Anaemia
Conditions
Keywords
Hemodialysis, GSK1278863, Pharmacokinetics, Erythropoiesis Stimulating Agents, Chronic Kidney Disease, Hemoglobin, Recombinant Erythropoietin, Prolyl Hydroxylase Inhibitor, Anemia
Brief summary
This study aims to characterize the relationship between dose of GSK1278863 and hemoglobin (Hgb) response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD). It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials. This study will consist of a screening phase of 3-9 weeks, a 4-week treatment phase and a follow-up visit approximately 4 weeks after completing treatment.
Interventions
DRUGGSK1278863
GSK1278863 will be supplied as film coated tablets for oral administration containing 1 mg, 2 mg, or 5 mg of GSK1278863.
DRUGPlacebo
Film coated tablets of GSK1278863 matching placebo for oral administration.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age (Informed concent): Japanese \>=20 years of age * Gender (Screening 2 verification only): Female and male * Females: must be of childbearing potential, and must agree to use one of the approved contraception methods from Screening 2 until completion of the Follow-up Visit. OR Of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone 23.0 - 116.3 million international units (MIU)/millilitre (mL) and estradiol \<= 10 picograms (pg)/mL is confirmatory\]. Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will be required to use one of the approved contraception methods if they wish to continue their HRT during the study. Otherwise they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Males: must agree to use one of the approved contraceptive methods from the time of Screening 2 until completion of the Follow-up Visit. * Corrected QT interval (QTc) (Screening 2 verification only): Bazett's Correction of QT Interval (QTcB) \<470 milliseconds (msec) or QTcB \<480 msec in subjects with bundle branch block. There is no QTc inclusion criterion for a subject with a predominantly paced rhythm. * Dialysis frequency: On hemodialysis (HD) three times weekly for at least 8 weeks prior to Screening 2 through Day 1. * Dialysis adequacy (Screening 2 only): A single-pool Kt/Vurea of 1.2 based on a historical value obtained within the prior month in order to ensure the adequacy of dialysis. If Kt/Vurea is not available, then an average of the last 2 values of urea reduction ratio (URR) of at least 65%. * Hemoglobin: Target stable Hgb between 9.5-12.0 g/dL at screening. * Stable erythropoiesis-stimulating agent (ESA) dose (Screening 2 only): Using the same ESA (epoetins or their biosimilar, or darbepoietin) with total weekly doses that varied by no more than 50% during the 4 weeks prior to Screening 2. * Iron replacement therapy: Subjects may be on stable maintenance oral or intravenous (IV) (\<100 milligrams \[mg\]/week) iron supplementation. If subjects are on oral or IV iron, then doses must be stable for the 4 weeks prior to Screening 2, and Screening 2 through Week 4.
Exclusion criteria
* Dialysis modality: Planned change from HD to peritoneal dialysis within the study time period. * Renal transplant: Renal transplant anticipated or scheduled within the study time period. * High ESA dose (Screening 2 verification only): As defined by an epoetin dose of \>=360 IU/kilograms (kg)/week IV or darbepoetin dose of \>=1.8 micrograms (μg)/kg/week IV within the prior 8 weeks through Screening 2. * methoxy polyethylene glycol epoetin beta (Screening 2 verification only): Use of methoxy polyethylene glycol epoetin beta within the prior 8 weeks through Screening 2. * Vitamin B12: At or below the lower limit of the reference range * Folate: \<2.0 nanograms (ng)/mL (\<4.5 nanomoles \[nmol\]/liters \[L\]) * Iron status: Ferritine \<100 ng/mL (\<100 μg/L) AND Transferrin saturation (TSAT) \<20% * Myocardial infarction or acute coronary syndrome: Within the 8 weeks prior to Screening 2 through Day 1. * Stroke or transient ischemic attack: Within the 8 weeks prior to Screening 2 through Day 1. * Heart failure: Class III/IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system or symptomatic right heart failure diagnosed prior to Screening 2 through Day 1. * Hypertension: Defined using pre-dialysis vitals of diastolic blood pressure \>100 mmHg or systolic blood pressure \>170 mmHg. * Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset or worsening limb ischemia requiring intervention), except vascular access thrombosis, within the 8 weeks prior to Screening 2 through Day 1 * Eyes: History of proliferative retinopathy requiring treatment within the prior 12 months or macular edema requiring treatment.. * Inflammatory disease: Active chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) diagnosed prior to Screening 2 through Day 1. * Hematological disease: Any hematological disease including those affecting platelets, white or red blood cells (e.g. sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia and thalassemia), coagulation disorders (e.g., antiphospholipid syndrome, Protein C or S deficiency), or any other cause of anemia other than renal disease diagnosed prior to Screening 2 through Day 1. * Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening of abnormal liver function tests \[alanine transaminase (ALT) or aspartate transaminase (AST) \>2.0 x upper limit of normal (ULN) or total bilirubin \> 1.5 x ULN\]; or other hepatic abnormalities that in the opinion of the investigator (subinvestigator) would preclude the subject from participation in the study. * Major surgery: Major surgery (excluding vascular access surgery) within the prior 8 weeks, within the Screening 2 to Day 1 or planned during the study. * Transfusion: Blood transfusion within the prior 8 weeks, within the Screening 2 to Day 1 or an anticipated need for blood transfusion during the study. * Gastrointestinal (GI) bleeding: Evidence of actively bleeding peptic, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding within the 8 weeks prior to Screening 2 through Day 1. * Acute infection: Clinical evidence of acute infection or history of infection requiring IV antibiotic therapy within 8 weeks prior to Screening 2 through Day 1. * Malignancy: Subjects with a history of malignancy within the prior 5 years, who receiving treatment for cancer, or who have a strong family history of cancer (e.g., familial cancer disorders); with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated prior to Screening 2 through Day 1. * Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product * Drugs and supplements: Use of any prescription or non-prescription drugs or dietary supplements that are prohibited from Screening 2 until the Follow-up Visit. * Prior investigational product exposure: The Subject has participated in a clinical trial and has received an experimental investigational product within the prior 30 days from Screening 2 through Day 1. * Pregnancy or lactation: Pregnant females as determined by positive serum Human Chorionic Gonadotrophin (hCG) test (Screening 2 only) OR women who are lactating at Screening 2 and/or Day 1 or during the trial. * Other conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the Investigator would consider inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 | Baseline (Day 1) and Week 4 | Baseline was defined as the value on Day 1. CFB was calculated by subtracting the baseline value from the post-dose value at Week 4. To model the dose-response relationship a four-parameter Emax model was used. E0 is the expected Hgb change from Baseline for a participant receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a participant receiving the highest dose above which no further increase in response can be achieved. ED50 is the dose that attains the intermediate response. Gamma is the slope parameter. Minimal Effective Dose (MED) is defined as the smallest dose that achieves a placebo-corrected change of 0.5 g/dL over Week 4. Target dose (TD) is defined as the dose that achieves a placebo-corrected 1.0 g/dL change over Week 4. Maximum Acceptable Dose (MAD) is defined as the dose that achieves a placebo-corrected 2.0 g/dL change over Week 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Hgb Response at Week 4 | Week 4 | Hgb response was defined as achieving an increase of at least 0.5 g/dL, 1.0 g/dL, 1.5 g/dL, and 2.0 g/dL in Hgb. The number of participants with Hgb response: Hgb increase \<-1.0, Hgb increase -1.0 -\< -0.5, Hgb increase -0.5 -\< 0.5, Hgb increase 0.5 -\< 1.0 and Hgb increase \>=1.0 have been presented. |
| Percentage of Participants Who Achieved Hgb Response at Week 4 | Week 4 | Hgb response was defined as achieving an increase of at least 0.5 g/dL, 1.0 g/dL, 1.5 g/dL, and 2.0 g/dL in Hgb. The percentage of participants with Hgb response: Hgb increase \<-1.0, Hgb increase -1.0 -\< -0.5, Hgb increase -0.5 -\< 0.5, Hgb increase 0.5 -\< 1.0 and Hgb increase \>=1.0 have been presented. |
| Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | Upto Week 4 | Hgb stopping criteria was defined as: (1) Hgb \<7.5 g/dL (2) 7.5 \<= Hgb \<1 3.0 g/dL and \>2 g/dL Hgb change over 2W (3) Hgb \>=13.0 g/dL. The number of participants who reached pre-defined Hgb stopping criteria have been presented. |
| Maximum Observed CFB in Erythropoietin (EPO) Upto Week 4 | Baseline (Day 1) Upto Week 4 | Blood samples for EPO were collected on Day 1 (pre-dose), Week 2 (collected approx 6-12 hours post-dose on arrival and after 1, 2 and 3 hours) and Week 4 (pre-dose and 3 hours post-dose). Maximum observed value meant maximum value between Week 1 and Week 4. Baseline was defined as the value on Day 1. Maximum observed CFB was calculated by subtracting the Baseline value from the maximum observed value between Week 1 and Week 4. |
| Maximum Observed Percent CFB in Peak Vascular Endothelial Growth Factor (VEGF) Upto Week 4 | Baseline (Day 1) Upto Week 4 | Blood samples for VEGF were collected on Day 1 (pre-dose), Week 2 (collected approximately 6-12 hours post-dose on arrival and after 1, 2 and 3 hours) and Week 4 (pre-dose and 3 hours post-dose). Maximum observed value meant maximum value between Week 1 and Week 4. Baseline was defined as the value on Day 1. Maximum observed percent CFB was calculated as 100 multiplied by the maximum observed exponential mean change on a log scale minus 1. |
| Percent CFB in Hepcidine Upto Week 4 | Baseline (Day 1) Upto Week 4 | Blood samples for hepcidine were collected on Day 1 (pre-dose), Week 2 (collected approximately 6-12 hours post-dose) and Week 4 (pre-dose). Baseline was defined as the value on Day 1. Percent CFB was calculated as 100 multiplied by the exponential mean change on a log scale minus 1. |
| CFB in Ferritin at Week 4 | Baseline (Day 1) and Week 4 | Ferritin was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post dose value at Week 4. |
| CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | Baseline (Day 1) and Week 4 | TIBC, UIBC and Iron were used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4. |
| CFB in Hgb Upto Week 8 | Baseline (Day 1) Upto Week 8 | Hgb assessments were performed at Baseline, Week 1, Week 2, Week 3, W eek4/Early withdrawal and Week 8 (follow-up) based on central laboratory (Quest diagnosis). Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4. |
| Percent CFB in Transferrin Saturation (TS) at Week 4 | Baseline (Day 1) and Week 4 | TS was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. Percent CFB was calculated as 100 multiplied by the exponential mean change on a log scale minus 1. |
| Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | Week 4 | Blood samples for plasma pharmacokinetic analysis were collected at Week 4 (pre-dose, 1, 2, 3 hours post-dose). Individual plasma GSK1278863 and M-GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531401, GSK2531403 concentrations have been presented. |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy | Upto Week 4 | An AE is defined as any untoward medical occurrence in clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any AE which results in death; is life-threatening; requires participant hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. |
| Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Upto Week 4 | The PCI range was as follows: alkaline phosphates \>= 3 times upper limit of normal range \[ULRR\]), potassium (\>0.5 millimoles/liter below the LLRR or \>1.0 millimoles/liter above the ULRR), phosphate (\>0.323 millimoles/liter above ULRR or below lower limit reference range \[LLRR\]), glucose (\<3.9 or \>22 millimoles/liter), magnesium (\<LLRR or \> 0.3 milimoles/liter above ULRR), lymphocytes \<0.5x LLRR, neutrophils (\<0.5 times LLRR), platelets (80 or \>500 times giga/liter), platelets (80 or \>500 times giga/liter) and leukocytes \>1 x giga/liter below the LLRR or \>5 x GI/L above the ULRR. The participants who had PCI values higher and lower than the reference range have been presented. |
| Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | Upto Week 4 | Vital signs SBP and DBP were recorded pre-dialysis and post-dialysis. Measurements were taken from the participant while in a seated position or semi-supine in the dialysis chair. PCI range for SBP was \< 85 or \> 170 and for DBP was \< 45 or \> 100 millimeters of mercury. Participant's with values high and low from the PCI range have been presented. |
| Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4 | Upto Week 4 | Vital sign HR was recorded pre-dialysis and post-dialysis. Measurements were taken from the participant while in a seated position or semi-supine in the dialysis chair. PCI range for HR was \< 40 or \> 110 beats per minute. Participant's with values higher than the PCI range have been presented. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4 | Upto Week 4 | Full 12-lead ECGs included heart rate, PR, QRS, QT and QTc intervals. Measurements were taken from the participant while in a supine position. ECGs were performed consistently either before or after dialysis throughout the study. ECG abnormalities characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS) upto W4 have been presented. |
| CFB in Transferrin at Week 4 | Baseline (Day 1) and Week 4 | Transferrin was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4. |
Countries
Japan
Participant flow
Recruitment details
This was a study to evaluate dose-response of GSK1278863 in approximately 95 Japanese Hemodialysis-dependent (HDD) participants with anemia associated with Chronic Kidney Disease (CKD) conducted across 21 centers in Japan from 05 November 2013 to 06 August 2014.
Pre-assignment details
This study consisted of a screening phase of 3-9 Week , a 4 Week treatment phase and a follow-up visit that occurred approximately 4 Week after completing treatment. Study completion was defined as completing the final visit including those in the follow-up period.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Eligible participant's received matching placebo to GSK1278863 once daily for the 4 Week treatment period. | 19 |
| GSK1278863 4 mg Eligible participant's received GSK1278863 4 mg once daily for the 4 Week treatment period. | 19 |
| GSK1278863 6 mg Eligible participant's received GSK1278863 6 mg once daily for the 4 Week treatment period. | 20 |
| GSK1278863 8 mg Eligible participant's received GSK1278863 8 mg once daily for the 4 Week treatment period. | 19 |
| GSK1278863 10 mg Eligible participant's received GSK1278863 10 mg once daily for the 4 Week treatment period. | 20 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 1 | 1 |
| Overall Study | Physician Decision | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol defined stopping criteria | 2 | 0 | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | GSK1278863 10 mg | GSK1278863 8 mg | GSK1278863 6 mg | GSK1278863 4 mg |
|---|---|---|---|---|---|---|
| Age, Continuous | 63.4 Years STANDARD_DEVIATION 8.98 | 62.4 Years STANDARD_DEVIATION 9.7 | 62.2 Years STANDARD_DEVIATION 11.13 | 66.0 Years STANDARD_DEVIATION 9.23 | 58.9 Years STANDARD_DEVIATION 9.9 | 61.6 Years STANDARD_DEVIATION 8.49 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 97 Participants | 20 Participants | 19 Participants | 20 Participants | 19 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 47 Participants | 9 Participants | 12 Participants | 8 Participants | 11 Participants |
| Sex: Female, Male Male | 12 Participants | 50 Participants | 11 Participants | 7 Participants | 12 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 20 | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 4 / 19 | 6 / 19 | 8 / 20 | 7 / 19 | 5 / 20 |
| serious Total, serious adverse events | 1 / 19 | 0 / 19 | 0 / 20 | 0 / 19 | 0 / 20 |
Outcome results
Primary
Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4
Baseline was defined as the value on Day 1. CFB was calculated by subtracting the baseline value from the post-dose value at Week 4. To model the dose-response relationship a four-parameter Emax model was used. E0 is the expected Hgb change from Baseline for a participant receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a participant receiving the highest dose above which no further increase in response can be achieved. ED50 is the dose that attains the intermediate response. Gamma is the slope parameter. Minimal Effective Dose (MED) is defined as the smallest dose that achieves a placebo-corrected change of 0.5 g/dL over Week 4. Target dose (TD) is defined as the dose that achieves a placebo-corrected 1.0 g/dL change over Week 4. Maximum Acceptable Dose (MAD) is defined as the dose that achieves a placebo-corrected 2.0 g/dL change over Week 4.
Time frame: Baseline (Day 1) and Week 4
Population: Intent-to-Treat (ITT) population comprised of all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on treatment assessment. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 | -1.52 grams/deciliter (g/dL) | Standard Error 0.212 |
| GSK1278863 4 mg | Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 | -0.29 grams/deciliter (g/dL) | Standard Error 0.2 |
| GSK1278863 6 mg | Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 | -0.02 grams/deciliter (g/dL) | Standard Error 0.193 |
| GSK1278863 8 mg | Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 | 0.60 grams/deciliter (g/dL) | Standard Error 0.202 |
| GSK1278863 10 mg | Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 | 0.92 grams/deciliter (g/dL) | Standard Error 0.196 |
95% CI: [-1.72, -1.03]
95% CI: [9.99, 42.64]
95% CI: [3.2, 8.61]
95% CI: [0.7, 1.68]
95% CI: [0.5, 0.88]
95% CI: [0.75, 3.41]
95% CI: [2.2, 5.63]
95% CI: [6.51, 11.44]
Secondary
CFB in Ferritin at Week 4
Ferritin was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post dose value at Week 4.
Time frame: Baseline (Day 1) and Week 4
Population: ITT population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | CFB in Ferritin at Week 4 | 4.7 micrograms/liter | Standard Deviation 114.79 |
| GSK1278863 4 mg | CFB in Ferritin at Week 4 | -50.6 micrograms/liter | Standard Deviation 40.28 |
| GSK1278863 6 mg | CFB in Ferritin at Week 4 | -78.3 micrograms/liter | Standard Deviation 52.32 |
| GSK1278863 8 mg | CFB in Ferritin at Week 4 | -92.6 micrograms/liter | Standard Deviation 107.07 |
| GSK1278863 10 mg | CFB in Ferritin at Week 4 | -113.3 micrograms/liter | Standard Deviation 94.69 |
Secondary
CFB in Hgb Upto Week 8
Hgb assessments were performed at Baseline, Week 1, Week 2, Week 3, W eek4/Early withdrawal and Week 8 (follow-up) based on central laboratory (Quest diagnosis). Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4.
Time frame: Baseline (Day 1) Upto Week 8
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | CFB in Hgb Upto Week 8 | CFB at Week 4 | -1.31 g/dL | Standard Deviation 0.923 |
| Placebo | CFB in Hgb Upto Week 8 | CFB at Week 1 | -0.34 g/dL | Standard Deviation 0.485 |
| Placebo | CFB in Hgb Upto Week 8 | CFB at Week 8, Follow-up | -1.20 g/dL | Standard Deviation 0.997 |
| Placebo | CFB in Hgb Upto Week 8 | CFB at Week 2 | -0.79 g/dL | Standard Deviation 0.538 |
| Placebo | CFB in Hgb Upto Week 8 | CFB at Week 3 | -1.14 g/dL | Standard Deviation 0.743 |
| GSK1278863 4 mg | CFB in Hgb Upto Week 8 | CFB at Week 4 | -0.33 g/dL | Standard Deviation 0.754 |
| GSK1278863 4 mg | CFB in Hgb Upto Week 8 | CFB at Week 3 | -0.42 g/dL | Standard Deviation 0.658 |
| GSK1278863 4 mg | CFB in Hgb Upto Week 8 | CFB at Week 2 | -0.32 g/dL | Standard Deviation 0.449 |
| GSK1278863 4 mg | CFB in Hgb Upto Week 8 | CFB at Week 8, Follow-up | -0.90 g/dL | Standard Deviation 0.953 |
| GSK1278863 4 mg | CFB in Hgb Upto Week 8 | CFB at Week 1 | -0.23 g/dL | Standard Deviation 0.374 |
| GSK1278863 6 mg | CFB in Hgb Upto Week 8 | CFB at Week 3 | -0.34 g/dL | Standard Deviation 0.776 |
| GSK1278863 6 mg | CFB in Hgb Upto Week 8 | CFB at Week 1 | -0.35 g/dL | Standard Deviation 0.462 |
| GSK1278863 6 mg | CFB in Hgb Upto Week 8 | CFB at Week 2 | -0.32 g/dL | Standard Deviation 0.78 |
| GSK1278863 6 mg | CFB in Hgb Upto Week 8 | CFB at Week 4 | -0.22 g/dL | Standard Deviation 1.008 |
| GSK1278863 6 mg | CFB in Hgb Upto Week 8 | CFB at Week 8, Follow-up | -0.38 g/dL | Standard Deviation 0.526 |
| GSK1278863 8 mg | CFB in Hgb Upto Week 8 | CFB at Week 8, Follow-up | -0.21 g/dL | Standard Deviation 1.218 |
| GSK1278863 8 mg | CFB in Hgb Upto Week 8 | CFB at Week 1 | -0.31 g/dL | Standard Deviation 0.481 |
| GSK1278863 8 mg | CFB in Hgb Upto Week 8 | CFB at Week 4 | 0.34 g/dL | Standard Deviation 1.069 |
| GSK1278863 8 mg | CFB in Hgb Upto Week 8 | CFB at Week 3 | 0.21 g/dL | Standard Deviation 0.692 |
| GSK1278863 8 mg | CFB in Hgb Upto Week 8 | CFB at Week 2 | 0.01 g/dL | Standard Deviation 0.586 |
| GSK1278863 10 mg | CFB in Hgb Upto Week 8 | CFB at Week 3 | 0.37 g/dL | Standard Deviation 0.471 |
| GSK1278863 10 mg | CFB in Hgb Upto Week 8 | CFB at Week 4 | 0.51 g/dL | Standard Deviation 0.679 |
| GSK1278863 10 mg | CFB in Hgb Upto Week 8 | CFB at Week 1 | -0.17 g/dL | Standard Deviation 0.318 |
| GSK1278863 10 mg | CFB in Hgb Upto Week 8 | CFB at Week 8, Follow-up | -0.34 g/dL | Standard Deviation 0.691 |
| GSK1278863 10 mg | CFB in Hgb Upto Week 8 | CFB at Week 2 | 0.24 g/dL | Standard Deviation 0.353 |
Secondary
CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4
TIBC, UIBC and Iron were used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4.
Time frame: Baseline (Day 1) and Week 4
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in TIBC at Week 4 | 0.2 micromoles/liter | Standard Deviation 1.97 |
| Placebo | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in Iron at Week 4 | 0.0 micromoles/liter | Standard Deviation 4.46 |
| Placebo | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in UIBC at Week 4 | 0.8 micromoles/liter | Standard Deviation 6.1 |
| GSK1278863 4 mg | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in UIBC at Week 4 | 11.7 micromoles/liter | Standard Deviation 6.61 |
| GSK1278863 4 mg | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in TIBC at Week 4 | 8.6 micromoles/liter | Standard Deviation 3.96 |
| GSK1278863 4 mg | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in Iron at Week 4 | -3.1 micromoles/liter | Standard Deviation 4.96 |
| GSK1278863 6 mg | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in UIBC at Week 4 | 19.2 micromoles/liter | Standard Deviation 9.17 |
| GSK1278863 6 mg | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in TIBC at Week 4 | 14.4 micromoles/liter | Standard Deviation 6.79 |
| GSK1278863 6 mg | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in Iron at Week 4 | -4.8 micromoles/liter | Standard Deviation 5.86 |
| GSK1278863 8 mg | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in TIBC at Week 4 | 14.3 micromoles/liter | Standard Deviation 5.67 |
| GSK1278863 8 mg | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in Iron at Week 4 | -2.4 micromoles/liter | Standard Deviation 7.16 |
| GSK1278863 8 mg | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in UIBC at Week 4 | 16.3 micromoles/liter | Standard Deviation 9.18 |
| GSK1278863 10 mg | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in UIBC at Week 4 | 22.1 micromoles/liter | Standard Deviation 7.65 |
| GSK1278863 10 mg | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in TIBC at Week 4 | 17.2 micromoles/liter | Standard Deviation 4.87 |
| GSK1278863 10 mg | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | CFB in Iron at Week 4 | -4.9 micromoles/liter | Standard Deviation 5.32 |
Secondary
CFB in Transferrin at Week 4
Transferrin was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4.
Time frame: Baseline (Day 1) and Week 4
Population: ITT population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | CFB in Transferrin at Week 4 | 0.041 grams/liter | Standard Deviation 0.2013 |
| GSK1278863 4 mg | CFB in Transferrin at Week 4 | 0.449 grams/liter | Standard Deviation 0.2958 |
| GSK1278863 6 mg | CFB in Transferrin at Week 4 | 0.626 grams/liter | Standard Deviation 0.3605 |
| GSK1278863 8 mg | CFB in Transferrin at Week 4 | 0.677 grams/liter | Standard Deviation 0.2948 |
| GSK1278863 10 mg | CFB in Transferrin at Week 4 | 0.804 grams/liter | Standard Deviation 0.3944 |
Secondary
Maximum Observed CFB in Erythropoietin (EPO) Upto Week 4
Blood samples for EPO were collected on Day 1 (pre-dose), Week 2 (collected approx 6-12 hours post-dose on arrival and after 1, 2 and 3 hours) and Week 4 (pre-dose and 3 hours post-dose). Maximum observed value meant maximum value between Week 1 and Week 4. Baseline was defined as the value on Day 1. Maximum observed CFB was calculated by subtracting the Baseline value from the maximum observed value between Week 1 and Week 4.
Time frame: Baseline (Day 1) Upto Week 4
Population: ITT population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Observed CFB in Erythropoietin (EPO) Upto Week 4 | 6.658 International units/liter | Standard Deviation 4.5414 |
| GSK1278863 4 mg | Maximum Observed CFB in Erythropoietin (EPO) Upto Week 4 | 34.951 International units/liter | Standard Deviation 28.2718 |
| GSK1278863 6 mg | Maximum Observed CFB in Erythropoietin (EPO) Upto Week 4 | 94.518 International units/liter | Standard Deviation 122.4985 |
| GSK1278863 8 mg | Maximum Observed CFB in Erythropoietin (EPO) Upto Week 4 | 151.012 International units/liter | Standard Deviation 151.2964 |
| GSK1278863 10 mg | Maximum Observed CFB in Erythropoietin (EPO) Upto Week 4 | 173.446 International units/liter | Standard Deviation 226.7241 |
Secondary
Maximum Observed Percent CFB in Peak Vascular Endothelial Growth Factor (VEGF) Upto Week 4
Blood samples for VEGF were collected on Day 1 (pre-dose), Week 2 (collected approximately 6-12 hours post-dose on arrival and after 1, 2 and 3 hours) and Week 4 (pre-dose and 3 hours post-dose). Maximum observed value meant maximum value between Week 1 and Week 4. Baseline was defined as the value on Day 1. Maximum observed percent CFB was calculated as 100 multiplied by the maximum observed exponential mean change on a log scale minus 1.
Time frame: Baseline (Day 1) Upto Week 4
Population: ITT population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo | Maximum Observed Percent CFB in Peak Vascular Endothelial Growth Factor (VEGF) Upto Week 4 | 45.05 Percent change |
| GSK1278863 4 mg | Maximum Observed Percent CFB in Peak Vascular Endothelial Growth Factor (VEGF) Upto Week 4 | 18.78 Percent change |
| GSK1278863 6 mg | Maximum Observed Percent CFB in Peak Vascular Endothelial Growth Factor (VEGF) Upto Week 4 | 18.94 Percent change |
| GSK1278863 8 mg | Maximum Observed Percent CFB in Peak Vascular Endothelial Growth Factor (VEGF) Upto Week 4 | 27.70 Percent change |
| GSK1278863 10 mg | Maximum Observed Percent CFB in Peak Vascular Endothelial Growth Factor (VEGF) Upto Week 4 | 44.29 Percent change |
Secondary
Number of Participants Who Achieved Hgb Response at Week 4
Hgb response was defined as achieving an increase of at least 0.5 g/dL, 1.0 g/dL, 1.5 g/dL, and 2.0 g/dL in Hgb. The number of participants with Hgb response: Hgb increase \<-1.0, Hgb increase -1.0 -\< -0.5, Hgb increase -0.5 -\< 0.5, Hgb increase 0.5 -\< 1.0 and Hgb increase \>=1.0 have been presented.
Time frame: Week 4
Population: ITT population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase 0.5 -< 1.0 | 0 Participants |
| Placebo | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase <-1.0 | 11 Participants |
| Placebo | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase >=1.0 | 0 Participants |
| Placebo | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -1.0 -< -0.5 | 2 Participants |
| Placebo | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -0.5 -< 0.5 | 2 Participants |
| GSK1278863 4 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase 0.5 -< 1.0 | 1 Participants |
| GSK1278863 4 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -0.5 -< 0.5 | 10 Participants |
| GSK1278863 4 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -1.0 -< -0.5 | 2 Participants |
| GSK1278863 4 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase >=1.0 | 1 Participants |
| GSK1278863 4 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase <-1.0 | 4 Participants |
| GSK1278863 6 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -0.5 -< 0.5 | 8 Participants |
| GSK1278863 6 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase <-1.0 | 3 Participants |
| GSK1278863 6 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -1.0 -< -0.5 | 2 Participants |
| GSK1278863 6 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase 0.5 -< 1.0 | 3 Participants |
| GSK1278863 6 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase >=1.0 | 4 Participants |
| GSK1278863 8 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase >=1.0 | 6 Participants |
| GSK1278863 8 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase <-1.0 | 0 Participants |
| GSK1278863 8 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase 0.5 -< 1.0 | 4 Participants |
| GSK1278863 8 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -0.5 -< 0.5 | 7 Participants |
| GSK1278863 8 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -1.0 -< -0.5 | 1 Participants |
| GSK1278863 10 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -0.5 -< 0.5 | 6 Participants |
| GSK1278863 10 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase 0.5 -< 1.0 | 4 Participants |
| GSK1278863 10 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase <-1.0 | 0 Participants |
| GSK1278863 10 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase >=1.0 | 9 Participants |
| GSK1278863 10 mg | Number of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -1.0 -< -0.5 | 0 Participants |
Secondary
Number of Participants Who Reached Pre-defined Hgb Stopping Criteria
Hgb stopping criteria was defined as: (1) Hgb \<7.5 g/dL (2) 7.5 \<= Hgb \<1 3.0 g/dL and \>2 g/dL Hgb change over 2W (3) Hgb \>=13.0 g/dL. The number of participants who reached pre-defined Hgb stopping criteria have been presented.
Time frame: Upto Week 4
Population: ITT population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | < 7.5 | 2 Participants |
| Placebo | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | 7..5 -< 13.0 and >2 g/dL change | 0 Participants |
| GSK1278863 4 mg | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | < 7.5 | 0 Participants |
| GSK1278863 4 mg | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | 7..5 -< 13.0 and >2 g/dL change | 0 Participants |
| GSK1278863 6 mg | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | < 7.5 | 0 Participants |
| GSK1278863 6 mg | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | 7..5 -< 13.0 and >2 g/dL change | 0 Participants |
| GSK1278863 8 mg | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | 7..5 -< 13.0 and >2 g/dL change | 2 Participants |
| GSK1278863 8 mg | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | < 7.5 | 0 Participants |
| GSK1278863 10 mg | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | < 7.5 | 0 Participants |
| GSK1278863 10 mg | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | 7..5 -< 13.0 and >2 g/dL change | 1 Participants |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4
Full 12-lead ECGs included heart rate, PR, QRS, QT and QTc intervals. Measurements were taken from the participant while in a supine position. ECGs were performed consistently either before or after dialysis throughout the study. ECG abnormalities characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS) upto W4 have been presented.
Time frame: Upto Week 4
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4 | A-NCS, Week 2 | 5 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4 | A-NCS, Week 4 | 2 Participants |
| GSK1278863 4 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4 | A-NCS, Week 2 | 8 Participants |
| GSK1278863 4 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4 | A-NCS, Week 4 | 8 Participants |
| GSK1278863 6 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4 | A-NCS, Week 2 | 6 Participants |
| GSK1278863 6 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4 | A-NCS, Week 4 | 5 Participants |
| GSK1278863 8 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4 | A-NCS, Week 4 | 8 Participants |
| GSK1278863 8 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4 | A-NCS, Week 2 | 7 Participants |
| GSK1278863 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4 | A-NCS, Week 2 | 7 Participants |
| GSK1278863 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4 | A-NCS, Week 4 | 6 Participants |
Secondary
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy
An AE is defined as any untoward medical occurrence in clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any AE which results in death; is life-threatening; requires participant hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
Time frame: Upto Week 4
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy | Any SAE | 1 Participants |
| Placebo | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy | Any AE | 5 Participants |
| GSK1278863 4 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy | Any AE | 6 Participants |
| GSK1278863 4 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy | Any SAE | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy | Any AE | 8 Participants |
| GSK1278863 6 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy | Any SAE | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy | Any AE | 7 Participants |
| GSK1278863 8 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy | Any SAE | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy | Any SAE | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy | Any AE | 5 Participants |
Secondary
Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4
The PCI range was as follows: alkaline phosphates \>= 3 times upper limit of normal range \[ULRR\]), potassium (\>0.5 millimoles/liter below the LLRR or \>1.0 millimoles/liter above the ULRR), phosphate (\>0.323 millimoles/liter above ULRR or below lower limit reference range \[LLRR\]), glucose (\<3.9 or \>22 millimoles/liter), magnesium (\<LLRR or \> 0.3 milimoles/liter above ULRR), lymphocytes \<0.5x LLRR, neutrophils (\<0.5 times LLRR), platelets (80 or \>500 times giga/liter), platelets (80 or \>500 times giga/liter) and leukocytes \>1 x giga/liter below the LLRR or \>5 x GI/L above the ULRR. The participants who had PCI values higher and lower than the reference range have been presented.
Time frame: Upto Week 4
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 1 | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Magnesium, low, Week 4 | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, low, Week 2 | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Phosphate, High, Week 2 | 1 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 4 | 1 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 4 | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Magnesium, low, Week 2 | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, High, Week 4 | 1 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, High, Week 2 | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 3 | 3 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 3 | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Lymphocytes, low ,Week 1 | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Glucose, Week 2, low | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, low, Week 4 | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 2 | 2 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Phosphate, High, Week 4 | 2 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Lymphocytes, low ,Week 3 | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 2 | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Alkaline phosphatase, Week 4, High | 0 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 1 | 3 Participants |
| Placebo | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Neutrophils, low, Week 1 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 4 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Neutrophils, low, Week 1 | 1 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 3 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 1 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 2 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, High, Week 2 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, low, Week 2 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Phosphate, High, Week 4 | 9 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Alkaline phosphatase, Week 4, High | 1 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Glucose, Week 2, low | 1 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Phosphate, High, Week 2 | 9 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 4 | 2 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Magnesium, low, Week 4 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 3 | 2 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Magnesium, low, Week 2 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, High, Week 4 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 2 | 3 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Lymphocytes, low ,Week 1 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 1 | 3 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Lymphocytes, low ,Week 3 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, low, Week 4 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Phosphate, High, Week 2 | 10 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Phosphate, High, Week 4 | 11 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, low, Week 4 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, low, Week 2 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Glucose, Week 2, low | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Magnesium, low, Week 4 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Magnesium, low, Week 2 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Lymphocytes, low ,Week 1 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Lymphocytes, low ,Week 3 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Neutrophils, low, Week 1 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 1 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 2 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 3 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 4 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 1 | 2 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 2 | 2 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 3 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 4 | 2 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Alkaline phosphatase, Week 4, High | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, High, Week 2 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, High, Week 4 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Neutrophils, low, Week 1 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, low, Week 4 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 4 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Lymphocytes, low ,Week 3 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 1 | 1 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Lymphocytes, low ,Week 1 | 1 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Phosphate, High, Week 2 | 7 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 2 | 4 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Magnesium, low, Week 2 | 1 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, High, Week 4 | 1 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 3 | 2 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Magnesium, low, Week 4 | 1 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 4 | 2 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Glucose, Week 2, low | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Phosphate, High, Week 4 | 8 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Alkaline phosphatase, Week 4, High | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, low, Week 2 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, High, Week 2 | 1 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 2 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 1 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 3 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, High, Week 4 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, High, Week 2 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 4 | 4 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 4 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Lymphocytes, low ,Week 3 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Lymphocytes, low ,Week 1 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Phosphate, High, Week 4 | 10 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, low, Week 2 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 1 | 2 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 2 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Magnesium, low, Week 2 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 3 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Alkaline phosphatase, Week 4, High | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 2 | 3 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Neutrophils, low, Week 1 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Magnesium, low, Week 4 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Potassium, low, Week 4 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Phosphate, High, Week 2 | 9 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Leukocyte, low, Week 3 | 3 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Platelets, low, Week 1 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Glucose, Week 2, low | 0 Participants |
Secondary
Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4
Vital sign HR was recorded pre-dialysis and post-dialysis. Measurements were taken from the participant while in a seated position or semi-supine in the dialysis chair. PCI range for HR was \< 40 or \> 110 beats per minute. Participant's with values higher than the PCI range have been presented.
Time frame: Upto Week 4
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4 | HR, high, Post-dialysis, Week 1 | 0 Participants |
| Placebo | Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4 | HR, high, Post-Dialysis, Week 3 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4 | HR, high, Post-dialysis, Week 1 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4 | HR, high, Post-Dialysis, Week 3 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4 | HR, high, Post-dialysis, Week 1 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4 | HR, high, Post-Dialysis, Week 3 | 1 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4 | HR, high, Post-Dialysis, Week 3 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4 | HR, high, Post-dialysis, Week 1 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4 | HR, high, Post-dialysis, Week 1 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4 | HR, high, Post-Dialysis, Week 3 | 0 Participants |
Secondary
Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4
Vital signs SBP and DBP were recorded pre-dialysis and post-dialysis. Measurements were taken from the participant while in a seated position or semi-supine in the dialysis chair. PCI range for SBP was \< 85 or \> 170 and for DBP was \< 45 or \> 100 millimeters of mercury. Participant's with values high and low from the PCI range have been presented.
Time frame: Upto Week 4
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis, Week 1 | 1 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 1 | 2 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 4 | 2 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 2 | 4 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, low, Post-dialysis, Week 2 | 0 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre dialysis, Week 3 | 2 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis,Week 4 | 0 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 4 | 1 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 2 | 1 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, low, Post-dialysis, Week 4 | 1 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 3 | 2 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 3 | 0 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis, Week 2 | 2 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 2 | 1 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 4 | 0 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 1 | 4 Participants |
| Placebo | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, low, Post-dialysis, Week 4 | 1 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 4 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 3 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 1 | 4 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, low, Post-dialysis, Week 2 | 1 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis, Week 2 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre dialysis, Week 3 | 3 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 1 | 1 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 2 | 3 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 3 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis, Week 1 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 2 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis,Week 4 | 1 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, low, Post-dialysis, Week 4 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 4 | 1 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 4 | 6 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, low, Post-dialysis, Week 4 | 0 Participants |
| GSK1278863 4 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 2 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 4 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis, Week 1 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis, Week 2 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis,Week 4 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 2 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 3 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 4 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, low, Post-dialysis, Week 4 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 1 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 2 | 3 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre dialysis, Week 3 | 2 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 1 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 2 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 3 | 3 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 4 | 1 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, low, Post-dialysis, Week 2 | 0 Participants |
| GSK1278863 6 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, low, Post-dialysis, Week 4 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 1 | 3 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, low, Post-dialysis, Week 4 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 4 | 4 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 4 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 1 | 1 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 3 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 2 | 1 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 2 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis, Week 1 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 3 | 2 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis,Week 4 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 4 | 2 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis, Week 2 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, low, Post-dialysis, Week 4 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 2 | 2 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, low, Post-dialysis, Week 2 | 0 Participants |
| GSK1278863 8 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre dialysis, Week 3 | 2 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre dialysis, Week 3 | 1 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 3 | 3 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis,Week 4 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 4 | 2 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 4 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 2 | 4 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, low, Post-dialysis, Week 2 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, low, Post-dialysis, Week 4 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 1 | 1 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 3 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, low, Post-dialysis, Week 4 | 0 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis, Week 1 | 1 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 4 | 3 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Post-dialysis, Week 2 | 3 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Post-dialysis, Week 2 | 1 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | DBP, high, Pre-dialysis, Week 2 | 2 Participants |
| GSK1278863 10 mg | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | SBP, high, Pre-dialysis, Week 1 | 1 Participants |
Secondary
Percentage of Participants Who Achieved Hgb Response at Week 4
Hgb response was defined as achieving an increase of at least 0.5 g/dL, 1.0 g/dL, 1.5 g/dL, and 2.0 g/dL in Hgb. The percentage of participants with Hgb response: Hgb increase \<-1.0, Hgb increase -1.0 -\< -0.5, Hgb increase -0.5 -\< 0.5, Hgb increase 0.5 -\< 1.0 and Hgb increase \>=1.0 have been presented.
Time frame: Week 4
Population: ITT population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase <-1.0 | 73 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -0.5 -< 0.5 | 13 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -1.0 -< -0.5 | 13 Percentage of participants |
| GSK1278863 4 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase <-1.0 | 22 Percentage of participants |
| GSK1278863 4 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase 0.5 -< 1.0 | 6 Percentage of participants |
| GSK1278863 4 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase >=1.0 | 6 Percentage of participants |
| GSK1278863 4 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -1.0 -< -0.5 | 11 Percentage of participants |
| GSK1278863 4 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -0.5 -< 0.5 | 56 Percentage of participants |
| GSK1278863 6 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase 0.5 -< 1.0 | 15 Percentage of participants |
| GSK1278863 6 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -0.5 -< 0.5 | 40 Percentage of participants |
| GSK1278863 6 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase <-1.0 | 15 Percentage of participants |
| GSK1278863 6 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase >=1.0 | 20 Percentage of participants |
| GSK1278863 6 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -1.0 -< -0.5 | 10 Percentage of participants |
| GSK1278863 8 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -0.5 -< 0.5 | 39 Percentage of participants |
| GSK1278863 8 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -1.0 -< -0.5 | 6 Percentage of participants |
| GSK1278863 8 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase 0.5 -< 1.0 | 22 Percentage of participants |
| GSK1278863 8 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase >=1.0 | 33 Percentage of participants |
| GSK1278863 10 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase -0.5 -< 0.5 | 32 Percentage of participants |
| GSK1278863 10 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase >=1.0 | 47 Percentage of participants |
| GSK1278863 10 mg | Percentage of Participants Who Achieved Hgb Response at Week 4 | Hgb increase 0.5 -< 1.0 | 21 Percentage of participants |
Secondary
Percent CFB in Hepcidine Upto Week 4
Blood samples for hepcidine were collected on Day 1 (pre-dose), Week 2 (collected approximately 6-12 hours post-dose) and Week 4 (pre-dose). Baseline was defined as the value on Day 1. Percent CFB was calculated as 100 multiplied by the exponential mean change on a log scale minus 1.
Time frame: Baseline (Day 1) Upto Week 4
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Percent CFB in Hepcidine Upto Week 4 | Percent CFB in hepcidine,Week 2 | 9.98 Percent change |
| Placebo | Percent CFB in Hepcidine Upto Week 4 | Percent CFB in hepcidine,Week 4 | 3.26 Percent change |
| GSK1278863 4 mg | Percent CFB in Hepcidine Upto Week 4 | Percent CFB in hepcidine,Week 2 | -50.71 Percent change |
| GSK1278863 4 mg | Percent CFB in Hepcidine Upto Week 4 | Percent CFB in hepcidine,Week 4 | -60.34 Percent change |
| GSK1278863 6 mg | Percent CFB in Hepcidine Upto Week 4 | Percent CFB in hepcidine,Week 2 | -64.90 Percent change |
| GSK1278863 6 mg | Percent CFB in Hepcidine Upto Week 4 | Percent CFB in hepcidine,Week 4 | -69.66 Percent change |
| GSK1278863 8 mg | Percent CFB in Hepcidine Upto Week 4 | Percent CFB in hepcidine,Week 4 | -69.06 Percent change |
| GSK1278863 8 mg | Percent CFB in Hepcidine Upto Week 4 | Percent CFB in hepcidine,Week 2 | -66.29 Percent change |
| GSK1278863 10 mg | Percent CFB in Hepcidine Upto Week 4 | Percent CFB in hepcidine,Week 2 | -73.52 Percent change |
| GSK1278863 10 mg | Percent CFB in Hepcidine Upto Week 4 | Percent CFB in hepcidine,Week 4 | -77.71 Percent change |
Secondary
Percent CFB in Transferrin Saturation (TS) at Week 4
TS was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. Percent CFB was calculated as 100 multiplied by the exponential mean change on a log scale minus 1.
Time frame: Baseline (Day 1) and Week 4
Population: ITT population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo | Percent CFB in Transferrin Saturation (TS) at Week 4 | 1.3 Percent change |
| GSK1278863 4 mg | Percent CFB in Transferrin Saturation (TS) at Week 4 | -31.3 Percent change |
| GSK1278863 6 mg | Percent CFB in Transferrin Saturation (TS) at Week 4 | -45.3 Percent change |
| GSK1278863 8 mg | Percent CFB in Transferrin Saturation (TS) at Week 4 | -35.2 Percent change |
| GSK1278863 10 mg | Percent CFB in Transferrin Saturation (TS) at Week 4 | -50.4 Percent change |
Secondary
Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4
Blood samples for plasma pharmacokinetic analysis were collected at Week 4 (pre-dose, 1, 2, 3 hours post-dose). Individual plasma GSK1278863 and M-GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531401, GSK2531403 concentrations have been presented.
Time frame: Week 4
Population: Pharmacokinetic Population: All participants from whom a Pharmacokinetic sample was obtained and analyzed. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,Pre-dose | 0.051 micrograms/liter | — |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,1 hour Post-dose | 0.838 micrograms/liter | Standard Deviation 1.0098 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4,3 hour Post-dose | 6.320 micrograms/liter | Standard Deviation 4.1558 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week 4,2 hour Post dose | 1.344 micrograms/liter | Standard Deviation 0.6015 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,Pre-dose | 3.023 micrograms/liter | Standard Deviation 2.4591 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4,2 hour Post-dose | 3.384 micrograms/liter | Standard Deviation 1.6984 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4,2 hour Post-dose | 1.715 micrograms/liter | Standard Deviation 1.3986 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4,3 hour Post-dose | 2.596 micrograms/liter | Standard Deviation 1.563 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,1 hour Post-dose | 57.974 micrograms/liter | Standard Deviation 86.6158 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4,1 hour Post-dose | 3.426 micrograms/liter | Standard Deviation 2.0445 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4, Pre-dose | 6.698 micrograms/liter | Standard Deviation 3.9349 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,1 hour Post-dose | 2.105 micrograms/liter | Standard Deviation 1.5209 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week 4,1 hour Post dose | 1.159 micrograms/liter | Standard Deviation 0.6277 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4, Pre-dose | 0.717 micrograms/liter | Standard Deviation 0.5356 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week4,3 hour Post dose | 1.569 micrograms/liter | Standard Deviation 0.7467 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,2 hour Post-dose | 4.596 micrograms/liter | Standard Deviation 3.2987 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4,3 hour Post-dose | 3.911 micrograms/liter | Standard Deviation 2.3475 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,2 hour Post-dose | 79.718 micrograms/liter | Standard Deviation 68.6691 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week 4,Pre-dose | 2.016 micrograms/liter | Standard Deviation 0.7719 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,3 hour Post-dose | 6.444 micrograms/liter | Standard Deviation 4.2038 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,Pre dose | 0.141 micrograms/liter | — |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,3 hour Post-dose | 5.548 micrograms/liter | Standard Deviation 3.708 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4,1 hour Post-dos | 0.593 micrograms/liter | Standard Deviation 0.4255 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4, Pre-dose | 5.609 micrograms/liter | Standard Deviation 3.6494 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,3 hour Post-dose | 47.629 micrograms/liter | Standard Deviation 38.0349 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,2 hour Post-dose | 4.005 micrograms/liter | Standard Deviation 3.2461 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4,1 hour Post-dose | 3.100 micrograms/liter | Standard Deviation 2.055 |
| GSK1278863 4 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4,2 hour Post-dose | 4.857 micrograms/liter | Standard Deviation 3.1705 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4,2 hour Post-dose | 6.906 micrograms/liter | Standard Deviation 4.0374 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week 4,Pre-dose | 2.943 micrograms/liter | Standard Deviation 1.0669 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4,1 hour Post-dos | 0.828 micrograms/liter | Standard Deviation 0.667 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4,3 hour Post-dose | 8.744 micrograms/liter | Standard Deviation 4.6123 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4,3 hour Post-dose | 5.849 micrograms/liter | Standard Deviation 2.9144 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,Pre dose | 0.171 micrograms/liter | Standard Deviation 0.1193 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,2 hour Post-dose | 4.510 micrograms/liter | Standard Deviation 4.429 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,2 hour Post-dose | 5.809 micrograms/liter | Standard Deviation 4.6207 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,2 hour Post-dose | 88.600 micrograms/liter | Standard Deviation 97.6852 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4,2 hour Post-dose | 2.141 micrograms/liter | Standard Deviation 1.8332 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,Pre-dose | 3.357 micrograms/liter | Standard Deviation 1.8819 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4,1 hour Post-dose | 6.383 micrograms/liter | Standard Deviation 3.076 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4,1 hour Post-dose | 5.093 micrograms/liter | Standard Deviation 1.9872 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4,3 hour Post-dose | 3.328 micrograms/liter | Standard Deviation 2.1302 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4, Pre-dose | 8.183 micrograms/liter | Standard Deviation 3.1169 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,3 hour Post-dose | 8.227 micrograms/liter | Standard Deviation 4.9024 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week4,3 hour Post dose | 2.163 micrograms/liter | Standard Deviation 1.041 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4, Pre-dose | 11.849 micrograms/liter | Standard Deviation 6.4817 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,1 hour Post-dose | 44.463 micrograms/liter | Standard Deviation 64.555 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week 4,1 hour Post dose | 1.705 micrograms/liter | Standard Deviation 0.5636 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,3 hour Post-dose | 6.932 micrograms/liter | Standard Deviation 4.5891 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,1 hour Post-dose | 2.883 micrograms/liter | Standard Deviation 1.9924 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,Pre-dose | 0.031 micrograms/liter | — |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,3 hour Post-dose | 86.753 micrograms/liter | Standard Deviation 73.4615 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week 4,2 hour Post dose | 1.851 micrograms/liter | Standard Deviation 0.8637 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4,2 hour Post-dose | 5.546 micrograms/liter | Standard Deviation 2.7423 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,1 hour Post-dose | 1.445 micrograms/liter | Standard Deviation 1.9773 |
| GSK1278863 6 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4, Pre-dose | 0.772 micrograms/liter | Standard Deviation 0.4409 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4,3 hour Post-dose | 4.813 micrograms/liter | Standard Deviation 3.4315 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,Pre-dose | 0.054 micrograms/liter | — |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,1 hour Post-dose | 69.804 micrograms/liter | Standard Deviation 104.4868 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,2 hour Post-dose | 90.774 micrograms/liter | Standard Deviation 95.5198 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,3 hour Post-dose | 82.612 micrograms/liter | Standard Deviation 91.3694 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,Pre-dose | 5.630 micrograms/liter | Standard Deviation 6.2908 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,1 hour Post-dose | 4.340 micrograms/liter | Standard Deviation 4.0699 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4,2 hour Post-dose | 8.910 micrograms/liter | Standard Deviation 5.2477 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4,3 hour Post-dose | 8.864 micrograms/liter | Standard Deviation 6.0433 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,2 hour Post-dose | 9.294 micrograms/liter | Standard Deviation 7.6842 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,3 hour Post-dose | 11.116 micrograms/liter | Standard Deviation 7.5314 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4, Pre-dose | 1.478 micrograms/liter | Standard Deviation 1.9681 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4, Pre-dose | 12.703 micrograms/liter | Standard Deviation 10.1144 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4,1 hour Post-dose | 7.607 micrograms/liter | Standard Deviation 5.5913 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4,2 hour Post-dose | 10.755 micrograms/liter | Standard Deviation 7.3841 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4,3 hour Post-dose | 12.119 micrograms/liter | Standard Deviation 7.6702 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4,1 hour Post-dos | 1.455 micrograms/liter | Standard Deviation 1.7174 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4,2 hour Post-dose | 3.496 micrograms/liter | Standard Deviation 3.0818 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4, Pre-dose | 17.427 micrograms/liter | Standard Deviation 11.3934 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4,1 hour Post-dose | 9.259 micrograms/liter | Standard Deviation 6.3198 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,Pre dose | 0.336 micrograms/liter | Standard Deviation 0.6143 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,1 hour Post-dose | 1.633 micrograms/liter | Standard Deviation 2.4994 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,2 hour Post-dose | 6.843 micrograms/liter | Standard Deviation 6.4944 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,3 hour Post-dose | 8.504 micrograms/liter | Standard Deviation 5.9293 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week 4,Pre-dose | 4.244 micrograms/liter | Standard Deviation 2.8092 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week 4,1 hour Post dose | 2.473 micrograms/liter | Standard Deviation 1.5656 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week 4,2 hour Post dose | 2.781 micrograms/liter | Standard Deviation 1.6266 |
| GSK1278863 8 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week4,3 hour Post dose | 3.045 micrograms/liter | Standard Deviation 1.879 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4,2 hour Post-dose | 15.573 micrograms/liter | Standard Deviation 10.2857 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4,1 hour Post-dose | 11.877 micrograms/liter | Standard Deviation 8.2571 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,2 hour Post-dose | 145.487 micrograms/liter | Standard Deviation 148.5738 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,1 hour Post-dose | 4.967 micrograms/liter | Standard Deviation 6.2427 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4, Pre-dose | 16.524 micrograms/liter | Standard Deviation 9.9794 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4,3 hour Post-dose | 11.417 micrograms/liter | Standard Deviation 6.2311 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week4,3 hour Post dose | 4.382 micrograms/liter | Standard Deviation 1.9892 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,2 hour Post-dose | 10.749 micrograms/liter | Standard Deviation 8.8713 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4, Pre-dose | 2.496 micrograms/liter | Standard Deviation 2.9738 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,3 hour Post-dose | 17.216 micrograms/liter | Standard Deviation 9.7376 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week 4,2 hour Post dose | 3.963 micrograms/liter | Standard Deviation 2.0477 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,3 hour Post-dose | 14.311 micrograms/liter | Standard Deviation 7.8161 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,2 hour Post-dose | 14.017 micrograms/liter | Standard Deviation 10.5152 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4,2 hour Post-dose | 11.008 micrograms/liter | Standard Deviation 6.8874 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,1 hour Post-dose | 105.200 micrograms/liter | Standard Deviation 109.5148 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week 4,Pre-dose | 5.670 micrograms/liter | Standard Deviation 2.2887 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,1 hour Post-dose | 8.417 micrograms/liter | Standard Deviation 7.7174 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2391220-M,Week 4,Pre-dose | 8.553 micrograms/liter | Standard Deviation 8.1226 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,Pre-dose | 0.767 micrograms/liter | — |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4, Pre-dose | 19.014 micrograms/liter | Standard Deviation 7.8014 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4,3 hour Post-dose | 6.861 micrograms/liter | Standard Deviation 3.7679 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4,2 hour Post-dose | 5.318 micrograms/liter | Standard Deviation 4.1121 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2506102-M,Week 4,1 hour Post dose | 3.552 micrograms/liter | Standard Deviation 1.7551 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531401-M,Week 4,1 hour Post-dose | 11.288 micrograms/liter | Standard Deviation 6.2673 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531398-M,Week 4,1 hour Post-dos | 2.820 micrograms/liter | Standard Deviation 2.8853 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2531403-M,Week 4,3 hour Post-dose | 18.369 micrograms/liter | Standard Deviation 9.009 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK1278863,Week 4,3 hour Post-dose | 111.182 micrograms/liter | Standard Deviation 104.4788 |
| GSK1278863 10 mg | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | GSK2487818-M,Week 4,Pre dose | 1.714 micrograms/liter | Standard Deviation 5.105 |