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Study to Test GSK256073 in Patients With Dyslipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00903617
Recruitment Status : Completed
First Posted : May 18, 2009
Results First Posted : September 21, 2017
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Dyslipidaemias
Dyslipidemias
Interventions Drug: GSK256073
Drug: Placebo
Drug: Niaspan
Enrollment 80
Recruitment Details This study was conducted at 11 centers in the United States from 15 June 2009 to 16 February 2010.
Pre-assignment Details A total of 80 participant were enrolled in the study. Participants on lipid-altering medications (prescription, over-the-counter and herbal preparations directed at lipid lowering) were washed out of their treatment for at least 6 weeks prior to randomization and 8 weeks wash out for participants on fibrate medications.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description Eligible participants received GSK256073 5 milligrams (mg) oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits. Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits. Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits. Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Period Title: Overall Study
Started 19 20 20 21
Completed 16 15 15 20
Not Completed 3 5 5 1
Reason Not Completed
Adverse Event             0             1             1             0
Protocol-defined stopping criteria             0             2             0             0
Lost to Follow-up             2             0             1             1
Withdrawal by Subject             1             2             3             0
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo Total
Hide Arm/Group Description Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits. Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits. Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits. Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits. Total of all reporting groups
Overall Number of Baseline Participants 19 20 20 21 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 20 participants 20 participants 21 participants 80 participants
58.3  (8.43) 53.8  (9.77) 57.0  (10.75) 57.7  (10.15) 56.7  (9.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 20 participants 21 participants 80 participants
Female
10
  52.6%
10
  50.0%
10
  50.0%
11
  52.4%
41
  51.2%
Male
9
  47.4%
10
  50.0%
10
  50.0%
10
  47.6%
39
  48.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 20 participants 21 participants 80 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
1
   1.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.3%
2
  10.0%
1
   5.0%
2
   9.5%
6
   7.5%
White
18
  94.7%
18
  90.0%
19
  95.0%
18
  85.7%
73
  91.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The GSK256073 Area Under Concentration-time Curve (AUC) and High Density Lipoprotein Cholesterol (HDLc) Data to Evolve the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship for Changes in HDLc Levels
Hide Description The potential PK/PD relationship was to be assessed by plotting GSK256073 AUCs against HDLc. The PK/PD model that was to be used for the simulations in the study design was to be refined with the Part A observed AUC exposures and HDLc levels. However, the study was stopped for futility at the end of Part A due to lack of a compelling PK/PD relationship between GSK256073 and lipid effects that would predict success in achieving significant HDLc raising.
Time Frame Week 2, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected as the study was stopped for futility at the end of Part A due to lack of a compelling PK/PD relationship between GSK256073 and lipid effects that would predict success in achieving significant HDLc raising.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is 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, medically significant or it is associated with liver injury and impaired liver function.
Time Frame Up to follow up (14 days from last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population was defined as all participants who received at least one dose of study drug.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
8
  42.1%
12
  60.0%
17
  85.0%
14
  66.7%
Any SAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Electrocardiography (ECG) Findings
Hide Description Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTc intervals. Participants with normal, abnormal- clinically significant (CS) and abnormal- not clinically significant (NCS) ECG values were reported.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline, Predose, Normal Number Analyzed 19 participants 20 participants 20 participants 21 participants
9
  47.4%
5
  25.0%
8
  40.0%
13
  61.9%
Baseline, Predose, Abnormal-NCS Number Analyzed 19 participants 20 participants 20 participants 21 participants
10
  52.6%
15
  75.0%
12
  60.0%
8
  38.1%
Baseline, Predose, Abnormal-CS Number Analyzed 19 participants 20 participants 20 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 2, Predose, Normal Number Analyzed 18 participants 19 participants 19 participants 20 participants
10
  55.6%
10
  52.6%
9
  47.4%
13
  65.0%
Week 2, Predose, Abnormal-NCS Number Analyzed 18 participants 19 participants 19 participants 20 participants
8
  44.4%
9
  47.4%
10
  52.6%
7
  35.0%
Week 2, Predose, Abnormal-CS Number Analyzed 18 participants 19 participants 19 participants 20 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 4, Predose, Normal Number Analyzed 17 participants 17 participants 18 participants 20 participants
8
  47.1%
5
  29.4%
10
  55.6%
16
  80.0%
Week 4, Predose, Abnormal-NCS Number Analyzed 17 participants 17 participants 18 participants 20 participants
9
  52.9%
12
  70.6%
8
  44.4%
4
  20.0%
Week 4, Predose, Abnormal-CS Number Analyzed 17 participants 17 participants 18 participants 20 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 6, Predose, Normal Number Analyzed 16 participants 16 participants 16 participants 20 participants
9
  56.3%
4
  25.0%
10
  62.5%
15
  75.0%
Week 6, Predose, Abnormal-CS Number Analyzed 16 participants 16 participants 16 participants 20 participants
7
  43.8%
12
  75.0%
6
  37.5%
5
  25.0%
Week 6, Predose, Abnormal-NCS Number Analyzed 16 participants 16 participants 16 participants 20 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 8, 0 hour, Normal Number Analyzed 16 participants 15 participants 15 participants 20 participants
10
  62.5%
5
  33.3%
9
  60.0%
13
  65.0%
Week 8, 0 hour, Abnormal-NCS Number Analyzed 16 participants 15 participants 15 participants 20 participants
6
  37.5%
10
  66.7%
6
  40.0%
7
  35.0%
Week 8, 0 hour, Abnormal-CS Number Analyzed 16 participants 15 participants 15 participants 20 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Change From Baseline in Vital Signs-Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description SBP and DBP was assessed at Baseline (Week 0), Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value.
Time Frame Baseline (Week 0) up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
DBP, Week 2, 0 hour Number Analyzed 18 participants 19 participants 19 participants 20 participants
-2.1  (6.39) -0.1  (4.93) -1.0  (3.42) 1.1  (4.86)
DBP, Week 4, 0 hour Number Analyzed 17 participants 17 participants 18 participants 20 participants
-2.6  (3.97) 0.8  (7.12) 0.8  (3.61) 1.6  (5.35)
DBP, Week 6, 0 hour Number Analyzed 16 participants 16 participants 16 participants 20 participants
-0.6  (5.37) -1.3  (7.53) 1.6  (5.51) 1.4  (5.28)
DBP, Week 8, 0 hour Number Analyzed 16 participants 15 participants 15 participants 20 participants
0.8  (6.41) -1.7  (8.47) 2.0  (6.89) 1.9  (5.43)
SBP, Week 2, 0 hour Number Analyzed 18 participants 19 participants 19 participants 20 participants
-3.0  (11.03) 2.7  (9.91) -2.7  (5.54) 2.1  (9.25)
SBP, Week 4, 0 hour Number Analyzed 17 participants 17 participants 18 participants 20 participants
-4.5  (11.27) 6.1  (11.74) -3.2  (5.17) 4.2  (9.46)
SBP, Week 6, 0 hour Number Analyzed 16 participants 16 participants 16 participants 20 participants
3.7  (9.86) 0.9  (12.12) -0.1  (10.21) 0.2  (9.29)
SBP, Week 8, 0 hour Number Analyzed 16 participants 15 participants 15 participants 20 participants
1.8  (10.64) 1.0  (13.96) -1.3  (8.35) 0.8  (9.00)
5.Secondary Outcome
Title Change From Baseline in Vital Signs-Heart Rate
Hide Description Heart rate was assessed at Baseline (Week 0), Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value.
Time Frame Baseline (Week 0) up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Week 2, 0 hour Number Analyzed 18 participants 19 participants 19 participants 20 participants
1.4  (8.14) -0.5  (7.17) 1.9  (4.21) 1.1  (4.20)
Week 4, 0 hour Number Analyzed 17 participants 17 participants 18 participants 20 participants
-1.2  (4.82) -1.9  (5.61) 3.6  (4.83) 1.9  (5.31)
Week 6, 0 hour Number Analyzed 16 participants 16 participants 16 participants 20 participants
-1.4  (6.85) -0.2  (5.96) 2.8  (4.97) 3.6  (5.61)
Week 8, 0 hour Number Analyzed 16 participants 15 participants 15 participants 20 participants
0.0  (7.25) 3.5  (4.37) 4.6  (5.87) 2.2  (4.53)
6.Secondary Outcome
Title Number of Participants With Abnormal Hematology Values
Hide Description Blood samples for assessment of hematology parameters of platelet count, red blood cell count, white blood cell count, hemoglobin, haptoglobin, reticulocyte count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, neutrophils, lymphocytes, monocytes, eosinophils and basophils was collected at Baseline and at Weeks 2, 4, 6 and 8.
Time Frame Baseline (Week 0) up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Abnormal Clinical Chemistry Values
Hide Description Blood samples for assessment of clinical chemistry parameters of blood urea nitrogen, creatinine, glucose (fasting), sodium, creatine phosphokinase, potassium, chloride, total carbon dioxide, calcium, total lactose dehydrogenase (LDH), aspartate aminotransferase (AST), alanine amino transferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, phosphate, total and direct bilirubin, uric acid, albumin and total protein was collected at Baseline and at Weeks 2, 4, 6 and 8.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Creatine kinase, Week 6, High Number Analyzed 16 participants 16 participants 16 participants 20 participants
0
   0.0%
1
   6.3%
0
   0.0%
0
   0.0%
Phosphorous, inorganic, Week 8, low Number Analyzed 16 participants 15 participants 15 participants 20 participants
1
   6.3%
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Abnormal Urinalysis Results
Hide Description Urinalysis assessment was done for urine occult blood, urine glucose, urine ketones and urine protein over eight weeks treatment period.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Urine Occult Blood, Baseline, Predose, 1+
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Urine Occult Blood, Baseline, Predose, Trace
0
   0.0%
1
   5.0%
0
   0.0%
1
   4.8%
Urine Occult Blood, Week 2, Predose, 1+
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Urine Occult Blood, Week 2, Predose, Trace
0
   0.0%
2
  10.0%
0
   0.0%
2
   9.5%
Urine Occult Blood, Week 4, Predose, 1+
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
Urine Occult Blood, Week 4, Predose, Trace
0
   0.0%
1
   5.0%
1
   5.0%
0
   0.0%
Urine Occult Blood, Week 6, Predose, 3+
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Urine Occult Blood, Week 6, Predose, Trace
0
   0.0%
2
  10.0%
0
   0.0%
0
   0.0%
Urine Occult Blood, Week 8, 0 hour, 1+
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
Urine Occult Blood, Week 8, 0 hour, Trace
0
   0.0%
0
   0.0%
2
  10.0%
0
   0.0%
Urine Ketones, Baseline, Predose, Trace
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
Urine Ketones, Week 2, Predose, Trace
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Urine Ketones, Week 4, Predose, 2+
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Urine Ketones, Week 6, Predose, Trace
0
   0.0%
1
   5.0%
0
   0.0%
0
   0.0%
Urine Ketones, Week 8, 0 hour, 1+
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Urine Protein, Baseline, Predose, Trace
0
   0.0%
1
   5.0%
1
   5.0%
2
   9.5%
Urine Protein, Week 2, Predose, Trace
1
   5.3%
1
   5.0%
0
   0.0%
1
   4.8%
Urine Protein, Week 4, Predose, 1+
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Urine Protein, Week 4, Predose, Trace
0
   0.0%
1
   5.0%
2
  10.0%
0
   0.0%
Urine Protein, Week 6, Predose, 1+
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Urine Protein, Week 6, Predose, Trace
1
   5.3%
1
   5.0%
1
   5.0%
1
   4.8%
Urine Protein, Week 8, 0 hour, 1+
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
Urine Protein, Week 8, 0 hour, Trace
1
   5.3%
0
   0.0%
3
  15.0%
2
   9.5%
9.Secondary Outcome
Title Average Global Flushing Score
Hide Description Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Flushing symptom questionnaire (FSQ) was used to measure participant reported feelings of severity associated with different types of flushing symptoms. The FSQ comprised of 11 items. The response scale combined verbal descriptors as well as a 0-10 numerical rating scale. Items 1, 2, 4 and 10 had verbal descriptors. The items 3, 5, 6, 7, 8, 9 and 11 were rated on a 0 to 10 scale (none=0, mild=1-3, moderate=4-6, severe=7-9 and extreme=10). The total score for these items ranged from 0 (not at all) to 70 (extreme). Higher score indicated more severe flushing symptoms and 0 indicated no flushing symptoms.
Time Frame Up to Week 8
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PD Population.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
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Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
None
15
  78.9%
16
  80.0%
8
  40.0%
15
  71.4%
Mild
2
  10.5%
2
  10.0%
8
  40.0%
4
  19.0%
Moderate
1
   5.3%
2
  10.0%
4
  20.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
10.Secondary Outcome
Title Number of Participants With Self Reported Assessment of Flushing
Hide Description Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participants were asked to perform an assessment of their perceived flushing intensity after their completion of VAS assessment once daily after their first flushing episode (if more than one happens to occur). The scale was from 0 to 3, where 0 represents no flushing, 1 represents mild flushing, 2 represents moderate flushing, and 3 represents severe flushing.
Time Frame Up to Week 8
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PD Population.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline, No flushing
17
  89.5%
14
  70.0%
9
  45.0%
18
  85.7%
Week 2, No flushing
15
  78.9%
17
  85.0%
18
  90.0%
19
  90.5%
Week 4, No flushing
12
  63.2%
17
  85.0%
15
  75.0%
20
  95.2%
Week 6, No flushing
14
  73.7%
14
  70.0%
14
  70.0%
20
  95.2%
Baseline, Mild flushing
1
   5.3%
1
   5.0%
6
  30.0%
0
   0.0%
Week 2, Mild flushing
1
   5.3%
1
   5.0%
1
   5.0%
0
   0.0%
Week 4, Mild flushing
1
   5.3%
0
   0.0%
1
   5.0%
0
   0.0%
Week 6, Mild flushing
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
Baseline, Moderate flushing
0
   0.0%
1
   5.0%
1
   5.0%
0
   0.0%
Baseline, Severe flushing
0
   0.0%
0
   0.0%
2
  10.0%
0
   0.0%
11.Secondary Outcome
Title Average Number of Flushing Episodes
Hide Description Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participants with average number of flushing episodes was reported as "did not have flushing episode", "1 flushing episode", "2 flushing episode" and "3 or more flushing episode".
Time Frame Up to Week 8
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PD Population.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Did not have flushing episodes
15
  78.9%
16
  80.0%
8
  40.0%
15
  71.4%
1 flushing episode
3
  15.8%
1
   5.0%
9
  45.0%
1
   4.8%
2 flushing episode
0
   0.0%
2
  10.0%
3
  15.0%
3
  14.3%
3 or more flushing episode
0
   0.0%
1
   5.0%
0
   0.0%
1
   4.8%
12.Secondary Outcome
Title Average Time to Onset of Flushing
Hide Description Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. The time to the onset of the first flushing (if more than one happens to occur on each day) was analyzed.
Time Frame Up to Week 8
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PD Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 3 4 12 5
Median (Full Range)
Unit of Measure: Hours
9.1
(6 to 13)
3.6
(0 to 12)
1.0
(0 to 9)
4.1
(0 to 20)
13.Secondary Outcome
Title Participant's Average Duration of Flushing
Hide Description Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participant's average duration of flushing was analyzed.
Time Frame Up to Week 8
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Hide Analysis Population Description
PD Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 3 4 12 5
Median (Full Range)
Unit of Measure: Minutes
36.7
(5 to 90)
151.7
(113 to 393)
60.0
(4 to 160)
72.1
(5 to 149)
14.Secondary Outcome
Title Number of Participants Who Withdrew Due to Flushing
Hide Description Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits.
Time Frame Up to follow up (14 days from last dose)
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Safety Population.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
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Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Mean Episode of Flushing as Measured by Visual Analogue Scale (VAS)
Hide Description Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participants self-assessed intensity of flushing using a 100 mm VAS once daily at the first flushing episode. The left hand side of the scale (0) represented 'No Flushing Sensation' and the right hand side of the scale (100) represented 'Unbearable Flushing Sensation'. The intensity of flushing of each episode was measured in centimeters (to the nearest 1/100) from the 0 point of the scale. Data is reported for average VAS scores over 8 weeks of treatment.
Time Frame Up to Week 8
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PD Population was defined as all participants who provided PD data.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
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Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 4 4 12 6
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
9.0  (9.58) 31.8  (19.24) 24.9  (15.14) 17.1  (26.76)
16.Secondary Outcome
Title Percent Change From Baseline in Fasting Plasma HDLc and Apolipoprotein A-I (ApoA1) Concentrations Over Eight Weeks of Administration With GSK256073 or Placebo
Hide Description Blood samples for analysis of fasting levels of HDLc and ApoA1 was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from baseline value with 100.
Time Frame Baseline (Week 0) up to Week 8
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PD Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
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Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Mean (Standard Deviation)
Unit of Measure: Percent change
ApoA1, Week 2 Number Analyzed 18 participants 19 participants 19 participants 20 participants
-2.7  (10.47) -5.7  (15.45) -5.9  (8.53) -2.2  (8.63)
ApoA1, Week 4 Number Analyzed 16 participants 17 participants 18 participants 19 participants
1.4  (8.73) -1.8  (11.55) -6.5  (11.01) 1.3  (9.85)
ApoA1, Week 6 Number Analyzed 16 participants 16 participants 16 participants 20 participants
0.6  (14.23) -3.1  (8.96) -1.1  (9.75) -1.3  (8.73)
ApoA1, Week 8 Number Analyzed 16 participants 15 participants 15 participants 19 participants
4.2  (10.48) -0.2  (13.50) -2.0  (9.38) 0.3  (9.25)
HDLc, Week 2 Number Analyzed 18 participants 19 participants 19 participants 20 participants
-2.2  (10.50) -8.4  (14.82) -9.4  (13.76) -2.8  (7.54)
HDLc, Week 4 Number Analyzed 16 participants 17 participants 18 participants 20 participants
-1.2  (7.60) -4.6  (19.54) -7.0  (17.24) -1.3  (8.00)
HDLc, Week 6 Number Analyzed 16 participants 16 participants 16 participants 20 participants
-2.0  (11.76) -4.9  (12.80) -7.9  (13.66) 0.2  (11.17)
HDLc, Week 8 Number Analyzed 16 participants 15 participants 15 participants 20 participants
4.2  (12.99) -1.9  (13.32) -9.1  (15.46) 1.1  (9.72)
17.Secondary Outcome
Title Percent Change From Baseline in Fasting Levels of Total Cholesterol (TC), Triglyceride (TG), Glucose, Low Density Lipoprotein Cholesterol (LDLc), Apolipoprotein A2 (ApoAII), Apolipoprotein B (ApoB) Over 8 Weeks of Administration With GSK256073 or Placebo
Hide Description Blood samples for analysis of fasting levels of TC, TG, glucose, LDLc, ApoAII and ApoB was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from baseline value with 100.
Time Frame Baseline (Week 0) up to Week 8
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Hide Analysis Population Description
PD Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Mean (Standard Deviation)
Unit of Measure: Percent change
ApoAII, Week 2 Number Analyzed 14 participants 17 participants 18 participants 19 participants
-9.9  (14.51) -6.9  (13.60) -4.7  (7.56) 0.1  (17.22)
ApoAII, Week 4 Number Analyzed 15 participants 16 participants 18 participants 18 participants
7.2  (38.06) 3.4  (28.15) -3.8  (11.36) -1.6  (10.98)
ApoAII, Week 6 Number Analyzed 15 participants 15 participants 16 participants 19 participants
5.9  (29.61) -7.0  (10.96) -5.3  (9.16) 2.0  (15.60)
ApoAII, Week 8 Number Analyzed 15 participants 14 participants 15 participants 20 participants
7.9  (30.30) 5.2  (23.43) 3.3  (27.68) 2.1  (18.62)
ApoB, Week 2 Number Analyzed 18 participants 19 participants 19 participants 20 participants
-8.1  (12.59) -9.8  (9.42) -2.2  (24.05) -2.6  (7.58)
ApoB, Week 4 Number Analyzed 16 participants 17 participants 18 participants 19 participants
-3.4  (8.85) -6.1  (7.45) 2.0  (22.30) -0.8  (11.16)
ApoB, Week 6 Number Analyzed 16 participants 16 participants 16 participants 20 participants
-3.8  (11.51) -6.5  (11.14) 5.9  (26.74) -1.8  (8.86)
ApoB, Week 8 Number Analyzed 16 participants 15 participants 15 participants 19 participants
-2.8  (12.82) -5.1  (12.14) 6.5  (22.21) -0.8  (8.37)
Glucose, Week 2 Number Analyzed 18 participants 19 participants 19 participants 20 participants
0.1  (8.74) 7.0  (20.03) 0.6  (13.64) 2.8  (6.93)
Glucose, Week 4 Number Analyzed 16 participants 17 participants 18 participants 20 participants
-0.3  (4.69) 1.2  (10.50) -2.2  (16.13) 0.9  (8.68)
Glucose, Week 6 Number Analyzed 16 participants 16 participants 16 participants 20 participants
0.7  (5.75) 2.3  (13.37) -2.6  (13.49) 1.0  (9.79)
Glucose, Week 8 Number Analyzed 16 participants 15 participants 15 participants 20 participants
-1.0  (10.19) 2.6  (9.40) -6.1  (14.98) -0.0  (9.85)
LDLc, Week 2 Number Analyzed 17 participants 16 participants 19 participants 20 participants
-2.7  (10.77) -10.0  (12.24) 2.1  (42.50) -2.9  (12.08)
LDLc, Week 4 Number Analyzed 16 participants 15 participants 18 participants 19 participants
-6.7  (6.19) -7.4  (12.11) 7.6  (50.51) -3.0  (12.28)
LDLc, Week 6 Number Analyzed 16 participants 15 participants 16 participants 19 participants
-4.3  (12.54) -7.9  (11.85) 7.7  (50.11) 0.6  (13.09)
LDLc, Week 8 Number Analyzed 16 participants 13 participants 15 participants 19 participants
-1.8  (12.25) -6.5  (12.01) 8.4  (50.73) -3.0  (7.75)
TC, Week 2 Number Analyzed 18 participants 19 participants 19 participants 20 participants
-4.0  (7.10) -9.3  (8.28) -3.3  (14.22) -2.4  (6.58)
TC, Week 4 Number Analyzed 16 participants 17 participants 18 participants 20 participants
-4.8  (5.28) -5.9  (7.36) -0.8  (12.57) -2.5  (9.07)
TC, Week 6 Number Analyzed 16 participants 16 participants 16 participants 20 participants
-2.9  (8.63) -6.2  (9.10) -0.5  (13.54) -1.3  (7.81)
TC, Week 8 Number Analyzed 16 participants 15 participants 15 participants 20 participants
-0.5  (9.00) -5.7  (8.96) 1.3  (12.09) -2.1  (5.49)
TG, Week 2 Number Analyzed 18 participants 19 participants 19 participants 20 participants
2.2  (32.06) 16.9  (108.85) 8.9  (48.90) 6.6  (30.75)
TG, Week 4 Number Analyzed 16 participants 17 participants 18 participants 20 participants
6.1  (26.36) 10.1  (55.36) 3.0  (27.41) 3.5  (24.63)
TG, Week 6 Number Analyzed 16 participants 16 participants 16 participants 20 participants
7.5  (21.81) 0.9  (38.38) 8.4  (23.84) -4.6  (16.82)
TG, Week 8 Number Analyzed 16 participants 15 participants 15 participants 20 participants
6.6  (34.96) 5.6  (41.75) 21.0  (28.14) -4.0  (17.76)
18.Secondary Outcome
Title Percent Change From Baseline in Insulin Over Eight Weeks of Administration With GSK256073 or Placebo
Hide Description Blood samples for analysis of insulin was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from Baseline value with 100.
Time Frame Baseline (Week 0) up to Week 8
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Hide Analysis Population Description
PD Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 2 Number Analyzed 18 participants 19 participants 19 participants 20 participants
23.1  (82.20) 21.2  (72.27) 25.3  (92.41) -2.8  (26.29)
Week 4 Number Analyzed 16 participants 17 participants 18 participants 20 participants
9.1  (22.14) 16.3  (73.97) 13.2  (50.01) -3.8  (22.33)
Week 6 Number Analyzed 16 participants 16 participants 16 participants 19 participants
16.6  (43.40) 17.8  (35.16) 4.2  (44.83) -3.4  (30.48)
Week 8 Number Analyzed 16 participants 15 participants 15 participants 20 participants
2.8  (20.31) 18.3  (47.56) 13.7  (41.44) -0.2  (29.89)
19.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein (a) (Lp[a]) Over Eight Weeks of Administration With GSK256073 or Placebo
Hide Description Blood samples for analysis of Lp[a] was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from Baseline value with 100.
Time Frame Baseline (Week 0) up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PD Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 2 Number Analyzed 11 participants 10 participants 14 participants 12 participants
1.8  (13.10) -10.3  (13.52) 4.5  (26.28) -4.6  (14.91)
Week 4 Number Analyzed 10 participants 9 participants 14 participants 12 participants
-6.6  (20.62) -11.3  (11.94) 1.6  (19.33) -1.7  (15.78)
Week 6 Number Analyzed 11 participants 10 participants 12 participants 12 participants
2.7  (18.04) -7.3  (16.50) 6.5  (32.24) -1.7  (13.73)
Week 8 Number Analyzed 11 participants 8 participants 11 participants 11 participants
4.0  (13.56) -15.8  (15.71) 6.4  (18.87) -5.6  (31.64)
20.Secondary Outcome
Title Percent Change From Baseline in Non-esterified Fatty Acids (NEFA) Over Eight Weeks of Administration With GSK256073 or Placebo
Hide Description Blood samples for analysis of NEFA was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from Baseline value with 100.
Time Frame Baseline (Week 0) up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
PD Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 19 20 20 21
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 2 Number Analyzed 18 participants 19 participants 19 participants 20 participants
32.1  (68.56) 16.8  (53.84) 29.1  (75.28) 24.4  (44.56)
Week 4 Number Analyzed 16 participants 17 participants 18 participants 20 participants
38.8  (70.88) 37.4  (91.98) 26.2  (80.52) 7.0  (31.02)
Week 6 Number Analyzed 16 participants 16 participants 16 participants 19 participants
47.8  (89.62) 29.1  (73.47) 8.0  (61.33) -1.1  (28.66)
Week 8 Number Analyzed 16 participants 15 participants 15 participants 20 participants
56.6  (112.49) 59.4  (134.96) 19.3  (60.35) 10.4  (34.75)
21.Secondary Outcome
Title Plasma PK- Maximum Observed Concentration (Cmax)
Hide Description All participants treated with GSK256073 or placebo participated in PK sampling. Blood samples for PK analysis of GSK256073 to determine Cmax was collected at Week 2, 4, 6 and 8. For samples obtained during time windows, every attempt was made to collect three samples during each time window: pre-dose to 2 hours after dosing, 2 hours to 4.5 hours after dose, and 6 hours to 12 hours after dose. During each window, 3 samples spaced at least 30 minutes apart were collected (i.e., avoid collection from all participants at the same time within a window or only at the extremes of a time window). The first occurrence of the Cmax was determined directly from the raw concentration-time data.
Time Frame 0-2 hours after dosing (pre-dose plus 3 samples spaced at least 30 minutes apart), 2 to 4.5 hours after dose (3 samples spaced at least 30 minutes apart) and 6-12 hours post dose (3 samples spaced at least 30 minutes apart) on Week 2, 4, 6 and 8
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Hide Analysis Population Description
PK Population was defined as all participants in the PK concentration population for whom PK parameters had been derived.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 15 15 17
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per mililiter (ng/mL)
923.709
(128.18%)
7223.709
(35.09%)
22961.25
(62.36%)
22.Secondary Outcome
Title Plasma PK- Time of Occurrence of Cmax (Tmax)
Hide Description All participants treated with GSK256073 or placebo participated in PK sampling. Blood samples for PK analysis of GSK256073 to determine Tmax was collected at Week 2, 4, 6 and 8. For samples obtained during time windows, every attempt was made to collect three samples during each time window: pre-dose to 2 hours after dosing, 2 hours to 4.5 hours after dose, and 6 hours to 12 hours after dose. During each window, 3 samples spaced at least 30 minutes apart were collected (i.e., avoid collection from all participants at the same time within a window or only at the extremes of a time window). The time at which Cmax was observed was determined directly from the raw concentration-time data.
Time Frame 0-2 hours after dosing (pre-dose plus 3 samples spaced at least 30 minutes apart), 2 to 4.5 hours after dose (3 samples spaced at least 30 minutes apart) and 6-12 hours post dose (3 samples spaced at least 30 minutes apart) on Week 2, 4, 6 and 8
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Hide Analysis Population Description
PK Population.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 15 15 17
Median (Full Range)
Unit of Measure: Hours
2.417
(0.50 to 7.73)
1.350
(0.63 to 9.00)
2.500
(0.50 to 25.98)
23.Secondary Outcome
Title Plasma PK- AUC(0-t)
Hide Description All participants treated with GSK256073 or placebo participated in PK sampling. Blood samples for PK analysis of GSK256073 to determine AUC(0-t) was collected at Week 2, 4, 6 and 8. For samples obtained during time windows, every attempt was made to collect three samples during each time window: pre-dose to 2 hours after dosing, 2 hours to 4.5 hours after dose, and 6 hours to 12 hours after dose. During each window, 3 samples spaced at least 30 minutes apart were collected (i.e., avoid collection from all participants at the same time within a window or only at the extremes of a time window). The AUC 0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
Time Frame 0-2 hours after dosing (pre-dose plus 3 samples spaced at least 30 minutes apart), 2 to 4.5 hours after dose (3 samples spaced at least 30 minutes apart) and 6-12 hours post dose (3 samples spaced at least 30 minutes apart) on Week 2, 4, 6 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg
Hide Arm/Group Description:
Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
Overall Number of Participants Analyzed 15 15 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour nanogram per milliliter (h*ng/mL)
8352.281
(99.96%)
75587.96
(71.88%)
340551.4
(60.67%)
Time Frame AEs and SAEs were collected up to follow up (14 days from last dose).
Adverse Event Reporting Description Safety population was used for the analysis of safety data.
 
Arm/Group Title GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Hide Arm/Group Description Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits. Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits. Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits. Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
All-Cause Mortality
GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/21 (0.00%) 
Hide Serious Adverse Events
GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/21 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GSK256073 5 mg GSK256073 50 mg GSK256073 150 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/19 (42.11%)   12/20 (60.00%)   17/20 (85.00%)   14/21 (66.67%) 
Blood and lymphatic system disorders         
Anaemia  1  1/19 (5.26%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Lymphadenopathy  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Gastrointestinal disorders         
Nausea  1  0/19 (0.00%)  0/0  3/20 (15.00%)  1/21 (4.76%) 
Constipation  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/21 (4.76%) 
Abdominal discomfort  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Dry mouth  1  1/19 (5.26%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Vomiting  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
General disorders         
Energy increased  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Fatigue  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Feeling hot  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Non-cardiac chest pain  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  2/19 (10.53%)  2/20 (10.00%)  0/20 (0.00%)  1/21 (4.76%) 
Influenza  1  1/19 (5.26%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Gastroenteritis  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Rhinitis  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Sinusitis  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Tinea pedis  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Urinary tract infection  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Injury, poisoning and procedural complications         
Joint sprain  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Muscle strain  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Investigations         
Blood creatine phosphokinase increased  1  0/19 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  1/21 (4.76%) 
Weight increased  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/21 (4.76%) 
Blood bilirubin increased  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Mean cell haemoglobin increased  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Mean cell volume increased  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  1/19 (5.26%)  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
Arthralgia  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Muscle spasms  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Musculoskeletal pain  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Myalgia  1  1/19 (5.26%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Neck pain  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Pain in jaw  1  1/19 (5.26%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Nervous system disorders         
Headache  1  1/19 (5.26%)  0/20 (0.00%)  2/20 (10.00%)  1/21 (4.76%) 
Paraesthesia  1  0/19 (0.00%)  1/20 (5.00%)  1/20 (5.00%)  0/21 (0.00%) 
Hyporeflexia  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Migraine  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Sinus headache  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Psychiatric disorders         
Insomnia  1  0/19 (0.00%)  1/20 (5.00%)  2/20 (10.00%)  0/21 (0.00%) 
Sleep disorder  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Renal and urinary disorders         
Haematuria  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Reproductive system and breast disorders         
Epididymitis  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  0/19 (0.00%)  2/20 (10.00%)  1/20 (5.00%)  0/21 (0.00%) 
Upper respiratory tract infection  1  0/19 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  1/21 (4.76%) 
Upper respiratory tract congestion  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
Cough  1  1/19 (5.26%)  0/20 (0.00%)  0/20 (0.00%)  0/21 (0.00%) 
Lower respiratory tract infection  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  1/19 (5.26%)  2/20 (10.00%)  1/20 (5.00%)  0/21 (0.00%) 
Dermatitis  1  0/19 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  0/21 (0.00%) 
Acne  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Dermatitis contact  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Rash macular  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Vascular disorders         
Flushing  1  4/19 (21.05%)  5/20 (25.00%)  12/20 (60.00%)  5/21 (23.81%) 
Hot flush  1  0/19 (0.00%)  1/20 (5.00%)  1/20 (5.00%)  0/21 (0.00%) 
Hypertension  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Subgaleal haematoma  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
1
Term from vocabulary, MedDRA 13.0
Indicates events were collected by systematic assessment
The study was stopped for futility at the end of Part A due to lack of a compelling PK/PD relationship between GSK256073 and lipid effects that would predict success in achieving significant HDLc raising.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00903617    
Other Study ID Numbers: 112795
First Submitted: May 14, 2009
First Posted: May 18, 2009
Results First Submitted: July 19, 2017
Results First Posted: September 21, 2017
Last Update Posted: December 5, 2019