Celiac Disease, Coeliac Disease
Conditions
Keywords
Celiac disease, Itraconazole, Grape fruit juice, GSK3915393, Healthy Participants, Pharmacokinetics, First time into human
Brief summary
This is a 3-part first time into human study (FTIH) study for GSK3915393. Parts A and B of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending and repeat oral doses of GSK3915393 in healthy adult participants. Part C will evaluate the impact of co-administration of GSK3915393 with grapefruit juice and itraconazole on the PK of GSK3915393.
Interventions
DRUGGSK3915393 Capsules
GSK3915393 capsules will be given orally.
DRUGGSK3915393 Solution for Infusion
GSK3915393 solution for infusion will be administered intravenously.
DRUGPlacebo capsules
Placebo matching GSK3915393 capsules will be given orally.
DRUGItraconazole
Participants will be administered with GSK3915393 along with ITZ orally
OTHERWater
Participants will be administered with GSK3915393 along with water orally
OTHERGrape fruit juice
Participants will be administered with GSK3915393 along with GFJ orally
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Parts A and B will be double blind and Part C will be open label.
Intervention model description
This is a 3-part study. Parts A and C will have a 5 period crossover design Part B will be conducted as a parallel group dose escalation study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18 and 50 years of age inclusive, at the time of signing the informed consent. * Healthy participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Negative coronavirus disease of 2019 (COVID-19) test on admission. * Body weight \>=40 kilograms (kg) and body mass index (BMI) within the range 18.5-29.9 kilograms per square meter (kg/m\^2) (inclusive). * Male or females: No restrictions for male participants. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method from 30 days prior to first dose until follow up visit. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention). A WOCBP must have a negative highly sensitive pregnancy test (serum) at screening and on admission to the clinical unit. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. * Capable of giving signed informed consent.
Exclusion criteria
* History or current evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (Irritable bowel syndrome \[IBS\], Gastroesophageal reflux disease \[GERD\], nausea, vomiting or dysphagia), endocrine, hematological, neurological, or psychiatric 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. * Current evidence of active infection. * Participants with signs/symptoms suggestive of COVID-19 (i.e. fever, cough, etc) within the past 14 days prior to screening and admission to clinical unit. * Participants with known COVID-19 positive contacts in the past 14 days prior to screening and admission to clinical unit. * Any history of suicidal behavior within the past 6 months or any history of attempted suicide in a participant's lifetime. * Alanine transaminase (ALT) \>1.5 times upper limit of normal (ULN). * Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent). * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * History of gastrointestinal (GI) surgery (with exception of appendectomy). * Average QT interval corrected using Fridericia's formula (QTcF) \>450 milliseconds (msec) at screening. * Any clinically relevant abnormality on the screening medical assessment, laboratory examination, or electrocardiogram. * History of QTc prolongation, symptomatic cardiac arrhythmias or cardiac arrest. * For Part C only, history of liver toxicity resulting from drug administration. * For Part C only, history of intolerance to itraconazole. * History of sensitivity to any of the study medication, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline Medical Monitor, contraindicates their participation. * Use of any immunosuppressive medications within 6 months prior to entry. * Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, probiotics, antacids, herbal and dietary supplements (including Saint \[St\] John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half- lives (whichever is longer) prior to the first dose of study medication for each dosing, unless in the opinion of the Investigator and GlaxoSmithKline Medical Monitor the medication will not interfere with the study procedures or compromise participant safety. (Paracetamol is acceptable at a dose of no more than 500 milligrams \[mg\] at a time and no more than 2 grams \[g\] per day). * Participants who have received a COVID-19 vaccine within 7 days of admission (or readmission) to the clinical unit or who are demonstrating signs/symptoms attributed to a COVID-19 vaccination that occurred greater than 7 days earlier. * Recent donation of blood or blood products such that participation in the study would result in loss of blood in excess of 500 milliliter (mL) within 56 days. * The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). * Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day. * Unwillingness or inability to follow the procedures outlined in the protocol or any other type of medical research within 30 days of randomization. * Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study treatment. * Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. * Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment. * A positive pre-study drug/alcohol screen. * Positive human immunodeficiency virus (HIV) antibody test. * History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual \[DSM\]) within 2 years before dosing, or a positive drug screen reflecting consumption of illicit drugs. * Regular alcohol consumption within 6 months prior to screening: An average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. * Urinary cotinine levels indicative of smoking or use of tobacco or nicotine-containing products (e.g. nicotine patches or vaporizing devices) at screening or on admission to the unit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of Participants With All Non-serious Adverse Events (AEs) and Serious AEs (SAEs) Following Administration of Oral Dose | Up to 70 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment. |
| Part A: Number of Participants With Treatment-related AEs Following Administration of Oral Dose | Up to 70 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs were presented. |
| Part B: Number of Participants With All Non-serious AEs and SAEs | Up to 28 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment. |
| Part B: Number of Participants With Treatment-related AEs | Up to 28 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs are presented. |
| Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Up to 70 days | 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 A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Up to 70 days | Blood samples were collected for analysis of creatinine. Participants were counted under increase of PCI if they had change from Baseline \> 44.2 micromoles per Liter for any post Baseline assessment. Participants who did not meet this PCI criteria are counted as within (w/in) range. |
| Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Up to 70 days | Blood samples were collected for analysis of chemistry parameters. PCI range for Urea: High \>10.5 mmol/L. Participants were counted in worst case category that their value changes to (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. |
| Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Up to 70 days | Blood samples were collected for analysis of hematology parameters. PCI ranges were \>1\*10\^9 cell per liter (cells/L) (eosinophils), \<0.2 or \>0.54 proportion of red blood cells in blood (hematocrit), \<80 or \>180 grams per liter(g/L) (hemoglobin), \<3 or \>20 x10\^9 cells/L (leukocytes), \<0.8\*10\^9 cells/L (lymphocytes), \<1.5 or \>16\*10\^9 cells/L (neutrophils) and \<100 or \>550\*10\^9 cells/L (platelets). 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 A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Up to 70 days | 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 A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Following Administration of Oral Dose | Up to 70 days | 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 A: Number of Participants With Abnormal Physical Examination Findings Following Administration of Oral Dose | Up to 70 days | A full physical examination was performed which included, at a minimum, assessments of the Skin, Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. |
| Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Up to 28 days | Blood samples were collected for analysis of chemistry parameters. PCI ranges were \>=2\*ULN (U/L)(ALT), \>=2\*ULN (U/L) (AST), \>=2\*ULN (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 B: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Up to 28 days | Blood samples were collected for analysis of chemistry parameters. PCI range for Urea: High \>10.5 mmol/L. Participants were counted in worst case category that their value changes to (within \[w/in\] range or 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. |
| Part B: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose | Up to 28 days | Blood samples were collected for analysis of creatinine. Participants were counted under increase of PCI if they had change from Baseline \> 44.2 micromoles per Liter for any post Baseline assessment. Participants who did not meet this PCI criteria are counted as w/in range. Participants whose laboratory value became within range, were recorded in 'To within Range' category. |
| Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Up to 28 days | Blood samples were collected for analysis of hematology parameters. PCI ranges were 1\*10\^9 cell per liter (cells/L) (eosinophils), \<0.2 or \>0.54 proportion of red blood cells in blood (hematocrit), \<80 or \>180 grams per liter(g/L) (hemoglobin), \<3 or \>20 x10\^9 cells/L (leukocytes), \<0.8\*10\^9 cells/L (lymphocytes), \<1.5 or \>16\*10\^9 cells/L (neutrophils) and \<100 or \>550\*10\^9 cells/L (platelets). 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 B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Up to 28 days | Vital signs included DBP, SBP, PR, body temperature, RR and were measured after resting for at least 5 minutes in semi-supine position. PCI ranges were, SBP (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 B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Repeat Oral Dose of GSK3915393 | Up to 28 days | 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 B: Number of Participants With Abnormal Physical Examination Findings Following Administration of Repeat Oral Dose of GSK3915393 | Up to 28 days | A full physical examination was performed which included, at a minimum, assessments of the Skin, Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. |
| Part C: Maximum Observed Plasma Drug Concentration (Cmax) Following IV Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: Cmax of GSK3915393 Following IV Dose of GSK3915393+ITZ | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: Cmax Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. For Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, concentrations after 24 hours post-dose were expected to be non-quantifiable. Cmax was derived based on collected assessments (up to 24 hours for Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, up to 60 hours for Part C: GSK3915393 20 mg+ ITZ). Only the quantifiable concentration time points were to be considered for assessment of pharmacokinetic parameters. |
| Part C: Time to Maximum Observed Plasma Drug Concentration (Tmax) Following IV Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: Tmax of GSK3915393 Following IV Dose of GSK3915393+ITZ | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: Tmax of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. For Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, concentrations after 24 hours post-dose were expected to be non-quantifiable. Tmax was derived based on collected assessments (up to 24 hours for Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, up to 60 hours for Part C: GSK3915393 20 mg+ ITZ). Only the quantifiable concentration time points were to be considered for assessment of pharmacokinetic parameters. |
| Part C: Area Under Curve up to the Last Measurable Concentration (AUCLST[0-10]) Following IV Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: AUCLST(0-24) of GSK3915393 Following IV Dose of GSK3915393+ITZ | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: AUCLST(0-24) of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: AUC From Time Zero to Infinity (AUC[0-inf]) Following IV Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: AUC(0-inf) of GSK3915393 Following IV Dose of GSK3915393+ITZ | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: AUC(0-inf) of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. For Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, concentrations after 24 hours post-dose were expected to be non-quantifiable. AUC(0-inf) was derived based on collected assessments (up to 24 hours for Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, up to 60 hours for Part C: GSK3915393 20 mg+ ITZ). Only the quantifiable concentration time points were to be considered for assessment of pharmacokinetic parameters. |
| Part C: Apparent Terminal Half-life (t1/2) of GSK3915393 Following IV Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: t1/2 of GSK3915393 Following IV Dose of GSK3915393+ITZ | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: t1/2 of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. For Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, concentrations after 24 hours post-dose were expected to be non-quantifiable. t1/2 was derived based on collected assessments (up to 24 hours for Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, up to 60 hours for Part C: GSK3915393 20 mg+ ITZ). Only the quantifiable concentration time points were to be considered for assessment of pharmacokinetic parameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Cmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Days 3, 5 and 7: Pre-dose, 20, 40 minutes, 1, 1.5, 2, 3, 4, 6 and 10 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: Tmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Days 3, 5 and 7: Pre-dose, 20, 40 minutes, 1, 1.5, 2, 3, 4, 6 and 10 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: AUCLST(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Days 3, 5 and 7: Pre-dose, 20, 40 minutes, 1, 1.5 ,2, 3, 4, 6 and 10 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: Trough Concentration (Ctau) Following Dose of 20 mg BID and 80 mg BID of GSK3915393 on Day 14 | Day 14: Pre-dose, 20, 40 minutes, 1, 1.5 ,2, 3, 4, 6, 10, 10 hour 20 minutes, 10 hours 40 minutes, 12, 12.5, 13, 14, 16 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: Trough Concentration (Ctau) Following Dose of 160 mg of GSK3915393 on Day 14 | Day 14: Pre-dose, 20, 40 minutes, 1, 1.5 ,2, 3, 4, 6, 10, and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: Number of Participants With All Non-serious AEs and SAEs | Up to 72 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment. |
| Part C: Number of Participants With Treatment-related AEs Following Dose of GSK3915393 | Up to 72 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs are presented. |
| Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Up to 72 days | Blood samples were collected for analysis of chemistry parameters. PCI ranges were \>=2\*ULN (U/L)(ALT), \>=2\*ULN (U/L) (AST), \>=2\*ULN (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 C: Number of Participants With Worst Case Chemistry Results: Creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Up to 72 days | Blood samples were collected for analysis of creatinine. Participants were counted under increase of PCI if they had change from Baseline \> 44.2 micromoles per Liter for any post Baseline assessment. Participants who did not meet this PCI criteria are counted as w/in range. Participants whose laboratory value became within range, were recorded in 'To within Range' category. |
| Part A: Cmax Following Single Oral Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, 24 and 36 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Up to 72 days | Blood samples were collected for analysis of hematology parameters. PCI ranges were 1\*10\^9 cell per liter (cells/L) (eosinophils), \<0.2 or \>0.54 proportion of red blood cells in blood (hematocrit), \<80 or \>180 grams per liter(g/L) (hemoglobin), \<3 or \>20 x10\^9 cells/L (leukocytes), \<0.8\*10\^9 cells/L (lymphocytes), \<1.5 or \>16\*10\^9 cells/L (neutrophils) and \<100 or \>550\*10\^9 cells/L (platelets). 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 C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Up to 72 days | Vital signs included DBP, SBP, PR, body temperature, RR and were measured after resting for at least 5 minutes in semi-supine position. PCI ranges were, SBP (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 C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of GSK3915393 | Up to 72 days | 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 C: Number of Participants With Abnormal Physical Examination Findings Following Administration of GSK3915393 | Up to 72 days | A full physical examination was performed which included, at a minimum, assessments of the Skin, Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. |
| Part C: Fraction of Drug Escaping Hepatic Metabolism (FH) Following IV Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hour 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. FH was expressed as ratio and was calculated as: 1 minus hepatic extraction ratio. Hepatic extraction ratio=hepatic blood clearance (milliliters per minute)/hepatic blood flow (milliliters per minute) |
| Part C: FH Following IV Administration of GSK3915393+ITZ | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hour 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. FH was expressed as ratio and was calculated as: 1 minus Hepatic extraction ratio. Hepatic extraction ratio=hepatic blood clearance (milliliters per minute)/hepatic blood flow (milliliters per minute) |
| Part C: Fraction of Drug Escaping Gut Metabolism (FG) Following Oral Administration of GSK3915393+Water | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. FG was expressed as ratio and calculated as: AUC of GSK3915393+water divided by AUC of GSK3915393+GFJ. |
| Part C: Fraction of Drug Absorbed (FA) Following Oral Administration of GSK3915393+Water | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. FA was expressed as ratio was calculated as absolute bioavailability (F) divided by the product of fraction of drug escaping hepatic metabolism (FH) and fraction of drug escaping gut metabolism (FG). |
| Part C: Number of Participants With Worst Case Chemistry Results: Urea by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Up to 72 days | Blood samples were collected for analysis of chemistry parameters. PCI range for Urea: High \>10.5 mmol/L. Participants were counted in worst case category that their value changes to ( 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. |
| Part A: Cmax Following Single IV Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part A: Tmax Following Single Oral Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, 24 and 36 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part A: Tmax Following IV Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part A: AUCLST(0-24) Following Single Oral Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part A: AUCLST(0-6) Following Single IV Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part A: AUC(0-inf) Following Single Oral Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, 24 and 36 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part A: AUC(0-inf) Following Single IV Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part A: t1/2 Following Single IV Dose of GSK3915393 100 mcg IV | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part A: Clearance (CL) Following Single IV Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part A: Volume of Distribution (Vd) Following Single IV Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part A: Absolute Bioavailability (F) Following Single Oral Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, 24 and 36 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose. It was expressed as ratio was calculated as (AUC\[0-inf\] for oral divided by oral dose) divided by (AUC\[0-inf\] for IV/dose given as IV). |
| Part A: Fraction of Drug Escaping Hepatic Metabolism (FH) Following Single Oral Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, 24 and 36 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. FH was expressed as ratio and was calculated as: 1 minus hepatic extraction ratio. Hepatic extraction ratio=hepatic blood clearance (milliliters per minute)/hepatic blood flow (milliliters per minute). |
| Part A: Product of Fraction of Drug Absorbed and Fraction of Drug Escaping Gut Metabolism (FA*FG) Following Oral Dose of GSK3915393 | Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, 24 and 36 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. Product of FA\*FG was calculated as: (absolute bioavailability \[F\] divided by fraction of drug escaping hepatic metabolism \[FH\]). |
| Part A: Number of Participants With All Non-serious AEs and SAEs Following Administration Administration of IV Dose of GSK3915393 | Up to 21 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment. |
| Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Up to 21 days | Blood samples were collected for analysis of chemistry parameters. PCI ranges were \>=2\*ULN (U/L)(ALT), \>=2\*ULN (U/L) (AST), \>=2\*ULN (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 A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Up to 21 days | Blood samples were collected for analysis of creatinine. Participants were counted under increase of PCI if they had change from Baseline \>44.2 micromoles per Liter for any post Baseline assessment. Participants who did not meet this PCI criteria are counted as w/in range. |
| Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Up to 21 days | Blood samples were collected for analysis of chemistry parameters. PCI range for Urea: High \>10.5 mmol/L. Participants were counted in worst case category that their value changes to (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. |
| Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Up to 21 days | Blood samples were collected for analysis of hematology parameters. PCI ranges were \>1\*10\^9 cell per liter (cells/L) (eosinophils), \<0.2 or \>0.54 proportion of red blood cells in blood (hematocrit), \<80 or \>180 grams per liter(g/L) (hemoglobin), \<3 or \>20 x10\^9 cells/L (leukocytes), \<0.8\*10\^9 cells/L (lymphocytes), \<1.5 or \>16\*10\^9 cells/L (neutrophils) and \<100 or \>550\*10\^9 cells/L (platelets). 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 A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | Up to 21 days | Vital signs included DBP, SBP, PR, body temperature, RR and were measured after resting for at least 5 minutes in semi-supine position. PCI ranges were, SBP (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 A: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of IV Dose of GSK3915393 | Up to 21 days | 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 A: Number of Participants With Abnormal Physical Examination Findings Following Administration of IV Dose of GSK3915393 | Up to 21 days | A full physical examination was performed which included, at a minimum, assessments of the Skin, Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. |
| Part B: Cmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Days 1 and 14: Pre-dose, 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, and 10 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: Cmax(10-24) Following Repeat Dose 20 mg and 80 mg of GSK3915393 | Days 1 and 14: 10 hours, 10 hours 20 minutes, 10 hours 40 minutes, 12, 12.5 ,13, 14, 16, and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: Cmax(10-24) Following Dose 160 mg (QD) of GSK3915393 | Days 1 and 14: 10, 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: Tmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Days 1 and 14: Pre-dose, 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, and 10 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: Tmax(10-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Days 1 and 14: 10 hours, 10 hours 20 minutes, 10 hours 40 minutes, 12, 12.5 ,13, 14, 16, and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: Tmax(10-24) Following Dose 160 mg (QD) of GSK3915393 | Days 1 and 14: 10, 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: AUCLST(0-10) Following Dosing of GSK3915393 | Days 1 and 14: Pre-dose, 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, and 10 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: AUCLST(0-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Days 1 and 14: Pre-dose, 20 minutes, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 10 hours 20 minutes, 10 hours 40 minutes, 12, 12.5 ,13, 14, 16, and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: AUCLST(0-24) Following Dose of GSK3915393 160 mg (QD) | Days 1 and 14: Pre-dose, 20 minutes, 40 minutess, 1, 1.5, 2, 3 ,4, 6, 10 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: AUC(10-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Days 1 and 14: 10 hours, 10 hours 20 minutes, 10 hours 40 minutes, 12, 12.5 ,13, 14, 16, and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
| Part B: AUC(10-24) Following Repeat Dose of GSK3915393 160 mg (QD) | Days 1 and 14: 10 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. |
Countries
United Kingdom
Participant flow
Recruitment details
This was a 3-part study in healthy participants. Part A was a crossover design, single-dose (SD), Part B was a parallel group, repeat oral dose and Part C was a drug:drug interaction study.
Pre-assignment details
Total 65 participants were enrolled at one center in United Kingdom. The dose escalation committee concluded that doses higher than 160 milligram (mg) once daily (QD) (Part A Period 4 dose) should not be given. Placebo arms across similar dosing strategies in Part B were combined as pre-specified in reporting and analysis plan.
Participants by arm
| Arm | Count |
|---|---|
| PartA: Placebo/GSK3915393 60mg/100mcg IV/160mg Participants in Part A received a single oral dose of Placebo on Day 1 in treatment Period 1; followed by a single oral dose of GSK3915393 60 milligrams (mg) on Day 1 in treatment Period 2; followed by a single dose of GSK3915393 100 micrograms (mcg) intravenous (IV) on Day 1 in treatment Period 3; further followed by a single oral dose of GSK3915393 160 mg on Day 1 in treatment Period 4. Participants were dosed in the fed state. There was a washout period of 20 days between periods 1 and 2, washout period between treatment 2 and 3 was of 12 days, washout period between treatment periods 3 and 4 was of 20 days. There was a follow-up period of 14 days. | 4 |
| Part A: GSK3915393 15mg/Placebo/100mcg IV/160mg Participants in Part A received a single oral dose of GSK3915393 15 mg on Day 1 in treatment Period 1; followed by a single oral dose of placebo on Day 1 in treatment Period 2; followed by a single dose of GSK3915393 100 mcg IV on Day 1 in treatment Period 3; further followed by a single oral dose of GSK3915393 160mg on Day 1 in treatment Period 4. Participants were dose in the fed state. There was a washout period of 20 days between periods 1 and 2, washout period between treatment 2 and 3 was of 12 days, washout period between treatment periods 3 and 4 was of 20 days. There was a follow-up period of 14 days. | 4 |
| Part A: GSK3915393 15mg/60mg/100mcg IV/Placebo Participants in Part A received a single oral dose of GSK3915393 15 mg on Day 1 in treatment Period 1; followed by a single oral dose of GSK3915393 60 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3915393 100 mcg IV on Day 1 in treatment Period 3; further followed by a single oral dose of placebo on Day 1 in treatment Period 4. Participants were dosed in fed state. There was a washout period of 20 days between Periods 1 and 2, washout period between treatment 2 and 3 was of 12 days, washout period between treatment periods 3 and 4 was of 20 days. There was a follow-up period of 14 days. | 3 |
| Part A: GSK3915393 15mg/60mg/100mcg IV/160mg Participants in Part A received a single oral dose of GSK3915393 15 mg on Day 1 in treatment Period 1; followed by a single oral dose of GSK3915393 60 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3915393 100 mcg IV on Day 1 in treatment Period 3; further followed by a single oral dose of GSK3915393 160 mg on Day 1 in treatment Period 4. Participants were dosed in fed state. There was a washout period of 20 days between Period 1 and 2, washout period between treatment 2 and 3 was of 12 days, washout period between treatment period 3 and 4 was of 20 days. There was follow-up period of 14 days. | 3 |
| Part B: Placebo Participants received placebo matching with GSK3915393 as repeat oral dose for 14 days (dosing frequency twice a day \[BID\] or QD, matched to the frequency of dosing in the concurrent active treatment arm). The impact of food effect on pharmacokinetic (PK) of GSK3915393 was investigated following Ante-Meridiem (AM) dose on three days in all cohort (Day 3=fasted, Day 5= high fat breakfast, Day 7=standard breakfast). | 10 |
| Part B: GSK3915393 20 mg (BID) Participants received GSK3915393 20 mg BID as repeat oral dose for 14 days. The impact of food effect on PK of GSK3915393 was investigated following AM dose on three days in all cohort (Day 3=fasted, Day 5= high fat breakfast, Day 7=standard breakfast). | 10 |
| Part B: GSK3915393 80 mg (BID) Participants received GSK3915393 80 mg BID as repeat oral dose for 14 days. The impact of food effect on PK of GSK3915393 was investigated following AM dose on three days in all cohort (Day 3=fasted, Day 5= high fat breakfast, Day 7=standard breakfast). | 9 |
| Part B: GSK3915393 160 mg (QD) Participants received GSK3915393 160 mg QD as repeat oral dose for 14 days. The impact of food effect on PK of GSK3915393 was investigated following AM dose on three days in all cohort (Day 3=fasted, Day 5= high fat breakfast, Day 7=standard breakfast). | 9 |
| PartC:GSK3915393 100mcg IV/100mcgIV+ITZ/20mg+GFJ/20+WTR/20+ITZ Participants in Part C received a single dose of GSK3915393 100 mcg IV on Day 1 in treatment Period 1; followed by a single dose of GSK3915393 100mcg IV along with Itraconazole (ITZ) on Day 1 in treatment Period 2; followed by a single oral dose of GSK3915393 20 mg along with grapefruit juice (GFJ) on Day 1 in treatment Period 3; followed by a single oral dose of GSK3915393 20mg along with water (WTR) on Day 1 in treatment Period 4; further followed by a single oral dose of GSK3915393 20 mg along with ITZ in treatment Period 5. There was a washout period of 6 days between treatment Periods 1 and 2, washout period of 24 days between treatment periods 2 and 3, washout period of 10 days between treatment periods 3 and 4 and washout period of 13 days between treatment periods 4 and 5. There was a follow-up of 14 days. | 6 |
| Part C:GSK3915393 100mg IV/100mcgIV+ITZ/20mg+WTR/20+GFJ/20+ITZ Participants in Part C received a single dose of GSK3915393 100 mcg IV on Day 1 in treatment Period 1; followed by a single dose of GSK3915393 100 mcg IV along with ITZ on Day 1 in treatment Period 2; followed by a single oral dose of GSK3915393 20 mg+ water on Day 1 in treatment Period 3; followed by a single oral dose of GSK3915393 20mg along with GFJ on Day 1 in treatment Period 4; further followed by a single oral dose of GSK3915393 20 mg along with ITZ in treatment Period 5. There was a washout period of 6 days between treatment Periods 1 and 2, washout period of 24 days between treatment periods 2 and 3, washout period of 10 days between treatment periods 3 and 4 and washout period of 13 days between treatment periods 4 and 5. There was a follow-up of 14 days. | 7 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A: Washout Period 1(Up to Day 20) | Physician Decision | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B: Up to Day 14 | Adverse Event | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 |
| Part C: Period 5 (Day 1) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Part C: Washout Period 1 (Up to Day 6) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Part C: Washout Period 3 (Up to Day10) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Part C: Washout Period 4 (Up to Day 13) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | PartA: Placebo/GSK3915393 60mg/100mcg IV/160mg | Part A: GSK3915393 15mg/Placebo/100mcg IV/160mg | Part A: GSK3915393 15mg/60mg/100mcg IV/Placebo | Part A: GSK3915393 15mg/60mg/100mcg IV/160mg | Part B: Placebo | Part B: GSK3915393 20 mg (BID) | Part B: GSK3915393 80 mg (BID) | Part B: GSK3915393 160 mg (QD) | PartC:GSK3915393 100mcg IV/100mcgIV+ITZ/20mg+GFJ/20+WTR/20+ITZ | Part C:GSK3915393 100mg IV/100mcgIV+ITZ/20mg+WTR/20+GFJ/20+ITZ | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized <=18 years | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Customized >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Between 19 and 65 years | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 10 Participants | 10 Participants | 9 Participants | 9 Participants | 6 Participants | 7 Participants | 64 Participants |
| Race/Ethnicity, Customized ASIAN -CENTRAL/SOUTH ASIAN HERITAGE | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized ASIAN -EAST ASIAN HERITAGE | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized ASIAN - SOUTH EAST ASIAN HERITAGE | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized MIXED RACE | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized WHITE -WHITE/CAUCASIAN/EUROPEAN HERITAGE | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 9 Participants | 9 Participants | 5 Participants | 8 Participants | 4 Participants | 4 Participants | 49 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 2 Participants | 15 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants | 2 Participants | 9 Participants | 9 Participants | 9 Participants | 6 Participants | 4 Participants | 5 Participants | 50 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 | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 12 | 0 / 10 | 0 / 10 | 0 / 9 | 0 / 9 | 0 / 12 | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 1 / 9 | 2 / 9 | 3 / 9 | 1 / 9 | 4 / 12 | 3 / 10 | 5 / 10 | 1 / 9 | 5 / 9 | 5 / 12 | 2 / 11 | 3 / 11 | 2 / 12 | 2 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 12 | 0 / 10 | 0 / 10 | 0 / 9 | 0 / 9 | 0 / 12 | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 10 |
Outcome results
Primary
Part A: Number of Participants With Abnormal Physical Examination Findings Following Administration of Oral Dose
A full physical examination was performed which included, at a minimum, assessments of the Skin, Cardiovascular, Respiratory, Gastrointestinal and Neurological systems.
Time frame: Up to 70 days
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Abnormal Physical Examination Findings Following Administration of Oral Dose | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Abnormal Physical Examination Findings Following Administration of Oral Dose | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Abnormal Physical Examination Findings Following Administration of Oral Dose | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Abnormal Physical Examination Findings Following Administration of Oral Dose | 0 Participants |
Primary
Part A: Number of Participants With All Non-serious Adverse Events (AEs) and Serious AEs (SAEs) Following Administration of Oral Dose
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.
Time frame: Up to 70 days
Population: Safety Population comprised of all randomized participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With All Non-serious Adverse Events (AEs) and Serious AEs (SAEs) Following Administration of Oral Dose | All non-serious AEs | 1 Participants |
| Part A: Placebo | Part A: Number of Participants With All Non-serious Adverse Events (AEs) and Serious AEs (SAEs) Following Administration of Oral Dose | SAEs | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With All Non-serious Adverse Events (AEs) and Serious AEs (SAEs) Following Administration of Oral Dose | SAEs | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With All Non-serious Adverse Events (AEs) and Serious AEs (SAEs) Following Administration of Oral Dose | All non-serious AEs | 2 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With All Non-serious Adverse Events (AEs) and Serious AEs (SAEs) Following Administration of Oral Dose | All non-serious AEs | 3 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With All Non-serious Adverse Events (AEs) and Serious AEs (SAEs) Following Administration of Oral Dose | SAEs | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With All Non-serious Adverse Events (AEs) and Serious AEs (SAEs) Following Administration of Oral Dose | All non-serious AEs | 1 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With All Non-serious Adverse Events (AEs) and Serious AEs (SAEs) Following Administration of Oral Dose | SAEs | 0 Participants |
Primary
Part A: Number of Participants With Treatment-related AEs Following Administration of Oral Dose
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs were presented.
Time frame: Up to 70 days
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Treatment-related AEs Following Administration of Oral Dose | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Treatment-related AEs Following Administration of Oral Dose | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Treatment-related AEs Following Administration of Oral Dose | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Treatment-related AEs Following Administration of Oral Dose | 0 Participants |
Primary
Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose
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: Up to 70 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | AST: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Calcium: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Potassium: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Glucose: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Sodium: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Glucose: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Potassium: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Glucose: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Potassium: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALT: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | AST: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Sodium: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALP: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALP: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Sodium: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALP: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALT: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Protein: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Bilirubin: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Bilirubin: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALT: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Protein: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Bilirubin: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Calcium: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | AST: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Protein: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Calcium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Protein: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Potassium: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Sodium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Calcium: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Sodium: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Bilirubin: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Glucose: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Protein: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Potassium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Protein: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Glucose: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | AST: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALP: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Calcium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Glucose: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | AST: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Potassium: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Calcium: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Bilirubin: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Sodium: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Bilirubin: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | AST: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALT: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALT: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALP: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALT: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Protein: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALT: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALT: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALT: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | AST: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | AST: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | AST: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALP: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALP: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Bilirubin: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Bilirubin: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Bilirubin: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Calcium: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Calcium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Calcium: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Glucose: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Glucose: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Glucose: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Potassium: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Potassium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Potassium: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Protein: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Protein: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Sodium: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Sodium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Sodium: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Calcium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Sodium: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Potassium: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Calcium: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Bilirubin: To High | 1 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Sodium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Protein: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Bilirubin: To w/in Range or No change | 8 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Bilirubin: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALT: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Protein: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALP: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALP: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Protein: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | AST: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | AST: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALT: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Sodium: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Glucose: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | AST: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Potassium: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Glucose: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Glucose: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | ALT: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Potassium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Calcium: To High | 0 Participants |
Primary
Part A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose
Blood samples were collected for analysis of creatinine. Participants were counted under increase of PCI if they had change from Baseline \> 44.2 micromoles per Liter for any post Baseline assessment. Participants who did not meet this PCI criteria are counted as within (w/in) range.
Time frame: Up to 70 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | W/in Range | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Increase of PCI | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Increase of PCI | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | W/in Range | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | W/in Range | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Increase of PCI | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | W/in Range | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Increase of PCI | 0 Participants |
Primary
Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose
Blood samples were collected for analysis of chemistry parameters. PCI range for Urea: High \>10.5 mmol/L. Participants were counted in worst case category that their value changes to (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.
Time frame: Up to 70 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | To High | 0 Participants |
Primary
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose
Blood samples were collected for analysis of hematology parameters. PCI ranges were \>1\*10\^9 cell per liter (cells/L) (eosinophils), \<0.2 or \>0.54 proportion of red blood cells in blood (hematocrit), \<80 or \>180 grams per liter(g/L) (hemoglobin), \<3 or \>20 x10\^9 cells/L (leukocytes), \<0.8\*10\^9 cells/L (lymphocytes), \<1.5 or \>16\*10\^9 cells/L (neutrophils) and \<100 or \>550\*10\^9 cells/L (platelets). 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: Up to 70 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Eosinophils: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Eosinophils: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Eosinophils: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hematocrit: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hematocrit: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hematocrit: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hemoglobin: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hemoglobin: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hemoglobin: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Leukocytes: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Leukocytes: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Leukocytes: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Lymphocytes: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Lymphocytes: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Lymphocytes: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Neutrophils: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Neutrophils: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Neutrophils: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Platelets: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Platelets: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Platelets: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Neutrophils: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Eosinophils: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hemoglobin: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Leukocytes: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Neutrophils: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Lymphocytes: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Lymphocytes: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Eosinophils: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Platelets: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Neutrophils: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Lymphocytes: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hemoglobin: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hematocrit: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hematocrit: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Platelets: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Leukocytes: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hematocrit: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Eosinophils: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Platelets: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Leukocytes: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Eosinophils: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hematocrit: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Neutrophils: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hemoglobin: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hemoglobin: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Leukocytes: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Leukocytes: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Platelets: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Leukocytes: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Lymphocytes: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Platelets: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Lymphocytes: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Lymphocytes: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Platelets: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Neutrophils: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Eosinophils: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Eosinophils: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Neutrophils: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hematocrit: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hematocrit: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Neutrophils: To Low | 1 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Leukocytes: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Neutrophils: To w/in Range or No change | 8 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Eosinophils: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Platelets: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Leukocytes: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hemoglobin: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Eosinophils: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Neutrophils: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hemoglobin: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hematocrit: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Eosinophils: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Platelets: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Lymphocytes: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Lymphocytes: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Platelets: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Lymphocytes: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hematocrit: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Leukocytes: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Hematocrit: To Low | 0 Participants |
Primary
Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Following Administration of Oral Dose
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 70 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Following Administration of Oral Dose | Abnormal: Not Clinically Significant | 2 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Following Administration of Oral Dose | Clinically Significant | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Following Administration of Oral Dose | Clinically Significant | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Following Administration of Oral Dose | Abnormal: Not Clinically Significant | 3 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Following Administration of Oral Dose | Abnormal: Not Clinically Significant | 1 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Following Administration of Oral Dose | Clinically Significant | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Following Administration of Oral Dose | Abnormal: Not Clinically Significant | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Following Administration of Oral Dose | Clinically Significant | 0 Participants |
Primary
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose
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 70 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | RR: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Body temperature: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | PR: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | DBP: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Body temperature: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Body temperature: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | DBP: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | SBP: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | SBP: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | PR: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | DBP: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | RR: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | RR: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | PR: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | SBP: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | SBP: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | DBP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | DBP: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | PR: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | PR: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | PR: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Body temperature: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Body temperature: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Body temperature: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | RR: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | RR: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | RR: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | SBP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | SBP: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | DBP: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | DBP: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Body temperature: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | PR: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | SBP: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | RR: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | RR: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | PR: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | DBP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | RR: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | SBP: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | DBP: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | SBP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Body temperature: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | PR: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Body temperature: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | PR: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Body temperature: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Body temperature: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | SBP: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | Body temperature: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | DBP: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | RR: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | PR: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | SBP: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | DBP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | RR: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | PR: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | SBP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | RR: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Oral Dose | DBP: To High | 0 Participants |
Primary
Part B: Number of Participants With Abnormal Physical Examination Findings Following Administration of Repeat Oral Dose of GSK3915393
A full physical examination was performed which included, at a minimum, assessments of the Skin, Cardiovascular, Respiratory, Gastrointestinal and Neurological systems.
Time frame: Up to 28 days
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Abnormal Physical Examination Findings Following Administration of Repeat Oral Dose of GSK3915393 | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Abnormal Physical Examination Findings Following Administration of Repeat Oral Dose of GSK3915393 | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Abnormal Physical Examination Findings Following Administration of Repeat Oral Dose of GSK3915393 | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Abnormal Physical Examination Findings Following Administration of Repeat Oral Dose of GSK3915393 | 0 Participants |
Primary
Part B: Number of Participants With All Non-serious AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.
Time frame: Up to 28 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part B: Number of Participants With All Non-serious AEs and SAEs | All non-serious AEs | 3 Participants |
| Part A: Placebo | Part B: Number of Participants With All Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With All Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With All Non-serious AEs and SAEs | All non-serious AEs | 5 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With All Non-serious AEs and SAEs | All non-serious AEs | 1 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With All Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With All Non-serious AEs and SAEs | All non-serious AEs | 5 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With All Non-serious AEs and SAEs | SAEs | 0 Participants |
Primary
Part B: Number of Participants With Treatment-related AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs are presented.
Time frame: Up to 28 days
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Treatment-related AEs | 1 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Treatment-related AEs | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Treatment-related AEs | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Treatment-related AEs | 0 Participants |
Primary
Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393
Blood samples were collected for analysis of chemistry parameters. PCI ranges were \>=2\*ULN (U/L)(ALT), \>=2\*ULN (U/L) (AST), \>=2\*ULN (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: Up to 28 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Calcium: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Calcium: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALP: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Calcium: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Bilirubin: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Sodium: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Bilirubin: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Bilirubin: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALP: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Sodium: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALT: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Protein: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Protein: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALT: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Glucose: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Protein: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Potassium: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | AST: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALP: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Potassium: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Potassium: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | AST: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALT: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Glucose: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Glucose: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | AST: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Sodium: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Protein: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALP: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Sodium: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALT: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALT: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | AST: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | AST: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | AST: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALP: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALP: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Bilirubin: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Bilirubin: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Bilirubin: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Calcium: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Calcium: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Calcium: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Glucose: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Glucose: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Glucose: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Potassium: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Potassium: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Potassium: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Protein: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Protein: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALT: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Sodium: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Sodium: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Bilirubin: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Protein: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Calcium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | AST: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Calcium: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Glucose: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | AST: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Sodium: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Glucose: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Sodium: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Glucose: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Potassium: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | AST: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALT: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Potassium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Potassium: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALT: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Sodium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Protein: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALP: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Protein: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Bilirubin: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALT: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Bilirubin: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALP: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Calcium: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALT: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Sodium: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Bilirubin: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Calcium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Potassium: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Protein: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Bilirubin: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Calcium: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | AST: To w/in Range or No change | 8 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALT: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Protein: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Glucose: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Calcium: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Protein: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALT: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Glucose: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Sodium: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Bilirubin: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Glucose: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | AST: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Sodium: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALP: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Potassium: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | ALP: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | AST: To High | 1 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | Potassium: To w/in Range or No change | 9 Participants |
Primary
Part B: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose
Blood samples were collected for analysis of creatinine. Participants were counted under increase of PCI if they had change from Baseline \> 44.2 micromoles per Liter for any post Baseline assessment. Participants who did not meet this PCI criteria are counted as w/in range. Participants whose laboratory value became within range, were recorded in 'To within Range' category.
Time frame: Up to 28 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose | W/in Range | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose | Increase of PCI | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose | Increase of PCI | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose | W/in Range | 10 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose | W/in Range | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose | Increase of PCI | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose | W/in Range | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose | Increase of PCI | 0 Participants |
Primary
Part B: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393
Blood samples were collected for analysis of chemistry parameters. PCI range for Urea: High \>10.5 mmol/L. Participants were counted in worst case category that their value changes to (within \[w/in\] range or 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.
Time frame: Up to 28 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | To W/in Range or No Change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | To W/in Range or No Change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | To W/in Range or No Change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of Repeat Oral Dose of GSK3915393 | To W/in Range or No Change | 9 Participants |
Primary
Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393
Blood samples were collected for analysis of hematology parameters. PCI ranges were 1\*10\^9 cell per liter (cells/L) (eosinophils), \<0.2 or \>0.54 proportion of red blood cells in blood (hematocrit), \<80 or \>180 grams per liter(g/L) (hemoglobin), \<3 or \>20 x10\^9 cells/L (leukocytes), \<0.8\*10\^9 cells/L (lymphocytes), \<1.5 or \>16\*10\^9 cells/L (neutrophils) and \<100 or \>550\*10\^9 cells/L (platelets). 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: Up to 28 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hemoglobin: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Neutrophils: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Neutrophils: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Lymphocytes: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hematocrit: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Lymphocytes: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Lymphocytes: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Eosinophils: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hemoglobin: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hematocrit: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Eosinophils: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Eosinophils: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Leukocytes: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hematocrit: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Platelets: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Platelets: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Leukocytes: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hemoglobin: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Platelets: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Neutrophils: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Leukocytes: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Eosinophils: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hemoglobin: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hemoglobin: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Leukocytes: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Leukocytes: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Leukocytes: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Lymphocytes: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Lymphocytes: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Lymphocytes: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Neutrophils: To Low | 1 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Neutrophils: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Neutrophils: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Platelets: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Platelets: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Platelets: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Eosinophils: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Eosinophils: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hematocrit: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hematocrit: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hematocrit: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Lymphocytes: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Eosinophils: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Platelets: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Neutrophils: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Leukocytes: To Low | 1 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Eosinophils: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hemoglobin: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hematocrit: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Lymphocytes: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Platelets: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Lymphocytes: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Platelets: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hematocrit: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hematocrit: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Neutrophils: To Low | 2 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Eosinophils: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Leukocytes: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Leukocytes: To w/in Range or No change | 8 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Neutrophils: To w/in Range or No change | 7 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hemoglobin: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Neutrophils: To w/in Range or No change | 7 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Neutrophils: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hematocrit: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Platelets: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Leukocytes: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Platelets: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Platelets: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hemoglobin: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Eosinophils: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Eosinophils: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Eosinophils: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hemoglobin: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hematocrit: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Lymphocytes: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Lymphocytes: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hematocrit: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Leukocytes: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Lymphocytes: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Neutrophils: To Low | 2 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Leukocytes: To w/in Range or No change | 9 Participants |
Primary
Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Repeat Oral Dose of GSK3915393
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 28 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Repeat Oral Dose of GSK3915393 | Abnormal: Not Clinically Significant | 3 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Repeat Oral Dose of GSK3915393 | Clinically Significant | 1 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Repeat Oral Dose of GSK3915393 | Clinically Significant | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Repeat Oral Dose of GSK3915393 | Abnormal: Not Clinically Significant | 5 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Repeat Oral Dose of GSK3915393 | Abnormal: Not Clinically Significant | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Repeat Oral Dose of GSK3915393 | Clinically Significant | 1 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Repeat Oral Dose of GSK3915393 | Abnormal: Not Clinically Significant | 1 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Repeat Oral Dose of GSK3915393 | Clinically Significant | 0 Participants |
Primary
Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393
Vital signs included DBP, SBP, PR, body temperature, RR and were measured after resting for at least 5 minutes in semi-supine position. PCI ranges were, SBP (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 28 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | SBP: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | SBP: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Body temperature: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | SBP: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | DBP: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | DBP: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | DBP: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | PR: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | PR: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | PR: To High | 1 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Body temperature: To w/in Range or No change | 10 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Body temperature: To High | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | RR: To Low | 0 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | RR: To w/in Range or No change | 9 Participants |
| Part A: Placebo | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | RR: To High | 1 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | DBP: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | RR: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | SBP: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Body temperature: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | RR: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | PR: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | SBP: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Body temperature: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Body temperature: To Low | 1 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | PR: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | DBP: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | DBP: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | RR: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | PR: To Low | 1 Participants |
| Part A: GSK3915393 15 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | SBP: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | PR: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | SBP: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | DBP: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | RR: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | DBP: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | RR: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | PR: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | RR: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | PR: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Body temperature: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Body temperature: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | DBP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Body temperature: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | SBP: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | SBP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | RR: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | PR: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | PR: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | DBP: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | DBP: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | RR: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Body temperature: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | SBP: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | DBP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | SBP: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Body temperature: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | RR: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | PR: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | SBP: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Repeat Oral Dose of GSK3915393 | Body temperature: To w/in Range or No change | 9 Participants |
Primary
Part C: Apparent Terminal Half-life (t1/2) of GSK3915393 Following IV Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part C: Apparent Terminal Half-life (t1/2) of GSK3915393 Following IV Dose of GSK3915393 | NA Hours |
Primary
Part C: Area Under Curve up to the Last Measurable Concentration (AUCLST[0-10]) Following IV Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part C: Area Under Curve up to the Last Measurable Concentration (AUCLST[0-10]) Following IV Dose of GSK3915393 | 5.0061 Nanogram*hour per milliliter | Geometric Coefficient of Variation 41.94 |
Primary
Part C: AUC(0-inf) of GSK3915393 Following IV Dose of GSK3915393+ITZ
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, and 60 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part C: AUC(0-inf) of GSK3915393 Following IV Dose of GSK3915393+ITZ | 13.4250 Nanogram*hour per milliliter | Geometric Coefficient of Variation 32.63 |
Primary
Part C: AUC(0-inf) of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. For Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, concentrations after 24 hours post-dose were expected to be non-quantifiable. AUC(0-inf) was derived based on collected assessments (up to 24 hours for Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, up to 60 hours for Part C: GSK3915393 20 mg+ ITZ). Only the quantifiable concentration time points were to be considered for assessment of pharmacokinetic parameters.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48 and 60 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part C: AUC(0-inf) of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | 155.5203 Nanogram*hour per milliliter | Geometric Coefficient of Variation 59.89 |
| Part A: GSK3915393 15 mg | Part C: AUC(0-inf) of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | 225.0856 Nanogram*hour per milliliter | Geometric Coefficient of Variation 52.73 |
| Part A: GSK3915393 60 mg | Part C: AUC(0-inf) of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | 2141.8345 Nanogram*hour per milliliter | Geometric Coefficient of Variation 39.15 |
90% CI: [1.268, 1.847]
90% CI: [10.141, 15.423]
Primary
Part C: AUC From Time Zero to Infinity (AUC[0-inf]) Following IV Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part C: AUC From Time Zero to Infinity (AUC[0-inf]) Following IV Dose of GSK3915393 | 5.0325 Nanogram*hour per milliliter | Geometric Coefficient of Variation 41.95 |
Primary
Part C: AUCLST(0-24) of GSK3915393 Following IV Dose of GSK3915393+ITZ
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part C: AUCLST(0-24) of GSK3915393 Following IV Dose of GSK3915393+ITZ | 13.3393 Nanogram*hour per milliliter | Geometric Coefficient of Variation 32.67 |
Primary
Part C: AUCLST(0-24) of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part C: AUCLST(0-24) of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | 153.8368 Nanogram*hour per milliliter | Geometric Coefficient of Variation 60.22 |
| Part A: GSK3915393 15 mg | Part C: AUCLST(0-24) of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | 223.1288 Nanogram*hour per milliliter | Geometric Coefficient of Variation 52.85 |
| Part A: GSK3915393 60 mg | Part C: AUCLST(0-24) of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | 2129.2407 Nanogram*hour per milliliter | Geometric Coefficient of Variation 39.04 |
Primary
Part C: Cmax Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. For Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, concentrations after 24 hours post-dose were expected to be non-quantifiable. Cmax was derived based on collected assessments (up to 24 hours for Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, up to 60 hours for Part C: GSK3915393 20 mg+ ITZ). Only the quantifiable concentration time points were to be considered for assessment of pharmacokinetic parameters.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48 and 60 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part C: Cmax Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | 145.5638 Nanogram per milliliter | Geometric Coefficient of Variation 63.79 |
| Part A: GSK3915393 15 mg | Part C: Cmax Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | 145.0510 Nanogram per milliliter | Geometric Coefficient of Variation 46.66 |
| Part A: GSK3915393 60 mg | Part C: Cmax Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | 982.5433 Nanogram per milliliter | Geometric Coefficient of Variation 33.02 |
90% CI: [0.833, 1.331]
90% CI: [4.916, 8.474]
Primary
Part C: Cmax of GSK3915393 Following IV Dose of GSK3915393+ITZ
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, and 60 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part C: Cmax of GSK3915393 Following IV Dose of GSK3915393+ITZ | 7.8839 Nanogram per milliliter | Geometric Coefficient of Variation 23.8 |
Primary
Part C: Maximum Observed Plasma Drug Concentration (Cmax) Following IV Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours post-dose
Population: Pharmacokinetic Population comprised of all participants in the safety population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part C: Maximum Observed Plasma Drug Concentration (Cmax) Following IV Dose of GSK3915393 | 4.7220 Nanogram per milliliter | Geometric Coefficient of Variation 36.38 |
Primary
Part C: t1/2 of GSK3915393 Following IV Dose of GSK3915393+ITZ
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, and 60 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part C: t1/2 of GSK3915393 Following IV Dose of GSK3915393+ITZ | NA Hour |
Primary
Part C: t1/2 of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. For Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, concentrations after 24 hours post-dose were expected to be non-quantifiable. t1/2 was derived based on collected assessments (up to 24 hours for Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, up to 60 hours for Part C: GSK3915393 20 mg+ ITZ). Only the quantifiable concentration time points were to be considered for assessment of pharmacokinetic parameters.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48 and 60 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part C: t1/2 of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | NA Hours |
| Part A: GSK3915393 15 mg | Part C: t1/2 of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | NA Hours |
| Part A: GSK3915393 60 mg | Part C: t1/2 of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | NA Hours |
Primary
Part C: Time to Maximum Observed Plasma Drug Concentration (Tmax) Following IV Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part C: Time to Maximum Observed Plasma Drug Concentration (Tmax) Following IV Dose of GSK3915393 | 0.98 Hour |
Primary
Part C: Tmax of GSK3915393 Following IV Dose of GSK3915393+ITZ
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, and 60 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part C: Tmax of GSK3915393 Following IV Dose of GSK3915393+ITZ | 0.98 Hour |
Primary
Part C: Tmax of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. For Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, concentrations after 24 hours post-dose were expected to be non-quantifiable. Tmax was derived based on collected assessments (up to 24 hours for Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, up to 60 hours for Part C: GSK3915393 20 mg+ ITZ). Only the quantifiable concentration time points were to be considered for assessment of pharmacokinetic parameters.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48 and 60 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part C: Tmax of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | 0.67 Hour |
| Part A: GSK3915393 15 mg | Part C: Tmax of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | 1.50 Hour |
| Part A: GSK3915393 60 mg | Part C: Tmax of GSK3915393 Following Oral Dose of GSK3915393 in Combination With Water, GFJ and ITZ | 1.25 Hour |
Secondary
Part A: Absolute Bioavailability (F) Following Single Oral Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose. It was expressed as ratio was calculated as (AUC\[0-inf\] for oral divided by oral dose) divided by (AUC\[0-inf\] for IV/dose given as IV).
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, 24 and 36 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part A: Absolute Bioavailability (F) Following Single Oral Dose of GSK3915393 | 0.20 Ratio | Geometric Coefficient of Variation 69.6 |
| Part A: GSK3915393 15 mg | Part A: Absolute Bioavailability (F) Following Single Oral Dose of GSK3915393 | 0.18 Ratio | Geometric Coefficient of Variation 40.7 |
| Part A: GSK3915393 60 mg | Part A: Absolute Bioavailability (F) Following Single Oral Dose of GSK3915393 | 0.29 Ratio | Geometric Coefficient of Variation 38.4 |
Secondary
Part A: AUC(0-inf) Following Single IV Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part A: AUC(0-inf) Following Single IV Dose of GSK3915393 | 4.4790 Nanogram*hour per milliliter | Geometric Coefficient of Variation 32.03 |
Secondary
Part A: AUC(0-inf) Following Single Oral Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, 24 and 36 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part A: AUC(0-inf) Following Single Oral Dose of GSK3915393 | 116.5279 Nanogram*hour per milliliter | Geometric Coefficient of Variation 101.68 |
| Part A: GSK3915393 15 mg | Part A: AUC(0-inf) Following Single Oral Dose of GSK3915393 | 431.3298 Nanogram*hour per milliliter | Geometric Coefficient of Variation 51.93 |
| Part A: GSK3915393 60 mg | Part A: AUC(0-inf) Following Single Oral Dose of GSK3915393 | 2235.3991 Nanogram*hour per milliliter | Geometric Coefficient of Variation 55.18 |
Secondary
Part A: AUCLST(0-24) Following Single Oral Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, and 24 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part A: AUCLST(0-24) Following Single Oral Dose of GSK3915393 | 113.7272 Nanogram*hour per milliliter | Geometric Coefficient of Variation 103.13 |
| Part A: GSK3915393 15 mg | Part A: AUCLST(0-24) Following Single Oral Dose of GSK3915393 | 424.6809 Nanogram*hour per milliliter | Geometric Coefficient of Variation 52.89 |
| Part A: GSK3915393 60 mg | Part A: AUCLST(0-24) Following Single Oral Dose of GSK3915393 | 2221.3816 Nanogram*hour per milliliter | Geometric Coefficient of Variation 55.49 |
Secondary
Part A: AUCLST(0-6) Following Single IV Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part A: AUCLST(0-6) Following Single IV Dose of GSK3915393 | 4.4466 Nanogram*hour per milliliter | Geometric Coefficient of Variation 31.95 |
Secondary
Part A: Clearance (CL) Following Single IV Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part A: Clearance (CL) Following Single IV Dose of GSK3915393 | 22.7675 Liters per hour | Geometric Coefficient of Variation 31.56 |
Secondary
Part A: Cmax Following Single IV Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part A: Cmax Following Single IV Dose of GSK3915393 | 4.3979 Nanogram per milliliter | Geometric Coefficient of Variation 35.65 |
Secondary
Part A: Cmax Following Single Oral Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, 24 and 36 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part A: Cmax Following Single Oral Dose of GSK3915393 | 58.7910 Nanogram per milliliter | Geometric Coefficient of Variation 71.78 |
| Part A: GSK3915393 15 mg | Part A: Cmax Following Single Oral Dose of GSK3915393 | 235.4331 Nanogram per milliliter | Geometric Coefficient of Variation 82.49 |
| Part A: GSK3915393 60 mg | Part A: Cmax Following Single Oral Dose of GSK3915393 | 1246.2994 Nanogram per milliliter | Geometric Coefficient of Variation 54.12 |
Secondary
Part A: Fraction of Drug Escaping Hepatic Metabolism (FH) Following Single Oral Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. FH was expressed as ratio and was calculated as: 1 minus hepatic extraction ratio. Hepatic extraction ratio=hepatic blood clearance (milliliters per minute)/hepatic blood flow (milliliters per minute).
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, 24 and 36 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part A: Fraction of Drug Escaping Hepatic Metabolism (FH) Following Single Oral Dose of GSK3915393 | 0.5367 Ratio |
| Part A: GSK3915393 15 mg | Part A: Fraction of Drug Escaping Hepatic Metabolism (FH) Following Single Oral Dose of GSK3915393 | 0.4617 Ratio |
| Part A: GSK3915393 60 mg | Part A: Fraction of Drug Escaping Hepatic Metabolism (FH) Following Single Oral Dose of GSK3915393 | 0.5107 Ratio |
Secondary
Part A: Number of Participants With Abnormal Physical Examination Findings Following Administration of IV Dose of GSK3915393
A full physical examination was performed which included, at a minimum, assessments of the Skin, Cardiovascular, Respiratory, Gastrointestinal and Neurological systems.
Time frame: Up to 21 days
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Abnormal Physical Examination Findings Following Administration of IV Dose of GSK3915393 | 0 Participants |
Secondary
Part A: Number of Participants With All Non-serious AEs and SAEs Following Administration Administration of IV Dose of GSK3915393
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.
Time frame: Up to 21 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With All Non-serious AEs and SAEs Following Administration Administration of IV Dose of GSK3915393 | SAEs | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With All Non-serious AEs and SAEs Following Administration Administration of IV Dose of GSK3915393 | All non-serious AEs | 4 Participants |
Secondary
Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393
Blood samples were collected for analysis of chemistry parameters. PCI ranges were \>=2\*ULN (U/L)(ALT), \>=2\*ULN (U/L) (AST), \>=2\*ULN (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: Up to 21 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Protein: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | ALT: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | ALT: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | ALT: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | AST: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | AST: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | AST: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | ALP: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | ALP: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | ALP: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Bilirubin: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Bilirubin: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Bilirubin: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Calcium: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Calcium: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Calcium: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Glucose: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Glucose: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Glucose: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Potassium: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Potassium: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Potassium: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Protein: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Protein: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Sodium: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Sodium: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Sodium: To High | 0 Participants |
Secondary
Part A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393
Blood samples were collected for analysis of creatinine. Participants were counted under increase of PCI if they had change from Baseline \>44.2 micromoles per Liter for any post Baseline assessment. Participants who did not meet this PCI criteria are counted as w/in range.
Time frame: Up to 21 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | W/in Range | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results-creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Administration Administration of IV Dose of GSK3915393 | Increase of PCI | 0 Participants |
Secondary
Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393
Blood samples were collected for analysis of chemistry parameters. PCI range for Urea: High \>10.5 mmol/L. Participants were counted in worst case category that their value changes to (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.
Time frame: Up to 21 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Chemistry Results-urea by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | To High | 0 Participants |
Secondary
Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393
Blood samples were collected for analysis of hematology parameters. PCI ranges were \>1\*10\^9 cell per liter (cells/L) (eosinophils), \<0.2 or \>0.54 proportion of red blood cells in blood (hematocrit), \<80 or \>180 grams per liter(g/L) (hemoglobin), \<3 or \>20 x10\^9 cells/L (leukocytes), \<0.8\*10\^9 cells/L (lymphocytes), \<1.5 or \>16\*10\^9 cells/L (neutrophils) and \<100 or \>550\*10\^9 cells/L (platelets). 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: Up to 21 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Hematocrit: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Hemoglobin: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Hemoglobin: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Hemoglobin: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Leukocytes: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Leukocytes: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Lymphocytes: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Neutrophils: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Platelets: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Platelets: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Platelets: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Eosinophils: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Eosinophils: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Eosinophils: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Hematocrit: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Hematocrit: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Leukocytes: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Lymphocytes: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Lymphocytes: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Neutrophils: To Low | 1 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Administration of IV Dose of GSK3915393 | Neutrophils: To w/in Range or No change | 11 Participants |
Secondary
Part A: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of IV Dose of GSK3915393
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 21 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of IV Dose of GSK3915393 | Clinically Significant | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of IV Dose of GSK3915393 | Abnormal: Not Clinically Significant | 7 Participants |
Secondary
Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393
Vital signs included DBP, SBP, PR, body temperature, RR and were measured after resting for at least 5 minutes in semi-supine position. PCI ranges were, SBP (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 21 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | DBP: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | DBP: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | DBP: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | PR: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | Body temperature: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | Body temperature: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | SBP: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | SBP: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | SBP: To High | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | PR: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | PR: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | Body temperature: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | RR: To Low | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | RR: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part A: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following IV Dose of GSK3915393 | RR: To High | 0 Participants |
Secondary
Part A: Product of Fraction of Drug Absorbed and Fraction of Drug Escaping Gut Metabolism (FA*FG) Following Oral Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. Product of FA\*FG was calculated as: (absolute bioavailability \[F\] divided by fraction of drug escaping hepatic metabolism \[FH\]).
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, 24 and 36 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part A: Product of Fraction of Drug Absorbed and Fraction of Drug Escaping Gut Metabolism (FA*FG) Following Oral Dose of GSK3915393 | 0.3062 Ratio |
| Part A: GSK3915393 15 mg | Part A: Product of Fraction of Drug Absorbed and Fraction of Drug Escaping Gut Metabolism (FA*FG) Following Oral Dose of GSK3915393 | 0.3814 Ratio |
| Part A: GSK3915393 60 mg | Part A: Product of Fraction of Drug Absorbed and Fraction of Drug Escaping Gut Metabolism (FA*FG) Following Oral Dose of GSK3915393 | 0.5563 Ratio |
Secondary
Part A: t1/2 Following Single IV Dose of GSK3915393 100 mcg IV
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part A: t1/2 Following Single IV Dose of GSK3915393 100 mcg IV | NA Hour |
Secondary
Part A: Tmax Following IV Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part A: Tmax Following IV Dose of GSK3915393 | 0.98 Hour |
Secondary
Part A: Tmax Following Single Oral Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 12, 14, 24 and 36 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part A: Tmax Following Single Oral Dose of GSK3915393 | 1.50 Hour |
| Part A: GSK3915393 15 mg | Part A: Tmax Following Single Oral Dose of GSK3915393 | 1.52 Hour |
| Part A: GSK3915393 60 mg | Part A: Tmax Following Single Oral Dose of GSK3915393 | 1.50 Hour |
Secondary
Part A: Volume of Distribution (Vd) Following Single IV Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hours 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5 and 6 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part A: Volume of Distribution (Vd) Following Single IV Dose of GSK3915393 | 30.7890 Liters | Geometric Coefficient of Variation 27.51 |
Secondary
Part B: AUC(10-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 1 and 14: 10 hours, 10 hours 20 minutes, 10 hours 40 minutes, 12, 12.5 ,13, 14, 16, and 24 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: AUC(10-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Day 1 | 115.2199 Nanograms*hour per milliliter | Geometric Coefficient of Variation 52.85 |
| Part A: Placebo | Part B: AUC(10-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Day 14 | 189.9773 Nanograms*hour per milliliter | Geometric Coefficient of Variation 47.3 |
| Part A: GSK3915393 15 mg | Part B: AUC(10-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Day 1 | 666.5290 Nanograms*hour per milliliter | Geometric Coefficient of Variation 62.91 |
| Part A: GSK3915393 15 mg | Part B: AUC(10-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Day 14 | 959.7659 Nanograms*hour per milliliter | Geometric Coefficient of Variation 49.53 |
Secondary
Part B: AUC(10-24) Following Repeat Dose of GSK3915393 160 mg (QD)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 1 and 14: 10 and 24 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: Placebo | Part B: AUC(10-24) Following Repeat Dose of GSK3915393 160 mg (QD) | Day 1 | NA Nanograms*hour per milliliter |
| Part A: Placebo | Part B: AUC(10-24) Following Repeat Dose of GSK3915393 160 mg (QD) | Day 14 | NA Nanograms*hour per milliliter |
Secondary
Part B: AUCLST(0-10) Following Dosing of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 1 and 14: Pre-dose, 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, and 10 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: AUCLST(0-10) Following Dosing of GSK3915393 | Day 14, n=9, 9, 9 | 173.2096 Nanograms*hour per milliliter | Geometric Coefficient of Variation 63.74 |
| Part A: Placebo | Part B: AUCLST(0-10) Following Dosing of GSK3915393 | Day 1, n=10, 9, 9 | 90.7283 Nanograms*hour per milliliter | Geometric Coefficient of Variation 47.48 |
| Part A: GSK3915393 15 mg | Part B: AUCLST(0-10) Following Dosing of GSK3915393 | Day 14, n=9, 9, 9 | 873.9352 Nanograms*hour per milliliter | Geometric Coefficient of Variation 44.84 |
| Part A: GSK3915393 15 mg | Part B: AUCLST(0-10) Following Dosing of GSK3915393 | Day 1, n=10, 9, 9 | 570.8621 Nanograms*hour per milliliter | Geometric Coefficient of Variation 73.35 |
| Part A: GSK3915393 60 mg | Part B: AUCLST(0-10) Following Dosing of GSK3915393 | Day 1, n=10, 9, 9 | 1268.9518 Nanograms*hour per milliliter | Geometric Coefficient of Variation 34.85 |
| Part A: GSK3915393 60 mg | Part B: AUCLST(0-10) Following Dosing of GSK3915393 | Day 14, n=9, 9, 9 | 1670.9421 Nanograms*hour per milliliter | Geometric Coefficient of Variation 36.52 |
Secondary
Part B: AUCLST(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 3, 5 and 7: Pre-dose, 20, 40 minutes, 1, 1.5 ,2, 3, 4, 6 and 10 hours post-dose
Population: Pharmacokinetic Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: AUCLST(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 5, n= 10, 9, 9 | 120.0480 Nanogram*hour per milliliter | Geometric Coefficient of Variation 56.72 |
| Part A: Placebo | Part B: AUCLST(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 3, n=10, 9, 9 | 115.6796 Nanogram*hour per milliliter | Geometric Coefficient of Variation 60.32 |
| Part A: Placebo | Part B: AUCLST(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 7, n= 9, 9, 9 | 135.3659 Nanogram*hour per milliliter | Geometric Coefficient of Variation 49.21 |
| Part A: GSK3915393 15 mg | Part B: AUCLST(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 5, n= 10, 9, 9 | 698.9908 Nanogram*hour per milliliter | Geometric Coefficient of Variation 61.8 |
| Part A: GSK3915393 15 mg | Part B: AUCLST(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 3, n=10, 9, 9 | 883.5828 Nanogram*hour per milliliter | Geometric Coefficient of Variation 75.58 |
| Part A: GSK3915393 15 mg | Part B: AUCLST(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 7, n= 9, 9, 9 | 754.3745 Nanogram*hour per milliliter | Geometric Coefficient of Variation 69.11 |
| Part A: GSK3915393 60 mg | Part B: AUCLST(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 3, n=10, 9, 9 | 1571.0637 Nanogram*hour per milliliter | Geometric Coefficient of Variation 25.05 |
| Part A: GSK3915393 60 mg | Part B: AUCLST(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 7, n= 9, 9, 9 | 1551.1980 Nanogram*hour per milliliter | Geometric Coefficient of Variation 21.66 |
| Part A: GSK3915393 60 mg | Part B: AUCLST(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 5, n= 10, 9, 9 | 1320.6847 Nanogram*hour per milliliter | Geometric Coefficient of Variation 25.74 |
90% CI: [0.867, 1.205]
90% CI: [0.941, 1.308]
90% CI: [0.671, 0.933]
90% CI: [0.724, 1.007]
90% CI: [0.713, 0.992]
90% CI: [0.837, 1.165]
Secondary
Part B: AUCLST(0-24) Following Dose of GSK3915393 160 mg (QD)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 1 and 14: Pre-dose, 20 minutes, 40 minutess, 1, 1.5, 2, 3 ,4, 6, 10 and 24 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: AUCLST(0-24) Following Dose of GSK3915393 160 mg (QD) | Day 1 | 1314.7399 Nanograms*hour per milliliter | Geometric Coefficient of Variation 34.62 |
| Part A: Placebo | Part B: AUCLST(0-24) Following Dose of GSK3915393 160 mg (QD) | Day 14 | 1738.3433 Nanograms*hour per milliliter | Geometric Coefficient of Variation 36.02 |
Secondary
Part B: AUCLST(0-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 1 and 14: Pre-dose, 20 minutes, 40 minutes, 1, 1.5, 2, 3, 4, 6, 10, 10 hours 20 minutes, 10 hours 40 minutes, 12, 12.5 ,13, 14, 16, and 24 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: AUCLST(0-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Day 1, n=10, 9 | 193.1524 Nanograms*hour per milliliter | Geometric Coefficient of Variation 48.59 |
| Part A: Placebo | Part B: AUCLST(0-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Day 14, n=9, 9 | 342.1653 Nanograms*hour per milliliter | Geometric Coefficient of Variation 62.25 |
| Part A: GSK3915393 15 mg | Part B: AUCLST(0-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Day 1, n=10, 9 | 1242.5500 Nanograms*hour per milliliter | Geometric Coefficient of Variation 67.19 |
| Part A: GSK3915393 15 mg | Part B: AUCLST(0-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Day 14, n=9, 9 | 1856.9207 Nanograms*hour per milliliter | Geometric Coefficient of Variation 45.22 |
Secondary
Part B: Cmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 1 and 14: Pre-dose, 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, and 10 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: Cmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Day 1, n=10, 9, 9 | 64.7843 Nanograms per milliliter | Geometric Coefficient of Variation 45.5 |
| Part A: Placebo | Part B: Cmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Day 14, n=9, 9, 9 | 95.4416 Nanograms per milliliter | Geometric Coefficient of Variation 93.47 |
| Part A: GSK3915393 15 mg | Part B: Cmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Day 1, n=10, 9, 9 | 408.5572 Nanograms per milliliter | Geometric Coefficient of Variation 107 |
| Part A: GSK3915393 15 mg | Part B: Cmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Day 14, n=9, 9, 9 | 820.5354 Nanograms per milliliter | Geometric Coefficient of Variation 67.59 |
| Part A: GSK3915393 60 mg | Part B: Cmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Day 14, n=9, 9, 9 | 1710.7385 Nanograms per milliliter | Geometric Coefficient of Variation 48.78 |
| Part A: GSK3915393 60 mg | Part B: Cmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Day 1, n=10, 9, 9 | 823.7704 Nanograms per milliliter | Geometric Coefficient of Variation 42.34 |
Secondary
Part B: Cmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 3, 5 and 7: Pre-dose, 20, 40 minutes, 1, 1.5, 2, 3, 4, 6 and 10 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: Cmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 5, n= 10, 9, 9 | 56.9187 Nanograms*hour per milliliter | Geometric Coefficient of Variation 54.99 |
| Part A: Placebo | Part B: Cmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 3, n=10, 9, 9 | 125.5298 Nanograms*hour per milliliter | Geometric Coefficient of Variation 76.57 |
| Part A: Placebo | Part B: Cmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 7, n= 9, 9, 9 | 77.0364 Nanograms*hour per milliliter | Geometric Coefficient of Variation 48.64 |
| Part A: GSK3915393 15 mg | Part B: Cmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 5, n= 10, 9, 9 | 235.7608 Nanograms*hour per milliliter | Geometric Coefficient of Variation 75.63 |
| Part A: GSK3915393 15 mg | Part B: Cmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 3, n=10, 9, 9 | 819.8381 Nanograms*hour per milliliter | Geometric Coefficient of Variation 99.6 |
| Part A: GSK3915393 15 mg | Part B: Cmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 7, n= 9, 9, 9 | 355.0055 Nanograms*hour per milliliter | Geometric Coefficient of Variation 104.08 |
| Part A: GSK3915393 60 mg | Part B: Cmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 3, n=10, 9, 9 | 1324.4415 Nanograms*hour per milliliter | Geometric Coefficient of Variation 25.48 |
| Part A: GSK3915393 60 mg | Part B: Cmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 7, n= 9, 9, 9 | 805.5202 Nanograms*hour per milliliter | Geometric Coefficient of Variation 28.13 |
| Part A: GSK3915393 60 mg | Part B: Cmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 5, n= 10, 9, 9 | 550.0071 Nanograms*hour per milliliter | Geometric Coefficient of Variation 75.02 |
90% CI: [0.318, 0.693]
90% CI: [0.405, 0.882]
90% CI: [0.194, 0.427]
90% CI: [0.292, 0.643]
90% CI: [0.28, 0.617]
90% CI: [0.41, 0.903]
Secondary
Part B: Cmax(10-24) Following Dose 160 mg (QD) of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 1 and 14: 10, 24 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: Placebo | Part B: Cmax(10-24) Following Dose 160 mg (QD) of GSK3915393 | Day 1 | NA Nanograms per milliliter |
| Part A: Placebo | Part B: Cmax(10-24) Following Dose 160 mg (QD) of GSK3915393 | Day 14 | NA Nanograms per milliliter |
Secondary
Part B: Cmax(10-24) Following Repeat Dose 20 mg and 80 mg of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 1 and 14: 10 hours, 10 hours 20 minutes, 10 hours 40 minutes, 12, 12.5 ,13, 14, 16, and 24 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: Cmax(10-24) Following Repeat Dose 20 mg and 80 mg of GSK3915393 | Day 1, n=10, 9 | 32.2127 Nanograms per milliliter | Geometric Coefficient of Variation 48.16 |
| Part A: Placebo | Part B: Cmax(10-24) Following Repeat Dose 20 mg and 80 mg of GSK3915393 | Day 14, n=9, 9 | 62.0235 Nanograms per milliliter | Geometric Coefficient of Variation 114.26 |
| Part A: GSK3915393 15 mg | Part B: Cmax(10-24) Following Repeat Dose 20 mg and 80 mg of GSK3915393 | Day 1, n=10, 9 | 338.2996 Nanograms per milliliter | Geometric Coefficient of Variation 85.59 |
| Part A: GSK3915393 15 mg | Part B: Cmax(10-24) Following Repeat Dose 20 mg and 80 mg of GSK3915393 | Day 14, n=9, 9 | 931.2098 Nanograms per milliliter | Geometric Coefficient of Variation 62.68 |
Secondary
Part B: Tmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 1 and 14: Pre-dose, 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, and 10 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo | Part B: Tmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Day 1, n=10, 9, 9 | 1.2583 Hour |
| Part A: Placebo | Part B: Tmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Day 14, n=9, 9, 9 | 1.5000 Hour |
| Part A: GSK3915393 15 mg | Part B: Tmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Day 1, n=10, 9, 9 | 1.0167 Hour |
| Part A: GSK3915393 15 mg | Part B: Tmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Day 14, n=9, 9, 9 | 0.7500 Hour |
| Part A: GSK3915393 60 mg | Part B: Tmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Day 1, n=10, 9, 9 | 1.5000 Hour |
| Part A: GSK3915393 60 mg | Part B: Tmax(0-10) Following Dosing of GSK3915393 on Days 1 and 14 | Day 14, n=9, 9, 9 | 0.6833 Hour |
Secondary
Part B: Tmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 3, 5 and 7: Pre-dose, 20, 40 minutes, 1, 1.5, 2, 3, 4, 6 and 10 hours post-dose
Population: Pharmacokinetic Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo | Part B: Tmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 5, n= 10, 9, 9 | 1.5000 Hour |
| Part A: Placebo | Part B: Tmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 3, n=10, 9, 9 | 0.6667 Hour |
| Part A: Placebo | Part B: Tmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 7, n= 9, 9, 9 | 1.5000 Hour |
| Part A: GSK3915393 15 mg | Part B: Tmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 5, n= 10, 9, 9 | 1.5167 Hour |
| Part A: GSK3915393 15 mg | Part B: Tmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 3, n=10, 9, 9 | 1.0000 Hour |
| Part A: GSK3915393 15 mg | Part B: Tmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 7, n= 9, 9, 9 | 1.5000 Hour |
| Part A: GSK3915393 60 mg | Part B: Tmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 3, n=10, 9, 9 | 1.0000 Hour |
| Part A: GSK3915393 60 mg | Part B: Tmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 7, n= 9, 9, 9 | 1.5000 Hour |
| Part A: GSK3915393 60 mg | Part B: Tmax(0-10) Following First Dosing of GSK3915393 on Days 3, 5 and 7 (for Food-effect Assessment) | Day 5, n= 10, 9, 9 | 3.0000 Hour |
Secondary
Part B: Tmax(10-24) Following Dose 160 mg (QD) of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 1 and 14: 10, 24 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo | Part B: Tmax(10-24) Following Dose 160 mg (QD) of GSK3915393 | Day 1 | NA Hour |
| Part A: Placebo | Part B: Tmax(10-24) Following Dose 160 mg (QD) of GSK3915393 | Day 14 | NA Hour |
Secondary
Part B: Tmax(10-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Days 1 and 14: 10 hours, 10 hours 20 minutes, 10 hours 40 minutes, 12, 12.5 ,13, 14, 16, and 24 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo | Part B: Tmax(10-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Day 1, n=10, 9 | 2.0000 Hour |
| Part A: Placebo | Part B: Tmax(10-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Day 14, n=9, 9 | 2.0000 Hour |
| Part A: GSK3915393 15 mg | Part B: Tmax(10-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Day 1, n=10, 9 | 2.0000 Hour |
| Part A: GSK3915393 15 mg | Part B: Tmax(10-24) Following Repeat Dose 20 mg BID and 80 mg BID of GSK3915393 | Day 14, n=9, 9 | 0.6667 Hour |
Secondary
Part B: Trough Concentration (Ctau) Following Dose of 160 mg of GSK3915393 on Day 14
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Day 14: Pre-dose, 20, 40 minutes, 1, 1.5 ,2, 3, 4, 6, 10, and 24 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part B: Trough Concentration (Ctau) Following Dose of 160 mg of GSK3915393 on Day 14 | 2.5423 Nanograms per milliliter | Standard Deviation 1.75889 |
Secondary
Part B: Trough Concentration (Ctau) Following Dose of 20 mg BID and 80 mg BID of GSK3915393 on Day 14
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Time frame: Day 14: Pre-dose, 20, 40 minutes, 1, 1.5 ,2, 3, 4, 6, 10, 10 hour 20 minutes, 10 hours 40 minutes, 12, 12.5, 13, 14, 16 and 24 hours post-dose
Population: Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part B: Trough Concentration (Ctau) Following Dose of 20 mg BID and 80 mg BID of GSK3915393 on Day 14 | 1.8808 Nanograms per milliliter | Standard Deviation 1.35678 |
| Part A: GSK3915393 15 mg | Part B: Trough Concentration (Ctau) Following Dose of 20 mg BID and 80 mg BID of GSK3915393 on Day 14 | 3.3181 Nanograms per milliliter | Standard Deviation 2.36137 |
Secondary
Part C: FH Following IV Administration of GSK3915393+ITZ
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. FH was expressed as ratio and was calculated as: 1 minus Hepatic extraction ratio. Hepatic extraction ratio=hepatic blood clearance (milliliters per minute)/hepatic blood flow (milliliters per minute)
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hour 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, and 60 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part C: FH Following IV Administration of GSK3915393+ITZ | 0.8717 Ratio |
Secondary
Part C: Fraction of Drug Absorbed (FA) Following Oral Administration of GSK3915393+Water
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. FA was expressed as ratio was calculated as absolute bioavailability (F) divided by the product of fraction of drug escaping hepatic metabolism (FH) and fraction of drug escaping gut metabolism (FG).
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part C: Fraction of Drug Absorbed (FA) Following Oral Administration of GSK3915393+Water | NA Ratio |
Secondary
Part C: Fraction of Drug Escaping Gut Metabolism (FG) Following Oral Administration of GSK3915393+Water
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. FG was expressed as ratio and calculated as: AUC of GSK3915393+water divided by AUC of GSK3915393+GFJ.
Time frame: Pre-dose and at 20, 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part C: Fraction of Drug Escaping Gut Metabolism (FG) Following Oral Administration of GSK3915393+Water | NA Ratio |
Secondary
Part C: Fraction of Drug Escaping Hepatic Metabolism (FH) Following IV Dose of GSK3915393
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. FH was expressed as ratio and was calculated as: 1 minus hepatic extraction ratio. Hepatic extraction ratio=hepatic blood clearance (milliliters per minute)/hepatic blood flow (milliliters per minute)
Time frame: Pre-dose and at 20, 40 minutes, 1, 1 hour 5 minutes, 1 hour 10 minutes, 1 hour 20 minutes, 1 hour 40 minutes, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 60 hours post-dose
Population: Pharmacokinetic Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: Placebo | Part C: Fraction of Drug Escaping Hepatic Metabolism (FH) Following IV Dose of GSK3915393 | 0.6525 Ratio |
Secondary
Part C: Number of Participants With Abnormal Physical Examination Findings Following Administration of GSK3915393
A full physical examination was performed which included, at a minimum, assessments of the Skin, Cardiovascular, Respiratory, Gastrointestinal and Neurological systems.
Time frame: Up to 72 days
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part C: Number of Participants With Abnormal Physical Examination Findings Following Administration of GSK3915393 | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Abnormal Physical Examination Findings Following Administration of GSK3915393 | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Abnormal Physical Examination Findings Following Administration of GSK3915393 | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Abnormal Physical Examination Findings Following Administration of GSK3915393 | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Abnormal Physical Examination Findings Following Administration of GSK3915393 | 0 Participants |
Secondary
Part C: Number of Participants With All Non-serious AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.
Time frame: Up to 72 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part C: Number of Participants With All Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With All Non-serious AEs and SAEs | All non-serious AEs | 5 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With All Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With All Non-serious AEs and SAEs | All non-serious AEs | 2 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With All Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With All Non-serious AEs and SAEs | All non-serious AEs | 3 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With All Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With All Non-serious AEs and SAEs | All non-serious AEs | 2 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With All Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With All Non-serious AEs and SAEs | All non-serious AEs | 2 Participants |
Secondary
Part C: Number of Participants With Treatment-related AEs Following Dose of GSK3915393
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs are presented.
Time frame: Up to 72 days
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part C: Number of Participants With Treatment-related AEs Following Dose of GSK3915393 | 3 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Treatment-related AEs Following Dose of GSK3915393 | 2 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Treatment-related AEs Following Dose of GSK3915393 | 1 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Treatment-related AEs Following Dose of GSK3915393 | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Treatment-related AEs Following Dose of GSK3915393 | 0 Participants |
Secondary
Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393
Blood samples were collected for analysis of chemistry parameters. PCI ranges were \>=2\*ULN (U/L)(ALT), \>=2\*ULN (U/L) (AST), \>=2\*ULN (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: Up to 72 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To Low | 1 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALP: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Potassium: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Protein: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Bilirubin: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | AST: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Sodium: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Calcium: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | ALT: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Glucose: To High | 0 Participants |
Secondary
Part C: Number of Participants With Worst Case Chemistry Results: Creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393
Blood samples were collected for analysis of creatinine. Participants were counted under increase of PCI if they had change from Baseline \> 44.2 micromoles per Liter for any post Baseline assessment. Participants who did not meet this PCI criteria are counted as w/in range. Participants whose laboratory value became within range, were recorded in 'To within Range' category.
Time frame: Up to 72 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results: Creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Increase of PCI | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results: Creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | W/in Range | 12 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results: Creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Increase of PCI | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results: Creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | W/in Range | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results: Creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Increase of PCI | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results: Creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | W/in Range | 11 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results: Creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Increase of PCI | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results: Creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | W/in Range | 12 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results: Creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Increase of PCI | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results: Creatinine by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | W/in Range | 10 Participants |
Secondary
Part C: Number of Participants With Worst Case Chemistry Results: Urea by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393
Blood samples were collected for analysis of chemistry parameters. PCI range for Urea: High \>10.5 mmol/L. Participants were counted in worst case category that their value changes to ( 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.
Time frame: Up to 72 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results: Urea by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | To W/in Range or No Change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Chemistry Results: Urea by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results: Urea by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | To W/in Range or No Change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Chemistry Results: Urea by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results: Urea by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | To W/in Range or No Change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Chemistry Results: Urea by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results: Urea by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Chemistry Results: Urea by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | To W/in Range or No Change | 12 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results: Urea by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | To W/in Range or No Change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Chemistry Results: Urea by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | To High | 0 Participants |
Secondary
Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393
Blood samples were collected for analysis of hematology parameters. PCI ranges were 1\*10\^9 cell per liter (cells/L) (eosinophils), \<0.2 or \>0.54 proportion of red blood cells in blood (hematocrit), \<80 or \>180 grams per liter(g/L) (hemoglobin), \<3 or \>20 x10\^9 cells/L (leukocytes), \<0.8\*10\^9 cells/L (lymphocytes), \<1.5 or \>16\*10\^9 cells/L (neutrophils) and \<100 or \>550\*10\^9 cells/L (platelets). 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: Up to 72 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To Low | 1 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To w/in Range or No change | 11 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Leukocytes: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Eosinophils: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Neutrophils: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Lymphocytes: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hemoglobin: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Platelets: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Hematocrit: To w/in Range or No change | 10 Participants |
Secondary
Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of GSK3915393
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 72 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of GSK3915393 | Abnormal: Not Clinically Significant | 2 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of GSK3915393 | Clinically Significant | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of GSK3915393 | Abnormal: Not Clinically Significant | 1 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of GSK3915393 | Clinically Significant | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of GSK3915393 | Abnormal: Not Clinically Significant | 1 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of GSK3915393 | Clinically Significant | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of GSK3915393 | Clinically Significant | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of GSK3915393 | Abnormal: Not Clinically Significant | 1 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of GSK3915393 | Abnormal: Not Clinically Significant | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings Following Administration of GSK3915393 | Clinically Significant | 0 Participants |
Secondary
Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393
Vital signs included DBP, SBP, PR, body temperature, RR and were measured after resting for at least 5 minutes in semi-supine position. PCI ranges were, SBP (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 72 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To High | 1 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To w/in Range or No change | 11 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To w/in Range or No change | 11 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To Low | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To w/in Range or No change | 12 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To High | 0 Participants |
| Part A: Placebo | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To High | 1 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To w/in Range or No change | 10 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To Low | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To High | 0 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 15 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To Low | 1 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To w/in Range or No change | 9 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To Low | 2 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To Low | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To High | 0 Participants |
| Part A: GSK3915393 60 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To Low | 1 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To w/in Range or No change | 12 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To w/in Range or No change | 11 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To High | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To Low | 0 Participants |
| Part A: GSK3915393 160 mg | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To w/in Range or No change | 12 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | DBP: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To Low | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | PR: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | RR: To High | 0 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | SBP: To w/in Range or No change | 10 Participants |
| Part C: SK3915393 20 mg+ITZ | Part C: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline Following Dose Administration of GSK3915393 | Temperature: To w/in Range or No change | 10 Participants |