A Phase 1 interventional study of GSK1325756H and Placebo in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 2 sites in Japan. Open to male participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-18.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 34 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion Criteria
Subjects will receive GSK1325756H 10 mg in P-1, GSK1325756H 50 mg in P-2 and placebo in P-3 after a high fat meal. There will be a washout period of at least 7 days between each treatment period.
Drug: GSK1325756H · Drug: Placebo
Subjects will receive GSK1325756H 10 mg in P-1, placebo in P-2 and GSK1325756H 100 mg in P-3 after a high fat meal. There will be a washout period of at least 7 days between each treatment period.
Drug: GSK1325756H · Drug: Placebo
Subjects will receive placebo in P-1, GSK1325756H 50 mg in P-2 and GSK1325756H 100 mg in P-3 after a high fat meal. There will be a washout period of at least 7 days between each treatment period.
Drug: GSK1325756H · Drug: Placebo
Subjects will receive GSK1325756H 50 mg after a low fat meal and fasted state respectively. There will be a washout period of at least 7 days between each treatment period.
Drug: GSK1325756H
Subjects will receive GSK1325756H 50 mg after a fasted state and a low fat meal respectively. There will be a washout period of at least 7 days between each treatment period.
Drug: GSK1325756H
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.
Subjects will receive visually matching danirixin placebo tablets. It will be administered with 240 mL of water.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
This study was conducted at a single center in Tokyo, Japan from 10-May-2017 to 31-July-2017.
| Milestone | Part 1-GSK1325756H 10 mg Then GSK1325756H 50 mg Then Placebo | Part 1-GSK1325756H 10 mg Then Placebo Then GSK1325756H 100 mg | Part 1-Placebo Then GSK1325756H 50 mg Then GSK1325756H 100 mg | Part 2-GSK1325756H Fed Followed by Fasted | Part 2-GSK1325756H Fasted Followed by Fed |
|---|---|---|---|---|---|
| Started | 6 | 6 | 6 | 0 | 0 |
| Completed | 6 | 6 | 6 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part 1-GSK1325756H 10 mg Then GSK1325756H 50 mg Then Placebo | Part 1-GSK1325756H 10 mg Then Placebo Then GSK1325756H 100 mg | Part 1-Placebo Then GSK1325756H 50 mg Then GSK1325756H 100 mg | Part 2-GSK1325756H Fed Followed by Fasted | Part 2-GSK1325756H Fasted Followed by Fed |
|---|---|---|---|---|---|
| Started | 6 | 6 | 6 | 0 | 0 |
| Completed | 6 | 6 | 6 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part 1-GSK1325756H 10 mg Then GSK1325756H 50 mg Then Placebo | Part 1-GSK1325756H 10 mg Then Placebo Then GSK1325756H 100 mg | Part 1-Placebo Then GSK1325756H 50 mg Then GSK1325756H 100 mg | Part 2-GSK1325756H Fed Followed by Fasted | Part 2-GSK1325756H Fasted Followed by Fed |
|---|---|---|---|---|---|
| Started | 6 | 6 | 6 | 0 | 0 |
| Completed | 6 | 6 | 6 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part 1-GSK1325756H 10 mg Then GSK1325756H 50 mg Then Placebo | Part 1-GSK1325756H 10 mg Then Placebo Then GSK1325756H 100 mg | Part 1-Placebo Then GSK1325756H 50 mg Then GSK1325756H 100 mg | Part 2-GSK1325756H Fed Followed by Fasted | Part 2-GSK1325756H Fasted Followed by Fed |
|---|---|---|---|---|---|
| Started | 6 | 6 | 6 | 0 | 0 |
| Completed | 6 | 5 | 6 | 0 | 0 |
| Not completed | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 0 |
| Milestone | Part 1-GSK1325756H 10 mg Then GSK1325756H 50 mg Then Placebo | Part 1-GSK1325756H 10 mg Then Placebo Then GSK1325756H 100 mg | Part 1-Placebo Then GSK1325756H 50 mg Then GSK1325756H 100 mg | Part 2-GSK1325756H Fed Followed by Fasted | Part 2-GSK1325756H Fasted Followed by Fed |
|---|---|---|---|---|---|
| Started | 6 | 5 | 6 | 0 | 0 |
| Completed | 6 | 5 | 6 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part 1-GSK1325756H 10 mg Then GSK1325756H 50 mg Then Placebo | Part 1-GSK1325756H 10 mg Then Placebo Then GSK1325756H 100 mg | Part 1-Placebo Then GSK1325756H 50 mg Then GSK1325756H 100 mg | Part 2-GSK1325756H Fed Followed by Fasted | Part 2-GSK1325756H Fasted Followed by Fed |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 8 | 8 |
| Completed | 0 | 0 | 0 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part 1-GSK1325756H 10 mg Then GSK1325756H 50 mg Then Placebo | Part 1-GSK1325756H 10 mg Then Placebo Then GSK1325756H 100 mg | Part 1-Placebo Then GSK1325756H 50 mg Then GSK1325756H 100 mg | Part 2-GSK1325756H Fed Followed by Fasted | Part 2-GSK1325756H Fasted Followed by Fed |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 8 | 8 |
| Completed | 0 | 0 | 0 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part 1-GSK1325756H 10 mg Then GSK1325756H 50 mg Then Placebo | Part 1-GSK1325756H 10 mg Then Placebo Then GSK1325756H 100 mg | Part 1-Placebo Then GSK1325756H 50 mg Then GSK1325756H 100 mg | Part 2-GSK1325756H Fed Followed by Fasted | Part 2-GSK1325756H Fasted Followed by Fed |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 8 | 8 |
| Completed | 0 | 0 | 0 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Any AE | 1 | 0 | 0 | 1 |
| Any SAE | 0 | 0 | 0 | 0 |
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
| Participants | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Any AE | 1 | 0 |
| Any SAE | 0 | 0 |
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).
| Millimoles/liter | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Calcium, 48 hours | -0.0208 ± 0.04617 | -0.0187 ± 0.04137 | 0.0021 ± 0.05675 | — |
| Calcium, 72 hours | -0.0000 ± 0.06312 | — | — | -0.0318 ± 0.05124 |
| Cholesterol, 48 hours | 0.0453 ± 0.36206 | 0.0129 ± 0.30588 | 0.1681 ± 0.53220 | — |
| Cholesterol, 72 hours | 0.2241 ± 0.62379 | — | — | -0.0541 ± 0.37997 |
| Chloride, 48 hours | 1.8 ± 1.11 | 1.9 ± 1.83 | 1.9 ± 1.44 | — |
| Chloride, 72 hours | 1.8 ± 1.17 | — | — | 1.5 ± 1.75 |
| Glucose, 48 hours | 0.2452 ± 0.27852 | 0.3516 ± 0.34246 | 0.1619 ± 0.32580 | — |
| Glucose, 72 hours | 0.2776 ± 0.16088 | — | — | 0.1463 ± 0.38958 |
| HDL cholesterol, 48 hours | -0.1789 ± 0.16035 | -0.1702 ± 0.12302 | -0.1228 ± 0.13910 | — |
| HDL cholesterol, 72 hours | -0.1509 ± 0.11380 | — | — | -0.2304 ± 0.10753 |
| Potassium, 48 hours | 0.04 ± 0.162 | 0.11 ± 0.231 | 0.28 ± 0.359 | — |
| Potassium, 72 hours | -0.17 ± 0.294 | — | — | 0.07 ± 0.200 |
| LDL cholesterol, 48 hours | -0.0065 ± 0.35150 | 0.0043 ± 0.26961 | 0.0711 ± 0.44012 | — |
| LDL cholesterol, 72 hours | 0.1896 ± 0.56007 | — | — | -0.0188 ± 0.36555 |
| Sodium, 48 hours | 0.6 ± 1.00 | 1.4 ± 2.07 | 0.9 ± 1.08 | — |
| Sodium, 72 hours | 1.0 ± 0.89 | — | — | 1.1 ± 1.45 |
| Phosphorus, 48 hours | -0.1588 ± 0.12039 | -0.1399 ± 0.08525 | -0.1426 ± 0.09972 | — |
| Phosphorus, 72 hours | -0.0969 ± 0.05776 | — | — | -0.1262 ± 0.11041 |
| Triglycerides, 48 hours | 0.6422 ± 0.31917 | 0.4963 ± 0.36405 | 0.5575 ± 0.38005 | — |
| Triglycerides, 72 hours | 0.3823 ± 0.34016 | — | — | 0.4910 ± 0.21744 |
| Urea/BUN, 48 hours | -0.7140 ± 0.79099 | -0.5355 ± 1.14422 | -0.1785 ± 0.95672 | — |
| Urea/BUN, 72 hours | -0.2975 ± 0.41735 | — | — | -0.5193 ± 0.96276 |
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).
| International units/liter | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Alkaline phosphatase, 48 hours | 1.1 ± 9.08 | -1.5 ± 8.44 | 0.0 ± 9.55 | — |
| Alkaline phosphatase,72 hours | 12.5 ± 13.37 | — | — | 4.6 ± 12.14 |
| ALT, 48 hours | -2.2 ± 2.89 | -0.5 ± 3.92 | -1.9 ± 2.94 | — |
| ALT, 72 hours | 2.5 ± 3.83 | — | — | 0.6 ± 2.29 |
| AST, 48 hours | -2.3 ± 4.38 | -0.6 ± 4.52 | -2.2 ± 3.19 | — |
| AST, 72 hours | 1.5 ± 3.67 | — | — | -1.4 ± 2.11 |
| Creatine kinase, 48 hours | -29.0 ± 27.10 | -34.3 ± 23.83 | -32.3 ± 22.18 | — |
| Creatine kinase, 72 hours | -34.7 ± 9.99 | — | — | -46.4 ± 32.96 |
| GGT, 48 hours | -1.0 ± 1.48 | 0.9 ± 1.44 | -1.9 ± 2.35 | — |
| GGT, 72 hours | 2.0 ± 1.10 | — | — | -0.1 ± 1.70 |
| Lactate dehydrogenase, 48 hours | -15.3 ± 20.20 | -13.8 ± 11.66 | -12.0 ± 10.08 | — |
| Lactate dehydrogenase, 72 hours | -2.8 ± 49.15 | — | — | -17.3 ± 7.40 |
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).
| Grams/liter | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Albumin, 48 hours | -0.3 ± 1.44 | -0.6 ± 1.44 | 0.3 ± 1.96 | — |
| Albumin, 72 hours | 1.2 ± 2.32 | — | — | -1.0 ± 1.34 |
| Total protein, 48 hours | 0.2 ± 2.59 | -0.3 ± 1.82 | 0.8 ± 3.01 | — |
| Total protein, 72 hours | 1.8 ± 2.64 | — | — | 0.0 ± 2.49 |
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).
| Micromoles/liter | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Direct bilirubin, 48 hours | -0.428 ± 0.7734 | 0.000 ± 1.2629 | -0.712 ± 0.8805 | — |
| Direct bilirubin, 72 hours | -0.855 ± 1.4307 | — | — | -0.466 ± 0.7987 |
| Total bilirubin, 48 hours | -1.283 ± 2.0784 | -0.428 ± 3.3513 | -1.425 ± 1.9060 | — |
| Total bilirubin, 72 hours | -2.565 ± 4.6830 | — | — | -2.332 ± 1.7560 |
| Creatinine, 48 hours | -1.9890 ± 4.33275 | -3.6833 ± 3.21689 | -1.8417 ± 3.02629 | — |
| Creatinine, 72 hours | -4.7147 ± 3.73658 | — | — | -4.0985 ± 3.79755 |
| Uric acid, 48 hours | -33.7053 ± 25.78160 | -33.7053 ± 17.26380 | -31.7227 ± 21.57043 | — |
| Uric acid, 72 hours | -27.7573 ± 43.97767 | — | — | -23.2513 ± 23.10621 |
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).
| Units/liter | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Amylase, 48 hours | 16.0 ± 9.16 | 20.6 ± 18.05 | 22.7 ± 13.21 | — |
| Amylase, 72 hours | 38.8 ± 28.84 | — | — | 14.4 ± 12.92 |
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.
| Millimoles/liter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Calcium, 48 hours | 0.0000 ± 0.05834 | 0.0000 ± 0.05154 |
| Cholesterol, 48 hours | 0.3119 ± 0.37218 | 0.3588 ± 0.25265 |
| Chloride, 48 hours | 0.2 ± 2.01 | 0.5 ± 1.86 |
| Glucose, 48 hours | 0.2116 ± 0.23744 | 0.1561 ± 0.35643 |
| HDL cholesterol, 48 hours | -0.1131 ± 0.12629 | -0.0808 ± 0.10678 |
| Potassium, 48 hours | 0.18 ± 0.377 | 0.14 ± 0.326 |
| LDL cholesterol, 48 hours | 0.1729 ± 0.30124 | 0.2279 ± 0.27614 |
| Sodium, 48 hours | -0.3 ± 1.65 | 0.8 ± 1.72 |
| Phosphorus inorganic, 48 hours | -0.0868 ± 0.08561 | -0.1433 ± 0.08821 |
| Triglycerides, 48 hours | 0.7402 ± 0.43390 | 0.6010 ± 0.39556 |
| Urea/BUN, 48 hours | -0.6024 ± 1.44409 | -0.3347 ± 0.90755 |
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.
| International units/liter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Alkaline phosphatase, 48 hours | 0.9 ± 9.96 | 6.5 ± 11.35 |
| ALT, 48 hours | -1.5 ± 1.93 | -1.5 ± 1.97 |
| AST, 48 hours | -2.0 ± 2.28 | -1.8 ± 1.29 |
| Creatine kinase, 48 hours | -29.7 ± 28.72 | -16.6 ± 18.89 |
| GGT, 48 hours | -0.5 ± 2.99 | -0.4 ± 2.50 |
| Lactate dehydrogenase, 48 hours | -14.8 ± 11.97 | -13.7 ± 6.80 |
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.
| Grams/liter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Albumin, 48 hours | 0.3 ± 1.54 | 0.8 ± 1.48 |
| Total protein, 48 hours | 1.1 ± 2.66 | 1.9 ± 2.25 |
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.
| Micromoles/liter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Direct bilirubin, 48 hours | -0.641 ± 1.5135 | -0.641 ± 1.2291 |
| Total bilirubin, 48 hours | -1.496 ± 4.6254 | -0.748 ± 2.6468 |
| Creatinine, 48 hours | -2.8178 ± 3.68348 | -4.2542 ± 3.32677 |
| Uric acid, 48 hours | -15.6135 ± 54.03085 | -8.5502 ± 75.89141 |
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.
| Units/liter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Change From Baseline in Clinical Chemistry Parameter Amylase for Part 2 | 18.2 ± 8.63 | 18.5 ± 8.75 |
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).
| Percentage of cells | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Basophils, 48 hours | 0.12 ± 0.221 | 0.09 ± 0.168 | 0.09 ± 0.131 | — |
| Basophils, 72 hours | 0.13 ± 0.082 | — | — | 0.03 ± 0.272 |
| Eosinophils, 48 hours | 1.39 ± 1.132 | 0.95 ± 1.301 | 0.73 ± 0.725 | — |
| Eosinophils, 72 hours | 1.10 ± 1.753 | — | — | 0.54 ± 0.923 |
| Lymphocytes, 48 hours | 5.18 ± 4.754 | 5.35 ± 5.907 | 4.39 ± 4.019 | — |
| Lymphocytes, 72 hours | 5.15 ± 3.363 | — | — | 2.85 ± 7.766 |
| Monocytes, 48 hours | -0.13 ± 0.677 | 0.01 ± 1.093 | -0.12 ± 0.920 | — |
| Monocytes, 72 hours | -0.18 ± 0.652 | — | — | 0.16 ± 1.249 |
| Total neutrophils, 48 hours | -6.56 ± 5.347 | -6.40 ± 7.071 | -5.10 ± 4.611 | — |
| Total neutrophils, 72 hours | -6.20 ± 3.946 | — | — | -3.57 ± 9.212 |
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).
| Grams/liter | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Hemoglobin, 48 hours | 3.7 ± 4.66 | 4.8 ± 4.24 | 5.5 ± 5.05 | — |
| Hemoglobin, 72 hours | 8.8 ± 5.23 | — | — | 5.0 ± 5.53 |
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).
| Proportion of red blood cells in blood | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Hematocrit, 48 hours | 0.0188 ± 0.01542 | 0.0177 ± 0.01293 | 0.0238 ± 0.01599 | — |
| Hematocrit, 72 hours | 0.0255 ± 0.01472 | — | — | 0.0121 ± 0.01700 |
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).
| Picograms | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Mean corpuscle hemoglobin, 48 hours | -0.32 ± 0.376 | -0.10 ± 0.429 | -0.14 ± 0.306 | — |
| Mean corpuscle hemoglobin, 72 hours | 0.22 ± 0.479 | — | — | 0.25 ± 0.362 |
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).
| Femtoliters | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Mean corpuscle volume, 48 hours | 0.7 ± 0.78 | 0.3 ± 0.65 | 1.3 ± 0.87 | — |
| Mean corpuscle volume, 72 hours | 0.2 ± 0.75 | — | — | 0.2 ± 0.75 |
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).
| Giga cells/liter | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Platelet count, 48 hours | 3.7 ± 14.59 | 1.4 ± 12.55 | 0.5 ± 15.95 | — |
| Platelet count, 72 hours | 14.5 ± 11.33 | — | — | 2.3 ± 10.53 |
| White blood cell count,48 hours | -0.54 ± 0.489 | -0.48 ± 0.956 | -0.67 ± 0.947 | — |
| White blood cell count,72 hours | -0.32 ± 0.471 | — | — | -0.75 ± 1.258 |
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).
| Trillion cells/liter | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Red blood cell count, 48 hours | 0.165 ± 0.1650 | 0.164 ± 0.1385 | 0.197 ± 0.1797 | — |
| Red blood cell count, 72 hours | 0.252 ± 0.1609 | — | — | 0.120 ± 0.1680 |
| Reticulocyte count, 48 hours | 0.0127 ± 0.01512 | 0.0038 ± 0.01765 | -0.0009 ± 0.01929 | — |
| Reticulocyte count, 72 hours | -0.0023 ± 0.01646 | — | — | -0.0037 ± 0.01780 |
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.
| Percentage of cells | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Basophils, 48 hours | -0.00 ± 0.250 | 0.09 ± 0.120 |
| Eosinophils, 48 hours | 0.44 ± 1.082 | 0.67 ± 0.960 |
| Lymphocytes, 48 hours | 3.58 ± 7.821 | 4.53 ± 5.248 |
| Monocytes, 48 hours | -0.04 ± 0.873 | -0.63 ± 0.936 |
| Total neutrophils, 48 hours | -3.97 ± 9.311 | -4.66 ± 6.035 |
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.
| Grams/liter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Change From Baseline in Hematology Parameter Hemoglobin for Part 2 | 9.4 ± 3.92 | 8.9 ± 4.51 |
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.
| Proportion of red blood cells in blood | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Change From Baseline in Hematology Parameter Hematocrit for Part 2 | 0.0304 ± 0.01286 | 0.0268 ± 0.01303 |
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.
| Picograms | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 2 | -0.12 ± 0.312 | 0.20 ± 0.268 |
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.
| Femtoliters | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 2 | 0.4 ± 0.96 | 0.6 ± 0.89 |
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.
| Giga cells/liter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Platelet count, 48 hours | 7.4 ± 15.32 | 13.1 ± 12.45 |
| White blood cell count,48 hours | 12.45 ± 0.995 | -0.36 ± 0.734 |
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.
| Trillion cells/liter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Red blood cell count, 48 hours | 0.318 ± 0.1462 | 0.255 ± 0.1590 |
| Reticulocyte count, 48 hours | -0.0018 ± 0.01203 | 0.0097 ± 0.01526 |
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.
| Participants | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Urine occult blood, Trace, 48 hours | 1 | 1 | 0 | 0 |
| Urine occult blood, + , 48 hours | 0 | 1 | 1 | 0 |
| Urine occult blood, Trace, 72 hours | 1 | 0 | 0 | 0 |
| Urine occult blood, + , 72 hours | 1 | 0 | 0 | 0 |
| Urine protein, Trace, 48 hours | 0 | 1 | 1 | 0 |
| Urine protein, Trace, 72 hours | 1 | 0 | 0 | 0 |
| Urine urobilinogen, Trace, 48 hours | 12 | 12 | 12 | 0 |
| Urine urobilinogen, Trace, 72 hours | 6 | 0 | 0 | 11 |
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).
| pH | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Urine pH, 48 hours | 6.42 ± 0.634 | 6.17 ± 0.389 | 6.42 ± 0.469 | — |
| Urine pH, 72 hours | 6.08 ± 0.492 | — | — | 6.36 ± 0.636 |
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.
| Ratio | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Urine Specific Gravity Analysis by Dipstick Method for Part 1 | 1.0167 ± 0.00753 | NA ± NA | NA ± NA | 1.0150 ± 0.00224 |
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.
| Participants | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Urine occult blood, Trace, 48 hours | 1 | 0 |
| Urine glucose, Trace , 48 hours | 1 | 0 |
| Urine protein, Trace, 48 hours | 0 | 2 |
| Urine urobilinogen, Trace, 48 hours | 15 | 15 |
| Urine urobilinogen, +, 48 hours | 1 | 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 dipstick method up to 48 hours in Part 2.
| pH | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Urine pH Analysis by Dipstick Method for Part 2 | 6.66 ± 0.724 | 6.47 ± 0.718 |
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.
| Ratio | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Urine Specific Gravity Analysis by Dipstick Method for Part 2 | 1.0153 ± 0.00618 | 1.0159 ± 0.00712 |
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).
| Millimeters of mercury | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| SBP, 4 hours | -4.8 ± 10.44 | -9.6 ± 9.21 | -4.2 ± 6.59 | -0.3 ± 7.02 |
| SBP, 24 hours | 1.7 ± 7.95 | 0.5 ± 13.61 | 1.7 ± 6.87 | 4.5 ± 13.55 |
| SBP, 48 hours | 4.5 ± 7.06 | 7.0 ± 10.76 | 5.9 ± 11.66 | 2.0 ± 10.47 |
| SBP, 72 hours | -0.8 ± 8.06 | — | — | 4.8 ± 12.18 |
| DBP, 4 hours | -3.6 ± 5.89 | -2.8 ± 3.33 | -2.2 ± 4.93 | -1.1 ± 5.36 |
| DBP, 24 hours | 0.8 ± 4.94 | 4.5 ± 4.58 | 0.8 ± 6.40 | 1.0 ± 6.32 |
| DBP, 48 hours | 2.0 ± 6.24 | 4.7 ± 6.07 | 2.1 ± 4.44 | 2.5 ± 6.12 |
| DBP, 72 hours | 3.8 ± 4.12 | — | — | 1.8 ± 7.69 |
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).
| Beats per minute | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Heart rate, 4 hours | -3.1 ± 3.92 | -3.2 ± 8.24 | -3.7 ± 6.17 | -2.9 ± 2.95 |
| Heart rate, 24 hours | -3.0 ± 4.67 | -7.5 ± 9.23 | -3.8 ± 4.97 | -2.2 ± 4.07 |
| Heart rate, 48 hours | -1.5 ± 3.09 | 1.2 ± 7.51 | -2.3 ± 6.59 | -2.7 ± 4.31 |
| Heart rate, 72 hours | -1.0 ± 4.98 | — | — | -1.0 ± 5.14 |
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).
| Degree Celsius | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| Temperature, 4 hours | 0.11 ± 0.363 | 0.07 ± 0.400 | 0.27 ± 0.393 | 0.14 ± 0.495 |
| Temperature 24 hours | -0.08 ± 0.269 | 0.01 ± 0.375 | 0.06 ± 0.394 | 0.05 ± 0.321 |
| Temperature, 48 hours | 0.02 ± 0.362 | -0.02 ± 0.364 | 0.01 ± 0.387 | 0.12 ± 0.460 |
| Temperature, 72 hours | 0.00 ± 0.179 | — | — | 0.17 ± 0.272 |
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.
| Millimeters of mercury | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| SBP, 4 hours | -1.5 ± 11.70 | -2.5 ± 12.46 |
| SBP, 24 hours | -2.8 ± 12.13 | -3.5 ± 11.64 |
| SBP, 48 hours | -1.9 ± 10.22 | -0.2 ± 14.47 |
| DBP, 4 hours | -0.8 ± 6.19 | -0.3 ± 6.63 |
| DBP, 24 hours | -0.7 ± 6.66 | -0.6 ± 6.15 |
| DBP, 48 hours | 0.1 ± 3.80 | 0.8 ± 6.31 |
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.
| Beats per minute | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Heart rate, 4 hours | -2.4 ± 4.69 | -1.8 ± 5.14 |
| Heart rate, 24 hours | 1.3 ± 5.46 | -0.1 ± 3.89 |
| Heart rate, 48 hours | 0.5 ± 3.83 | 0.5 ± 4.07 |
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.
| Degree Celsius | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Temperature, 4 hours | 0.06 ± 0.236 | 0.21 ± 0.340 |
| Temperature 24 hours | 0.04 ± 0.250 | 0.10 ± 0.316 |
| Temperature, 48 hours | 0.10 ± 0.228 | 0.10 ± 0.312 |
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).
| Milliseconds | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|---|
| PR Interval, 4 hours | -0.9 ± 11.65 | 0.7 ± 5.28 | 1.3 ± 4.29 | 0.5 ± 3.70 |
| PR Interval 24 hours | 2.3 ± 5.63 | 3.0 ± 7.56 | 4.3 ± 6.20 | 3.6 ± 5.57 |
| PR Interval, 48 hours | 5.6 ± 9.22 | -0.8 ± 8.50 | 5.7 ± 9.18 | 5.8 ± 6.84 |
| PR Interval, 72 hours | 6.7 ± 11.57 | — | — | 6.0 ± 6.26 |
| QRS duration, 4 hours | -0.4 ± 2.12 | -0.3 ± 2.39 | -0.2 ± 1.59 | -0.2 ± 3.03 |
| QRS duration, 24 hours | 0.4 ± 1.89 | 0.7 ± 1.97 | 0.7 ± 1.56 | 0.4 ± 1.75 |
| QRS duration, 48 hours | 1.0 ± 1.97 | 2.8 ± 1.99 | 1.7 ± 1.87 | 0.5 ± 2.02 |
| QRS duration, 72 hours | 1.7 ± 2.34 | — | — | 0.9 ± 2.74 |
| Uncorrected QT Interval, 4 hours | -1.7 ± 10.98 | -4.2 ± 15.90 | -4.0 ± 10.23 | -2.9 ± 11.08 |
| Uncorrected QT Interval, 24 hours | -1.8 ± 10.74 | 6.8 ± 15.69 | -1.0 ± 9.82 | -1.5 ± 11.70 |
| Uncorrected QT Interval, 48 hours | -4.4 ± 8.69 | -6.8 ± 12.52 | -1.5 ± 11.48 | -0.2 ± 14.76 |
| Uncorrected QT Interval, 72 hours | -8.3 ± 13.29 | — | — | -4.5 ± 14.54 |
| Corrected QT Interval, 4 hours | -9.7 ± 5.32 | -11.3 ± 5.14 | -10.8 ± 7.16 | -8.1 ± 5.36 |
| Corrected QT Interval, 24 hours | -7.6 ± 6.39 | -8.3 ± 7.75 | -9.5 ± 4.83 | -6.5 ± 6.02 |
| Corrected QT Interval, 48 hours | -8.7 ± 6.45 | -5.9 ± 7.44 | -10.7 ± 6.51 | -6.9 ± 9.59 |
| Corrected QT Interval,, 72 hours | -10.3 ± 3.27 | — | — | -7.6 ± 7.10 |
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.
| Milliseconds | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| PR Interval, 4 hours | -1.5 ± 5.59 | -0.6 ± 4.18 |
| PR Interval 24 hours | -2.5 ± 7.50 | 1.3 ± 4.37 |
| PR Interval, 48 hours | 1.5 ± 8.84 | 4.1 ± 6.13 |
| QRS duration, 4 hours | -0.6 ± 2.28 | -1.3 ± 4.12 |
| QRS duration, 24 hours | -1.0 ± 2.19 | -1.8 ± 5.00 |
| QRS duration, 48 hours | -0.6 ± 2.50 | -0.9 ± 4.26 |
| Uncorrected QT Interval, 4 hours | 3.1 ± 12.31 | 6.4 ± 10.02 |
| Uncorrected QT Interval, 24 hours | -10.0 ± 15.85 | -3.9 ± 13.83 |
| Uncorrected QT Interval, 48 hours | -6.4 ± 11.25 | -9.5 ± 17.84 |
| Corrected QT Interval, 4 hours | -3.1 ± 6.55 | 3.1 ± 7.20 |
| Corrected QT Interval, 24 hours | -6.1 ± 6.73 | -3.8 ± 7.38 |
| Corrected QT Interval, 48 hours | -5.7 ± 5.58 | -7.3 ± 8.69 |
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.
| Nanograms/milliliter | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|
| Blood concentration, Pre-dose | 0.000 ± NA | 0.000 ± NA | 0.000 ± NA |
| Blood concentration, 0.25 hours | 1.425 ± NA | 9.289 ± NA | 32.318 ± NA |
| Blood concentration, 0.5 hours | 24.350 ± NA | 151.658 ± 196.5556 | 201.782 ± NA |
| Blood concentration, 0.75 hours | 59.951 ± 67.9706 | 373.193 ± 376.8749 | 426.032 ± 611.1420 |
| Blood concentration, 1 hour | 94.150 ± 86.0423 | 455.042 ± 350.7416 | 634.955 ± 767.2316 |
| Blood concentration,, 2 hours | 153.395 ± 100.0463 | 971.417 ± 598.1981 | 1285.524 ± 1017.193 |
| Blood concentration, 3 hours | 154.733 ± 67.6734 | 950.852 ± 443.1637 | 1235.273 ± 740.0601 |
| Blood concentration, 4 hours | 177.417 ± 47.6187 | 966.658 ± 395.2375 | 1498.000 ± 607.8816 |
| Blood concentration, 6 hours | 126.817 ± 37.7057 | 639.667 ± 251.0068 | 1418.545 ± 497.2105 |
| Blood concentration, 8 hours | 76.567 ± 25.8472 | 386.667 ± 153.4840 | 735.700 ± 234.1135 |
| Blood concentration, 10 hours | 55.358 ± 16.1098 | 295.250 ± 96.3848 | 620.636 ± 217.5446 |
| Blood concentration,12 hours | 39.742 ± 10.1591 | 204.192 ± 70.3804 | 411.091 ± 143.5280 |
| Blood concentration, 24 hours | 16.363 ± 4.9104 | 77.342 ± 37.3054 | 160.982 ± 61.3081 |
| Blood concentration, 48 hours | 3.423 ± NA | 24.387 ± 13.2219 | 43.282 ± 17.8091 |
| Blood concentration, 60 hours | NA ± NA | NA ± NA | 19.087 ± 11.6452 |
| Blood concentration, 72 hours | NA ± NA | NA ± NA | 18.403 ± 12.5176 |
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.
| Nanograms/milliliter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Blood concentration, Pre-dose | 0.000 ± NA | 0.000 ± NA |
| Blood concentration, 0.25 hours | 23.888 ± NA | 434.557 ± 551.7663 |
| Blood concentration, 0.5 hours | 248.749 ± NA | 2233.813 ± 1476.075 |
| Blood concentration, 0.75 hours | 363.644 ± 745.3481 | 3599.500 ± 1240.578 |
| Blood concentration, 1 hour | 470.700 ± 711.2266 | 4210.625 ± 1361.315 |
| Blood concentration, 2 hours | 1039.688 ± 638.7844 | 3176.000 ± 691.7762 |
| Blood concentration, 3 hours | 1499.250 ± 657.7378 | 2156.250 ± 521.9307 |
| Blood concentration, 4 hours | 1682.667 ± 478.1134 | 1960.625 ± 402.0194 |
| Blood concentration, 6 hours | 774.938 ± 305.5721 | 640.500 ± 140.6840 |
| Blood concentration, 8 hours | 463.750 ± 143.7101 | 410.625 ± 105.4564 |
| Blood concentration, 10 hours | 364.438 ± 117.3348 | 350.813 ± 112.8440 |
| Blood concentration,12 hours | 244.938 ± 76.6059 | 254.188 ± 68.8847 |
| Blood concentration, 24 hours | 111.163 ± 43.6251 | 118.888 ± 53.3676 |
| Blood concentration, 48 hours | 40.568 ± 61.6334 | 29.918 ± 32.5396 |
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.
| Nanograms/milliliter | Part 1: GSK1325756H 10 mg (Fed) | Part 1:GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|
| Maximum Observed Concentration (Cmax) of GSK1325756H for Part 1 | 217.082 ± 17.8 | 1219.883 ± 37.3 | 1924.864 ± 39.6 |
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.
| Hours*nanograms/milliliter | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of GSK1325756H for Part 1 | 1622.2891 ± 21.7 | 8872.6074 ± 30.2 | 16681.8331 ± 25.2 |
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.
| Hours*nanograms/milliliter | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of GSK1325756H for Part 1 | 1779.0163 ± 18.8 | 9253.2108 ± 31.3 | 17072.6642 ± 24.4 |
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.
| Hours*nanograms/milliliter | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of GSK1325756H for Part 1 | 1500.0109 ± 14.7 | 7831.8861 ± 29.9 | 14000.5473 ± 27.1 |
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.
| Hours | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|
| Time to Maximum Observed Concentration (Tmax) of GSK1325756H for Part 1 | 3.50000 (2.0000 to 6.0000) | 3.00000 (2.0000 to 6.0000) | 4.00000 (2.0000 to 6.0000) |
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.
| Hours | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|
| Terminal Half-life (t1/2) of GSK1325756H for Part 1 | 10.53043 ± 2.938579 | 11.17318 ± 2.284423 | 13.15755 ± 4.540486 |
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.
| Hours | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|
| Lag Time Before Observable Concentration (Tlag) of GSK1325756H for Part 1 | 0.37500 (0.0000 to 1.0000) | 0.25000 (0.0000 to 2.0000) | 0.25000 (0.0000 to 1.0000) |
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.
| Hours | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) |
|---|---|---|---|
| Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of GSK1325756H for Part 1 | 36.00000 (24.0000 to 48.0000) | 48.00000 (48.0000 to 48.0000) | 72.00000 (48.0000 to 72.0000) |
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.
| Nanograms/milliliter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Cmax of GSK1325756H for Part 2 | 1818.544 ± 32.5 | 4146.886 ± 34.5 |
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.
| Hours*nanograms/milliliter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| AUC (0-t) of GSK1325756H for Part 2 | 11880.9038 ± 28.9 | 18303.0441 ± 22.1 |
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. Only those participants with data available at the indicated time points were analyzed.
| Hours*nanograms/milliliter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| AUC (0-inf) of GSK1325756H for Part 2 | 12143.8862 ± 28.8 | 18910.7975 ± 24.2 |
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.
| Hours*nanograms/milliliter | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| AUC (0-24) of GSK1325756H for Part 2 | 10433.9293 ± 25.8 | 16856.0664 ± 21.2 |
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.
| Hours | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Tmax of GSK1325756H for Part 2 | 3.00000 (0.5000 to 6.0000) | 1.00000 (0.5000 to 3.0000) |
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.
| Hours | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| t1/2 of GSK1325756H for Part 2 | 10.75500 ± 2.928804 | 11.09246 ± 5.259109 |
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.
| Hours | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Tlag of GSK1325756H for Part 2 | 0.25000 (0.0000 to 1.0000) | 0.00000 (0.00000 to 0.00000) |
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.
| Hours | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|
| Tlast of the Blood Concentration of GSK1325756H for Part 2 | 48.00000 (24.0000 to 48.0000) | 48.00000 (48.0000 to 48.0000) |
Collected over AEs and SAEs were collected from the Day -1 up to follow-up ( 32 days for Part 1 and up to 21 days for Part 2). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Placebo (Fed) | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| Part 1: GSK1325756H 10 mg (Fed) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Part 1: GSK1325756H 50 mg (Fed) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Part 1: GSK1325756H 100 mg (Fed) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) |
| Part 2: GSK1325756H 50 mg (Fed) | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) |
| Part 2: GSK1325756H 50 mg (Fasted) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Event | Part 1: Placebo (Fed) | Part 1: GSK1325756H 10 mg (Fed) | Part 1: GSK1325756H 50 mg (Fed) | Part 1: GSK1325756H 100 mg (Fed) | Part 2: GSK1325756H 50 mg (Fed) | Part 2: GSK1325756H 50 mg (Fasted) |
|---|---|---|---|---|---|---|
| Herpes zosterInfections and infestations | 0/18 | 0/12 | 0/12 | 1/11 | 0/16 | 0/16 |
| Blood uric acid increasedInvestigations | 0/18 | 0/12 | 0/12 | 0/11 | 1/16 | 0/16 |
| Viral upper respiratory tract infectionInfections and infestations | 1/18 | 0/12 | 0/12 | 0/11 | 0/16 | 0/16 |
| Age, Continuous(Years) | Part 1-Total Participants | Part 2-Total Participants | Total |
|---|---|---|---|
| Mean | 70.0 ± 3.01 | 69.3 ± 2.89 | 69.6 ± 2.93 |
| Sex: Female, Male(Participants) | Part 1-Total Participants | Part 2-Total Participants | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 18 | 16 | 34 |
| Race/Ethnicity, Customized(Participants) | Part 1-Total Participants | Part 2-Total Participants | Total |
|---|---|---|---|
| Japanese/East Asian /South East Asian Heritage | 18 | 16 | 34 |
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Pulmonary Disease, Chronic Obstructive→
GlaxoSmithKline