Heart Failure
Conditions
Keywords
First Time in Human, GSK3884464, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability
Brief summary
This will be a FTIH study which aims to evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat oral doses of GSK3884464 administered to healthy participants.
Interventions
DRUGGSK3884464
GSK3884464 will be administered
DRUGPlacebo
Placebo to match GSK3884464 will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy as determined by the experienced investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring/assessment. * Part 1: Body weight greater than or equal to (\>=)50 kilograms (kg), body mass index (BMI) \>=18 and less than or equal to (\<=)30 kilograms per square meter (kg/m\^2) (inclusive). Part 2: Body weight \>=50 kg, BMI \>=22 and \<=30 kg/m\^2 (inclusive). * Participants with 18 to 50 years of age inclusive at the time of signing the informed consent. * Male or females of non-childbearing potential. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Exclusion criteria
* History or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal (Gastroesophageal reflux disease \[GERD\], nausea, vomiting or dysphagia), endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data. * History of current or past significant renal diseases. * Clinically significant high blood pressure and/or history of hypertension as determined by the investigator. * Serum troponin I or troponin-T greater than (\>) the upper limit of normal (ULN). * Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * Breast cancer within the past 10 years. * Any clinically relevant abnormality on the screening medical assessments. * Alanine transaminase (ALT) \> ULN. * Bilirubin \> ULN. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Unable to refrain from the use of prescription or non-prescription drug including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer \[ for example (e.g.) Rifampin, St John's Wort extract\]) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GlaxoSmithKline (GSK) Medical Monitor the medication will not interfere with the study procedures or compromise participant safety. By exception, all participants may take Paracetamol (\<=2 grams/day) up to 48 hours prior to the first dose of study drug. * A positive laboratory confirmation of Coronavirus Disease-2019 (COVID-19) infection, or high clinical index of suspicion for COVID-19. * Participants with Glycated hemoglobin (HbA1c) greater than (\>)48 millimoles per mol (mmol/mol) at screening. * Presence of Hepatitis B surface antigen at screening. * Positive Hepatitis C antibody test result at screening. * Positive Hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment. * Positive pre-study drug/alcohol screen. * Positive Human immunodeficiency virus (HIV) antibody test. * Screening urine albumin to creatinine ratio \>=30 milligrams/grams (mg/gm) (\>=3 mg/mmol). * Regular use of known drugs of abuse. * Regular alcohol consumption within six months prior to the study defined as: An average weekly intake of \>=14 units for males \>=14 units for females. One unit is equivalent to 8 gm of alcohol: a half-pint (approximately 240 milliliters \[mL\]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. * Smokelyzer test levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g.nicotine patches or vaporizing devices) within 3 months prior to screening. * Participants with a history or current evidence of depression, bipolar disorder, suicidal ideation and behavior, or a lifetime history of suicide attempt will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Cohorts 4: Accumulation Ratio Based on Ctau (RCtau) of GSK3884464 Following Repeat Dose Administration | 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 | 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. |
| Part 2: Cohorts 4: Accumulation Ratio Based on AUC(Tau) (RAUC) of GSK3884464 Following Repeat Dose Administration | 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 | 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. |
| Part 2: Cohorts 4: Accumulation Ratio Based on Cmax (RCmax) of GSK3884464 Following Repeat Dose Administration | 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 | 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. |
| Parts 1: Number of Participants With Adverse Events (AEs) | Up to Day 17 | 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. |
| Parts 2: Number of Participants With Adverse Events (AEs) | Up to Day 29 | 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. |
| Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Up to Week 10 | 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 (%). |
| Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Up to Week 10 | 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%. |
| Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Up to Week 10 | 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. |
| Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Up to Week 10 | 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. |
| Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Up to Week 10 | 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. |
| Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Up to Week 10 | 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%. |
| Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Upto Day 3 | 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. |
| Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Upto Week 9 | 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 (%) |
| Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Upto Week 9 | 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%. |
| Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Upto Week 9 | 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. |
| Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Upto Week 9 | 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. |
| Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Upto Week 9 | 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. |
| Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Upto Week 9 | 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%. |
| Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Echocardiogram | Upto Week 9 | Echocardiography was performed at screening and Part 2 of the study using sound waves. |
| Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Upto Day 14 | 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. |
| 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 | 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 | Blood samples were collected at indicated time points for pharmacokinetic analysis of AUC\[0-t\]. |
| Part 1: AUC From Time Zero to Infinity (AUC[0-inf]) of GSK3884464 Following Single Dose Administration | 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 | Blood samples were collected at indicated time points for pharmacokinetic analysis of AUC\[0-t\]. |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3884464 Following Single Dose Administration | 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 | Blood samples were collected at indicated time points for pharmacokinetic analysis of Cmax. |
| Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3884464 Following Single Dose Administration | 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 | Blood samples were collected at indicated time points for pharmacokinetic analysis of Tmax. |
| Part 1: Terminal Half-life (T1/2) of GSK3884464 Following Single Dose Administration | 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 | Blood samples were collected at indicated time points for pharmacokinetic analysis of T1/2. |
| Part 2: Cohorts 4: Trough Plasma Concentration (Ctau) of GSK3884464 Following Repeat Dose Administration | 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 | 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. |
| Part 2: Cohorts 4: AUC Over the Dosing Interval (AUC[Tau]) of GSK3884464 Following Repeat Dose Administration | 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 | 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. |
| Part 2: Cohorts 4: Cmax of GSK3884464 Following Repeat Dose Administration | 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 | 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. |
| Part 2: Cohorts 4: Tmax of GSK3884464 Following Repeat Dose Administration | 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 | 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. |
| Part 2: Cohorts 4: T1/2 of GSK3884464 Following Repeat Dose Administration | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Cohorts 4: Change From Baseline in NQO1 mRNA in Whole Blood Post Treatment With GSK3884464 | 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 | 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. |
| Part 1: Change From Baseline in NAD(P)H Dehydrogenase Quinone 1 (NQO1) Messenger Ribonucleic Acid (mRNA) in Whole Blood Post Treatment With GSK3884464 | Day1: pre-dose,30 minutes,1,1.5,2,3,4,6, 8,12,18,24 hours post-dose | Blood samples were collected at indicated time points for pharmacodynamic analysis of NQO1 mRNA. |
Countries
United Kingdom
Participant flow
Recruitment details
Total of 27 participants were enrolled in both Part 1 and Part 2 together.
Pre-assignment details
This was a two parts study with single dose escalation in Part 1 and repeat dose in Part 2 in healthy participants. Part 1 was a 3-period crossover design with 3 cohorts, randomized to 3 periods in a 1:1:1 ratio. Within each period, allocation to GSK3884464 and placebo were a 2:1 ratio. Part 2 was a sequential design with 3 cohorts. The study was terminated after dosing 2 sentinel participants in Cohort 4 (which was first cohort to receive repeat doses). Hence, Cohort 5 and 6 were not conducted.
Participants by arm
| Arm | Count |
|---|---|
| Part 1 Cohort 1 (C1): Placebo C1/ GSK3884464 3 Milligrams (mg)/ GSK3884464 9mg Participants received GSK3884464 or placebo through oral administration in the treatment sequence: Placebo C1/ GSK3884464 3 milligrams (mg)/ GSK3884464 9mg across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session. | 3 |
| Part 1 Cohort 1: GSK3884464 1 mg/ Placebo C1/ GSK3884464 9mg Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 1 mg/ Placebo C1/ GSK3884464 9mg across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session. | 4 |
| Part 1 Cohort 1: GSK3884464 1 mg/ GSK3884464 3 mg / Placebo C1 Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 1 mg/ GSK3884464 3 mg / Placebo C1 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session. | 4 |
| Part 1 Cohort 2 (C2): Placebo C2/ GSK3884464 110 mg/ SD6 Participants received GSK3884464 or placebo through oral administration in the treatment sequence: Placebo C2/ GSK3884464 110 mg/ Single Dose (SD) 6 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session. | 3 |
| Part 1 Cohort 2: GSK3884464 30 mg/ Placebo C2/ SD6 Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 30 mg/ Placebo C2/ SD6 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session. | 4 |
| Part 1 Cohort 2: GSK3884464 30 mg/ GSK3884464 110 mg / Placebo C2 Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 30 mg/ GSK3884464 110 mg / Placebo C2 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session. | 5 |
| Part 1 Cohort 3 (C3): Placebo C3/ SD8/ SD9 Participants received GSK3884464 or placebo through oral administration in the treatment sequence: Placebo C3/ SD8/ SD9 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session. | 1 |
| Part 1 Cohort 3: GSK3884464 70 mg/ SD8/ Placebo C3 Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 70 mg/ SD8/ Placebo C3 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session. | 1 |
| Part 2 Cohort 4 (C4): GSK3884464 15 mg Participants received GSK3884464 15 mg through oral administration. | 1 |
| Part 2 Cohort 4: Placebo C4 Participants received placebo through oral administration in Cohort 4. | 1 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A:Treatment Period 1 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Part A:Treatment Period 1 | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Part A:Treatment Period 1 | Sponsor Terminated study treatment | 0 | 0 | 0 | 2 | 2 | 2 | 0 | 0 | 0 | 0 |
| Part A:Treatment Period 1 | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A:Treatment Period 2 | Adverse Event | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Part A:Treatment Period 2 | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Part A:Treatment Period 2 | Sponsor Terminated study treatment | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1 Cohort 1 (C1): Placebo C1/ GSK3884464 3 Milligrams (mg)/ GSK3884464 9mg | Part 1 Cohort 1: GSK3884464 1 mg/ Placebo C1/ GSK3884464 9mg | Part 1 Cohort 1: GSK3884464 1 mg/ GSK3884464 3 mg / Placebo C1 | Part 1 Cohort 2 (C2): Placebo C2/ GSK3884464 110 mg/ SD6 | Part 1 Cohort 2: GSK3884464 30 mg/ Placebo C2/ SD6 | Part 1 Cohort 2: GSK3884464 30 mg/ GSK3884464 110 mg / Placebo C2 | Part 1 Cohort 3 (C3): Placebo C3/ SD8/ SD9 | Part 1 Cohort 3: GSK3884464 70 mg/ SD8/ Placebo C3 | Part 2 Cohort 4 (C4): GSK3884464 15 mg | Part 2 Cohort 4: Placebo C4 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 30.3 YEARS STANDARD_DEVIATION 9.71 | 37.5 YEARS STANDARD_DEVIATION 6.61 | 36.5 YEARS STANDARD_DEVIATION 8.58 | 44.0 YEARS STANDARD_DEVIATION 6.08 | 31.8 YEARS STANDARD_DEVIATION 6.29 | 36.6 YEARS STANDARD_DEVIATION 6.15 | 37.0 YEARS | 36.0 YEARS | 24.0 YEARS | 46.0 YEARS | 36.0 YEARS STANDARD_DEVIATION 7.6 |
| Race/Ethnicity, Customized ASIAN | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized MULTIPLE | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized WHITE | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 17 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 5 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 3 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 2 / 9 | 1 / 6 | 0 / 6 | 3 / 6 | 3 / 5 | 1 / 6 | 3 / 3 | 1 / 1 | 1 / 1 | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 9 | 0 / 6 | 0 / 6 | 0 / 6 | 1 / 5 | 0 / 6 | 0 / 3 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 |
Outcome results
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\[0-t\].
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | 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 | 1031.06 Hour*Picograms Per Milliliter (h*pg/mL) | Geometric Coefficient of Variation 35.88 |
| Part 1 Cohort 1: GSK3884464 1 mg | 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 | 3104.28 Hour*Picograms Per Milliliter (h*pg/mL) | Geometric Coefficient of Variation 27.33 |
| Part 1 Cohort 1: GSK3884464 3 mg | 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 | 8510.99 Hour*Picograms Per Milliliter (h*pg/mL) | Geometric Coefficient of Variation 30.7 |
| Part 1 Cohort 1: GSK3884464 9 mg | 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 | 23966.53 Hour*Picograms Per Milliliter (h*pg/mL) | Geometric Coefficient of Variation 24.35 |
| Part 1 Cohort 2: Placebo C2 | 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 | 76886.06 Hour*Picograms Per Milliliter (h*pg/mL) | Geometric Coefficient of Variation 11.2 |
| Part 1 Cohort 2: GSK3884464 30 mg | 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 | 99220.48 Hour*Picograms Per Milliliter (h*pg/mL) | — |
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\[0-t\].
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 1: AUC From Time Zero to Infinity (AUC[0-inf]) of GSK3884464 Following Single Dose Administration | 1177.89 Hour*Picograms Per Milliliter (h*pg/mL) | Geometric Coefficient of Variation 39.36 |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: AUC From Time Zero to Infinity (AUC[0-inf]) of GSK3884464 Following Single Dose Administration | 3422.89 Hour*Picograms Per Milliliter (h*pg/mL) | Geometric Coefficient of Variation 32.86 |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: AUC From Time Zero to Infinity (AUC[0-inf]) of GSK3884464 Following Single Dose Administration | 9632.76 Hour*Picograms Per Milliliter (h*pg/mL) | Geometric Coefficient of Variation 36.64 |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: AUC From Time Zero to Infinity (AUC[0-inf]) of GSK3884464 Following Single Dose Administration | 27096.66 Hour*Picograms Per Milliliter (h*pg/mL) | Geometric Coefficient of Variation 28.9 |
| Part 1 Cohort 2: Placebo C2 | Part 1: AUC From Time Zero to Infinity (AUC[0-inf]) of GSK3884464 Following Single Dose Administration | 81971.94 Hour*Picograms Per Milliliter (h*pg/mL) | Geometric Coefficient of Variation 11.22 |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: AUC From Time Zero to Infinity (AUC[0-inf]) of GSK3884464 Following Single Dose Administration | 101162.62 Hour*Picograms Per Milliliter (h*pg/mL) | — |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3884464 Following Single Dose Administration | 70.69 Nanograms Per Milliliter (ng/mL) | Geometric Coefficient of Variation 17.52 |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3884464 Following Single Dose Administration | 211.56 Nanograms Per Milliliter (ng/mL) | Geometric Coefficient of Variation 23.51 |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3884464 Following Single Dose Administration | 551.75 Nanograms Per Milliliter (ng/mL) | Geometric Coefficient of Variation 23.6 |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3884464 Following Single Dose Administration | 1892.92 Nanograms Per Milliliter (ng/mL) | Geometric Coefficient of Variation 36.46 |
| Part 1 Cohort 2: Placebo C2 | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3884464 Following Single Dose Administration | 5093.44 Nanograms Per Milliliter (ng/mL) | Geometric Coefficient of Variation 22.38 |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3884464 Following Single Dose Administration | 6650.00 Nanograms Per Milliliter (ng/mL) | — |
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.
Time frame: Up to Week 10
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 4, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 4, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 3, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 3, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 1, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day -1, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 4, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 6, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day -1, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Not Clinically Significant | 8 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 6, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 5, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 5, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 1, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 3, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 1, Not Clinically Significant | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day -1, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 6, Not Clinically Significant | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 5, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Not Clinically Significant | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day -1, Not Clinically Significant | 5 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 6, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 3, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 5, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 4, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 1, Not Clinically Significant | 3 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day -1, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 1, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 2, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 3, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 4, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 5, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 6, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Not Clinically Significant | 5 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 2, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 6, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 4, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 1, Not Clinically Significant | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day -1, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Not Clinically Significant | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 5, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 3, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 3 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 1, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 5, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 3, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day -1, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 3, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 6, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 4, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 5, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 6, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 4, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day -1, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Not Clinically Significant | 4 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 1, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 4, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 6, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Not Clinically Significant | 5 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 3, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 2, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 1, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day -1, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 5, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 6, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day -1, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 1, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 3, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 5, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 4, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 2 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 1, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 4, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 3, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day -1, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 6, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 5, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 1, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 4, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 6, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 3, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day -1, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Period 1 Day 5, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values | Worst Case Post Baseline, Clinically Significant | 0 Participants |
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.
Time frame: Upto Day 3
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 3, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Not Clinically Significant | 4 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 2, Not Clinically Significant | 2 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 3 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 3 Day 3, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 3 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 3, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 2, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 3 Day 2, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 3, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 3, Not Clinically Significant | 3 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 2, Not Clinically Significant | 3 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Not Clinically Significant | 3 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 3 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 3 Day 3, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 3 Day 2, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 3 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 3, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 2, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 3, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 3, Clinically Significant | 1 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 3, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 2, Clinically Significant | 1 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Clinically Significant | 1 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 3, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 2 Day 2, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 3, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Period 1 Day 3, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Not Clinically Significant | 1 Participants |
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.
Time frame: Up to Week 10
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 8xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT > 1.5xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 3xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 5xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 20xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 10xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >3xULN and BIL >= 2xULN and (ALP <2xULN) | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >=3xULN and BIL >=2xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury and BIL >2xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >3xULN and BIL >= 2xULN and (ALP <2xULN) | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 5xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 8xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 20xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 3xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT > 1.5xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 10xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >=3xULN and BIL >=2xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury and BIL >2xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT > 1.5xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 3xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >3xULN and BIL >= 2xULN and (ALP <2xULN) | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 5xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >=3xULN and BIL >=2xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 20xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury and BIL >2xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 8xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 10xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 3xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury and BIL >2xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 8xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 5xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >3xULN and BIL >= 2xULN and (ALP <2xULN) | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 10xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT > 1.5xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >=3xULN and BIL >=2xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 20xULN | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 5xULN | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 20xULN | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 8xULN | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >3xULN and BIL >= 2xULN and (ALP <2xULN) | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >=3xULN and BIL >=2xULN | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury and BIL >2xULN | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT > 1.5xULN | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 10xULN | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 3xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 5xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 3xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 20xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 10xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >=3xULN and BIL >=2xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury and BIL >2xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >3xULN and BIL >= 2xULN and (ALP <2xULN) | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 8xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT > 1.5xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 10xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >=3xULN and BIL >=2xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >3xULN and BIL >= 2xULN and (ALP <2xULN) | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >3xULN and INR >1.5 | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury | 1 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury and BIL >2xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT > 1.5xULN | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 3xULN | 1 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 5xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 8xULN | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 20xULN | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 8xULN | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 5xULN | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 3xULN | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT > 1.5xULN | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury and BIL >2xULN | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 10xULN | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >3xULN and BIL >= 2xULN and (ALP <2xULN) | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >=3xULN and BIL >=2xULN | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 20xULN | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 10xULN | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 8xULN | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 3xULN | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 5xULN | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT > 1.5xULN | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >3xULN and BIL >= 2xULN and (ALP <2xULN) | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury and BIL >2xULN | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 20xULN | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >=3xULN and BIL >=2xULN | 0 Participants |
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 (%).
Time frame: Up to Week 10
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 3 Worst Case Post-Baseline, To High | 1 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 5 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 5 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To High | 1 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 2 Worst Case Post-Baseline, To High | 2 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 2 Worst Case Post-Baseline, To High | 2 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Period 1 Worst Case Post-Baseline, To High | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To High | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
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%.
Time frame: Up to Week 10
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 3 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 3 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 3 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 2 Worst Case Post-Baseline, To Low | 1 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 2 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 2 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 2 Worst Case Post-Baseline, To W/in Range or No Change | 3 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Period 1 Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Period 1 Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
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.
Time frame: Up to Week 10
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 9 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 9 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 9 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, Increase to TRACE | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, Increase to TRACE | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, Increase to TRACE | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, Increase to TRACE | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 6 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 5 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 5 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, Increase to TRACE | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 5 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 5 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, Increase to TRACE | 1 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, Increase to TRACE | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, Increase to TRACE | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, Increase to TRACE | 0 Participants |
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%.
Time frame: Up to Week 10
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 3 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 3 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 3 Worst Case Post Baseline, To Low | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 3 Worst Case Post Baseline, To w/in Range or No Change | 2 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 3 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To Low | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 2 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 3 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 3 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 3 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 3 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 3 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 3 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 3 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 3 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 3 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 3 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 5 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To Low | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 3 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 3 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 3 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 3 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 3 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 3 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 3 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 3 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 3 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 3 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 3 Worst Case Post Baseline, To Low | 1 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 3 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 3 Worst Case Post Baseline, To w/in Range or No Change | 5 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 3 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 3 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 2 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: Placebo C2 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To Low | 1 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 5 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 6 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To w/in Range or No Change | 3 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 2 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: Placebo C3 | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 1: Terminal Half-life (T1/2) of GSK3884464 Following Single Dose Administration | 38.87 Hour (h) |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Terminal Half-life (T1/2) of GSK3884464 Following Single Dose Administration | 32.39 Hour (h) |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Terminal Half-life (T1/2) of GSK3884464 Following Single Dose Administration | 37.58 Hour (h) |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Terminal Half-life (T1/2) of GSK3884464 Following Single Dose Administration | 31.845 Hour (h) |
| Part 1 Cohort 2: Placebo C2 | Part 1: Terminal Half-life (T1/2) of GSK3884464 Following Single Dose Administration | 31.49 Hour (h) |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Terminal Half-life (T1/2) of GSK3884464 Following Single Dose Administration | 21.50 Hour (h) |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3884464 Following Single Dose Administration | 0.51 Hour (h) |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3884464 Following Single Dose Administration | 1.0 Hour (h) |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3884464 Following Single Dose Administration | 1.01 Hour (h) |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3884464 Following Single Dose Administration | 1.00 Hour (h) |
| Part 1 Cohort 2: Placebo C2 | Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3884464 Following Single Dose Administration | 1.51 Hour (h) |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3884464 Following Single Dose Administration | 2.00 Hour (h) |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Accumulation Ratio Based on AUC(Tau) (RAUC) of GSK3884464 Following Repeat Dose Administration | 1.77 Ratio |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Accumulation Ratio Based on Cmax (RCmax) of GSK3884464 Following Repeat Dose Administration | 1.49 Ratio |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Accumulation Ratio Based on Ctau (RCtau) of GSK3884464 Following Repeat Dose Administration | 1.68 Ratio |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: AUC Over the Dosing Interval (AUC[Tau]) of GSK3884464 Following Repeat Dose Administration | 11902.86 Hour*Picograms Per Milliliter (h*pg/mL) |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Cmax of GSK3884464 Following Repeat Dose Administration | Cohort 4 Day 1 | 754.00 Nanograms Per Milliliter (ng/mL) |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Cmax of GSK3884464 Following Repeat Dose Administration | Cohort 4 Day 14 | 1120.00 Nanograms Per Milliliter (ng/mL) |
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.
Time frame: Upto Week 9
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 5, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 1, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 3, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 4, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day -1, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 6, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 7, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 7, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 8, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 8, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 9, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 9, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 10, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 10, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 11, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 11, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 12, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 12, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 13, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 13, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 14, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 14, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 15, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 15, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 16, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 16, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 17, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 17, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 18, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 18, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 19, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 19, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Worst Case Post Baseline, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 15, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day -1, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 10, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day -1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 19, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 1, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 11, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 1, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 16, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 11, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 18, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 3, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 12, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 16, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 4, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 12, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 5, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 13, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 17, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 6, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 13, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 19, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 7, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 14, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 7, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 17, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 8, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 14, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 8, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Worst Case Post Baseline, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 9, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 15, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 9, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 18, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values | Cohort 4 Day 10, Not Clinically Significant | 0 Participants |
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.
Time frame: Upto Day 14
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 9, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 4, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 9, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 6, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 10, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 10, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 11, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 11, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 7, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 12, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 12, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 7, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 13, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 5, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 13, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 8, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 15, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 3, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 15, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 8, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 2, Not Clinically Significant | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 2, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 2, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 3, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 3, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 4, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 4, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 5, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 5, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 6, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 6, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 7, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 7, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 8, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 8, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 9, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 9, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 10, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 10, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 11, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 11, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 12, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 12, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 13, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 13, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 15, Not Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Cohort 4 Day 15, Clinically Significant | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry | Worst Case Post Baseline, Not Clinically Significant | 0 Participants |
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.
Time frame: Upto Week 9
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Echocardiogram | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Echocardiogram | 0 Participants |
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.
Time frame: Upto Week 9
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >=3xULN and BIL >=2xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >3xULN and BIL >= 2xULN and (ALP <2xULN) | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury and BIL >2xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT > 1.5xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 3xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 5xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 8xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 10xULN | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 20xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 8xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >=3xULN and BIL >=2xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 3xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >3xULN and BIL >= 2xULN and (ALP <2xULN) | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 20xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 5xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | Hepatocellular injury and BIL >2xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT >= 10xULN | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values | ALT > 1.5xULN | 1 Participants |
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 (%)
Time frame: Upto Week 9
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Worst Case Post-Baseline, To W/in Range or No Change | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | ALT, Worst Case Post-Baseline, To High | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Calcium, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AP, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Sodium, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | AST, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Worst Case Post-Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Potassium, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Worst Case Post-Baseline, To W/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, Worst Case Post-Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Bilirubin, Worst Case Post-Baseline, To High | 0 Participants |
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%.
Time frame: Upto Week 9
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Baseline, Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Baseline, W/in Range | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Baseline, High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Baseline, Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Baseline, W/in Range | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Baseline, High | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Baseline, Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Baseline, W/in Range | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Baseline, High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Baseline, Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Baseline, W/in Range | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Baseline, High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Baseline, Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Baseline, W/in Range | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Baseline, High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Baseline, Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Baseline, W/in Range | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Baseline, High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Baseline, W/in Range | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Baseline, Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Baseline, Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Baseline, W/in Range | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Baseline, High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Erythrocytes, Baseline, High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Baseline, W/in Range | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Baseline, Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Baseline, High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Baseline, W/in Range | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes, Baseline, High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit, Baseline, High | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Baseline, W/in Range | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Baseline, Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils, Baseline, Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Baseline, W/in Range | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets, Baseline, Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin, Baseline, High | 0 Participants |
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.
Time frame: Upto Week 9
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, Increase to TRACE | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Protein, No Change/Decreased | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Glucose, No Change/Decreased | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, Increase to TRACE | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Ketones, No Change/Decreased | 1 Participants |
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%.
Time frame: Upto Week 9
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | PR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | RR, Period 1 Worst Case Post Baseline, To High | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To Low | 0 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Temperature, Period 1 Worst Case Post Baseline, To w/in Range or No Change | 1 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: T1/2 of GSK3884464 Following Repeat Dose Administration | Cohort 4 Day 1 | 70.59 Hour (h) |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: T1/2 of GSK3884464 Following Repeat Dose Administration | Cohort 4 Day 14 | 45.05 Hour (h) |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Tmax of GSK3884464 Following Repeat Dose Administration | Cohort 4 Day 1 | 0.57 Hour (h) |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Tmax of GSK3884464 Following Repeat Dose Administration | Cohort 4 Day 14 | 0.57 Hour (h) |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Trough Plasma Concentration (Ctau) of GSK3884464 Following Repeat Dose Administration | Cohort 4 Day 1 | 246.00 Nanograms Per Milliliter (ng/mL) |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Trough Plasma Concentration (Ctau) of GSK3884464 Following Repeat Dose Administration | Cohort 4 Day 14 | 415.99 Nanograms Per Milliliter (ng/mL) |
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.
Time frame: Up to Day 17
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Parts 1: Number of Participants With Adverse Events (AEs) | 2 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Parts 1: Number of Participants With Adverse Events (AEs) | 1 Participants |
| Part 1 Cohort 1: GSK3884464 3 mg | Parts 1: Number of Participants With Adverse Events (AEs) | 0 Participants |
| Part 1 Cohort 1: GSK3884464 9 mg | Parts 1: Number of Participants With Adverse Events (AEs) | 3 Participants |
| Part 1 Cohort 2: Placebo C2 | Parts 1: Number of Participants With Adverse Events (AEs) | 3 Participants |
| Part 1 Cohort 2: GSK3884464 30 mg | Parts 1: Number of Participants With Adverse Events (AEs) | 1 Participants |
| Part 1 Cohort 2: GSK3884464 110 mg | Parts 1: Number of Participants With Adverse Events (AEs) | 3 Participants |
| Part 1 Cohort 3: Placebo C3 | Parts 1: Number of Participants With Adverse Events (AEs) | 1 Participants |
| Part 1 Cohort 3: GSK3884464 70 mg | Parts 1: Number of Participants With Adverse Events (AEs) | 1 Participants |
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.
Time frame: Up to Day 29
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Parts 2: Number of Participants With Adverse Events (AEs) | 1 Participants |
| Part 1 Cohort 1: GSK3884464 1 mg | Parts 2: Number of Participants With Adverse Events (AEs) | 1 Participants |
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.
Time frame: Day1: pre-dose,30 minutes,1,1.5,2,3,4,6, 8,12,18,24 hours post-dose
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 1: Change From Baseline in NAD(P)H Dehydrogenase Quinone 1 (NQO1) Messenger Ribonucleic Acid (mRNA) in Whole Blood Post Treatment With GSK3884464 | 1.19 Fold Change | Standard Deviation 0.17 |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 1: Change From Baseline in NAD(P)H Dehydrogenase Quinone 1 (NQO1) Messenger Ribonucleic Acid (mRNA) in Whole Blood Post Treatment With GSK3884464 | 1.17 Fold Change | Standard Deviation 0.11 |
| Part 1 Cohort 1: GSK3884464 3 mg | Part 1: Change From Baseline in NAD(P)H Dehydrogenase Quinone 1 (NQO1) Messenger Ribonucleic Acid (mRNA) in Whole Blood Post Treatment With GSK3884464 | 1.13 Fold Change | Standard Deviation 0.1 |
| Part 1 Cohort 1: GSK3884464 9 mg | Part 1: Change From Baseline in NAD(P)H Dehydrogenase Quinone 1 (NQO1) Messenger Ribonucleic Acid (mRNA) in Whole Blood Post Treatment With GSK3884464 | 1.31 Fold Change | Standard Deviation 0.29 |
| Part 1 Cohort 2: Placebo C2 | Part 1: Change From Baseline in NAD(P)H Dehydrogenase Quinone 1 (NQO1) Messenger Ribonucleic Acid (mRNA) in Whole Blood Post Treatment With GSK3884464 | 1.16 Fold Change | Standard Deviation 0.2 |
| Part 1 Cohort 2: GSK3884464 30 mg | Part 1: Change From Baseline in NAD(P)H Dehydrogenase Quinone 1 (NQO1) Messenger Ribonucleic Acid (mRNA) in Whole Blood Post Treatment With GSK3884464 | 2.79 Fold Change | Standard Deviation 0.69 |
| Part 1 Cohort 2: GSK3884464 110 mg | Part 1: Change From Baseline in NAD(P)H Dehydrogenase Quinone 1 (NQO1) Messenger Ribonucleic Acid (mRNA) in Whole Blood Post Treatment With GSK3884464 | 7.66 Fold Change | Standard Deviation 1.52 |
| Part 1 Cohort 3: Placebo C3 | Part 1: Change From Baseline in NAD(P)H Dehydrogenase Quinone 1 (NQO1) Messenger Ribonucleic Acid (mRNA) in Whole Blood Post Treatment With GSK3884464 | 0.96 Fold Change | — |
| Part 1 Cohort 3: GSK3884464 70 mg | Part 1: Change From Baseline in NAD(P)H Dehydrogenase Quinone 1 (NQO1) Messenger Ribonucleic Acid (mRNA) in Whole Blood Post Treatment With GSK3884464 | 8.5830 Fold Change | — |
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.
Time frame: 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
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Change From Baseline in NQO1 mRNA in Whole Blood Post Treatment With GSK3884464 | Cohort 4 Day 1 | 1.035 Fold Change |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Change From Baseline in NQO1 mRNA in Whole Blood Post Treatment With GSK3884464 | Cohort 4 Day 7 | 1.095 Fold Change |
| Part 1 Cohort 1: Placebo C1 | Part 2: Cohorts 4: Change From Baseline in NQO1 mRNA in Whole Blood Post Treatment With GSK3884464 | Cohort 4 Day 14 | 1.029 Fold Change |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Change From Baseline in NQO1 mRNA in Whole Blood Post Treatment With GSK3884464 | Cohort 4 Day 1 | 1.684 Fold Change |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Change From Baseline in NQO1 mRNA in Whole Blood Post Treatment With GSK3884464 | Cohort 4 Day 7 | 2.560 Fold Change |
| Part 1 Cohort 1: GSK3884464 1 mg | Part 2: Cohorts 4: Change From Baseline in NQO1 mRNA in Whole Blood Post Treatment With GSK3884464 | Cohort 4 Day 14 | 2.405 Fold Change |