Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
healthy Japanese subjects, CXCR2 inhibitor, Danirixin
Brief summary
Danirixin is a selective chemokine receptor antagonist being developed as a potential anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD). The aim of the study is to assess the safety, tolerability and pharmacokinetics (PK) in healthy Japanese subjects over the age of 65 years (inclusive). The study will be conducted in two parts: Part 1 will be a double blind, placebo-controlled, 3-period crossover, ascending single oral dose administration of GSK1325756H (Hydrobromide Salt Tablet Formulations of Danirixin) 10, 50 and 100 milligram (mg) in the fed condition. Part 2 will be an open label, 2-period crossover, single oral dose of GSK1325756H 50 mg in fed and fasted state. This study will provide an understanding of PK of hydrobromide salt of GSK1325756 in population of healthy elderly subjects and also contribute to the selection of appropriate dosing for Phase IIa study in Japan.
Interventions
DRUGGSK1325756H
Danirixin will be available as 10 and 50 milligram (mg) white film coated, round and oval tablets intended for oral administration. It will be administered with 240 mL of water.
DRUGPlacebo
Subjects will receive visually matching danirixin placebo tablets. It will be administered with 240 mL of water.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant must be over 65 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Participants whose peripheral blood neutrophil counts and hematocrit values are within normal range at screening visit. * Body weight \>=50 kilogram (Kg) and body mass index (BMI) within the range 18.5-24.9 kg/square meter (m\^2) (inclusive). * Japanese Male: A male participant must agree to use contraception during the treatment period and until follow up visit. * Capable of giving signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 1 | Up to 32 days in Part 1 | AE is any untoward medical occurrence in a participant or clinical investigation 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 or is medically significant. Safety population comprised of all participants who took at least one dose of study treatment. |
| Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 2 | Up to 21 days in Part 2 | AE is any untoward medical occurrence in a participant or clinical investigation 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 or is medically significant |
| Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Baseline and up to 72 hours in Part 1 | Blood samples were collected for the assessment of chemistry parameters namely calcium, cholesterol, chloride, glucose, HDL cholesterol, potassium, LDL cholesterol, sodium, phosphorus, triglycerides, and urea/BUN results for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Baseline and up to 72 hours in Part 1 | Blood samples were collected for the assessment of chemistry parameters namely alkaline phosphatase, ALT, AST, creatine kinase, GGT and lactate dehydrogenase for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1 | Baseline and up to 72 hours in Part 1 | Blood samples were collected for the assessment of chemistry parameters namely albumin and total protein for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Baseline and up to 72 hours in Part 1 | Blood samples were collected for the assessment of chemistry parameters namely direct bilirubin, total bilirubin, creatinine and uric acid for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Clinical Chemistry Parameter Amylase for Part 1 | Baseline and up to 72 hours in Part 1 | Blood samples were collected for the assessment of chemistry parameters namely amylase for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Baseline and up to 48 hours in Part 2 | Blood samples were collected for the assessment of chemistry parameters namely calcium, cholesterol, chloride, glucose, HDL cholesterol, potassium, LDL cholesterol, sodium, phosphorus, triglycerides, urea/BUN results for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | Baseline and up to 48 hours in Part 2 | Blood samples were collected for the assessment of chemistry parameters namely alkaline phosphatase, ALT, AST, creatine kinase, GGT and lactate dehydrogenase for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 2 | Baseline and up to 48 hours in Part 2 | Blood samples were collected for the assessment of chemistry parameters namely albumin and total protein for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 2 | Baseline and up to 48 hours in Part 2 | Blood samples were collected for the assessment of chemistry parameters namely direct bilirubin, total bilirubin, creatinine and uric acid for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Clinical Chemistry Parameter Amylase for Part 2 | Baseline and up to 48 hours in Part 2 | Blood samples were collected for the assessment of chemistry parameter namely amylase for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Baseline and up to 72 hours in Part 1 | Blood samples were collected for the assessment of hematology parameters namely basophils, eosinophils, leukocytes, lymphocytes, monocytes, total neutrophils and platelets for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Hematology Parameter Hemoglobin for Part 1 | Baseline and up to 72 hours in Part 1 | Blood samples were collected for the assessment of hematology parameter namely hemoglobin for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Hematology Parameter Hematocrit for Part 1 | Baseline and up to 72 hours in Part 1 | Blood samples were collected for the assessment of hematology parameter namely hematocrit for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 1 | Baseline and up to 72 hours in Part 1 | Blood samples were collected for the assessment of hematology parameter namely mean corpuscle hemoglobin for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 1 | Baseline and up to 72 hours in Part 1 | Blood samples were collected for the assessment of hematology parameter namely mean corpuscle volume for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1 | Baseline and up to 72 hours in Part 1 | Blood samples were collected for the assessment of hematology parameters namely platelet count and white blood cell count for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1 | Baseline and up to 72 hours in Part 1 | Blood samples were collected for the assessment of hematology parameters namely red blood count and reticulocyte count for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2 | Baseline and up to 48 hours in Part 2 | Blood samples were collected for the assessment of hematology parameters namely basophils, eosinophils, leukocytes, lymphocytes, monocytes, total neutrophils and platelets for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Hematology Parameter Hemoglobin for Part 2 | Baseline and up to 48 hours in Part 2 | Blood samples were collected for the assessment of hematology parameter namely hemoglobin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Hematology Parameter Hematocrit for Part 2 | Baseline and up to 48 hours in Part 2 | Blood samples were collected for the assessment of hematology parameter namely hematocrit for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 2 | Baseline and up to 48 hours in Part 2 | Blood samples were collected for the assessment of hematology parameter namely mean corpuscle hemoglobin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 2 | Baseline and up to 48 hours in Part 2 | Blood samples were collected for the assessment of hematology parameter namely mean corpuscle volume for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 2 | Baseline and up to 48 hours in Part 2 | Blood samples were collected for the assessment of hematology parameters namely platelet count and white blood cell count for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 2 | Baseline and up to 48 hours in Part 2 | Blood samples were collected for the assessment of hematology parameters namely red blood count and reticulocyte count for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Up to 72 hours in Part 1 | Urinalysis parameters assessed were urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen. In this dipstick test, the level of bilirubin, occult blood, glucose, ketones, urine protein and urobilinogen in urine samples was recorded as negative, trace and +. Urine samples were collected for the measurement of urinalysis parameters by dipstick method up to 72 hours in Part 1. Only categories with significant values have been presented. |
| Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1 | Up to 72 hours in Part 1 | Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 72 hours in Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Urine Specific Gravity Analysis by Dipstick Method for Part 1 | Up to 72 hours in Part 1 | Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up to 72 hours in Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Density is the mass per unit volume and has units (such as g/cm\^3), however, the specific gravity is a ratio so it has no unit. |
| Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Up to 48 hours in Part 2 | Urinalysis parameters assessed were urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen. In this dipstick test, the level of bilirubin, occult blood, glucose, ketones, urine protein and urobilinogen in urine samples was recorded as negative, trace and +. Urine samples were collected for the measurement of urinalysis parameters by dipstick method up to 48 hours in Part 2. Only categories with significant values have been presented. |
| Urine pH Analysis by Dipstick Method for Part 2 | Up to 48 hours in Part 2 | Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up to 48 hours in Part 2. |
| Urine Specific Gravity Analysis by Dipstick Method for Part 2 | Up to 72 hours in Part 2 | Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up to 48 hours in Part 2. Density is the mass per unit volume and has units (such as g/cm\^3), however, the specific gravity is a ratio so it has no unit. |
| Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | Baseline and up to 72 hours in Part 1 | Vital sign measurements included SBP and DBP at Baseline and up to 72 hours in Part 1. SBP and DBP measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Baseline and up to 72 hours in Part 1 | Vital sign measurements included heart rate at Baseline and up to 72 hours in Part 1. Heart rate measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Baseline and up to 72 hours in Part 1 | Vital sign measurements included temperature at Baseline and up to 72 hours in Part 1. Temperature measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | Baseline and up to 48 hours in Part 2 | Vital sign measurements included SBP and DBP at Baseline and up to 72 hours in Part 2. SBP and DBP measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Vital Sign Parameter Heart Rate for Part 2 | Baseline and up to 48 hours in Part 2 | Vital sign measurements included heart rate at Baseline and up to 72 hours in Part 2. Heart rate measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Vital Sign Parameter Temperature for Part 2 | Baseline and up to 48 hours in Part 2 | Vital sign measurements included temperature at Baseline and up to 72 hours in Part 2. Temperature measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Baseline and up to 72 hours in Part 1 | Single 12-lead ECG's were obtained from Baseline and up to 72 hours in Part 1 using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Baseline and up to 48 hours in Part 2 | Single 12-lead ECG's were obtained from Baseline and up to 72 hours in Part 2 using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Frederica's correction) interval. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. |
| Blood Concentration of GSK1325756 in Part 1 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1 | Whole blood samples of approximately 1 milliliters were collected for measurement of blood concentrations of GSK1325756 at pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of part 1. Data has been presented for blood concentrations of GSK1325756 in fed state. Pharmacokinetic (PK) population was defined as participants who were administered at least one dose of study treatment and who had PK sample taken and analyzed. NA indicates standard deviation could not be calculated due to high proportion of non-quantifiable \[NQ\] values (more than 30% of values were imputed i.e., NQ assigned zero concentration) which affected the standard deviation and no sample was obtained per protocol for 60 and 72 hours. |
| Blood Concentration of GSK1325756 in Part 2 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2 | Whole blood samples of approximately 1 milliliters were collected for measurement of blood concentrations of GSK1325756 at Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in part 1. Data has been presented for blood concentrations of GSK1325756 in fasted and fed state. NA indicates standard deviation could not be calculated due to high proportion of NQ values (more than 30% of values were imputed i.e., NQ assigned zero concentration) which affected the standard deviation. |
| Maximum Observed Concentration (Cmax) of GSK1325756H for Part 1 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of GSK1325756H for Part 1 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of GSK1325756H for Part 1 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of GSK1325756H for Part 1 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Time to Maximum Observed Concentration (Tmax) of GSK1325756H for Part 1 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Terminal Half-life (t1/2) of GSK1325756H for Part 1 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756 in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Lag Time Before Observable Concentration (Tlag) of GSK1325756H for Part 1 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756 in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of GSK1325756H for Part 1 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Cmax of GSK1325756H for Part 2 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| AUC (0-t) of GSK1325756H for Part 2 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| AUC (0-inf) of GSK1325756H for Part 2 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. Only those participants with data available at the indicated time points were analyzed. |
| AUC (0-24) of GSK1325756H for Part 2 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Tmax of GSK1325756H for Part 2 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| t1/2 of GSK1325756H for Part 2 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. Only those participants with data available at the indicated time points were analyzed. |
| Tlag of GSK1325756H for Part 2 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
| Tlast of the Blood Concentration of GSK1325756H for Part 2 | Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 post-dose in Part 2 | Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. |
Countries
Japan
Participant flow
Recruitment details
This study was conducted at a single center in Tokyo, Japan from 10-May-2017 to 31-July-2017.
Pre-assignment details
A total of 147 participants were screened of which 113 were screen failures the reasons of which were investigator discretion (1), lost to follow-up (2) screened but enrollment target reached prior to enrollment (5) and did not met inclusion/exclusion criteria (105). A total of 18 participants in Part 1 and 16 in Part 2 were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Part 1-Total Participants Participants received a single dose of GSK1325756H 10 mg (fed), GSK1325756 50 mg (fed), GSK1325756 100 mg (fed) and matching placebo in one of the three treatment periods in a crossover manner. The treatment periods were separated by a minimum of one-week washout period. The maximum duration of participation of participants, in Part 1 was 24 days. | 18 |
| Part 2-Total Participants Participants received a single dose of GSK1325756 50 mg (fed) and GSK1325756 50 mg (fasted) in one of the two treatment periods in a crossover manner. The treatment periods were separated by a minimum of one-week washout period. The maximum duration of participation of participants, in Part 2 was 13 days. | 16 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Part 1, Washout Period 2 (7 Days) | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1-Total Participants | Part 2-Total Participants | Total |
|---|---|---|---|
| Age, Continuous | 70.0 Years STANDARD_DEVIATION 3.01 | 69.3 Years STANDARD_DEVIATION 2.89 | 69.6 Years STANDARD_DEVIATION 2.93 |
| Race/Ethnicity, Customized Japanese/East Asian /South East Asian Heritage | 18 Participants | 16 Participants | 34 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 18 Participants | 16 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 12 | 0 / 12 | 0 / 11 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 1 / 18 | 0 / 12 | 0 / 12 | 1 / 11 | 1 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 12 | 0 / 12 | 0 / 11 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of GSK1325756H for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of GSK1325756H for Part 1 | 1500.0109 Hours*nanograms/milliliter | Geometric Coefficient of Variation 14.7 |
| Part 1: GSK1325756H 10 mg (Fed) | Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of GSK1325756H for Part 1 | 7831.8861 Hours*nanograms/milliliter | Geometric Coefficient of Variation 29.9 |
| Part 1: GSK1325756H 50 mg (Fed) | Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of GSK1325756H for Part 1 | 14000.5473 Hours*nanograms/milliliter | Geometric Coefficient of Variation 27.1 |
Primary
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of GSK1325756H for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of GSK1325756H for Part 1 | 1779.0163 Hours*nanograms/milliliter | Geometric Coefficient of Variation 18.8 |
| Part 1: GSK1325756H 10 mg (Fed) | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of GSK1325756H for Part 1 | 9253.2108 Hours*nanograms/milliliter | Geometric Coefficient of Variation 31.3 |
| Part 1: GSK1325756H 50 mg (Fed) | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of GSK1325756H for Part 1 | 17072.6642 Hours*nanograms/milliliter | Geometric Coefficient of Variation 24.4 |
Primary
Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of GSK1325756H for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of GSK1325756H for Part 1 | 1622.2891 Hours*nanograms/milliliter | Geometric Coefficient of Variation 21.7 |
| Part 1: GSK1325756H 10 mg (Fed) | Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of GSK1325756H for Part 1 | 8872.6074 Hours*nanograms/milliliter | Geometric Coefficient of Variation 30.2 |
| Part 1: GSK1325756H 50 mg (Fed) | Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of GSK1325756H for Part 1 | 16681.8331 Hours*nanograms/milliliter | Geometric Coefficient of Variation 25.2 |
Primary
AUC (0-24) of GSK1325756H for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | AUC (0-24) of GSK1325756H for Part 2 | 10433.9293 Hours*nanograms/milliliter | Geometric Coefficient of Variation 25.8 |
| Part 1: GSK1325756H 10 mg (Fed) | AUC (0-24) of GSK1325756H for Part 2 | 16856.0664 Hours*nanograms/milliliter | Geometric Coefficient of Variation 21.2 |
Primary
AUC (0-inf) of GSK1325756H for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. Only those participants with data available at the indicated time points were analyzed.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | AUC (0-inf) of GSK1325756H for Part 2 | 12143.8862 Hours*nanograms/milliliter | Geometric Coefficient of Variation 28.8 |
| Part 1: GSK1325756H 10 mg (Fed) | AUC (0-inf) of GSK1325756H for Part 2 | 18910.7975 Hours*nanograms/milliliter | Geometric Coefficient of Variation 24.2 |
Primary
AUC (0-t) of GSK1325756H for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | AUC (0-t) of GSK1325756H for Part 2 | 11880.9038 Hours*nanograms/milliliter | Geometric Coefficient of Variation 28.9 |
| Part 1: GSK1325756H 10 mg (Fed) | AUC (0-t) of GSK1325756H for Part 2 | 18303.0441 Hours*nanograms/milliliter | Geometric Coefficient of Variation 22.1 |
Primary
Blood Concentration of GSK1325756 in Part 1
Whole blood samples of approximately 1 milliliters were collected for measurement of blood concentrations of GSK1325756 at pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of part 1. Data has been presented for blood concentrations of GSK1325756 in fed state. Pharmacokinetic (PK) population was defined as participants who were administered at least one dose of study treatment and who had PK sample taken and analyzed. NA indicates standard deviation could not be calculated due to high proportion of non-quantifiable \[NQ\] values (more than 30% of values were imputed i.e., NQ assigned zero concentration) which affected the standard deviation and no sample was obtained per protocol for 60 and 72 hours.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1
Population: PK Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 1 hour | 94.150 Nanograms/milliliter | Standard Deviation 86.0423 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 0.25 hours | 1.425 Nanograms/milliliter | — |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 0.5 hours | 24.350 Nanograms/milliliter | — |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 0.75 hours | 59.951 Nanograms/milliliter | Standard Deviation 67.9706 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, Pre-dose | 0.000 Nanograms/milliliter | — |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration,, 2 hours | 153.395 Nanograms/milliliter | Standard Deviation 100.0463 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 3 hours | 154.733 Nanograms/milliliter | Standard Deviation 67.6734 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 4 hours | 177.417 Nanograms/milliliter | Standard Deviation 47.6187 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 6 hours | 126.817 Nanograms/milliliter | Standard Deviation 37.7057 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 8 hours | 76.567 Nanograms/milliliter | Standard Deviation 25.8472 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 10 hours | 55.358 Nanograms/milliliter | Standard Deviation 16.1098 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration,12 hours | 39.742 Nanograms/milliliter | Standard Deviation 10.1591 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 24 hours | 16.363 Nanograms/milliliter | Standard Deviation 4.9104 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 48 hours | 3.423 Nanograms/milliliter | — |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 60 hours | NA Nanograms/milliliter | — |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 72 hours | NA Nanograms/milliliter | — |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration,, 2 hours | 971.417 Nanograms/milliliter | Standard Deviation 598.1981 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 3 hours | 950.852 Nanograms/milliliter | Standard Deviation 443.1637 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 4 hours | 966.658 Nanograms/milliliter | Standard Deviation 395.2375 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 48 hours | 24.387 Nanograms/milliliter | Standard Deviation 13.2219 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 6 hours | 639.667 Nanograms/milliliter | Standard Deviation 251.0068 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 8 hours | 386.667 Nanograms/milliliter | Standard Deviation 153.484 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 72 hours | NA Nanograms/milliliter | — |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 10 hours | 295.250 Nanograms/milliliter | Standard Deviation 96.3848 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, Pre-dose | 0.000 Nanograms/milliliter | — |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 60 hours | NA Nanograms/milliliter | — |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 0.25 hours | 9.289 Nanograms/milliliter | — |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration,12 hours | 204.192 Nanograms/milliliter | Standard Deviation 70.3804 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 0.5 hours | 151.658 Nanograms/milliliter | Standard Deviation 196.5556 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 0.75 hours | 373.193 Nanograms/milliliter | Standard Deviation 376.8749 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 1 hour | 455.042 Nanograms/milliliter | Standard Deviation 350.7416 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 24 hours | 77.342 Nanograms/milliliter | Standard Deviation 37.3054 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 10 hours | 620.636 Nanograms/milliliter | Standard Deviation 217.5446 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration,, 2 hours | 1285.524 Nanograms/milliliter | Standard Deviation 1017.193 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 24 hours | 160.982 Nanograms/milliliter | Standard Deviation 61.3081 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 0.5 hours | 201.782 Nanograms/milliliter | — |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 3 hours | 1235.273 Nanograms/milliliter | Standard Deviation 740.0601 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 72 hours | 18.403 Nanograms/milliliter | Standard Deviation 12.5176 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, Pre-dose | 0.000 Nanograms/milliliter | — |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 4 hours | 1498.000 Nanograms/milliliter | Standard Deviation 607.8816 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration,12 hours | 411.091 Nanograms/milliliter | Standard Deviation 143.528 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 1 hour | 634.955 Nanograms/milliliter | Standard Deviation 767.2316 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 6 hours | 1418.545 Nanograms/milliliter | Standard Deviation 497.2105 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 48 hours | 43.282 Nanograms/milliliter | Standard Deviation 17.8091 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 0.25 hours | 32.318 Nanograms/milliliter | — |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 8 hours | 735.700 Nanograms/milliliter | Standard Deviation 234.1135 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 0.75 hours | 426.032 Nanograms/milliliter | Standard Deviation 611.142 |
| Part 1: GSK1325756H 50 mg (Fed) | Blood Concentration of GSK1325756 in Part 1 | Blood concentration, 60 hours | 19.087 Nanograms/milliliter | Standard Deviation 11.6452 |
Primary
Blood Concentration of GSK1325756 in Part 2
Whole blood samples of approximately 1 milliliters were collected for measurement of blood concentrations of GSK1325756 at Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in part 1. Data has been presented for blood concentrations of GSK1325756 in fasted and fed state. NA indicates standard deviation could not be calculated due to high proportion of NQ values (more than 30% of values were imputed i.e., NQ assigned zero concentration) which affected the standard deviation.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 6 hours | 774.938 Nanograms/milliliter | Standard Deviation 305.5721 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, Pre-dose | 0.000 Nanograms/milliliter | — |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 0.25 hours | 23.888 Nanograms/milliliter | — |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 0.5 hours | 248.749 Nanograms/milliliter | — |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 0.75 hours | 363.644 Nanograms/milliliter | Standard Deviation 745.3481 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 1 hour | 470.700 Nanograms/milliliter | Standard Deviation 711.2266 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 2 hours | 1039.688 Nanograms/milliliter | Standard Deviation 638.7844 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 3 hours | 1499.250 Nanograms/milliliter | Standard Deviation 657.7378 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 4 hours | 1682.667 Nanograms/milliliter | Standard Deviation 478.1134 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 8 hours | 463.750 Nanograms/milliliter | Standard Deviation 143.7101 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 10 hours | 364.438 Nanograms/milliliter | Standard Deviation 117.3348 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration,12 hours | 244.938 Nanograms/milliliter | Standard Deviation 76.6059 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 24 hours | 111.163 Nanograms/milliliter | Standard Deviation 43.6251 |
| Part 1: Placebo (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 48 hours | 40.568 Nanograms/milliliter | Standard Deviation 61.6334 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 10 hours | 350.813 Nanograms/milliliter | Standard Deviation 112.844 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 6 hours | 640.500 Nanograms/milliliter | Standard Deviation 140.684 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 3 hours | 2156.250 Nanograms/milliliter | Standard Deviation 521.9307 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, Pre-dose | 0.000 Nanograms/milliliter | — |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 24 hours | 118.888 Nanograms/milliliter | Standard Deviation 53.3676 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 0.25 hours | 434.557 Nanograms/milliliter | Standard Deviation 551.7663 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 4 hours | 1960.625 Nanograms/milliliter | Standard Deviation 402.0194 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 0.5 hours | 2233.813 Nanograms/milliliter | Standard Deviation 1476.075 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration,12 hours | 254.188 Nanograms/milliliter | Standard Deviation 68.8847 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 0.75 hours | 3599.500 Nanograms/milliliter | Standard Deviation 1240.578 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 8 hours | 410.625 Nanograms/milliliter | Standard Deviation 105.4564 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 1 hour | 4210.625 Nanograms/milliliter | Standard Deviation 1361.315 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 48 hours | 29.918 Nanograms/milliliter | Standard Deviation 32.5396 |
| Part 1: GSK1325756H 10 mg (Fed) | Blood Concentration of GSK1325756 in Part 2 | Blood concentration, 2 hours | 3176.000 Nanograms/milliliter | Standard Deviation 691.7762 |
Primary
Change From Baseline in Clinical Chemistry Parameter Amylase for Part 1
Blood samples were collected for the assessment of chemistry parameters namely amylase for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameter Amylase for Part 1 | Amylase, 48 hours | 16.0 Units/liter | Standard Deviation 9.16 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameter Amylase for Part 1 | Amylase, 72 hours | 38.8 Units/liter | Standard Deviation 28.84 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameter Amylase for Part 1 | Amylase, 48 hours | 20.6 Units/liter | Standard Deviation 18.05 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameter Amylase for Part 1 | Amylase, 48 hours | 22.7 Units/liter | Standard Deviation 13.21 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameter Amylase for Part 1 | Amylase, 72 hours | 14.4 Units/liter | Standard Deviation 12.92 |
Primary
Change From Baseline in Clinical Chemistry Parameter Amylase for Part 2
Blood samples were collected for the assessment of chemistry parameter namely amylase for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameter Amylase for Part 2 | 18.2 Units/liter | Standard Deviation 8.63 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameter Amylase for Part 2 | 18.5 Units/liter | Standard Deviation 8.75 |
Primary
Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1
Blood samples were collected for the assessment of chemistry parameters namely albumin and total protein for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1 | Albumin, 48 hours | -0.3 Grams/liter | Standard Deviation 1.44 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1 | Albumin, 72 hours | 1.2 Grams/liter | Standard Deviation 2.32 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1 | Total protein, 48 hours | 0.2 Grams/liter | Standard Deviation 2.59 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1 | Total protein, 72 hours | 1.8 Grams/liter | Standard Deviation 2.64 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1 | Total protein, 48 hours | -0.3 Grams/liter | Standard Deviation 1.82 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1 | Albumin, 48 hours | -0.6 Grams/liter | Standard Deviation 1.44 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1 | Albumin, 48 hours | 0.3 Grams/liter | Standard Deviation 1.96 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1 | Total protein, 48 hours | 0.8 Grams/liter | Standard Deviation 3.01 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1 | Albumin, 72 hours | -1.0 Grams/liter | Standard Deviation 1.34 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1 | Total protein, 72 hours | 0.0 Grams/liter | Standard Deviation 2.49 |
Primary
Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 2
Blood samples were collected for the assessment of chemistry parameters namely albumin and total protein for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 2 | Total protein, 48 hours | 1.1 Grams/liter | Standard Deviation 2.66 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 2 | Albumin, 48 hours | 0.3 Grams/liter | Standard Deviation 1.54 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 2 | Albumin, 48 hours | 0.8 Grams/liter | Standard Deviation 1.48 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 2 | Total protein, 48 hours | 1.9 Grams/liter | Standard Deviation 2.25 |
Primary
Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1
Blood samples were collected for the assessment of chemistry parameters namely alkaline phosphatase, ALT, AST, creatine kinase, GGT and lactate dehydrogenase for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Alkaline phosphatase, 48 hours | 1.1 International units/liter | Standard Deviation 9.08 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Lactate dehydrogenase, 48 hours | -15.3 International units/liter | Standard Deviation 20.2 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Lactate dehydrogenase, 72 hours | -2.8 International units/liter | Standard Deviation 49.15 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Creatine kinase, 48 hours | -29.0 International units/liter | Standard Deviation 27.1 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | ALT, 48 hours | -2.2 International units/liter | Standard Deviation 2.89 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | ALT, 72 hours | 2.5 International units/liter | Standard Deviation 3.83 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | AST, 48 hours | -2.3 International units/liter | Standard Deviation 4.38 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | AST, 72 hours | 1.5 International units/liter | Standard Deviation 3.67 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Creatine kinase, 72 hours | -34.7 International units/liter | Standard Deviation 9.99 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Alkaline phosphatase,72 hours | 12.5 International units/liter | Standard Deviation 13.37 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | GGT, 48 hours | -1.0 International units/liter | Standard Deviation 1.48 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | GGT, 72 hours | 2.0 International units/liter | Standard Deviation 1.1 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | AST, 48 hours | -0.6 International units/liter | Standard Deviation 4.52 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Lactate dehydrogenase, 48 hours | -13.8 International units/liter | Standard Deviation 11.66 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | GGT, 48 hours | 0.9 International units/liter | Standard Deviation 1.44 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Creatine kinase, 48 hours | -34.3 International units/liter | Standard Deviation 23.83 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | ALT, 48 hours | -0.5 International units/liter | Standard Deviation 3.92 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Alkaline phosphatase, 48 hours | -1.5 International units/liter | Standard Deviation 8.44 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Creatine kinase, 48 hours | -32.3 International units/liter | Standard Deviation 22.18 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | AST, 48 hours | -2.2 International units/liter | Standard Deviation 3.19 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | GGT, 48 hours | -1.9 International units/liter | Standard Deviation 2.35 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Lactate dehydrogenase, 48 hours | -12.0 International units/liter | Standard Deviation 10.08 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | ALT, 48 hours | -1.9 International units/liter | Standard Deviation 2.94 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Alkaline phosphatase, 48 hours | 0.0 International units/liter | Standard Deviation 9.55 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Lactate dehydrogenase, 72 hours | -17.3 International units/liter | Standard Deviation 7.4 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Alkaline phosphatase,72 hours | 4.6 International units/liter | Standard Deviation 12.14 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | ALT, 72 hours | 0.6 International units/liter | Standard Deviation 2.29 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | AST, 72 hours | -1.4 International units/liter | Standard Deviation 2.11 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | Creatine kinase, 72 hours | -46.4 International units/liter | Standard Deviation 32.96 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1 | GGT, 72 hours | -0.1 International units/liter | Standard Deviation 1.7 |
Primary
Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2
Blood samples were collected for the assessment of chemistry parameters namely alkaline phosphatase, ALT, AST, creatine kinase, GGT and lactate dehydrogenase for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | Alkaline phosphatase, 48 hours | 0.9 International units/liter | Standard Deviation 9.96 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | ALT, 48 hours | -1.5 International units/liter | Standard Deviation 1.93 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | AST, 48 hours | -2.0 International units/liter | Standard Deviation 2.28 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | Creatine kinase, 48 hours | -29.7 International units/liter | Standard Deviation 28.72 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | GGT, 48 hours | -0.5 International units/liter | Standard Deviation 2.99 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | Lactate dehydrogenase, 48 hours | -14.8 International units/liter | Standard Deviation 11.97 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | GGT, 48 hours | -0.4 International units/liter | Standard Deviation 2.5 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | Alkaline phosphatase, 48 hours | 6.5 International units/liter | Standard Deviation 11.35 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | Creatine kinase, 48 hours | -16.6 International units/liter | Standard Deviation 18.89 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | ALT, 48 hours | -1.5 International units/liter | Standard Deviation 1.97 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | Lactate dehydrogenase, 48 hours | -13.7 International units/liter | Standard Deviation 6.8 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2 | AST, 48 hours | -1.8 International units/liter | Standard Deviation 1.29 |
Primary
Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1
Blood samples were collected for the assessment of chemistry parameters namely direct bilirubin, total bilirubin, creatinine and uric acid for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Direct bilirubin, 48 hours | -0.428 Micromoles/liter | Standard Deviation 0.7734 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Direct bilirubin, 72 hours | -0.855 Micromoles/liter | Standard Deviation 1.4307 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Total bilirubin, 48 hours | -1.283 Micromoles/liter | Standard Deviation 2.0784 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Total bilirubin, 72 hours | -2.565 Micromoles/liter | Standard Deviation 4.683 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Creatinine, 48 hours | -1.9890 Micromoles/liter | Standard Deviation 4.33275 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Creatinine, 72 hours | -4.7147 Micromoles/liter | Standard Deviation 3.73658 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Uric acid, 48 hours | -33.7053 Micromoles/liter | Standard Deviation 25.7816 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Uric acid, 72 hours | -27.7573 Micromoles/liter | Standard Deviation 43.97767 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Total bilirubin, 48 hours | -0.428 Micromoles/liter | Standard Deviation 3.3513 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Direct bilirubin, 48 hours | 0.000 Micromoles/liter | Standard Deviation 1.2629 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Uric acid, 48 hours | -33.7053 Micromoles/liter | Standard Deviation 17.2638 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Creatinine, 48 hours | -3.6833 Micromoles/liter | Standard Deviation 3.21689 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Total bilirubin, 48 hours | -1.425 Micromoles/liter | Standard Deviation 1.906 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Creatinine, 48 hours | -1.8417 Micromoles/liter | Standard Deviation 3.02629 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Direct bilirubin, 48 hours | -0.712 Micromoles/liter | Standard Deviation 0.8805 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Uric acid, 48 hours | -31.7227 Micromoles/liter | Standard Deviation 21.57043 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Direct bilirubin, 72 hours | -0.466 Micromoles/liter | Standard Deviation 0.7987 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Creatinine, 72 hours | -4.0985 Micromoles/liter | Standard Deviation 3.79755 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Total bilirubin, 72 hours | -2.332 Micromoles/liter | Standard Deviation 1.756 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1 | Uric acid, 72 hours | -23.2513 Micromoles/liter | Standard Deviation 23.10621 |
Primary
Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 2
Blood samples were collected for the assessment of chemistry parameters namely direct bilirubin, total bilirubin, creatinine and uric acid for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 2 | Direct bilirubin, 48 hours | -0.641 Micromoles/liter | Standard Deviation 1.5135 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 2 | Total bilirubin, 48 hours | -1.496 Micromoles/liter | Standard Deviation 4.6254 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 2 | Creatinine, 48 hours | -2.8178 Micromoles/liter | Standard Deviation 3.68348 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 2 | Uric acid, 48 hours | -15.6135 Micromoles/liter | Standard Deviation 54.03085 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 2 | Uric acid, 48 hours | -8.5502 Micromoles/liter | Standard Deviation 75.89141 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 2 | Direct bilirubin, 48 hours | -0.641 Micromoles/liter | Standard Deviation 1.2291 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 2 | Creatinine, 48 hours | -4.2542 Micromoles/liter | Standard Deviation 3.32677 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 2 | Total bilirubin, 48 hours | -0.748 Micromoles/liter | Standard Deviation 2.6468 |
Primary
Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2
Blood samples were collected for the assessment of chemistry parameters namely calcium, cholesterol, chloride, glucose, HDL cholesterol, potassium, LDL cholesterol, sodium, phosphorus, triglycerides, urea/BUN results for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Glucose, 48 hours | 0.2116 Millimoles/liter | Standard Deviation 0.23744 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | LDL cholesterol, 48 hours | 0.1729 Millimoles/liter | Standard Deviation 0.30124 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Chloride, 48 hours | 0.2 Millimoles/liter | Standard Deviation 2.01 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Sodium, 48 hours | -0.3 Millimoles/liter | Standard Deviation 1.65 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | HDL cholesterol, 48 hours | -0.1131 Millimoles/liter | Standard Deviation 0.12629 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Phosphorus inorganic, 48 hours | -0.0868 Millimoles/liter | Standard Deviation 0.08561 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Cholesterol, 48 hours | 0.3119 Millimoles/liter | Standard Deviation 0.37218 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Triglycerides, 48 hours | 0.7402 Millimoles/liter | Standard Deviation 0.4339 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Potassium, 48 hours | 0.18 Millimoles/liter | Standard Deviation 0.377 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Urea/BUN, 48 hours | -0.6024 Millimoles/liter | Standard Deviation 1.44409 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Calcium, 48 hours | 0.0000 Millimoles/liter | Standard Deviation 0.05834 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Urea/BUN, 48 hours | -0.3347 Millimoles/liter | Standard Deviation 0.90755 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Calcium, 48 hours | 0.0000 Millimoles/liter | Standard Deviation 0.05154 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Cholesterol, 48 hours | 0.3588 Millimoles/liter | Standard Deviation 0.25265 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Chloride, 48 hours | 0.5 Millimoles/liter | Standard Deviation 1.86 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Glucose, 48 hours | 0.1561 Millimoles/liter | Standard Deviation 0.35643 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | HDL cholesterol, 48 hours | -0.0808 Millimoles/liter | Standard Deviation 0.10678 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Potassium, 48 hours | 0.14 Millimoles/liter | Standard Deviation 0.326 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | LDL cholesterol, 48 hours | 0.2279 Millimoles/liter | Standard Deviation 0.27614 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Sodium, 48 hours | 0.8 Millimoles/liter | Standard Deviation 1.72 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Phosphorus inorganic, 48 hours | -0.1433 Millimoles/liter | Standard Deviation 0.08821 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2 | Triglycerides, 48 hours | 0.6010 Millimoles/liter | Standard Deviation 0.39556 |
Primary
Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1
Blood samples were collected for the assessment of chemistry parameters namely calcium, cholesterol, chloride, glucose, HDL cholesterol, potassium, LDL cholesterol, sodium, phosphorus, triglycerides, and urea/BUN results for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Triglycerides, 72 hours | 0.3823 Millimoles/liter | Standard Deviation 0.34016 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | LDL cholesterol, 48 hours | -0.0065 Millimoles/liter | Standard Deviation 0.3515 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | HDL cholesterol, 72 hours | -0.1509 Millimoles/liter | Standard Deviation 0.1138 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Potassium, 72 hours | -0.17 Millimoles/liter | Standard Deviation 0.294 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Potassium, 48 hours | 0.04 Millimoles/liter | Standard Deviation 0.162 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Urea/BUN, 72 hours | -0.2975 Millimoles/liter | Standard Deviation 0.41735 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Cholesterol, 48 hours | 0.0453 Millimoles/liter | Standard Deviation 0.36206 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Calcium, 48 hours | -0.0208 Millimoles/liter | Standard Deviation 0.04617 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Triglycerides, 48 hours | 0.6422 Millimoles/liter | Standard Deviation 0.31917 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Cholesterol, 72 hours | 0.2241 Millimoles/liter | Standard Deviation 0.62379 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Phosphorus, 72 hours | -0.0969 Millimoles/liter | Standard Deviation 0.05776 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Chloride, 48 hours | 1.8 Millimoles/liter | Standard Deviation 1.11 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Urea/BUN, 48 hours | -0.7140 Millimoles/liter | Standard Deviation 0.79099 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Phosphorus, 48 hours | -0.1588 Millimoles/liter | Standard Deviation 0.12039 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Chloride, 72 hours | 1.8 Millimoles/liter | Standard Deviation 1.17 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Sodium, 72 hours | 1.0 Millimoles/liter | Standard Deviation 0.89 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Glucose, 48 hours | 0.2452 Millimoles/liter | Standard Deviation 0.27852 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Calcium, 72 hours | -0.0000 Millimoles/liter | Standard Deviation 0.06312 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Sodium, 48 hours | 0.6 Millimoles/liter | Standard Deviation 1 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Glucose, 72 hours | 0.2776 Millimoles/liter | Standard Deviation 0.16088 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | LDL cholesterol, 72 hours | 0.1896 Millimoles/liter | Standard Deviation 0.56007 |
| Part 1: Placebo (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | HDL cholesterol, 48 hours | -0.1789 Millimoles/liter | Standard Deviation 0.16035 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Potassium, 48 hours | 0.11 Millimoles/liter | Standard Deviation 0.231 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Calcium, 48 hours | -0.0187 Millimoles/liter | Standard Deviation 0.04137 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Cholesterol, 48 hours | 0.0129 Millimoles/liter | Standard Deviation 0.30588 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Chloride, 48 hours | 1.9 Millimoles/liter | Standard Deviation 1.83 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Glucose, 48 hours | 0.3516 Millimoles/liter | Standard Deviation 0.34246 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | HDL cholesterol, 48 hours | -0.1702 Millimoles/liter | Standard Deviation 0.12302 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | LDL cholesterol, 48 hours | 0.0043 Millimoles/liter | Standard Deviation 0.26961 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Sodium, 48 hours | 1.4 Millimoles/liter | Standard Deviation 2.07 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Phosphorus, 48 hours | -0.1399 Millimoles/liter | Standard Deviation 0.08525 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Triglycerides, 48 hours | 0.4963 Millimoles/liter | Standard Deviation 0.36405 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Urea/BUN, 48 hours | -0.5355 Millimoles/liter | Standard Deviation 1.14422 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Glucose, 48 hours | 0.1619 Millimoles/liter | Standard Deviation 0.3258 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Calcium, 48 hours | 0.0021 Millimoles/liter | Standard Deviation 0.05675 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Cholesterol, 48 hours | 0.1681 Millimoles/liter | Standard Deviation 0.5322 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Urea/BUN, 48 hours | -0.1785 Millimoles/liter | Standard Deviation 0.95672 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Triglycerides, 48 hours | 0.5575 Millimoles/liter | Standard Deviation 0.38005 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Chloride, 48 hours | 1.9 Millimoles/liter | Standard Deviation 1.44 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Potassium, 48 hours | 0.28 Millimoles/liter | Standard Deviation 0.359 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Sodium, 48 hours | 0.9 Millimoles/liter | Standard Deviation 1.08 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Phosphorus, 48 hours | -0.1426 Millimoles/liter | Standard Deviation 0.09972 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | HDL cholesterol, 48 hours | -0.1228 Millimoles/liter | Standard Deviation 0.1391 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | LDL cholesterol, 48 hours | 0.0711 Millimoles/liter | Standard Deviation 0.44012 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Triglycerides, 72 hours | 0.4910 Millimoles/liter | Standard Deviation 0.21744 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Glucose, 72 hours | 0.1463 Millimoles/liter | Standard Deviation 0.38958 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | LDL cholesterol, 72 hours | -0.0188 Millimoles/liter | Standard Deviation 0.36555 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Chloride, 72 hours | 1.5 Millimoles/liter | Standard Deviation 1.75 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Sodium, 72 hours | 1.1 Millimoles/liter | Standard Deviation 1.45 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Urea/BUN, 72 hours | -0.5193 Millimoles/liter | Standard Deviation 0.96276 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Cholesterol, 72 hours | -0.0541 Millimoles/liter | Standard Deviation 0.37997 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Phosphorus, 72 hours | -0.1262 Millimoles/liter | Standard Deviation 0.11041 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Calcium, 72 hours | -0.0318 Millimoles/liter | Standard Deviation 0.05124 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | HDL cholesterol, 72 hours | -0.2304 Millimoles/liter | Standard Deviation 0.10753 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1 | Potassium, 72 hours | 0.07 Millimoles/liter | Standard Deviation 0.2 |
Primary
Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval
Single 12-lead ECG's were obtained from Baseline and up to 72 hours in Part 1 using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 4 hours | -1.7 Milliseconds | Standard Deviation 10.98 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval 24 hours | 2.3 Milliseconds | Standard Deviation 5.63 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 24 hours | 0.4 Milliseconds | Standard Deviation 1.89 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval, 24 hours | -7.6 Milliseconds | Standard Deviation 6.39 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval, 48 hours | 5.6 Milliseconds | Standard Deviation 9.22 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 72 hours | 1.7 Milliseconds | Standard Deviation 2.34 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 48 hours | 1.0 Milliseconds | Standard Deviation 1.97 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval, 4 hours | -9.7 Milliseconds | Standard Deviation 5.32 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 48 hours | -4.4 Milliseconds | Standard Deviation 8.69 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 4 hours | -0.4 Milliseconds | Standard Deviation 2.12 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval, 48 hours | -8.7 Milliseconds | Standard Deviation 6.45 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval, 72 hours | 6.7 Milliseconds | Standard Deviation 11.57 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 24 hours | -1.8 Milliseconds | Standard Deviation 10.74 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 72 hours | -8.3 Milliseconds | Standard Deviation 13.29 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval,, 72 hours | -10.3 Milliseconds | Standard Deviation 3.27 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval, 4 hours | -0.9 Milliseconds | Standard Deviation 11.65 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval, 4 hours | 0.7 Milliseconds | Standard Deviation 5.28 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval, 4 hours | -11.3 Milliseconds | Standard Deviation 5.14 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval, 24 hours | -8.3 Milliseconds | Standard Deviation 7.75 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval, 48 hours | -5.9 Milliseconds | Standard Deviation 7.44 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 4 hours | -0.3 Milliseconds | Standard Deviation 2.39 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval 24 hours | 3.0 Milliseconds | Standard Deviation 7.56 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 24 hours | 0.7 Milliseconds | Standard Deviation 1.97 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 48 hours | 2.8 Milliseconds | Standard Deviation 1.99 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 4 hours | -4.2 Milliseconds | Standard Deviation 15.9 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval, 48 hours | -0.8 Milliseconds | Standard Deviation 8.5 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 24 hours | 6.8 Milliseconds | Standard Deviation 15.69 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 48 hours | -6.8 Milliseconds | Standard Deviation 12.52 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 4 hours | -0.2 Milliseconds | Standard Deviation 1.59 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval, 24 hours | -9.5 Milliseconds | Standard Deviation 4.83 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 4 hours | -4.0 Milliseconds | Standard Deviation 10.23 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval, 4 hours | -10.8 Milliseconds | Standard Deviation 7.16 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval, 48 hours | -10.7 Milliseconds | Standard Deviation 6.51 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 48 hours | -1.5 Milliseconds | Standard Deviation 11.48 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 24 hours | -1.0 Milliseconds | Standard Deviation 9.82 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval, 48 hours | 5.7 Milliseconds | Standard Deviation 9.18 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 48 hours | 1.7 Milliseconds | Standard Deviation 1.87 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval, 4 hours | 1.3 Milliseconds | Standard Deviation 4.29 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval 24 hours | 4.3 Milliseconds | Standard Deviation 6.2 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 24 hours | 0.7 Milliseconds | Standard Deviation 1.56 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval,, 72 hours | -7.6 Milliseconds | Standard Deviation 7.1 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval, 4 hours | 0.5 Milliseconds | Standard Deviation 3.7 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval 24 hours | 3.6 Milliseconds | Standard Deviation 5.57 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval, 48 hours | 5.8 Milliseconds | Standard Deviation 6.84 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | PR Interval, 72 hours | 6.0 Milliseconds | Standard Deviation 6.26 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 4 hours | -0.2 Milliseconds | Standard Deviation 3.03 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 24 hours | 0.4 Milliseconds | Standard Deviation 1.75 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 48 hours | 0.5 Milliseconds | Standard Deviation 2.02 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | QRS duration, 72 hours | 0.9 Milliseconds | Standard Deviation 2.74 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 4 hours | -2.9 Milliseconds | Standard Deviation 11.08 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 24 hours | -1.5 Milliseconds | Standard Deviation 11.7 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 48 hours | -0.2 Milliseconds | Standard Deviation 14.76 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Uncorrected QT Interval, 72 hours | -4.5 Milliseconds | Standard Deviation 14.54 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval, 4 hours | -8.1 Milliseconds | Standard Deviation 5.36 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval, 24 hours | -6.5 Milliseconds | Standard Deviation 6.02 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval | Corrected QT Interval, 48 hours | -6.9 Milliseconds | Standard Deviation 9.59 |
Primary
Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2
Single 12-lead ECG's were obtained from Baseline and up to 72 hours in Part 2 using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Frederica's correction) interval. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | PR Interval, 4 hours | -1.5 Milliseconds | Standard Deviation 5.59 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | PR Interval 24 hours | -2.5 Milliseconds | Standard Deviation 7.5 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | PR Interval, 48 hours | 1.5 Milliseconds | Standard Deviation 8.84 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | QRS duration, 4 hours | -0.6 Milliseconds | Standard Deviation 2.28 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | QRS duration, 24 hours | -1.0 Milliseconds | Standard Deviation 2.19 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | QRS duration, 48 hours | -0.6 Milliseconds | Standard Deviation 2.5 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Uncorrected QT Interval, 4 hours | 3.1 Milliseconds | Standard Deviation 12.31 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Uncorrected QT Interval, 24 hours | -10.0 Milliseconds | Standard Deviation 15.85 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Uncorrected QT Interval, 48 hours | -6.4 Milliseconds | Standard Deviation 11.25 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Corrected QT Interval, 4 hours | -3.1 Milliseconds | Standard Deviation 6.55 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Corrected QT Interval, 24 hours | -6.1 Milliseconds | Standard Deviation 6.73 |
| Part 1: Placebo (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Corrected QT Interval, 48 hours | -5.7 Milliseconds | Standard Deviation 5.58 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Corrected QT Interval, 24 hours | -3.8 Milliseconds | Standard Deviation 7.38 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | PR Interval, 4 hours | -0.6 Milliseconds | Standard Deviation 4.18 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Uncorrected QT Interval, 4 hours | 6.4 Milliseconds | Standard Deviation 10.02 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | PR Interval 24 hours | 1.3 Milliseconds | Standard Deviation 4.37 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Corrected QT Interval, 4 hours | 3.1 Milliseconds | Standard Deviation 7.2 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | PR Interval, 48 hours | 4.1 Milliseconds | Standard Deviation 6.13 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Uncorrected QT Interval, 24 hours | -3.9 Milliseconds | Standard Deviation 13.83 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | QRS duration, 4 hours | -1.3 Milliseconds | Standard Deviation 4.12 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Corrected QT Interval, 48 hours | -7.3 Milliseconds | Standard Deviation 8.69 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | QRS duration, 24 hours | -1.8 Milliseconds | Standard Deviation 5 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | Uncorrected QT Interval, 48 hours | -9.5 Milliseconds | Standard Deviation 17.84 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2 | QRS duration, 48 hours | -0.9 Milliseconds | Standard Deviation 4.26 |
Primary
Change From Baseline in Hematology Parameter Hematocrit for Part 1
Blood samples were collected for the assessment of hematology parameter namely hematocrit for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameter Hematocrit for Part 1 | Hematocrit, 48 hours | 0.0188 Proportion of red blood cells in blood | Standard Deviation 0.01542 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameter Hematocrit for Part 1 | Hematocrit, 72 hours | 0.0255 Proportion of red blood cells in blood | Standard Deviation 0.01472 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameter Hematocrit for Part 1 | Hematocrit, 48 hours | 0.0177 Proportion of red blood cells in blood | Standard Deviation 0.01293 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameter Hematocrit for Part 1 | Hematocrit, 48 hours | 0.0238 Proportion of red blood cells in blood | Standard Deviation 0.01599 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameter Hematocrit for Part 1 | Hematocrit, 72 hours | 0.0121 Proportion of red blood cells in blood | Standard Deviation 0.017 |
Primary
Change From Baseline in Hematology Parameter Hematocrit for Part 2
Blood samples were collected for the assessment of hematology parameter namely hematocrit for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameter Hematocrit for Part 2 | 0.0304 Proportion of red blood cells in blood | Standard Deviation 0.01286 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameter Hematocrit for Part 2 | 0.0268 Proportion of red blood cells in blood | Standard Deviation 0.01303 |
Primary
Change From Baseline in Hematology Parameter Hemoglobin for Part 1
Blood samples were collected for the assessment of hematology parameter namely hemoglobin for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameter Hemoglobin for Part 1 | Hemoglobin, 48 hours | 3.7 Grams/liter | Standard Deviation 4.66 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameter Hemoglobin for Part 1 | Hemoglobin, 72 hours | 8.8 Grams/liter | Standard Deviation 5.23 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameter Hemoglobin for Part 1 | Hemoglobin, 48 hours | 4.8 Grams/liter | Standard Deviation 4.24 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameter Hemoglobin for Part 1 | Hemoglobin, 48 hours | 5.5 Grams/liter | Standard Deviation 5.05 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameter Hemoglobin for Part 1 | Hemoglobin, 72 hours | 5.0 Grams/liter | Standard Deviation 5.53 |
Primary
Change From Baseline in Hematology Parameter Hemoglobin for Part 2
Blood samples were collected for the assessment of hematology parameter namely hemoglobin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameter Hemoglobin for Part 2 | 9.4 Grams/liter | Standard Deviation 3.92 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameter Hemoglobin for Part 2 | 8.9 Grams/liter | Standard Deviation 4.51 |
Primary
Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 1
Blood samples were collected for the assessment of hematology parameter namely mean corpuscle hemoglobin for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 1 | Mean corpuscle hemoglobin, 48 hours | -0.32 Picograms | Standard Deviation 0.376 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 1 | Mean corpuscle hemoglobin, 72 hours | 0.22 Picograms | Standard Deviation 0.479 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 1 | Mean corpuscle hemoglobin, 48 hours | -0.10 Picograms | Standard Deviation 0.429 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 1 | Mean corpuscle hemoglobin, 48 hours | -0.14 Picograms | Standard Deviation 0.306 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 1 | Mean corpuscle hemoglobin, 72 hours | 0.25 Picograms | Standard Deviation 0.362 |
Primary
Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 2
Blood samples were collected for the assessment of hematology parameter namely mean corpuscle hemoglobin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 2 | -0.12 Picograms | Standard Deviation 0.312 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 2 | 0.20 Picograms | Standard Deviation 0.268 |
Primary
Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 1
Blood samples were collected for the assessment of hematology parameter namely mean corpuscle volume for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 1 | Mean corpuscle volume, 48 hours | 0.7 Femtoliters | Standard Deviation 0.78 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 1 | Mean corpuscle volume, 72 hours | 0.2 Femtoliters | Standard Deviation 0.75 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 1 | Mean corpuscle volume, 48 hours | 0.3 Femtoliters | Standard Deviation 0.65 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 1 | Mean corpuscle volume, 48 hours | 1.3 Femtoliters | Standard Deviation 0.87 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 1 | Mean corpuscle volume, 72 hours | 0.2 Femtoliters | Standard Deviation 0.75 |
Primary
Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 2
Blood samples were collected for the assessment of hematology parameter namely mean corpuscle volume for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 2 | 0.4 Femtoliters | Standard Deviation 0.96 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 2 | 0.6 Femtoliters | Standard Deviation 0.89 |
Primary
Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1
Blood samples were collected for the assessment of hematology parameters namely basophils, eosinophils, leukocytes, lymphocytes, monocytes, total neutrophils and platelets for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Monocytes, 48 hours | -0.13 Percentage of cells | Standard Deviation 0.677 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Eosinophils, 72 hours | 1.10 Percentage of cells | Standard Deviation 1.753 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Lymphocytes, 48 hours | 5.18 Percentage of cells | Standard Deviation 4.754 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Basophils, 48 hours | 0.12 Percentage of cells | Standard Deviation 0.221 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Lymphocytes, 72 hours | 5.15 Percentage of cells | Standard Deviation 3.363 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Total neutrophils, 48 hours | -6.56 Percentage of cells | Standard Deviation 5.347 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Basophils, 72 hours | 0.13 Percentage of cells | Standard Deviation 0.082 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Monocytes, 72 hours | -0.18 Percentage of cells | Standard Deviation 0.652 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Total neutrophils, 72 hours | -6.20 Percentage of cells | Standard Deviation 3.946 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Eosinophils, 48 hours | 1.39 Percentage of cells | Standard Deviation 1.132 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Monocytes, 48 hours | 0.01 Percentage of cells | Standard Deviation 1.093 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Eosinophils, 48 hours | 0.95 Percentage of cells | Standard Deviation 1.301 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Basophils, 48 hours | 0.09 Percentage of cells | Standard Deviation 0.168 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Lymphocytes, 48 hours | 5.35 Percentage of cells | Standard Deviation 5.907 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Total neutrophils, 48 hours | -6.40 Percentage of cells | Standard Deviation 7.071 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Lymphocytes, 48 hours | 4.39 Percentage of cells | Standard Deviation 4.019 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Basophils, 48 hours | 0.09 Percentage of cells | Standard Deviation 0.131 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Eosinophils, 48 hours | 0.73 Percentage of cells | Standard Deviation 0.725 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Monocytes, 48 hours | -0.12 Percentage of cells | Standard Deviation 0.92 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Total neutrophils, 48 hours | -5.10 Percentage of cells | Standard Deviation 4.611 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Lymphocytes, 72 hours | 2.85 Percentage of cells | Standard Deviation 7.766 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Eosinophils, 72 hours | 0.54 Percentage of cells | Standard Deviation 0.923 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Total neutrophils, 72 hours | -3.57 Percentage of cells | Standard Deviation 9.212 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Basophils, 72 hours | 0.03 Percentage of cells | Standard Deviation 0.272 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1 | Monocytes, 72 hours | 0.16 Percentage of cells | Standard Deviation 1.249 |
Primary
Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2
Blood samples were collected for the assessment of hematology parameters namely basophils, eosinophils, leukocytes, lymphocytes, monocytes, total neutrophils and platelets for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2 | Eosinophils, 48 hours | 0.44 Percentage of cells | Standard Deviation 1.082 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2 | Monocytes, 48 hours | -0.04 Percentage of cells | Standard Deviation 0.873 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2 | Lymphocytes, 48 hours | 3.58 Percentage of cells | Standard Deviation 7.821 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2 | Total neutrophils, 48 hours | -3.97 Percentage of cells | Standard Deviation 9.311 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2 | Basophils, 48 hours | -0.00 Percentage of cells | Standard Deviation 0.25 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2 | Total neutrophils, 48 hours | -4.66 Percentage of cells | Standard Deviation 6.035 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2 | Basophils, 48 hours | 0.09 Percentage of cells | Standard Deviation 0.12 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2 | Eosinophils, 48 hours | 0.67 Percentage of cells | Standard Deviation 0.96 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2 | Lymphocytes, 48 hours | 4.53 Percentage of cells | Standard Deviation 5.248 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2 | Monocytes, 48 hours | -0.63 Percentage of cells | Standard Deviation 0.936 |
Primary
Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1
Blood samples were collected for the assessment of hematology parameters namely platelet count and white blood cell count for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1 | Platelet count, 48 hours | 3.7 Giga cells/liter | Standard Deviation 14.59 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1 | Platelet count, 72 hours | 14.5 Giga cells/liter | Standard Deviation 11.33 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1 | White blood cell count,48 hours | -0.54 Giga cells/liter | Standard Deviation 0.489 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1 | White blood cell count,72 hours | -0.32 Giga cells/liter | Standard Deviation 0.471 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1 | White blood cell count,48 hours | -0.48 Giga cells/liter | Standard Deviation 0.956 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1 | Platelet count, 48 hours | 1.4 Giga cells/liter | Standard Deviation 12.55 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1 | Platelet count, 48 hours | 0.5 Giga cells/liter | Standard Deviation 15.95 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1 | White blood cell count,48 hours | -0.67 Giga cells/liter | Standard Deviation 0.947 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1 | Platelet count, 72 hours | 2.3 Giga cells/liter | Standard Deviation 10.53 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1 | White blood cell count,72 hours | -0.75 Giga cells/liter | Standard Deviation 1.258 |
Primary
Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 2
Blood samples were collected for the assessment of hematology parameters namely platelet count and white blood cell count for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 2 | Platelet count, 48 hours | 7.4 Giga cells/liter | Standard Deviation 15.32 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 2 | White blood cell count,48 hours | 12.45 Giga cells/liter | Standard Deviation 0.995 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 2 | Platelet count, 48 hours | 13.1 Giga cells/liter | Standard Deviation 12.45 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 2 | White blood cell count,48 hours | -0.36 Giga cells/liter | Standard Deviation 0.734 |
Primary
Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1
Blood samples were collected for the assessment of hematology parameters namely red blood count and reticulocyte count for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1 | Red blood cell count, 48 hours | 0.165 Trillion cells/liter | Standard Deviation 0.165 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1 | Red blood cell count, 72 hours | 0.252 Trillion cells/liter | Standard Deviation 0.1609 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1 | Reticulocyte count, 48 hours | 0.0127 Trillion cells/liter | Standard Deviation 0.01512 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1 | Reticulocyte count, 72 hours | -0.0023 Trillion cells/liter | Standard Deviation 0.01646 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1 | Reticulocyte count, 48 hours | 0.0038 Trillion cells/liter | Standard Deviation 0.01765 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1 | Red blood cell count, 48 hours | 0.164 Trillion cells/liter | Standard Deviation 0.1385 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1 | Red blood cell count, 48 hours | 0.197 Trillion cells/liter | Standard Deviation 0.1797 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1 | Reticulocyte count, 48 hours | -0.0009 Trillion cells/liter | Standard Deviation 0.01929 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1 | Red blood cell count, 72 hours | 0.120 Trillion cells/liter | Standard Deviation 0.168 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1 | Reticulocyte count, 72 hours | -0.0037 Trillion cells/liter | Standard Deviation 0.0178 |
Primary
Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 2
Blood samples were collected for the assessment of hematology parameters namely red blood count and reticulocyte count for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 2 | Red blood cell count, 48 hours | 0.318 Trillion cells/liter | Standard Deviation 0.1462 |
| Part 1: Placebo (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 2 | Reticulocyte count, 48 hours | -0.0018 Trillion cells/liter | Standard Deviation 0.01203 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 2 | Red blood cell count, 48 hours | 0.255 Trillion cells/liter | Standard Deviation 0.159 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 2 | Reticulocyte count, 48 hours | 0.0097 Trillion cells/liter | Standard Deviation 0.01526 |
Primary
Change From Baseline in Vital Sign Parameter Heart Rate for Part 1
Vital sign measurements included heart rate at Baseline and up to 72 hours in Part 1. Heart rate measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 24 hours | -3.0 Beats per minute | Standard Deviation 4.67 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 72 hours | -1.0 Beats per minute | Standard Deviation 4.98 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 48 hours | -1.5 Beats per minute | Standard Deviation 3.09 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 4 hours | -3.1 Beats per minute | Standard Deviation 3.92 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 48 hours | 1.2 Beats per minute | Standard Deviation 7.51 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 4 hours | -3.2 Beats per minute | Standard Deviation 8.24 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 24 hours | -7.5 Beats per minute | Standard Deviation 9.23 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 4 hours | -3.7 Beats per minute | Standard Deviation 6.17 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 24 hours | -3.8 Beats per minute | Standard Deviation 4.97 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 48 hours | -2.3 Beats per minute | Standard Deviation 6.59 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 72 hours | -1.0 Beats per minute | Standard Deviation 5.14 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 4 hours | -2.9 Beats per minute | Standard Deviation 2.95 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 24 hours | -2.2 Beats per minute | Standard Deviation 4.07 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 1 | Heart rate, 48 hours | -2.7 Beats per minute | Standard Deviation 4.31 |
Primary
Change From Baseline in Vital Sign Parameter Heart Rate for Part 2
Vital sign measurements included heart rate at Baseline and up to 72 hours in Part 2. Heart rate measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 2 | Heart rate, 4 hours | -2.4 Beats per minute | Standard Deviation 4.69 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 2 | Heart rate, 24 hours | 1.3 Beats per minute | Standard Deviation 5.46 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 2 | Heart rate, 48 hours | 0.5 Beats per minute | Standard Deviation 3.83 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 2 | Heart rate, 4 hours | -1.8 Beats per minute | Standard Deviation 5.14 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 2 | Heart rate, 24 hours | -0.1 Beats per minute | Standard Deviation 3.89 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameter Heart Rate for Part 2 | Heart rate, 48 hours | 0.5 Beats per minute | Standard Deviation 4.07 |
Primary
Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2
Vital sign measurements included SBP and DBP at Baseline and up to 72 hours in Part 2. SBP and DBP measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | SBP, 4 hours | -1.5 Millimeters of mercury | Standard Deviation 11.7 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | SBP, 24 hours | -2.8 Millimeters of mercury | Standard Deviation 12.13 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | SBP, 48 hours | -1.9 Millimeters of mercury | Standard Deviation 10.22 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | DBP, 4 hours | -0.8 Millimeters of mercury | Standard Deviation 6.19 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | DBP, 24 hours | -0.7 Millimeters of mercury | Standard Deviation 6.66 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | DBP, 48 hours | 0.1 Millimeters of mercury | Standard Deviation 3.8 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | DBP, 24 hours | -0.6 Millimeters of mercury | Standard Deviation 6.15 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | SBP, 4 hours | -2.5 Millimeters of mercury | Standard Deviation 12.46 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | DBP, 4 hours | -0.3 Millimeters of mercury | Standard Deviation 6.63 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | SBP, 24 hours | -3.5 Millimeters of mercury | Standard Deviation 11.64 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | DBP, 48 hours | 0.8 Millimeters of mercury | Standard Deviation 6.31 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 | SBP, 48 hours | -0.2 Millimeters of mercury | Standard Deviation 14.47 |
Primary
Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1
Vital sign measurements included SBP and DBP at Baseline and up to 72 hours in Part 1. SBP and DBP measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 48 hours | 2.0 Millimeters of mercury | Standard Deviation 6.24 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 48 hours | 4.5 Millimeters of mercury | Standard Deviation 7.06 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 24 hours | 0.8 Millimeters of mercury | Standard Deviation 4.94 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 4 hours | -4.8 Millimeters of mercury | Standard Deviation 10.44 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 72 hours | -0.8 Millimeters of mercury | Standard Deviation 8.06 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 24 hours | 1.7 Millimeters of mercury | Standard Deviation 7.95 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 72 hours | 3.8 Millimeters of mercury | Standard Deviation 4.12 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 4 hours | -3.6 Millimeters of mercury | Standard Deviation 5.89 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 48 hours | 7.0 Millimeters of mercury | Standard Deviation 10.76 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 24 hours | 0.5 Millimeters of mercury | Standard Deviation 13.61 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 48 hours | 4.7 Millimeters of mercury | Standard Deviation 6.07 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 4 hours | -9.6 Millimeters of mercury | Standard Deviation 9.21 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 24 hours | 4.5 Millimeters of mercury | Standard Deviation 4.58 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 4 hours | -2.8 Millimeters of mercury | Standard Deviation 3.33 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 48 hours | 5.9 Millimeters of mercury | Standard Deviation 11.66 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 24 hours | 0.8 Millimeters of mercury | Standard Deviation 6.4 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 48 hours | 2.1 Millimeters of mercury | Standard Deviation 4.44 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 4 hours | -2.2 Millimeters of mercury | Standard Deviation 4.93 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 24 hours | 1.7 Millimeters of mercury | Standard Deviation 6.87 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 4 hours | -4.2 Millimeters of mercury | Standard Deviation 6.59 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 72 hours | 1.8 Millimeters of mercury | Standard Deviation 7.69 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 4 hours | -0.3 Millimeters of mercury | Standard Deviation 7.02 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 24 hours | 4.5 Millimeters of mercury | Standard Deviation 13.55 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 48 hours | 2.0 Millimeters of mercury | Standard Deviation 10.47 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | SBP, 72 hours | 4.8 Millimeters of mercury | Standard Deviation 12.18 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 4 hours | -1.1 Millimeters of mercury | Standard Deviation 5.36 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 24 hours | 1.0 Millimeters of mercury | Standard Deviation 6.32 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1 | DBP, 48 hours | 2.5 Millimeters of mercury | Standard Deviation 6.12 |
Primary
Change From Baseline in Vital Sign Parameter Temperature for Part 1
Vital sign measurements included temperature at Baseline and up to 72 hours in Part 1. Temperature measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Baseline and up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature 24 hours | -0.08 Degree Celsius | Standard Deviation 0.269 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature, 72 hours | 0.00 Degree Celsius | Standard Deviation 0.179 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature, 48 hours | 0.02 Degree Celsius | Standard Deviation 0.362 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature, 4 hours | 0.11 Degree Celsius | Standard Deviation 0.363 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature, 48 hours | -0.02 Degree Celsius | Standard Deviation 0.364 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature, 4 hours | 0.07 Degree Celsius | Standard Deviation 0.4 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature 24 hours | 0.01 Degree Celsius | Standard Deviation 0.375 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature, 4 hours | 0.27 Degree Celsius | Standard Deviation 0.393 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature 24 hours | 0.06 Degree Celsius | Standard Deviation 0.394 |
| Part 1: GSK1325756H 50 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature, 48 hours | 0.01 Degree Celsius | Standard Deviation 0.387 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature, 72 hours | 0.17 Degree Celsius | Standard Deviation 0.272 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature, 4 hours | 0.14 Degree Celsius | Standard Deviation 0.495 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature 24 hours | 0.05 Degree Celsius | Standard Deviation 0.321 |
| Part 1: GSK1325756H 100 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 1 | Temperature, 48 hours | 0.12 Degree Celsius | Standard Deviation 0.46 |
Primary
Change From Baseline in Vital Sign Parameter Temperature for Part 2
Vital sign measurements included temperature at Baseline and up to 72 hours in Part 2. Temperature measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.
Time frame: Baseline and up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 2 | Temperature, 4 hours | 0.06 Degree Celsius | Standard Deviation 0.236 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 2 | Temperature 24 hours | 0.04 Degree Celsius | Standard Deviation 0.25 |
| Part 1: Placebo (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 2 | Temperature, 48 hours | 0.10 Degree Celsius | Standard Deviation 0.228 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 2 | Temperature, 4 hours | 0.21 Degree Celsius | Standard Deviation 0.34 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 2 | Temperature 24 hours | 0.10 Degree Celsius | Standard Deviation 0.316 |
| Part 1: GSK1325756H 10 mg (Fed) | Change From Baseline in Vital Sign Parameter Temperature for Part 2 | Temperature, 48 hours | 0.10 Degree Celsius | Standard Deviation 0.312 |
Primary
Cmax of GSK1325756H for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Cmax of GSK1325756H for Part 2 | 1818.544 Nanograms/milliliter | Geometric Coefficient of Variation 32.5 |
| Part 1: GSK1325756H 10 mg (Fed) | Cmax of GSK1325756H for Part 2 | 4146.886 Nanograms/milliliter | Geometric Coefficient of Variation 34.5 |
Primary
Lag Time Before Observable Concentration (Tlag) of GSK1325756H for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756 in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Placebo (Fed) | Lag Time Before Observable Concentration (Tlag) of GSK1325756H for Part 1 | 0.37500 Hours |
| Part 1: GSK1325756H 10 mg (Fed) | Lag Time Before Observable Concentration (Tlag) of GSK1325756H for Part 1 | 0.25000 Hours |
| Part 1: GSK1325756H 50 mg (Fed) | Lag Time Before Observable Concentration (Tlag) of GSK1325756H for Part 1 | 0.25000 Hours |
Primary
Maximum Observed Concentration (Cmax) of GSK1325756H for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Maximum Observed Concentration (Cmax) of GSK1325756H for Part 1 | 217.082 Nanograms/milliliter | Geometric Coefficient of Variation 17.8 |
| Part 1: GSK1325756H 10 mg (Fed) | Maximum Observed Concentration (Cmax) of GSK1325756H for Part 1 | 1219.883 Nanograms/milliliter | Geometric Coefficient of Variation 37.3 |
| Part 1: GSK1325756H 50 mg (Fed) | Maximum Observed Concentration (Cmax) of GSK1325756H for Part 1 | 1924.864 Nanograms/milliliter | Geometric Coefficient of Variation 39.6 |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1
Urinalysis parameters assessed were urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen. In this dipstick test, the level of bilirubin, occult blood, glucose, ketones, urine protein and urobilinogen in urine samples was recorded as negative, trace and +. Urine samples were collected for the measurement of urinalysis parameters by dipstick method up to 72 hours in Part 1. Only categories with significant values have been presented.
Time frame: Up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, Trace, 48 hours | 1 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, + , 48 hours | 0 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, Trace, 72 hours | 1 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, + , 72 hours | 1 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine protein, Trace, 48 hours | 0 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine protein, Trace, 72 hours | 1 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine urobilinogen, Trace, 48 hours | 12 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine urobilinogen, Trace, 72 hours | 6 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine protein, Trace, 72 hours | 0 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine protein, Trace, 48 hours | 1 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, + , 48 hours | 1 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine urobilinogen, Trace, 72 hours | 0 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine urobilinogen, Trace, 48 hours | 12 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, + , 72 hours | 0 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, Trace, 72 hours | 0 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, Trace, 48 hours | 1 Participants |
| Part 1: GSK1325756H 50 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine urobilinogen, Trace, 48 hours | 12 Participants |
| Part 1: GSK1325756H 50 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, Trace, 72 hours | 0 Participants |
| Part 1: GSK1325756H 50 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, + , 72 hours | 0 Participants |
| Part 1: GSK1325756H 50 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine protein, Trace, 48 hours | 1 Participants |
| Part 1: GSK1325756H 50 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine protein, Trace, 72 hours | 0 Participants |
| Part 1: GSK1325756H 50 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine urobilinogen, Trace, 72 hours | 0 Participants |
| Part 1: GSK1325756H 50 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, Trace, 48 hours | 0 Participants |
| Part 1: GSK1325756H 50 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, + , 48 hours | 1 Participants |
| Part 1: GSK1325756H 100 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, Trace, 72 hours | 0 Participants |
| Part 1: GSK1325756H 100 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, + , 72 hours | 0 Participants |
| Part 1: GSK1325756H 100 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, + , 48 hours | 0 Participants |
| Part 1: GSK1325756H 100 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine occult blood, Trace, 48 hours | 0 Participants |
| Part 1: GSK1325756H 100 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine protein, Trace, 48 hours | 0 Participants |
| Part 1: GSK1325756H 100 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine urobilinogen, Trace, 72 hours | 11 Participants |
| Part 1: GSK1325756H 100 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine urobilinogen, Trace, 48 hours | 0 Participants |
| Part 1: GSK1325756H 100 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1 | Urine protein, Trace, 72 hours | 0 Participants |
Primary
Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2
Urinalysis parameters assessed were urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen. In this dipstick test, the level of bilirubin, occult blood, glucose, ketones, urine protein and urobilinogen in urine samples was recorded as negative, trace and +. Urine samples were collected for the measurement of urinalysis parameters by dipstick method up to 48 hours in Part 2. Only categories with significant values have been presented.
Time frame: Up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine glucose, Trace , 48 hours | 1 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine urobilinogen, Trace, 48 hours | 15 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine protein, Trace, 48 hours | 0 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine urobilinogen, +, 48 hours | 1 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine occult blood, Trace, 48 hours | 1 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine urobilinogen, +, 48 hours | 1 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine occult blood, Trace, 48 hours | 0 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine glucose, Trace , 48 hours | 0 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine protein, Trace, 48 hours | 2 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2 | Urine urobilinogen, Trace, 48 hours | 15 Participants |
Primary
Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 1
AE is any untoward medical occurrence in a participant or clinical investigation 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 or is medically significant. Safety population comprised of all participants who took at least one dose of study treatment.
Time frame: Up to 32 days in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Placebo (Fed) | Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 1 | Any AE | 1 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 1 | Any SAE | 0 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 1 | Any SAE | 0 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 1 | Any AE | 0 Participants |
| Part 1: GSK1325756H 50 mg (Fed) | Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 1 | Any AE | 0 Participants |
| Part 1: GSK1325756H 50 mg (Fed) | Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 1 | Any SAE | 0 Participants |
| Part 1: GSK1325756H 100 mg (Fed) | Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 1 | Any AE | 1 Participants |
| Part 1: GSK1325756H 100 mg (Fed) | Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 1 | Any SAE | 0 Participants |
Primary
Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 2
AE is any untoward medical occurrence in a participant or clinical investigation 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 or is medically significant
Time frame: Up to 21 days in Part 2
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Placebo (Fed) | Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 2 | Any AE | 1 Participants |
| Part 1: Placebo (Fed) | Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 2 | Any SAE | 0 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 2 | Any AE | 0 Participants |
| Part 1: GSK1325756H 10 mg (Fed) | Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 2 | Any SAE | 0 Participants |
Primary
t1/2 of GSK1325756H for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. Only those participants with data available at the indicated time points were analyzed.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | t1/2 of GSK1325756H for Part 2 | 10.75500 Hours | Standard Deviation 2.928804 |
| Part 1: GSK1325756H 10 mg (Fed) | t1/2 of GSK1325756H for Part 2 | 11.09246 Hours | Standard Deviation 5.259109 |
Primary
Terminal Half-life (t1/2) of GSK1325756H for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756 in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1
Population: PK Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Terminal Half-life (t1/2) of GSK1325756H for Part 1 | 10.53043 Hours | Standard Deviation 2.938579 |
| Part 1: GSK1325756H 10 mg (Fed) | Terminal Half-life (t1/2) of GSK1325756H for Part 1 | 11.17318 Hours | Standard Deviation 2.284423 |
| Part 1: GSK1325756H 50 mg (Fed) | Terminal Half-life (t1/2) of GSK1325756H for Part 1 | 13.15755 Hours | Standard Deviation 4.540486 |
Primary
Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of GSK1325756H for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Placebo (Fed) | Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of GSK1325756H for Part 1 | 36.00000 Hours |
| Part 1: GSK1325756H 10 mg (Fed) | Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of GSK1325756H for Part 1 | 48.00000 Hours |
| Part 1: GSK1325756H 50 mg (Fed) | Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of GSK1325756H for Part 1 | 72.00000 Hours |
Primary
Time to Maximum Observed Concentration (Tmax) of GSK1325756H for Part 1
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Placebo (Fed) | Time to Maximum Observed Concentration (Tmax) of GSK1325756H for Part 1 | 3.50000 Hours |
| Part 1: GSK1325756H 10 mg (Fed) | Time to Maximum Observed Concentration (Tmax) of GSK1325756H for Part 1 | 3.00000 Hours |
| Part 1: GSK1325756H 50 mg (Fed) | Time to Maximum Observed Concentration (Tmax) of GSK1325756H for Part 1 | 4.00000 Hours |
Primary
Tlag of GSK1325756H for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Placebo (Fed) | Tlag of GSK1325756H for Part 2 | 0.25000 Hours |
| Part 1: GSK1325756H 10 mg (Fed) | Tlag of GSK1325756H for Part 2 | 0.00000 Hours |
Primary
Tlast of the Blood Concentration of GSK1325756H for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Placebo (Fed) | Tlast of the Blood Concentration of GSK1325756H for Part 2 | 48.00000 Hours |
| Part 1: GSK1325756H 10 mg (Fed) | Tlast of the Blood Concentration of GSK1325756H for Part 2 | 48.00000 Hours |
Primary
Tmax of GSK1325756H for Part 2
Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Placebo (Fed) | Tmax of GSK1325756H for Part 2 | 3.00000 Hours |
| Part 1: GSK1325756H 10 mg (Fed) | Tmax of GSK1325756H for Part 2 | 1.00000 Hours |
Primary
Urine pH Analysis by Dipstick Method for Part 2
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up to 48 hours in Part 2.
Time frame: Up to 48 hours in Part 2
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Urine pH Analysis by Dipstick Method for Part 2 | 6.66 pH | Standard Deviation 0.724 |
| Part 1: GSK1325756H 10 mg (Fed) | Urine pH Analysis by Dipstick Method for Part 2 | 6.47 pH | Standard Deviation 0.718 |
Primary
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 72 hours in Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Time frame: Up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Fed) | Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1 | Urine pH, 48 hours | 6.42 pH | Standard Deviation 0.634 |
| Part 1: Placebo (Fed) | Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1 | Urine pH, 72 hours | 6.08 pH | Standard Deviation 0.492 |
| Part 1: GSK1325756H 10 mg (Fed) | Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1 | Urine pH, 48 hours | 6.17 pH | Standard Deviation 0.389 |
| Part 1: GSK1325756H 50 mg (Fed) | Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1 | Urine pH, 48 hours | 6.42 pH | Standard Deviation 0.469 |
| Part 1: GSK1325756H 100 mg (Fed) | Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1 | Urine pH, 72 hours | 6.36 pH | Standard Deviation 0.636 |
Primary
Urine Specific Gravity Analysis by Dipstick Method for Part 1
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up to 72 hours in Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Density is the mass per unit volume and has units (such as g/cm\^3), however, the specific gravity is a ratio so it has no unit.
Time frame: Up to 72 hours in Part 1
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Urine Specific Gravity Analysis by Dipstick Method for Part 1 | 1.0167 Ratio | Standard Deviation 0.00753 |
| Part 1: GSK1325756H 10 mg (Fed) | Urine Specific Gravity Analysis by Dipstick Method for Part 1 | NA Ratio | — |
| Part 1: GSK1325756H 50 mg (Fed) | Urine Specific Gravity Analysis by Dipstick Method for Part 1 | NA Ratio | — |
| Part 1: GSK1325756H 100 mg (Fed) | Urine Specific Gravity Analysis by Dipstick Method for Part 1 | 1.0150 Ratio | Standard Deviation 0.00224 |
Primary
Urine Specific Gravity Analysis by Dipstick Method for Part 2
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up to 48 hours in Part 2. Density is the mass per unit volume and has units (such as g/cm\^3), however, the specific gravity is a ratio so it has no unit.
Time frame: Up to 72 hours in Part 2
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Fed) | Urine Specific Gravity Analysis by Dipstick Method for Part 2 | 1.0153 Ratio | Standard Deviation 0.00618 |
| Part 1: GSK1325756H 10 mg (Fed) | Urine Specific Gravity Analysis by Dipstick Method for Part 2 | 1.0159 Ratio | Standard Deviation 0.00712 |