standard Deviation 0.14906 |
| Placebo | Change From Baseline in Reticulocyte Production Index | Day 113: n=7,3,20 | -0.1006 Unitless | Standard Deviation 0.21168 |
| GSK2330811 100 mg | Change From Baseline in Reticulocyte Production Index | Day 71: n=8,3,19 | -0.4643 Unitless | Standard Deviation 0.13444 |
| GSK2330811 100 mg | Change From Baseline in Reticulocyte Production Index | Day 113: n=7,3,20 | -0.2633 Unitless | Standard Deviation 0.29016 |
| GSK2330811 100 mg | Change From Baseline in Reticulocyte Production Index | Day 43: n=8,3,22 | -0.3437 Unitless | Standard Deviation 0.55192 |
| GSK2330811 100 mg | Change From Baseline in Reticulocyte Production Index | Day 15: n=8,3,23 | -0.1787 Unitless | Standard Deviation 0.53867 |
| GSK2330811 100 mg | Change From Baseline in Reticulocyte Production Index | Day 155: n=7,3,17 | -0.4720 Unitless | Standard Deviation 0.24857 |
| GSK2330811 100 mg | Change From Baseline in Reticulocyte Production Index | Day 29: n=8,3,23 | -0.2397 Unitless | Standard Deviation 0.5185 |
| GSK2330811 100 mg | Change From Baseline in Reticulocyte Production Index | Day 85: n=7,3,22 | -0.4530 Unitless | Standard Deviation 0.48914 |
| GSK2330811 100 mg | Change From Baseline in Reticulocyte Production Index | Day 197: n=7,3,15 | -0.5693 Unitless | Standard Deviation 0.4316 |
| GSK2330811 100 mg | Change From Baseline in Reticulocyte Production Index | Day 57: n=6,3,22 | -0.2877 Unitless | Standard Deviation 0.48015 |
| GSK2330811 300 mg | Change From Baseline in Reticulocyte Production Index | Day 197: n=7,3,15 | 0.0087 Unitless | Standard Deviation 0.16995 |
| GSK2330811 300 mg | Change From Baseline in Reticulocyte Production Index | Day 15: n=8,3,23 | -0.2757 Unitless | Standard Deviation 0.20191 |
| GSK2330811 300 mg | Change From Baseline in Reticulocyte Production Index | Day 29: n=8,3,23 | -0.2460 Unitless | Standard Deviation 0.3546 |
| GSK2330811 300 mg | Change From Baseline in Reticulocyte Production Index | Day 43: n=8,3,22 | -0.2342 Unitless | Standard Deviation 0.34389 |
| GSK2330811 300 mg | Change From Baseline in Reticulocyte Production Index | Day 71: n=8,3,19 | -0.1344 Unitless | Standard Deviation 0.29111 |
| GSK2330811 300 mg | Change From Baseline in Reticulocyte Production Index | Day 85: n=7,3,22 | -0.0112 Unitless | Standard Deviation 0.32736 |
| GSK2330811 300 mg | Change From Baseline in Reticulocyte Production Index | Day 113: n=7,3,20 | 0.2826 Unitless | Standard Deviation 0.33003 |
| GSK2330811 300 mg | Change From Baseline in Reticulocyte Production Index | Day 155: n=7,3,17 | 0.1105 Unitless | Standard Deviation 0.28718 |
| GSK2330811 300 mg | Change From Baseline in Reticulocyte Production Index | Day 57: n=6,3,22 | -0.1933 Unitless | Standard Deviation 0.32326 |
Primary
Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick
Urine samples were collected for the assessment of potential of hydrogen, specific gravity, glucose, ketones, occult blood and protein by dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters: potential of hydrogen, specific gravity, glucose, ketones, occult blood and protein were categorized as 'any increase from Baseline', which imply any increase in their concentrations in the urine sample. Only participants with emergent worst case any increase from Baseline values are presented.
Time frame: Up to Day 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Potential of hydrogen, Any increase | 0 Participants |
| Placebo | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Specific gravity, Any increase | 0 Participants |
| Placebo | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Glucose, Any increase | 0 Participants |
| Placebo | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Ketones, Any increase | 1 Participants |
| Placebo | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Occult blood, Any increase | 2 Participants |
| Placebo | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Protein, Any increase | 1 Participants |
| GSK2330811 100 mg | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Protein, Any increase | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Potential of hydrogen, Any increase | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Ketones, Any increase | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Occult blood, Any increase | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Specific gravity, Any increase | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Glucose, Any increase | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Specific gravity, Any increase | 3 Participants |
| GSK2330811 300 mg | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Glucose, Any increase | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Protein, Any increase | 4 Participants |
| GSK2330811 300 mg | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Ketones, Any increase | 4 Participants |
| GSK2330811 300 mg | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Potential of hydrogen, Any increase | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Emergent Worst Case Urinalysis Results by Dipstick | Occult blood, Any increase | 3 Participants |
Primary
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. SAEs were collected up to Day 197, but the protocol also allowed investigators to report SAEs occurring after participants had completed the study. This outcome measure includes two SAEs reported after participants had completed the study, occurring on Day 306 and Day 603 following first dose. Safety Population consisted of all randomized participants who have taken at least 1 dose of study treatment.
Time frame: Up to Day 197, but protocol allowed for additional events to be collected; up to Day 603 post first dose
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Non-SAEs | 8 Participants |
| Placebo | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| GSK2330811 100 mg | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Non-SAEs | 3 Participants |
| GSK2330811 100 mg | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Non-SAEs | 24 Participants |
| GSK2330811 300 mg | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | SAEs | 2 Participants |
Primary
Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria
Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) were measured in a seated or semi-supine position after 5 minutes of rest using a completely automated device. PCI ranges were: SBP (increase or decrease from Baseline of \>=40 millimeter of mercury \[mmHg\]), DBP (increase or decrease from Baseline of \>=20 mmHg), and HR (increase or decrease from Baseline of \>=30 beats per minute). Baseline was defined as the pre-dose Day 1 assessment, unless unavailable, in which case it was the latest pre-dose assessment.
Time frame: Baseline (Day 1: Pre-dose) and up to Day 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | DBP: Decrease >=20 | 2 Participants |
| Placebo | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | DBP: Increase >=20 | 0 Participants |
| Placebo | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | SBP: Decrease >=40 | 0 Participants |
| Placebo | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | SBP: Increase >=40 | 0 Participants |
| Placebo | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | HR: Decrease >=30 | 0 Participants |
| Placebo | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | HR: Increase >=30 | 1 Participants |
| GSK2330811 100 mg | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | HR: Increase >=30 | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | DBP: Decrease >=20 | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | SBP: Increase >=40 | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | HR: Decrease >=30 | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | DBP: Increase >=20 | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | SBP: Decrease >=40 | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | DBP: Increase >=20 | 1 Participants |
| GSK2330811 300 mg | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | SBP: Decrease >=40 | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | HR: Increase >=30 | 2 Participants |
| GSK2330811 300 mg | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | SBP: Increase >=40 | 2 Participants |
| GSK2330811 300 mg | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | DBP: Decrease >=20 | 2 Participants |
| GSK2330811 300 mg | Number of Participants With Vital Signs Relative to Change From Baseline by Potential Clinical Importance (PCI) Criteria | HR: Decrease >=30 | 0 Participants |
Primary
Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Blood samples were collected for analysis of clinical chemistry parameters. PCI ranges were low: \<30 grams per liter (g/L) (albumin), high: \>44.2 micromoles per liter (µmol/L) increase from Baseline (creatinine), low: \<3 or high: \>9 mmol/L (glucose), low: \<3 or high: \>5.5 mmol/L (potassium), and low: \<130 or high: \>150 mmol/L (sodium). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there was no change in their category. Participants whose laboratory value category was unchanged (e.g. High to High), or whose value became within range, were recorded in the To within Range or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add up to 100%.
Time frame: Up to Day 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 7 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 8 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 8 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 8 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 8 Participants |
| Placebo | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To High | 1 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 3 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 3 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 2 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To High | 1 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 3 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 3 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To High | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 23 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 22 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To within Range or No Change | 23 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Creatinine: To Low | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To High | 1 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To High | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To Low | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 19 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Albumin: To within Range or No Change | 23 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To High | 3 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 1 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-Case Chemistry Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
Primary
Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT intervals. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.
Time frame: Up to Day 57
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal- not clinically significant | 3 Participants |
| Placebo | Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal- clinically significant | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal- not clinically significant | 2 Participants |
| GSK2330811 100 mg | Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal- clinically significant | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal- not clinically significant | 10 Participants |
| GSK2330811 300 mg | Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal- clinically significant | 1 Participants |
Secondary
Apparent Clearance (CL/F) of GSK2330811
Blood samples were collected at the indicated time points for PK analysis of GSK2330811. Data was analyzed by population pharmacokinetic methods using a non-linear mixed-effects modelling approach.
Time frame: Days 1, 15, 29, 57, 85, 113, 155 and 197
Population: PK Population. Only those participants with data available at the specified time points were analyzed. CL/F was estimated based on population PK modelling on the combination of data of participants dosed with GSK2330811, as it was more appropriate due to limited dose range (100 mg and 300 mg).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo | Apparent Clearance (CL/F) of GSK2330811 | 0.0147 Liter per hour |
Secondary
Apparent Volume of Distribution (Vss/F) of GSK2330811
Blood samples were collected at the indicated time points for PK analysis of GSK2330811. Data was analyzed by population pharmacokinetic methods using a non-linear mixed-effects modelling approach.
Time frame: Days 1, 15, 29, 57, 85, 113, 155 and 197
Population: PK Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo | Apparent Volume of Distribution (Vss/F) of GSK2330811 | 3.25 Liter |
Secondary
Concentration at the End of the Dosing Interval (Ctrough) of GSK2330811
Blood samples were collected at the indicated time points for PK analysis of GSK2330811.
Time frame: Days 1, 15, 29, 57, 85, 113, 155 and 197
Population: PK Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Concentration at the End of the Dosing Interval (Ctrough) of GSK2330811 | 10993.0 Nanogram per milliliter | Standard Deviation 717.89 |
| GSK2330811 100 mg | Concentration at the End of the Dosing Interval (Ctrough) of GSK2330811 | 29254.4 Nanogram per milliliter | Standard Deviation 16911.55 |
Secondary
Number of Participants With Positive Anti-GSK2330811 Antibodies
Serum samples were collected for the determination of anti-GSK2330811 antibodies (ADA) using a binding antibody detection assay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that were confirmed positive in the confirmation assay were reported as 'positive'.
Time frame: Days 1, 15, 57, 85 and 197
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 85: n=8,3,22 | 0 Participants |
| Placebo | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 57: n=7,3,22 | 0 Participants |
| Placebo | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 1: n=8,3,23 | 0 Participants |
| Placebo | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 15: n=8,3,23 | 0 Participants |
| Placebo | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 197: n=7,3,17 | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 57: n=7,3,22 | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 1: n=8,3,23 | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 15: n=8,3,23 | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 85: n=8,3,22 | 0 Participants |
| GSK2330811 100 mg | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 197: n=7,3,17 | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 197: n=7,3,17 | 0 Participants |
| GSK2330811 300 mg | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 85: n=8,3,22 | 1 Participants |
| GSK2330811 300 mg | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 1: n=8,3,23 | 3 Participants |
| GSK2330811 300 mg | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 57: n=7,3,22 | 2 Participants |
| GSK2330811 300 mg | Number of Participants With Positive Anti-GSK2330811 Antibodies | Day 15: n=8,3,23 | 1 Participants |
Secondary
Plasma Concentrations of GSK2330811
Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK2330811. Pharmacokinetic (PK) Population was defined as participants in the 'Safety' population who received an active dose and for whom a PK sample was obtained and analyzed.
Time frame: Days 1, 15, 29, 57, 85, 113, 155 and 197
Population: PK Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Plasma Concentrations of GSK2330811 | Day 85: n=3,22 | 10993.0 Nanogram per milliliter | Standard Deviation 717.89 |
| Placebo | Plasma Concentrations of GSK2330811 | Day 29: n=3,23 | 7782.3 Nanogram per milliliter | Standard Deviation 1563.04 |
| Placebo | Plasma Concentrations of GSK2330811 | Day 113: n=3,20 | 4123.0 Nanogram per milliliter | Standard Deviation 420.29 |
| Placebo | Plasma Concentrations of GSK2330811 | Day 15: n=3,23 | 5510.7 Nanogram per milliliter | Standard Deviation 2455.19 |
| Placebo | Plasma Concentrations of GSK2330811 | Day 155: n=3,16 | 580.0 Nanogram per milliliter | Standard Deviation 408.47 |
| Placebo | Plasma Concentrations of GSK2330811 | Day 57: n=3,22 | 9868.7 Nanogram per milliliter | Standard Deviation 818.51 |
| Placebo | Plasma Concentrations of GSK2330811 | Day 197: n=3,17 | 114.0 Nanogram per milliliter | — |
| Placebo | Plasma Concentrations of GSK2330811 | Day 1: n=3,24 | NA Nanogram per milliliter | — |
| GSK2330811 100 mg | Plasma Concentrations of GSK2330811 | Day 197: n=3,17 | 729.2 Nanogram per milliliter | Standard Deviation 841.17 |
| GSK2330811 100 mg | Plasma Concentrations of GSK2330811 | Day 15: n=3,23 | 16197.9 Nanogram per milliliter | Standard Deviation 6354.54 |
| GSK2330811 100 mg | Plasma Concentrations of GSK2330811 | Day 29: n=3,23 | 23407.0 Nanogram per milliliter | Standard Deviation 8830.49 |
| GSK2330811 100 mg | Plasma Concentrations of GSK2330811 | Day 57: n=3,22 | 32645.7 Nanogram per milliliter | Standard Deviation 15225.01 |
| GSK2330811 100 mg | Plasma Concentrations of GSK2330811 | Day 85: n=3,22 | 29254.4 Nanogram per milliliter | Standard Deviation 16911.55 |
| GSK2330811 100 mg | Plasma Concentrations of GSK2330811 | Day 113: n=3,20 | 11087.1 Nanogram per milliliter | Standard Deviation 7661.76 |
| GSK2330811 100 mg | Plasma Concentrations of GSK2330811 | Day 155: n=3,16 | 2892.9 Nanogram per milliliter | Standard Deviation 4093.61 |
| GSK2330811 100 mg | Plasma Concentrations of GSK2330811 | Day 1: n=3,24 | 0.0 Nanogram per milliliter | — |
Secondary
Serum Level of Free OSM
Blood samples were collected at indicated timepoints for analysis of free OSM levels in serum.
Time frame: Days 1, 15, 29, 57, 85, 113, 155 and 197
Population: Per Protocol Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Serum Level of Free OSM | Day 1: n=8,3,22 | 19.72 Picogram per milliliter |
| Placebo | Serum Level of Free OSM | Day 15: n=8,3,23 | 23.85 Picogram per milliliter |
| Placebo | Serum Level of Free OSM | Day 29: n=8,3,23 | 19.35 Picogram per milliliter |
| Placebo | Serum Level of Free OSM | Day 57: n=7,3,22 | 27.62 Picogram per milliliter |
| Placebo | Serum Level of Free OSM | Day 85: n=8,3,22 | 12.37 Picogram per milliliter |
| Placebo | Serum Level of Free OSM | Day 113: n=7,3,20 | 16.78 Picogram per milliliter |
| Placebo | Serum Level of Free OSM | Day 155: n=7,3,17 | 14.54 Picogram per milliliter |
| Placebo | Serum Level of Free OSM | Day 197: n=7,3,17 | 18.43 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Free OSM | Day 29: n=8,3,23 | 0.73 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Free OSM | Day 155: n=7,3,17 | 0.73 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Free OSM | Day 57: n=7,3,22 | 0.73 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Free OSM | Day 85: n=8,3,22 | 0.73 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Free OSM | Day 113: n=7,3,20 | 0.73 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Free OSM | Day 1: n=8,3,22 | 28.93 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Free OSM | Day 15: n=8,3,23 | 0.73 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Free OSM | Day 197: n=7,3,17 | 0.73 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Free OSM | Day 29: n=8,3,23 | 0.73 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Free OSM | Day 15: n=8,3,23 | 0.73 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Free OSM | Day 1: n=8,3,22 | 20.74 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Free OSM | Day 57: n=7,3,22 | 0.73 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Free OSM | Day 155: n=7,3,17 | 0.73 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Free OSM | Day 113: n=7,3,20 | 0.73 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Free OSM | Day 85: n=8,3,22 | 0.73 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Free OSM | Day 197: n=7,3,17 | 0.73 Picogram per milliliter |
Secondary
Serum Level of Total Oncostatin M (OSM)
Blood samples were collected at indicated timepoints for analysis of total OSM levels in serum. Per Protocol Population comprised of participants in the 'Safety' population who complied with the protocol.
Time frame: Days 1, 15, 29, 57, 85, 113, 155 and 197
Population: Per Protocol Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Serum Level of Total Oncostatin M (OSM) | Day 197: n=7,3,17 | 28.800 Picogram per milliliter |
| Placebo | Serum Level of Total Oncostatin M (OSM) | Day 113: n=7,3,20 | 23.350 Picogram per milliliter |
| Placebo | Serum Level of Total Oncostatin M (OSM) | Day 29: n=8,3,23 | 26.210 Picogram per milliliter |
| Placebo | Serum Level of Total Oncostatin M (OSM) | Day 85: n=8,3,22 | 17.275 Picogram per milliliter |
| Placebo | Serum Level of Total Oncostatin M (OSM) | Day 1: n=8,3,22 | 22.110 Picogram per milliliter |
| Placebo | Serum Level of Total Oncostatin M (OSM) | Day 57: n=7,3,22 | 34.700 Picogram per milliliter |
| Placebo | Serum Level of Total Oncostatin M (OSM) | Day 155: n=7,3,17 | 23.850 Picogram per milliliter |
| Placebo | Serum Level of Total Oncostatin M (OSM) | Day 15: n=8,3,23 | 28.175 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Total Oncostatin M (OSM) | Day 29: n=8,3,23 | 499.540 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Total Oncostatin M (OSM) | Day 57: n=7,3,22 | 651.710 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Total Oncostatin M (OSM) | Day 1: n=8,3,22 | 30.590 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Total Oncostatin M (OSM) | Day 15: n=8,3,23 | 576.850 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Total Oncostatin M (OSM) | Day 85: n=8,3,22 | 613.290 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Total Oncostatin M (OSM) | Day 113: n=7,3,20 | 687.810 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Total Oncostatin M (OSM) | Day 155: n=7,3,17 | 206.900 Picogram per milliliter |
| GSK2330811 100 mg | Serum Level of Total Oncostatin M (OSM) | Day 197: n=7,3,17 | 54.290 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Total Oncostatin M (OSM) | Day 29: n=8,3,23 | 974.220 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Total Oncostatin M (OSM) | Day 113: n=7,3,20 | 1044.650 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Total Oncostatin M (OSM) | Day 1: n=8,3,22 | 27.455 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Total Oncostatin M (OSM) | Day 197: n=7,3,17 | 142.830 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Total Oncostatin M (OSM) | Day 57: n=7,3,22 | 1211.570 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Total Oncostatin M (OSM) | Day 155: n=7,3,17 | 359.340 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Total Oncostatin M (OSM) | Day 85: n=8,3,22 | 1357.645 Picogram per milliliter |
| GSK2330811 300 mg | Serum Level of Total Oncostatin M (OSM) | Day 15: n=8,3,23 | 721.020 Picogram per milliliter |