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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002662-45 | EudraCT Number |
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This study is designed to evaluate the safety, tolerability and PK of GSK2982772, in repeat oral doses in healthy subjects. This study is being conducted to support administration of higher dose levels of GSK2982772 than initially studied in the First Time in Human (FTiH) study. This study will also assess the impact of food during the repeat doses of GSK2982772. This will be a two part study; Part A and Part B. Part A (cohort 1) - single ascending dose, randomized, placebo-controlled, 3-way crossover. Part B (cohorts 2, 3, 4 and 5) - repeat dose, randomized, placebo-controlled, sequential-group. Subjects will be randomized in 3:1 ratio to receive GSK2982772 or placebo in crossover manner on Day 1 of each of the three periods in Part A. Subjects will be randomized in 3:1 ratio to receive GSK2982772 or placebo in sequential groups for 14 days in cohort 2 of Part B and in 9:5 ratio to receive GSK2982772 or placebo in sequential groups for 14 days in cohorts 3, 4 and 5 of Part B. Approximately 66 subjects will be included in this study. The study duration, including screening and follow-up, will not be expected to exceed 13 weeks for Part A and 8 weeks for Part B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving treatment sequence ABC in cohort 1: Part A | Experimental | Eligible subjects will be randomized to receive treatment sequence ABC in Part A; A= GSK2982772 120 mg TID, B= GSK2982772 240 mg TID, and C= GSK2982772 360 mg BID. Subjects will receive oral capsule of GSK2982772 or placebo on Day 1 in each of the 3 treatment periods followed by a wash-out period of at least 7 days between dosing regimens. |
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| Subjects receiving treatment sequence ABP in cohort 1: Part A | Experimental | Eligible subjects will be randomized to receive treatment sequence ABP in Part A; A= GSK2982772 120 mg TID, B= GSK2982772 240 mg TID, and P= Placebo. Subjects will receive oral capsule of GSK2982772 or placebo on Day 1 in each of the 3 treatment periods followed by a wash-out period of at least 7 days between dosing regimens. |
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| Subjects receiving treatment sequence APC in cohort 1: Part A | Experimental | Eligible subjects will be randomized to receive treatment sequence APC in Part A; A= GSK2982772 120 mg TID, P= Placebo and C= GSK2982772 360 mg BID. Subjects will receive oral capsule of GSK2982772 or placebo on Day 1 in each of the 3 treatment periods followed by a wash-out period of at least 7 days between dosing regimens. |
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| Subjects receiving treatment sequence PBC in cohort 1: Part A | Experimental | Eligible subjects will be randomized to receive treatment sequence PBC in Part A; P= Placebo, B= GSK2982772 240 mg TID and C= GSK2982772 360 mg BID. Subjects will receive oral capsule of GSK2982772 or placebo on Day 1 in each of the 3 treatment periods followed by a wash-out period of at least 7 days between dosing regimens. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2982772 capsule | Drug | GSK2982772 will be available as size 00, white, opaque capsule containing white to almost white Solid (120 mg maximum fill per capsule). It will be administered orally with water to receive total dose of 120 mg, 240 mg or 360 mg per randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events (AEs) and Serious AEs (SAEs): Part A | An AE is any untoward medical occurrence in a clinical study subjects, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE. | Up to Day 14 |
| Number of Participants With AEs and SAEs: Part B | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. | Up to Day 28 |
| Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A | Blood samples were collected from participants for the analysis of following clinical chemistry parameters: alanine amino transferase (ALT), albumin, alkaline phosphatase, aspartate amino transferase (AST), calcium, creatinine, glucose, potassium, sodium and total bilirubin. PCI ranges were >=2 times Upper Limit of Normal (ULN) units per liter (U/L) for ALT, <30 grams per liter (g/L) for albumin, >=2 times ULN U/L for alkaline phosphatase, >=2 times ULN U/L for AST, <2 or >2.75 millimoles per liter (mmol/L) for calcium, >44.2 micromoles per liter (µmol/L) for creatinine, <3 or >9 mmol/L for glucose, <3 or >5.5 mmol/L for potassium, <130 or >150 mmol/L for sodium and >=1.5 times ULN for total bilirubin. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category. | Up to Week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours (AUC[0-24]) Following TID Dosing of GSK2982772: Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20, 40minutes, 1 hour, 1hr 30min, 2, 3, 5, 7hour, 7hr 20min,and 7hr 40 min, 8hr, 8hr 30min, 9hr, 10hr, 12hr, 14hr, 14hr 20min, 14hr 40 min, 15hr, 15hr 30min, 16hr, 17hr, 19hr, 22hr, 24hours post dose on Day1 |
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Inclusion Criteria:
Exclusion Criteria:
PART B Specific exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | CB2 2GG | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33165774 | Derived | Tompson DJ, Davies C, Scott NE, Cannons EP, Kostapanos M, Gross AS, Powell M, Ino H, Shimamura R, Ogura H, Nagakubo T, Igarashi H, Nakano A. Comparison of the Pharmacokinetics of RIPK1 Inhibitor GSK2982772 in Healthy Western and Japanese Subjects. Eur J Drug Metab Pharmacokinet. 2021 Jan;46(1):71-83. doi: 10.1007/s13318-020-00652-2. |
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Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
A total of 62 participants (15 in Part A and 47 in Part B) were enrolled in the study. Participants were not enrolled into the GSK2982772 360 milligram (mg) twice daily (BID) arm of Part B as one participant in the 360 mg BID dose level in Part A exceeded the maximum concentration (Cmax) stopping criteria.
This study consisted of two parts; part A was single ascending dose, 3-way crossover and part B was repeat dose, sequential assignment which investigated the safety, tolerability, and pharmacokinetics of GSK2982772, in healthy participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A:GSK2982772 120 mg TID/240 mg TID/360 mg BID | Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by 240 mg TID in treatment period 2 followed by 360 mg BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days. |
| FG001 | Part A:GSK2982772 120 mg TID/240 mg TID/Placebo | Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by 240 mg TID in treatment period 2 followed by matching Placebo in treatment period 3. The treatment periods were separated by a washout period of at least 7 days. |
| FG002 | Part A:GSK2982772 120 mg TID/Placebo/GSK2982772 360 mg BID | Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by matching Placebo in treatment period 2 followed by 360 mg GSK2982772 BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days. |
| FG003 | Part A:Placebo/GSK2982772 240 mg TID/360 mg BID | Participants received oral capsule of matching Placebo in treatment period 1 followed by 240 mg GSK2982772 TID in treatment period 2 followed by 360 mg GSK2982772 BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days. |
| FG004 | Part B:Placebo | Participants received matching oral placebo capsule to GSK2928772 for 14 days. |
| FG005 | Part B:GSK2982772 120 mg TID | Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days |
| FG006 | Part B:GSK2982772 240 mg TID | Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days. |
| FG007 | Part B:GSK2982772 360 mg BID | Participants were planned to receive GSK2982772 oral capsule at a dose of 360 mg BID for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A Period 1 (1Day) + Washout (7days) |
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| Part A Period 2 (1Day) + Washout (7days) |
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| Part A Period 3 (1Day) + Washout (7days) |
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| Part B (14 Days) |
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Participants were not enrolled into the GSK2982772 360 mg BID of Part B as one participant in the 360 mg BID dose level in Part A exceeded the maximum concentration (Cmax) stopping criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A:GSK2982772 120 mg TID/240 mg TID/360 mg BID | Participants received oral capsule of 120 mg GSK2982772 three times a day in treatment period 1 followed by 240 mg TID in treatment period 2 followed by 360 mg BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days. |
| BG001 |
| Units | Counts |
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| 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 Subjects With Adverse Events (AEs) and Serious AEs (SAEs): Part A | An AE is any untoward medical occurrence in a clinical study subjects, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE. | Safety population. Safety population consists of all randomized participants who take at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to Day 14 |
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On-treatment SAEs and non serious AEs were collected from the start of study treatment up to Day 14 for Part A and up to Day 28 for Part B.
Safety population consists of all randomized participants who take at least 1 dose of study treatment.
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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 A: Placebo | Participants received matching oral placebo capsule to GSK2928772 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis contact | Skin and subcutaneous tissue disorders | 20.1 | 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 | Feb 26, 2018 | Sep 26, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2018 | Sep 26, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000708951 | GSK2982772 |
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This study will consist of two parts; Part A and Part B. Part A will be a 3-way crossover design and Part B will be a sequential-group design.
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This will be a double-blind study. Subjects and investigator will be masked.
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| Subjects receiving GSK2982772 120 mg TID in cohort 2 : Part B | Experimental | Eligible subjects will receive GSK2982772 oral capsule with a dose of 120 mg TID for 14 days in Part B. |
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| Subjects receiving GSK2982772 120 mg TID in cohort 3 : Part B | Experimental | Eligible subjects will receive GSK2982772 oral capsule with a dose of 120 mg TID for 14 days in Part B. |
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| Subjects receiving GSK2982772 240 mg TID in cohort 4: Part B | Experimental | Eligible subjects will receive GSK2982772 oral capsule with a dose of 240 mg TID for 14 days in Part B. |
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| Subjects receiving GSK2982772 360 mg BID in cohort 5: Part B | Experimental | Eligible subjects will receive GSK2982772 oral capsule with a dose of 360 mg BID for 14 days in Part B. |
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| Subjects receiving placebo in cohort 2 : Part B | Placebo Comparator | Subjects will receive placebo oral capsule for 14 days in Part B. |
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| Subjects receiving placebo in cohort 3 : Part B | Placebo Comparator | Subjects will receive placebo oral capsule for 14 days in Part B. |
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| Subjects receiving placebo in cohort 4 : Part B | Placebo Comparator | Subjects will receive placebo oral capsule for 14 days in Part B. |
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| Subjects receiving placebo in cohort 5: Part B | Placebo Comparator | Subjects will receive placebo oral capsule for 14 days in Part B. |
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| Placebo capsule | Drug | Placebo will be available as size 00, white, opaque capsule containing white to almost white Solid. It will be administered orally with water. |
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| Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B | Blood samples were collected from participants for the analysis of following clinical chemistry parameters: ALT, albumin, alkaline phosphatase, AST, calcium, creatinine, glucose, potassium, sodium and total bilirubin. PCI ranges were >=2 times ULN U/L for ALT, <30 g/L for albumin, >=2 times ULN U/L for alkaline phosphatase, >=2 times ULN U/L for AST, <2 or >2.75 mmol/L for calcium, >44.2 µmol/L for creatinine, <3 or >9 mmol/L for glucose, <3 or >5.5 mmol/L for potassium, <130 or >150 mmol/L for sodium and >=1.5 times ULN for total bilirubin. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category. | Up to Week 4 |
| Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A | Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, lymphocytes, platelet count, total neutrophils and white blood cell (WBC) counts. PCI ranges were >0.54 or < 0.075 proportion of red blood cells (RBC) in blood for hematocrit, <25 or >180 g/L for hemoglobin, 0.8 x10^9 cells/L for lymphocytes, <1.5 x10^9 cells/L for neutrophils, <100 or >550 x10^9 cells/L for platelets and <3 or 20> x 10^9 cells per liter WBC. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category. | Up to Week 9 |
| Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B | Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, lymphocytes, platelet count, total neutrophils and WBC counts. PCI ranges were >0.54 or < 0.075 proportion of RBC in blood for hematocrit, <25 or >180 g/L for hemoglobin, 0.8 x10^9 cells/L for lymphocytes, <1.5 x10^9 cells/L for neutrophils, <100 or >550 x10^9 cells/L for platelets and <3 or 20> x 10^9 cells per liter WBC. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category. | Up to Week 4 |
| Number of Participants With Worst Case Urinalysis Results: Part A | Urine samples were collected from participants for analysis of following parameters: cellular casts, granular casts, hyaline casts, RBC and WBC and were counted as cells per high-power field (cells/HPF). The number of participants with cells in urine has been presented. | Up to Week 9 |
| Number of Participants With Worst Case Urinalysis Results: Part B | Urine samples were collected from participants for analysis of following parameters: cellular casts, granular casts, hyaline casts, RBC and WBC and were counted as cells per high-power field (cells/HPF). The number of participants with cells in urine has been presented. | Up to Week 4 |
| Number of Participants With Abnormal Vital Signs: Part A | Vital signs were measured in a supine position after 5 minutes rest. The PCI criteria for vital signs included: systolic blood pressure <85 and >160 millimeters of mercury [mmHg]), diastolic blood pressure <45 mmHg and >100 mmHg, heart rate <40 and >100 beats per minute, body temperature <=35.5 and >=37.8 degrees Celsius and respiration rate <=8 and >=20 breaths per minute. Data of participants with potential clinical importance has been reported. | Up to Week 9 |
| Number of Participants With Abnormal Vital Signs: Part B | Vital signs were measured in a supine position after 5 minutes rest. The PCI criteria for vital signs included: systolic blood pressure <85 and >160 mmHg, diastolic blood pressure <45 mmHg and >100 mmHg, heart rate <40 and >100 beats per minute, body temperature <=35.5 and >=37.8 degrees Celsius and respiration rate <=8 and >=20 breaths per minute. Data of participants with potential clinical importance has been reported. | Up to Week 4 |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings: Part A | 12-lead ECG's were obtained in the supine position after 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Up to Day 4 |
| Number of Participants With Abnormal ECG Findings: Part B | 12-lead ECG's were obtained in the supine position after 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Up to Week 4 |
| AUC(0-24) Following BID Dosing of GSK2982772: Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20min, 40min, 1hr, 1hr 30min, 2hr, 3hr, 4hr, 6hr, 8hr, 10hr, 12hr, 12hr 20min, 12hr 40min, 13hr, 13hr 30min, 14hr, 15hr, 16hr, 19hr, 22hr, 24hr post dose on Day 1. |
| AUC[0-24] Following TID Dosing of GSK2982772: Part B | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20, 40minutes, 1 hour, 1hr 30min, 2, 3, 5, 7hour, 7hr 20min,and 7hr 40 min, 8hr, 8hr 30min, 9hr, 10hr, 12hr, 14hr, 14hr 20min, 14hr 40 min, 15hr, 15hr 30min, 16hr, 17hr, 19hr, 22hr, 24hours post dose on Day14 |
| AUC (0-7) Following TID Dosing of GSK2982772 : Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Day 1 |
| AUC (7-14) Following TID Dosing of GSK2982772 : Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 7 hours, 7 hours 20 and 40 minutes, 8 hours, 8 hours 30 minutes, 9, 10, 12, 14 hours on Day 1 |
| AUC (14-24) Following TID Dosing of GSK2982772 : Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 14 hours, 14 hours 20 and 40 minutes, 15 hours ,15 hours 30 minutes, 16, 19, 22 and 24 hours on Day 1 |
| AUC (0-12) Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 4, 6, 8, 10 hours,12 hours on Day 1 |
| AUC (12-24) Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 12 hours, 12 hours 20 and 40 minutes, 13 and 13 hours 30 minutes, 14, 15, 16, 19, 22 and 24 hours on Day 1 |
| AUC(0-7) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 1 and 14 |
| AUC (7-14) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 7 and 7 hours 20 and 40 minutes, 8 and 8 hours 30 minutes, 9, 10, 12, 14 hours on Day 14 |
| AUC (14-24) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 14 hours, 14 hours 20 minutes, 14 hours 40 minutes, 15 hours, 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours on Day 14 |
| Maximum Observed Plasma Drug Concentration Cmax (0-7) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, and 7 hours post dose on Day 1 |
| Cmax (7-14) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 7 hours, 7 hours 20 and 40 minutes, 8 and 8 hours 30 minutes, 9, 10, 12, 14 hours post dose on Day 1 |
| Cmax (14-24) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 14 hours, 14 hours 20 and 40 minutes, 15 and 15 hours 30 minutes, 16, 19, 22 and 24 hours post dose on Day 1 |
| Cmax (0-12) Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 4, 6, 8, 10 hours and 12 hours post dose on Day 1 |
| Cmax (12-24) Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 12 hours, 12 hours 20 and 40 minutes, 13 and 13 hours 30 minutes, 14, 15, 16, 19, 22 and 24 hours post dose on Day 1 |
| Cmax (0-7) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours post dose on Days 1 and 14 |
| Cmax (7-14) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 7hours, 7 hours 20 and 40 minutes, 8 hours, 8 hours 30 minutes, 9, 10, 12, 14 hours on Day 14 |
| Cmax (14-24) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 14 hours, 14 hours 20 and 40 minutes, 15 hours, 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours post dose on Day 14 |
| Time to Cmax (Tmax) (0-7) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, and 7 hours post dose on Day 1 |
| Tmax (7-14) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 7hours, 7 hours 20 and 40 minutes, 8 hours, 8 hours 30 minutes, 9, 10, 12, 14 hours post dose on Day 1 |
| Tmax (14-24) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 14 hours, 14 hours 20 and 40 minutes, 15 hours, 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours post dose on Day 1 |
| Tmax (0-12) Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20 and 40 minutes, 1hour, 1 hour 30 minutes, 2, 3, 4, 6, 8, 10 hours and 12 hours post dose on Day 1 |
| Tmax (12-24) Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 12 hours, 12 hours 20 and 40 minutes, 13 hours, 13 hours 30 minutes, 14, 15, 16, 19, 22 and 24 hours post dose on Day 1 |
| Tmax (0-7) Following TID Dosing of GSK2982772 Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20 and 40 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 5, 7 hours post dose on Days 1 and 14 |
| Tmax (7-14) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 7hours and 7 hours 20 and 40 minutes, 8hours, 8 hours 30 minutes, 9, 10, 12, 14 hours post dose on Day 14 |
| Tmax (14-24) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 14hours, 14 hours 20 and 40 minutes, 15 hours and 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours post dose on Day 14 |
| Observed Trough Plasma Drug Concentration at 7 Hour (C7),Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 7 hours post-dose on Day 1 |
| Observed Trough Plasma Drug Concentration at 14 Hours (C14) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 14 hours post-dose on Day 1 |
| C24 Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 24 hours post-dose on Day 1 |
| C12 Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 12 hours post-dose on Day 1 |
| C24 Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 24 hours post-dose on Day 1 |
| C0 Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose on Day 14 |
| C7 Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 7 hours post-dose on Days 1 and 14 |
| C14 Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 14 hours post-dose on Day 14 |
| C24 Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | 24 hours post-dose on Day 14 |
| AUC([0-7] Following TID Dosing of GSK2982772 in Fed State of Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 9 and 11 |
| Cmax (0-7) Following TID Dosing of GSK2982772 in Fed State of Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 9 and 11 |
| Tmax (0-7) Following TID Dosing of GSK2982772 in Fed State of Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 9 and 11 |
| Ratio of Plasma 4 Beta-hydroxycholesterol to Cholesterol: Part B | Blood samples were collected into EDTA tubes and processed to plasma for 4 beta-hydroxycholesterol and cholesterol. Ratio of 4 beta-hydroxycholesterol to cholesterol is presented | Pre-dose on Day 1 and 24 hours post first dose on Day 14 |
| COMPLETED | Par. discontinuation was only collected at FU visits.Thus, treatment & washout periods are combined |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Part A:GSK2982772 120 mg TID/240 mg TID/Placebo |
Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by 240 mg TID in treatment period 2 followed by matching Placebo in treatment period 3. The treatment periods were separated by a washout period of at least 7 days. |
| BG002 | Part A:GSK2982772 120 mg TID/Placebo/GSK2982772 360 mg BID | Participants received oral capsule of 120 mg GSK2982772 TID in treatment period 1 followed by matching Placebo in treatment period 2 followed by 360 mg GSK2982772 BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days. |
| BG003 | Part A:Placebo/GSK2982772 240 mg TID/360 mg BID | Participants received oral capsule of matching Placebo in treatment period 1 followed by 240 mg GSK2982772 TID in treatment period 2 followed by 360 mg GSK2982772 BID in treatment period 3. The treatment periods were separated by a washout period of at least 7 days. |
| BG004 | Part B:Placebo | Participants received matching oral placebo capsule to GSK2928772 for 14 days. |
| BG005 | Part B:GSK2982772 120 mg TID | Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days |
| BG006 | Part B:GSK2982772 240 mg TID | Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days. |
| BG007 | Part B:GSK2982772 360 mg TID | Participants received GSK2982772 oral capsule at a dose of 360 mg TID for 14 days. |
| BG008 | 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 | Number | Participants |
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| OG001 | Part A:GSK2982772 120 mg TID | Participants received GSK2982772 oral capsule at a dose of 120 mg TID |
| OG002 | Part A:GSK2982772 240 mg TID | Participants received GSK2982772 oral capsule at a dose of 240 mg TID |
| OG003 | Part A:GSK2982772 360 mg BID | Participants received GSK2982772 oral capsule at a dose of 360 mg BID |
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| Primary | Number of Participants With AEs and SAEs: Part B | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. | Safety population. GSK2982772 360 mg BID was not started in Part B as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria | Posted | Count of Participants | Participants | Up to Day 28 |
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| Primary | Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A | Blood samples were collected from participants for the analysis of following clinical chemistry parameters: alanine amino transferase (ALT), albumin, alkaline phosphatase, aspartate amino transferase (AST), calcium, creatinine, glucose, potassium, sodium and total bilirubin. PCI ranges were >=2 times Upper Limit of Normal (ULN) units per liter (U/L) for ALT, <30 grams per liter (g/L) for albumin, >=2 times ULN U/L for alkaline phosphatase, >=2 times ULN U/L for AST, <2 or >2.75 millimoles per liter (mmol/L) for calcium, >44.2 micromoles per liter (µmol/L) for creatinine, <3 or >9 mmol/L for glucose, <3 or >5.5 mmol/L for potassium, <130 or >150 mmol/L for sodium and >=1.5 times ULN for total bilirubin. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category. | Safety population | Posted | Count of Participants | Participants | Up to Week 9 |
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| Primary | Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B | Blood samples were collected from participants for the analysis of following clinical chemistry parameters: ALT, albumin, alkaline phosphatase, AST, calcium, creatinine, glucose, potassium, sodium and total bilirubin. PCI ranges were >=2 times ULN U/L for ALT, <30 g/L for albumin, >=2 times ULN U/L for alkaline phosphatase, >=2 times ULN U/L for AST, <2 or >2.75 mmol/L for calcium, >44.2 µmol/L for creatinine, <3 or >9 mmol/L for glucose, <3 or >5.5 mmol/L for potassium, <130 or >150 mmol/L for sodium and >=1.5 times ULN for total bilirubin. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category. | Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria | Posted | Count of Participants | Participants | Up to Week 4 |
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| Primary | Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A | Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, lymphocytes, platelet count, total neutrophils and white blood cell (WBC) counts. PCI ranges were >0.54 or < 0.075 proportion of red blood cells (RBC) in blood for hematocrit, <25 or >180 g/L for hemoglobin, 0.8 x10^9 cells/L for lymphocytes, <1.5 x10^9 cells/L for neutrophils, <100 or >550 x10^9 cells/L for platelets and <3 or 20> x 10^9 cells per liter WBC. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category. | Safety population. | Posted | Count of Participants | Participants | Up to Week 9 |
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| Primary | Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B | Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, lymphocytes, platelet count, total neutrophils and WBC counts. PCI ranges were >0.54 or < 0.075 proportion of RBC in blood for hematocrit, <25 or >180 g/L for hemoglobin, 0.8 x10^9 cells/L for lymphocytes, <1.5 x10^9 cells/L for neutrophils, <100 or >550 x10^9 cells/L for platelets and <3 or 20> x 10^9 cells per liter WBC. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category. | Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria | Posted | Count of Participants | Participants | Up to Week 4 |
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| Primary | Number of Participants With Worst Case Urinalysis Results: Part A | Urine samples were collected from participants for analysis of following parameters: cellular casts, granular casts, hyaline casts, RBC and WBC and were counted as cells per high-power field (cells/HPF). The number of participants with cells in urine has been presented. | Safety population. Only those participants with available data at specified time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 9 |
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| Primary | Number of Participants With Worst Case Urinalysis Results: Part B | Urine samples were collected from participants for analysis of following parameters: cellular casts, granular casts, hyaline casts, RBC and WBC and were counted as cells per high-power field (cells/HPF). The number of participants with cells in urine has been presented. | Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria. Only those participants with data available at specified timepoints were analyzed. | Posted | Count of Participants | Participants | Up to Week 4 |
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| Primary | Number of Participants With Abnormal Vital Signs: Part A | Vital signs were measured in a supine position after 5 minutes rest. The PCI criteria for vital signs included: systolic blood pressure <85 and >160 millimeters of mercury [mmHg]), diastolic blood pressure <45 mmHg and >100 mmHg, heart rate <40 and >100 beats per minute, body temperature <=35.5 and >=37.8 degrees Celsius and respiration rate <=8 and >=20 breaths per minute. Data of participants with potential clinical importance has been reported. | Safety population | Posted | Count of Participants | Participants | Up to Week 9 |
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| Primary | Number of Participants With Abnormal Vital Signs: Part B | Vital signs were measured in a supine position after 5 minutes rest. The PCI criteria for vital signs included: systolic blood pressure <85 and >160 mmHg, diastolic blood pressure <45 mmHg and >100 mmHg, heart rate <40 and >100 beats per minute, body temperature <=35.5 and >=37.8 degrees Celsius and respiration rate <=8 and >=20 breaths per minute. Data of participants with potential clinical importance has been reported. | Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria | Posted | Count of Participants | Participants | Up to Week 4 |
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| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings: Part A | 12-lead ECG's were obtained in the supine position after 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Safety population | Posted | Count of Participants | Participants | Up to Day 4 |
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| Primary | Number of Participants With Abnormal ECG Findings: Part B | 12-lead ECG's were obtained in the supine position after 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria | Posted | Count of Participants | Participants | Up to Week 4 |
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| Secondary | Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours (AUC[0-24]) Following TID Dosing of GSK2982772: Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Pharmacokinetic population consists of participants in the safety population for whom a pharmacokinetic sample were obtained and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per millilter | Pre-dose, 20, 40minutes, 1 hour, 1hr 30min, 2, 3, 5, 7hour, 7hr 20min,and 7hr 40 min, 8hr, 8hr 30min, 9hr, 10hr, 12hr, 14hr, 14hr 20min, 14hr 40 min, 15hr, 15hr 30min, 16hr, 17hr, 19hr, 22hr, 24hours post dose on Day1 |
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| Secondary | AUC(0-24) Following BID Dosing of GSK2982772: Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per millilter | Pre-dose, 20min, 40min, 1hr, 1hr 30min, 2hr, 3hr, 4hr, 6hr, 8hr, 10hr, 12hr, 12hr 20min, 12hr 40min, 13hr, 13hr 30min, 14hr, 15hr, 16hr, 19hr, 22hr, 24hr post dose on Day 1. |
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| Secondary | AUC[0-24] Following TID Dosing of GSK2982772: Part B | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified timepoints were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per millilter | Pre-dose, 20, 40minutes, 1 hour, 1hr 30min, 2, 3, 5, 7hour, 7hr 20min,and 7hr 40 min, 8hr, 8hr 30min, 9hr, 10hr, 12hr, 14hr, 14hr 20min, 14hr 40 min, 15hr, 15hr 30min, 16hr, 17hr, 19hr, 22hr, 24hours post dose on Day14 |
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| Secondary | AUC (0-7) Following TID Dosing of GSK2982772 : Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per millilter | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Day 1 |
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| Secondary | AUC (7-14) Following TID Dosing of GSK2982772 : Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per millilter | 7 hours, 7 hours 20 and 40 minutes, 8 hours, 8 hours 30 minutes, 9, 10, 12, 14 hours on Day 1 |
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| Secondary | AUC (14-24) Following TID Dosing of GSK2982772 : Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per millilter | 14 hours, 14 hours 20 and 40 minutes, 15 hours ,15 hours 30 minutes, 16, 19, 22 and 24 hours on Day 1 |
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| Secondary | AUC (0-12) Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per millilter | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 4, 6, 8, 10 hours,12 hours on Day 1 |
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| Secondary | AUC (12-24) Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per millilter | 12 hours, 12 hours 20 and 40 minutes, 13 and 13 hours 30 minutes, 14, 15, 16, 19, 22 and 24 hours on Day 1 |
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| Secondary | AUC(0-7) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*microgram per millilter | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 1 and 14 |
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| Secondary | AUC (7-14) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per millilter | 7 and 7 hours 20 and 40 minutes, 8 and 8 hours 30 minutes, 9, 10, 12, 14 hours on Day 14 |
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| Secondary | AUC (14-24) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per millilter | 14 hours, 14 hours 20 minutes, 14 hours 40 minutes, 15 hours, 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours on Day 14 |
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| Secondary | Maximum Observed Plasma Drug Concentration Cmax (0-7) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, and 7 hours post dose on Day 1 |
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| Secondary | Cmax (7-14) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 7 hours, 7 hours 20 and 40 minutes, 8 and 8 hours 30 minutes, 9, 10, 12, 14 hours post dose on Day 1 |
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| Secondary | Cmax (14-24) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 14 hours, 14 hours 20 and 40 minutes, 15 and 15 hours 30 minutes, 16, 19, 22 and 24 hours post dose on Day 1 |
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| Secondary | Cmax (0-12) Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 4, 6, 8, 10 hours and 12 hours post dose on Day 1 |
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| Secondary | Cmax (12-24) Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 12 hours, 12 hours 20 and 40 minutes, 13 and 13 hours 30 minutes, 14, 15, 16, 19, 22 and 24 hours post dose on Day 1 |
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| Secondary | Cmax (0-7) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours post dose on Days 1 and 14 |
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| Secondary | Cmax (7-14) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 7hours, 7 hours 20 and 40 minutes, 8 hours, 8 hours 30 minutes, 9, 10, 12, 14 hours on Day 14 |
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| Secondary | Cmax (14-24) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per millilter | 14 hours, 14 hours 20 and 40 minutes, 15 hours, 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours post dose on Day 14 |
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| Secondary | Time to Cmax (Tmax) (0-7) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. | Posted | Median | Full Range | Hours | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, and 7 hours post dose on Day 1 |
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| Secondary | Tmax (7-14) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. | Posted | Median | Full Range | Hours | 7hours, 7 hours 20 and 40 minutes, 8 hours, 8 hours 30 minutes, 9, 10, 12, 14 hours post dose on Day 1 |
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| Secondary | Tmax (14-24) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. | Posted | Median | Full Range | Hours | 14 hours, 14 hours 20 and 40 minutes, 15 hours, 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours post dose on Day 1 |
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| Secondary | Tmax (0-12) Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. | Posted | Median | Full Range | Hours | Pre-dose, 20 and 40 minutes, 1hour, 1 hour 30 minutes, 2, 3, 4, 6, 8, 10 hours and 12 hours post dose on Day 1 |
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| Secondary | Tmax (12-24) Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. | Posted | Median | Full Range | Hours | 12 hours, 12 hours 20 and 40 minutes, 13 hours, 13 hours 30 minutes, 14, 15, 16, 19, 22 and 24 hours post dose on Day 1 |
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| Secondary | Tmax (0-7) Following TID Dosing of GSK2982772 Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Median | Full Range | Hours | Pre-dose, 20 and 40 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 5, 7 hours post dose on Days 1 and 14 |
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| Secondary | Tmax (7-14) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Hours | 7hours and 7 hours 20 and 40 minutes, 8hours, 8 hours 30 minutes, 9, 10, 12, 14 hours post dose on Day 14 |
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| Secondary | Tmax (14-24) Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Hours | 14hours, 14 hours 20 and 40 minutes, 15 hours and 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours post dose on Day 14 |
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| Secondary | Observed Trough Plasma Drug Concentration at 7 Hour (C7),Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 7 hours post-dose on Day 1 |
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| Secondary | Observed Trough Plasma Drug Concentration at 14 Hours (C14) Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 14 hours post-dose on Day 1 |
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| Secondary | C24 Following TID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 24 hours post-dose on Day 1 |
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| Secondary | C12 Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per millilter | 12 hours post-dose on Day 1 |
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| Secondary | C24 Following BID Dosing of GSK2982772 in Part A | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per millililter | 24 hours post-dose on Day 1 |
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| Secondary | C0 Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | Pre-dose on Day 14 |
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| Secondary | C7 Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 7 hours post-dose on Days 1 and 14 |
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| Secondary | C14 Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 14 hours post-dose on Day 14 |
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| Secondary | C24 Following TID Dosing of GSK2982772 in Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 24 hours post-dose on Day 14 |
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| Secondary | AUC([0-7] Following TID Dosing of GSK2982772 in Fed State of Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 9 and 11 |
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| Secondary | Cmax (0-7) Following TID Dosing of GSK2982772 in Fed State of Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 9 and 11 |
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| Secondary | Tmax (0-7) Following TID Dosing of GSK2982772 in Fed State of Part B | Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Hours | Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 9 and 11 |
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| Secondary | Ratio of Plasma 4 Beta-hydroxycholesterol to Cholesterol: Part B | Blood samples were collected into EDTA tubes and processed to plasma for 4 beta-hydroxycholesterol and cholesterol. Ratio of 4 beta-hydroxycholesterol to cholesterol is presented | Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Ratio | Pre-dose on Day 1 and 24 hours post first dose on Day 14 |
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|
| 0 |
| 9 |
| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | Part A:GSK2982772 120 mg TID | Participants received GSK2982772 oral capsule at a dose of 120 mg TID | 0 | 9 | 0 | 9 | 6 | 9 |
| EG002 | Part A: GSK2982772 240 mg TID | Participants received GSK2982772 oral capsule at a dose of 240 mg TID | 0 | 9 | 0 | 9 | 4 | 9 |
| EG003 | Part A: GSK2982772 360 mg BID | Participants received GSK2982772 oral capsule at a dose of 360 mg BID | 0 | 9 | 0 | 9 | 7 | 9 |
| EG004 | Part B:Placebo | Participants received matching oral placebo capsule to GSK2928772 for 14 days. | 0 | 14 | 1 | 14 | 9 | 14 |
| EG005 | Part B: GSK2982772 120 mg TID | Participants received GSK2982772 oral capsule at a dose of 120 mg TID for 14 days | 0 | 20 | 0 | 20 | 17 | 20 |
| EG006 | Part B: GSK2982772 240 mg TID | Participants received GSK2982772 oral capsule at a dose of 240 mg TID for 14 days | 0 | 13 | 0 | 13 | 12 | 13 |
| EG007 | Part B: GSK2982772 360 mg BID | Participants were planned to receive GSK2982772 oral capsule at a dose of 360 mg TID for 14 days | 0 | 0 | 0 | 0 | 0 | 0 |
| Abdominal pain | Gastrointestinal disorders | 20.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | 20.1 | Systematic Assessment |
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| Faeces soft | Gastrointestinal disorders | 20.1 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 20.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | 20.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | 20.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | 20.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | 20.1 | Systematic Assessment |
|
| Medical device site dermatitis | General disorders | 20.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | 20.1 | Systematic Assessment |
|
| Thirst | General disorders | 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | 20.1 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | 20.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | 20.1 | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | 20.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 20.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | 20.1 | Systematic Assessment |
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| Catheter site bruise | General disorders | 20.1 | Systematic Assessment |
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| Fatigue | General disorders | 20.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | 20.1 | Systematic Assessment |
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| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | 20.1 | Systematic Assessment |
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| Catheter site pain | General disorders | 20.1 | Systematic Assessment |
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| Catheter site swelling | General disorders | 20.1 | Systematic Assessment |
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| Feeling hot | General disorders | 20.1 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | 20.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | 20.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | 20.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 20.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | 20.1 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | 20.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | 20.1 | Systematic Assessment |
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| Hordeolum | Infections and infestations | 20.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | 20.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | 20.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | 20.1 | Systematic Assessment |
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| Mood altered | Psychiatric disorders | 20.1 | Systematic Assessment |
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| Nightmare | Psychiatric disorders | 20.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment |
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| Polyuria | Renal and urinary disorders | 20.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | 20.1 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | 20.1 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | 20.1 | Systematic Assessment |
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| Ear disorder | Ear and labyrinth disorders | 20.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | 20.1 | Systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | 20.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | 20.1 | Systematic Assessment |
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| Antinuclear antibody positive | Investigations | 20.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | 20.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | 20.1 | Systematic Assessment |
|
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.
| Title | Measurements |
|---|---|
|
| ALT, No change |
|
| ALT, High |
|
| Albumin, Low |
|
| Albumin, No change |
|
| Albumin, High |
|
| Alkaline phosphatase, Low |
|
| Alkaline phosphatase, No change |
|
| Alkaline phosphatase, High |
|
| AST, Low |
|
| AST, No change |
|
| AST, High |
|
| Calcium, Low |
|
| Calcium, No change |
|
| Calcium, High |
|
| Creatinine, Low |
|
| Creatinine, No change |
|
| Creatinine, High |
|
| Glucose, Low |
|
| Glucose, No change |
|
| Glucose, High |
|
| Potassium, Low |
|
| Potassium, No change |
|
| Potassium, High |
|
| Sodium, Low |
|
| Sodium, No change |
|
| Sodium, High |
|
| Total Bilirubin, Low |
|
| Total Bilirubin, No change |
|
| Total Bilirubin, High |
|
| Title | Measurements |
|---|---|
|
| ALT, High |
|
| Albumin, Low |
|
| Albumin, No change |
|
| Albumin, High |
|
| Alkaline phosphatase, Low |
|
| Alkaline phosphatase, No change |
|
| Alkaline phosphatase, High |
|
| AST, Low |
|
| AST, No change |
|
| AST, High |
|
| Calcium, Low |
|
| Calcium, No change |
|
| Calcium, High |
|
| Creatinine, Low |
|
| Creatinine, No change |
|
| Creatinine, High |
|
| Glucose, Low |
|
| Glucose, No change |
|
| Glucose, High |
|
| Potassium, Low |
|
| Potassium, No change |
|
| Potassium, High |
|
| Sodium, Low |
|
| Sodium, No change |
|
| Sodium, High |
|
| Total Bilirubin, Low |
|
| Total Bilirubin, No change |
|
| Total Bilirubin, High |
|
| Hematocrit, No change |
|
| Hematocrit, High |
|
| Hemoglobin, Low |
|
| Hemoglobin, No change |
|
| Hemoglobin, High |
|
| Lymphocytes, Low |
|
| Lymphocytes, No change |
|
| Lymphocytes, High |
|
| Platelet count, Low |
|
| Platelet, No change |
|
| Platelet, High |
|
| Total Neutrophils, Low |
|
| Total Neutrophils, No change |
|
| Total Neutrophils, High |
|
| WBC count, Low |
|
| WBC, No change |
|
| WBC, High |
|
| Title | Measurements |
|---|---|
|
| Hematocrit, High |
|
| Hemoglobin, Low |
|
| Hemoglobin, No change |
|
| Hemoglobin, High |
|
| Lymphocytes, Low |
|
| Lymphocytes, No change |
|
| Lymphocytes, High |
|
| Platelet count, Low |
|
| Platelet, No change |
|
| Platelet, High |
|
| Total Neutrophils, Low |
|
| Total Neutrophils, No change |
|
| Total Neutrophils, High |
|
| WBC count, Low |
|
| WBC, No change |
|
| WBC, High |
|
| Cellular casts, Any increase |
|
| Cellular casts, Increase to 1-9/HPF |
|
| Cellular casts, Increase to 10-50/HPF |
|
| Granular casts, No change |
|
| Granular casts, Any increase |
|
| Granular casts, Increase 1-9/HPF |
|
| Granular casts, Increase 10-50/HPF |
|
| Hyaline casts, No change |
|
| Hyaline casts, Any increase |
|
| Hyaline casts, Increase 1-9/HPF |
|
| Hyaline casts, Increase 10-50/HPF |
|
| RBC, No change |
|
| RBC, Any increase |
|
| RBC, Increase 1-9/HPF |
|
| RBC, Increase 10-50/HPF |
|
| WBC, No change |
|
| WBC, Any increase |
|
| WBC, Increase 1-9/HPF |
|
| WBC, Increase 10-50/HPF |
|
| Cellular casts, Increase to 1-9/HPF |
|
| Cellular casts, Increase to 10-50/HPF |
|
| Granular casts, No change |
|
| Granular casts, Any increase |
|
| Granular casts, Increase 1-9/HPF |
|
| Granular casts, Increase 10-50/HPF |
|
| Hyaline casts, No change |
|
| Hyaline casts, Any increase |
|
| Hyaline casts, Increase 1-9/HPF |
|
| Hyaline casts, Increase 10-50/HPF |
|
| RBC, No change |
|
| RBC, Any increase |
|
| RBC, Increase 1-9/HPF |
|
| RBC, Increase 10-50/HPF |
|
| WBC, No change |
|
| WBC, Any increase |
|
| WBC, Increase 1-9/HPF |
|
| WBC, Increase 10-50/HPF |
|
| Abnormal, clinically significant |
|
|
| AUC (0-7), Day 14, n=10, 9 |
|
|
| Cmax (0-7), Day 14, n=10, 9 |
|
|
| Tmax (0-7), Day 14, n=10, 9 |
|
|
| C7, Day 14, n=10, 9 |
|
|
| Day 14, 24 hour; n=1, 10, 9 |
|
|