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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Group A | Experimental | 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. |
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| Part 1: Group B | Experimental | 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. |
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| Part 1: Group C | Experimental | 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. |
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| Part 2: Group D | Experimental | 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. |
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| Part 2: Group E | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1325756H | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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). | 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 |
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Inclusion Criteria
Exclusion Criteria
Japanese Healthy Elderly Male Subjects
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tokyo | 162-0053 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31056840 | Derived | Iida T, Matsuzawa Y, Ogura H, Nagakubo T, Wakamatsu A, Ambery C, Miller BE, Lazaar AL, Numachi Y. Evaluation of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Danirixin Hydrobromide Tablets in Japanese Healthy Elderly Participants. Clin Pharmacol Drug Dev. 2019 Nov;8(8):1081-1087. doi: 10.1002/cpdd.693. Epub 2019 May 6. |
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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.
This study was conducted at a single center in Tokyo, Japan from 10-May-2017 to 31-July-2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1-GSK1325756H 10 mg Then GSK1325756H 50 mg Then Placebo | Participants in this arm received GSK1325756H 10 milligrams (mg) in treatment period 1 followed by GSK1325756H 50 mg in treatment period 2 followed by placebo in treatment period 3. The treatment periods were separated were separated by a minimum of one-week washout period. |
| FG001 | Part 1-GSK1325756H 10 mg Then Placebo Then GSK1325756H 100 mg | Participants in this arm received GSK1325756H 10 mg in treatment period 1 followed placebo in treatment period 2 followed by GSK1325756H 100 mg in treatment period 3. The treatment periods were separated were separated by a minimum of one-week washout period. |
| FG002 | Part 1-Placebo Then GSK1325756H 50 mg Then GSK1325756H 100 mg | Participants in this arm received placebo in treatment period 1 followed by GSK1325756H 50 mg in treatment period 2 followed by GSK1325756H 100 mg in treatment period 3. The treatment periods were separated were separated by a minimum of one-week washout period. |
| FG003 | Part 2-GSK1325756H Fed Followed by Fasted | Participants were randomized to receive GSK1325756H 50 mg (fed) in Period 1 followed by GSK1325756H (fasted) in Period 2 of Part 2. The treatment periods were separated were separated by a minimum of one-week washout period. |
| FG004 | Part 2-GSK1325756H Fasted Followed by Fed | Participants were randomized to receive GSK1325756H 50 mg (fasted) in Period 1 followed by GSK1325756H (fed) in Period 2 of Part 2. The treatment periods were separated were separated by a minimum of one-week washout period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1, Period 1 (3 Days) |
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| Part 1, Washout Period 1 (7 Days) |
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| Part 1, Period 2 (3 Days) |
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| Part 1, Washout Period 2 (7 Days) |
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| Part 1, Period 3 (4 Days) |
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| Part 2, Period 1 (3 Days) |
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| Part 2, Washout Period 1 (7 Days) |
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| Part 2, Period 2 (3 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Population | Posted | Number | Participants | Up to 32 days in Part 1 |
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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)
Safety Population was used for analysis of AE and SAE's.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Placebo (Fed) | Participants received matching placebo tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2017 | Mar 7, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2017 | Mar 7, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Placebo | Drug | Subjects will receive visually matching danirixin placebo tablets. It will be administered with 240 mL of water. |
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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). |
| 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 |
| Tokyo |
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| COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | Part 1: GSK1325756H 10 mg (Fed) | Participants received GSK1325756H 10 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1. |
| OG002 | Part 1: GSK1325756H 50 mg (Fed) | Participants received GSK1325756H 50 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1. |
| OG003 | Part 1: GSK1325756H 100 mg (Fed) | Participants received GSK1325756H 100 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1. |
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| 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 | Safety Population | Posted | Number | Participants | Up to 21 days in Part 2 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Millimoles/liter | Baseline and up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | International units/liter | Baseline and up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Grams/liter | Baseline and up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Micromoles/liter | Baseline and up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Units/liter | Baseline and up to 72 hours in Part 1 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Millimoles/liter | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | International units/liter | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Grams/liter | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Micromoles/liter | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Units/liter | Baseline and up to 48 hours in Part 2 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Percentage of cells | Baseline and up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Grams/liter | Baseline and up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline and up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Picograms | Baseline and up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Femtoliters | Baseline and up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Giga cells/liter | Baseline and up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Trillion cells/liter | Baseline and up to 72 hours in Part 1 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Percentage of cells | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Grams/liter | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Picograms | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Femtoliters | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Giga cells/liter | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Trillion cells/liter | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Number | Participants | Up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | pH | Up to 72 hours in Part 1 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Ratio | Up to 72 hours in Part 1 |
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| 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. | Safety Population | Posted | Number | Participants | Up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | pH | Up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Ratio | Up to 72 hours in Part 2 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline and up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline and up to 72 hours in Part 1 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Degree Celsius | Baseline and up to 72 hours in Part 1 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline and up to 48 hours in Part 2 |
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| 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. | Safety Population | Posted | Mean | Standard Deviation | Degree Celsius | Baseline and up to 48 hours in Part 2 |
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| 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). | Safety Population | Posted | Mean | Standard Deviation | Milliseconds | Baseline and up to 72 hours in Part 1 |
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|
|
| 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. | Safety Population | Posted | Mean | Standard Deviation | Milliseconds | Baseline and up to 48 hours in Part 2 |
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|
| 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. | PK Population | Posted | Mean | Standard Deviation | Nanograms/milliliter | 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 |
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|
| 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. | PK Population | Posted | Mean | Standard Deviation | Nanograms/milliliter | 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 |
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| 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. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms/milliliter | 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 |
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|
| 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. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms/milliliter | 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 |
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|
| 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. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms/milliliter | 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 |
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|
| 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. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms/milliliter | 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 |
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| 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. | PK Population | Posted | Median | Full Range | Hours | 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 |
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|
| 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. | PK Population | Posted | Mean | Standard Deviation | Hours | 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 |
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|
| 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. | PK Population | Posted | Median | Full Range | Hours | 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 |
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| 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. | PK Population | Posted | Median | Full Range | Hours | 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 |
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| 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. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms/milliliter | 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 |
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| 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. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms/milliliter | 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 |
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| 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. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms/milliliter | 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 |
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| 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. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms/milliliter | 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 |
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| 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. | PK Population | Posted | Median | Full Range | Hours | 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 |
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| 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. | PK Population | Posted | Mean | Standard Deviation | Hours | 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 |
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| 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. | PK Population | Posted | Median | Full Range | Hours | 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 |
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| 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. | PK Population | Posted | Median | Full Range | Hours | 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 |
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|
| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | Part 1: GSK1325756H 10 mg (Fed) | Participants received GSK1325756H 10 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Part 1: GSK1325756H 50 mg (Fed) | Participants received GSK1325756H 50 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | Part 1: GSK1325756H 100 mg (Fed) | Participants received GSK1325756H 100 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 1. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG004 | Part 2: GSK1325756H 50 mg (Fed) | Participants received GSK1325756H 50 mg tablets via the oral route with food (fed state) and 240 milliliters of water in Part 2. | 0 | 16 | 0 | 16 | 1 | 16 |
| EG005 | Part 2: GSK1325756H 50 mg (Fasted) | Participants received GSK1325756H 50 mg tablets via the oral route without food (fasted state) and 240 mililiters of water in Part 2. | 0 | 16 | 0 | 16 | 0 | 16 |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Calcium, 72 hours |
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| Cholesterol, 48 hours |
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| Cholesterol, 72 hours |
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| Chloride, 48 hours |
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| Chloride, 72 hours |
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| Glucose, 48 hours |
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| Glucose, 72 hours |
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| HDL cholesterol, 48 hours |
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| HDL cholesterol, 72 hours |
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| Potassium, 48 hours |
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| Potassium, 72 hours |
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| LDL cholesterol, 48 hours |
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| LDL cholesterol, 72 hours |
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| Sodium, 48 hours |
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| Sodium, 72 hours |
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| Phosphorus, 48 hours |
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| Phosphorus, 72 hours |
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| Triglycerides, 48 hours |
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| Triglycerides, 72 hours |
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| Urea/BUN, 48 hours |
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| Urea/BUN, 72 hours |
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|
| Alkaline phosphatase,72 hours |
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| ALT, 48 hours |
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| ALT, 72 hours |
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| AST, 48 hours |
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| AST, 72 hours |
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| Creatine kinase, 48 hours |
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| Creatine kinase, 72 hours |
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| GGT, 48 hours |
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| GGT, 72 hours |
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| Lactate dehydrogenase, 48 hours |
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| Lactate dehydrogenase, 72 hours |
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| Albumin, 72 hours |
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| Total protein, 48 hours |
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| Total protein, 72 hours |
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| Direct bilirubin, 72 hours |
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| Total bilirubin, 48 hours |
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| Total bilirubin, 72 hours |
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| Creatinine, 48 hours |
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| Creatinine, 72 hours |
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| Uric acid, 48 hours |
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| Uric acid, 72 hours |
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| Amylase, 72 hours |
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| Chloride, 48 hours |
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| Glucose, 48 hours |
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| HDL cholesterol, 48 hours |
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| Potassium, 48 hours |
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| LDL cholesterol, 48 hours |
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| Sodium, 48 hours |
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| Phosphorus inorganic, 48 hours |
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| Triglycerides, 48 hours |
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| Urea/BUN, 48 hours |
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| AST, 48 hours |
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| Creatine kinase, 48 hours |
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| GGT, 48 hours |
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| Lactate dehydrogenase, 48 hours |
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| Creatinine, 48 hours |
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| Uric acid, 48 hours |
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| Basophils, 72 hours |
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| Eosinophils, 48 hours |
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| Eosinophils, 72 hours |
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| Lymphocytes, 48 hours |
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| Lymphocytes, 72 hours |
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| Monocytes, 48 hours |
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| Monocytes, 72 hours |
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| Total neutrophils, 48 hours |
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| Total neutrophils, 72 hours |
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| Hemoglobin, 72 hours |
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| Hematocrit, 72 hours |
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| Mean corpuscle hemoglobin, 72 hours |
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| Mean corpuscle volume, 72 hours |
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| Platelet count, 72 hours |
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| White blood cell count,48 hours |
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| White blood cell count,72 hours |
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| Red blood cell count, 72 hours |
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| Reticulocyte count, 48 hours |
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| Reticulocyte count, 72 hours |
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| Lymphocytes, 48 hours |
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| Monocytes, 48 hours |
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| Total neutrophils, 48 hours |
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| Urine occult blood, + , 48 hours |
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| Urine occult blood, Trace, 72 hours |
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| Urine occult blood, + , 72 hours |
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| Urine protein, Trace, 48 hours |
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| Urine protein, Trace, 72 hours |
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| Urine urobilinogen, Trace, 48 hours |
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| Urine urobilinogen, Trace, 72 hours |
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| Urine pH, 72 hours |
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| Urine protein, Trace, 48 hours |
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| Urine urobilinogen, Trace, 48 hours |
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| Urine urobilinogen, +, 48 hours |
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| SBP, 24 hours |
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| SBP, 48 hours |
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| SBP, 72 hours |
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| DBP, 4 hours |
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| DBP, 24 hours |
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| DBP, 48 hours |
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| DBP, 72 hours |
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| Heart rate, 24 hours |
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| Heart rate, 48 hours |
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| Heart rate, 72 hours |
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| Temperature 24 hours |
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| Temperature, 48 hours |
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| Temperature, 72 hours |
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| SBP, 48 hours |
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| DBP, 4 hours |
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| DBP, 24 hours |
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| DBP, 48 hours |
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| Heart rate, 48 hours |
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| Temperature, 48 hours |
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| PR Interval 24 hours |
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| PR Interval, 48 hours |
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| PR Interval, 72 hours |
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| QRS duration, 4 hours |
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| QRS duration, 24 hours |
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| QRS duration, 48 hours |
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| QRS duration, 72 hours |
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| Uncorrected QT Interval, 4 hours |
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| Uncorrected QT Interval, 24 hours |
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| Uncorrected QT Interval, 48 hours |
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| Uncorrected QT Interval, 72 hours |
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| Corrected QT Interval, 4 hours |
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| Corrected QT Interval, 24 hours |
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| Corrected QT Interval, 48 hours |
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| Corrected QT Interval,, 72 hours |
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| PR Interval, 48 hours |
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| QRS duration, 4 hours |
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| QRS duration, 24 hours |
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| QRS duration, 48 hours |
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| Uncorrected QT Interval, 4 hours |
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| Uncorrected QT Interval, 24 hours |
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| Uncorrected QT Interval, 48 hours |
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| Corrected QT Interval, 4 hours |
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| Corrected QT Interval, 24 hours |
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| Corrected QT Interval, 48 hours |
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| Blood concentration, 0.25 hours |
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| Blood concentration, 0.5 hours |
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| Blood concentration, 0.75 hours |
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| Blood concentration, 1 hour |
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| Blood concentration,, 2 hours |
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| Blood concentration, 3 hours |
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| Blood concentration, 4 hours |
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| Blood concentration, 6 hours |
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| Blood concentration, 8 hours |
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| Blood concentration, 10 hours |
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| Blood concentration,12 hours |
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| Blood concentration, 24 hours |
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| Blood concentration, 48 hours |
|
| Blood concentration, 60 hours |
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| Blood concentration, 72 hours |
|
| Title |
|---|
| Measurements |
|---|
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| Blood concentration, 0.5 hours |
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| Blood concentration, 0.75 hours |
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| Blood concentration, 1 hour |
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| Blood concentration, 2 hours |
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| Blood concentration, 3 hours |
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| Blood concentration, 4 hours |
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| Blood concentration, 6 hours |
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| Blood concentration, 8 hours |
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| Blood concentration, 10 hours |
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| Blood concentration,12 hours |
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| Blood concentration, 24 hours |
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| Blood concentration, 48 hours |
|