| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. | Safety Population comprised of all participants who took at least one dose of study intervention. Participants were analyzed according to the intervention they actually received. | Posted | | Count of Participants | | Participants | | Up to Day 40 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo | Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3. | | OG001 | Part A: GSK3439171A 5 mg | Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3. | | OG002 | Part A: GSK3439171A 10 mg | Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3. | | OG003 | Part A: GSK3439171A 30 mg | Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3. | | OG004 | Part A: GSK3439171A 60 mg | Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3. | | OG005 | Part A: GSK3439171A 120 mg | Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3. | | OG006 | Part A: GSK3439171A 180 mg | Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3. |
| | | Title | Denominators | Categories |
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| Any AE | | |
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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 intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. | | Posted | | Count of Participants | | Participants | | Up to Day 34 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo | Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG002 | Part B: GSK3439171A 11 mg | |
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| Primary | Number of Participants With AEs and SAEs-Part C | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. | | Posted | | Count of Participants | | Participants | | Up to Day 29 | | | | ID | Title | Description |
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| OG000 | Part C: GSK3439171A 60 mg Fasted | Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2. | | OG001 | Part C: GSK3439171A 60 mg Fed | Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2. |
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| Primary | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part A | Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: <30 grams per liter [g/L]); alanine aminotransferase (ALT) (high: >=2xupper limit of normal [ULN]); aspartate aminotransferase (AST) (high: >=2xULN); alkaline phosphatase (ALP) (high: >=2xULN); total bilirubin (high: >=1.5xULN); calcium (low: <2 millimoles (mmol)/L and high: >2.75 mmol/L); creatinine (high: change from Baseline >44.2 micromoles/L); glucose (low: <3 mmol/L and high: >9 mmol/L); magnesium (low: 0.5 mmol/L and high: 1.23 mmol/L); phosphorus (low: 0.8 mmol/L and high: 1.6 mmol/L); potassium (low: <3 mmol/L and high: >5.5 mmol/L); sodium (low: <130 mmol/L and high: >150 mmol/L) and creatine kinase (high: >500 units per liter). The number of participants with any clinical chemistry abnormality of potential clinical importance is reported. | | Posted | | Count of Participants | | Participants | | Up to Day 40 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo | Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3. | | OG001 | Part A: GSK3439171A 5 mg | Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3. |
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| Primary | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part B | Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: <30 g/L); ALT (high: >=2xULN); AST (high: >=2xULN); ALP (high: >=2xULN); total bilirubin (high: >=1.5xULN); calcium (low: <2 mmol/L and high: >2.75 mmol/L); creatinine (high: change from Baseline >44.2 micromoles/L); glucose (low: <3 mmol/L and high: >9 mmol/L); magnesium (low: 0.5 mmol/L and high: 1.23 mmol/L); phosphorus (low: 0.8 mmol/L and high: 1.6 mmol/L); potassium (low: <3 mmol/L and high: >5.5 mmol/L); sodium (low: <130 mmol/L and high: >150 mmol/L) and creatine kinase (high: >500 units per liter). The number of participants with any clinical chemistry abnormality of potential clinical importance is reported. | | Posted | | Count of Participants | | Participants | | Up to Day 34 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo | Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Primary | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part C | Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: <30 g/L); ALT (high: >=2xULN); AST (high: >=2xULN); ALP (high: >=2xULN); total bilirubin (high: >=1.5xULN); calcium (low: <2 mmol/L and high: >2.75 mmol/L); creatinine (high: change from Baseline >44.2 micromoles/L); glucose (low: <3 mmol/L and high: >9 mmol/L); magnesium (low: 0.5 mmol/L and high: 1.23 mmol/L); phosphorus (low: 0.8 mmol/L and high: 1.6 mmol/L); potassium (low: <3 mmol/L and high: >5.5 mmol/L); sodium (low: <130 mmol/L and high: >150 mmol/L) and creatine kinase (high: >500 units per liter). The number of participants with any clinical chemistry abnormality of potential clinical importance is reported. | | Posted | | Count of Participants | | Participants | | Up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Part C: GSK3439171A 60 mg Fasted | Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2. | | OG001 | Part C: GSK3439171A 60 mg Fed | Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2. |
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| Primary | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part A | Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: >0.54 proportion of red blood cells in blood); hemoglobin (high: >180 g/L), lymphocytes (low: <0.8x10^9 cells per liter [cells/L]); neutrophil count (low: <1.5x10^9 cells/L); platelet count (low: <100x10^9 cells/L and high: >550x10^9 cells/L); white blood cells count (low: <3x10^9 cells/L and high: >20x10^9 cells/L). The number of participants with any hematology abnormality of potential clinical importance is reported. | | Posted | | Count of Participants | | Participants | | Up to Day 40 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo | Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3. | | OG001 | Part A: GSK3439171A 5 mg | Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3. | | OG002 | Part A: GSK3439171A 10 mg | Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3. |
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| Primary | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part B | Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: >0.54 proportion of red blood cells in blood); hemoglobin (high: >180 g/L), lymphocytes (low: <0.8x10^9 cells/L); neutrophil count (low: <1.5x10^9 cells/L); platelet count (low: <100x10^9 cells/L and high: >550x10^9 cells/L); white blood cells count (low: <3x10^9 cells/L and high: >20x10^9 cells/L). The number of participants with any hematology abnormality of potential clinical importance is reported. | | Posted | | Count of Participants | | Participants | | Up to Day 34 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo | Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG002 | Part B: GSK3439171A 11 mg | |
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| Primary | Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part C | Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: >0.54 proportion of red blood cells in blood); hemoglobin (high: >180 g/L), lymphocytes (low: <0.8x10^9 cells/L); neutrophil count (low: <1.5x10^9 cells/L); platelet count (low: <100x10^9 cells/L and high: >550x10^9 cells/L); white blood cells count (low: <3x10^9 cells/L and high: >20x10^9 cells/L). The number of participants with any hematology abnormality of potential clinical importance is reported. | | Posted | | Count of Participants | | Participants | | Up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Part C: GSK3439171A 60 mg Fasted | Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2. | | OG001 | Part C: GSK3439171A 60 mg Fed | Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2. |
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| Primary | Number of Participants With Abnormal Urinalysis Dipstick Results-Part A | Urine samples were taken for the assessment of following urine parameters: glucose, ketones, occult blood (OB) and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample. | Safety Population. All participants in Part A (17, 6, 6, 5, 6, 6, 6) were included in the analysis; however, only participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | | Count of Participants | | Participants | | 8 hours, 24 hours, 48 hours and 72 hours in Periods 1, 2 and 3 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3. | | OG001 | Part A: GSK3439171A 5 mg | Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3. | | OG002 | Part A: GSK3439171A 10 mg | Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3. |
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| Primary | Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A | Urine samples were taken for the assessment of urine pH. 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 to 6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 7, 8 or 9. | Safety Population. All participants in Part A (17, 6, 6, 5, 6, 6, 6) were included in the analysis; however, only participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | | Count of Participants | | Participants | | 8 hours, 24 hours, 48 hours and 72 hours in Periods 1, 2 and 3 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo | Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3. | | OG001 | Part A: GSK3439171A 5 mg | Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3. | | OG002 | Part A: GSK3439171A 10 mg | |
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| Primary | Number of Participants With Abnormal Urinalysis Dipstick Results-Part B | Urine samples were taken for the assessment of following urine parameters: glucose, ketones, OB and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | | Count of Participants | | Participants | | Day 2 (24 hours); Day 3 (48 hours); Days 4, 13 and 20 (72 hours); pre-dose on Days 7, 10, 11 and 17 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo | Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG002 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Primary | Number of Participants With Urinalysis Dipstick Results (pH)-Part B | Urine samples were taken for the assessment of urine pH. 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 to 6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 7, 8 or 9. | Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | | Count of Participants | | Participants | | Day 2 (24 hours); Day 3 (48 hours); Days 4, 13 and 20 (72 hours); pre-dose on Days 7, 10, 11 and 17 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo | Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG002 | Part B: GSK3439171A 11 mg |
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| Primary | Number of Participants With Abnormal Urinalysis Dipstick Results-Part C | Urine samples were taken for the assessment of following urine parameters: glucose, ketones, OB and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample. | Safety Population. All participants in Part C (11, 11) were included in the analysis; however, only participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | | Count of Participants | | Participants | | 8 hours, 24 hours, 48 hours and 72 hours in Period 1 and Period 2 | | | | ID | Title | Description |
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| OG000 | Part C: GSK3439171A 60 mg Fasted | Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2. | | OG001 | Part C: GSK3439171A 60 mg Fed | Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2. |
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| Primary | Number of Participants With Urinalysis Dipstick Results (pH)-Part C | Urine samples were taken for the assessment of urine pH. 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 to 6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 7, 8 or 9. | Safety Population. All participants in Part C (11, 11) were included in the analysis; however, only participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | | Count of Participants | | Participants | | 8 hours, 24 hours, 48 hours and 72 hours in Period 1 and Period 2 | | | | ID | Title | Description |
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| OG000 | Part C: GSK3439171A 60 mg Fasted | Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2. | | OG001 | Part C: GSK3439171A 60 mg Fed | Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2. |
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| Primary | Number of Participants With Vital Signs of Potential Clinical Importance-Part A | Vital signs were measured in a supine position after five minutes of rest and included temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and respiratory rate. The clinical concern range for the parameters included: SBP (low: <85 millimeters of mercury [mmHg] and high: >160 mmHg), DBP (low: <45 mmHg and high: >100 mmHg) and heart rate (low: <40 beats per minute [bpm] and high: >110 bpm). Number of participants with any vital signs of potential clinical importance is reported. | | Posted | | Count of Participants | | Participants | | Up to Day 40 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo | Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3. | | OG001 | Part A: GSK3439171A 5 mg | Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3. | | OG002 | Part A: GSK3439171A 10 mg | Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3. | |
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| Primary | Number of Participants With Vital Signs of Potential Clinical Importance-Part B | Vital signs were measured in a supine position after five minutes of rest and included temperature, SBP, DBP, heart rate and respiratory rate. The clinical concern range for the parameters included: SBP (low: <85 mmHg and high: >160 mmHg), DBP (low: <45 mmHg and high: >100 mmHg) and heart rate (low: <40 bpm and high: >110 bpm). Number of participants with any vital signs of potential clinical importance is reported. | | Posted | | Count of Participants | | Participants | | Up to Day 34 | | | | ID | Title | Description |
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| OG000 | Part B: Placebo | Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG002 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Primary | Number of Participants With Vital Signs of Potential Clinical Importance-Part C | Vital signs were measured in a supine position after five minutes of rest and included temperature, SBP, DBP, heart rate and respiratory rate. The clinical concern range for the parameters included: SBP (low: <85 mmHg and high: >160 mmHg), DBP (low: <45 mmHg and high: >100 mmHg) and heart rate (low: <40 bpm and high: >110 bpm). Number of participants with any vital signs of potential clinical importance is reported. | | Posted | | Count of Participants | | Participants | | Up to Day 29 | | | | ID | Title | Description |
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| OG000 | Part C: GSK3439171A 60 mg Fasted | Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2. | | OG001 | Part C: GSK3439171A 60 mg Fed | Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2. |
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| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A | Twelve-lead ECGs were recorded with the participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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. Data for worst case post-Baseline is presented. Baseline value is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. | | Posted | | Count of Participants | | Participants | | Up to Day 40 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo | Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3. | | OG001 | Part A: GSK3439171A 5 mg | Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3. | | OG002 | Part A: GSK3439171A 10 mg | Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3. |
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| Primary | Number of Participants With Abnormal ECG Findings-Part B | Twelve-lead ECGs were recorded with the participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS, QT and QTc intervals. CS and NCS abnormal ECG findings have been presented. CS 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. Data for worst case post-Baseline is presented. Baseline value is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. | | Posted | | Count of Participants | | Participants | | Up to Day 34 | | | | ID | Title | Description |
|---|
| OG000 | Part B: Placebo | Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG002 | Part B: GSK3439171A 11 mg | |
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| Primary | Number of Participants With Abnormal ECG Findings-Part C | Twelve-lead ECGs were recorded with the participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS, QT and QTc intervals. CS and NCS abnormal ECG findings have been presented. CS 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. Data for worst case post-Baseline is presented. Baseline value is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. | | Posted | | Count of Participants | | Participants | | Up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Part C: GSK3439171A 60 mg Fasted | Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2. | | OG001 | Part C: GSK3439171A 60 mg Fed | Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2. |
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| Primary | Area Under Tha Plasma Drug Concentration Versus Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0 to t]) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population comprised of participants in the Safety population for whom a Pharmacokinetic sample was taken and analyzed for GSK3439171A and result reported | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part A: GSK3439171A 5 mg | Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3. |
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| Primary | AUC(0 to t) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: GSK3439171A 10 mg | Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3. | | OG001 | Part A: GSK3439171A 30 mg | Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3. | | OG002 | Part A: GSK3439171A 60 mg | Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3. | | OG003 | Part A: GSK3439171A 120 mg |
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| Primary | AUC(0 to t) of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Primary | AUC(0 to t) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | AUC(0 to t) of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | AUC(0 to t) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: GSK3439171A 5 mg | Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3. |
| |
| Primary | AUC(0 to Inf) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: GSK3439171A 10 mg | Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3. | | OG001 | Part A: GSK3439171A 30 mg | Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3. | | OG002 | Part A: GSK3439171A 60 mg | Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3. | | OG003 | Part A: GSK3439171A 120 mg |
|
| Primary | AUC(0 to Inf) of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | AUC(0 to Inf) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | AUC(0 to Inf) of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | AUC(0 to Inf) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | Maximum Observed Plasma Concentration (Cmax) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: GSK3439171A 5 mg | Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3. |
| |
| Primary | Cmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: GSK3439171A 10 mg | Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3. | | OG001 | Part A: GSK3439171A 30 mg | Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3. | | OG002 | Part A: GSK3439171A 60 mg | Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3. | | OG003 | Part A: GSK3439171A 120 mg | |
|
| Primary | Cmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | Cmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | Cmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | Cmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | Time to Maximum Observed Plasma Concentration (Tmax) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: GSK3439171A 5 mg | Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3. |
| |
| Primary | Tmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: GSK3439171A 10 mg | Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3. | | OG001 | Part A: GSK3439171A 30 mg | Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3. | | OG002 | Part A: GSK3439171A 60 mg | Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3. | | OG003 | Part A: GSK3439171A 120 mg | |
|
| Primary | Tmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | Tmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Median | Full Range | Hours | | Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | Tmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | Tmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | Apparent Terminal Half-life (T1/2) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: GSK3439171A 5 mg | Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3. |
| |
| Primary | T1/2 of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: GSK3439171A 10 mg | Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3. | | OG001 | Part A: GSK3439171A 30 mg | Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3. | | OG002 | Part A: GSK3439171A 60 mg | Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3. | | OG003 | Part A: GSK3439171A 120 mg | |
|
| Primary | T1/2 of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | T1/2 of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | T1/2 of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Primary | T1/2 of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
| |
| Secondary | AUC(0 to t) of GSK3439171A (Food Effect)-Part C | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part C: GSK3439171A 60 mg Fasted | Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2. | | OG001 | Part C: GSK3439171A 60 mg Fed | Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2. |
| |
| Secondary | AUC(0 to Inf) of GSK3439171A (Food Effect)-Part C | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part C: GSK3439171A 60 mg Fasted | Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2. | | OG001 | Part C: GSK3439171A 60 mg Fed | Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2. |
| |
| Secondary | Cmax for GSK3439171A (Food Effect)-Part C | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part C: GSK3439171A 60 mg Fasted | Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2. | | OG001 | Part C: GSK3439171A 60 mg Fed | Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2. |
| |
| Secondary | Tmax for GSK3439171A-Part C | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part C: GSK3439171A 60 mg Fasted | Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2. | | OG001 | Part C: GSK3439171A 60 mg Fed | Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2. |
| |
| Secondary | T1/2 for GSK3439171A-Part C | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part C: GSK3439171A 60 mg Fasted | Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2. | | OG001 | Part C: GSK3439171A 60 mg Fed | Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2. |
| |
| Secondary | Dose Proportionality of GSK3439171A Using AUC(0 to t) Following a Single Dose-Part A | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented. | Pharmacokinetic Population | Posted | | Number | 90% Confidence Interval | Slope of log dose | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | GSK3439171A 5 mg to 180 mg | Participants were administered single oral doses of GSK3439171A 5 mg, 10 mg, 30 mg, 60 mg, 120 mg and 180 mg in either treatment period 1, 2 or 3. |
| |
| Secondary | Dose Proportionality of GSK3439171A Using AUC(0 to Inf) Following a Single Dose-Part A | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90 % confidence interval for the slope are presented. | Pharmacokinetic Population | Posted | | Number | 90% Confidence Interval | Slope of log dose | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | GSK3439171A 5 mg to 180 mg | Participants were administered single oral doses of GSK3439171A 5 mg, 10 mg, 30 mg, 60 mg, 120 mg and 180 mg in either treatment period 1, 2 or 3. |
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| Secondary | Dose Proportionality of GSK3439171A Using Cmax Following a Single Dose-Part A | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented. | Pharmacokinetic Population | Posted | | Number | 90% Confidence Interval | Slope of log dose | | pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose | | | | ID | Title | Description |
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| OG000 | GSK3439171A 5 mg to 180 mg | Participants were administered single oral doses of GSK3439171A 5 mg, 10 mg, 30 mg, 60 mg, 120 mg and 180 mg in either treatment period 1, 2 or 3. |
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| Secondary | Dose Proportionality of GSK3439171A Using AUC(0 to Tau) Following Repeat Dose-Part B | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented. | Pharmacokinetic Population | Posted | | Number | 90% Confidence Interval | Slope of log dose | | Days 10 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
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| OG000 | GSK3439171A 5 mg to 40 mg | Participants were administered once daily oral doses of GSK3439171A 5 mg, 11 mg and 40 mg for up to 14 days. |
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| Secondary | Dose Proportionality of GSK3439171A Using Cmax Following Repeat Dose-Part B | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented. | Pharmacokinetic Population | Posted | | Number | 90% Confidence Interval | Slope of log dose | | Days 10 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
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| OG000 | GSK3439171A 5 mg to 40 mg | Participants were administered once daily oral doses of GSK3439171A 5 mg, 11 mg and 40 mg for up to 14 days. |
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| Secondary | Observed Accumulation Ratio for AUC (AUC[Ro])-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. AUC(Ro) was calculated as Day17 AUC(0 to tau) divided by Day 1 AUC (0 to tau). Analysis was performed using Mixed effect model with AUC (0 to tau) as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Number | 90% Confidence Interval | Ratio | | Days 1 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
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| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Secondary | Observed Accumulation Ratio for AUC (AUC[Ro])-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. AUC(Ro) was calculated as Day10 AUC(0 to tau) divided by Day 1 AUC (0 to tau). Analysis was performed using Mixed effect model with AUC (0 to tau) as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented. | Pharmacokinetic Population | Posted | | Number | 90% Confidence Interval | Ratio | | Days 1 and 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
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| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Secondary | Observed Accumulation Ratio for Cmax (RCmax)-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. RCmax was calculated as Day17 Cmax divided by Day 1 Cmax. Analysis was performed using Mixed effect model with Cmax as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Number | 90% Confidence Interval | Ratio | | Days 1 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
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| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Secondary | Observed Accumulation Ratio for Cmax (RCmax)-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. RCmax was calculated as Day10 Cmax divided by Day 1 Cmax. Analysis was performed using Mixed effect model with Cmax as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented. | Pharmacokinetic Population | Posted | | Number | 90% Confidence Interval | Ratio | | Days 1 and 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
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| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Secondary | Steady State Accumulation Ratio (Rss)-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Rss was calculated as Day 17 AUC(0-tau) divided by Day 1 AUC(0-inf). Analysis was performed using Mixed Effect Model, with AUC(0-tau) and AUC(0-inf) as the response variables. Treatment, visit, parameter and parameter-by-treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Number | 90% Confidence Interval | Ratio | | Days 1 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
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| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Secondary | Steady State Accumulation Ratio (Rss)-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Rss was calculated as Day 10 AUC(0-tau) divided by Day 1 AUC(0-inf). Analysis was performed using Mixed Effect Model, with AUC(0-tau) and AUC(0-inf) as the response variables. Treatment, visit, parameter and parameter-by-treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented. | Pharmacokinetic Population | Posted | | Number | 90% Confidence Interval | Ratio | | Days 1 and 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose) | | | | ID | Title | Description |
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| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Secondary | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | pre-dose on Days 6, 7, 9, 10, 11, 15, 16 and 17 | | | | ID | Title | Description |
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| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Secondary | Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9 and 10-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | pre-dose on Days 6, 7, 9 and 10 | | | | ID | Title | Description |
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| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Secondary | Steady State Assessment Using Trough Plasma Concentration at the End of Dosing Interval for Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg) | Blood samples were collected at indicated time points for pharmacokinetic analysis. The slope estimate of the day effect was obtained from Mixed Effect Model, with visit as the fixed effect and participant as random effect. The analysis was done separately for each treatment. "Variance Component" covariance structure was used. The back transformed slope and 90% confidence interval for the slope is presented. | Pharmacokinetic Population | Posted | | Number | 90% Confidence Interval | Slope | | pre-dose on Days 6, 7, 9, 10, 11, 15, 16 and 17 | | | | ID | Title | Description |
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| OG000 | Part B: GSK3439171A 5 mg | Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. | | OG001 | Part B: GSK3439171A 11 mg | Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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| Secondary | Steady State Assessment Using Trough Plasma Concentration at the End of Dosing Interval for Repeat Dose-Part B (GSK3439171A 40 mg Only) | Blood samples were collected at indicated time points for pharmacokinetic analysis. The slope estimate of the day effect was obtained from Mixed Effect Model, with visit as the fixed effect and participant as random effect. The analysis was done separately for each treatment. "Variance Component" covariance structure is used. The back transformed slope and 90% confidence interval for the slope is presented. | Pharmacokinetic Population | Posted | | Number | 90% Confidence Interval | Slope | | pre-dose on Days 6, 7, 9 and 10 | | | | ID | Title | Description |
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| OG000 | Part B: GSK3439171A 40 mg | Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment. |
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