| Primary | Parts 1: Number of Participants With Adverse Events (AEs) | An AE is defined as 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. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. | Posted | | Count of Participants | | Participants | | Up to Day 17 | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: Placebo C1 | Participants received placebo through oral administration in Cohort 1. | | OG001 | Part 1 Cohort 1: GSK3884464 1 mg | Participants received GSK3884464 1 mg through oral administration. | | OG002 | Part 1 Cohort 1: GSK3884464 3 mg | Participants received GSK3884464 3 mg through oral administration. | | OG003 | Part 1 Cohort 1: GSK3884464 9 mg | Participants received GSK3884464 9 mg through oral administration. | | OG004 | Part 1 Cohort 2: Placebo C2 | Participants received placebo through oral administration in Cohort 2. | | OG005 | Part 1 Cohort 2: GSK3884464 30 mg | Participants received GSK3884464 30 mg through oral administration. | | OG006 | Part 1 Cohort 2: GSK3884464 110 mg | Participants received GSK3884464 110 mg through oral administration. | | OG007 | Part 1 Cohort 3: Placebo C3 | Participants received placebo through oral administration in Cohort 3. | | OG008 | Part 1 Cohort 3: GSK3884464 70 mg | Participants received GSK3884464 70 mg through oral administration in Cohort 3. |
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| Primary | Parts 2: Number of Participants With Adverse Events (AEs) | An AE is defined as 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. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. | Posted | | Count of Participants | | Participants | | Up to Day 29 | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: Placebo C4 | Participants received placebo through oral administration in Cohort 4. | | OG001 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Blood samples were collected for analysis of chemistry parameters. PCI ranges were >2*Upper limit of normal (ULN) units per liter (U/L)(Alanine Aminotransferase [ALT]), >2*ULN (U/L) (Aspartate Aminotransferase ([AST]), >2*ULN (Alkaline Phosphatase [ALP]) (U/L), >1.5*ULN (micromoles per liter) (bilirubin), <2 or >2.75 millimoles/liter (L) (mmol/L)(calcium), <3 or >7.5 mmol/L (glucose), <3 or >5.3 mmol/L (potassium), <130 or >149 mmol/L (sodium). Participants were counted in worst case category that their value changes to (low, within [w/in] range or no change [NC], or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To within Range No Change' category. Participants were counted twice if participant had values that changed 'To Low' and 'To High', so percentages may not add to 100 percentage (%). | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: Placebo C1 | Participants received placebo through oral administration in Cohort 1. | | OG001 | Part 1 Cohort 1: GSK3884464 1 mg |
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| Primary | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Blood samples were collected for analysis of hematology parameters. The ranges for hematology parameters are as follows: Hematocrit[>51 percent(%)-male, >45%-female], Hemoglobin [Higher: >175 grams/Liter(g/L) in male, >150g/L in female and Low: less than(<) 100g/L in male, <95g/L in female], Lymphocytes[<0.97 10^9/L], Neutrophils[<1.5 10^9/L], Platelets[High: >550 10^9/ L and Low: <100 10^9/ L], White blood cells[High:>18 10^9/L Low:<2 10^9/L], Red blood cells[Low: <3.0 10^12/L in male, <2.5 10^12/L]. Participants were counted in worst case category that their value changes to (low, within range [W/in] or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example-High to High), or whose value became within range, were recorded in "To within Range or No Change" category. Participants were counted twice if participant has values that changed 'To Low' & 'To High', so the percentages may not add to 100%. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: Placebo C1 | Participants received placebo through oral administration in Cohort 1. | |
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| Primary | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Urine samples were collected to assess urine glucose, protein and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: Placebo C1 | Participants received placebo through oral administration in Cohort 1. | | OG001 | Part 1 Cohort 1: GSK3884464 1 mg | Participants received GSK3884464 1 mg through oral administration. | | OG002 | Part 1 Cohort 1: GSK3884464 3 mg | |
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| Primary | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Blood samples were collected to evaluate hepatobiliary abnormalities. Number of participants with Bilirubin (BIL), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT)/combination of these with levels more than the defined hepatobiliary abnormality criteria were presented. Hepatocellular injury is defined as ([ALT/ALT ULN]/[ALP/ALP ULN]) >= 5 and ALT >=3xULN. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: Placebo C1 | Participants received placebo through oral administration in Cohort 1. | | OG001 | Part 1 Cohort 1: GSK3884464 1 mg | Participants received GSK3884464 1 mg through oral administration. | | OG002 | Part 1 Cohort 1: GSK3884464 3 mg | Participants received GSK3884464 3 mg through oral administration. | |
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| Primary | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Twelve lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured QTc, PR, QRS intervals. Abnormal findings were categorized as clinically significant and not clinically significant. 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. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. | Posted | | Count of Participants | | Participants | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: Placebo C1 | Participants received placebo through oral administration in Cohort 1. | | OG001 | Part 1 Cohort 1: GSK3884464 1 mg | Participants received GSK3884464 1 mg through oral administration. | | OG002 | Part 1 Cohort 1: GSK3884464 3 mg | Participants received GSK3884464 3 mg through oral administration. |
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| Primary | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP), pulse rate (PR), body temperature, respiratory rate (RR) and were measured after resting for at least 5 minutes in semi-supine position. PCI ranges were, SBP (millimeters of mercury[mmHg]): <85 (low) or >160 (high), DBP (mmHg): <45 (low) or >100 (high), heart rate (beats per minute): <40 (low) or >110 (high), respiration rate (breaths per minute):<=8 (low) or >20 (high) and body temperature (degrees Celsius) <=35.5 (low) or >38.0 (high). Participants were counted in worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To W/in Range No Change' category. Participants were counted twice if participant had values that changed 'To Low' and 'To High', so percentages may not add to 100%. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Up to Week 10 | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: Placebo C1 | Participants received placebo through oral administration in Cohort 1. | | OG001 |
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| Primary | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Continuous cardiac telemetry was performed in a supine position after at least 5 minutes of rest. Number of participants who had abnormal findings upon cardiac telemetry assessment have been presented. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Upto Day 3 | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: Placebo C1 | Participants received placebo through oral administration in Cohort 1. | | OG001 | Part 1 Cohort 1: GSK3884464 1 mg | Participants received GSK3884464 1 mg through oral administration. | | OG002 | Part 1 Cohort 1: GSK3884464 3 mg | Participants received GSK3884464 3 mg through oral administration. | | OG003 | Part 1 Cohort 1: GSK3884464 9 mg | |
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| Primary | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Blood samples were collected for analysis of chemistry parameters. PCI ranges were >=2*Upper limit of normal (ULN) units per liter (U/L)(Alanine Aminotransferase [ALT]), >=2*ULN (U/L) (Aspartate Aminotransferase ([AST]), >=2*ULN (Alkaline Phosphatase [ALP]) (U/L), >=1.5*ULN (micromoles per liter) (bilirubin), <2 or >2.75 millimoles/liter (L) (mmol/L)(calcium), <3 or >11 mmol/L (glucose), <3 or >5.5 mmol/L (potassium), <130 or >150 mmol/L (sodium),<50 or >85 grams/liter (protein). Participants were counted in worst case category that their value changes to (low, within [w/in] range or no change [NC], or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To within Range No Change' category. Participants were counted twice if participant had values that changed 'To Low' and 'To High', so percentages may not add to 100 percentage (%) | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted. | Posted | | Count of Participants | | Participants | | Upto Week 9 | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: Placebo C4 | Participants received placebo through oral administration in Cohort 4. | | OG001 |
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| Primary | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Blood samples were collected for analysis of hematology parameters. The ranges for hematology parameters are as follows: Hematocrit[>51 % in male, >45% in female], Haemoglobin[Higher: > 175 grams/Litre (g/L) in male, >150 g/L in female and Low: less than (<) 100 g/L in male, <95 g/L in female], Lymphocytes[<0.97 10^9/L], Neutrophils[<1.5 10^9/L], Platelets[High: > 550 10^9/ L and Low: < 100 10^9/ L], White blood cells[High:>18 10^9/L Low:<2 10^9/L], Red blood cells[Low: <3.0 10^12/L in male, <2.5 10^12/L]. Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example [e.g.], High to High), or whose value became within range, were recorded in "To within Range or No Change" category. Participants were counted twice if participant has values that changed 'To Low' & 'To High', so the percentages may not add to 100%. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted. | Posted | | Count of Participants | | Participants | | Upto Week 9 | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: Placebo C4 | Participants received placebo through oral administration in Cohort 4. | |
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| Primary | Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted. | Posted | | Count of Participants | | Participants | | Upto Week 9 | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: Placebo C4 | Participants received placebo through oral administration in Cohort 4. | | OG001 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Blood samples were collected to evaluate hepatobiliary abnormalities. Number of participants with Bilirubin (BIL), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT) in combination of these with levels more than the defined hepatobiliary abnormality criteria were presented. Hepatocellular injury is defined as ([ALT/ALT ULN]/[ALP/ALP ULN]) greater than or equal to (>=) 5 and ALT >=3xULN. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted. | Posted | | Count of Participants | | Participants | | Upto Week 9 | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: Placebo C4 | Participants received placebo through oral administration in Cohort 4. | | OG001 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Twelve lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured QTc, PR, QRS intervals. Abnormal findings were categorized as clinically significant and not clinically significant. 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. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted. | Posted | | Count of Participants | | Participants | | Upto Week 9 | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: Placebo C4 | Participants received placebo through oral administration in Cohort 4. | | OG001 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP), pulse rate (PR), body temperature, respiratory rate (RR) and were measured after resting for at least 5 minutes in semi-supine position. PCI ranges were, SBP (millimeters of mercury[mmHg]): <85 (low) or >160 (high), DBP (mmHg): <45 (low) or >100 (high), heart rate (beats per minute): <40 (low) or >110 (high), respiration rate (breaths per minute):<=8 (low) or >20 (high) and body temperature (degrees Celsius) <=35.5 (low) or >38.0 (high). Participants were counted in worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To W/in Range No Change' category. Participants were counted twice if participant had values that changed 'To Low' and 'To High', so percentages may not add to 100%. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted. | Posted | | Count of Participants | | Participants | | Upto Week 9 | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: Placebo C4 | Participants received placebo through oral administration in Cohort 4. | | OG001 |
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| Primary | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Echocardiogram | Echocardiography was performed at screening and Part 2 of the study using sound waves. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted. | Posted | | Count of Participants | | Participants | | Upto Week 9 | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: Placebo C4 | Participants received placebo through oral administration in Cohort 4. | | OG001 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Continuous cardiac telemetry was performed in a supine position after at least 5 minutes of rest. Number of participants who had abnormal findings upon cardiac telemetry assessment have been presented. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted. | Posted | | Count of Participants | | Participants | | Upto Day 14 | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: Placebo C4 | Participants received placebo through oral administration in Cohort 4. | | OG001 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 1: Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK3884464 Following Single Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of AUC[0-t]. | The analysis was performed on the Pharmacokinetic (PK) Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*Picograms Per Milliliter (h*pg/mL) | | Day 1 pre-dose,15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: GSK3884464 1 mg | Participants received GSK3884464 1 mg through oral administration. | | OG001 | Part 1 Cohort 1: GSK3884464 3 mg | Participants received GSK3884464 3 mg through oral administration. | | OG002 | Part 1 Cohort 1: GSK3884464 9 mg | Participants received GSK3884464 9 mg through oral administration. |
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| Primary | Part 1: AUC From Time Zero to Infinity (AUC[0-inf]) of GSK3884464 Following Single Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of AUC[0-t]. | The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*Picograms Per Milliliter (h*pg/mL) | | Day 1 pre-dose,15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: GSK3884464 1 mg | Participants received GSK3884464 1 mg through oral administration. | | OG001 | Part 1 Cohort 1: GSK3884464 3 mg | Participants received GSK3884464 3 mg through oral administration. | | OG002 | Part 1 Cohort 1: GSK3884464 9 mg | Participants received GSK3884464 9 mg through oral administration. |
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| Primary | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3884464 Following Single Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of Cmax. | The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms Per Milliliter (ng/mL) | | Day 1 pre-dose,15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: GSK3884464 1 mg | Participants received GSK3884464 1 mg through oral administration. | | OG001 | Part 1 Cohort 1: GSK3884464 3 mg | Participants received GSK3884464 3 mg through oral administration. | | OG002 | Part 1 Cohort 1: GSK3884464 9 mg | Participants received GSK3884464 9 mg through oral administration. |
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| Primary | Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3884464 Following Single Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of Tmax. | The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Full Range | Hour (h) | | Day 1 pre-dose,15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: GSK3884464 1 mg | Participants received GSK3884464 1 mg through oral administration. | | OG001 | Part 1 Cohort 1: GSK3884464 3 mg | Participants received GSK3884464 3 mg through oral administration. | | OG002 | Part 1 Cohort 1: GSK3884464 9 mg | Participants received GSK3884464 9 mg through oral administration. | | OG003 |
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| Primary | Part 1: Terminal Half-life (T1/2) of GSK3884464 Following Single Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of T1/2. | The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Full Range | Hour (h) | | Day 1 pre-dose,15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: GSK3884464 1 mg | Participants received GSK3884464 1 mg through oral administration. | | OG001 | Part 1 Cohort 1: GSK3884464 3 mg | Participants received GSK3884464 3 mg through oral administration. | | OG002 | Part 1 Cohort 1: GSK3884464 9 mg | Participants received GSK3884464 9 mg through oral administration. | | OG003 |
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| Primary | Part 2: Cohorts 4: AUC Over the Dosing Interval (AUC[Tau]) of GSK3884464 Following Repeat Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of AUC [tau] for repeat dose administration. NA indicates geometric coefficient of variation could not be calculated for single participant. | The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*Picograms Per Milliliter (h*pg/mL) | | Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 2: Cohorts 4: Cmax of GSK3884464 Following Repeat Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of Cmax for repeat dose administration. NA indicates geometric coefficient of variation could not be calculated for single participant. | The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms Per Milliliter (ng/mL) | | Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 2: Cohorts 4: Trough Plasma Concentration (Ctau) of GSK3884464 Following Repeat Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of Ctau for repeat dose administration. NA indicates geometric coefficient of variation could not be calculated for single participant. | The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (NQ values were considered as valid PK assessment). This population was based on the treatment the participant actually received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms Per Milliliter (ng/mL) | | Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 2: Cohorts 4: Tmax of GSK3884464 Following Repeat Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of Tmax for repeat dose administration. NA indicates full range could not be calculated for single participant. | The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. | Posted | | Median | Full Range | Hour (h) | | Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 2: Cohorts 4: T1/2 of GSK3884464 Following Repeat Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of T1/2 for repeat dose administration. NA indicates full range could not be calculated for single participant. | The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. | Posted | | Median | Full Range | Hour (h) | | Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 2: Cohorts 4: Accumulation Ratio Based on AUC(Tau) (RAUC) of GSK3884464 Following Repeat Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of RAUC for repeat dose administration. NA indicates geometric coefficient of variation could not be calculated for single participant. | The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 2: Cohorts 4: Accumulation Ratio Based on Cmax (RCmax) of GSK3884464 Following Repeat Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of RCmax for repeat dose administration. NA indicates geometric coefficient of variation could not be calculated for single participant. | The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Primary | Part 2: Cohorts 4: Accumulation Ratio Based on Ctau (RCtau) of GSK3884464 Following Repeat Dose Administration | Blood samples were collected at indicated time points for pharmacokinetic analysis of RCtau for repeat dose administration. NA indicates geometric coefficient of variation could not be calculated for single participant. | The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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| Secondary | Part 1: Change From Baseline in NAD(P)H Dehydrogenase Quinone 1 (NQO1) Messenger Ribonucleic Acid (mRNA) in Whole Blood Post Treatment With GSK3884464 | Blood samples were collected at indicated time points for pharmacodynamic analysis of NQO1 mRNA. | The analysis was performed on the Pharmacodynamic (PD) Set that includes all participants in the Safety population with baseline and at least one post baseline PD measure (e.g., NQO1 mRNA). Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Fold Change | | Day1: pre-dose,30 minutes,1,1.5,2,3,4,6, 8,12,18,24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 1 Cohort 1: Placebo C1 | Participants received placebo through oral administration in Cohort 1. | | OG001 | Part 1 Cohort 1: GSK3884464 1 mg | Participants received GSK3884464 1 mg through oral administration. | | OG002 | Part 1 Cohort 1: GSK3884464 3 mg | Participants received GSK3884464 3 mg through oral administration. | | OG003 | Part 1 Cohort 1: GSK3884464 9 mg |
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| Secondary | Part 2: Cohorts 4: Change From Baseline in NQO1 mRNA in Whole Blood Post Treatment With GSK3884464 | Blood samples were collected at indicated time points for pharmacodynamic analysis of NQO1 mRNA for repeat dose administration. NA indicates standard deviation could not be calculated for single participant. | The analysis was performed on the PD Set that includes all participants in the Safety population with baseline and at least one post baseline PD measure (e.g., NQO1 mRNA). | Posted | | Mean | Standard Deviation | Fold Change | | Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part 2 Cohort 4: Placebo C4 | Participants received placebo through oral administration in Cohort 4. | | OG001 | Part 2 Cohort 4: GSK3884464 15 mg | Participants received GSK3884464 15 mg through oral administration in Cohort 4. |
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