| Primary | 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 | 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. | 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. | Posted | | | | | | Week 2, 4, 6 and 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. | | OG002 | GSK256073 150 mg | 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. |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety Population was defined as all participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Up to follow up (14 days from last dose) | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | Number of Participants With Electrocardiography (ECG) Findings | 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. | Safety Population. Only those participants available at the indicated time points were analyzed. | Posted | | Count of Participants | | Participants | | Up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | Change From Baseline in Vital Signs-Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 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. | Safety population. Only those participants available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Millimeters of mercury (mmHg) | | Baseline (Week 0) up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. | |
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| Secondary | Change From Baseline in Vital Signs-Heart Rate | 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. | Safety Population. Only those participants available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Week 0) up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. | | OG002 | GSK256073 150 mg |
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| Secondary | Number of Participants With Abnormal Hematology Values | 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. | | Posted | | Count of Participants | | Participants | | Baseline (Week 0) up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | Number of Participants With Abnormal Clinical Chemistry Values | 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. | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Count of Participants | | Participants | | Up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | Number of Participants With Abnormal Urinalysis Results | Urinalysis assessment was done for urine occult blood, urine glucose, urine ketones and urine protein over eight weeks treatment period. | | Posted | | Count of Participants | | Participants | | Up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. | | OG002 | GSK256073 150 mg | 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. |
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| Secondary | Average Global Flushing Score | 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. | | Posted | | Count of Participants | | Participants | | Up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | |
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| Secondary | Number of Participants With Self Reported Assessment of Flushing | 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. | | Posted | | Count of Participants | | Participants | | Up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | Average Number of Flushing Episodes | 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". | | Posted | | Count of Participants | | Participants | | Up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | Average Time to Onset of Flushing | 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. | PD Population. Only those participants available at the indicated time points were analyzed. | Posted | | Median | Full Range | Hours | | Up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | Participant's Average Duration of Flushing | 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. | PD Population. Only those participants available at the indicated time points were analyzed. | Posted | | Median | Full Range | Minutes | | Up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. | |
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| Secondary | Number of Participants Who Withdrew Due to Flushing | 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. | | Posted | | Count of Participants | | Participants | | Up to follow up (14 days from last dose) | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. | | OG002 |
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| Secondary | Mean Episode of Flushing as Measured by Visual Analogue Scale (VAS) | 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. | PD Population was defined as all participants who provided PD data. | Posted | | Mean | Standard Deviation | Scores on a scale | | Up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | Percent Change From Baseline in Fasting Plasma HDLc and Apolipoprotein A-I (ApoA1) Concentrations Over Eight Weeks of Administration With GSK256073 or Placebo | 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. | PD Population. Only those participants available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Percent change | | Baseline (Week 0) up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | 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 | 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. | PD Population. Only those participants available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Percent change | | Baseline (Week 0) up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | Percent Change From Baseline in Insulin Over Eight Weeks of Administration With GSK256073 or Placebo | 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. | PD Population. Only those participants available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Percent change | | Baseline (Week 0) up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) Over Eight Weeks of Administration With GSK256073 or Placebo | 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. | PD Population. Only those participants available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Percent change | | Baseline (Week 0) up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | Percent Change From Baseline in Non-esterified Fatty Acids (NEFA) Over Eight Weeks of Administration With GSK256073 or Placebo | 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. | PD Population. Only those participants available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Percent change | | Baseline (Week 0) up to Week 8 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | 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. |
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| Secondary | Plasma PK- Maximum Observed Concentration (Cmax) | 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. | PK Population was defined as all participants in the PK concentration population for whom PK parameters had been derived. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per mililiter (ng/mL) | | 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 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | |
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| Secondary | Plasma PK- Time of Occurrence of Cmax (Tmax) | 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. | | Posted | | Median | Full Range | Hours | | 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 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. | | OG001 | GSK256073 50 mg | |
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| Secondary | Plasma PK- AUC(0-t) | 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. | PK Analysis Population. Only those participants available at the indicated time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour nanogram per milliliter (h*ng/mL) | | 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 | | | | ID | Title | Description |
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| OG000 | GSK256073 5 mg | 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. |
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