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Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia

A Phase IIB, Randomized, Blinded, Dose-ranging, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Dose Response Relationship of GSK1278863 Over the First 4 Weeks of Treatment and Evaluate the Safety and Efficacy of GSK1278863 Over 24 Weeks in Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Switch From Recombinant Human Erythropoietin

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01977482
Enrollment
216
Registered
2013-11-06
Start date
2013-11-01
Completion date
2015-02-06
Last updated
2018-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaemia

Keywords

hemoglobin, recombinant human erythropoietin, Chronic kidney disease, hemodialysis, pharmacokinetics, erythropoiesis stimulating agents, Anemia, GSK1278863

Brief summary

This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD) who are switched from a stable dose of recombinant human erythropoietin (rhEPO). The data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

Interventions

Film coated tablets containing 1 mg, 2 mg, 5 mg, or 25 mg of GSK1278863

DRUGPlacebo

Matching placebo tablet for GSK1278863

DRUGrhEPO

rhEPO will be procured from local market

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* \- Subjects are eligible if they meet all of the inclusion criteria below: * General criteria * Age: \>=18 years of age. (Week -4 verification only) * Gender: Female and male subjects. (Week -4 verification only) Females: If of childbearing potential, must agree to use one of the approved contraception methods, from Screening until completion of the Follow-up Visit OR of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy, or oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) 23.0-116.3 International units per liter (IU/L) and estradiol \<=10 picomole per liter (pmol/L) is confirmatory\]. 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 must 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; * Q-T Interval Corrected for Heart Rate (QTc): Bazett's Correction of QT Interval (QTcB) \<470 millisecond (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. * CKD-related criteria * Dialysis frequency: On hemodialysis (HD) three to five times weekly for at least 4 weeks prior to Week -4 Screening through Week 4. NOTE: Combination methods including hemofiltration (HF) or ultrafiltration (UF) with HD are allowed. However, the type of dialysis (HD, hemodiafiltration (HDF) or UF) should not change during the study. * Dialysis adequacy: A single-pool dialyzer clearance multiplied by dialyzer time divided by volume of distribution of urea (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%. NOTE: Only needs confirming at Week -4. * Hemoglobin: Baseline Hgb of 9.0-11.5 g/dL (may rescreen in a minimum of 2 weeks). * Stable rhEPO dose: Using the same rhEPO (epoetins or their biosimilars, or darbepoetin) with total weekly doses varying by no more than 50% during the 4 weeks prior to Week -4. At Day 1 (randomization), confirm that total weekly doses varied by no more than 50% during the screening period. * Iron replacement therapy: Subjects may be on stable maintenance oral or IV (\<=100 mg/week) iron supplementation. If subjects are on oral or IV iron, then doses must be stable for the 4 weeks prior to Week -4, during the screening phase, and through the first 4 weeks after Randomization.

Exclusion criteria

* Subjects are not eligible if they meet any of the

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Hemoglobin (Hgb) at Week 4Baseline (Week -4, Week-2 and Day 1) and Week 4Baseline Hgb value was the average of three Hgb values taken during screening period at Week (W) -4, W-2 and Day 1. Change from Baseline in Hgb was calculated as W4 value minus the Baseline value. To model the dose-response relationship a four-parameter Emax model was used. The dose response dataset was based on all non-missing data collected up to W4. Participants (par.) who had a Week 2 Hgb measurement, but a missing Week 4 Hgb measurement were included with a change from Baseline at Week 4 value imputed as twice the change from Baseline at Week 2. E0 is the expected Hgb change from Baseline for a par. receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a par. 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. Alpha is the coefficient of the model covariate for centred Baseline.

Secondary

MeasureTime frameDescription
Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Week 20 to Week 24The percentage of time in Hgb target range between Weeks 20 and 24 for a participant was calculated by dividing the total number of days that Hgb was within the target range (10.0 to 11.5 g/dL) while on treatment during Weeks 20 to 24 (using linear interpolation) by the total number of days the participant remained on treatment during the defined period. Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated.
Number of Participants With Hgb in the Target Range at Week 24Week 24The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 24 was recorded for each arm.
Number of Participants Reaching Pre-defined Hgb Stopping CriteriaUp to 24 weeksThe number of participants who reached the Hgb stopping criteria of Hgb concentration \<7.5 g/dL were presented.
Maximum Observed Change From Baseline in Erythropoietin (EPO)Baseline (Day 1) to Week 28Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-dose values minus the Baseline value.
Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)Baseline (Day 1) to Week 28Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF was recorded for each arm. Baseline value for VEGF is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.
Population Plasma PK Parameters of GSK1278863 and MetabolitesDay 1, Week 4, and Week 20Blood samples were collected for individual plasma GSK1278863and metabolite (GSK2391220, GSK2499166, GSK2531403, GSK2531400, GSK2531399, and GSK2531398) concentrations measurement on Day (D) 1 (pre-dose \[PrD), at Week (W) 4 (6-12, 7-13, 8-14, and 9-15 hour \[hr\] post-dose \[PoD), and at W20 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed.
Percent Change From Baseline in Hepcidin at Week 24Baseline (Day 1) and Week 24Hepcidin is a regulator of iron metabolism. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.
Change From Baseline in Ferritin at Week 24Baseline (Day 1) and Week 24Baseline value for ferritin is the pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 24 value minus the Baseline value.
Hgb Concentration at Week 24Week 24Hgb values measured at Week 24 are presented.
Percent Change From Baseline in Transferrin Saturation at Week 24Baseline (Day 1) and Week 24Transferrin saturation is measured as a percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline =: 100\*(exp(Mean change log scale)-1).
Change From Baseline in Total Iron at Week 24Baseline (Day 1) and Week 24Baseline value for total iron is the pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 24 value minus the Baseline value.
Change From Baseline in Total Iron Binding Capacity at Week 24Baseline (Day 1) and Week 24Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 24 value minus the Baseline value.
Change From Baseline in Reticulocyte Hemoglobin at Week 24Baseline (Day 1) and Week 24Baseline value for reticulocyte hemoglobin is the pre-dose value on Day 1. Change from Baseline in reticulocyte hemoglobin was calculated as the Week 24 value minus the Baseline value.
Change From Baseline in Hematocrit at Week 24Baseline (Day 1) and Week 24Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 24 value minus the Baseline value.
Change From Baseline in Red Blood Cells at Week 24Baseline (Day 1) and Week 24Baseline value for red blood cells is the pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 24 value minus the Baseline value.
Change From Baseline in Reticulocyte Count at Week 24Baseline (Day 1) and Week 24A reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline value for reticulocyte count is the pre-dose value on Day 1. Change from Baseline in reticulocyte count was calculated as the Week 24 value minus the Baseline value.
Change From Baseline in Transferrin at Week 24Baseline (Day 1) and Week 24Baseline value for transferrin is the pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 24 value minus the Baseline value.

Countries

Australia, Canada, Czechia, Denmark, France, Germany, Hungary, Japan, Norway, Poland, Russia, South Korea, Spain, Sweden, United Kingdom, United States

Participant flow

Recruitment details

Eligible participants were hemodialysis-dependent with anemia associated with chronic kidney disease who were switched from a stable dose of recombinant human erythropoietin (rhEPO).

Pre-assignment details

A total of 216 participants with a stable hemoglobin (Hgb) between 9.0-11.5 grams (g)/deciliter (dL) (France sites only: 10.0-11.5 g/dL) were randomized.

Participants by arm

ArmCount
Control
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
39
GSK1278863 4 mg
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
39
GSK1278863 6 mg
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
40
GSK1278863 8 mg
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
39
GSK1278863 10 mg
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
40
GSK1278863 12 mg
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
19
Total216

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyAdverse Event011020
Overall StudyLost to Follow-up100000
Overall StudyOther-Protocol-defined Stopping Criteria032100
Overall StudyPhysician Decision010000
Overall StudyProtocol Violation001000
Overall StudyWithdrawal by Subject241315

Baseline characteristics

CharacteristicControlGSK1278863 4 mgGSK1278863 6 mgGSK1278863 8 mgGSK1278863 10 mgGSK1278863 12 mgTotal
Age, Continuous
Years
59.7 Years
STANDARD_DEVIATION 18.74
58.7 Years
STANDARD_DEVIATION 13.33
63.5 Years
STANDARD_DEVIATION 14
60.1 Years
STANDARD_DEVIATION 10.36
55.4 Years
STANDARD_DEVIATION 15.5
59.9 Years
STANDARD_DEVIATION 13.26
59.5 Years
STANDARD_DEVIATION 14.58
Race/Ethnicity, Customized
African American
7 Participants4 Participants5 Participants3 Participants4 Participants4 Participants27 Participants
Race/Ethnicity, Customized
Asian
7 Participants6 Participants7 Participants7 Participants5 Participants3 Participants35 Participants
Race/Ethnicity, Customized
Other
2 Participants1 Participants0 Participants1 Participants0 Participants0 Participants4 Participants
Race/Ethnicity, Customized
White
23 Participants28 Participants28 Participants28 Participants31 Participants12 Participants150 Participants
Sex: Female, Male
Female
13 Participants15 Participants12 Participants15 Participants17 Participants8 Participants80 Participants
Sex: Female, Male
Male
26 Participants24 Participants28 Participants24 Participants23 Participants11 Participants136 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
17 / 3928 / 3917 / 4025 / 3921 / 406 / 19
serious
Total, serious adverse events
11 / 3910 / 398 / 408 / 3911 / 401 / 19

Outcome results

Primary

Change From Baseline in Hemoglobin (Hgb) at Week 4

Baseline Hgb value was the average of three Hgb values taken during screening period at Week (W) -4, W-2 and Day 1. Change from Baseline in Hgb was calculated as W4 value minus the Baseline value. To model the dose-response relationship a four-parameter Emax model was used. The dose response dataset was based on all non-missing data collected up to W4. Participants (par.) who had a Week 2 Hgb measurement, but a missing Week 4 Hgb measurement were included with a change from Baseline at Week 4 value imputed as twice the change from Baseline at Week 2. E0 is the expected Hgb change from Baseline for a par. receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a par. 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. Alpha is the coefficient of the model covariate for centred Baseline.

Time frame: Baseline (Week -4, Week-2 and Day 1) and Week 4

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (MEAN)Dispersion
ControlChange From Baseline in Hemoglobin (Hgb) at Week 4-0.64 grams (g)/deciliter (dL)Standard Deviation 0.829
GSK1278863 4 mgChange From Baseline in Hemoglobin (Hgb) at Week 4-0.24 grams (g)/deciliter (dL)Standard Deviation 0.989
GSK1278863 6 mgChange From Baseline in Hemoglobin (Hgb) at Week 40.08 grams (g)/deciliter (dL)Standard Deviation 1.131
GSK1278863 8 mgChange From Baseline in Hemoglobin (Hgb) at Week 40.42 grams (g)/deciliter (dL)Standard Deviation 0.796
GSK1278863 10 mgChange From Baseline in Hemoglobin (Hgb) at Week 40.64 grams (g)/deciliter (dL)Standard Deviation 1.177
GSK1278863 12 mgChange From Baseline in Hemoglobin (Hgb) at Week 40.61 grams (g)/deciliter (dL)Standard Deviation 1.245
95% CI: [-0.96, -0.387]
95% CI: [15.566, 48.948]
95% CI: [2.691, 7.94]
95% CI: [0.748, 1.738]
95% CI: [0.84, 1.234]
95% CI: [-0.397, -0.014]
95% CI: [0, 2.342]
95% CI: [0, 4.15]
95% CI: [2.544, 5.995]
95% CI: [4.698, 8.01]
95% CI: [6.931, 10.523]
95% CI: [9.024, 14.004]
95% CI: [10.891, 18.916]
Secondary

Change From Baseline in Ferritin at Week 24

Baseline value for ferritin is the pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 24 value minus the Baseline value.

Time frame: Baseline (Day 1) and Week 24

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (MEAN)Dispersion
ControlChange From Baseline in Ferritin at Week 2456.8 Micrograms/LiterStandard Deviation 214.27
GSK1278863 4 mgChange From Baseline in Ferritin at Week 24-29.4 Micrograms/LiterStandard Deviation 357.1
GSK1278863 6 mgChange From Baseline in Ferritin at Week 24-50.4 Micrograms/LiterStandard Deviation 408.99
GSK1278863 8 mgChange From Baseline in Ferritin at Week 24-95.6 Micrograms/LiterStandard Deviation 304.61
GSK1278863 10 mgChange From Baseline in Ferritin at Week 24-20.2 Micrograms/LiterStandard Deviation 227.34
GSK1278863 12 mgChange From Baseline in Ferritin at Week 24-125.2 Micrograms/LiterStandard Deviation 354.64
Secondary

Change From Baseline in Hematocrit at Week 24

Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 24 value minus the Baseline value.

Time frame: Baseline (Day 1) and Week 24

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (MEAN)Dispersion
ControlChange From Baseline in Hematocrit at Week 24-0.0028 RatioStandard Deviation 0.04358
GSK1278863 4 mgChange From Baseline in Hematocrit at Week 24-0.0096 RatioStandard Deviation 0.04073
GSK1278863 6 mgChange From Baseline in Hematocrit at Week 240.0020 RatioStandard Deviation 0.03579
GSK1278863 8 mgChange From Baseline in Hematocrit at Week 240.0043 RatioStandard Deviation 0.04254
GSK1278863 10 mgChange From Baseline in Hematocrit at Week 24-0.0021 RatioStandard Deviation 0.02678
GSK1278863 12 mgChange From Baseline in Hematocrit at Week 240.0108 RatioStandard Deviation 0.03557
Secondary

Change From Baseline in Red Blood Cells at Week 24

Baseline value for red blood cells is the pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 24 value minus the Baseline value.

Time frame: Baseline (Day 1) and Week 24

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (MEAN)Dispersion
ControlChange From Baseline in Red Blood Cells at Week 240.01 10^12 cells/LiterStandard Deviation 0.46
GSK1278863 4 mgChange From Baseline in Red Blood Cells at Week 24-0.06 10^12 cells/LiterStandard Deviation 0.396
GSK1278863 6 mgChange From Baseline in Red Blood Cells at Week 240.04 10^12 cells/LiterStandard Deviation 0.374
GSK1278863 8 mgChange From Baseline in Red Blood Cells at Week 240.07 10^12 cells/LiterStandard Deviation 0.399
GSK1278863 10 mgChange From Baseline in Red Blood Cells at Week 240.03 10^12 cells/LiterStandard Deviation 0.3
GSK1278863 12 mgChange From Baseline in Red Blood Cells at Week 240.17 10^12 cells/LiterStandard Deviation 0.366
Secondary

Change From Baseline in Reticulocyte Count at Week 24

A reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline value for reticulocyte count is the pre-dose value on Day 1. Change from Baseline in reticulocyte count was calculated as the Week 24 value minus the Baseline value.

Time frame: Baseline (Day 1) and Week 24

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (MEAN)Dispersion
ControlChange From Baseline in Reticulocyte Count at Week 240.40 Percentage of reticulocytes in bloodStandard Deviation 0.663
GSK1278863 4 mgChange From Baseline in Reticulocyte Count at Week 240.16 Percentage of reticulocytes in bloodStandard Deviation 1.162
GSK1278863 6 mgChange From Baseline in Reticulocyte Count at Week 240.18 Percentage of reticulocytes in bloodStandard Deviation 0.571
GSK1278863 8 mgChange From Baseline in Reticulocyte Count at Week 240.03 Percentage of reticulocytes in bloodStandard Deviation 0.684
GSK1278863 10 mgChange From Baseline in Reticulocyte Count at Week 24-0.15 Percentage of reticulocytes in bloodStandard Deviation 0.838
GSK1278863 12 mgChange From Baseline in Reticulocyte Count at Week 240.10 Percentage of reticulocytes in bloodStandard Deviation 0.527
Secondary

Change From Baseline in Reticulocyte Hemoglobin at Week 24

Baseline value for reticulocyte hemoglobin is the pre-dose value on Day 1. Change from Baseline in reticulocyte hemoglobin was calculated as the Week 24 value minus the Baseline value.

Time frame: Baseline (Day 1) and Week 24

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (MEAN)Dispersion
ControlChange From Baseline in Reticulocyte Hemoglobin at Week 24-0.19 PicogramStandard Deviation 1.61
GSK1278863 4 mgChange From Baseline in Reticulocyte Hemoglobin at Week 24-0.28 PicogramStandard Deviation 1.948
GSK1278863 6 mgChange From Baseline in Reticulocyte Hemoglobin at Week 24-0.62 PicogramStandard Deviation 2.046
GSK1278863 8 mgChange From Baseline in Reticulocyte Hemoglobin at Week 24-0.42 PicogramStandard Deviation 1.458
GSK1278863 10 mgChange From Baseline in Reticulocyte Hemoglobin at Week 24-0.51 PicogramStandard Deviation 1.377
GSK1278863 12 mgChange From Baseline in Reticulocyte Hemoglobin at Week 24-0.63 PicogramStandard Deviation 1.119
Secondary

Change From Baseline in Total Iron at Week 24

Baseline value for total iron is the pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 24 value minus the Baseline value.

Time frame: Baseline (Day 1) and Week 24

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (MEAN)Dispersion
ControlChange From Baseline in Total Iron at Week 24-0.8 Micromoles/LiterStandard Deviation 7.64
GSK1278863 4 mgChange From Baseline in Total Iron at Week 240.9 Micromoles/LiterStandard Deviation 9.75
GSK1278863 6 mgChange From Baseline in Total Iron at Week 240.3 Micromoles/LiterStandard Deviation 5.2
GSK1278863 8 mgChange From Baseline in Total Iron at Week 240.2 Micromoles/LiterStandard Deviation 6.51
GSK1278863 10 mgChange From Baseline in Total Iron at Week 242.0 Micromoles/LiterStandard Deviation 3.96
GSK1278863 12 mgChange From Baseline in Total Iron at Week 241.6 Micromoles/LiterStandard Deviation 3.18
Secondary

Change From Baseline in Total Iron Binding Capacity at Week 24

Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 24 value minus the Baseline value.

Time frame: Baseline (Day 1) and Week 24

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (MEAN)Dispersion
ControlChange From Baseline in Total Iron Binding Capacity at Week 24-2.0 Micromoles/LiterStandard Deviation 4.48
GSK1278863 4 mgChange From Baseline in Total Iron Binding Capacity at Week 246.0 Micromoles/LiterStandard Deviation 7.93
GSK1278863 6 mgChange From Baseline in Total Iron Binding Capacity at Week 244.2 Micromoles/LiterStandard Deviation 6.79
GSK1278863 8 mgChange From Baseline in Total Iron Binding Capacity at Week 246.6 Micromoles/LiterStandard Deviation 5.75
GSK1278863 10 mgChange From Baseline in Total Iron Binding Capacity at Week 244.8 Micromoles/LiterStandard Deviation 6.25
GSK1278863 12 mgChange From Baseline in Total Iron Binding Capacity at Week 246.2 Micromoles/LiterStandard Deviation 6.44
Secondary

Change From Baseline in Transferrin at Week 24

Baseline value for transferrin is the pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 24 value minus the Baseline value.

Time frame: Baseline (Day 1) and Week 24

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (MEAN)Dispersion
ControlChange From Baseline in Transferrin at Week 24-0.133 grams (g)/Liter (L)Standard Deviation 0.2903
GSK1278863 4 mgChange From Baseline in Transferrin at Week 240.238 grams (g)/Liter (L)Standard Deviation 0.3709
GSK1278863 6 mgChange From Baseline in Transferrin at Week 240.198 grams (g)/Liter (L)Standard Deviation 0.2891
GSK1278863 8 mgChange From Baseline in Transferrin at Week 240.226 grams (g)/Liter (L)Standard Deviation 0.2706
GSK1278863 10 mgChange From Baseline in Transferrin at Week 240.249 grams (g)/Liter (L)Standard Deviation 0.3213
GSK1278863 12 mgChange From Baseline in Transferrin at Week 240.393 grams (g)/Liter (L)Standard Deviation 0.3165
Secondary

Hgb Concentration at Week 24

Hgb values measured at Week 24 are presented.

Time frame: Week 24

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (MEAN)Dispersion
ControlHgb Concentration at Week 2410.56 g/dLStandard Deviation 0.974
GSK1278863 4 mgHgb Concentration at Week 2410.29 g/dLStandard Deviation 0.864
GSK1278863 6 mgHgb Concentration at Week 2410.54 g/dLStandard Deviation 1.01
GSK1278863 8 mgHgb Concentration at Week 2410.63 g/dLStandard Deviation 1.099
GSK1278863 10 mgHgb Concentration at Week 2410.28 g/dLStandard Deviation 0.856
GSK1278863 12 mgHgb Concentration at Week 2410.70 g/dLStandard Deviation 0.867
Secondary

Maximum Observed Change From Baseline in Erythropoietin (EPO)

Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-dose values minus the Baseline value.

Time frame: Baseline (Day 1) to Week 28

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (MEAN)Dispersion
ControlMaximum Observed Change From Baseline in Erythropoietin (EPO)1946.45 international units(IU)/Liter (L)Standard Deviation 8456.313
GSK1278863 4 mgMaximum Observed Change From Baseline in Erythropoietin (EPO)48.86 international units(IU)/Liter (L)Standard Deviation 117.05
GSK1278863 6 mgMaximum Observed Change From Baseline in Erythropoietin (EPO)36.63 international units(IU)/Liter (L)Standard Deviation 35.485
GSK1278863 8 mgMaximum Observed Change From Baseline in Erythropoietin (EPO)84.53 international units(IU)/Liter (L)Standard Deviation 225.768
GSK1278863 10 mgMaximum Observed Change From Baseline in Erythropoietin (EPO)82.00 international units(IU)/Liter (L)Standard Deviation 99.66
GSK1278863 12 mgMaximum Observed Change From Baseline in Erythropoietin (EPO)24.63 international units(IU)/Liter (L)Standard Deviation 235.82
Secondary

Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)

Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF was recorded for each arm. Baseline value for VEGF is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.

Time frame: Baseline (Day 1) to Week 28

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)
ControlMaximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)36.02 Percent change
GSK1278863 4 mgMaximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)36.92 Percent change
GSK1278863 6 mgMaximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)41.73 Percent change
GSK1278863 8 mgMaximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)54.91 Percent change
GSK1278863 10 mgMaximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)50.65 Percent change
GSK1278863 12 mgMaximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)50.97 Percent change
Secondary

Number of Participants Reaching Pre-defined Hgb Stopping Criteria

The number of participants who reached the Hgb stopping criteria of Hgb concentration \<7.5 g/dL were presented.

Time frame: Up to 24 weeks

Population: ITT Population

ArmMeasureValue (NUMBER)
ControlNumber of Participants Reaching Pre-defined Hgb Stopping Criteria0 Participants
GSK1278863 4 mgNumber of Participants Reaching Pre-defined Hgb Stopping Criteria0 Participants
GSK1278863 6 mgNumber of Participants Reaching Pre-defined Hgb Stopping Criteria0 Participants
GSK1278863 8 mgNumber of Participants Reaching Pre-defined Hgb Stopping Criteria0 Participants
GSK1278863 10 mgNumber of Participants Reaching Pre-defined Hgb Stopping Criteria0 Participants
GSK1278863 12 mgNumber of Participants Reaching Pre-defined Hgb Stopping Criteria0 Participants
Secondary

Number of Participants With Hgb in the Target Range at Week 24

The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 24 was recorded for each arm.

Time frame: Week 24

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (NUMBER)
ControlNumber of Participants With Hgb in the Target Range at Week 2414 Participants
GSK1278863 4 mgNumber of Participants With Hgb in the Target Range at Week 2413 Participants
GSK1278863 6 mgNumber of Participants With Hgb in the Target Range at Week 2416 Participants
GSK1278863 8 mgNumber of Participants With Hgb in the Target Range at Week 2410 Participants
GSK1278863 10 mgNumber of Participants With Hgb in the Target Range at Week 2415 Participants
GSK1278863 12 mgNumber of Participants With Hgb in the Target Range at Week 248 Participants
Secondary

Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24

The percentage of time in Hgb target range between Weeks 20 and 24 for a participant was calculated by dividing the total number of days that Hgb was within the target range (10.0 to 11.5 g/dL) while on treatment during Weeks 20 to 24 (using linear interpolation) by the total number of days the participant remained on treatment during the defined period. Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated.

Time frame: Week 20 to Week 24

Population: ITT population. Only participants with data available at specific timepoint were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
ControlPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time above target range24.65 Percentage of daysStandard Deviation 38.556
ControlPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time within target range54.59 Percentage of daysStandard Deviation 42.044
ControlPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time below target range20.76 Percentage of daysStandard Deviation 36.587
GSK1278863 4 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time above target range6.89 Percentage of daysStandard Deviation 22.137
GSK1278863 4 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time within target range74.77 Percentage of daysStandard Deviation 38.797
GSK1278863 4 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time below target range18.34 Percentage of daysStandard Deviation 35.778
GSK1278863 6 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time above target range17.18 Percentage of daysStandard Deviation 30.446
GSK1278863 6 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time within target range57.38 Percentage of daysStandard Deviation 40.505
GSK1278863 6 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time below target range25.44 Percentage of daysStandard Deviation 40.12
GSK1278863 8 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time above target range33.15 Percentage of daysStandard Deviation 42.856
GSK1278863 8 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time within target range37.46 Percentage of daysStandard Deviation 41.775
GSK1278863 8 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time below target range29.39 Percentage of daysStandard Deviation 42.67
GSK1278863 10 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time above target range18.27 Percentage of daysStandard Deviation 33.698
GSK1278863 10 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time within target range48.97 Percentage of daysStandard Deviation 42.49
GSK1278863 10 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time below target range32.76 Percentage of daysStandard Deviation 43.78
GSK1278863 12 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time within target range55.23 Percentage of daysStandard Deviation 40.35
GSK1278863 12 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time below target range17.89 Percentage of daysStandard Deviation 36.836
GSK1278863 12 mgPercentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24Percentage of time above target range26.88 Percentage of daysStandard Deviation 36.154
Secondary

Percent Change From Baseline in Hepcidin at Week 24

Hepcidin is a regulator of iron metabolism. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.

Time frame: Baseline (Day 1) and Week 24

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)
ControlPercent Change From Baseline in Hepcidin at Week 243.63 Percent change
GSK1278863 4 mgPercent Change From Baseline in Hepcidin at Week 24-17.39 Percent change
GSK1278863 6 mgPercent Change From Baseline in Hepcidin at Week 24-11.85 Percent change
GSK1278863 8 mgPercent Change From Baseline in Hepcidin at Week 24-30.28 Percent change
GSK1278863 10 mgPercent Change From Baseline in Hepcidin at Week 24-6.91 Percent change
GSK1278863 12 mgPercent Change From Baseline in Hepcidin at Week 24-42.13 Percent change
Secondary

Percent Change From Baseline in Transferrin Saturation at Week 24

Transferrin saturation is measured as a percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline =: 100\*(exp(Mean change log scale)-1).

Time frame: Baseline (Day 1) and Week 24

Population: ITT Population. Only participants with data available at specific time point were analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)
ControlPercent Change From Baseline in Transferrin Saturation at Week 24-9.0 Percent change
GSK1278863 4 mgPercent Change From Baseline in Transferrin Saturation at Week 24-3.7 Percent change
GSK1278863 6 mgPercent Change From Baseline in Transferrin Saturation at Week 24-12.1 Percent change
GSK1278863 8 mgPercent Change From Baseline in Transferrin Saturation at Week 24-8.3 Percent change
GSK1278863 10 mgPercent Change From Baseline in Transferrin Saturation at Week 248.2 Percent change
GSK1278863 12 mgPercent Change From Baseline in Transferrin Saturation at Week 24-2.5 Percent change
Secondary

Population Plasma PK Parameters of GSK1278863 and Metabolites

Blood samples were collected for individual plasma GSK1278863and metabolite (GSK2391220, GSK2499166, GSK2531403, GSK2531400, GSK2531399, and GSK2531398) concentrations measurement on Day (D) 1 (pre-dose \[PrD), at Week (W) 4 (6-12, 7-13, 8-14, and 9-15 hour \[hr\] post-dose \[PoD), and at W20 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed.

Time frame: Day 1, Week 4, and Week 20

Population: Pharmacokinetic Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the pharmacokinetic population

ArmMeasureGroupValue (MEAN)Dispersion
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 7-13 hr PoD, n=36, 37, 35, 35, 156.3 nanograms (ng)/milliliter (mL)Standard Deviation 4.84
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, PrD, n=23, 28, 27, 23, 147.7 nanograms (ng)/milliliter (mL)Standard Deviation 7.71
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 9-15 hr PoD, n=35, 36, 36, 35, 153.3 nanograms (ng)/milliliter (mL)Standard Deviation 3.76
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 2 hr PoD, n=23, 27, 27, 24, 1334.2 nanograms (ng)/milliliter (mL)Standard Deviation 31.76
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 1 hr PoD, n=23, 27, 27, 24, 134.9 nanograms (ng)/milliliter (mL)Standard Deviation 5.56
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 7-13 hr PoD, n=36, 37, 35, 35, 151.8 nanograms (ng)/milliliter (mL)Standard Deviation 1.31
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 9-15 hr PoD, n=35, 36, 36, 35, 153.3 nanograms (ng)/milliliter (mL)Standard Deviation 3.36
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, PrD, n=23, 28, 27, 23, 145.0 nanograms (ng)/milliliter (mL)Standard Deviation 7.72
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 6-12 hr PoD, n=36, 37, 37, 35, 153.4 nanograms (ng)/milliliter (mL)Standard Deviation 2.46
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 8-14 hr PoD, n=35, 37, 36, 35, 157.5 nanograms (ng)/milliliter (mL)Standard Deviation 16.8
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 1 hr PoD, n=23, 27, 27, 24, 1325.9 nanograms (ng)/milliliter (mL)Standard Deviation 35.74
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 8-14 hr PoD, n=35, 37, 36, 35, 154.0 nanograms (ng)/milliliter (mL)Standard Deviation 3.63
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 1 hr PoD, n=23, 27, 27, 24, 133.9 nanograms (ng)/milliliter (mL)Standard Deviation 5.59
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1511.4 nanograms (ng)/milliliter (mL)Standard Deviation 7.47
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 3 hr PoD, n=23, 27, 27, 24, 1443.6 nanograms (ng)/milliliter (mL)Standard Deviation 58.36
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 7-13 hr PoD, n=36, 37, 35, 35, 155.4 nanograms (ng)/milliliter (mL)Standard Deviation 4.49
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 2 hr PoD, n=23, 27, 27, 24, 135.4 nanograms (ng)/milliliter (mL)Standard Deviation 5.58
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 2 hr PoD, n=23, 27, 27, 24, 135.7 nanograms (ng)/milliliter (mL)Standard Deviation 5.43
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 3 hr PoD, n=23, 27, 27, 24, 145.5 nanograms (ng)/milliliter (mL)Standard Deviation 4.52
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 1 hr PoD, n=23, 27, 27, 24, 131.4 nanograms (ng)/milliliter (mL)Standard Deviation 1.27
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 6-12 hr PoD, n=36, 37, 37, 35, 159.9 nanograms (ng)/milliliter (mL)Standard Deviation 8
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 3 hr PoD, n=23, 27, 27, 24, 145.3 nanograms (ng)/milliliter (mL)Standard Deviation 4.64
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 8-14 hr PoD, n=35, 37, 36, 35, 151.3 nanograms (ng)/milliliter (mL)Standard Deviation 1.07
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 7-13 hr PoD, n=36, 37, 35, 35, 1510.6 nanograms (ng)/milliliter (mL)Standard Deviation 25.15
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, PrD, n=23, 28, 27, 23, 147.8 nanograms (ng)/milliliter (mL)Standard Deviation 8.53
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 9-15 hr PoD, n=35, 36, 36, 35, 151.1 nanograms (ng)/milliliter (mL)Standard Deviation 1.16
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 3 hr PoD, n=23, 27, 27, 24, 142.3 nanograms (ng)/milliliter (mL)Standard Deviation 2.04
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 6-12 hr PoD, n=36, 37, 37, 35, 153.1 nanograms (ng)/milliliter (mL)Standard Deviation 2.82
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 3 hr PoD, n=23, 27, 27, 24, 144.1 nanograms (ng)/milliliter (mL)Standard Deviation 4.07
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 9-15 hr PoD, n=35, 36, 36, 35, 156.8 nanograms (ng)/milliliter (mL)Standard Deviation 14.53
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 6-12 hr PoD, n=36, 37, 37, 35, 159.1 nanograms (ng)/milliliter (mL)Standard Deviation 6.68
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 2 hr PoD, n=23, 27, 27, 24, 132.1 nanograms (ng)/milliliter (mL)Standard Deviation 2.24
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 7-13 hr PoD, n=36, 37, 35, 35, 151.8 nanograms (ng)/milliliter (mL)Standard Deviation 1.75
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 3 hr PoD, n=23, 27, 27, 24, 141.4 nanograms (ng)/milliliter (mL)Standard Deviation 1.12
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 6-12 hr PoD, n=36, 37, 37, 35, 153.2 nanograms (ng)/milliliter (mL)Standard Deviation 1.98
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 1 hr PoD, n=23, 27, 27, 24, 131.3 nanograms (ng)/milliliter (mL)Standard Deviation 1.89
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 8-14 hr PoD, n=35, 37, 36, 35, 151.5 nanograms (ng)/milliliter (mL)Standard Deviation 1.67
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 2 hr PoD, n=23, 27, 27, 24, 134.2 nanograms (ng)/milliliter (mL)Standard Deviation 4.44
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 6-12 hr PoD, n=36, 37, 37, 35, 156.3 nanograms (ng)/milliliter (mL)Standard Deviation 10.04
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 7-13 hr PoD, n=36, 37, 35, 35, 155.1 nanograms (ng)/milliliter (mL)Standard Deviation 4.22
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, PrD, n=23, 28, 27, 23, 141.5 nanograms (ng)/milliliter (mL)Standard Deviation 2.31
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 9-15 hr PoD, n=35, 36, 36, 35, 151.4 nanograms (ng)/milliliter (mL)Standard Deviation 1.88
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, PrD, n=23, 28, 27, 23, 142.3 nanograms (ng)/milliliter (mL)Standard Deviation 1.99
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 8-14 hr PoD, n=35, 37, 36, 35, 154.7 nanograms (ng)/milliliter (mL)Standard Deviation 4.23
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 9-15 hr PoD, n=35, 36, 36, 35, 151.4 nanograms (ng)/milliliter (mL)Standard Deviation 1.58
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, PrD, n=23, 28, 27, 23, 141.2 nanograms (ng)/milliliter (mL)Standard Deviation 3.38
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 1 hr PoD, n=23, 27, 27, 24, 134.2 nanograms (ng)/milliliter (mL)Standard Deviation 4.52
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 9-15 hr PoD, n=35, 36, 36, 35, 154.1 nanograms (ng)/milliliter (mL)Standard Deviation 4.6
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 8-14 hr PoD, n=35, 37, 36, 35, 153.8 nanograms (ng)/milliliter (mL)Standard Deviation 3.66
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 8-14 hr PoD, n=35, 37, 36, 35, 151.5 nanograms (ng)/milliliter (mL)Standard Deviation 1.46
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 1 hr PoD, n=23, 27, 27, 24, 132.0 nanograms (ng)/milliliter (mL)Standard Deviation 3.82
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 3 hr PoD, n=23, 27, 27, 24, 143.9 nanograms (ng)/milliliter (mL)Standard Deviation 3.49
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, PrD, n=23, 28, 27, 23, 142.3 nanograms (ng)/milliliter (mL)Standard Deviation 6.44
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 2 hr PoD, n=23, 27, 27, 24, 131.5 nanograms (ng)/milliliter (mL)Standard Deviation 1.25
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 7-13 hr PoD, n=36, 37, 35, 35, 152.0 nanograms (ng)/milliliter (mL)Standard Deviation 1.72
ControlPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 2 hr PoD, n=23, 27, 27, 24, 133.8 nanograms (ng)/milliliter (mL)Standard Deviation 4.58
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 7-13 hr PoD, n=36, 37, 35, 35, 157.1 nanograms (ng)/milliliter (mL)Standard Deviation 5.53
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, PrD, n=23, 28, 27, 23, 140.7 nanograms (ng)/milliliter (mL)Standard Deviation 2.55
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 6-12 hr PoD, n=36, 37, 37, 35, 154.9 nanograms (ng)/milliliter (mL)Standard Deviation 3.11
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 3 hr PoD, n=23, 27, 27, 24, 144.3 nanograms (ng)/milliliter (mL)Standard Deviation 4.76
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 6-12 hr PoD, n=36, 37, 37, 35, 159.3 nanograms (ng)/milliliter (mL)Standard Deviation 19.06
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 8-14 hr PoD, n=35, 37, 36, 35, 155.7 nanograms (ng)/milliliter (mL)Standard Deviation 4.63
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 3 hr PoD, n=23, 27, 27, 24, 141.3 nanograms (ng)/milliliter (mL)Standard Deviation 1.26
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 6-12 hr PoD, n=36, 37, 37, 35, 154.9 nanograms (ng)/milliliter (mL)Standard Deviation 2.68
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 2 hr PoD, n=23, 27, 27, 24, 131.2 nanograms (ng)/milliliter (mL)Standard Deviation 1.24
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 7-13 hr PoD, n=36, 37, 35, 35, 152.5 nanograms (ng)/milliliter (mL)Standard Deviation 1.71
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 1 hr PoD, n=23, 27, 27, 24, 131.1 nanograms (ng)/milliliter (mL)Standard Deviation 1.4
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 8-14 hr PoD, n=35, 37, 36, 35, 151.6 nanograms (ng)/milliliter (mL)Standard Deviation 1.16
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 1 hr PoD, n=23, 27, 27, 24, 1337.6 nanograms (ng)/milliliter (mL)Standard Deviation 53.77
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, PrD, n=23, 28, 27, 23, 141.9 nanograms (ng)/milliliter (mL)Standard Deviation 2.05
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 9-15 hr PoD, n=35, 36, 36, 35, 151.2 nanograms (ng)/milliliter (mL)Standard Deviation 0.88
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 7-13 hr PoD, n=36, 37, 35, 35, 158.6 nanograms (ng)/milliliter (mL)Standard Deviation 6.43
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 2 hr PoD, n=23, 27, 27, 24, 1352.4 nanograms (ng)/milliliter (mL)Standard Deviation 53.32
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 2 hr PoD, n=23, 27, 27, 24, 134.7 nanograms (ng)/milliliter (mL)Standard Deviation 4.91
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1517.0 nanograms (ng)/milliliter (mL)Standard Deviation 9.89
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 3 hr PoD, n=23, 27, 27, 24, 1439.2 nanograms (ng)/milliliter (mL)Standard Deviation 44.59
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 3 hr PoD, n=23, 27, 27, 24, 143.6 nanograms (ng)/milliliter (mL)Standard Deviation 4.55
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1512.9 nanograms (ng)/milliliter (mL)Standard Deviation 8.32
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 7-13 hr PoD, n=36, 37, 35, 35, 1516.3 nanograms (ng)/milliliter (mL)Standard Deviation 57.24
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 2 hr PoD, n=23, 27, 27, 24, 133.6 nanograms (ng)/milliliter (mL)Standard Deviation 4.5
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 7-13 hr PoD, n=36, 37, 35, 35, 156.7 nanograms (ng)/milliliter (mL)Standard Deviation 5.51
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 3 hr PoD, n=23, 27, 27, 24, 145.1 nanograms (ng)/milliliter (mL)Standard Deviation 5.18
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 1 hr PoD, n=23, 27, 27, 24, 134.0 nanograms (ng)/milliliter (mL)Standard Deviation 6.77
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 8-14 hr PoD, n=35, 37, 36, 35, 154.5 nanograms (ng)/milliliter (mL)Standard Deviation 4.16
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 1 hr PoD, n=23, 27, 27, 24, 133.8 nanograms (ng)/milliliter (mL)Standard Deviation 4.88
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, PrD, n=23, 28, 27, 23, 147.3 nanograms (ng)/milliliter (mL)Standard Deviation 7.34
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 9-15 hr PoD, n=35, 36, 36, 35, 153.3 nanograms (ng)/milliliter (mL)Standard Deviation 3.15
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 9-15 hr PoD, n=35, 36, 36, 35, 153.2 nanograms (ng)/milliliter (mL)Standard Deviation 2.35
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, PrD, n=23, 28, 27, 23, 143.2 nanograms (ng)/milliliter (mL)Standard Deviation 4.97
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 8-14 hr PoD, n=35, 37, 36, 35, 154.5 nanograms (ng)/milliliter (mL)Standard Deviation 3.5
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 1 hr PoD, n=23, 27, 27, 24, 132.7 nanograms (ng)/milliliter (mL)Standard Deviation 3.6
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 8-14 hr PoD, n=35, 37, 36, 35, 158.1 nanograms (ng)/milliliter (mL)Standard Deviation 23.76
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 2 hr PoD, n=23, 27, 27, 24, 133.6 nanograms (ng)/milliliter (mL)Standard Deviation 4.36
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 2 hr PoD, n=23, 27, 27, 24, 134.5 nanograms (ng)/milliliter (mL)Standard Deviation 4.96
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1514.7 nanograms (ng)/milliliter (mL)Standard Deviation 10.02
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 3 hr PoD, n=23, 27, 27, 24, 145.0 nanograms (ng)/milliliter (mL)Standard Deviation 5.26
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, PrD, n=23, 28, 27, 23, 146.0 nanograms (ng)/milliliter (mL)Standard Deviation 8.08
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 3 hr PoD, n=23, 27, 27, 24, 142.2 nanograms (ng)/milliliter (mL)Standard Deviation 2.22
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 6-12 hr PoD, n=36, 37, 37, 35, 154.1 nanograms (ng)/milliliter (mL)Standard Deviation 4.47
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 2 hr PoD, n=23, 27, 27, 24, 131.9 nanograms (ng)/milliliter (mL)Standard Deviation 2.09
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 7-13 hr PoD, n=36, 37, 35, 35, 152.6 nanograms (ng)/milliliter (mL)Standard Deviation 3.81
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 9-15 hr PoD, n=35, 36, 36, 35, 154.6 nanograms (ng)/milliliter (mL)Standard Deviation 10.49
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 1 hr PoD, n=23, 27, 27, 24, 131.0 nanograms (ng)/milliliter (mL)Standard Deviation 1.34
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 8-14 hr PoD, n=35, 37, 36, 35, 151.9 nanograms (ng)/milliliter (mL)Standard Deviation 3.21
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, PrD, n=23, 28, 27, 23, 141.2 nanograms (ng)/milliliter (mL)Standard Deviation 2.03
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 9-15 hr PoD, n=35, 36, 36, 35, 151.5 nanograms (ng)/milliliter (mL)Standard Deviation 2.46
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 9-15 hr PoD, n=35, 36, 36, 35, 154.1 nanograms (ng)/milliliter (mL)Standard Deviation 3.41
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 9-15 hr PoD, n=35, 36, 36, 35, 151.4 nanograms (ng)/milliliter (mL)Standard Deviation 1.49
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, PrD, n=23, 28, 27, 23, 140.5 nanograms (ng)/milliliter (mL)Standard Deviation 1.05
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 8-14 hr PoD, n=35, 37, 36, 35, 151.8 nanograms (ng)/milliliter (mL)Standard Deviation 1.86
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 1 hr PoD, n=23, 27, 27, 24, 131.3 nanograms (ng)/milliliter (mL)Standard Deviation 1.73
GSK1278863 4 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 7-13 hr PoD, n=36, 37, 35, 35, 152.7 nanograms (ng)/milliliter (mL)Standard Deviation 2.41
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 9-15 hr PoD, n=35, 36, 36, 35, 151.9 nanograms (ng)/milliliter (mL)Standard Deviation 1.52
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 6-12 hr PoD, n=36, 37, 37, 35, 157.7 nanograms (ng)/milliliter (mL)Standard Deviation 18.46
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 7-13 hr PoD, n=36, 37, 35, 35, 158.7 nanograms (ng)/milliliter (mL)Standard Deviation 19.85
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 8-14 hr PoD, n=35, 37, 36, 35, 155.6 nanograms (ng)/milliliter (mL)Standard Deviation 11.75
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 9-15 hr PoD, n=35, 36, 36, 35, 154.4 nanograms (ng)/milliliter (mL)Standard Deviation 9.19
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, PrD, n=23, 28, 27, 23, 140.9 nanograms (ng)/milliliter (mL)Standard Deviation 2.82
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 1 hr PoD, n=23, 27, 27, 24, 1388.2 nanograms (ng)/milliliter (mL)Standard Deviation 153.06
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 2 hr PoD, n=23, 27, 27, 24, 1362.8 nanograms (ng)/milliliter (mL)Standard Deviation 85.37
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 3 hr PoD, n=23, 27, 27, 24, 1444.1 nanograms (ng)/milliliter (mL)Standard Deviation 70.53
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1518.5 nanograms (ng)/milliliter (mL)Standard Deviation 13.72
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 7-13 hr PoD, n=36, 37, 35, 35, 1510.3 nanograms (ng)/milliliter (mL)Standard Deviation 8.55
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 8-14 hr PoD, n=35, 37, 36, 35, 157.4 nanograms (ng)/milliliter (mL)Standard Deviation 6.44
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 9-15 hr PoD, n=35, 36, 36, 35, 155.3 nanograms (ng)/milliliter (mL)Standard Deviation 4.86
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, PrD, n=23, 28, 27, 23, 144.1 nanograms (ng)/milliliter (mL)Standard Deviation 5.84
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 1 hr PoD, n=23, 27, 27, 24, 134.3 nanograms (ng)/milliliter (mL)Standard Deviation 4.9
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 2 hr PoD, n=23, 27, 27, 24, 136.5 nanograms (ng)/milliliter (mL)Standard Deviation 6.93
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 3 hr PoD, n=23, 27, 27, 24, 147.3 nanograms (ng)/milliliter (mL)Standard Deviation 6.69
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 6-12 hr PoD, n=36, 37, 37, 35, 155.7 nanograms (ng)/milliliter (mL)Standard Deviation 6.31
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 7-13 hr PoD, n=36, 37, 35, 35, 153.5 nanograms (ng)/milliliter (mL)Standard Deviation 4.55
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 8-14 hr PoD, n=35, 37, 36, 35, 152.7 nanograms (ng)/milliliter (mL)Standard Deviation 3.58
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 9-15 hr PoD, n=35, 36, 36, 35, 151.9 nanograms (ng)/milliliter (mL)Standard Deviation 2.85
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, PrD, n=23, 28, 27, 23, 140.7 nanograms (ng)/milliliter (mL)Standard Deviation 1.28
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 1 hr PoD, n=23, 27, 27, 24, 132.7 nanograms (ng)/milliliter (mL)Standard Deviation 3.97
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 2 hr PoD, n=23, 27, 27, 24, 135.0 nanograms (ng)/milliliter (mL)Standard Deviation 5.82
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 3 hr PoD, n=23, 27, 27, 24, 145.7 nanograms (ng)/milliliter (mL)Standard Deviation 5.28
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 6-12 hr PoD, n=36, 37, 37, 35, 156.6 nanograms (ng)/milliliter (mL)Standard Deviation 4.16
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 7-13 hr PoD, n=36, 37, 35, 35, 153.7 nanograms (ng)/milliliter (mL)Standard Deviation 2.6
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 8-14 hr PoD, n=35, 37, 36, 35, 152.6 nanograms (ng)/milliliter (mL)Standard Deviation 1.94
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, PrD, n=23, 28, 27, 23, 142.3 nanograms (ng)/milliliter (mL)Standard Deviation 2.09
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 1 hr PoD, n=23, 27, 27, 24, 131.4 nanograms (ng)/milliliter (mL)Standard Deviation 1.22
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 2 hr PoD, n=23, 27, 27, 24, 131.8 nanograms (ng)/milliliter (mL)Standard Deviation 1.72
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 3 hr PoD, n=23, 27, 27, 24, 141.9 nanograms (ng)/milliliter (mL)Standard Deviation 1.53
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 6-12 hr PoD, n=36, 37, 37, 35, 156.9 nanograms (ng)/milliliter (mL)Standard Deviation 4.52
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 7-13 hr PoD, n=36, 37, 35, 35, 154.0 nanograms (ng)/milliliter (mL)Standard Deviation 2.97
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 8-14 hr PoD, n=35, 37, 36, 35, 152.9 nanograms (ng)/milliliter (mL)Standard Deviation 2.3
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 9-15 hr PoD, n=35, 36, 36, 35, 152.1 nanograms (ng)/milliliter (mL)Standard Deviation 1.99
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, PrD, n=23, 28, 27, 23, 141.4 nanograms (ng)/milliliter (mL)Standard Deviation 1.93
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 1 hr PoD, n=23, 27, 27, 24, 131.6 nanograms (ng)/milliliter (mL)Standard Deviation 1.81
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 2 hr PoD, n=23, 27, 27, 24, 132.9 nanograms (ng)/milliliter (mL)Standard Deviation 3.28
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 3 hr PoD, n=23, 27, 27, 24, 143.3 nanograms (ng)/milliliter (mL)Standard Deviation 2.89
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1522.2 nanograms (ng)/milliliter (mL)Standard Deviation 14.71
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 7-13 hr PoD, n=36, 37, 35, 35, 1511.8 nanograms (ng)/milliliter (mL)Standard Deviation 8.49
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 8-14 hr PoD, n=35, 37, 36, 35, 158.1 nanograms (ng)/milliliter (mL)Standard Deviation 5.74
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 9-15 hr PoD, n=35, 36, 36, 35, 155.9 nanograms (ng)/milliliter (mL)Standard Deviation 4.66
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, PrD, n=23, 28, 27, 23, 147.9 nanograms (ng)/milliliter (mL)Standard Deviation 7.37
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 1 hr PoD, n=23, 27, 27, 24, 134.7 nanograms (ng)/milliliter (mL)Standard Deviation 4.18
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 2 hr PoD, n=23, 27, 27, 24, 134.8 nanograms (ng)/milliliter (mL)Standard Deviation 4.08
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 3 hr PoD, n=23, 27, 27, 24, 145.0 nanograms (ng)/milliliter (mL)Standard Deviation 4.64
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1523.1 nanograms (ng)/milliliter (mL)Standard Deviation 15.22
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 7-13 hr PoD, n=36, 37, 35, 35, 1513.1 nanograms (ng)/milliliter (mL)Standard Deviation 9.73
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 8-14 hr PoD, n=35, 37, 36, 35, 159.3 nanograms (ng)/milliliter (mL)Standard Deviation 7.37
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 9-15 hr PoD, n=35, 36, 36, 35, 156.7 nanograms (ng)/milliliter (mL)Standard Deviation 5.5
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, PrD, n=23, 28, 27, 23, 146.7 nanograms (ng)/milliliter (mL)Standard Deviation 6.74
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 1 hr PoD, n=23, 27, 27, 24, 135.0 nanograms (ng)/milliliter (mL)Standard Deviation 4.71
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 2 hr PoD, n=23, 27, 27, 24, 136.8 nanograms (ng)/milliliter (mL)Standard Deviation 6.54
GSK1278863 6 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 3 hr PoD, n=23, 27, 27, 24, 147.4 nanograms (ng)/milliliter (mL)Standard Deviation 6.43
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 8-14 hr PoD, n=35, 37, 36, 35, 1512.7 nanograms (ng)/milliliter (mL)Standard Deviation 28.6
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, PrD, n=23, 28, 27, 23, 149.3 nanograms (ng)/milliliter (mL)Standard Deviation 10.95
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 3 hr PoD, n=23, 27, 27, 24, 143.8 nanograms (ng)/milliliter (mL)Standard Deviation 3.1
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, PrD, n=23, 28, 27, 23, 141.6 nanograms (ng)/milliliter (mL)Standard Deviation 3.8
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 7-13 hr PoD, n=36, 37, 35, 35, 1510.9 nanograms (ng)/milliliter (mL)Standard Deviation 6.37
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 1 hr PoD, n=23, 27, 27, 24, 136.2 nanograms (ng)/milliliter (mL)Standard Deviation 8.65
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 1 hr PoD, n=23, 27, 27, 24, 135.6 nanograms (ng)/milliliter (mL)Standard Deviation 7.48
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, PrD, n=23, 28, 27, 23, 141.3 nanograms (ng)/milliliter (mL)Standard Deviation 4.09
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 3 hr PoD, n=23, 27, 27, 24, 148.2 nanograms (ng)/milliliter (mL)Standard Deviation 6.52
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1520.1 nanograms (ng)/milliliter (mL)Standard Deviation 12.32
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 2 hr PoD, n=23, 27, 27, 24, 136.1 nanograms (ng)/milliliter (mL)Standard Deviation 8.21
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 9-15 hr PoD, n=35, 36, 36, 35, 151.9 nanograms (ng)/milliliter (mL)Standard Deviation 1.92
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 7-13 hr PoD, n=36, 37, 35, 35, 154.1 nanograms (ng)/milliliter (mL)Standard Deviation 3.73
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 3 hr PoD, n=23, 27, 27, 24, 145.5 nanograms (ng)/milliliter (mL)Standard Deviation 5.38
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 2 hr PoD, n=23, 27, 27, 24, 138.1 nanograms (ng)/milliliter (mL)Standard Deviation 10.33
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, PrD, n=23, 28, 27, 23, 147.8 nanograms (ng)/milliliter (mL)Standard Deviation 11.14
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 3 hr PoD, n=23, 27, 27, 24, 1471.2 nanograms (ng)/milliliter (mL)Standard Deviation 110.91
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1525.4 nanograms (ng)/milliliter (mL)Standard Deviation 53.37
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1524.5 nanograms (ng)/milliliter (mL)Standard Deviation 18.27
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 9-15 hr PoD, n=35, 36, 36, 35, 1511.3 nanograms (ng)/milliliter (mL)Standard Deviation 25.36
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 2 hr PoD, n=23, 27, 27, 24, 1382.7 nanograms (ng)/milliliter (mL)Standard Deviation 117.97
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 3 hr PoD, n=23, 27, 27, 24, 148.4 nanograms (ng)/milliliter (mL)Standard Deviation 6.86
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1525.4 nanograms (ng)/milliliter (mL)Standard Deviation 14.25
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 1 hr PoD, n=23, 27, 27, 24, 132.0 nanograms (ng)/milliliter (mL)Standard Deviation 3.58
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 9-15 hr PoD, n=35, 36, 36, 35, 156.9 nanograms (ng)/milliliter (mL)Standard Deviation 4.25
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 1 hr PoD, n=23, 27, 27, 24, 135.0 nanograms (ng)/milliliter (mL)Standard Deviation 8.1
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 1 hr PoD, n=23, 27, 27, 24, 1358.5 nanograms (ng)/milliliter (mL)Standard Deviation 85.91
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 2 hr PoD, n=23, 27, 27, 24, 138.5 nanograms (ng)/milliliter (mL)Standard Deviation 10.83
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 9-15 hr PoD, n=35, 36, 36, 35, 152.1 nanograms (ng)/milliliter (mL)Standard Deviation 1.23
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 9-15 hr PoD, n=35, 36, 36, 35, 152.2 nanograms (ng)/milliliter (mL)Standard Deviation 1.38
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 7-13 hr PoD, n=36, 37, 35, 35, 1513.1 nanograms (ng)/milliliter (mL)Standard Deviation 9.5
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 8-14 hr PoD, n=35, 37, 36, 35, 152.9 nanograms (ng)/milliliter (mL)Standard Deviation 1.68
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 7-13 hr PoD, n=36, 37, 35, 35, 1513.9 nanograms (ng)/milliliter (mL)Standard Deviation 7.66
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, PrD, n=23, 28, 27, 23, 142.6 nanograms (ng)/milliliter (mL)Standard Deviation 2.87
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 1 hr PoD, n=23, 27, 27, 24, 133.4 nanograms (ng)/milliliter (mL)Standard Deviation 5.88
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 6-12 hr PoD, n=36, 37, 37, 35, 157.2 nanograms (ng)/milliliter (mL)Standard Deviation 6.57
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 7-13 hr PoD, n=36, 37, 35, 35, 154.1 nanograms (ng)/milliliter (mL)Standard Deviation 2.15
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, PrD, n=23, 28, 27, 23, 144.6 nanograms (ng)/milliliter (mL)Standard Deviation 9.29
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 1 hr PoD, n=23, 27, 27, 24, 131.8 nanograms (ng)/milliliter (mL)Standard Deviation 2.12
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 8-14 hr PoD, n=35, 37, 36, 35, 153.1 nanograms (ng)/milliliter (mL)Standard Deviation 1.95
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 8-14 hr PoD, n=35, 37, 36, 35, 159.0 nanograms (ng)/milliliter (mL)Standard Deviation 7.05
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 6-12 hr PoD, n=36, 37, 37, 35, 157.6 nanograms (ng)/milliliter (mL)Standard Deviation 4.3
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 2 hr PoD, n=23, 27, 27, 24, 133.5 nanograms (ng)/milliliter (mL)Standard Deviation 4.69
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 2 hr PoD, n=23, 27, 27, 24, 132.2 nanograms (ng)/milliliter (mL)Standard Deviation 2.53
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 8-14 hr PoD, n=35, 37, 36, 35, 152.7 nanograms (ng)/milliliter (mL)Standard Deviation 2.44
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 9-15 hr PoD, n=35, 36, 36, 35, 155.4 nanograms (ng)/milliliter (mL)Standard Deviation 3.63
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, PrD, n=23, 28, 27, 23, 147.9 nanograms (ng)/milliliter (mL)Standard Deviation 30.99
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 3 hr PoD, n=23, 27, 27, 24, 142.1 nanograms (ng)/milliliter (mL)Standard Deviation 1.66
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 7-13 hr PoD, n=36, 37, 35, 35, 1519.9 nanograms (ng)/milliliter (mL)Standard Deviation 42.65
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 9-15 hr PoD, n=35, 36, 36, 35, 156.3 nanograms (ng)/milliliter (mL)Standard Deviation 4.9
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 3 hr PoD, n=23, 27, 27, 24, 146.5 nanograms (ng)/milliliter (mL)Standard Deviation 5.05
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 7-13 hr PoD, n=36, 37, 35, 35, 154.5 nanograms (ng)/milliliter (mL)Standard Deviation 2.7
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 8-14 hr PoD, n=35, 37, 36, 35, 157.4 nanograms (ng)/milliliter (mL)Standard Deviation 4.51
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 2 hr PoD, n=23, 27, 27, 24, 136.3 nanograms (ng)/milliliter (mL)Standard Deviation 8.04
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 8-14 hr PoD, n=35, 37, 36, 35, 159.6 nanograms (ng)/milliliter (mL)Standard Deviation 5.5
GSK1278863 8 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 6-12 hr PoD, n=36, 37, 37, 35, 158.0 nanograms (ng)/milliliter (mL)Standard Deviation 4.87
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 6-12 hr PoD, n=36, 37, 37, 35, 159.0 nanograms (ng)/milliliter (mL)Standard Deviation 18.8
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 1 hr PoD, n=23, 27, 27, 24, 131.0 nanograms (ng)/milliliter (mL)Standard Deviation 1.34
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 8-14 hr PoD, n=35, 37, 36, 35, 159.9 nanograms (ng)/milliliter (mL)Standard Deviation 9.05
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 7-13 hr PoD, n=36, 37, 35, 35, 154.9 nanograms (ng)/milliliter (mL)Standard Deviation 4.05
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, PrD, n=23, 28, 27, 23, 140.7 nanograms (ng)/milliliter (mL)Standard Deviation 1.84
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 9-15 hr PoD, n=35, 36, 36, 35, 1511.2 nanograms (ng)/milliliter (mL)Standard Deviation 33.59
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 8-14 hr PoD, n=35, 37, 36, 35, 152.5 nanograms (ng)/milliliter (mL)Standard Deviation 1.78
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 9-15 hr PoD, n=35, 36, 36, 35, 151.9 nanograms (ng)/milliliter (mL)Standard Deviation 2.21
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 9-15 hr PoD, n=35, 36, 36, 35, 152.3 nanograms (ng)/milliliter (mL)Standard Deviation 1.42
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 8-14 hr PoD, n=35, 37, 36, 35, 151.7 nanograms (ng)/milliliter (mL)Standard Deviation 1.68
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, PrD, n=23, 28, 27, 23, 141.2 nanograms (ng)/milliliter (mL)Standard Deviation 2.67
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 7-13 hr PoD, n=36, 37, 35, 35, 153.7 nanograms (ng)/milliliter (mL)Standard Deviation 4.61
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 9-15 hr PoD, n=35, 36, 36, 35, 158.9 nanograms (ng)/milliliter (mL)Standard Deviation 7.79
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 1 hr PoD, n=23, 27, 27, 24, 131.0 nanograms (ng)/milliliter (mL)Standard Deviation 1.45
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W4, 6-12 hr PoD, n=36, 37, 37, 35, 155.2 nanograms (ng)/milliliter (mL)Standard Deviation 4.66
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 8-14 hr PoD, n=35, 37, 36, 35, 154.6 nanograms (ng)/milliliter (mL)Standard Deviation 6.87
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 2 hr PoD, n=23, 27, 27, 24, 132.1 nanograms (ng)/milliliter (mL)Standard Deviation 1.79
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W20, 3 hr PoD, n=23, 27, 27, 24, 142.8 nanograms (ng)/milliliter (mL)Standard Deviation 2.34
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 3 hr PoD, n=23, 27, 27, 24, 146.1 nanograms (ng)/milliliter (mL)Standard Deviation 4.92
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0.02
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 2 hr PoD, n=23, 27, 27, 24, 134.9 nanograms (ng)/milliliter (mL)Standard Deviation 4.08
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1529.1 nanograms (ng)/milliliter (mL)Standard Deviation 24.55
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, 1 hr PoD, n=23, 27, 27, 24, 132.6 nanograms (ng)/milliliter (mL)Standard Deviation 3.64
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, PrD, n=23, 28, 27, 23, 146.2 nanograms (ng)/milliliter (mL)Standard Deviation 8.78
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 7-13 hr PoD, n=36, 37, 35, 35, 1517.3 nanograms (ng)/milliliter (mL)Standard Deviation 16.03
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W20, PrD, n=23, 28, 27, 23, 143.5 nanograms (ng)/milliliter (mL)Standard Deviation 6.69
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W4, 7-13 hr PoD, n=36, 37, 35, 35, 158.0 nanograms (ng)/milliliter (mL)Standard Deviation 16.92
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 8-14 hr PoD, n=35, 37, 36, 35, 1510.1 nanograms (ng)/milliliter (mL)Standard Deviation 10.61
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 9-15 hr PoD, n=35, 36, 36, 35, 156.6 nanograms (ng)/milliliter (mL)Standard Deviation 5.72
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W4, 9-15 hr PoD, n=35, 36, 36, 35, 158.7 nanograms (ng)/milliliter (mL)Standard Deviation 8.72
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 8-14 hr PoD, n=35, 37, 36, 35, 157.2 nanograms (ng)/milliliter (mL)Standard Deviation 6.97
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 3 hr PoD, n=23, 27, 27, 24, 146.5 nanograms (ng)/milliliter (mL)Standard Deviation 5.14
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, PrD, n=23, 28, 27, 23, 147.2 nanograms (ng)/milliliter (mL)Standard Deviation 10.04
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 7-13 hr PoD, n=36, 37, 35, 35, 1513.1 nanograms (ng)/milliliter (mL)Standard Deviation 12.44
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 1 hr PoD, n=23, 27, 27, 24, 134.5 nanograms (ng)/milliliter (mL)Standard Deviation 5.44
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1521.3 nanograms (ng)/milliliter (mL)Standard Deviation 17.34
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 1 hr PoD, n=23, 27, 27, 24, 134.0 nanograms (ng)/milliliter (mL)Standard Deviation 4.8
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 2 hr PoD, n=23, 27, 27, 24, 134.4 nanograms (ng)/milliliter (mL)Standard Deviation 4.41
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2391220, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, W4, 6-12 hr PoD, n=36, 37, 37, 35, 157.9 nanograms (ng)/milliliter (mL)Standard Deviation 5.75
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531401, W20, 3 hr PoD, n=23, 27, 27, 24, 144.5 nanograms (ng)/milliliter (mL)Standard Deviation 4.28
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 3 hr PoD, n=23, 27, 27, 24, 1465.8 nanograms (ng)/milliliter (mL)Standard Deviation 100.8
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 2 hr PoD, n=23, 27, 27, 24, 1363.3 nanograms (ng)/milliliter (mL)Standard Deviation 102.15
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 6-12 hr PoD, n=36, 37, 37, 35, 1528.8 nanograms (ng)/milliliter (mL)Standard Deviation 21.46
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, 1 hr PoD, n=23, 27, 27, 24, 1365.2 nanograms (ng)/milliliter (mL)Standard Deviation 127.21
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 9-15 hr PoD, n=35, 36, 36, 35, 152.7 nanograms (ng)/milliliter (mL)Standard Deviation 2.04
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 8-14 hr PoD, n=35, 37, 36, 35, 152.9 nanograms (ng)/milliliter (mL)Standard Deviation 2.24
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, PrD, n=23, 28, 27, 23, 142.2 nanograms (ng)/milliliter (mL)Standard Deviation 2.87
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 7-13 hr PoD, n=36, 37, 35, 35, 155.4 nanograms (ng)/milliliter (mL)Standard Deviation 4.1
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W4, 7-13 hr PoD, n=36, 37, 35, 35, 1517.4 nanograms (ng)/milliliter (mL)Standard Deviation 14.72
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 1 hr PoD, n=23, 27, 27, 24, 131.4 nanograms (ng)/milliliter (mL)Standard Deviation 1.57
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W4, 6-12 hr PoD, n=36, 37, 37, 35, 159.0 nanograms (ng)/milliliter (mL)Standard Deviation 6.19
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK1278863, W20, PrD, n=23, 28, 27, 23, 146.6 nanograms (ng)/milliliter (mL)Standard Deviation 20.22
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 2 hr PoD, n=23, 27, 27, 24, 131.6 nanograms (ng)/milliliter (mL)Standard Deviation 1.37
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2506102, W20, 3 hr PoD, n=23, 27, 27, 24, 141.7 nanograms (ng)/milliliter (mL)Standard Deviation 1.42
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 3 hr PoD, n=23, 27, 27, 24, 145.0 nanograms (ng)/milliliter (mL)Standard Deviation 4.43
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531403, W20, 2 hr PoD, n=23, 27, 27, 24, 135.5 nanograms (ng)/milliliter (mL)Standard Deviation 4.58
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2531398, D1, PrD, n=39, 40, 39, 40, 180.0 nanograms (ng)/milliliter (mL)Standard Deviation 0
GSK1278863 10 mgPopulation Plasma PK Parameters of GSK1278863 and MetabolitesGSK2487818, W20, 2 hr PoD, n=23, 27, 27, 24, 133.7 nanograms (ng)/milliliter (mL)Standard Deviation 3.28

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026