Trial Outcomes & Findings for A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin (NCT NCT01218204)

Last Updated: 2019-07-16

Results Overview

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

287 participants

Primary outcome timeframe

Up to Day 26

Results posted on

2019-07-16

Participant Flow

The study was conducted at 21 centers in the United States during the period 14 September 2010 to 29 June 2011. There were 6 total participants in Part A, then Part B started with total of 281 participants which flowed through the rest of the phases of the trial. Part B had washout phase and run-In phase followed by treatment phase.

Total 130 participants were randomized and received at least one dose of study drug in the treatment period phase. Part B Run-In excludes those participants randomized to monotherapy arms; that is, these participant counts are only those who were receiving Atorvastatin.

Participant milestones

Participant milestones
Measure	Part A Four participants on 80 milligrams (mg) atorvastatin \[either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40mg\], received GSK1292263 800 mg for 2 weeks, and 2 participants not on lipid-modifying treatment received GSK1282263 800 mg alone for 2 weeks.	Part B Washout Participants were washed off their prior lipid-lowering therapy for 4 weeks.	Part B Run-in Eligible participants were randomized to receive 10 mg open-labeled atorvastatin or 80 mg open-labeled atorvastatin for a 4-week stabilization run-in period.	Part B Pooled Treatment Arm In this pooled arm, after washout, randomized participants were stratified into 11 arms to receive either atorvastatin 10 mg along with 100 mg or 300 mg or 800 mg of GSK129226 or placebo or ezetimibe 10 mg once daily for 2 weeks; or atorvastatin 80 mg along with 800 mg of GSK129226 or placebo once daily for 2 weeks; or monotherapy (100 mg, 300 mg or 800 mg of GSK1292263 or placebo) once daily for 2 weeks.
Part A STARTED	6	0	0	0
Part A COMPLETED	6	0	0	0
Part A NOT COMPLETED	0	0	0	0
Part B Washout STARTED	0	281	0	0
Part B Washout COMPLETED	0	136	0	0
Part B Washout NOT COMPLETED	0	145	0	0
Part B Run-in STARTED	0	0	89	0
Part B Run-in COMPLETED	0	0	83	0
Part B Run-in NOT COMPLETED	0	0	6	0
Part B Pooled Treatment Arm STARTED	0	0	0	130
Part B Pooled Treatment Arm COMPLETED	0	0	0	127
Part B Pooled Treatment Arm NOT COMPLETED	0	0	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Part B Washout Participants were washed off their prior lipid-lowering therapy for 4 weeks.	Part B Run-in Eligible participants were randomized to receive 10 mg open-labeled atorvastatin or 80 mg open-labeled atorvastatin for a 4-week stabilization run-in period.	Part B Pooled Treatment Arm In this pooled arm, after washout, randomized participants were stratified into 11 arms to receive either atorvastatin 10 mg along with 100 mg or 300 mg or 800 mg of GSK129226 or placebo or ezetimibe 10 mg once daily for 2 weeks; or atorvastatin 80 mg along with 800 mg of GSK129226 or placebo once daily for 2 weeks; or monotherapy (100 mg, 300 mg or 800 mg of GSK1292263 or placebo) once daily for 2 weeks.
Part B Washout Adverse Event	1	0	0
Part B Washout Lost to Follow-up	2	0	0
Part B Washout Physician Decision	14	0	0
Part B Washout Withdrawal by Subject	14	0	0
Part B Washout Reached defined stopping criteria	2	0	0
Part B Washout Did not meet continuation criteria	112	0	0
Part B Run-in Adverse Event	0	1	0
Part B Run-in Protocol Violation	0	2	0
Part B Run-in Withdrawal by Subject	0	3	0
Part B Pooled Treatment Arm Adverse Event	0	0	2
Part B Pooled Treatment Arm Protocol Violation	0	0	1

Baseline Characteristics

N=6

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A n=6 Participants Four participants on 80 mg atorvastatin \[either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg\], received GSK1292263 800 mg for 2 weeks, and 2 participants not on lipid-modifying treatment received GSK1282263 800 mg alone for 2 weeks.	Part B n=281 Participants Part B included Washout phase (Participants were washed off their prior lipid-lowering therapy for 4 weeks), Run-in phase (Eligible participants were randomized to receive 10 mg open-labeled atorvastatin or 80 mg open-labeled atorvastatin for a 4-week stabilization run-in period) and Treatment phase (Randomized participants after washout received monotherpy (100 mg, 300 mg or 800 mg of GSK1292263 or placebo) for 2 weeks. Participants in the 10mg atorvastatin run-in group received GSK1292263, 300 mg QD GSK1292263, 800 mg QD GSK1292263, placebo for GSK1292263 or 10 mg open-label ezetimibe for 2 weeks. Participants in the 80 mg atorvastatin run-in group received 800 mg QD GSK1292263 and placebo for GSK1292263 for 2 weeks)	Total n=287 Participants Total of all reporting groups
Age, Continuous	49.2 Years STANDARD_DEVIATION 5.34 • n=6 Participants • N=6	57.7 Years STANDARD_DEVIATION 9.97 • n=281 Participants • N=281	57.7 Years STANDARD_DEVIATION 9.97 • n=281 Participants • N=281
Sex: Female, Male Female	0 Participants n=6 Participants	152 Participants n=281 Participants	152 Participants n=287 Participants
Sex: Female, Male Male	6 Participants n=6 Participants	129 Participants n=281 Participants	135 Participants n=287 Participants
Race/Ethnicity, Customized African American/African Heritage	1 Participants n=6 Participants	32 Participants n=281 Participants	33 Participants n=287 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=6 Participants	1 Participants n=281 Participants	1 Participants n=287 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=6 Participants	2 Participants n=281 Participants	2 Participants n=287 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	0 Participants n=6 Participants	2 Participants n=281 Participants	2 Participants n=287 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=6 Participants	1 Participants n=281 Participants	1 Participants n=287 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=6 Participants	1 Participants n=281 Participants	1 Participants n=287 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	0 Participants n=6 Participants	7 Participants n=281 Participants	7 Participants n=287 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	5 Participants n=6 Participants	230 Participants n=281 Participants	235 Participants n=287 Participants
Race/Ethnicity, Customized White - Mixed Race	0 Participants n=6 Participants	1 Participants n=281 Participants	1 Participants n=287 Participants
Race/Ethnicity, Customized Mixed Race	0 Participants n=6 Participants	3 Participants n=281 Participants	3 Participants n=287 Participants

PRIMARY outcome

Timeframe: Up to Day 26

Population: Safety Population consisted of all participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=2 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A Any SAE	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A Any AE	0 Participants	2 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 28

Population: All subject Population consisted of all participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=281 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=281 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Any AEs and SAEs- Part B (Washout) Any AE	14 Participants	37 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Any AEs and SAEs- Part B (Washout) Any SAE	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 28

Population: All subject Population

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=62 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=27 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Any AEs and SAEs- Part B (Run-in) Any AE	19 Participants	8 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Any AEs and SAEs- Part B (Run-in) Any SAE	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 26

Population: All subject Population

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=11 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=11 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=13 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg n=11 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg n=12 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg n=13 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo n=11 Participants After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Any AEs and SAEs- Part B (Pooled Treatment Arm) Any AE	6 Participants	2 Participants	3 Participants	3 Participants	4 Participants	6 Participants	4 Participants	5 Participants	7 Participants	8 Participants	4 Participants
Number of Participants With Any AEs and SAEs- Part B (Pooled Treatment Arm) Any SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 26

Population: Safety Population.

Single ECGs were taken after admission on Day -1 and at Follow-up (up to Day 26). On Days 1, 7, and 14 single ECGS were taken pre-breakfast (fasting) and at 1, 3, 6, 8, 14 and 24 hours post-dose. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. No value found to be abnormal clinically significant in Part A of the study.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=2 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Abnormal- Clinically Significant Electrocardiogram (ECG) Findings- Part A	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 28

Population: All subject Population. Only those participants available at the specified time points were analyzed.

ECGs were taken at Screening, and on Day1 and Day 28. Single assessments were made. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=281 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Washout) Day 1	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Washout) Day 28	1 Participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 28

Population: All subjects Population. Only those participants present during Run in/Day 28 were evaluated/included.

ECGs were taken on Day 28. Single assessments were made. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. No data found to be abnormal clinically significant in run-in phase.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=59 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=25 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Run-in)	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 26

Population: All subjects Population.

Single ECGs were taken after admission on Day -2, and pre-breakfast on Days -1, 4, 10, and at Follow-up. On Days 1, 7, and 14 single ECGS were taken pre-breakfast (fasting) and at 1, 3, 6, 8, 14 and 24 hours post-dose. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. The data was found to be abnormal clinically significant in treatment phase.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=11 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=11 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=13 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg n=11 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg n=12 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg n=13 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo n=11 Participants After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Pooled Treatment Arm)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 26

Population: Safety Population.

Assessment of vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate was performed after admission on Day -1 and at Follow-up. On Days 1, 7 and 14, they were taken at pre-dose, 1, 3, 6, 8, 14 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=2 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Vital Signs of Potential Clinical Importance (PCI)- Part A DBP, low	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Vital Signs of Potential Clinical Importance (PCI)- Part A DBP, high	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to day 28

Population: All subjects Population.

Assessment of vital signs including SBP, DBP heart rate was performed at Screening, on Days 1, 14 and 28 in the morning. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=281 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Vital Signs of PCI- Part B (Washout) SBP, high	4 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Vital Signs of PCI- Part B (Washout) Heart rate, high	1 Participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to day 28

Population: All subjects Population.

Assessment of vital signs including SBP, DBP and heart rate was performed on Days 1, 14 and 28 in the morning. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=62 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=27 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Run-in) SBP, high	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Run-in) SBP, low	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 26

Population: All subjects Population.

Assessment of vital signs including SBP, DBP and heart rate was performed after admission on Day-2, and pre-breakfast on Days -1, 4, and 10 in a fasting state early in the morning (prior to dosing), and at Follow-up. On Days 1, 7 and 14, they were also be taken at 1, 3, 6, 9, 12 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=11 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=11 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=13 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg n=11 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg n=12 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg n=13 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo n=11 Participants After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Pooled Treatment Arm) SBP, high	0 Participants	0 Participants	1 Participants	3 Participants	2 Participants	1 Participants	2 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Pooled Treatment Arm) DBP, high	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Pooled Treatment Arm) DBP, low	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Pooled Treatment Arm) Heart rate, high	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 26

Population: Safety Population.

Blood samples were collected fasting on Day -1, and prior to breakfast (early in the morning, fasting) on Days 2, 4, 7, 11 and on Day 15 prior to checkout (24 hours post last-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Data for only those parameters (Hematocrit, Hemoglobin and Total neutrophils) are presented for which findings are of PCI either high or low.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=2 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Abnormal Hematology Value of PCI- Part A Hematocrit, high	2 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Hematology Value of PCI- Part A Hemoglobin, high	2 Participants	0 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Hematology Value of PCI- Part A Total neutrophil, low	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 28

Population: All subjects Population.

Blood samples were collected at screening, and on Days 1 (first day of washout), 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (White blood cells \[WBC\], Total neutrophils, Hematocrit and Lymphocytes) are presented for which findings are of PCI either high or low.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=281 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Abnormal Hematology Value of PCI- Part B (Washout) WBC, high	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Hematology Value of PCI- Part B (Washout) WBC, low	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Hematology Value of PCI- Part B (Washout) Hematocrit, high	2 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Hematology Value of PCI- Part B (Washout) Lymphocytes, low	2 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Hematology Value of PCI- Part B (Washout) Total neutrophil, low	1 Participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Days 14 and 28

Population: All subjects Population.

Blood samples were collected on Day 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Lymphocytes) are presented for which findings are of PCI either high or low.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=62 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=27 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Abnormal Hematology Value of PCI- Part B (Run-in) Lymphocytes, low	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Hematology Value of PCI- Part B (Run-in) Lymphocytes, high	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 26

Population: All subjects Population.

Blood samples were collected fasting on Day -2, and prior to breakfast (early in the morning, fasting) on Days 2 (pre-dose), 4, 7, 10, 13 and on Day 15 prior to checkout (24hrs post-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24hrs post dose = pre-dose (time 0) for the next dose). Data for only those parameters (Platelet count, Total neutrophils and Lymphocytes) are presented for which findings are of PCI either high or low.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=11 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=11 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=13 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg n=11 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg n=12 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg n=13 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo n=11 Participants After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Abnormal Hematology Value of PCI- Part B (Pooled Treatment Arm) Platelet count, low	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology Value of PCI- Part B (Pooled Treatment Arm) Total neutrophils, low	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology Value of PCI- Part B (Pooled Treatment Arm) Lymphocytes, low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 26

Population: Safety Population.

Samples were collected fasting on Day -1, and prior to breakfast (early in the morning, fasting) on Days 2, 4, 7, 11 and on Day 15 prior to checkout (24 hours post last-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). No parameter was found to have any value of PCI.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=2 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part A	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 28

Population: All subjects Population.

Samples were collected at screening, and on Days1 (first day of washout), 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Inorganic phosphorus, Sodium, Alanine aminotransferase \[ALT\], Potassium, Creatinine, Calcium, magnesium, Glucose, Total Bilirubin, Carbon dioxide/bicarbonate \[CO2/HCO3\] and Aspartate aminotransferase \[AST\]) are presented for which findings are of PCI either high or low.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=281 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) Inorganic phosphorus, high	3 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) Inorganic phosphorus, low	2 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) Sodium, high	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) Sodium, low	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) ALT, high	3 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) Potassium, high	3 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) Potassium, low	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) Creatinine, high	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) Calcium, high	2 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) Magnesium, high	32 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) Glucose, high	4 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) Glucose, low	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) Total bilirubin, high	6 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) CO2/bicarbonate, low	1 Participants	—	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout) AST, high	1 Participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Days 14 and 28

Population: All subjects Population.

Samples were collected on Day 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Glucose, Magnesium, ALT, AST, Calcium, Inorganic phosphorus and Total bilirubin) are presented for which findings are of PCI either high or low.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=62 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=27 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (run-in) AST, high	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (run-in) Calcium, high	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (run-in) Glucose, high	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (run-in) Magnesium, high	5 Participants	5 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (run-in) ALT, high	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (run-in) Inorganic phosphorus, low	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (run-in) Total bilirubin, high	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 26

Population: All subjects Population.

Samples were collected fasting on Day -2, and prior to breakfast (early in the morning, fasting) on Days 2 (pre-dose), 4, 7, 10, 13 and on Day 15 prior to checkout (24 hours post-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post dose = pre-dose (time 0) for the next dose). Data for only those parameters (Glucose, Total bilirubin, Albumin, Magnesium, CO2/HCO3, Calcium, ALT, AST, Inorganic phosphorus, Potassium and Sodium) are presented for which findings are of PCI either high or low.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=11 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=11 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=13 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg n=11 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg n=12 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg n=13 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo n=11 Participants After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) Glucose, low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) Total bilirubin, high	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) Albumin, low	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) Calcium, high	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) Calcium, low	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) ALT, high	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) AST, high	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) Inorganic phosphorus, high	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) Potassium, low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) Sodium, high	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) Glucose, high	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) Magnesium, high	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants	3 Participants	2 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) CO2/HCO3, high	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm) CO2/HCO3, low	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose

Population: Pharmacokinetic (PK) Parameter Population was defined as participants in the 'PK Concentration' population for whom PK parameters were derived. The 'PK Concentration Population' was defined as participants in the 'All Subjects' Population for whom a PK sample was obtained and analyzed.

Serial blood samples for the determination of the PK for GSK1292263 on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=2 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Maximum Observed Concentration (Cmax) of GSK1292263- Part A Day 1	976.335 nanograms per milliliter Geometric Coefficient of Variation 16.6353	986.811 nanograms per milliliter Geometric Coefficient of Variation 46.4825	—	—	—	—	—	—	—	—	—
Maximum Observed Concentration (Cmax) of GSK1292263- Part A Day 14	1118.344 nanograms per milliliter Geometric Coefficient of Variation 20.6141	948.764 nanograms per milliliter Geometric Coefficient of Variation 6.5356	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose

Population: PK parameter Population. Only those participants available at the specified time points were analyzed.

For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=7 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=7 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=11 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Cmax of GSK1292263- Part B (Pooled Treatment Arm) Day 14	361.595 nanograms per milliliter Geometric Coefficient of Variation 25.9981	639.687 nanograms per milliliter Geometric Coefficient of Variation 33.6608	886.418 nanograms per milliliter Geometric Coefficient of Variation 31.3931	848.082 nanograms per milliliter Geometric Coefficient of Variation 25.1892	364.936 nanograms per milliliter Geometric Coefficient of Variation 39.1918	590.949 nanograms per milliliter Geometric Coefficient of Variation 20.7601	782.914 nanograms per milliliter Geometric Coefficient of Variation 81.2992	—	—	—	—
Cmax of GSK1292263- Part B (Pooled Treatment Arm) Day 1	281.321 nanograms per milliliter Geometric Coefficient of Variation 35.9671	475.297 nanograms per milliliter Geometric Coefficient of Variation 36.5131	808.278 nanograms per milliliter Geometric Coefficient of Variation 20.0646	790.315 nanograms per milliliter Geometric Coefficient of Variation 32.5080	263.279 nanograms per milliliter Geometric Coefficient of Variation 43.0140	478.676 nanograms per milliliter Geometric Coefficient of Variation 21.2079	787.922 nanograms per milliliter Geometric Coefficient of Variation 36.7864	—	—	—	—

PRIMARY outcome

Timeframe: On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose

Population: PK parameter Population. Only those participants available at the specified time points were analyzed.

Serial blood samples for the determination of the PK for GSK1292263, on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=2 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Time of Occurrence of Cmax (Tmax) and Terminal Phase Half-life (t1/2) GSK1292263- Part A tmax, Day 1	6.000 hours Interval 4.0 to 8.0	5.000 hours Interval 4.0 to 6.0	—	—	—	—	—	—	—	—	—
Time of Occurrence of Cmax (Tmax) and Terminal Phase Half-life (t1/2) GSK1292263- Part A tmax, Day 14	3.000 hours Interval 3.0 to 4.0	5.067 hours Interval 4.0 to 6.13	—	—	—	—	—	—	—	—	—
Time of Occurrence of Cmax (Tmax) and Terminal Phase Half-life (t1/2) GSK1292263- Part A t1/2, Day 1	11.185 hours Interval 8.81 to 11.61	16.164 hours Interval 16.164 to 16.164	—	—	—	—	—	—	—	—	—
Time of Occurrence of Cmax (Tmax) and Terminal Phase Half-life (t1/2) GSK1292263- Part A t1/2, Day 14	20.629 hours Interval 13.76 to 28.8	19.395 hours Interval 16.54 to 22.25	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose

Population: PK parameter Population

Serial blood samples for the determination of the PK for GSK1292263 on Days 1 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48h sample on Day 1).

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=2 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of GSK1292263- Part A	0.250 hours Interval 0.0 to 0.5	0.000 hours Interval 0.0 to 0.0	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Population: PK parameter Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=7 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=7 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=11 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Tmax and t1/2 of GSK1292263- Part B (Pooled Treatment Arm) tmax, Day 14	5.000 hours Interval 0.83 to 8.0	4.000 hours Interval 2.08 to 4.02	4.000 hours Interval 1.5 to 4.05	4.000 hours Interval 1.5 to 4.0	4.000 hours Interval 3.98 to 6.0	3.983 hours Interval 1.98 to 6.0	4.000 hours Interval 0.43 to 5.98	—	—	—	—
Tmax and t1/2 of GSK1292263- Part B (Pooled Treatment Arm) tmax, Day 1	3.983 hours Interval 3.0 to 6.0	5.008 hours Interval 3.98 to 8.0	4.000 hours Interval 4.0 to 8.33	4.000 hours Interval 3.98 to 8.08	4.000 hours Interval 1.5 to 8.0	4.000 hours Interval 2.0 to 8.0	3.475 hours Interval 1.98 to 7.97	—	—	—	—
Tmax and t1/2 of GSK1292263- Part B (Pooled Treatment Arm) t1/2, Day 1	12.630 hours Interval 12.63 to 12.63	10.270 hours Interval 6.07 to 10.55	10.416 hours Interval 9.29 to 26.11	12.372 hours Interval 6.72 to 23.08	15.305 hours Interval 12.25 to 21.78	14.342 hours Interval 13.38 to 20.3	14.464 hours Interval 14.464 to 14.464	—	—	—	—
Tmax and t1/2 of GSK1292263- Part B (Pooled Treatment Arm) t1/2, Day 14	26.453 hours Interval 17.02 to 163.25	21.569 hours Interval 15.73 to 37.15	21.846 hours Interval 10.52 to 36.52	24.225 hours Interval 16.86 to 34.21	23.893 hours Interval 17.43 to 43.62	25.203 hours Interval 10.67 to 62.63	19.478 hours Interval 12.4 to 67.78	—	—	—	—

PRIMARY outcome

Timeframe: On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose.

Population: PK parameter Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=5 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=6 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=8 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=11 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=12 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Tlag of GSK1292263- Part B (Pooled Treatment Arm)	0.000 hours Interval 0.0 to 0.5	0.000 hours Interval 0.0 to 0.5	0.000 hours Interval 0.0 to 1.03	0.000 hours Interval 0.0 to 0.5	0.000 hours Interval 0.0 to 1.03	0.000 hours Interval 0.0 to 1.0	0.000 hours Interval 0.0 to 0.5	—	—	—	—

PRIMARY outcome

Timeframe: On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose

Population: PK parameter Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=2 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours [AUC(0-24)] of GSK1292263- Part A Day 1	12953.89 nanograms hour per milliliter Geometric Coefficient of Variation 16.976	12032.21 nanograms hour per milliliter Geometric Coefficient of Variation NA Only one participant was analyzed.	—	—	—	—	—	—	—	—	—
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours [AUC(0-24)] of GSK1292263- Part A Day 14	13206.52 nanograms hour per milliliter Geometric Coefficient of Variation 15.070	11890.40 nanograms hour per milliliter Geometric Coefficient of Variation 5.730	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Population: PK parameter Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=7 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=7 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=11 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
AUC(0-24) of GSK1292263- Part B (Pooled Treatment Arm) Day 1	4218.02 nanograms hour per milliliter Geometric Coefficient of Variation 54.264	5373.78 nanograms hour per milliliter Geometric Coefficient of Variation 64.021	10384.24 nanograms hour per milliliter Geometric Coefficient of Variation 15.165	9812.21 nanograms hour per milliliter Geometric Coefficient of Variation 25.708	2753.61 nanograms hour per milliliter Geometric Coefficient of Variation 48.535	5342.77 nanograms hour per milliliter Geometric Coefficient of Variation 18.108	8937.99 nanograms hour per milliliter Geometric Coefficient of Variation 21.080	—	—	—	—
AUC(0-24) of GSK1292263- Part B (Pooled Treatment Arm) Day 14	4968.29 nanograms hour per milliliter Geometric Coefficient of Variation 24.683	7484.67 nanograms hour per milliliter Geometric Coefficient of Variation 51.772	11224.58 nanograms hour per milliliter Geometric Coefficient of Variation 44.087	10760.74 nanograms hour per milliliter Geometric Coefficient of Variation 22.081	4061.78 nanograms hour per milliliter Geometric Coefficient of Variation 35.242	6737.82 nanograms hour per milliliter Geometric Coefficient of Variation 28.082	8837.31 nanograms hour per milliliter Geometric Coefficient of Variation 79.003	—	—	—	—

PRIMARY outcome

Timeframe: On Days 13, 14, 15 and 16 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose

Population: PK concentration Population. Data was not collected for this outcome measure.

Trough samples for GSK1292263 PK (all treatment arms) were planned to be collected early in the morning on Days 13, 14, 15 and 16 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48h PK sample was collected on Day 16). (pre-dose for Days 13 and 14; trough Day 15 = 24h post last dose; trough Day 16 = 48h post last dose).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.

Population: PK parameter Population.

Serial blood samples for the determination of the PK for atorvastatin on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Cmax of Atorvastatin- Part A Day -1	45.587 nanograms per milliliter Geometric Coefficient of Variation 130.4168	—	—	—	—	—	—	—	—	—	—
Cmax of Atorvastatin- Part A Day 1	25.867 nanograms per milliliter Geometric Coefficient of Variation 88.8156	—	—	—	—	—	—	—	—	—	—
Cmax of Atorvastatin- Part A Day 14	38.443 nanograms per milliliter Geometric Coefficient of Variation 71.1418	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose

Population: PK parameter Population. Only those participants available at the specified time points were analyzed.

For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=7 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=7 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=6 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Cmax of Atorvastatin- Part B (Pooled Treatment Arm) Day -1	2.045 nanograms per milliliter Geometric Coefficient of Variation 41.3980	2.454 nanograms per milliliter Geometric Coefficient of Variation 34.6820	1.683 nanograms per milliliter Geometric Coefficient of Variation 54.1388	1.816 nanograms per milliliter Geometric Coefficient of Variation 54.6608	2.003 nanograms per milliliter Geometric Coefficient of Variation 73.2912	42.376 nanograms per milliliter Geometric Coefficient of Variation 113.1276	37.058 nanograms per milliliter Geometric Coefficient of Variation 47.5590	—	—	—	—
Cmax of Atorvastatin- Part B (Pooled Treatment Arm) Day 1	1.292 nanograms per milliliter Geometric Coefficient of Variation 26.6345	2.195 nanograms per milliliter Geometric Coefficient of Variation 47.6989	1.926 nanograms per milliliter Geometric Coefficient of Variation 47.0899	1.852 nanograms per milliliter Geometric Coefficient of Variation 57.6472	1.872 nanograms per milliliter Geometric Coefficient of Variation 64.1762	31.018 nanograms per milliliter Geometric Coefficient of Variation 81.5136	45.781 nanograms per milliliter Geometric Coefficient of Variation 38.4790	—	—	—	—
Cmax of Atorvastatin- Part B (Pooled Treatment Arm) Day 14	1.453 nanograms per milliliter Geometric Coefficient of Variation 14.5258	2.154 nanograms per milliliter Geometric Coefficient of Variation 69.0856	2.139 nanograms per milliliter Geometric Coefficient of Variation 74.2524	1.640 nanograms per milliliter Geometric Coefficient of Variation 68.6754	1.949 nanograms per milliliter Geometric Coefficient of Variation 56.7747	38.419 nanograms per milliliter Geometric Coefficient of Variation 71.2059	41.092 nanograms per milliliter Geometric Coefficient of Variation 73.0152	—	—	—	—

PRIMARY outcome

Population: PK parameter Population.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Tmax of Atorvastatin- Part A Day -1	3.000 hours Interval 0.5 to 4.0	—	—	—	—	—	—	—	—	—	—
Tmax of Atorvastatin- Part A Day 1	4.000 hours Interval 3.0 to 6.0	—	—	—	—	—	—	—	—	—	—
Tmax of Atorvastatin- Part A Day 14	2.250 hours Interval 1.0 to 3.0	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Population: PK parameter Population. Only those participants available at specified time points were analyzed.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=7 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=7 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=6 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Tmax of Atorvastatin- Part B (Pooled Treatment Arm) Day -1	2.500 hours Interval 0.5 to 6.08	3.000 hours Interval 1.5 to 6.0	3.983 hours Interval 0.5 to 5.97	3.017 hours Interval 0.5 to 6.08	4.000 hours Interval 3.0 to 4.0	2.508 hours Interval 0.5 to 6.0	1.517 hours Interval 0.5 to 4.0	—	—	—	—
Tmax of Atorvastatin- Part B (Pooled Treatment Arm) Day 1	4.992 hours Interval 3.98 to 6.0	6.000 hours Interval 3.95 to 6.0	3.000 hours Interval 0.5 to 8.33	3.992 hours Interval 1.5 to 6.08	4.000 hours Interval 2.0 to 4.0	3.492 hours Interval 1.03 to 6.03	2.000 hours Interval 0.5 to 4.0	—	—	—	—
Tmax of Atorvastatin- Part B (Pooled Treatment Arm) Day 14	4.000 hours Interval 2.83 to 6.0	4.000 hours Interval 3.0 to 6.0	3.500 hours Interval 1.5 to 6.08	3.525 hours Interval 1.5 to 6.0	2.000 hours Interval 1.0 to 3.0	2.067 hours Interval 0.5 to 5.93	3.000 hours Interval 1.0 to 6.05	—	—	—	—

PRIMARY outcome

Population: PK parameter Population.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
AUC (0-24) of Atorvastatin- Part A Day -1	219.27 nanograms hour per milliliter Geometric Coefficient of Variation 77.893	—	—	—	—	—	—	—	—	—	—
AUC (0-24) of Atorvastatin- Part A Day 1	199.15 nanograms hour per milliliter Geometric Coefficient of Variation 73.974	—	—	—	—	—	—	—	—	—	—
AUC (0-24) of Atorvastatin- Part A Day 14	187.25 nanograms hour per milliliter Geometric Coefficient of Variation 52.566	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Population: PK parameter Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=7 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=7 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=6 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
AUC (0-24) of Atorvastatin- Part B (Pooled Treatment Arm) Day -1	23.16 nanograms hour per milliliter Geometric Coefficient of Variation 18.115	28.78 nanograms hour per milliliter Geometric Coefficient of Variation 26.611	19.26 nanograms hour per milliliter Geometric Coefficient of Variation 54.767	18.77 nanograms hour per milliliter Geometric Coefficient of Variation 51.122	19.59 nanograms hour per milliliter Geometric Coefficient of Variation 47.952	188.88 nanograms hour per milliliter Geometric Coefficient of Variation 70.744	173.62 nanograms hour per milliliter Geometric Coefficient of Variation 31.333	—	—	—	—
AUC (0-24) of Atorvastatin- Part B (Pooled Treatment Arm) Day 1	17.84 nanograms hour per milliliter Geometric Coefficient of Variation 35.028	26.19 nanograms hour per milliliter Geometric Coefficient of Variation 30.561	20.83 nanograms hour per milliliter Geometric Coefficient of Variation 50.427	19.33 nanograms hour per milliliter Geometric Coefficient of Variation 55.620	19.05 nanograms hour per milliliter Geometric Coefficient of Variation 48.448	174.13 nanograms hour per milliliter Geometric Coefficient of Variation 55.829	186.73 nanograms hour per milliliter Geometric Coefficient of Variation 35.837	—	—	—	—
AUC (0-24) of Atorvastatin- Part B (Pooled Treatment Arm) Day 14	15.58 nanograms hour per milliliter Geometric Coefficient of Variation 14.934	23.77 nanograms hour per milliliter Geometric Coefficient of Variation 38.501	20.41 nanograms hour per milliliter Geometric Coefficient of Variation 70.602	18.60 nanograms hour per milliliter Geometric Coefficient of Variation 56.102	20.24 nanograms hour per milliliter Geometric Coefficient of Variation 41.371	174.93 nanograms hour per milliliter Geometric Coefficient of Variation 59.199	188.31 nanograms hour per milliliter Geometric Coefficient of Variation 54.020	—	—	—	—

PRIMARY outcome

Population: PK parameter Population. Data was not collected for this outcome measure.

For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were planned to be collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were planned to be collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were planned to be collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was planned to be collected on Day 16).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and Day 14

Population: All subjects Population. Only those participants available at the specified time points were analyzed.

Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=11 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=11 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=13 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg n=11 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg n=12 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg n=13 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo n=11 Participants After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Percent Change From Baseline for Lipid Metabolism: Apolipoprotein A1 and Apolipoprotein B100 at Day 14 Apolipoprotein B100, 24 hours	2.85 Percent change Standard Deviation 31.217	-17.93 Percent change Standard Deviation 19.839	-22.22 Percent change Standard Deviation 20.393	-5.03 Percent change Standard Deviation 19.932	-15.49 Percent change Standard Deviation 13.681	-27.08 Percent change Standard Deviation 14.132	4.25 Percent change Standard Deviation 27.890	-10.21 Percent change Standard Deviation 22.072	-7.62 Percent change Standard Deviation 23.573	-10.95 Percent change Standard Deviation 23.811	-2.39 Percent change Standard Deviation 15.932
Percent Change From Baseline for Lipid Metabolism: Apolipoprotein A1 and Apolipoprotein B100 at Day 14 Apolipoprotein A1, 24 hours	-1.93 Percent change Standard Deviation 27.152	-8.72 Percent change Standard Deviation 31.791	4.17 Percent change Standard Deviation 38.410	-7.19 Percent change Standard Deviation 27.383	-3.88 Percent change Standard Deviation 26.818	-1.00 Percent change Standard Deviation 35.805	-5.81 Percent change Standard Deviation 47.800	3.76 Percent change Standard Deviation 41.281	29.90 Percent change Standard Deviation 99.331	-0.15 Percent change Standard Deviation 39.226	-0.18 Percent change Standard Deviation 49.478

PRIMARY outcome

Timeframe: Baseline and Day 14

Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=10 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=10 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=10 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=13 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=11 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg n=10 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg n=12 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg n=13 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo n=11 Participants After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Percent Change From Baseline in Lipid Metabolism: Apolipoprotein E at Day 14 (24 Hours)	-21.97 Perecent change Standard Deviation 16.373	-3.92 Perecent change Standard Deviation 29.382	-31.41 Perecent change Standard Deviation 17.369	34.28 Perecent change Standard Deviation 141.042	-12.27 Perecent change Standard Deviation 42.191	-13.19 Perecent change Standard Deviation 19.202	-13.41 Perecent change Standard Deviation 30.613	1.35 Perecent change Standard Deviation 46.155	-21.98 Perecent change Standard Deviation 37.910	-33.75 Perecent change Standard Deviation 16.915	-1.58 Perecent change Standard Deviation 36.044

PRIMARY outcome

Timeframe: Baseline and Day 14

Population: All subjects Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=11 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=11 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=13 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg n=11 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg n=12 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg n=13 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo n=11 Participants After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Percent Change From Baseline in Lipid Metabolism: High Density Lipids Cholesterol (HDLc), Low Density Lipids Cholesterol (LDLc), Tryglycerides, Non-HDLc and Total Cholesterol at Day 14 (24 Hours) Non-HDLc	-9.53 Percent change Standard Deviation 8.502	-11.67 Percent change Standard Deviation 18.562	-26.59 Percent change Standard Deviation 13.742	2.08 Percent change Standard Deviation 16.176	-21.19 Percent change Standard Deviation 11.920	-21.88 Percent change Standard Deviation 11.157	-0.94 Percent change Standard Deviation 8.977	-9.32 Percent change Standard Deviation 13.107	-17.02 Percent change Standard Deviation 12.376	-22.62 Percent change Standard Deviation 10.290	3.17 Percent change Standard Deviation 9.283
Percent Change From Baseline in Lipid Metabolism: High Density Lipids Cholesterol (HDLc), Low Density Lipids Cholesterol (LDLc), Tryglycerides, Non-HDLc and Total Cholesterol at Day 14 (24 Hours) Triglyceides	-18.67 Percent change Standard Deviation 16.693	-15.98 Percent change Standard Deviation 24.307	-32.81 Percent change Standard Deviation 21.249	10.70 Percent change Standard Deviation 32.177	-10.44 Percent change Standard Deviation 21.628	-21.39 Percent change Standard Deviation 28.190	2.27 Percent change Standard Deviation 17.025	-3.95 Percent change Standard Deviation 23.855	-30.84 Percent change Standard Deviation 11.753	-34.66 Percent change Standard Deviation 21.197	18.90 Percent change Standard Deviation 18.225
Percent Change From Baseline in Lipid Metabolism: High Density Lipids Cholesterol (HDLc), Low Density Lipids Cholesterol (LDLc), Tryglycerides, Non-HDLc and Total Cholesterol at Day 14 (24 Hours) Total cholesterol	-5.17 Percent change Standard Deviation 9.210	-3.61 Percent change Standard Deviation 12.355	-10.31 Percent change Standard Deviation 8.912	0.89 Percent change Standard Deviation 12.671	-14.23 Percent change Standard Deviation 9.640	-5.52 Percent change Standard Deviation 7.721	1.09 Percent change Standard Deviation 6.724	-5.81 Percent change Standard Deviation 10.091	-12.06 Percent change Standard Deviation 9.650	-14.05 Percent change Standard Deviation 7.614	2.18 Percent change Standard Deviation 7.900
Percent Change From Baseline in Lipid Metabolism: High Density Lipids Cholesterol (HDLc), Low Density Lipids Cholesterol (LDLc), Tryglycerides, Non-HDLc and Total Cholesterol at Day 14 (24 Hours) HDLc	7.50 Percent change Standard Deviation 13.639	14.97 Percent change Standard Deviation 7.700	31.09 Percent change Standard Deviation 11.966	-0.03 Percent change Standard Deviation 14.714	6.03 Percent change Standard Deviation 11.850	26.22 Percent change Standard Deviation 15.840	4.50 Percent change Standard Deviation 10.936	9.17 Percent change Standard Deviation 10.277	9.76 Percent change Standard Deviation 17.160	18.95 Percent change Standard Deviation 12.847	-1.37 Percent change Standard Deviation 7.140
Percent Change From Baseline in Lipid Metabolism: High Density Lipids Cholesterol (HDLc), Low Density Lipids Cholesterol (LDLc), Tryglycerides, Non-HDLc and Total Cholesterol at Day 14 (24 Hours) LDLc	-6.80 Percent change Standard Deviation 14.522	-10.01 Percent change Standard Deviation 21.231	-24.09 Percent change Standard Deviation 18.017	-0.37 Percent change Standard Deviation 19.794	-24.81 Percent change Standard Deviation 12.317	-18.63 Percent change Standard Deviation 16.534	15.01 Percent change Standard Deviation 59.194	-10.24 Percent change Standard Deviation 11.438	-11.86 Percent change Standard Deviation 16.873	-19.94 Percent change Standard Deviation 10.688	0.77 Percent change Standard Deviation 11.347

PRIMARY outcome

Timeframe: Baseline and Day 14

Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=11 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=11 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=10 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=13 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=11 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=12 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg n=10 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg n=11 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg n=13 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo n=10 Participants After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Percent Change From Baseline in Lipid Metabolism: LDL/HDL Ratio at Day 14 (24 Hours)	-12.25 Percent change Standard Deviation 14.784	-21.12 Percent change Standard Deviation 20.549	-41.61 Percent change Standard Deviation 14.248	0.94 Percent change Standard Deviation 20.727	-28.69 Percent change Standard Deviation 11.963	-34.35 Percent change Standard Deviation 16.047	10.84 Percent change Standard Deviation 56.487	-16.78 Percent change Standard Deviation 15.615	-17.63 Percent change Standard Deviation 23.327	-32.01 Percent change Standard Deviation 11.287	2.55 Percent change Standard Deviation 12.789

PRIMARY outcome

Timeframe: Baseline and Day 14

Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed.

Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was Day -1 value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=10 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=10 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=10 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=13 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=11 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg n=10 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg n=12 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg n=13 Participants After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo n=11 Participants After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Weighted Mean Area Under Concentration Curve From 0 to 24 Hours (AUC [0-24]) Change From Baseline for Triglycerides at Day 14	0.13341 millimoles per liter Geometric Coefficient of Variation -167.395	0.30812 millimoles per liter Geometric Coefficient of Variation -360.966	0.12845 millimoles per liter Geometric Coefficient of Variation -68.4294	0.25228 millimoles per liter Geometric Coefficient of Variation 477.0380	0.09060 millimoles per liter Geometric Coefficient of Variation -146.956	0.04974 millimoles per liter Geometric Coefficient of Variation -76.1973	0.20164 millimoles per liter Geometric Coefficient of Variation -485.961	0.30543 millimoles per liter Geometric Coefficient of Variation -159.012	0.37442 millimoles per liter Geometric Coefficient of Variation -111.818	0.13079 millimoles per liter Geometric Coefficient of Variation -115.210	0.28863 millimoles per liter Geometric Coefficient of Variation 93.3050

SECONDARY outcome

Population: PK parameter Population.

Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A Day -1	17.521 nanograms per milliliter Geometric Coefficient of Variation 66.1066	—	—	—	—	—	—	—	—	—	—
Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A Day 1	15.535 nanograms per milliliter Geometric Coefficient of Variation 48.2576	—	—	—	—	—	—	—	—	—	—
Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A Day 14	21.271 nanograms per milliliter Geometric Coefficient of Variation 30.4382	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: PK parameter Population. Only those participants available at the specified time points were analyzed.

For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=7 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=7 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=6 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm) Day -1	1.298 nanograms per milliliter Geometric Coefficient of Variation 37.3615	1.388 nanograms per milliliter Geometric Coefficient of Variation 42.8163	0.947 nanograms per milliliter Geometric Coefficient of Variation 39.3947	0.952 nanograms per milliliter Geometric Coefficient of Variation 63.1814	1.185 nanograms per milliliter Geometric Coefficient of Variation 119.9675	26.106 nanograms per milliliter Geometric Coefficient of Variation 102.2617	21.149 nanograms per milliliter Geometric Coefficient of Variation 39.5618	—	—	—	—
Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm) Day 1	1.073 nanograms per milliliter Geometric Coefficient of Variation 19.3329	1.217 nanograms per milliliter Geometric Coefficient of Variation 36.0597	1.048 nanograms per milliliter Geometric Coefficient of Variation 33.9165	1.028 nanograms per milliliter Geometric Coefficient of Variation 67.0630	1.234 nanograms per milliliter Geometric Coefficient of Variation 44.7679	19.991 nanograms per milliliter Geometric Coefficient of Variation 71.2442	26.400 nanograms per milliliter Geometric Coefficient of Variation 44.9589	—	—	—	—
Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm) Day 14	0.634 nanograms per milliliter Geometric Coefficient of Variation 12.5545	1.152 nanograms per milliliter Geometric Coefficient of Variation 53.4256	1.084 nanograms per milliliter Geometric Coefficient of Variation 49.9097	0.869 nanograms per milliliter Geometric Coefficient of Variation 62.0112	1.349 nanograms per milliliter Geometric Coefficient of Variation 42.0203	22.645 nanograms per milliliter Geometric Coefficient of Variation 75.7161	27.236 nanograms per milliliter Geometric Coefficient of Variation 68.7891	—	—	—	—

SECONDARY outcome

Population: PK parameter Population.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A Day -1	3.000 hours Interval 1.0 to 4.0	—	—	—	—	—	—	—	—	—	—
Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A Day 1	4.000 hours Interval 4.0 to 6.0	—	—	—	—	—	—	—	—	—	—
Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A Day 14	2.500 hours Interval 2.0 to 4.0	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose and on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose

Population: PK parameter Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=7 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=7 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=6 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm) Day 1	6.000 hours Interval 6.0 to 6.0	6.000 hours Interval 4.0 to 8.0	4.000 hours Interval 2.0 to 14.1	4.000 hours Interval 1.5 to 10.0	4.000 hours Interval 2.0 to 6.0	4.000 hours Interval 1.5 to 6.08	3.000 hours Interval 0.5 to 6.02	—	—	—	—
Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm) Day -1	4.500 hours Interval 1.0 to 6.08	4.000 hours Interval 3.0 to 8.0	5.000 hours Interval 2.0 to 8.02	4.000 hours Interval 3.0 to 8.0	4.000 hours Interval 4.0 to 6.0	3.992 hours Interval 1.0 to 6.0	3.000 hours Interval 1.0 to 4.0	—	—	—	—
Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm) Day 14	6.000 hours Interval 2.83 to 8.0	4.000 hours Interval 3.0 to 14.0	4.025 hours Interval 3.0 to 6.08	5.000 hours Interval 1.5 to 14.02	6.000 hours Interval 3.0 to 6.0	4.000 hours Interval 1.5 to 6.0	3.983 hours Interval 1.0 to 6.05	—	—	—	—

SECONDARY outcome

Population: PK parameter Population.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=4 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A Day -1	119.66 nanograms hour per milliliter Geometric Coefficient of Variation 72.635	—	—	—	—	—	—	—	—	—	—
AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A Day 1	127.70 nanograms hour per milliliter Geometric Coefficient of Variation 49.098	—	—	—	—	—	—	—	—	—	—
AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A Day 14	139.78 nanograms hour per milliliter Geometric Coefficient of Variation 47.491	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: PK parameter Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	80 mg Atorvastatin + 800 mg GSK1292263 n=7 Participants Participants on 80 mg atorvastatin (either for \>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.	800 mg GSK1292263 n=7 Participants Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.	Atorvastatin 10 mg + GSK1292263 800 mg n=11 Participants Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 10 mg + Placebo n=12 Participants Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	Atorvastatin 10 mg + Ezetimibe 10 mg n=6 Participants Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.	Atorvastatin 80 mg + GSK1292263 800 mg n=12 Participants Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.	Atorvastatin 80 mg + Placebo n=13 Participants Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.	GSK1292263 100 mg After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks	GSK1292263 300 mg After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks	GSK1292263 800 mg After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks	Placebo After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks
AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm) Day -1	16.72 nanograms hour per milliliter Geometric Coefficient of Variation 19.509	20.25 nanograms hour per milliliter Geometric Coefficient of Variation 47.047	14.37 nanograms hour per milliliter Geometric Coefficient of Variation 48.598	12.38 nanograms hour per milliliter Geometric Coefficient of Variation 74.286	12.41 nanograms hour per milliliter Geometric Coefficient of Variation 53.128	163.16 nanograms hour per milliliter Geometric Coefficient of Variation 73.666	133.96 nanograms hour per milliliter Geometric Coefficient of Variation 36.159	—	—	—	—
AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm) Day 1	16.02 nanograms hour per milliliter Geometric Coefficient of Variation 9.355	18.28 nanograms hour per milliliter Geometric Coefficient of Variation 40.611	14.89 nanograms hour per milliliter Geometric Coefficient of Variation 33.541	13.60 nanograms hour per milliliter Geometric Coefficient of Variation 78.379	15.10 nanograms hour per milliliter Geometric Coefficient of Variation 26.181	146.23 nanograms hour per milliliter Geometric Coefficient of Variation 55.353	150.41 nanograms hour per milliliter Geometric Coefficient of Variation 37.440	—	—	—	—
AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm) Day 14	10.07 nanograms hour per milliliter Geometric Coefficient of Variation 12.346	16.54 nanograms hour per milliliter Geometric Coefficient of Variation 37.123	13.82 nanograms hour per milliliter Geometric Coefficient of Variation 43.131	12.03 nanograms hour per milliliter Geometric Coefficient of Variation 63.145	18.18 nanograms hour per milliliter Geometric Coefficient of Variation 36.758	144.23 nanograms hour per milliliter Geometric Coefficient of Variation 58.954	156.41 nanograms hour per milliliter Geometric Coefficient of Variation 42.286	—	—	—	—

SECONDARY outcome

For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were supposed to collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were supposed to collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were supposed to collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16). However no data was collected.