Urinary Tract Infections
Conditions
Keywords
SAD, MAD, FTIH, Pharmacokinetics, Urinary Tract Infections, GSK3882347
Brief summary
This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, first time in human (FTIH) study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and pharmacokinetics (PK) of GSK3882347 in healthy adult men and Woman of Non Childbearing Potential (WONCBP). Part 1 will be the single ascending dose (SAD) phase and Part 2 will be the multiple ascending dose (MAD) phase. Each participant in the SAD cohort will receive a single dose of GSK3882347 or placebo (PBO) in 3:1 ratio and in Part 2 (MAD), participants will be randomized in a 4:1 ratio to receive active treatment and placebo. Part 1 will consist of two cohorts with a maximum of four-period for each cohort, the food effect evaluation will be conducted in last period (Period 4) in only one of the cohorts based on the observed human pharmacokinetics (PK). Part 2 will consist of maximum of four cohorts for each of the MAD dose or placebo.
Interventions
DRUGGSK3882347
Capsule of 10-200mg dose strength will be provided in labelled High Density Polyethylene (HDPE) bottles.
DRUGPlacebo
Matching strength placebo capsules will be provided
Sponsors
Department of Health and Human Services
Wellcome Trust
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This will be a double-blind study with participants and the site staff blinded.
Intervention model description
Part 1 will consist of two cohorts (Cohorts 1 and 2) with a maximum of four periods in a cross-over design conducted in two separate cohorts. Part 2 consists of a maximum of four ascending repeat-dose cohorts (Cohorts 3 to 6) for which participants, will receive a single oral dose of GSK3882347 or placebo for 7 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A participant with a clinical abnormality or laboratory parameter(s) not specifically listed in the exclusion or
Exclusion criteria
that is outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor (if required), agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Participants with Body weight at least 50.0 kilograms (kg) (110 pound \[lbs\]) for males and 45.0 kg (99 lbs.) for females; and body mass index (BMI) within the range 18.5 - 32.0 kilograms per meter square (kg/m\^2) (inclusive). * Male and female participants; a female participant is eligible to participate if she is of WONCBP; Male participants are eligible to participate if they agree to the following during the intervention period for at least five days, corresponding to time needed to eliminate study intervention(s) (e.g. 5 terminal half-lives) after the last dose of study intervention), refrain from donating sperm, be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; must agree to use contraception/barrier, agree to use a male condom. * Capable of giving signed informed consent as described in which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Renal Clearance of Drug (CLr) After Single Dose Administration of GSK3882347 | At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment period | Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t) |
| Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | Up to 26 days | Vital signs were assessed including Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). PCI ranges were \<85 (Low), 85-160 (Normal) and \>160 (High) for SBP; \<45 (Low), 45-100 (Normal), \>100 (High) for DBP; \<40 (Low), 40-110 (Normal), \>110 (High) for pulse rate. Participants were counted in worst case category that their value changes to(low,within range or no change, 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, were recorded inTo within Range or No Change category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits |
| Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Up to 3 months | A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline | Up to 26 days | A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose in each treatment period | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Time to Cmax (Tmax) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Lag Time for Absorption (Tlag) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Terminal Elimination Half-life (T1/2) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347 | Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2: Cmax After Repeat Dose Administration of GSK3882347 | Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2: Tmax After Repeat Dose Administration of GSK3882347 | Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347 | Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Urine Concentration Between 22-24 Hours (C22-24) After Single Dose Administration of GSK3882347 | Day 1: 22-24 hours post-dose in each treatment period | Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347 | Day 1 and Day 7: 22-24 hours post-dose | Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Single Dose Administration of GSK3882347 | At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment period | Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347 | Days 1 and 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dose | Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment period | Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. %fe was calculated as: (Ae total/Dose)\*100 percent (%). |
| Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | Day 1 and Day 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dose | Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. %fe was calculated as: (Ae total/Dose)\*100%. |
| Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 3 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (greater than or equal to \[\>=\]5 percent \[%\]) non-serious AEs is presented. |
| Part 2: Number of Participants With Non-serious AEs and SAEs | Up to 26 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. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs is presented. |
| Part 1: Number of Participants With Treatment Related AEs | Up to 3 months | 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 is presented. |
| Part 2: Number of Participants With Treatment Related AEs | Up to 26 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 is presented. |
| Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Up to 3 months | Blood samples were collected to analyze hematocrit,hemoglobin,leukocytes,lymphocytes,neutrophils and platelets. PCI ranges were \<0.075 or \>0.54 proportion of red blood cells in blood for hematocrit, \<25 or \>180 grams per liter(g/L) for hemoglobin,\<3 or \>20 x10\^9 cells per liter(cells/L) for leukocytes,\<0.8 x10\^9 cells/L for lymphocytes,\<1.5 x10\^9 cells/L for neutrophils and \<100 or \>550 x10\^9 cells/L for 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 inTo within Range or No Change category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value, including those from unscheduled visits |
| Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Up to 26 days | Blood samples were collected to analyze hematocrit,hemoglobin,leukocytes,lymphocytes,neutrophils and platelets. PCI ranges were \<0.075 or \>0.54 proportion of red blood cells in blood for hematocrit, \<25 or \>180 grams per liter(g/L) for hemoglobin,\<3 or \>20 x10\^9 cells per liter(cells/L) for leukocytes,\<0.8 x10\^9 cells/L for lymphocytes,\<1.5 x10\^9 cells/L for neutrophils and \<100 or \>550 x10\^9 cells/L for 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(e.g.,High to High),or whose value became within range, were recorded inTo within Range or No Change category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value, including those from unscheduled visits |
| Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Up to 3 months | Blood samples were collected to analyze PCI ranges: \>=2 times Upper limit of Normal(ULN) Units per Liter(U/L) for Alanine aminotransferase(ALT),\>=2 times ULN U/L for alkaline phosphatase(ALP), \>=2 times ULN U/L for aspartate aminotransferase(AST),\>=1.5 times ULN micromoles/L for bilirubin,\<2 or \>2.75 millimoles/L (mmol/L) for calcium,\<3 or \>9 mmol/L for glucose,\<3 or \>5.5 mmol/L for potassium and \<130 or \>150 mmol/L for sodium.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,were recorded inTo within Range or No Change category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value,including those from unscheduled visits |
| Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Up to 26 days | Blood samples were collected to analyze PCI ranges: \>=2 times ULN U/L for Alanine aminotransferase(ALT),\>=2 times ULN U/L for alkaline phosphatase(ALP), \>=2 times ULN U/L for aspartate aminotransferase(AST),\>=1.5 times ULN micromoles/L for bilirubin,\<2 or \>2.75 mmol/L for calcium,\<3 or \>9 mmol/L for glucose,\<3 or \>5.5 mmol/L for potassium and \<130 or \>150 mmol/L for sodium.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,were recorded inTo within Range or No Change category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value,including those from unscheduled visits. |
| Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Up to 3 months | Urine samples were collected for the analysis of urine parameters including occult blood and protein by dipstick. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased, increase to positive for urine occult blood and protein indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst case urinalysis results Post Baseline relative to Baseline is presented. |
| Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Up to 26 days | Urine samples were collected for the analysis of urine parameters including occult blood and protein by dipstick. The dipstick test gave results in a semi-quantitative manner (proportional concentrations in urine samples), and results for urinalysis parameters were recorded as no change/decreased, increase to positive for urine occult blood and protein. 'No change/decreased' indicates no change from Baseline results or decreased in results from Baseline including change in negative results. 'Increase to positive' indicates increase in result from Baseline. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst case urinalysis results Post Baseline relative to Baseline is presented. |
| Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347 | Day 1 and Day 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dose | Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t). |
| Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | Up to 3 months | Vital signs were assessed including Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). PCI ranges were \<85 (Low), 85-160 (Normal) and \>160 (High) for SBP; \<45 (Low), 45-100 (Normal), \>100 (High) for DBP; \<40 (Low), 40-110 (Normal), \>110 (High) for pulse rate. Participants were counted in worst case category that their value changes to(low,within range or no change, 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, were recorded inTo within Range or No Change category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Plasma Concentrations at 12 Hours (C12) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Apparent Oral Clearance (CL/F) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Apparent Volume of Distribution After Oral Administration (Vz/F) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Mean Residence Time (MRT) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347 | Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347 | Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Dose Proportionality of GSK3882347 for Dose Levels 15 mg to 900 mg Using AUC(0-infinity) After Single Dose Administration of GSK3882347 Under Fasted Condition | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented. The SD 250 mg fed treatment was not considered in the analysis. |
| Part 1: Dose Proportionality of GSK3882347 for Dose Levels 15 mg to 900 mg Using Cmax After Single Dose Administration of GSK3882347 Under Fasted Condition | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented. The SD 250 mg fed treatment was not considered in the analysis. |
| Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using AUC(0-tau) After Repeat Dose Administration of GSK3882347 | Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented. |
| Part 1: Tmax After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using Cmax After Repeat Dose Administration of GSK3882347 | Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented. |
| Part 2: Observed Accumulation Ratio (Ro) Using AUC(0-tau) After Repeat Dose Administration of GSK3882347 | Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) at Day 7 divided by AUC(0-tau) at Day 1 for GSK3882347. Mixed effect model was used to assess accumulation ratio for the log transformed parameters. Treatment, day and the interaction of treatment and day were fitted as fixed effect. Participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. |
| Part 2: Time Invariance of GSK3882347 | Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose | Blood samples were collected at indicated time points for the analysis of time invariance. Time invariance was calculated as AUC(0-tau) at Day 7 divided by AUC(0-infinity) at Day 1 for GSK3882347. Mixed effect ANOVA model was used to assess time invariance for the log transformed parameters. Treatment, day and the interaction of treatment and day were fitted as fixed effect. Participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. |
| Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Days 3, 4, 5, 6 and 7: Pre-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347. |
| Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC [0-t]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC [0-infinity]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Tlag After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Single Dose Administration of GSK3882347 | Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose in each treatment period | Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. |
Countries
United Kingdom
Participant flow
Recruitment details
This was a 2-part, first-time-in-human (FTIH), dose-escalation, placebo (PBO)-controlled, single dose (SD) (Part 1) and repeat dose (RD) (Part 2) study to determine the safety, tolerability and pharmacokinetic (PK) profile of GSK3882347 in healthy participants. The study was conducted at a single center in the United Kingdom.
Pre-assignment details
A total of 61 participants (21 participants in Part 1 and 40 participants in Part 2) were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Part1-Cohort1:GSK3882347 SD 50mg/SD 150mg/SD 250 mg/SD PBO Healthy participants in Part 1 Cohort 1 received a single dose (SD) of GSK3882347 50 milligrams (mg) on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of Placebo (PBO) on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over. | 3 |
| Part1-Cohort1:GSK3882347 SD 50mg/SD 150mg/SD PBO/SD 250mg Fed Healthy participants in Part 1 Cohort 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of PBO on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over. | 2 |
| Part1-Cohort1: GSK3882347 SD 50mg/SD PBO/SD 250mg/SD 250mg Fed Healthy participants in Part 1 Cohort 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1, followed by a SD of PBO on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over. | 2 |
| Part1-Cohort1:SD PBO/GSK3882347 SD 150mg/SD 250mg/SD 250mg Fed Healthy participants in Part 1 Cohort 1 received a SD of PBO on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over. | 3 |
| Part 1-Cohort 2: SD PBO/GSK3882347 SD 900 mg/SD 15 mg Healthy participants in Part 1 Cohort 2 received a SD of PBO on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over. | 3 |
| Part 1-Cohort 2: GSK3882347 SD 500 mg/SD PBO/SD 15 mg Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of PBO on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over. | 3 |
| Part 1-Cohort 2: GSK3882347 SD 500 mg/SD 900 mg/SD PBO Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of PBO on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over. | 3 |
| Part 1-Cohort 2: GSK3882347 SD 500 mg/SD 900 mg/SD 15 mg Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over. | 2 |
| Part 2: Repeat Dose Placebo Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7. | 8 |
| Part 2: Repeat Dose GSK3882347 50 mg Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7. | 8 |
| Part 2: Repeat Dose GSK3882347 150 mg Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7. | 8 |
| Part 2: Repeat Dose GSK3882347 500 mg Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7. | 8 |
| Part 2: Repeat Dose GSK3882347 900 mg Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7. | 8 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1-Cohort 1: Period 1 (Up to 5 Days) | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1-Cohort 1: Period 3 (Up to 5 Days) | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1-Cohort 2: Period 1 (Up to 5 Days) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1-Cohort 2: Period 2 (Up to 5 Days) | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part1-Cohort1:GSK3882347 SD 50mg/SD 150mg/SD PBO/SD 250mg Fed | Part1-Cohort1: GSK3882347 SD 50mg/SD PBO/SD 250mg/SD 250mg Fed | Part1-Cohort1:GSK3882347 SD 50mg/SD 150mg/SD 250 mg/SD PBO | Part1-Cohort1:SD PBO/GSK3882347 SD 150mg/SD 250mg/SD 250mg Fed | Part 1-Cohort 2: SD PBO/GSK3882347 SD 900 mg/SD 15 mg | Part 1-Cohort 2: GSK3882347 SD 500 mg/SD PBO/SD 15 mg | Part 1-Cohort 2: GSK3882347 SD 500 mg/SD 900 mg/SD PBO | Part 1-Cohort 2: GSK3882347 SD 500 mg/SD 900 mg/SD 15 mg | Part 2: Repeat Dose Placebo | Part 2: Repeat Dose GSK3882347 50 mg | Part 2: Repeat Dose GSK3882347 150 mg | Part 2: Repeat Dose GSK3882347 500 mg | Part 2: Repeat Dose GSK3882347 900 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian- South East Asian Heritage | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Mixed race | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White- White/Caucasian/European Heritage | 51 Participants | 2 Participants | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 6 Participants | 8 Participants | 6 Participants | 7 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 61 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 7 / 14 | 1 / 6 | 2 / 6 | 2 / 6 | 3 / 6 | 2 / 6 | 3 / 6 | 2 / 6 | 5 / 8 | 4 / 8 | 2 / 8 | 7 / 8 | 7 / 8 |
| serious Total, serious adverse events | 0 / 14 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Part 1: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Single Dose Administration of GSK3882347 | 11.16 Milligrams | Geometric Coefficient of Variation 15.7 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Single Dose Administration of GSK3882347 | 32.01 Milligrams | Geometric Coefficient of Variation 9.4 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Single Dose Administration of GSK3882347 | 106.86 Milligrams | Geometric Coefficient of Variation 25.5 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Single Dose Administration of GSK3882347 | 146.43 Milligrams | Geometric Coefficient of Variation 20.5 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Single Dose Administration of GSK3882347 | 95.17 Milligrams | Geometric Coefficient of Variation 9.2 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Single Dose Administration of GSK3882347 | 306.93 Milligrams | Geometric Coefficient of Variation 20.8 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Single Dose Administration of GSK3882347 | 430.03 Milligrams | Geometric Coefficient of Variation 22.5 |
Primary
Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3882347 | 2167.0 Hours*nanograms per milliliter | Geometric Coefficient of Variation 23.4 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3882347 | 8425.5 Hours*nanograms per milliliter | Geometric Coefficient of Variation 18.1 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3882347 | 22433.7 Hours*nanograms per milliliter | Geometric Coefficient of Variation 16.8 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3882347 | 36768.0 Hours*nanograms per milliliter | Geometric Coefficient of Variation 26.5 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3882347 | 29316.1 Hours*nanograms per milliliter | Geometric Coefficient of Variation 10.5 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3882347 | 63377.3 Hours*nanograms per milliliter | Geometric Coefficient of Variation 26.1 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3882347 | 89424.5 Hours*nanograms per milliliter | Geometric Coefficient of Variation 32.1 |
Primary
Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose in each treatment period
Population: PK Population comprised of all participants in the safety population who had at least 1 non-missing PK assessment.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 | 1671.7 Hours*nanograms per milliliter | Geometric Coefficient of Variation 20.9 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 | 6514.1 Hours*nanograms per milliliter | Geometric Coefficient of Variation 12.3 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 | 17717.9 Hours*nanograms per milliliter | Geometric Coefficient of Variation 18 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 | 28472.2 Hours*nanograms per milliliter | Geometric Coefficient of Variation 27.9 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 | 21456.4 Hours*nanograms per milliliter | Geometric Coefficient of Variation 7.8 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 | 48381.2 Hours*nanograms per milliliter | Geometric Coefficient of Variation 26.9 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 | 65150.2 Hours*nanograms per milliliter | Geometric Coefficient of Variation 28.3 |
Primary
Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3882347 | 1954.3 Hours*nanograms per milliliter | Geometric Coefficient of Variation 24.7 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3882347 | 8249.8 Hours*nanograms per milliliter | Geometric Coefficient of Variation 18.2 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3882347 | 22266.9 Hours*nanograms per milliliter | Geometric Coefficient of Variation 16.9 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3882347 | 36561.0 Hours*nanograms per milliliter | Geometric Coefficient of Variation 26.7 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3882347 | 29091.9 Hours*nanograms per milliliter | Geometric Coefficient of Variation 10.6 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3882347 | 63052.2 Hours*nanograms per milliliter | Geometric Coefficient of Variation 26.1 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3882347 | 88901.9 Hours*nanograms per milliliter | Geometric Coefficient of Variation 31.8 |
Primary
Part 1: Lag Time for Absorption (Tlag) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Lag Time for Absorption (Tlag) After Single Dose Administration of GSK3882347 | 0.375 Hours |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Lag Time for Absorption (Tlag) After Single Dose Administration of GSK3882347 | 0.250 Hours |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Lag Time for Absorption (Tlag) After Single Dose Administration of GSK3882347 | 0.250 Hours |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Lag Time for Absorption (Tlag) After Single Dose Administration of GSK3882347 | 0.250 Hours |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Lag Time for Absorption (Tlag) After Single Dose Administration of GSK3882347 | 0.250 Hours |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Lag Time for Absorption (Tlag) After Single Dose Administration of GSK3882347 | 0.250 Hours |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Lag Time for Absorption (Tlag) After Single Dose Administration of GSK3882347 | 0.250 Hours |
Primary
Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 | 165.7 Nanograms per milliliter | Geometric Coefficient of Variation 22.3 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 | 661.7 Nanograms per milliliter | Geometric Coefficient of Variation 14.8 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 | 1825.8 Nanograms per milliliter | Geometric Coefficient of Variation 21.2 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 | 3126.7 Nanograms per milliliter | Geometric Coefficient of Variation 31.3 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 | 1834.5 Nanograms per milliliter | Geometric Coefficient of Variation 13.4 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 | 4671.3 Nanograms per milliliter | Geometric Coefficient of Variation 27.4 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 | 5771.6 Nanograms per milliliter | Geometric Coefficient of Variation 24.6 |
Primary
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (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. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (greater than or equal to \[\>=\]5 percent \[%\]) non-serious AEs is presented.
Time frame: Up to 3 months
Population: Safety Population comprised of all participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Non-serious AEs | 7 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Non-serious AEs | 1 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Non-serious AEs | 2 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Non-serious AEs | 2 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Non-serious AEs | 3 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Non-serious AEs | 2 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Non-serious AEs | 3 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Non-serious AEs | 2 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Primary
Part 1: 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 is presented.
Time frame: Up to 3 months
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Treatment Related AEs | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Treatment Related AEs | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Treatment Related AEs | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Treatment Related AEs | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Treatment Related AEs | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Treatment Related AEs | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Treatment Related AEs | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Treatment Related AEs | 0 Participants |
Primary
Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Up to 3 months
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: NCS | 3 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: NCS | 1 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: NCS | 1 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: NCS | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: NCS | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: NCS | 2 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: NCS | 1 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: NCS | 1 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
Primary
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Blood samples were collected to analyze PCI ranges: \>=2 times Upper limit of Normal(ULN) Units per Liter(U/L) for Alanine aminotransferase(ALT),\>=2 times ULN U/L for alkaline phosphatase(ALP), \>=2 times ULN U/L for aspartate aminotransferase(AST),\>=1.5 times ULN micromoles/L for bilirubin,\<2 or \>2.75 millimoles/L (mmol/L) for calcium,\<3 or \>9 mmol/L for glucose,\<3 or \>5.5 mmol/L for potassium and \<130 or \>150 mmol/L for sodium.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,were recorded inTo within Range or No Change category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value,including those from unscheduled visits
Time frame: Up to 3 months
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
Primary
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Blood samples were collected to analyze hematocrit,hemoglobin,leukocytes,lymphocytes,neutrophils and platelets. PCI ranges were \<0.075 or \>0.54 proportion of red blood cells in blood for hematocrit, \<25 or \>180 grams per liter(g/L) for hemoglobin,\<3 or \>20 x10\^9 cells per liter(cells/L) for leukocytes,\<0.8 x10\^9 cells/L for lymphocytes,\<1.5 x10\^9 cells/L for neutrophils and \<100 or \>550 x10\^9 cells/L for 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 inTo within Range or No Change category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Time frame: Up to 3 months
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 12 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 2 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 4 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 2 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 1 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 5 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 1 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 5 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 5 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 1 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 1 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 5 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 0 Participants |
Primary
Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Urine samples were collected for the analysis of urine parameters including occult blood and protein by dipstick. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased, increase to positive for urine occult blood and protein indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst case urinalysis results Post Baseline relative to Baseline is presented.
Time frame: Up to 3 months
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 1 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 5 Participants |
Primary
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
Vital signs were assessed including Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). PCI ranges were \<85 (Low), 85-160 (Normal) and \>160 (High) for SBP; \<45 (Low), 45-100 (Normal), \>100 (High) for DBP; \<40 (Low), 40-110 (Normal), \>110 (High) for pulse rate. Participants were counted in worst case category that their value changes to(low,within range or no change, 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, were recorded inTo within Range or No Change category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Time frame: Up to 3 months
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 14 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 900 mg | Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
Primary
Part 1: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. %fe was calculated as: (Ae total/Dose)\*100 percent (%).
Time frame: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | 74.43 Percent dose excreted | Geometric Coefficient of Variation 15.7 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | 64.02 Percent dose excreted | Geometric Coefficient of Variation 9.4 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | 71.24 Percent dose excreted | Geometric Coefficient of Variation 25.5 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | 58.57 Percent dose excreted | Geometric Coefficient of Variation 20.5 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | 38.07 Percent dose excreted | Geometric Coefficient of Variation 9.2 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | 61.39 Percent dose excreted | Geometric Coefficient of Variation 20.8 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | 47.78 Percent dose excreted | Geometric Coefficient of Variation 22.5 |
Primary
Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 | 27.32 Nanograms per milliliter | Geometric Coefficient of Variation 29.7 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 | 106.70 Nanograms per milliliter | Geometric Coefficient of Variation 39.5 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 | 283.18 Nanograms per milliliter | Geometric Coefficient of Variation 24.7 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 | 500.35 Nanograms per milliliter | Geometric Coefficient of Variation 28.8 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 | 453.82 Nanograms per milliliter | Geometric Coefficient of Variation 13.6 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 | 853.98 Nanograms per milliliter | Geometric Coefficient of Variation 35 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 | 1291.37 Nanograms per milliliter | Geometric Coefficient of Variation 41 |
Primary
Part 1: Renal Clearance of Drug (CLr) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)
Time frame: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Renal Clearance of Drug (CLr) After Single Dose Administration of GSK3882347 | 5.71 Liters per hour | Geometric Coefficient of Variation 31.7 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Renal Clearance of Drug (CLr) After Single Dose Administration of GSK3882347 | 3.88 Liters per hour | Geometric Coefficient of Variation 25.8 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Renal Clearance of Drug (CLr) After Single Dose Administration of GSK3882347 | 4.80 Liters per hour | Geometric Coefficient of Variation 30.9 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Renal Clearance of Drug (CLr) After Single Dose Administration of GSK3882347 | 4.00 Liters per hour | Geometric Coefficient of Variation 19.1 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Renal Clearance of Drug (CLr) After Single Dose Administration of GSK3882347 | 3.27 Liters per hour | Geometric Coefficient of Variation 14.2 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Renal Clearance of Drug (CLr) After Single Dose Administration of GSK3882347 | 4.87 Liters per hour | Geometric Coefficient of Variation 17.5 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Renal Clearance of Drug (CLr) After Single Dose Administration of GSK3882347 | 4.84 Liters per hour | Geometric Coefficient of Variation 22.7 |
Primary
Part 1: Terminal Elimination Half-life (T1/2) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Terminal Elimination Half-life (T1/2) After Single Dose Administration of GSK3882347 | 11.407 Hours | Geometric Coefficient of Variation 17.7 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Terminal Elimination Half-life (T1/2) After Single Dose Administration of GSK3882347 | 12.269 Hours | Geometric Coefficient of Variation 14.5 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Terminal Elimination Half-life (T1/2) After Single Dose Administration of GSK3882347 | 11.538 Hours | Geometric Coefficient of Variation 10.1 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Terminal Elimination Half-life (T1/2) After Single Dose Administration of GSK3882347 | 12.277 Hours | Geometric Coefficient of Variation 16 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Terminal Elimination Half-life (T1/2) After Single Dose Administration of GSK3882347 | 12.984 Hours | Geometric Coefficient of Variation 10.3 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Terminal Elimination Half-life (T1/2) After Single Dose Administration of GSK3882347 | 12.630 Hours | Geometric Coefficient of Variation 11.6 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Terminal Elimination Half-life (T1/2) After Single Dose Administration of GSK3882347 | 12.690 Hours | Geometric Coefficient of Variation 13.8 |
Primary
Part 1: Time to Cmax (Tmax) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Time to Cmax (Tmax) After Single Dose Administration of GSK3882347 | 3.000 Hours |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Time to Cmax (Tmax) After Single Dose Administration of GSK3882347 | 4.000 Hours |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Time to Cmax (Tmax) After Single Dose Administration of GSK3882347 | 4.000 Hours |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Time to Cmax (Tmax) After Single Dose Administration of GSK3882347 | 4.000 Hours |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Time to Cmax (Tmax) After Single Dose Administration of GSK3882347 | 4.000 Hours |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Time to Cmax (Tmax) After Single Dose Administration of GSK3882347 | 4.000 Hours |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Time to Cmax (Tmax) After Single Dose Administration of GSK3882347 | 4.000 Hours |
Primary
Part 1: Urine Concentration Between 22-24 Hours (C22-24) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Day 1: 22-24 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Urine Concentration Between 22-24 Hours (C22-24) After Single Dose Administration of GSK3882347 | 1.55 Micrograms per milliliter | Geometric Coefficient of Variation 71.3 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Urine Concentration Between 22-24 Hours (C22-24) After Single Dose Administration of GSK3882347 | 2.99 Micrograms per milliliter | Geometric Coefficient of Variation 95.9 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Urine Concentration Between 22-24 Hours (C22-24) After Single Dose Administration of GSK3882347 | 11.27 Micrograms per milliliter | Geometric Coefficient of Variation 146.7 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Urine Concentration Between 22-24 Hours (C22-24) After Single Dose Administration of GSK3882347 | 15.26 Micrograms per milliliter | Geometric Coefficient of Variation 133.9 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Urine Concentration Between 22-24 Hours (C22-24) After Single Dose Administration of GSK3882347 | 11.42 Micrograms per milliliter | Geometric Coefficient of Variation 148 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Urine Concentration Between 22-24 Hours (C22-24) After Single Dose Administration of GSK3882347 | 48.54 Micrograms per milliliter | Geometric Coefficient of Variation 161.8 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Urine Concentration Between 22-24 Hours (C22-24) After Single Dose Administration of GSK3882347 | 33.50 Micrograms per milliliter | Geometric Coefficient of Variation 75 |
Primary
Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Days 1 and 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dose
Population: PK Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347 | Day 1 | 24.77 Milligrams | Geometric Coefficient of Variation 17.6 |
| Part 1: Single Dose Placebo | Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347 | Day 7 | 26.71 Milligrams | Geometric Coefficient of Variation 19 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347 | Day 7 | 108.20 Milligrams | Geometric Coefficient of Variation 17.4 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347 | Day 1 | 88.30 Milligrams | Geometric Coefficient of Variation 14.2 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347 | Day 1 | 188.49 Milligrams | Geometric Coefficient of Variation 32.5 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347 | Day 7 | 258.08 Milligrams | Geometric Coefficient of Variation 18.7 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347 | Day 1 | 267.16 Milligrams | Geometric Coefficient of Variation 18.4 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347 | Day 7 | 390.10 Milligrams | Geometric Coefficient of Variation 13 |
Primary
Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Population: PK Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347 | Day 1 | 5862.9 Hours*nanograms per milliliter | Geometric Coefficient of Variation 16.2 |
| Part 1: Single Dose Placebo | Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347 | Day 7 | 6144.9 Hours*nanograms per milliliter | Geometric Coefficient of Variation 8.7 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347 | Day 7 | 21109.5 Hours*nanograms per milliliter | Geometric Coefficient of Variation 27.9 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347 | Day 1 | 20191.4 Hours*nanograms per milliliter | Geometric Coefficient of Variation 25.6 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347 | Day 1 | 45400.0 Hours*nanograms per milliliter | Geometric Coefficient of Variation 38.8 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347 | Day 7 | 61202.0 Hours*nanograms per milliliter | Geometric Coefficient of Variation 27.4 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347 | Day 1 | 53753.9 Hours*nanograms per milliliter | Geometric Coefficient of Variation 27.8 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347 | Day 7 | 82351.1 Hours*nanograms per milliliter | Geometric Coefficient of Variation 22.7 |
Primary
Part 2: Cmax After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Population: PK Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Cmax After Repeat Dose Administration of GSK3882347 | Day 1 | 586.0 Nanograms per milliliter | Geometric Coefficient of Variation 20.8 |
| Part 1: Single Dose Placebo | Part 2: Cmax After Repeat Dose Administration of GSK3882347 | Day 7 | 600.4 Nanograms per milliliter | Geometric Coefficient of Variation 21.9 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Cmax After Repeat Dose Administration of GSK3882347 | Day 7 | 2007.4 Nanograms per milliliter | Geometric Coefficient of Variation 31.7 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Cmax After Repeat Dose Administration of GSK3882347 | Day 1 | 2179.1 Nanograms per milliliter | Geometric Coefficient of Variation 29.5 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Cmax After Repeat Dose Administration of GSK3882347 | Day 1 | 4409.4 Nanograms per milliliter | Geometric Coefficient of Variation 34.2 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Cmax After Repeat Dose Administration of GSK3882347 | Day 7 | 5370.3 Nanograms per milliliter | Geometric Coefficient of Variation 21.2 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Cmax After Repeat Dose Administration of GSK3882347 | Day 1 | 4933.1 Nanograms per milliliter | Geometric Coefficient of Variation 24 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Cmax After Repeat Dose Administration of GSK3882347 | Day 7 | 6575.2 Nanograms per milliliter | Geometric Coefficient of Variation 28.6 |
Primary
Part 2: Number of Participants With 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. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs is presented.
Time frame: Up to 26 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Non-serious AEs and SAEs | Non-serious AEs | 5 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Non-serious AEs and SAEs | Non-serious AEs | 4 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Non-serious AEs and SAEs | Non-serious AEs | 2 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Non-serious AEs and SAEs | Non-serious AEs | 7 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Non-serious AEs and SAEs | Non-serious AEs | 7 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Non-serious AEs and SAEs | SAEs | 0 Participants |
Primary
Part 2: 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 is presented.
Time frame: Up to 26 days
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Treatment Related AEs | 1 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Treatment Related AEs | 2 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Treatment Related AEs | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Treatment Related AEs | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Treatment Related AEs | 0 Participants |
Primary
Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Up to 26 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline | Abnormal: NCS | 3 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline | Abnormal: NCS | 3 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline | Abnormal: NCS | 6 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline | Abnormal: NCS | 6 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline | Abnormal: NCS | 3 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline | Abnormal: CS | 0 Participants |
Primary
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Blood samples were collected to analyze PCI ranges: \>=2 times ULN U/L for Alanine aminotransferase(ALT),\>=2 times ULN U/L for alkaline phosphatase(ALP), \>=2 times ULN U/L for aspartate aminotransferase(AST),\>=1.5 times ULN micromoles/L for bilirubin,\<2 or \>2.75 mmol/L for calcium,\<3 or \>9 mmol/L for glucose,\<3 or \>5.5 mmol/L for potassium and \<130 or \>150 mmol/L for sodium.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,were recorded inTo within Range or No Change category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value,including those from unscheduled visits.
Time frame: Up to 26 days
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 8 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 8 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium:To within Range or No Change | 8 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 8 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 4 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 8 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 1 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin:To within Range or No Change | 7 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin:To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium:To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium:To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Glucose: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin:To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin:To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium:To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium:To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin:To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Bilirubin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Sodium: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Calcium: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | AST: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Potassium: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | ALT: To Low | 0 Participants |
Primary
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Blood samples were collected to analyze hematocrit,hemoglobin,leukocytes,lymphocytes,neutrophils and platelets. PCI ranges were \<0.075 or \>0.54 proportion of red blood cells in blood for hematocrit, \<25 or \>180 grams per liter(g/L) for hemoglobin,\<3 or \>20 x10\^9 cells per liter(cells/L) for leukocytes,\<0.8 x10\^9 cells/L for lymphocytes,\<1.5 x10\^9 cells/L for neutrophils and \<100 or \>550 x10\^9 cells/L for 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(e.g.,High to High),or whose value became within range, were recorded inTo within Range or No Change category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Time frame: Up to 26 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 7 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 1 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 8 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 6 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 8 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 2 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 8 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 8 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 2 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 6 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 1 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 7 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 7 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 7 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 1 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 1 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To Low | 1 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Lymphocytes: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Leukocytes: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hemoglobin: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Neutrophils: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Hematocrit: To within Range or No Change | 7 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline | Platelets: To High | 0 Participants |
Primary
Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Urine samples were collected for the analysis of urine parameters including occult blood and protein by dipstick. The dipstick test gave results in a semi-quantitative manner (proportional concentrations in urine samples), and results for urinalysis parameters were recorded as no change/decreased, increase to positive for urine occult blood and protein. 'No change/decreased' indicates no change from Baseline results or decreased in results from Baseline including change in negative results. 'Increase to positive' indicates increase in result from Baseline. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst case urinalysis results Post Baseline relative to Baseline is presented.
Time frame: Up to 26 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 8 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 7 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to trace | 1 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to trace | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to trace | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 1 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 7 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to trace | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, Increase to trace | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Protein, No change/decreased | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult blood, Increase to positive | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline | Occult Blood, No change/decreased | 8 Participants |
Primary
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
Vital signs were assessed including Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). PCI ranges were \<85 (Low), 85-160 (Normal) and \>160 (High) for SBP; \<45 (Low), 45-100 (Normal), \>100 (High) for DBP; \<40 (Low), 40-110 (Normal), \>110 (High) for pulse rate. Participants were counted in worst case category that their value changes to(low,within range or no change, 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, were recorded inTo within Range or No Change category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Time frame: Up to 26 days
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 1 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 7 Participants |
| Part 1: Single Dose Placebo | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 7 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 1 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To Low | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To within Range or No Change | 8 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | SBP: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | PR: To High | 0 Participants |
| Part 1: Single Dose GSK3882347 250 mg | Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline | DBP: To High | 0 Participants |
Primary
Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. %fe was calculated as: (Ae total/Dose)\*100%.
Time frame: Day 1 and Day 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dose
Population: PK Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | Day 1 | 49.54 Percent dose excreted | Geometric Coefficient of Variation 17.6 |
| Part 1: Single Dose Placebo | Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | Day 7 | 53.42 Percent dose excreted | Geometric Coefficient of Variation 19 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | Day 7 | 72.13 Percent dose excreted | Geometric Coefficient of Variation 17.4 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | Day 1 | 58.87 Percent dose excreted | Geometric Coefficient of Variation 14.2 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | Day 1 | 37.70 Percent dose excreted | Geometric Coefficient of Variation 32.5 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | Day 7 | 51.62 Percent dose excreted | Geometric Coefficient of Variation 18.7 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | Day 1 | 29.68 Percent dose excreted | Geometric Coefficient of Variation 18.4 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347 | Day 7 | 43.34 Percent dose excreted | Geometric Coefficient of Variation 13 |
Primary
Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Population: PK Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347 | Day 1 | 90.98 Nanograms per milliliter | Geometric Coefficient of Variation 46.8 |
| Part 1: Single Dose Placebo | Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347 | Day 7 | 109.28 Nanograms per milliliter | Geometric Coefficient of Variation 26.8 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347 | Day 7 | 368.34 Nanograms per milliliter | Geometric Coefficient of Variation 29.7 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347 | Day 1 | 292.53 Nanograms per milliliter | Geometric Coefficient of Variation 22.2 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347 | Day 1 | 789.85 Nanograms per milliliter | Geometric Coefficient of Variation 46.7 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347 | Day 7 | 1170.62 Nanograms per milliliter | Geometric Coefficient of Variation 39.2 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347 | Day 1 | 1084.55 Nanograms per milliliter | Geometric Coefficient of Variation 31.8 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347 | Day 7 | 1864.47 Nanograms per milliliter | Geometric Coefficient of Variation 23.1 |
Primary
Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t).
Time frame: Day 1 and Day 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dose
Population: PK Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347 | Day 1 | 4.24 Liters per hour | Geometric Coefficient of Variation 20.8 |
| Part 1: Single Dose Placebo | Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347 | Day 7 | 4.34 Liters per hour | Geometric Coefficient of Variation 16.9 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347 | Day 7 | 5.12 Liters per hour | Geometric Coefficient of Variation 19.8 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347 | Day 1 | 4.38 Liters per hour | Geometric Coefficient of Variation 28.6 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347 | Day 1 | 4.16 Liters per hour | Geometric Coefficient of Variation 28.7 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347 | Day 7 | 4.22 Liters per hour | Geometric Coefficient of Variation 28.6 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347 | Day 7 | 4.73 Liters per hour | Geometric Coefficient of Variation 18 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347 | Day 1 | 4.98 Liters per hour | Geometric Coefficient of Variation 19.1 |
Primary
Part 2: Tmax After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Population: PK Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Tmax After Repeat Dose Administration of GSK3882347 | Day 1 | 4.000 Hours |
| Part 1: Single Dose Placebo | Part 2: Tmax After Repeat Dose Administration of GSK3882347 | Day 7 | 4.000 Hours |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Tmax After Repeat Dose Administration of GSK3882347 | Day 7 | 4.000 Hours |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Tmax After Repeat Dose Administration of GSK3882347 | Day 1 | 3.000 Hours |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Tmax After Repeat Dose Administration of GSK3882347 | Day 1 | 4.000 Hours |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Tmax After Repeat Dose Administration of GSK3882347 | Day 7 | 4.000 Hours |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Tmax After Repeat Dose Administration of GSK3882347 | Day 1 | 4.008 Hours |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Tmax After Repeat Dose Administration of GSK3882347 | Day 7 | 4.000 Hours |
Primary
Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Day 1 and Day 7: 22-24 hours post-dose
Population: PK Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347 | Day 1 | 2.95 Micrograms per milliliter | Geometric Coefficient of Variation 52.5 |
| Part 1: Single Dose Placebo | Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347 | Day 7 | 2.56 Micrograms per milliliter | Geometric Coefficient of Variation 84.4 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347 | Day 7 | 16.50 Micrograms per milliliter | Geometric Coefficient of Variation 26.7 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347 | Day 1 | 11.98 Micrograms per milliliter | Geometric Coefficient of Variation 64.8 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347 | Day 1 | 18.15 Micrograms per milliliter | Geometric Coefficient of Variation 42.8 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347 | Day 7 | 23.60 Micrograms per milliliter | Geometric Coefficient of Variation 69.6 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347 | Day 1 | 38.43 Micrograms per milliliter | Geometric Coefficient of Variation 90.6 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347 | Day 7 | 57.15 Micrograms per milliliter | Geometric Coefficient of Variation 75.2 |
Secondary
Part 1: Apparent Oral Clearance (CL/F) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Apparent Oral Clearance (CL/F) After Single Dose Administration of GSK3882347 | 6.92 Liters per hour | Geometric Coefficient of Variation 23.4 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Apparent Oral Clearance (CL/F) After Single Dose Administration of GSK3882347 | 5.93 Liters per hour | Geometric Coefficient of Variation 18.1 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Apparent Oral Clearance (CL/F) After Single Dose Administration of GSK3882347 | 6.69 Liters per hour | Geometric Coefficient of Variation 16.8 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Apparent Oral Clearance (CL/F) After Single Dose Administration of GSK3882347 | 6.80 Liters per hour | Geometric Coefficient of Variation 26.5 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Apparent Oral Clearance (CL/F) After Single Dose Administration of GSK3882347 | 8.53 Liters per hour | Geometric Coefficient of Variation 10.5 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Apparent Oral Clearance (CL/F) After Single Dose Administration of GSK3882347 | 7.89 Liters per hour | Geometric Coefficient of Variation 26.1 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Apparent Oral Clearance (CL/F) After Single Dose Administration of GSK3882347 | 10.06 Liters per hour | Geometric Coefficient of Variation 32.1 |
Secondary
Part 1: Apparent Volume of Distribution After Oral Administration (Vz/F) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Apparent Volume of Distribution After Oral Administration (Vz/F) After Single Dose Administration of GSK3882347 | 113.92 Liters | Geometric Coefficient of Variation 22.8 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Apparent Volume of Distribution After Oral Administration (Vz/F) After Single Dose Administration of GSK3882347 | 105.04 Liters | Geometric Coefficient of Variation 6.7 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Apparent Volume of Distribution After Oral Administration (Vz/F) After Single Dose Administration of GSK3882347 | 111.30 Liters | Geometric Coefficient of Variation 22.7 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Apparent Volume of Distribution After Oral Administration (Vz/F) After Single Dose Administration of GSK3882347 | 120.43 Liters | Geometric Coefficient of Variation 34.3 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Apparent Volume of Distribution After Oral Administration (Vz/F) After Single Dose Administration of GSK3882347 | 159.74 Liters | Geometric Coefficient of Variation 11.3 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Apparent Volume of Distribution After Oral Administration (Vz/F) After Single Dose Administration of GSK3882347 | 143.76 Liters | Geometric Coefficient of Variation 30.1 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Apparent Volume of Distribution After Oral Administration (Vz/F) After Single Dose Administration of GSK3882347 | 184.26 Liters | Geometric Coefficient of Variation 24.1 |
Secondary
Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC [0-infinity]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC [0-infinity]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 36768.0 Hours*nanogram per milliliter | Standard Error 0.08 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC [0-infinity]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 29316.1 Hours*nanogram per milliliter | Standard Error 0.08 |
90% CI: [0.65, 0.98]
Secondary
Part 1: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Single Dose Administration of GSK3882347 | 1181.6 Hours*nanogram per milliliter | Geometric Coefficient of Variation 20.3 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Single Dose Administration of GSK3882347 | 4609.1 Hours*nanogram per milliliter | Geometric Coefficient of Variation 10.2 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Single Dose Administration of GSK3882347 | 12519.7 Hours*nanogram per milliliter | Geometric Coefficient of Variation 19.7 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Single Dose Administration of GSK3882347 | 20127.1 Hours*nanogram per milliliter | Geometric Coefficient of Variation 29.1 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Single Dose Administration of GSK3882347 | 14009.0 Hours*nanogram per milliliter | Geometric Coefficient of Variation 10.1 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Single Dose Administration of GSK3882347 | 33030.8 Hours*nanogram per milliliter | Geometric Coefficient of Variation 26.8 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Single Dose Administration of GSK3882347 | 42353.5 Hours*nanogram per milliliter | Geometric Coefficient of Variation 26.6 |
Secondary
Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 28472.2 Hours*nanogram per milliliter | Standard Error 0.08 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 21456.4 Hours*nanogram per milliliter | Standard Error 0.08 |
90% CI: [0.61, 0.93]
Secondary
Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC [0-t]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC [0-t]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 36561.0 Hours*nanogram per milliliter | Standard Error 0.08 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC [0-t]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 29091.9 Hours*nanogram per milliliter | Standard Error 0.08 |
90% CI: [0.65, 0.98]
Secondary
Part 1: Dose Proportionality of GSK3882347 for Dose Levels 15 mg to 900 mg Using AUC(0-infinity) After Single Dose Administration of GSK3882347 Under Fasted Condition
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented. The SD 250 mg fed treatment was not considered in the analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Population: PK Population. Only those participants with data available at the specified data points were analyzed. The dose proportionality was assessed for doses administered under fasted conditions only. Being a FTIH study, the impact of food on drug PK was unknown; hence it would have been inaccurate to include fed arm in dose proportionality assessment in this FTIH study. Therefore, 250 mg fed arm was not considered in dose proportionality assessment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Dose Proportionality of GSK3882347 for Dose Levels 15 mg to 900 mg Using AUC(0-infinity) After Single Dose Administration of GSK3882347 Under Fasted Condition | 0.919 Slope of log dose |
Secondary
Part 1: Dose Proportionality of GSK3882347 for Dose Levels 15 mg to 900 mg Using Cmax After Single Dose Administration of GSK3882347 Under Fasted Condition
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented. The SD 250 mg fed treatment was not considered in the analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Population: PK Population. Only those participants with data available at the specified data points were analyzed. The dose proportionality was assessed for doses administered under fasted conditions only. Being a FTIH study, the impact of food on drug PK was unknown; hence it would have been inaccurate to include fed arm in dose proportionality assessment in this FTIH study. Therefore, 250 mg fed arm was not considered in dose proportionality assessment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Dose Proportionality of GSK3882347 for Dose Levels 15 mg to 900 mg Using Cmax After Single Dose Administration of GSK3882347 Under Fasted Condition | 0.903 Slope of log dose |
Secondary
Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 3126.7 Nanograms per milliliter | Standard Error 0.1 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 1834.5 Nanograms per milliliter | Standard Error 0.1 |
90% CI: [0.46, 0.75]
Secondary
Part 1: Mean Residence Time (MRT) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Mean Residence Time (MRT) After Single Dose Administration of GSK3882347 | 15.775 Hours |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Mean Residence Time (MRT) After Single Dose Administration of GSK3882347 | 16.843 Hours |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Mean Residence Time (MRT) After Single Dose Administration of GSK3882347 | 15.614 Hours |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Mean Residence Time (MRT) After Single Dose Administration of GSK3882347 | 16.262 Hours |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Mean Residence Time (MRT) After Single Dose Administration of GSK3882347 | 18.818 Hours |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Mean Residence Time (MRT) After Single Dose Administration of GSK3882347 | 17.259 Hours |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Mean Residence Time (MRT) After Single Dose Administration of GSK3882347 | 18.630 Hours |
Secondary
Part 1: Plasma Concentrations at 12 Hours (C12) After Single Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose in each treatment period
Population: PK Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Plasma Concentrations at 12 Hours (C12) After Single Dose Administration of GSK3882347 | 58.73 Nanograms per milliliter | Geometric Coefficient of Variation 26.7 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Plasma Concentrations at 12 Hours (C12) After Single Dose Administration of GSK3882347 | 232.96 Nanograms per milliliter | Geometric Coefficient of Variation 17.1 |
| Part 1: Single Dose GSK3882347 50 mg | Part 1: Plasma Concentrations at 12 Hours (C12) After Single Dose Administration of GSK3882347 | 636.41 Nanograms per milliliter | Geometric Coefficient of Variation 18.5 |
| Part 1: Single Dose GSK3882347 150 mg | Part 1: Plasma Concentrations at 12 Hours (C12) After Single Dose Administration of GSK3882347 | 947.62 Nanograms per milliliter | Geometric Coefficient of Variation 27.5 |
| Part 1: Single Dose GSK3882347 250 mg | Part 1: Plasma Concentrations at 12 Hours (C12) After Single Dose Administration of GSK3882347 | 857.73 Nanograms per milliliter | Geometric Coefficient of Variation 9.5 |
| Part 1: Single Dose GSK3882347 250 mg Fed | Part 1: Plasma Concentrations at 12 Hours (C12) After Single Dose Administration of GSK3882347 | 1806.50 Nanograms per milliliter | Geometric Coefficient of Variation 33.9 |
| Part 1: Single Dose GSK3882347 500 mg | Part 1: Plasma Concentrations at 12 Hours (C12) After Single Dose Administration of GSK3882347 | 2714.12 Nanograms per milliliter | Geometric Coefficient of Variation 43.9 |
Secondary
Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 494.7 Nanograms per milliliter | Standard Error 0.09 |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 449.2 Nanograms per milliliter | Standard Error 0.09 |
90% CI: [0.74, 1.11]
Secondary
Part 1: Tlag After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Tlag After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 0.250 Hours |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Tlag After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 0.250 Hours |
90% CI: [0, 0.25]
Secondary
Part 1: Tmax After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Single Dose Placebo | Part 1: Tmax After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 4.000 Hours |
| Part 1: Single Dose GSK3882347 15 mg | Part 1: Tmax After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect | 4.000 Hours |
90% CI: [0, 2]
Secondary
Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose
Population: PK Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347 | Day 1 | 4076.3 Hours*nanogram per milliliter | Geometric Coefficient of Variation 16.4 |
| Part 1: Single Dose Placebo | Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347 | Day 7 | 4222.8 Hours*nanogram per milliliter | Geometric Coefficient of Variation 11 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347 | Day 7 | 14506.3 Hours*nanogram per milliliter | Geometric Coefficient of Variation 28.9 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347 | Day 1 | 14411.9 Hours*nanogram per milliliter | Geometric Coefficient of Variation 28.9 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347 | Day 1 | 30660.3 Hours*nanogram per milliliter | Geometric Coefficient of Variation 37.1 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347 | Day 7 | 41187.1 Hours*nanogram per milliliter | Geometric Coefficient of Variation 24.1 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347 | Day 1 | 35231.6 Hours*nanogram per milliliter | Geometric Coefficient of Variation 26.3 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347 | Day 7 | 53121.9 Hours*nanogram per milliliter | Geometric Coefficient of Variation 23.9 |
Secondary
Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using AUC(0-tau) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented.
Time frame: Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using AUC(0-tau) After Repeat Dose Administration of GSK3882347 | Day 1 | 0.770 Slope of log dose |
| Part 1: Single Dose Placebo | Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using AUC(0-tau) After Repeat Dose Administration of GSK3882347 | Day 7 | 0.908 Slope of log dose |
Secondary
Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using Cmax After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented.
Time frame: Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using Cmax After Repeat Dose Administration of GSK3882347 | Day 1 | 0.736 Slope of log dose |
| Part 1: Single Dose Placebo | Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using Cmax After Repeat Dose Administration of GSK3882347 | Day 7 | 0.841 Slope of log dose |
Secondary
Part 2: Observed Accumulation Ratio (Ro) Using AUC(0-tau) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) at Day 7 divided by AUC(0-tau) at Day 1 for GSK3882347. Mixed effect model was used to assess accumulation ratio for the log transformed parameters. Treatment, day and the interaction of treatment and day were fitted as fixed effect. Participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used.
Time frame: Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Population: PK Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Observed Accumulation Ratio (Ro) Using AUC(0-tau) After Repeat Dose Administration of GSK3882347 | 1.05 Ratio |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Observed Accumulation Ratio (Ro) Using AUC(0-tau) After Repeat Dose Administration of GSK3882347 | 1.05 Ratio |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Observed Accumulation Ratio (Ro) Using AUC(0-tau) After Repeat Dose Administration of GSK3882347 | 1.35 Ratio |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Observed Accumulation Ratio (Ro) Using AUC(0-tau) After Repeat Dose Administration of GSK3882347 | 1.53 Ratio |
Secondary
Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose
Population: PK Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347 | Day 1 | 214.4 Nanograms per milliliter | Geometric Coefficient of Variation 23.5 |
| Part 1: Single Dose Placebo | Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347 | Day 7 | 221.5 Nanograms per milliliter | Geometric Coefficient of Variation 11.8 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347 | Day 7 | 776.1 Nanograms per milliliter | Geometric Coefficient of Variation 28.3 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347 | Day 1 | 709.1 Nanograms per milliliter | Geometric Coefficient of Variation 19.9 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347 | Day 7 | 2360.8 Nanograms per milliliter | Geometric Coefficient of Variation 30.6 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347 | Day 1 | 1704.8 Nanograms per milliliter | Geometric Coefficient of Variation 42.1 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347 | Day 1 | 2068.2 Nanograms per milliliter | Geometric Coefficient of Variation 36 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347 | Day 7 | 3218.5 Nanograms per milliliter | Geometric Coefficient of Variation 21.6 |
Secondary
Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7
Blood samples were collected at indicated time points for PK analysis of GSK3882347.
Time frame: Days 3, 4, 5, 6 and 7: Pre-dose
Population: PK Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 6: Pre-dose | 97.50 Nanograms per milliliter | Standard Deviation 21.275 |
| Part 1: Single Dose Placebo | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 7: Pre-dose | 92.46 Nanograms per milliliter | Standard Deviation 14.39 |
| Part 1: Single Dose Placebo | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 4: Pre-dose | 96.66 Nanograms per milliliter | Standard Deviation 16.722 |
| Part 1: Single Dose Placebo | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 5: Pre-dose | 96.16 Nanograms per milliliter | Standard Deviation 15.683 |
| Part 1: Single Dose Placebo | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 3: Pre-dose | 99.48 Nanograms per milliliter | Standard Deviation 19.36 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 5: Pre-dose | 329.37 Nanograms per milliliter | Standard Deviation 88.1 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 6: Pre-dose | 339.83 Nanograms per milliliter | Standard Deviation 100.604 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 4: Pre-dose | 344.56 Nanograms per milliliter | Standard Deviation 112.891 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 3: Pre-dose | 326.89 Nanograms per milliliter | Standard Deviation 81.306 |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 7: Pre-dose | 300.16 Nanograms per milliliter | Standard Deviation 75.925 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 7: Pre-dose | 1105.470 Nanograms per milliliter | Standard Deviation 464.5923 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 3: Pre-dose | 1157.589 Nanograms per milliliter | Standard Deviation 432.3864 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 4: Pre-dose | 1212.368 Nanograms per milliliter | Standard Deviation 438.9076 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 5: Pre-dose | 1166.770 Nanograms per milliliter | Standard Deviation 369.9656 |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 6: Pre-dose | 1157.068 Nanograms per milliliter | Standard Deviation 384.6052 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 6: Pre-dose | 1776.54 Nanograms per milliliter | Standard Deviation 513.638 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 5: Pre-dose | 1724.07 Nanograms per milliliter | Standard Deviation 524.054 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 4: Pre-dose | 1883.90 Nanograms per milliliter | Standard Deviation 560.646 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 7: Pre-dose | 1769.40 Nanograms per milliliter | Standard Deviation 618.929 |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7 | Day 3: Pre-dose | 1578.14 Nanograms per milliliter | Standard Deviation 328.085 |
Secondary
Part 2: Time Invariance of GSK3882347
Blood samples were collected at indicated time points for the analysis of time invariance. Time invariance was calculated as AUC(0-tau) at Day 7 divided by AUC(0-infinity) at Day 1 for GSK3882347. Mixed effect ANOVA model was used to assess time invariance for the log transformed parameters. Treatment, day and the interaction of treatment and day were fitted as fixed effect. Participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used.
Time frame: Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Population: PK Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Single Dose Placebo | Part 2: Time Invariance of GSK3882347 | 0.83 Ratio |
| Part 1: Single Dose GSK3882347 15 mg | Part 2: Time Invariance of GSK3882347 | 0.87 Ratio |
| Part 1: Single Dose GSK3882347 50 mg | Part 2: Time Invariance of GSK3882347 | 1.07 Ratio |
| Part 1: Single Dose GSK3882347 150 mg | Part 2: Time Invariance of GSK3882347 | 1.13 Ratio |