HIV Infections
Conditions
Keywords
GSK3640254, Moxifloxacin, Electrocardiogram, Cardiac Conduction, Supratherapeutic dose
Brief summary
This study will aim to evaluate the effect of therapeutic and supratherapeutic oral doses of GSK3640254 on cardiac conduction compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. The study has 2 parts: Part 1 will determine the supratherapeutic dose for Part 2, which will be the main corrected QT interval (QTc) study. Part 1 will evaluate once daily (QD) dosing of GSK3640254 or placebo and Part 2 will investigate the safety, tolerability and Pharmacokinetics (PK) of GSK3640254 doses on cardiac conduction as compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. Moxifloxacin will be included as a positive control.
Interventions
DRUGGSK3640254
GSK3640254 will be administered.
DRUGPlacebo
Placebo will be administered.
DRUGMoxifloxacin
Moxifloxacin will be administered.
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination (including cardiopulmonary examination), laboratory tests, and cardiac monitoring (history and ECG). * Body weight more than or equal to (\>=)50.0 kilograms (kg) (110 pounds \[lbs\]) for men and \>=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 31.0 kilograms per square meter (kg/m\^2) (inclusive). * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Male or female participants: 1. Male participants should not engage in intercourse while confined in the clinic. There is no need for an extended period of double barrier use or prolonged abstinence after study discharge. 2. Female participants: (i) A female participant is eligible to participate if she is not pregnant, planning to become pregnant within the next 6 months, or breastfeeding, and at least 1 of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a non-hormonal contraceptive method that is highly effective, with a failure rate of less than (\<)1 percent (%) for 28 days before intervention, during the intervention period, and for at least 28 days after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. (ii) A WOCBP must have a negative highly sensitive serum pregnancy test at Screening and Check-in. * Capable of giving signed informed, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
Exclusion criteria
* Participants with current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * A pre-existing condition interfering with normal Gastrointestinal (GI) anatomy or motility (for example \[e.g.\], gastro-esophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study intervention or render the participant unable to take oral study intervention. * Prior cholecystectomy (prior appendectomy is acceptable). * Clinically significant illness, including viral syndromes, within 3 weeks of dosing. * A participant with known or suspected active Coronavirus Disease-2019 (COVID-19) infection OR contact with an individual with known COVID-19, within 14 days of study enrollment (World Health Organization \[WHO\] definitions). * Any history of significant underlying psychiatric disorder, including, but not limited to, schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder. * Any history of major depressive disorder with or without suicidal features, or anxiety disorders that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (more than \[\>\]6 months) outpatient treatment. Participants with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (\<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the ViiV Healthcare/GlaxoSmithKline (VH/GSK) Medical Monitor. * Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the participant's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the participant. * Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome. * History indicative of an increased risk of a cardiac arrhythmia or cardiac disease, including the following: 1. History of symptomatic cardiac arrhythmias or palpitations associated with pre-syncope or syncope, or history of unexplained syncope. 2. History of cardiac arrest. 3. History of clinically relevant cardiac disease including symptomatic or asymptomatic arrhythmias (including but not limited to ventricular fibrillation, ventricular tachycardia, any degree of atrioventricular block, Brugada syndrome, Wolff-Parkinson-White Syndrome, and sinus bradycardia, defined as HR less than 50 bpm based on vital signs or ECG), presyncope or syncopal episodes, or additional risk factors for torsades de pointes (e.g., heart failure). 4. History of clinically relevant structural cardiac disease including hypertrophic obstructive cardiomyopathy. 5. History of hypokalemia. * History of heart disease (e.g., coronary heart disease, angina). * Presence of hepatitis B surface antigen at Screening or within 3 months prior to starting study intervention. * Positive hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention. * Positive Human Immunodeficiency virus (HIV)-1 and -2 antigen/antibody immunoassay at Screening. * Alanine aminotransferase (ALT) \>=1.5 times upper limit of normal (ULN). A single repeat of ALT is allowed within a single Screening period to determine eligibility. * Bilirubin \>=1.5 times ULN (isolated bilirubin \>=1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). A single repeat of any laboratory abnormality is allowed within a single Screening period to determine eligibility. * Any acute laboratory abnormality (including hypokalemia, hypercalcemia, or hypomagnesemia) at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound. * Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT (previously described), will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single Screening period to determine eligibility. * Urine drug screen positive (showing presence of): amphetamines, barbiturates, cocaine, Methylenedioxymethamphetamine (MDMA), cannabinoids, methamphetamines, phencyclidine, or non-prescribed opiates, oxycodone, benzodiazepines, methadone, or tricyclic antidepressants at screening or before dosing of study intervention. * Unable to refrain from the use of prescription or nonprescription drugs including vitamins, herbal and dietary supplements (including Saint \[St\] John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study intervention and for the duration of the study. * Treatment with any vaccine within 30 days prior to receiving study intervention. * Unwillingness to abstain from consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study. * Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the study intervention (whichever is longer). * Prior exposure to GSK3640254 in this or another clinical study. * Prior intolerance to Moxifloxacin. * Prior participation in this clinical study (participants may not participate in both Part 1 and Part 2 of the study). * Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days. * Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia-Suicide Severity Rating Scale (C-SSRS). * A sustained supine systolic blood pressure \>150 millimeters of mercury (mm Hg) or \<90 mm Hg or a supine diastolic blood pressure \>95 mm Hg or \<50 mm Hg at Screening or Check-in (Day -2). Blood pressure may be retested once in the supine position. The blood pressure abnormality is considered sustained if either the systolic or the diastolic pressure values are outside the stated limits after 2 assessments, in which case the participant may not be randomized. * A resting HR of \<50 bpm or \>100 bpm when vital signs are measured at Screening or Check-in (Day -2). A HR from 100 to 110 bpm can be rechecked by ECG or vital signs within up to 2 hours to verify eligibility. * An uninterpretable ECG or any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months, significant pathological Q-waves (defined as Q-wave \>40 ms or depth greater than 0.4-0.5 millivolts \[mV\], symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, ventricular pre-excitation, non-sustained or sustained ventricular tachycardia, any degree of atrioventricular block, complete left bundle branch block, or conduction abnormality) which, in the opinion of the investigator or VH/GSK Medical Monitor, will interfere with the safety of the individual participant. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Plasma Concentration of Major Metabolites of GSK3640254 | Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period | Blood samples were to be collected at indicated time points to analyze the plasma concentration of major metabolites of GSK3640254. |
| Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) of GSK3640254 | Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 | Blood samples were collected at indicated time points. Pharmacokinetic (PK) analysis was conducted using standard non-compartmental methods. |
| Part 1: AUC From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254 | Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 | Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods. |
| Part 1: Maximum Observed Concentration (Cmax) of GSK3640254 | Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 | Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods. |
| Part 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254 | Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 | Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods |
| Part 1: Time of Maximum Observed Concentration (Tmax) of GSK3640254 | Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 | Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods. |
| Part 1: Plasma Concentration of GSK3640254 | Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 | Blood samples were collected at indicated time points to analyze the plasma concentration of GSK3640254. |
| Part 1: Plasma Concentration of Major Metabolites of GSK3640254 | Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 | Blood samples were to be collected at indicated time points to analyze the plasma concentration of major metabolites of GSK3640254. |
| Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Up to Day 9 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events. |
| Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. . |
| Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated timepoints to analyze hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at idicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze the hematology parameter: Erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Baseline (Day -2), Day 3, Day 7, Day 9 | Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Baseline (Day -2), Day 3, Day 7, Day 9 | Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value |
| Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Baseline (Day -2), Day 3, Day 7, and Day 9 | Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -2), Day 3, Day 7, and Day 9 | Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH) | Baseline (Day -2), Day 3, Day 7, and Day 9 | Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Baseline (Day -2), Day 3, Day 7, and Day 9 | Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Absolute Values for Vital Parameter: Temperature | Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9 | Temperature was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions.Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Change From Baseline in Urinalysis Parameter: pH | Baseline (Day -2), Day 3, Day 7, and Day 9 | Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Baseline(Day-2), Day1: 2 Hours, 4 Hours, 6 Hours; Day 4: 2 Hours, 4 Hours, 6 Hours, Day 7: 2 Hours, 4 Hours, 6 Hours and Day 9 | A 12-lead ECG was recorded with the participant in a supine position. 12-lead ECGs were obtained by using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal 12-Lead ECG findings has reported |
| Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9 | SBP and DBP were measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Vital Parameter: Pulse Rate | Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9 | Pulse rate was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg Using Concentration-QTc (C-QTc) Analysis | Baseline (Pre-dose, Day 1) and up to Day 7 | Twelve-lead ECGs were recorded in participant using automated ECG machine & performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline was calculated by subtracting Baseline value from post dose value. Placebo-corrected change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated as difference in model-predicted mean change from Baseline in QTcF between treatment groups using C-QTc analysis. A linear mixed-effects model with change from Baseline in QTcF as the dependent variable, time-matched GSK3640254 plasma concentration as a fixed effect, centered Baseline as additional covariate,treatment &time as categorical factors, & a random intercept & slope per participant. In all calculations, concentrations in participants who received placebo were set to 0. |
| Part 2: Plasma Concentration of GSK3640254 | Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period | Blood samples were collected at indicated time points to analyze the plasma concentration of GSK3640254. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated timepoints to analyze amylase, lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -2), Day 8, Day 9, and Day 14 | Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. |
| Part 2: Absolute Values for Urinalysis Parameter: pH | Baseline (Day -2), Day 8, Day 9, and Day 14 | Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. |
| Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Baseline (Day -2), Day 8, Day 9, and Day 14 | Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Baseline(Day-2), Day1: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours; Day 2: 24 Hours, Day 4: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, Day 5: 24 Hours; Day 7: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours; Day 8: 24 Hours; Day 9 and Day 14 | A 12-lead ECG was recorded with the participant in a supine position. 12-lead ECGs were obtained by using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal 12-Lead ECG findings has reported. |
| Part 2: Absolute Values for Vital Parameters: SBP and DBP | Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, and Day 14 | SBP and DBP were measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. |
| Part 2: Absolute Values for Vital Parameter: Pulse Rate | Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, and Day 14 | Pulse rate was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. |
| Part 2: Absolute Values for Vital Parameter: Temperature | Baseline (Pre-dose, Day 1), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, and Day 14 | Temperature was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. |
| Part 2: Change From Baseline in Urinalysis Parameter: pH | Baseline (Day -2), Day 8, Day 9, and Day 14 | Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -2), Day 8, Day 9, Day 14 | Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits |
| Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose | Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose | Twelve-lead ECGs were recorded in participant using automated ECG machine & performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated by subtracting Baseline value from post dose value. |
| Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose | Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose | Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose | Twelve-lead ECGs were recorded in participant using automated ECG machine & performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline was calculated by subtracting Baseline value from post dose value. Placebo-corrected change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated as model-predicted mean change from Baseline in QTcF in GSK3640254 group minus model-predicted mean change from Baseline in QTcF in the placebo group (by-time point analysis). Time point analysis was performed based on a linear mixed-effects model: Change from Baseline in QTcF = Time + Treatment + Time\*Treatment +Baseline QTcF + Period + Sequence. An unstructured covariance structure was used to specify the repeated measures (time within participant and period). A random intercept per participant was also included. |
| Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -2), Day 8, Day 9, Day 14 | Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. |
| Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose | Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in HR was calculated as model-predicted mean change from Baseline in HR in GSK3640254 group minus model-predicted mean change from Baseline in HR in the placebo group. |
| Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose | Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in PR was calculated as model-predicted mean change from Baseline in PR interval in GSK3640254 group minus model-predicted mean change from Baseline in PR interval in the placebo group. |
| Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose | Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in QRS was calculated as model-predicted mean change from Baseline in QRS interval in GSK3640254 group minus model-predicted mean change from Baseline in QRS interval in the placebo group. |
| Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | Up to Day 51 | Twelve-lead ECGs were recorded using an automated ECG machine with participant in a supine position after a rest of at least 10 minutes. Number of participants with outlier results for HR, QTcF, ΔQTcF, PR interval and QRS interval were summarized.Categorical outlier criteria was as follows:change from Baseline in QTcF (ΔQTcF) \>60 ms: Increase of QTc from Baseline \> 60 ms, QTcF \> 500 ms:Treatment-emergent value of \> 500 ms when not present at Baseline (new onset), HR \< 50 bpm with a decrease in change from Baseline in heart rate (ΔHR) \> 25%:Decrease of HR from Baseline \>25% resulting in HR \< 50 bpm, HR \> 100 bpm with an increase in ΔHR \> 25% :Increase of HR from Baseline \>25% resulting in HR \> 100 bpm, PR \> 200 ms with an increase in change from Baseline in PR interval (ΔPR) \> 25%:Increase of PR from Baseline \> 25% resulting in PR \> 200 ms, QRS \> 120 ms with an increase in change from Baseline in QRS interval (ΔQRS) \> 25%:Increase of QRS from Baseline \> 25% resulting in QRS \> 120 ms. |
| Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Up to Day 51 | Twelve-lead ECGs were recorded using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Flat T-wave=T-amplitude \< 1 mm (either positive \[+\] or negative \[-\]), including flat isoelectric line, Notched T-wave (+)=Presence of notch(es) of at least 0.05 millivolt (mV) amplitude on ascending or descending arm of the positive T-wave, Biphasic= T-wave that contains a second component with an opposite phase that is at least 0.1 mV deep (both positive/negative and negative/positive and polyphasic T-waves included), Normal T-wave (-)=T-amplitude that is negative, without biphasic T-wave or notches, Notched T-wave (-): Presence of notch(es) of at least 0.05 mV amplitude on descending or ascending arm of the negative T-wave, U-waves= Presence of abnormal U-waves. Data has been reported for Flat T-wave, Notched T-wave (Positive), Biphasic, Normal T-wave (Negative), Notched T-wave (Negative) and T-U wave Fusion. |
| Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose | Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in QTcF was calculated as model-predicted mean change from Baseline in QTcF in moxifloxacin group minus model-predicted mean change from Baseline in QTcF in the placebo group. |
| Part 2: AUC(0-t) of GSK3640254 100 mg and GSK3640254 500 mg | Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period | Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods . |
| Part 2: AUC(0-tau) of GSK3640254 100 mg and GSK3640254 500 mg | Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period | Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods. |
| Part 2: Cmax of GSK3640254 100 mg and GSK3640254 500 mg | Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period | Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods. |
| Part 2: Ctau of GSK3640254 100 mg and GSK3640254 500 mg | Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period | Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods. |
| Part 2: Tmax of GSK3640254 100 mg and GSK3640254 500 mg | Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period | Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods. |
| Part 2: Cmax of Moxifloxacin 400 mg | Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period | Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods |
| Part 2: Tmax of Moxifloxacin 400 mg | Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period | Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods. |
| Part 2: Number of Participants With Non-SAEs and SAEs | Up to Day 51 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events. |
| Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. |
| Part 2: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day -2), Day 8, Day 9, Day 14 | Blood samples were collected at indicated time points to analyze hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits |
| Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Baseline (Day -2), Day 8, Day 9, Day 14 | Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. |
| Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated time points to analyze Erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. |
| Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated time points to analyze hematocrit . Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated time points to analyze erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. |
| Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. |
| Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. |
| Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. |
| Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. |
| Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen.Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Baseline (Day -2), Day 8, Day 9, and Day 14 | Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose | Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value |
Countries
United States
Participant flow
Recruitment details
This study was conducted at a single center in the United States.
Pre-assignment details
A total of 50 participants (8 in Part 1 and 42 in Part 2) were enrolled in the study (Safety Population: It comprised of all participants who received at least 1 dose of study intervention).
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Placebo Participants received a single dose of placebo once daily for 7 days following ingestion of a moderate fat meal. | 2 |
| Part 1: GSK3640254 500 mg Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal. | 6 |
| Part 2: GSK3640254 100 mg/GSK3640254 500 mg/Placebo/Moxifloxacin 400 mg Participants received a single therapeutic dose of GSK3640254 100 mg once daily on Days 1 through 7 (Treatment T) in treatment period 1. In treatment period 2, participants received single supratherapeutic dose of GSK3640254 500 mg once daily on Days 1 through 7 (Treatment ST). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). There was a washout period of at least 7 days between each treatment periods. | 3 |
| Part 2: GSK3640254 500 mg/Moxifloxacin 400 mg/GSK3640254 100 mg/Placebo Participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 3, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). There was a washout period of at least 7 days between each treatment periods. | 4 |
| Part 2: Placebo/GSK3640254 100 mg/Moxifloxacin 400 mg/GSK3640254 500 mg Participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P) in treatment period 1. In treatment period 2, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 4, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). There was a washout period of at least 7 days between each treatment periods. | 4 |
| Part 2: Moxifloxacin 400 mg/Placebo/GSK3640254 500 mg/GSK3640254 100 mg Participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 3, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 4, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). There was a washout period of at least 7 days between each treatment periods. | 4 |
| Part 2: GSK3640254 500 mg/Placebo/GSK3640254 100 mg/Moxifloxacin 400 mg Participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 3, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7(Treatment M). There was a washout period of at least 7 days between each treatment periods. | 4 |
| Part 2: Placebo/Moxifloxacin 400 mg/GSK3640254 500 mg/GSK3640254 100 mg Participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 3, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 4, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). There was a washout period of at least 7 days between each treatment periods. | 3 |
| Part 2: GSK3640254 100 mg/GSK3640254 500 mg/Moxifloxacin 400 mg/ Placebo Participants received a single therapeutic dose of GSK3640254 100 mg Days 1 through 7 (Treatment T) in treatment period 1. In treatment period 2, participants received single supratherapeutic dose of GSK3640254 500 mg Days 1 through 7 (Treatment ST). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). There was a washout period of at least 7 days between each treatment periods. | 3 |
| Part 2: Moxifloxacin 400 mg/GSK3640254 100 mg/Placebo/GSK3640254 500 mg Participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M) in treatment period 1. In treatment period 2, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 4, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). There was a washout period of at least 7 days between each treatment periods. | 3 |
| Part 2: Placebo/GSK3640254 100 mg/GSK3640254 500 mg/Moxifloxacin 400 mg Participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P) in treatment period 1. In treatment period 2, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 3, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). There was a washout period of at least 7 days between each treatment periods. | 4 |
| Part 2: GSK3640254 100 mg/Moxifloxacin 400 mg/Placebo/GSK3640254 500 mg Participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 4, participants received single supratherapeutic dose of GSK3640254 500 mg Days 1 through 7 (Treatment ST). There was a washout period of at least 7 days between each treatment periods. | 4 |
| Part 2: GSK3640254 500 mg/Placebo/Moxifloxacin 400 mg/GSK3640254 100 mg Participants received single supratherapeutic dose of GSK3640254 500 mg Days 1 through 7 (Treatment ST) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 4, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). There was a washout period of at least 7 days between each treatment periods. | 3 |
| Part 2: Moxifloxacin 400 mg/GSK3640254 500 mg/GSK3640254 100 mg/Placebo Participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M) in treatment period 1. In treatment period 2, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 3, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). There was a washout period of at least 7 days between each treatment periods. | 3 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 2:Treatment Period 1(Up to 7 Days) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 2:Washout Period 1(Up to 7 Days) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1: GSK3640254 500 mg | Part 2: GSK3640254 100 mg/GSK3640254 500 mg/Placebo/Moxifloxacin 400 mg | Part 2: GSK3640254 500 mg/Moxifloxacin 400 mg/GSK3640254 100 mg/Placebo | Part 2: Placebo/GSK3640254 100 mg/Moxifloxacin 400 mg/GSK3640254 500 mg | Part 2: Moxifloxacin 400 mg/Placebo/GSK3640254 500 mg/GSK3640254 100 mg | Part 2: GSK3640254 500 mg/Placebo/GSK3640254 100 mg/Moxifloxacin 400 mg | Part 2: Placebo/Moxifloxacin 400 mg/GSK3640254 500 mg/GSK3640254 100 mg | Part 2: GSK3640254 100 mg/GSK3640254 500 mg/Moxifloxacin 400 mg/ Placebo | Part 2: Moxifloxacin 400 mg/GSK3640254 100 mg/Placebo/GSK3640254 500 mg | Part 2: Placebo/GSK3640254 100 mg/GSK3640254 500 mg/Moxifloxacin 400 mg | Part 2: GSK3640254 100 mg/Moxifloxacin 400 mg/Placebo/GSK3640254 500 mg | Part 2: GSK3640254 500 mg/Placebo/Moxifloxacin 400 mg/GSK3640254 100 mg | Part 1: Placebo | Part 2: Moxifloxacin 400 mg/GSK3640254 500 mg/GSK3640254 100 mg/Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18-50 years | 6 Participants | 3 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 4 Participants | 3 Participants | 2 Participants | 3 Participants | 50 Participants |
| Age, Customized >50 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 | 0 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian Heritage | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 20 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other pacific islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 28 Participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 15 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 3 Participants | 4 Participants | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 35 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 6 | 0 / 42 | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 2 / 2 | 1 / 6 | 7 / 42 | 4 / 40 | 5 / 40 | 10 / 40 |
| serious Total, serious adverse events | 0 / 2 | 0 / 6 | 0 / 42 | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Creatine kinase, Day 9 | 60.5 International units per liter | Standard Deviation 34.65 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Lactate dehydrogenase, Baseline (Day -2) | 161.5 International units per liter | Standard Deviation 36.06 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Lactate dehydrogenase, Day 3 | 150.0 International units per liter | Standard Deviation 46.67 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Lactate dehydrogenase, Day 7 | 142.0 International units per liter | Standard Deviation 22.63 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Lactate dehydrogenase, Day 9 | 133.0 International units per liter | Standard Deviation 24.04 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Creatine kinase, Day 3 | 64.5 International units per liter | Standard Deviation 24.75 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Creatine kinase, Day 7 | 71.5 International units per liter | Standard Deviation 53.03 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALT, Day 3 | 37.5 International units per liter | Standard Deviation 33.23 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALT, Day 7 | 33.5 International units per liter | Standard Deviation 26.16 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALT, Day 9 | 28.5 International units per liter | Standard Deviation 23.33 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALP, Baseline (Day -2) | 73.0 International units per liter | Standard Deviation 22.63 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALP, Day 3 | 76.5 International units per liter | Standard Deviation 23.33 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALP, Day 7 | 75.0 International units per liter | Standard Deviation 26.87 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALP, Day 9 | 75.5 International units per liter | Standard Deviation 26.16 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | AST, Baseline (Day -2) | 25.0 International units per liter | Standard Deviation 9.9 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | AST, Day 3 | 24.5 International units per liter | Standard Deviation 12.02 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | AST, Day 7 | 21.5 International units per liter | Standard Deviation 7.78 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | AST, Day 9 | 18.0 International units per liter | Standard Deviation 5.66 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | GGT, Baseline (Day -2) | 21.0 International units per liter | Standard Deviation 14.14 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | GGT, Day 3 | 21.5 International units per liter | Standard Deviation 14.85 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | GGT, Day 7 | 20.0 International units per liter | Standard Deviation 14.14 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | GGT, Day 9 | 19.5 International units per liter | Standard Deviation 13.44 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Creatine kinase, Baseline (Day -2) | 93.0 International units per liter | Standard Deviation 50.91 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALT, Baseline (Day -2), | 33.0 International units per liter | Standard Deviation 28.28 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | AST, Day 7 | 18.0 International units per liter | Standard Deviation 2.53 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Creatine kinase, Day 9 | 75.5 International units per liter | Standard Deviation 56.79 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALP, Day 3 | 50.0 International units per liter | Standard Deviation 15.05 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Lactate dehydrogenase, Baseline (Day -2) | 132.0 International units per liter | Standard Deviation 22.04 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | GGT, Day 3 | 10.8 International units per liter | Standard Deviation 3.37 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Lactate dehydrogenase, Day 3 | 113.3 International units per liter | Standard Deviation 22.55 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALP, Day 7 | 54.8 International units per liter | Standard Deviation 16.22 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Lactate dehydrogenase, Day 7 | 115.8 International units per liter | Standard Deviation 22.05 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | AST, Day 9 | 17.5 International units per liter | Standard Deviation 3.99 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Lactate dehydrogenase, Day 9 | 114.5 International units per liter | Standard Deviation 26.1 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Creatine kinase, Baseline (Day -2) | 160.7 International units per liter | Standard Deviation 124.55 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALP, Day 9 | 54.5 International units per liter | Standard Deviation 17.44 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Creatine kinase, Day 3 | 91.2 International units per liter | Standard Deviation 69.29 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | GGT, Day 9 | 12.0 International units per liter | Standard Deviation 3.69 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | Creatine kinase, Day 7 | 71.5 International units per liter | Standard Deviation 53.73 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALT, Baseline (Day -2), | 19.7 International units per liter | Standard Deviation 10.97 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | AST, Baseline (Day -2) | 19.8 International units per liter | Standard Deviation 6.49 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALT, Day 3 | 16.8 International units per liter | Standard Deviation 7.94 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | GGT, Baseline (Day -2) | 11.0 International units per liter | Standard Deviation 3.22 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALT, Day 7 | 17.7 International units per liter | Standard Deviation 5.92 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | AST, Day 3 | 17.5 International units per liter | Standard Deviation 2.35 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALT, Day 9 | 18.2 International units per liter | Standard Deviation 8.75 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | GGT, Day 7 | 12.0 International units per liter | Standard Deviation 3.29 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase | ALP, Baseline (Day -2) | 54.3 International units per liter | Standard Deviation 26.79 |
Primary
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 3, Day 7, Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Baseline (Day -2) | 26.5 Grams per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Day 3 | 26.0 Grams per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Day 7 | 25.0 Grams per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Day 9 | 25.5 Grams per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Total protein, Baseline (Day -2) | 73.0 Grams per liter | Standard Deviation 4.24 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Total protein, Day 3 | 72.0 Grams per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Total protein, Day 7 | 72.5 Grams per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Total Bilirubin, Day 9 | 71.0 Grams per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Baseline (Day -2) | 46.5 Grams per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Day 3 | 46.0 Grams per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Day 7 | 47.5 Grams per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Day 9 | 45.5 Grams per liter | Standard Deviation 0.71 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Day 7 | 44.3 Grams per liter | Standard Deviation 3.61 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Baseline (Day -2) | 25.5 Grams per liter | Standard Deviation 5.13 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Total protein, Day 7 | 72.2 Grams per liter | Standard Deviation 4.07 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Day 3 | 27.7 Grams per liter | Standard Deviation 2.34 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Day 3 | 41.8 Grams per liter | Standard Deviation 3.31 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Day 7 | 27.8 Grams per liter | Standard Deviation 3.66 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Total Bilirubin, Day 9 | 70.7 Grams per liter | Standard Deviation 4.76 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Day 9 | 27.5 Grams per liter | Standard Deviation 4.28 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Day 9 | 43.2 Grams per liter | Standard Deviation 2.64 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Total protein, Baseline (Day -2) | 68.5 Grams per liter | Standard Deviation 5.47 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Baseline (Day -2) | 43.0 Grams per liter | Standard Deviation 3.03 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein | Total protein, Day 3 | 69.5 Grams per liter | Standard Deviation 3.27 |
Primary
Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase
Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Baseline (Day -2) | 64.5 Units per liter | Standard Deviation 26.16 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Baseline (Day -2) | 33.5 Units per liter | Standard Deviation 20.51 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 7 | 67.0 Units per liter | Standard Deviation 45.25 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 3 | 18.5 Units per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 7 | 19.5 Units per liter | Standard Deviation 3.54 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 3 | 64.0 Units per liter | Standard Deviation 33.94 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 9 | 18.5 Units per liter | Standard Deviation 3.54 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 9 | 64.5 Units per liter | Standard Deviation 41.72 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 9 | 29.3 Units per liter | Standard Deviation 11.29 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Baseline (Day -2) | 63.8 Units per liter | Standard Deviation 22.54 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 3 | 61.8 Units per liter | Standard Deviation 25.31 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 7 | 62.8 Units per liter | Standard Deviation 22.45 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 9 | 59.5 Units per liter | Standard Deviation 22.05 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Baseline (Day -2) | 35.5 Units per liter | Standard Deviation 11.84 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 7 | 32.3 Units per liter | Standard Deviation 16.24 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 3 | 30.2 Units per liter | Standard Deviation 12.24 |
Primary
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 3, Day 7, Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Creatinine, Baseline (Day -2) | 89.75 Micromoles per liter | Standard Deviation 16.9 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Creatinine, Day 3 | 83.10 Micromoles per liter | Standard Deviation 13.718 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Creatinine, Day 7 | 86.60 Micromoles per liter | Standard Deviation 14.991 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Creatinine, Day 9 | 85.30 Micromoles per liter | Standard Deviation 10.607 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Urate, Baseline (Day -2) | 363.0 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Urate, Day 3 | 351.0 Micromoles per liter | Standard Deviation 50.91 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Urate, Day 7 | 365.5 Micromoles per liter | Standard Deviation 54.45 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Urate, Day 9 | 348.0 Micromoles per liter | Standard Deviation 55.15 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Total Bilirubin, Baseline (Day -2) | 5.60 Micromoles per liter | Standard Deviation 1.697 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Total Bilirubin, Day 3 | 8.55 Micromoles per liter | Standard Deviation 0.212 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Total Bilirubin, Day 7 | 8.75 Micromoles per liter | Standard Deviation 0.212 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Total Bilirubin, Day 9 | 7.80 Micromoles per liter | Standard Deviation 1.556 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Direct Bilirubin, Baseline (Day -2) | 0.95 Micromoles per liter | Standard Deviation 0.354 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Direct Bilirubin, Day 3 | 1.45 Micromoles per liter | Standard Deviation 0.071 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Direct Bilirubin, Day 7 | 1.60 Micromoles per liter | Standard Deviation 0.141 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Direct Bilirubin, Day 9 | 1.55 Micromoles per liter | Standard Deviation 0.212 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Direct Bilirubin, Day 9 | 2.05 Micromoles per liter | Standard Deviation 0.862 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Creatinine, Baseline (Day -2) | 74.85 Micromoles per liter | Standard Deviation 15.104 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Total Bilirubin, Baseline (Day -2) | 7.00 Micromoles per liter | Standard Deviation 3.033 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Creatinine, Day 3 | 72.20 Micromoles per liter | Standard Deviation 8.322 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Direct Bilirubin, Baseline (Day -2) | 1.42 Micromoles per liter | Standard Deviation 0.605 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Creatinine, Day 7 | 70.13 Micromoles per liter | Standard Deviation 8.411 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Total Bilirubin, Day 3 | 9.63 Micromoles per liter | Standard Deviation 3.059 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Creatinine, Day 9 | 71.00 Micromoles per liter | Standard Deviation 8.919 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Direct Bilirubin, Day 7 | 2.10 Micromoles per liter | Standard Deviation 1.016 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Urate, Baseline (Day -2) | 274.5 Micromoles per liter | Standard Deviation 72.37 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Total Bilirubin, Day 7 | 11.33 Micromoles per liter | Standard Deviation 5.201 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Urate, Day 3 | 259.0 Micromoles per liter | Standard Deviation 61.48 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Direct Bilirubin, Day 3 | 1.68 Micromoles per liter | Standard Deviation 0.571 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Urate, Day 7 | 246.0 Micromoles per liter | Standard Deviation 60.52 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Total Bilirubin, Day 9 | 10.20 Micromoles per liter | Standard Deviation 5.043 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin | Urate, Day 9 | 257.0 Micromoles per liter | Standard Deviation 59.67 |
Primary
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Triglycerides, Baseline (Day -2) | 1.295 Millimoles per liter | Standard Deviation 0.8839 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Glucose, Day 3 | 4.495 Millimoles per liter | Standard Deviation 0.2333 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Glucose, Day 7 | 4.465 Millimoles per liter | Standard Deviation 0.1202 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Glucose, Day 9 | 4.635 Millimoles per liter | Standard Deviation 0.5162 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Cholesterol, Baseline (Day-2) | 5.025 Millimoles per liter | Standard Deviation 0.6576 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Cholesterol, Day 3 | 5.390 Millimoles per liter | Standard Deviation 1.1738 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Cholesterol, Day 7 | 5.180 Millimoles per liter | Standard Deviation 1.1031 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Cholesterol, Day 9 | 5.000 Millimoles per liter | Standard Deviation 0.9192 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Magnesium, Baseline (Day -2) | 0.760 Millimoles per liter | Standard Deviation 0.0283 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Magnesium, Day 3 | 0.800 Millimoles per liter | Standard Deviation 0.0849 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Magnesium, Day 7 | 0.800 Millimoles per liter | Standard Deviation 0.0283 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Magnesium, Day 9 | 0.800 Millimoles per liter | Standard Deviation 0.0283 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Glucose, Baseline (Day -2) | 5.050 Millimoles per liter | Standard Deviation 0.396 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Triglycerides, Day 3 | 1.205 Millimoles per liter | Standard Deviation 0.1909 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Triglycerides, Day 7 | 1.005 Millimoles per liter | Standard Deviation 0.2192 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Triglycerides, Day 9 | 0.965 Millimoles per liter | Standard Deviation 0.1626 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Anion gap, Baseline (Day-2) | 12.5 Millimoles per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Anion gap, Day 3 | 11.5 Millimoles per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Anion gap, Day 7 | 10.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Anion gap, Day 9 | 11.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Calcium, Baseline (Day -2) | 2.440 Millimoles per liter | Standard Deviation 0.0566 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Calcium, Day 3 | 2.430 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Calcium, Day 7 | 2.440 Millimoles per liter | Standard Deviation 0.0566 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Calcium, Day 9 | 2.390 Millimoles per liter | Standard Deviation 0.0566 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Carbon dioxide, Baseline (Day -2) | 29.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Carbon dioxide, Day 3 | 30.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Carbon dioxide, Day 7 | 30.5 Millimoles per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Carbon dioxide, Day 9 | 30.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Chloride, Baseline (Day -2) | 101.0 Millimoles per liter | Standard Deviation 2.83 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Chloride, Day 3 | 100.5 Millimoles per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Chloride, Day 7 | 101.5 Millimoles per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Chloride, Day 9 | 102.5 Millimoles per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Phosphate, Baseline (Day -2) | 1.195 Millimoles per liter | Standard Deviation 0.0919 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Phosphate, Day 3 | 1.210 Millimoles per liter | Standard Deviation 0.0707 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Phosphate, Day 7 | 1.195 Millimoles per liter | Standard Deviation 0.0495 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Phosphate, Day 9 | 1.130 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Potassium, Baseline (Day -2) | 4.05 Millimoles per liter | Standard Deviation 0.071 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Potassium, Day 3 | 4.00 Millimoles per liter | Standard Deviation 0.141 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Potassium, Day 7 | 4.35 Millimoles per liter | Standard Deviation 0.071 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Potassium, Day 9 | 4.05 Millimoles per liter | Standard Deviation 0.071 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Sodium, Baseline (Day -2) | 138.5 Millimoles per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Sodium, Day 3 | 138.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Sodium, Day 7 | 138.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Sodium, Day 9 | 139.5 Millimoles per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Blood Urea Nitrogen, Baseline (Day -2) | 4.300 Millimoles per liter | Standard Deviation 1.4425 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Blood Urea Nitrogen, Day 3 | 4.625 Millimoles per liter | Standard Deviation 1.2374 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Blood Urea Nitrogen, Day 7 | 5.230 Millimoles per liter | Standard Deviation 0.7778 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Blood Urea Nitrogen, Day 9 | 4.715 Millimoles per liter | Standard Deviation 0.4031 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Blood Urea Nitrogen, Day 7 | 4.690 Millimoles per liter | Standard Deviation 0.6622 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Glucose, Baseline (Day -2) | 4.682 Millimoles per liter | Standard Deviation 0.3788 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Carbon dioxide, Baseline (Day -2) | 28.7 Millimoles per liter | Standard Deviation 1.75 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Glucose, Day 3 | 4.745 Millimoles per liter | Standard Deviation 0.3566 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Potassium, Baseline (Day -2) | 4.10 Millimoles per liter | Standard Deviation 0.41 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Glucose, Day 7 | 4.728 Millimoles per liter | Standard Deviation 0.3251 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Carbon dioxide, Day 3 | 28.7 Millimoles per liter | Standard Deviation 2.16 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Glucose, Day 9 | 4.605 Millimoles per liter | Standard Deviation 0.266 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Sodium, Day 7 | 137.7 Millimoles per liter | Standard Deviation 1.51 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Cholesterol, Baseline (Day-2) | 4.112 Millimoles per liter | Standard Deviation 0.6916 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Carbon dioxide, Day 7 | 29.2 Millimoles per liter | Standard Deviation 1.6 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Cholesterol, Day 3 | 4.370 Millimoles per liter | Standard Deviation 0.5531 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Potassium, Day 3 | 4.28 Millimoles per liter | Standard Deviation 0.232 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Cholesterol, Day 7 | 4.413 Millimoles per liter | Standard Deviation 0.7692 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Carbon dioxide, Day 9 | 29.3 Millimoles per liter | Standard Deviation 2.25 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Cholesterol, Day 9 | 4.205 Millimoles per liter | Standard Deviation 0.8352 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Blood Urea Nitrogen, Day 3 | 4.648 Millimoles per liter | Standard Deviation 0.6614 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Magnesium, Baseline (Day -2) | 0.767 Millimoles per liter | Standard Deviation 0.0413 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Chloride, Baseline (Day -2) | 103.7 Millimoles per liter | Standard Deviation 1.63 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Magnesium, Day 3 | 0.787 Millimoles per liter | Standard Deviation 0.0301 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Potassium, Day 7 | 4.22 Millimoles per liter | Standard Deviation 0.133 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Magnesium, Day 7 | 0.787 Millimoles per liter | Standard Deviation 0.0393 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Chloride, Day 3 | 102.7 Millimoles per liter | Standard Deviation 1.75 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Magnesium, Day 9 | 0.813 Millimoles per liter | Standard Deviation 0.0301 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Sodium, Day 9 | 139.0 Millimoles per liter | Standard Deviation 0.89 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Triglycerides, Baseline (Day -2) | 0.763 Millimoles per liter | Standard Deviation 0.2595 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Chloride, Day 7 | 102.2 Millimoles per liter | Standard Deviation 1.6 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Triglycerides, Day 3 | 0.857 Millimoles per liter | Standard Deviation 0.2474 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Potassium, Day 9 | 4.20 Millimoles per liter | Standard Deviation 0.228 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Triglycerides, Day 7 | 0.658 Millimoles per liter | Standard Deviation 0.2024 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Chloride, Day 9 | 103.2 Millimoles per liter | Standard Deviation 1.17 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Triglycerides, Day 9 | 0.615 Millimoles per liter | Standard Deviation 0.1946 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Blood Urea Nitrogen, Day 9 | 4.332 Millimoles per liter | Standard Deviation 0.7889 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Anion gap, Baseline (Day-2) | 10.3 Millimoles per liter | Standard Deviation 1.51 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Phosphate, Baseline (Day -2) | 1.142 Millimoles per liter | Standard Deviation 0.1443 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Anion gap, Day 3 | 9.5 Millimoles per liter | Standard Deviation 1.52 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Sodium, Baseline (Day -2) | 138.5 Millimoles per liter | Standard Deviation 1.64 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Anion gap, Day 7 | 10.3 Millimoles per liter | Standard Deviation 1.03 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Phosphate, Day 3 | 1.238 Millimoles per liter | Standard Deviation 0.0519 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Anion gap, Day 9 | 10.7 Millimoles per liter | Standard Deviation 1.75 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Blood Urea Nitrogen, Baseline (Day -2) | 4.482 Millimoles per liter | Standard Deviation 1.2674 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Calcium, Baseline (Day -2) | 2.332 Millimoles per liter | Standard Deviation 0.0659 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Phosphate, Day 7 | 1.223 Millimoles per liter | Standard Deviation 0.1203 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Calcium, Day 3 | 2.370 Millimoles per liter | Standard Deviation 0.093 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Sodium, Day 3 | 136.5 Millimoles per liter | Standard Deviation 1.05 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Calcium, Day 7 | 2.408 Millimoles per liter | Standard Deviation 0.1114 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Phosphate, Day 9 | 1.212 Millimoles per liter | Standard Deviation 0.1983 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen | Calcium, Day 9 | 2.337 Millimoles per liter | Standard Deviation 0.0843 |
Primary
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. .
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 7 | 0.525 10^9 cells per liter | Standard Deviation 0.0919 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Baseline (Day -2) | 0.375 10^9 cells per liter | Standard Deviation 0.0071 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 9 | 0.490 10^9 cells per liter | Standard Deviation 0.198 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Baseline (Day -2) | 2.520 10^9 cells per liter | Standard Deviation 0.2828 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Baseline (Day -2) | 4.010 10^9 cells per liter | Standard Deviation 3.3375 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 3 | 0.065 10^9 cells per liter | Standard Deviation 0.0212 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 3 | 4.300 10^9 cells per liter | Standard Deviation 3.8608 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 3 | 2.715 10^9 cells per liter | Standard Deviation 0.502 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 7 | 4.205 10^9 cells per liter | Standard Deviation 3.6557 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 3 | 0.350 10^9 cells per liter | Standard Deviation 0.1838 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 9 | 5.215 10^9 cells per liter | Standard Deviation 5.1831 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 7 | 2.515 10^9 cells per liter | Standard Deviation 0.1202 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Baseline (Day -2) | 228.0 10^9 cells per liter | Standard Deviation 50.91 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 9 | 0.060 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 3 | 233.0 10^9 cells per liter | Standard Deviation 59.4 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 9 | 2.100 10^9 cells per liter | Standard Deviation 0.099 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 7 | 243.5 10^9 cells per liter | Standard Deviation 68.59 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 7 | 0.345 10^9 cells per liter | Standard Deviation 0.2758 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 9 | 239.0 10^9 cells per liter | Standard Deviation 82.02 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Baseline (Day -2) | 0.550 10^9 cells per liter | Standard Deviation 0.1414 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Baseline (Day -2) | 7.35 10^9 cells per liter | Standard Deviation 3.606 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 7 | 0.065 10^9 cells per liter | Standard Deviation 0.0212 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 3 | 8.00 10^9 cells per liter | Standard Deviation 4.384 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 3 | 0.570 10^9 cells per liter | Standard Deviation 0.198 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 7 | 7.65 10^9 cells per liter | Standard Deviation 3.606 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 9 | 0.330 10^9 cells per liter | Standard Deviation 0.2546 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 9 | 8.15 10^9 cells per liter | Standard Deviation 5.02 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Baseline (Day -2) | 0.070 10^9 cells per liter | Standard Deviation 0.0424 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 9 | 5.75 10^9 cells per liter | Standard Deviation 1.738 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Baseline (Day -2) | 0.057 10^9 cells per liter | Standard Deviation 0.0163 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 3 | 0.053 10^9 cells per liter | Standard Deviation 0.0186 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 7 | 0.048 10^9 cells per liter | Standard Deviation 0.016 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 9 | 0.065 10^9 cells per liter | Standard Deviation 0.0176 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Baseline (Day -2) | 0.137 10^9 cells per liter | Standard Deviation 0.1166 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 3 | 0.115 10^9 cells per liter | Standard Deviation 0.0794 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 7 | 0.102 10^9 cells per liter | Standard Deviation 0.0804 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 9 | 0.097 10^9 cells per liter | Standard Deviation 0.0833 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Baseline (Day -2) | 1.822 10^9 cells per liter | Standard Deviation 0.6201 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 3 | 1.657 10^9 cells per liter | Standard Deviation 0.5352 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 7 | 1.668 10^9 cells per liter | Standard Deviation 0.578 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 9 | 1.935 10^9 cells per liter | Standard Deviation 0.7973 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Baseline (Day -2) | 0.537 10^9 cells per liter | Standard Deviation 0.1878 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 3 | 0.462 10^9 cells per liter | Standard Deviation 0.1253 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 7 | 0.490 10^9 cells per liter | Standard Deviation 0.1685 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 9 | 0.508 10^9 cells per liter | Standard Deviation 0.1411 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Baseline (Day -2) | 3.910 10^9 cells per liter | Standard Deviation 0.4029 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 3 | 3.015 10^9 cells per liter | Standard Deviation 1.0263 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 7 | 3.278 10^9 cells per liter | Standard Deviation 0.8286 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 9 | 3.168 10^9 cells per liter | Standard Deviation 0.8168 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Baseline (Day -2) | 266.5 10^9 cells per liter | Standard Deviation 83.32 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 3 | 264.2 10^9 cells per liter | Standard Deviation 75.68 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 7 | 280.0 10^9 cells per liter | Standard Deviation 72.09 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 9 | 269.8 10^9 cells per liter | Standard Deviation 74.88 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Baseline (Day -2) | 6.47 10^9 cells per liter | Standard Deviation 1.025 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 3 | 5.30 10^9 cells per liter | Standard Deviation 1.499 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 7 | 5.58 10^9 cells per liter | Standard Deviation 1.466 |
Primary
Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time points to analyze erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -2) | 4.740 10^12 cells per liter | Standard Deviation 0.0849 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 3 | 5.010 10^12 cells per liter | Standard Deviation 0.3253 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 9 | 5.065 10^12 cells per liter | Standard Deviation 0.2475 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 7 | 5.060 10^12 cells per liter | Standard Deviation 0.3677 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 9 | 4.852 10^12 cells per liter | Standard Deviation 0.2556 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -2) | 4.647 10^12 cells per liter | Standard Deviation 0.3336 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 3 | 4.820 10^12 cells per liter | Standard Deviation 0.2626 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Day 7 | 4.915 10^12 cells per liter | Standard Deviation 0.3246 |
Primary
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day-2) | 30.35 Picograms | Standard Deviation 2.475 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 3 | 29.85 Picograms | Standard Deviation 2.616 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 30.00 Picograms | Standard Deviation 2.546 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | 30.00 Picograms | Standard Deviation 2.828 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | 28.33 Picograms | Standard Deviation 2.087 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day-2) | 28.35 Picograms | Standard Deviation 2.299 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 28.50 Picograms | Standard Deviation 2.269 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 3 | 28.43 Picograms | Standard Deviation 2.417 |
Primary
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -2) | 87.70 Femtoliter | Standard Deviation 7.92 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | 87.30 Femtoliter | Standard Deviation 7.637 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 3 | 87.30 Femtoliter | Standard Deviation 7.071 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | 88.20 Femtoliter | Standard Deviation 7.495 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 3 | 83.95 Femtoliter | Standard Deviation 5.315 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -2) | 84.42 Femtoliter | Standard Deviation 5.398 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | 83.67 Femtoliter | Standard Deviation 4.815 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | 84.05 Femtoliter | Standard Deviation 4.98 |
Primary
Part 1: Absolute Values for Hematology Parameter: Hematocrit
Blood samples were collected at indicated time points to analyze hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day -2) | 0.4155 Proportion of red blood cells in blood | Standard Deviation 0.03041 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Day 3 | 0.4365 Proportion of red blood cells in blood | Standard Deviation 0.00636 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Day 7 | 0.4405 Proportion of red blood cells in blood | Standard Deviation 0.00636 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Day 9 | 0.4465 Proportion of red blood cells in blood | Standard Deviation 0.01626 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Day 9 | 0.4062 Proportion of red blood cells in blood | Standard Deviation 0.03896 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day -2) | 0.3920 Proportion of red blood cells in blood | Standard Deviation 0.03663 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Day 7 | 0.4140 Proportion of red blood cells in blood | Standard Deviation 0.04358 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Day 3 | 0.4048 Proportion of red blood cells in blood | Standard Deviation 0.03596 |
Primary
Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -2) | 143.5 Grams per liter | Standard Deviation 9.19 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 3 | 149.5 Grams per liter | Standard Deviation 3.54 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 7 | 151.5 Grams per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 9 | 152.0 Grams per liter | Standard Deviation 7.07 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 9 | 137.7 Grams per liter | Standard Deviation 15.82 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -2) | 131.8 Grams per liter | Standard Deviation 15.65 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 7 | 140.5 Grams per liter | Standard Deviation 18.51 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Day 3 | 137.3 Grams per liter | Standard Deviation 15.81 |
Primary
Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH)
Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH) | Baseline (Day -2) | 6.50 pH | Standard Deviation 0.707 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH) | Day 3 | 6.50 pH | Standard Deviation 0.707 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH) | Day 7 | 6.25 pH | Standard Deviation 0.354 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH) | Day 9 | 6.50 pH | Standard Deviation 0.707 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH) | Day 9 | 6.25 pH | Standard Deviation 0.418 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH) | Baseline (Day -2) | 7.08 pH | Standard Deviation 0.585 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH) | Day 7 | 6.25 pH | Standard Deviation 0.524 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH) | Day 3 | 6.33 pH | Standard Deviation 0.606 |
Primary
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 7 | 1.0190 Ratio | Standard Deviation 0.00283 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -2) | 1.0080 Ratio | Standard Deviation 0.00707 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 9 | 1.0145 Ratio | Standard Deviation 0.00212 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 3 | 1.0150 Ratio | Standard Deviation 0.00141 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 9 | 1.0097 Ratio | Standard Deviation 0.00557 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -2) | 1.0092 Ratio | Standard Deviation 0.00574 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 7 | 1.0167 Ratio | Standard Deviation 0.0045 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 3 | 1.0125 Ratio | Standard Deviation 0.00565 |
Primary
Part 1: Absolute Values for Vital Parameter: Pulse Rate
Pulse rate was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 2 | 63.0 Beats per minute (bpm) | Standard Deviation 7.07 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 6 | 66.5 Beats per minute (bpm) | Standard Deviation 3.54 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 4 | 71.0 Beats per minute (bpm) | Standard Deviation 5.66 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 7 | 70.0 Beats per minute (bpm) | Standard Deviation 7.07 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 3 | 70.5 Beats per minute (bpm) | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 8 | 70.0 Beats per minute (bpm) | Standard Deviation 8.49 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 5 | 67.0 Beats per minute (bpm) | Standard Deviation 14.14 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 9 | 73.0 Beats per minute (bpm) | Standard Deviation 2.83 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Baseline (Pre-dose, Day 1 ) | 70.5 Beats per minute (bpm) | Standard Deviation 7.78 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 9 | 67.8 Beats per minute (bpm) | Standard Deviation 9.02 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Baseline (Pre-dose, Day 1 ) | 67.8 Beats per minute (bpm) | Standard Deviation 13.44 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 2 | 68.7 Beats per minute (bpm) | Standard Deviation 10.6 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 3 | 65.0 Beats per minute (bpm) | Standard Deviation 10.24 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 4 | 68.8 Beats per minute (bpm) | Standard Deviation 12.29 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 5 | 72.5 Beats per minute (bpm) | Standard Deviation 12.32 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 6 | 67.2 Beats per minute (bpm) | Standard Deviation 8.57 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 7 | 70.5 Beats per minute (bpm) | Standard Deviation 7.5 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Pulse Rate | Day 8 | 81.3 Beats per minute (bpm) | Standard Deviation 9.63 |
Primary
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Baseline (Pre-dose, Day 1) | 120.0 Millimeters (mm) of mercury | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2 | 115.5 Millimeters (mm) of mercury | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 3 | 123.0 Millimeters (mm) of mercury | Standard Deviation 2.83 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 4 | 121.5 Millimeters (mm) of mercury | Standard Deviation 17.68 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 5 | 111.5 Millimeters (mm) of mercury | Standard Deviation 9.19 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 6 | 114.0 Millimeters (mm) of mercury | Standard Deviation 15.56 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 7 | 117.5 Millimeters (mm) of mercury | Standard Deviation 4.95 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 8 | 125.0 Millimeters (mm) of mercury | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 9 | 127.0 Millimeters (mm) of mercury | Standard Deviation 5.66 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Baseline (Pre-dose, Day 1) | 74.0 Millimeters (mm) of mercury | Standard Deviation 4.24 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2 | 70.5 Millimeters (mm) of mercury | Standard Deviation 4.95 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 3 | 76.0 Millimeters (mm) of mercury | Standard Deviation 5.66 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 4 | 66.0 Millimeters (mm) of mercury | Standard Deviation 14.14 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 5 | 69.5 Millimeters (mm) of mercury | Standard Deviation 21.92 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 6 | 65.5 Millimeters (mm) of mercury | Standard Deviation 12.02 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 7 | 72.0 Millimeters (mm) of mercury | Standard Deviation 11.31 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 8 | 67.0 Millimeters (mm) of mercury | Standard Deviation 8.49 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 9 | 69.5 Millimeters (mm) of mercury | Standard Deviation 9.19 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 5 | 62.3 Millimeters (mm) of mercury | Standard Deviation 5.57 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Baseline (Pre-dose, Day 1) | 109.2 Millimeters (mm) of mercury | Standard Deviation 12.22 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Baseline (Pre-dose, Day 1) | 61.5 Millimeters (mm) of mercury | Standard Deviation 8.22 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2 | 103.8 Millimeters (mm) of mercury | Standard Deviation 10.42 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 9 | 64.7 Millimeters (mm) of mercury | Standard Deviation 7.5 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 3 | 106.8 Millimeters (mm) of mercury | Standard Deviation 9.87 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2 | 59.8 Millimeters (mm) of mercury | Standard Deviation 5.74 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 4 | 107.5 Millimeters (mm) of mercury | Standard Deviation 13.74 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 6 | 61.2 Millimeters (mm) of mercury | Standard Deviation 4.49 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 5 | 105.3 Millimeters (mm) of mercury | Standard Deviation 5.2 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 3 | 59.7 Millimeters (mm) of mercury | Standard Deviation 3.14 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 6 | 107.0 Millimeters (mm) of mercury | Standard Deviation 6.57 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 8 | 64.5 Millimeters (mm) of mercury | Standard Deviation 9.65 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 7 | 107.7 Millimeters (mm) of mercury | Standard Deviation 10.07 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 4 | 64.0 Millimeters (mm) of mercury | Standard Deviation 9.9 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 8 | 109.0 Millimeters (mm) of mercury | Standard Deviation 6.48 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 7 | 63.7 Millimeters (mm) of mercury | Standard Deviation 5.79 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 9 | 109.8 Millimeters (mm) of mercury | Standard Deviation 7.81 |
Primary
Part 1: Absolute Values for Vital Parameter: Temperature
Temperature was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions.Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 2 | 36.10 Degrees Celsius | Standard Deviation 0.424 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 6 | 36.45 Degrees Celsius | Standard Deviation 0.354 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Baseline (Pre-dose, Day 1) | 35.90 Degrees Celsius | Standard Deviation 0.424 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 7 | 35.95 Degrees Celsius | Standard Deviation 0.495 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 3 | 36.10 Degrees Celsius | Standard Deviation 0.283 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 8 | 36.35 Degrees Celsius | Standard Deviation 0.071 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 4 | 36.15 Degrees Celsius | Standard Deviation 0.354 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 9 | 36.35 Degrees Celsius | Standard Deviation 0.212 |
| Part 1: GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 5 | 36.35 Degrees Celsius | Standard Deviation 0.354 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 9 | 36.47 Degrees Celsius | Standard Deviation 0.234 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Baseline (Pre-dose, Day 1) | 36.50 Degrees Celsius | Standard Deviation 0.341 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 2 | 36.53 Degrees Celsius | Standard Deviation 0.225 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 4 | 36.52 Degrees Celsius | Standard Deviation 0.479 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 5 | 36.58 Degrees Celsius | Standard Deviation 0.36 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 6 | 36.47 Degrees Celsius | Standard Deviation 0.25 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 7 | 36.47 Degrees Celsius | Standard Deviation 0.383 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 8 | 36.63 Degrees Celsius | Standard Deviation 0.28 |
| Part 1 : GSK3640254 500 mg | Part 1: Absolute Values for Vital Parameter: Temperature | Day 3 | 36.58 Degrees Celsius | Standard Deviation 0.264 |
Primary
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) of GSK3640254
Blood samples were collected at indicated time points. Pharmacokinetic (PK) analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7
Population: Pharmacokinetic Parameter Population comprised of all participants who undergone plasma PK sampling and had evaluable PK parameters estimated. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) of GSK3640254 | 102400 Hours*nanograms per milliliter | Geometric Coefficient of Variation 25.3 |
Primary
Part 1: AUC From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: AUC From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254 | 68790 Hours*nanograms per milliliter | Geometric Coefficient of Variation 25.1 |
Primary
Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein
Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Day 7 | 1.0 Grams per liter | Standard Deviation 2.83 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Day 9 | -1.0 Grams per liter | Standard Deviation 2.83 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Day 3 | -0.5 Grams per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Total protein, Day 3 | -1.0 Grams per liter | Standard Deviation 5.66 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Day 9 | -1.0 Grams per liter | Standard Deviation 2.83 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Total protein, Day 7 | -0.5 Grams per liter | Standard Deviation 6.36 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Day 7 | -1.5 Grams per liter | Standard Deviation 3.54 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Total Bilirubin, Day 9 | -2.0 Grams per liter | Standard Deviation 5.66 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Day 3 | -0.5 Grams per liter | Standard Deviation 3.54 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Total Bilirubin, Day 9 | 2.2 Grams per liter | Standard Deviation 3.19 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Day 3 | -1.2 Grams per liter | Standard Deviation 0.75 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Day 7 | 1.3 Grams per liter | Standard Deviation 2.94 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Albumin, Day 9 | 0.2 Grams per liter | Standard Deviation 2.14 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Day 3 | 2.2 Grams per liter | Standard Deviation 3.49 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Day 7 | 2.3 Grams per liter | Standard Deviation 2.07 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Globulin, Day 9 | 2.0 Grams per liter | Standard Deviation 1.41 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Total protein, Day 3 | 1.0 Grams per liter | Standard Deviation 4.2 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein | Total protein, Day 7 | 3.7 Grams per liter | Standard Deviation 4.8 |
Primary
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 7 | 2.0 International units per liter | Standard Deviation 4.24 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 3 | 0.5 International units per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 9 | -4.5 International units per liter | Standard Deviation 4.95 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 7 | -1.0 International units per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 9 | 2.5 International units per liter | Standard Deviation 3.54 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 7 | 0.5 International units per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 3 | -28.5 International units per liter | Standard Deviation 26.16 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 3 | -0.5 International units per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 7 | -21.5 International units per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 3 | 3.5 International units per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 9 | -32.5 International units per liter | Standard Deviation 16.26 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 7 | -3.5 International units per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 3 | -11.5 International units per liter | Standard Deviation 10.61 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 3 | 4.5 International units per liter | Standard Deviation 4.95 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 7 | -19.5 International units per liter | Standard Deviation 13.44 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 9 | -7.0 International units per liter | Standard Deviation 4.24 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 9 | -28.5 International units per liter | Standard Deviation 12.02 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 9 | -1.5 International units per liter | Standard Deviation 0.71 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 9 | -17.5 International units per liter | Standard Deviation 19.41 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 3 | -2.8 International units per liter | Standard Deviation 3.71 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 7 | -2.0 International units per liter | Standard Deviation 9.7 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 9 | -1.5 International units per liter | Standard Deviation 12.77 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 3 | -4.3 International units per liter | Standard Deviation 12.14 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 7 | 0.5 International units per liter | Standard Deviation 12.53 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 9 | 0.2 International units per liter | Standard Deviation 10.8 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 3 | -2.3 International units per liter | Standard Deviation 5.5 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 7 | -1.8 International units per liter | Standard Deviation 7.91 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 9 | -2.3 International units per liter | Standard Deviation 8.8 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 3 | -0.2 International units per liter | Standard Deviation 1.17 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 7 | 1.0 International units per liter | Standard Deviation 0.89 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 9 | 1.0 International units per liter | Standard Deviation 0.89 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 3 | -69.5 International units per liter | Standard Deviation 104.08 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 7 | -89.2 International units per liter | Standard Deviation 121.9 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 9 | -85.2 International units per liter | Standard Deviation 127.35 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 3 | -18.7 International units per liter | Standard Deviation 9.27 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 7 | -16.2 International units per liter | Standard Deviation 9.99 |
Primary
Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase
Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Amylase, Day 3 | -0.5 Units per liter | Standard Deviation 7.78 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Amylase, Day 7 | 2.5 Units per liter | Standard Deviation 19.09 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Amylase, Day 9 | 0.0 Units per liter | Standard Deviation 15.56 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Lipase, Day 3 | -15.0 Units per liter | Standard Deviation 18.38 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Lipase, Day 7 | -14.0 Units per liter | Standard Deviation 16.97 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Lipase, Day 9 | -15.0 Units per liter | Standard Deviation 16.97 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Lipase, Day 7 | -3.2 Units per liter | Standard Deviation 7.73 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Amylase, Day 3 | -2.0 Units per liter | Standard Deviation 8.72 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Lipase, Day 3 | -5.3 Units per liter | Standard Deviation 8.12 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Amylase, Day 7 | -1.0 Units per liter | Standard Deviation 3.95 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Lipase, Day 9 | -6.2 Units per liter | Standard Deviation 4.31 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase | Amylase, Day 9 | -4.3 Units per liter | Standard Deviation 5.57 |
Primary
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 3 | -6.65 Micromoles per liter | Standard Deviation 3.182 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 7 | -3.15 Micromoles per liter | Standard Deviation 1.909 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 9 | -4.45 Micromoles per liter | Standard Deviation 6.293 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 3 | -12.0 Micromoles per liter | Standard Deviation 50.91 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 7 | 2.5 Micromoles per liter | Standard Deviation 54.45 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 9 | -15.0 Micromoles per liter | Standard Deviation 55.15 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 3 | 2.95 Micromoles per liter | Standard Deviation 1.909 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 7 | 3.15 Micromoles per liter | Standard Deviation 1.485 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 9 | 2.20 Micromoles per liter | Standard Deviation 0.141 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 3 | 0.50 Micromoles per liter | Standard Deviation 0.283 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 7 | 0.65 Micromoles per liter | Standard Deviation 0.212 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 9 | 0.60 Micromoles per liter | Standard Deviation 0.141 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 7 | 0.68 Micromoles per liter | Standard Deviation 0.534 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 3 | -2.65 Micromoles per liter | Standard Deviation 12.451 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 3 | 2.63 Micromoles per liter | Standard Deviation 2.534 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 7 | -4.72 Micromoles per liter | Standard Deviation 10.794 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 3 | 0.27 Micromoles per liter | Standard Deviation 0.535 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 9 | -3.85 Micromoles per liter | Standard Deviation 10.095 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 7 | 4.33 Micromoles per liter | Standard Deviation 2.653 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 3 | -15.5 Micromoles per liter | Standard Deviation 33.59 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 9 | 0.63 Micromoles per liter | Standard Deviation 0.398 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 7 | -28.5 Micromoles per liter | Standard Deviation 32.72 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 9 | 3.20 Micromoles per liter | Standard Deviation 2.225 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 9 | -17.5 Micromoles per liter | Standard Deviation 23.86 |
Primary
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 3 | 1.0 Millimoles per liter | Standard Deviation 2.83 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 9 | -0.025 Millimoles per liter | Standard Deviation 0.2616 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 7 | 1.5 Millimoles per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 7 | -0.290 Millimoles per liter | Standard Deviation 0.6647 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 9 | 1.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 3 | 0.365 Millimoles per liter | Standard Deviation 0.5162 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 3 | -0.5 Millimoles per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 9 | -0.330 Millimoles per liter | Standard Deviation 0.7212 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 7 | 0.5 Millimoles per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 3 | 0.040 Millimoles per liter | Standard Deviation 0.0566 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 9 | 1.5 Millimoles per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 3 | -1.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 3 | 0.015 Millimoles per liter | Standard Deviation 0.1626 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 9 | -0.415 Millimoles per liter | Standard Deviation 0.9122 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 7 | 0.000 Millimoles per liter | Standard Deviation 0.1414 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 7 | -2.5 Millimoles per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 9 | -0.065 Millimoles per liter | Standard Deviation 0.0919 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 7 | 0.040 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 3 | -0.05 Millimoles per liter | Standard Deviation 0.071 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 9 | -1.5 Millimoles per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 7 | 0.30 Millimoles per liter | Standard Deviation 0.141 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 7 | 0.155 Millimoles per liter | Standard Deviation 0.4455 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 9 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 3 | -0.010 Millimoles per liter | Standard Deviation 0.0566 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 3 | -0.5 Millimoles per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 9 | 0.040 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 7 | -0.5 Millimoles per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 7 | 0.000 Millimoles per liter | Standard Deviation 0.1131 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 9 | 1.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 7 | -0.585 Millimoles per liter | Standard Deviation 0.5162 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 3 | 0.325 Millimoles per liter | Standard Deviation 0.2051 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 9 | -0.050 Millimoles per liter | Standard Deviation 0.1131 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 7 | 0.930 Millimoles per liter | Standard Deviation 0.6647 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 3 | -0.090 Millimoles per liter | Standard Deviation 0.693 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 9 | 0.415 Millimoles per liter | Standard Deviation 1.0394 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 3 | -0.555 Millimoles per liter | Standard Deviation 0.6293 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 9 | -0.150 Millimoles per liter | Standard Deviation 1.251 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 3 | 0.063 Millimoles per liter | Standard Deviation 0.3773 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 7 | 0.047 Millimoles per liter | Standard Deviation 0.2914 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 9 | -0.077 Millimoles per liter | Standard Deviation 0.3626 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 3 | 0.258 Millimoles per liter | Standard Deviation 0.357 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 7 | 0.302 Millimoles per liter | Standard Deviation 0.2662 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 9 | 0.093 Millimoles per liter | Standard Deviation 0.2144 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 3 | 0.020 Millimoles per liter | Standard Deviation 0.0335 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 7 | 0.020 Millimoles per liter | Standard Deviation 0.0551 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 9 | 0.047 Millimoles per liter | Standard Deviation 0.0468 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 3 | 0.093 Millimoles per liter | Standard Deviation 0.2432 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 7 | -0.105 Millimoles per liter | Standard Deviation 0.2076 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 9 | -0.148 Millimoles per liter | Standard Deviation 0.2494 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 3 | -0.8 Millimoles per liter | Standard Deviation 1.6 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 7 | 0.0 Millimoles per liter | Standard Deviation 1.9 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 9 | 0.3 Millimoles per liter | Standard Deviation 2.5 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 3 | 0.038 Millimoles per liter | Standard Deviation 0.0527 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 7 | 0.077 Millimoles per liter | Standard Deviation 0.0712 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 9 | 0.005 Millimoles per liter | Standard Deviation 0.0558 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 3 | 0.0 Millimoles per liter | Standard Deviation 2 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 7 | 0.5 Millimoles per liter | Standard Deviation 0.84 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 9 | 0.7 Millimoles per liter | Standard Deviation 1.86 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 3 | -1.0 Millimoles per liter | Standard Deviation 1.55 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 7 | -1.5 Millimoles per liter | Standard Deviation 1.97 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 9 | -0.5 Millimoles per liter | Standard Deviation 1.64 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 3 | 0.097 Millimoles per liter | Standard Deviation 0.1136 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 7 | 0.082 Millimoles per liter | Standard Deviation 0.1625 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 9 | 0.070 Millimoles per liter | Standard Deviation 0.1898 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 3 | 0.18 Millimoles per liter | Standard Deviation 0.366 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 7 | 0.12 Millimoles per liter | Standard Deviation 0.331 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 9 | 0.10 Millimoles per liter | Standard Deviation 0.363 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 3 | -2.0 Millimoles per liter | Standard Deviation 1.9 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 7 | -0.8 Millimoles per liter | Standard Deviation 2.04 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 9 | 0.5 Millimoles per liter | Standard Deviation 1.87 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 3 | 0.167 Millimoles per liter | Standard Deviation 1.4356 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 7 | 0.208 Millimoles per liter | Standard Deviation 1.5113 |
Primary
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 3 | -0.005 10^9 cells per liter | Standard Deviation 0.0212 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 7 | -0.005 10^9 cells per liter | Standard Deviation 0.0212 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 9 | -0.010 10^9 cells per liter | Standard Deviation 0.0424 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 3 | -0.025 10^9 cells per liter | Standard Deviation 0.1909 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 7 | -0.030 10^9 cells per liter | Standard Deviation 0.2828 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 9 | -0.045 10^9 cells per liter | Standard Deviation 0.2616 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 3 | 0.195 10^9 cells per liter | Standard Deviation 0.2192 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 7 | -0.005 10^9 cells per liter | Standard Deviation 0.1626 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 9 | -0.420 10^9 cells per liter | Standard Deviation 0.3818 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 3 | 0.020 10^9 cells per liter | Standard Deviation 0.0566 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 7 | -0.025 10^9 cells per liter | Standard Deviation 0.0495 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 9 | -0.060 10^9 cells per liter | Standard Deviation 0.0566 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 3 | 0.290 10^9 cells per liter | Standard Deviation 0.5233 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 7 | 0.195 10^9 cells per liter | Standard Deviation 0.3182 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 9 | 1.205 10^9 cells per liter | Standard Deviation 1.8455 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 3 | 5.0 10^9 cells per liter | Standard Deviation 8.49 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 7 | 15.5 10^9 cells per liter | Standard Deviation 17.68 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 9 | 11.0 10^9 cells per liter | Standard Deviation 31.11 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 3 | 0.65 10^9 cells per liter | Standard Deviation 0.778 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 7 | 0.30 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 9 | 0.80 10^9 cells per liter | Standard Deviation 1.414 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 7 | -0.047 10^9 cells per liter | Standard Deviation 0.1111 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 3 | -0.003 10^9 cells per liter | Standard Deviation 0.0137 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 3 | -1.17 10^9 cells per liter | Standard Deviation 0.942 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 7 | -0.008 10^9 cells per liter | Standard Deviation 0.016 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 9 | -0.028 10^9 cells per liter | Standard Deviation 0.0755 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils, Day 9 | 0.008 10^9 cells per liter | Standard Deviation 0.0098 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 7 | 13.5 10^9 cells per liter | Standard Deviation 29.49 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 3 | -0.022 10^9 cells per liter | Standard Deviation 0.0462 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 3 | -0.895 10^9 cells per liter | Standard Deviation 0.7988 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 7 | -0.035 10^9 cells per liter | Standard Deviation 0.0497 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 9 | -0.72 10^9 cells per liter | Standard Deviation 1.011 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils, Day 9 | -0.040 10^9 cells per liter | Standard Deviation 0.0559 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 7 | -0.632 10^9 cells per liter | Standard Deviation 0.5515 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 3 | -0.165 10^9 cells per liter | Standard Deviation 0.287 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 9 | 3.3 10^9 cells per liter | Standard Deviation 36.74 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 7 | -0.153 10^9 cells per liter | Standard Deviation 0.3222 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Day 9 | -0.742 10^9 cells per liter | Standard Deviation 0.8588 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes, Day 9 | 0.113 10^9 cells per liter | Standard Deviation 0.2908 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Day 7 | -0.88 10^9 cells per liter | Standard Deviation 0.818 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes, Day 3 | -0.075 10^9 cells per liter | Standard Deviation 0.0885 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 3 | -2.3 10^9 cells per liter | Standard Deviation 17.68 |
Primary
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time points to analyze the hematology parameter: Erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 3 | 0.270 10^12 cells per liter | Standard Deviation 0.2404 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 7 | 0.320 10^12 cells per liter | Standard Deviation 0.2828 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 9 | 0.325 10^12 cells per liter | Standard Deviation 0.1626 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 3 | 0.173 10^12 cells per liter | Standard Deviation 0.2062 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 7 | 0.268 10^12 cells per liter | Standard Deviation 0.2513 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Day 9 | 0.205 10^12 cells per liter | Standard Deviation 0.3761 |
Primary
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected at idicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 3 | -0.50 Picograms | Standard Deviation 0.141 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | -0.35 Picograms | Standard Deviation 0.071 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | -0.35 Picograms | Standard Deviation 0.354 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 3 | 0.08 Picograms | Standard Deviation 0.343 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7 | 0.15 Picograms | Standard Deviation 0.501 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | -0.02 Picograms | Standard Deviation 0.412 |
Primary
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 3 | -0.40 Femtoliter | Standard Deviation 0.849 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | -0.40 Femtoliter | Standard Deviation 0.283 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | 0.50 Femtoliter | Standard Deviation 0.424 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 3 | -0.47 Femtoliter | Standard Deviation 0.403 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7 | -0.37 Femtoliter | Standard Deviation 0.709 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | -0.75 Femtoliter | Standard Deviation 0.802 |
Primary
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected at indicated timepoints to analyze hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 3 | 0.0210 Proportion of red blood cells in blood | Standard Deviation 0.02404 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 7 | 0.0250 Proportion of red blood cells in blood | Standard Deviation 0.02404 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 9 | 0.0310 Proportion of red blood cells in blood | Standard Deviation 0.01414 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 3 | 0.0128 Proportion of red blood cells in blood | Standard Deviation 0.01779 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 7 | 0.0220 Proportion of red blood cells in blood | Standard Deviation 0.02194 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Day 9 | 0.0142 Proportion of red blood cells in blood | Standard Deviation 0.0333 |
Primary
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 3 | 6.0 Grams per liter | Standard Deviation 5.66 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 7 | 8.0 Grams per liter | Standard Deviation 7.07 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 9 | 8.5 Grams per liter | Standard Deviation 2.12 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 3 | 5.5 Grams per liter | Standard Deviation 6.95 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 7 | 8.7 Grams per liter | Standard Deviation 8.29 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Day 9 | 5.8 Grams per liter | Standard Deviation 10.3 |
Primary
Part 1: Change From Baseline in Urinalysis Parameter: pH
Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Urinalysis Parameter: pH | Day 3 | 0.00 pH | Standard Deviation 1.414 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Urinalysis Parameter: pH | Day 7 | -0.25 pH | Standard Deviation 1.061 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Urinalysis Parameter: pH | Day 9 | 0.00 pH | Standard Deviation 1.414 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Urinalysis Parameter: pH | Day 7 | -0.83 pH | Standard Deviation 0.408 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Urinalysis Parameter: pH | Day 3 | -0.75 pH | Standard Deviation 0.612 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Urinalysis Parameter: pH | Day 9 | -0.83 pH | Standard Deviation 0.258 |
Primary
Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 3, Day 7, and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 3 | 0.0070 Ratio | Standard Deviation 0.00566 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 7 | 0.0110 Ratio | Standard Deviation 0.00424 |
| Part 1: GSK3640254 500 mg | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 9 | 0.0065 Ratio | Standard Deviation 0.00495 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 3 | 0.0033 Ratio | Standard Deviation 0.00653 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 7 | 0.0075 Ratio | Standard Deviation 0.00731 |
| Part 1 : GSK3640254 500 mg | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 9 | 0.0005 Ratio | Standard Deviation 0.00912 |
Primary
Part 1: Maximum Observed Concentration (Cmax) of GSK3640254
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Maximum Observed Concentration (Cmax) of GSK3640254 | 4439 Nanograms per milliliter | Geometric Coefficient of Variation 22.7 |
Primary
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
A 12-lead ECG was recorded with the participant in a supine position. 12-lead ECGs were obtained by using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal 12-Lead ECG findings has reported
Time frame: Baseline(Day-2), Day1: 2 Hours, 4 Hours, 6 Hours; Day 4: 2 Hours, 4 Hours, 6 Hours, Day 7: 2 Hours, 4 Hours, 6 Hours and Day 9
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 1: 6 hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 4: 6 hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 1: 4 hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 7: 2 hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 4: 2 hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 7: 4 hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 1: 2 hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 7: 6 hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 4: 4 hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 9 | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Baseline (Day -2) | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 9 | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Baseline (Day -2) | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 1: 2 hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 1: 4 hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 1: 6 hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 4: 2 hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 4: 4 hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 4: 6 hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 7: 2 hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 7: 4 hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Day 7: 6 hours | 0 Participants |
Primary
Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-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 defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.
Time frame: Up to Day 9
Population: Safety Population comprised of all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Non SAE | 2 Participants |
| Part 1: GSK3640254 500 mg | Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | SAE | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Non SAE | 1 Participants |
| Part 1 : GSK3640254 500 mg | Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs | SAE | 0 Participants |
Primary
Part 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254 | 2081 Nanograms per milliliter | Geometric Coefficient of Variation 32.4 |
Primary
Part 1: Plasma Concentration of GSK3640254
Blood samples were collected at indicated time points to analyze the plasma concentration of GSK3640254.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7
Population: Pharmacokinetic concentration Population comprised of all participants who undergone plasma PK sampling and had evaluable PK assay results. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | 3 Hours 30 minutes, Day 7 | 4155 Nanograms per milliliter | Standard Deviation 1042.5 |
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | Pre-dose, Day 7 | 2168 Nanograms per milliliter | Standard Deviation 668.17 |
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | 30 minutes, Day 7 | 2000 Nanograms per milliliter | Standard Deviation 638.53 |
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | 1 Hour, Day 7 | 2579 Nanograms per milliliter | Standard Deviation 972.02 |
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | 2 Hour, Day 7 | 3513 Nanograms per milliliter | Standard Deviation 1297.2 |
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | 3 Hour, Day 7 | 4228 Nanograms per milliliter | Standard Deviation 997.39 |
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | 4 Hour, Day 7 | 4213 Nanograms per milliliter | Standard Deviation 921.36 |
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | 4 Hours 30 minutes, Day 7 | 4452 Nanograms per milliliter | Standard Deviation 916.01 |
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | 5 Hour, Day 7 | 3840 Nanograms per milliliter | Standard Deviation 1299.8 |
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | 6 Hour, Day 7 | 4010 Nanograms per milliliter | Standard Deviation 934.73 |
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | 12 Hour, Day 7 | 2773 Nanograms per milliliter | Standard Deviation 535.66 |
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | 24 Hour, Day 7 | 2115 Nanograms per milliliter | Standard Deviation 640.77 |
| Part 1: GSK3640254 500 mg | Part 1: Plasma Concentration of GSK3640254 | 48 Hour, Day 7 | 1070 Nanograms per milliliter | Standard Deviation 412.36 |
Primary
Part 1: Plasma Concentration of Major Metabolites of GSK3640254
Blood samples were to be collected at indicated time points to analyze the plasma concentration of major metabolites of GSK3640254.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7
Population: Pharmacokinetic concentration Population. Data was not collected for metabolites of GSK3640254 as there were not enough residual plasma left to analyze metabolites.
Primary
Part 1: Time of Maximum Observed Concentration (Tmax) of GSK3640254
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 500 mg | Part 1: Time of Maximum Observed Concentration (Tmax) of GSK3640254 | 4.500 Hours |
Primary
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg Using Concentration-QTc (C-QTc) Analysis
Twelve-lead ECGs were recorded in participant using automated ECG machine & performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline was calculated by subtracting Baseline value from post dose value. Placebo-corrected change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated as difference in model-predicted mean change from Baseline in QTcF between treatment groups using C-QTc analysis. A linear mixed-effects model with change from Baseline in QTcF as the dependent variable, time-matched GSK3640254 plasma concentration as a fixed effect, centered Baseline as additional covariate,treatment &time as categorical factors, & a random intercept & slope per participant. In all calculations, concentrations in participants who received placebo were set to 0.
Time frame: Baseline (Pre-dose, Day 1) and up to Day 7
Population: PK/QTc Population comprised of all participants who are in both QT/QTc and PK concentration Populations with at least 1 pair of post-dose PK and change from Baseline in QTc data from the same time point as well as participants in the QT/QTc Population who received placebo. Only those participants with data available at specified time points were analyzed. This outcome measure(OM) intended to provide Placebo-corrected data. Summary of change from Baseline data is provided in OM43.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg Using Concentration-QTc (C-QTc) Analysis | 2.72 Milliseconds (ms) |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg Using Concentration-QTc (C-QTc) Analysis | 11.49 Milliseconds (ms) |
Primary
Part 2: Plasma Concentration of GSK3640254
Blood samples were collected at indicated time points to analyze the plasma concentration of GSK3640254.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period
Population: Pharmacokinetic Concentration Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | Pre-dose, Day 7 | 496.0 Nanograms per milliliter | Standard Deviation 209.03 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 30 minutes, Day 7 | 462.3 Nanograms per milliliter | Standard Deviation 188.61 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 1 Hour, Day 7 | 486.6 Nanograms per milliliter | Standard Deviation 198.56 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 2 Hour, Day 7 | 587.8 Nanograms per milliliter | Standard Deviation 298.21 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 3 Hour, Day 7 | 682.4 Nanograms per milliliter | Standard Deviation 329.52 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 3 Hours 30 minutes, Day 7 | 738.6 Nanograms per milliliter | Standard Deviation 368.38 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 4 Hour, Day 7 | 765.5 Nanograms per milliliter | Standard Deviation 349.05 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 4 Hours 30 minutes, Day 7 | 782.4 Nanograms per milliliter | Standard Deviation 318.09 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 5 Hour, Day 7 | 811.3 Nanograms per milliliter | Standard Deviation 326.24 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 6 Hour, Day 7 | 769.8 Nanograms per milliliter | Standard Deviation 265.82 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 8 Hour, Day 7 | 740.9 Nanograms per milliliter | Standard Deviation 280.65 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 10 Hour, Day 7 | 698.7 Nanograms per milliliter | Standard Deviation 280.28 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 12 Hour, Day 7 | 625.4 Nanograms per milliliter | Standard Deviation 231.5 |
| Part 1: GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 24 Hour, Day 7 | 469.9 Nanograms per milliliter | Standard Deviation 183.24 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 8 Hour, Day 7 | 3762 Nanograms per milliliter | Standard Deviation 1727 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | Pre-dose, Day 7 | 2357 Nanograms per milliliter | Standard Deviation 1137.1 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 4 Hours 30 minutes, Day 7 | 4157 Nanograms per milliliter | Standard Deviation 1927 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 30 minutes, Day 7 | 2252 Nanograms per milliliter | Standard Deviation 1266 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 12 Hour, Day 7 | 3098 Nanograms per milliliter | Standard Deviation 1347.5 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 1 Hour, Day 7 | 2339 Nanograms per milliliter | Standard Deviation 1289.3 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 5 Hour, Day 7 | 4172 Nanograms per milliliter | Standard Deviation 1804.9 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 2 Hour, Day 7 | 2779 Nanograms per milliliter | Standard Deviation 1670.6 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 10 Hour, Day 7 | 3564 Nanograms per milliliter | Standard Deviation 1603.7 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 3 Hour, Day 7 | 3372 Nanograms per milliliter | Standard Deviation 1757.9 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 6 Hour, Day 7 | 4102 Nanograms per milliliter | Standard Deviation 1719.5 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 3 Hours 30 minutes, Day 7 | 3698 Nanograms per milliliter | Standard Deviation 1812.2 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 24 Hour, Day 7 | 2257 Nanograms per milliliter | Standard Deviation 1127.6 |
| Part 1 : GSK3640254 500 mg | Part 2: Plasma Concentration of GSK3640254 | 4 Hour, Day 7 | 4011 Nanograms per milliliter | Standard Deviation 1880.5 |
Primary
Part 2: Plasma Concentration of Major Metabolites of GSK3640254
Blood samples were to be collected at indicated time points to analyze the plasma concentration of major metabolites of GSK3640254.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period
Population: Pharmacokinetic concentration Population. Data was not collected for metabolites of GSK3640254 as there were not enough residual plasma left to analyze metabolites.
Secondary
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 8 | 66.8 Grams per liter | Standard Deviation 4.09 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 14 | 68.2 Grams per liter | Standard Deviation 4.26 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 14 | 25.0 Grams per liter | Standard Deviation 3.33 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Baseline (Day -2) | 43.8 Grams per liter | Standard Deviation 2.89 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Baseline (Day -2) | 70.4 Grams per liter | Standard Deviation 5.22 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 9 | 42.7 Grams per liter | Standard Deviation 2.83 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 14 | 43.2 Grams per liter | Standard Deviation 2.96 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 8 | 41.7 Grams per liter | Standard Deviation 2.86 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 9 | 72.0 Grams per liter | Standard Deviation 3.09 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Baseline (Day -2) | 26.6 Grams per liter | Standard Deviation 4.43 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 8 | 25.1 Grams per liter | Standard Deviation 4.04 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 9 | 29.3 Grams per liter | Standard Deviation 1.89 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 8 | 42.0 Grams per liter | Standard Deviation 3.39 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 9 | 24.5 Grams per liter | Standard Deviation 3.01 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 14 | 42.8 Grams per liter | Standard Deviation 2.68 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Baseline (Day -2) | 70.0 Grams per liter | Standard Deviation 4.69 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 8 | 68.4 Grams per liter | Standard Deviation 4.7 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 14 | 26.6 Grams per liter | Standard Deviation 3.88 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Baseline (Day -2) | 44.0 Grams per liter | Standard Deviation 3.12 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 8 | 26.4 Grams per liter | Standard Deviation 3.89 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Baseline (Day -2) | 26.0 Grams per liter | Standard Deviation 3.77 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 9 | 43.5 Grams per liter | Standard Deviation 1.63 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 14 | 69.4 Grams per liter | Standard Deviation 3.8 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 9 | 67.9 Grams per liter | Standard Deviation 3.83 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 14 | 26.4 Grams per liter | Standard Deviation 4.21 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Baseline (Day -2) | 43.6 Grams per liter | Standard Deviation 3.18 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 8 | 42.2 Grams per liter | Standard Deviation 2.55 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 9 | 44.0 Grams per liter | Standard Deviation 3.28 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 14 | 43.9 Grams per liter | Standard Deviation 3.2 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Baseline (Day -2) | 25.9 Grams per liter | Standard Deviation 3.99 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 8 | 25.5 Grams per liter | Standard Deviation 4.06 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 9 | 26.9 Grams per liter | Standard Deviation 3.89 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Baseline (Day -2) | 69.5 Grams per liter | Standard Deviation 4.55 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 8 | 67.8 Grams per liter | Standard Deviation 4.31 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 9 | 70.9 Grams per liter | Standard Deviation 4.14 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 14 | 70.3 Grams per liter | Standard Deviation 5.01 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 8 | 26.4 Grams per liter | Standard Deviation 3.51 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Baseline (Day -2) | 26.3 Grams per liter | Standard Deviation 3.58 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Baseline (Day -2) | 44.5 Grams per liter | Standard Deviation 3.33 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 8 | 69.2 Grams per liter | Standard Deviation 4.11 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 14 | 42.8 Grams per liter | Standard Deviation 2.59 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 9 | 43.5 Grams per liter | Standard Deviation 2.59 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 14 | 68.8 Grams per liter | Standard Deviation 5.09 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 9 | 69.1 Grams per liter | Standard Deviation 4.15 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 14 | 26.1 Grams per liter | Standard Deviation 3.84 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 9 | 25.6 Grams per liter | Standard Deviation 3.86 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 8 | 42.8 Grams per liter | Standard Deviation 2.57 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Baseline (Day -2) | 70.7 Grams per liter | Standard Deviation 5.02 |
Secondary
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 9 | 56.1 International units per liter | Standard Deviation 15.32 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 8 | 14.0 International units per liter | Standard Deviation 7.46 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 14 | 14.1 International units per liter | Standard Deviation 3.1 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 9 | 17.3 International units per liter | Standard Deviation 5.14 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 14 | 56.7 International units per liter | Standard Deviation 13.21 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Baseline (Day -2) | 18.3 International units per liter | Standard Deviation 10.92 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 8 | 14.0 International units per liter | Standard Deviation 3.18 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Baseline (Day -2) | 15.8 International units per liter | Standard Deviation 4.73 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactatedehydrogenase, Baseline(Day-2) | 119.9 International units per liter | Standard Deviation 21.33 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 14 | 102.1 International units per liter | Standard Deviation 113.21 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 9 | 26.6 International units per liter | Standard Deviation 16.04 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 14 | 113.4 International units per liter | Standard Deviation 17.68 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 9 | 173.4 International units per liter | Standard Deviation 136.99 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 8 | 72.8 International units per liter | Standard Deviation 42 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 14 | 13.8 International units per liter | Standard Deviation 6.38 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Baseline (Day -2) | 103.0 International units per liter | Standard Deviation 61.1 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Baseline (Day -2) | 58.7 International units per liter | Standard Deviation 13.67 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 9 | 124.0 International units per liter | Standard Deviation 20.88 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 14 | 14.7 International units per liter | Standard Deviation 10.48 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 9 | 20.3 International units per liter | Standard Deviation 7.63 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 8 | 56.8 International units per liter | Standard Deviation 11.95 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 8 | 107.5 International units per liter | Standard Deviation 18.24 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 8 | 15.0 International units per liter | Standard Deviation 11.16 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Baseline (Day -2) | 16.7 International units per liter | Standard Deviation 11.06 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 14 | 18.7 International units per liter | Standard Deviation 12.07 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Baseline (Day -2) | 16.8 International units per liter | Standard Deviation 10.26 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 8 | 17.2 International units per liter | Standard Deviation 9.8 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 9 | 12.5 International units per liter | Standard Deviation 9.5 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Baseline (Day -2) | 58.3 International units per liter | Standard Deviation 13.52 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 8 | 55.6 International units per liter | Standard Deviation 12.06 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 9 | 63.5 International units per liter | Standard Deviation 15.28 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 14 | 55.1 International units per liter | Standard Deviation 10.8 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Baseline (Day -2) | 15.5 International units per liter | Standard Deviation 4.56 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 8 | 16.0 International units per liter | Standard Deviation 9.92 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 9 | 13.6 International units per liter | Standard Deviation 3.26 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 14 | 15.3 International units per liter | Standard Deviation 3.81 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Baseline (Day -2) | 17.2 International units per liter | Standard Deviation 11.41 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 8 | 17.9 International units per liter | Standard Deviation 11.53 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 9 | 12.5 International units per liter | Standard Deviation 6.56 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 14 | 17.5 International units per liter | Standard Deviation 12.44 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Baseline (Day -2) | 120.8 International units per liter | Standard Deviation 95.6 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 8 | 163.9 International units per liter | Standard Deviation 428.51 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 9 | 75.5 International units per liter | Standard Deviation 45.25 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 14 | 104.9 International units per liter | Standard Deviation 63.56 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactatedehydrogenase, Baseline(Day-2) | 122.8 International units per liter | Standard Deviation 21.04 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 8 | 111.8 International units per liter | Standard Deviation 19.37 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 9 | 107.4 International units per liter | Standard Deviation 20.66 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 14 | 113.5 International units per liter | Standard Deviation 17.09 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Baseline (Day -2) | 58.0 International units per liter | Standard Deviation 13.82 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Baseline (Day -2) | 16.6 International units per liter | Standard Deviation 8.75 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 8 | 57.1 International units per liter | Standard Deviation 12.81 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 8 | 15.2 International units per liter | Standard Deviation 7.3 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 8 | 108.0 International units per liter | Standard Deviation 17.13 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 9 | 19.1 International units per liter | Standard Deviation 11.61 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 14 | 15.1 International units per liter | Standard Deviation 7.28 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Baseline (Day -2) | 17.5 International units per liter | Standard Deviation 10.4 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Baseline (Day -2) | 112.6 International units per liter | Standard Deviation 91.5 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 14 | 116.6 International units per liter | Standard Deviation 18.19 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 8 | 82.5 International units per liter | Standard Deviation 48.77 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 9 | 14.2 International units per liter | Standard Deviation 4.29 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 9 | 118.2 International units per liter | Standard Deviation 16.69 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 9 | 171.1 International units per liter | Standard Deviation 184.31 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 14 | 91.7 International units per liter | Standard Deviation 55 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 8 | 15.7 International units per liter | Standard Deviation 10.63 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Baseline (Day -2) | 15.5 International units per liter | Standard Deviation 3.78 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 14 | 58.8 International units per liter | Standard Deviation 13.98 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 14 | 16.6 International units per liter | Standard Deviation 11.05 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 8 | 13.7 International units per liter | Standard Deviation 3.14 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactatedehydrogenase, Baseline(Day-2) | 119.6 International units per liter | Standard Deviation 18.16 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 9 | 15.6 International units per liter | Standard Deviation 5.05 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 9 | 58.9 International units per liter | Standard Deviation 12.64 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 14 | 14.5 International units per liter | Standard Deviation 3.96 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Baseline (Day -2) | 15.3 International units per liter | Standard Deviation 3.88 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Baseline (Day -2) | 16.3 International units per liter | Standard Deviation 9.35 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 14 | 15.8 International units per liter | Standard Deviation 5.22 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Baseline (Day -2) | 16.7 International units per liter | Standard Deviation 10.53 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactatedehydrogenase, Baseline(Day-2) | 121.2 International units per liter | Standard Deviation 24.03 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 14 | 118.8 International units per liter | Standard Deviation 20.87 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 9 | 81.1 International units per liter | Standard Deviation 40.14 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 8 | 18.7 International units per liter | Standard Deviation 10.22 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Baseline (Day -2) | 58.9 International units per liter | Standard Deviation 14.23 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 8 | 19.5 International units per liter | Standard Deviation 11.46 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 9 | 108.1 International units per liter | Standard Deviation 17.01 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 9 | 10.8 International units per liter | Standard Deviation 2.44 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 8 | 59.6 International units per liter | Standard Deviation 13.52 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 8 | 113.5 International units per liter | Standard Deviation 16.87 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 9 | 15.1 International units per liter | Standard Deviation 3.75 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 14 | 17.7 International units per liter | Standard Deviation 9.01 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 14 | 19.0 International units per liter | Standard Deviation 11.34 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 14 | 110.1 International units per liter | Standard Deviation 76.61 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 14 | 59.4 International units per liter | Standard Deviation 14.15 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Baseline (Day -2) | 117.8 International units per liter | Standard Deviation 105.69 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 9 | 16.4 International units per liter | Standard Deviation 8.69 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 8 | 15.6 International units per liter | Standard Deviation 4.01 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 9 | 53.0 International units per liter | Standard Deviation 8.03 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 8 | 90.3 International units per liter | Standard Deviation 51.09 |
Secondary
Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase
Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Baseline (Day -2) | 55.7 Units per liter | Standard Deviation 21.74 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 8 | 52.4 Units per liter | Standard Deviation 21.7 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 9 | 66.3 Units per liter | Standard Deviation 19.41 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 14 | 50.9 Units per liter | Standard Deviation 20.92 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Baseline (Day -2), | 25.3 Units per liter | Standard Deviation 10.98 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 8 | 29.3 Units per liter | Standard Deviation 27.5 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 9 | 28.4 Units per liter | Standard Deviation 12.99 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 14 | 23.6 Units per liter | Standard Deviation 9.21 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 8 | 26.5 Units per liter | Standard Deviation 12.22 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Baseline (Day -2), | 26.5 Units per liter | Standard Deviation 11.59 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 8 | 59.1 Units per liter | Standard Deviation 26.8 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 14 | 26.7 Units per liter | Standard Deviation 10.84 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 9 | 23.7 Units per liter | Standard Deviation 10.47 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 14 | 58.5 Units per liter | Standard Deviation 24.58 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 9 | 49.2 Units per liter | Standard Deviation 16.7 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Baseline (Day -2) | 55.9 Units per liter | Standard Deviation 22.19 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 9 | 28.1 Units per liter | Standard Deviation 12.26 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 9 | 61.0 Units per liter | Standard Deviation 26.37 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 14 | 52.9 Units per liter | Standard Deviation 20.11 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Baseline (Day -2), | 27.0 Units per liter | Standard Deviation 11.06 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 8 | 25.2 Units per liter | Standard Deviation 12.39 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 14 | 24.8 Units per liter | Standard Deviation 9.45 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Baseline (Day -2) | 58.2 Units per liter | Standard Deviation 24.65 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 8 | 53.4 Units per liter | Standard Deviation 19.71 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 9 | 44.6 Units per liter | Standard Deviation 17.4 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 14 | 58.0 Units per liter | Standard Deviation 21.02 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Day 8 | 57.7 Units per liter | Standard Deviation 22.34 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Amylase, Baseline (Day -2) | 56.2 Units per liter | Standard Deviation 25.45 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Baseline (Day -2), | 27.5 Units per liter | Standard Deviation 13.93 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 14 | 26.6 Units per liter | Standard Deviation 11.79 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 9 | 22.7 Units per liter | Standard Deviation 6.99 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase | Lipase, Day 8 | 26.6 Units per liter | Standard Deviation 12.87 |
Secondary
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Baseline (Day -2) | 297.5 Micromoles per liter | Standard Deviation 60.11 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 8 | 78.45 Micromoles per liter | Standard Deviation 16.058 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 9 | 86.89 Micromoles per liter | Standard Deviation 13.446 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 14 | 79.56 Micromoles per liter | Standard Deviation 16.792 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Baseline (Day -2) | 80.51 Micromoles per liter | Standard Deviation 13.855 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 8 | 288.3 Micromoles per liter | Standard Deviation 53.21 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 9 | 290.2 Micromoles per liter | Standard Deviation 64.04 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 14 | 291.4 Micromoles per liter | Standard Deviation 49.07 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Baseline (Day -2) | 12.18 Micromoles per liter | Standard Deviation 6.249 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 8 | 9.91 Micromoles per liter | Standard Deviation 3.647 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 9 | 12.50 Micromoles per liter | Standard Deviation 6.712 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 14 | 11.42 Micromoles per liter | Standard Deviation 4.666 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Baseline (Day -2) | 2.22 Micromoles per liter | Standard Deviation 0.988 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 8 | 1.86 Micromoles per liter | Standard Deviation 0.689 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 9 | 2.23 Micromoles per liter | Standard Deviation 1.033 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 14 | 2.06 Micromoles per liter | Standard Deviation 0.781 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 8 | 302.1 Micromoles per liter | Standard Deviation 51.5 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Baseline (Day -2) | 11.79 Micromoles per liter | Standard Deviation 5.406 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 14 | 2.21 Micromoles per liter | Standard Deviation 1.113 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 14 | 12.89 Micromoles per liter | Standard Deviation 7.36 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 9 | 2.39 Micromoles per liter | Standard Deviation 0.646 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 8 | 10.36 Micromoles per liter | Standard Deviation 4.712 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 9 | 77.07 Micromoles per liter | Standard Deviation 17.015 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 9 | 13.71 Micromoles per liter | Standard Deviation 2.889 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Baseline (Day -2) | 294.6 Micromoles per liter | Standard Deviation 57.22 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 9 | 295.3 Micromoles per liter | Standard Deviation 55.91 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 14 | 84.19 Micromoles per liter | Standard Deviation 13.996 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 8 | 88.55 Micromoles per liter | Standard Deviation 16.38 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Baseline (Day -2) | 2.12 Micromoles per liter | Standard Deviation 0.916 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 14 | 293.1 Micromoles per liter | Standard Deviation 54.91 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 8 | 1.90 Micromoles per liter | Standard Deviation 0.796 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Baseline (Day -2) | 79.38 Micromoles per liter | Standard Deviation 14.34 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 8 | 286.7 Micromoles per liter | Standard Deviation 58.76 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Baseline (Day -2) | 293.6 Micromoles per liter | Standard Deviation 62.59 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 8 | 1.97 Micromoles per liter | Standard Deviation 0.811 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 9 | 307.2 Micromoles per liter | Standard Deviation 46.23 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 14 | 290.1 Micromoles per liter | Standard Deviation 56.69 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 14 | 2.22 Micromoles per liter | Standard Deviation 0.887 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Baseline (Day -2) | 11.13 Micromoles per liter | Standard Deviation 4.812 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 8 | 10.68 Micromoles per liter | Standard Deviation 4.792 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 9 | 2.30 Micromoles per liter | Standard Deviation 1.127 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 9 | 13.16 Micromoles per liter | Standard Deviation 6.586 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 14 | 12.40 Micromoles per liter | Standard Deviation 5.214 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Baseline (Day -2) | 81.86 Micromoles per liter | Standard Deviation 14.819 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 8 | 78.38 Micromoles per liter | Standard Deviation 15.118 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Baseline (Day -2) | 2.05 Micromoles per liter | Standard Deviation 0.834 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 9 | 89.38 Micromoles per liter | Standard Deviation 14.323 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 14 | 79.16 Micromoles per liter | Standard Deviation 15.043 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 14 | 2.10 Micromoles per liter | Standard Deviation 0.844 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 14 | 285.4 Micromoles per liter | Standard Deviation 56.39 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 9 | 80.63 Micromoles per liter | Standard Deviation 15.048 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Baseline (Day -2) | 79.83 Micromoles per liter | Standard Deviation 14.976 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 8 | 2.22 Micromoles per liter | Standard Deviation 0.934 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 9 | 261.1 Micromoles per liter | Standard Deviation 50.55 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Baseline (Day -2) | 2.07 Micromoles per liter | Standard Deviation 0.686 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 8 | 82.01 Micromoles per liter | Standard Deviation 16.558 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Baseline (Day -2) | 295.3 Micromoles per liter | Standard Deviation 59.89 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 8 | 11.63 Micromoles per liter | Standard Deviation 4.09 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 8 | 277.6 Micromoles per liter | Standard Deviation 58.06 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 9 | 12.00 Micromoles per liter | Standard Deviation 4.901 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 9 | 2.23 Micromoles per liter | Standard Deviation 0.772 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Baseline (Day -2) | 11.79 Micromoles per liter | Standard Deviation 4.654 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 14 | 81.47 Micromoles per liter | Standard Deviation 14.487 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 14 | 11.53 Micromoles per liter | Standard Deviation 4.675 |
Secondary
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Baseline (Day -2) | 1.011 Millimoles per liter | Standard Deviation 0.4865 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 8 | 4.777 Millimoles per liter | Standard Deviation 0.2914 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 9 | 4.763 Millimoles per liter | Standard Deviation 0.2295 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 14 | 4.794 Millimoles per liter | Standard Deviation 0.2526 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Baseline (Day -2) | 4.323 Millimoles per liter | Standard Deviation 0.8707 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 8, | 4.300 Millimoles per liter | Standard Deviation 0.834 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 9 | 3.988 Millimoles per liter | Standard Deviation 0.5501 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 14 | 4.361 Millimoles per liter | Standard Deviation 0.829 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Baseline (Day -2) | 0.794 Millimoles per liter | Standard Deviation 0.0653 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 8 | 0.793 Millimoles per liter | Standard Deviation 0.0499 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 9 | 0.736 Millimoles per liter | Standard Deviation 0.061 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 14 | 0.796 Millimoles per liter | Standard Deviation 0.0627 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose,Baseline (Day -2) | 4.813 Millimoles per liter | Standard Deviation 0.318 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 8 | 0.977 Millimoles per liter | Standard Deviation 0.4124 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 9 | 1.036 Millimoles per liter | Standard Deviation 0.4571 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 14 | 0.948 Millimoles per liter | Standard Deviation 0.3862 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Baseline (Day -2) | 10.0 Millimoles per liter | Standard Deviation 1.46 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 8 | 10.1 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 9 | 10.0 Millimoles per liter | Standard Deviation 1.56 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 14 | 9.9 Millimoles per liter | Standard Deviation 1.36 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Baseline (Day -2) | 2.371 Millimoles per liter | Standard Deviation 0.0868 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 8 | 2.317 Millimoles per liter | Standard Deviation 0.092 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 9 | 2.357 Millimoles per liter | Standard Deviation 0.0793 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 14 | 2.367 Millimoles per liter | Standard Deviation 0.0913 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Baseline (Day -2) | 30.4 Millimoles per liter | Standard Deviation 2.08 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 8 | 29.3 Millimoles per liter | Standard Deviation 2.32 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 9 | 30.2 Millimoles per liter | Standard Deviation 1.55 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 14 | 30.3 Millimoles per liter | Standard Deviation 1.84 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Baseline (Day -2) | 102.8 Millimoles per liter | Standard Deviation 1.57 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 8 | 103.5 Millimoles per liter | Standard Deviation 1.91 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 9 | 102.4 Millimoles per liter | Standard Deviation 1.51 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 14 | 103.9 Millimoles per liter | Standard Deviation 1.77 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Baseline (Day -2) | 1.190 Millimoles per liter | Standard Deviation 0.1394 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 8 | 1.194 Millimoles per liter | Standard Deviation 0.1272 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 9 | 1.166 Millimoles per liter | Standard Deviation 0.1436 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 14 | 1.233 Millimoles per liter | Standard Deviation 0.145 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Baseline (Day -2) | 4.30 Millimoles per liter | Standard Deviation 0.337 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 8 | 4.29 Millimoles per liter | Standard Deviation 0.291 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 9 | 4.26 Millimoles per liter | Standard Deviation 0.222 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 14 | 4.39 Millimoles per liter | Standard Deviation 0.389 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Baseline (Day -2) | 138.8 Millimoles per liter | Standard Deviation 1.91 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 8 | 138.6 Millimoles per liter | Standard Deviation 1.89 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 9 | 138.4 Millimoles per liter | Standard Deviation 0.7 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 14 | 139.6 Millimoles per liter | Standard Deviation 1.65 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Baseline(Day-2) | 4.325 Millimoles per liter | Standard Deviation 1.0398 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 8 | 5.242 Millimoles per liter | Standard Deviation 0.9369 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 9 | 4.472 Millimoles per liter | Standard Deviation 0.502 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 14 | 4.637 Millimoles per liter | Standard Deviation 0.7997 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Baseline (Day -2) | 1.059 Millimoles per liter | Standard Deviation 0.4907 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Baseline (Day -2) | 30.2 Millimoles per liter | Standard Deviation 1.42 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Baseline (Day -2) | 10.2 Millimoles per liter | Standard Deviation 1.42 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 14 | 4.440 Millimoles per liter | Standard Deviation 0.9129 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 9 | 139.9 Millimoles per liter | Standard Deviation 2.21 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 8 | 29.6 Millimoles per liter | Standard Deviation 1.76 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 14 | 4.180 Millimoles per liter | Standard Deviation 0.8088 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 14 | 1.164 Millimoles per liter | Standard Deviation 0.1264 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 9 | 4.253 Millimoles per liter | Standard Deviation 0.8441 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 9 | 29.2 Millimoles per liter | Standard Deviation 1.54 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Baseline (Day -2) | 139.4 Millimoles per liter | Standard Deviation 1.8 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 9 | 1.292 Millimoles per liter | Standard Deviation 0.1254 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 8 | 1.195 Millimoles per liter | Standard Deviation 0.141 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 14 | 30.3 Millimoles per liter | Standard Deviation 1.85 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 8 | 10.3 Millimoles per liter | Standard Deviation 1.2 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Baseline(Day-2) | 4.419 Millimoles per liter | Standard Deviation 0.9822 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Baseline (Day -2) | 1.199 Millimoles per liter | Standard Deviation 0.1552 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Baseline (Day -2) | 103.4 Millimoles per liter | Standard Deviation 1.87 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 9 | 0.820 Millimoles per liter | Standard Deviation 0.04 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 14 | 103.3 Millimoles per liter | Standard Deviation 1.34 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 14 | 139.0 Millimoles per liter | Standard Deviation 1.61 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 8 | 102.6 Millimoles per liter | Standard Deviation 1.61 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 8, | 4.246 Millimoles per liter | Standard Deviation 0.8197 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 9 | 103.9 Millimoles per liter | Standard Deviation 1.76 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 14 | 0.789 Millimoles per liter | Standard Deviation 0.0662 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 9 | 11.1 Millimoles per liter | Standard Deviation 1.64 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 9 | 0.935 Millimoles per liter | Standard Deviation 0.2874 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 8 | 4.26 Millimoles per liter | Standard Deviation 0.324 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Baseline (Day -2) | 4.330 Millimoles per liter | Standard Deviation 0.7859 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 14 | 9.9 Millimoles per liter | Standard Deviation 1.36 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 14 | 4.41 Millimoles per liter | Standard Deviation 0.232 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 8 | 5.156 Millimoles per liter | Standard Deviation 1.0329 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 9 | 5.453 Millimoles per liter | Standard Deviation 0.9684 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Baseline (Day -2) | 2.363 Millimoles per liter | Standard Deviation 0.0942 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 8 | 0.769 Millimoles per liter | Standard Deviation 0.0565 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 14 | 4.777 Millimoles per liter | Standard Deviation 0.2745 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 8 | 138.2 Millimoles per liter | Standard Deviation 1.55 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 8 | 2.316 Millimoles per liter | Standard Deviation 0.0893 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 9 | 4.17 Millimoles per liter | Standard Deviation 0.31 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 9 | 4.668 Millimoles per liter | Standard Deviation 0.4071 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 14 | 0.941 Millimoles per liter | Standard Deviation 0.3983 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 9 | 2.366 Millimoles per liter | Standard Deviation 0.0595 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 8 | 0.958 Millimoles per liter | Standard Deviation 0.4513 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 8 | 4.749 Millimoles per liter | Standard Deviation 0.2843 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Baseline (Day -2) | 4.34 Millimoles per liter | Standard Deviation 0.327 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 14 | 2.349 Millimoles per liter | Standard Deviation 0.0802 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Baseline (Day -2) | 0.796 Millimoles per liter | Standard Deviation 0.0688 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose,Baseline (Day -2) | 4.739 Millimoles per liter | Standard Deviation 0.3538 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Baseline (Day -2) | 9.9 Millimoles per liter | Standard Deviation 1.61 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Baseline (Day -2) | 0.996 Millimoles per liter | Standard Deviation 0.4214 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 8 | 0.980 Millimoles per liter | Standard Deviation 0.3876 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 14 | 4.43 Millimoles per liter | Standard Deviation 0.301 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 9 | 0.891 Millimoles per liter | Standard Deviation 0.376 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 14 | 1.013 Millimoles per liter | Standard Deviation 0.4432 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 14 | 4.428 Millimoles per liter | Standard Deviation 0.9272 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 8 | 10.1 Millimoles per liter | Standard Deviation 1.44 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Baseline (Day -2) | 139.2 Millimoles per liter | Standard Deviation 2.18 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 9 | 10.8 Millimoles per liter | Standard Deviation 1.3 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 14 | 10.2 Millimoles per liter | Standard Deviation 1.42 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Baseline (Day -2) | 2.350 Millimoles per liter | Standard Deviation 0.0939 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 8 | 2.316 Millimoles per liter | Standard Deviation 0.0876 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 8 | 138.1 Millimoles per liter | Standard Deviation 1.25 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 9 | 2.402 Millimoles per liter | Standard Deviation 0.0978 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 14 | 2.391 Millimoles per liter | Standard Deviation 0.0918 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 9 | 5.251 Millimoles per liter | Standard Deviation 0.6649 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Baseline (Day -2) | 30.5 Millimoles per liter | Standard Deviation 1.58 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 8 | 29.2 Millimoles per liter | Standard Deviation 1.63 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 9 | 139.2 Millimoles per liter | Standard Deviation 1.39 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 9 | 30.0 Millimoles per liter | Standard Deviation 2.18 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 14 | 30.5 Millimoles per liter | Standard Deviation 1.82 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Baseline (Day -2) | 103.3 Millimoles per liter | Standard Deviation 2.05 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 8 | 103.0 Millimoles per liter | Standard Deviation 1.64 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 14 | 139.9 Millimoles per liter | Standard Deviation 1.2 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 9 | 102.8 Millimoles per liter | Standard Deviation 1.72 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 14 | 103.6 Millimoles per liter | Standard Deviation 1.7 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Baseline (Day -2) | 1.182 Millimoles per liter | Standard Deviation 0.155 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 8 | 1.186 Millimoles per liter | Standard Deviation 0.1408 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Baseline(Day-2) | 4.573 Millimoles per liter | Standard Deviation 1.3349 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 9 | 1.212 Millimoles per liter | Standard Deviation 0.1213 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 14 | 1.222 Millimoles per liter | Standard Deviation 0.1415 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose,Baseline (Day -2) | 4.810 Millimoles per liter | Standard Deviation 0.3038 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 8 | 4.798 Millimoles per liter | Standard Deviation 0.2707 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Baseline (Day -2) | 4.35 Millimoles per liter | Standard Deviation 0.315 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 9 | 4.811 Millimoles per liter | Standard Deviation 0.3717 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 14 | 4.713 Millimoles per liter | Standard Deviation 0.3106 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Baseline (Day -2) | 4.243 Millimoles per liter | Standard Deviation 0.8603 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 8, | 4.147 Millimoles per liter | Standard Deviation 0.7439 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 8 | 4.20 Millimoles per liter | Standard Deviation 0.275 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 9 | 4.467 Millimoles per liter | Standard Deviation 0.8551 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 14 | 4.233 Millimoles per liter | Standard Deviation 0.7982 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 8 | 4.805 Millimoles per liter | Standard Deviation 0.8952 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Baseline (Day -2) | 0.791 Millimoles per liter | Standard Deviation 0.0679 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 8 | 0.783 Millimoles per liter | Standard Deviation 0.061 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 9 | 4.42 Millimoles per liter | Standard Deviation 0.484 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 9 | 0.771 Millimoles per liter | Standard Deviation 0.0521 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 14 | 0.801 Millimoles per liter | Standard Deviation 0.0675 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Baseline (Day -2) | 30.2 Millimoles per liter | Standard Deviation 2.07 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 14 | 2.358 Millimoles per liter | Standard Deviation 0.104 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 14 | 0.796 Millimoles per liter | Standard Deviation 0.0579 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose,Baseline (Day -2) | 4.753 Millimoles per liter | Standard Deviation 0.2744 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 8 | 137.8 Millimoles per liter | Standard Deviation 1.7 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 9 | 2.332 Millimoles per liter | Standard Deviation 0.0627 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 14 | 1.049 Millimoles per liter | Standard Deviation 0.3844 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 8 | 4.670 Millimoles per liter | Standard Deviation 0.242 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 9 | 0.817 Millimoles per liter | Standard Deviation 0.0736 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 8 | 2.316 Millimoles per liter | Standard Deviation 0.0945 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Baseline (Day -2) | 0.793 Millimoles per liter | Standard Deviation 0.0709 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 9 | 4.791 Millimoles per liter | Standard Deviation 0.2795 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Baseline (Day -2) | 4.32 Millimoles per liter | Standard Deviation 0.331 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Baseline (Day -2) | 2.375 Millimoles per liter | Standard Deviation 0.0922 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 14 | 4.44 Millimoles per liter | Standard Deviation 0.337 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 14 | 4.749 Millimoles per liter | Standard Deviation 0.2474 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 14 | 9.8 Millimoles per liter | Standard Deviation 1.35 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Baseline (Day -2) | 139.4 Millimoles per liter | Standard Deviation 1.51 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 9 | 0.778 Millimoles per liter | Standard Deviation 0.4061 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Baseline (Day -2) | 4.350 Millimoles per liter | Standard Deviation 0.7624 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 9 | 10.8 Millimoles per liter | Standard Deviation 1.69 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 8 | 10.1 Millimoles per liter | Standard Deviation 1.41 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 9 | 4.18 Millimoles per liter | Standard Deviation 0.416 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 8, | 4.186 Millimoles per liter | Standard Deviation 0.7233 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 8 | 0.793 Millimoles per liter | Standard Deviation 0.0539 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 8 | 102.5 Millimoles per liter | Standard Deviation 1.8 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Baseline (Day -2) | 10.5 Millimoles per liter | Standard Deviation 1.65 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 9 | 103.0 Millimoles per liter | Standard Deviation 1.63 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 14 | 139.6 Millimoles per liter | Standard Deviation 2.01 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Baseline (Day -2) | 103.2 Millimoles per liter | Standard Deviation 1.98 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Baseline (Day -2) | 0.978 Millimoles per liter | Standard Deviation 0.4082 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 14 | 103.5 Millimoles per liter | Standard Deviation 1.74 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 14 | 4.451 Millimoles per liter | Standard Deviation 0.9627 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 9 | 4.243 Millimoles per liter | Standard Deviation 0.886 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 9 | 4.050 Millimoles per liter | Standard Deviation 0.7872 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Baseline (Day -2) | 1.172 Millimoles per liter | Standard Deviation 0.1686 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 14 | 30.8 Millimoles per liter | Standard Deviation 1.68 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 9 | 138.6 Millimoles per liter | Standard Deviation 1.43 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 8 | 4.07 Millimoles per liter | Standard Deviation 0.296 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 8 | 1.168 Millimoles per liter | Standard Deviation 0.1644 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 8 | 4.675 Millimoles per liter | Standard Deviation 0.9487 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 9 | 28.9 Millimoles per liter | Standard Deviation 2.13 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 8 | 0.894 Millimoles per liter | Standard Deviation 0.3583 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 9 | 1.193 Millimoles per liter | Standard Deviation 0.1076 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Baseline(Day-2) | 4.414 Millimoles per liter | Standard Deviation 1.2366 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 8 | 29.3 Millimoles per liter | Standard Deviation 1.95 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 14 | 4.145 Millimoles per liter | Standard Deviation 0.7483 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 14 | 1.219 Millimoles per liter | Standard Deviation 0.1625 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 8, Day 9, Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Baseline (Day -2) | 0.035 10^9 cells per liter | Standard Deviation 0.0194 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 9 | 5.27 10^9 cells per liter | Standard Deviation 1.125 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 14 | 0.413 10^9 cells per liter | Standard Deviation 0.1474 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Baseline (Day -2) | 0.124 10^9 cells per liter | Standard Deviation 0.0775 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets,Baseline (Day -2) | 233.7 10^9 cells per liter | Standard Deviation 42.39 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Baseline (Day -2) | 2.842 10^9 cells per liter | Standard Deviation 0.9011 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 8 | 2.889 10^9 cells per liter | Standard Deviation 0.9751 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 9 | 0.485 10^9 cells per liter | Standard Deviation 0.1499 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 14 | 2.712 10^9 cells per liter | Standard Deviation 0.8786 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 9 | 2.990 10^9 cells per liter | Standard Deviation 0.9534 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 8 | 0.116 10^9 cells per liter | Standard Deviation 0.0637 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 8 | 5.10 10^9 cells per liter | Standard Deviation 1.223 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 9 | 0.167 10^9 cells per liter | Standard Deviation 0.0859 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 14 | 4.97 10^9 cells per liter | Standard Deviation 1.184 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 14 | 0.113 10^9 cells per liter | Standard Deviation 0.0765 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 9 | 0.032 10^9 cells per liter | Standard Deviation 0.0155 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Baseline (Day -2) | 5.12 10^9 cells per liter | Standard Deviation 1.205 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Baseline (Day -2) | 1.694 10^9 cells per liter | Standard Deviation 0.5355 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 8 | 1.641 10^9 cells per liter | Standard Deviation 0.4661 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 14 | 231.6 10^9 cells per liter | Standard Deviation 48.26 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 9 | 1.603 10^9 cells per liter | Standard Deviation 0.2137 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 14 | 1.710 10^9 cells per liter | Standard Deviation 0.5906 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 14 | 0.033 10^9 cells per liter | Standard Deviation 0.0178 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 9 | 221.4 10^9 cells per liter | Standard Deviation 34.16 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Baseline (Day -2) | 0.427 10^9 cells per liter | Standard Deviation 0.1533 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 8 | 0.426 10^9 cells per liter | Standard Deviation 0.109 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 8 | 0.035 10^9 cells per liter | Standard Deviation 0.0228 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 8 | 228.9 10^9 cells per liter | Standard Deviation 43.1 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 9 | 5.14 10^9 cells per liter | Standard Deviation 1.307 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 9 | 0.468 10^9 cells per liter | Standard Deviation 0.1376 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 14 | 0.131 10^9 cells per liter | Standard Deviation 0.0918 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets,Baseline (Day -2) | 237.1 10^9 cells per liter | Standard Deviation 46.09 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 9 | 233.3 10^9 cells per liter | Standard Deviation 62.32 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 14 | 0.399 10^9 cells per liter | Standard Deviation 0.1469 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Baseline (Day -2) | 0.442 10^9 cells per liter | Standard Deviation 0.1429 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 14 | 1.606 10^9 cells per liter | Standard Deviation 0.5602 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Baseline (Day -2) | 1.830 10^9 cells per liter | Standard Deviation 0.5683 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Baseline (Day -2) | 2.902 10^9 cells per liter | Standard Deviation 0.8438 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Baseline (Day -2) | 0.127 10^9 cells per liter | Standard Deviation 0.0794 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 14 | 2.506 10^9 cells per liter | Standard Deviation 0.727 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 9 | 0.036 10^9 cells per liter | Standard Deviation 0.0191 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 8 | 2.671 10^9 cells per liter | Standard Deviation 0.8247 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 14 | 227.1 10^9 cells per liter | Standard Deviation 44.07 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 14 | 0.031 10^9 cells per liter | Standard Deviation 0.0161 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 8 | 1.605 10^9 cells per liter | Standard Deviation 0.4496 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 9 | 2.618 10^9 cells per liter | Standard Deviation 0.8351 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 8 | 0.032 10^9 cells per liter | Standard Deviation 0.0176 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 8 | 4.87 10^9 cells per liter | Standard Deviation 0.985 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 14 | 4.67 10^9 cells per liter | Standard Deviation 1.04 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 8 | 0.136 10^9 cells per liter | Standard Deviation 0.0757 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Baseline (Day -2) | 0.036 10^9 cells per liter | Standard Deviation 0.0228 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 8 | 226.4 10^9 cells per liter | Standard Deviation 43.06 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 8 | 0.436 10^9 cells per liter | Standard Deviation 0.1518 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 9 | 0.120 10^9 cells per liter | Standard Deviation 0.0754 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 9 | 1.907 10^9 cells per liter | Standard Deviation 0.6142 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Baseline (Day -2) | 5.34 10^9 cells per liter | Standard Deviation 1.153 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 8 | 2.825 10^9 cells per liter | Standard Deviation 0.8364 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Baseline (Day -2) | 0.037 10^9 cells per liter | Standard Deviation 0.0218 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 8 | 0.030 10^9 cells per liter | Standard Deviation 0.0149 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 9 | 0.039 10^9 cells per liter | Standard Deviation 0.0145 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 14 | 0.033 10^9 cells per liter | Standard Deviation 0.0177 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Baseline (Day -2) | 0.135 10^9 cells per liter | Standard Deviation 0.0966 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 8 | 0.130 10^9 cells per liter | Standard Deviation 0.0797 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 9 | 0.114 10^9 cells per liter | Standard Deviation 0.0688 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 14 | 0.126 10^9 cells per liter | Standard Deviation 0.0717 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Baseline (Day -2) | 1.736 10^9 cells per liter | Standard Deviation 0.5498 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 8 | 1.675 10^9 cells per liter | Standard Deviation 0.5013 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 9 | 1.637 10^9 cells per liter | Standard Deviation 0.5265 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 14 | 1.705 10^9 cells per liter | Standard Deviation 0.4747 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Baseline (Day -2) | 0.451 10^9 cells per liter | Standard Deviation 0.1588 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 8 | 0.456 10^9 cells per liter | Standard Deviation 0.1521 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 9 | 0.389 10^9 cells per liter | Standard Deviation 0.1312 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 14 | 0.431 10^9 cells per liter | Standard Deviation 0.1514 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Baseline (Day -2) | 2.957 10^9 cells per liter | Standard Deviation 1.0517 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 9 | 2.619 10^9 cells per liter | Standard Deviation 1.1073 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 14 | 2.758 10^9 cells per liter | Standard Deviation 0.8062 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets,Baseline (Day -2) | 234.0 10^9 cells per liter | Standard Deviation 48.15 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 8 | 234.8 10^9 cells per liter | Standard Deviation 47.94 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 9 | 225.9 10^9 cells per liter | Standard Deviation 52.6 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 14 | 234.0 10^9 cells per liter | Standard Deviation 40.87 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Baseline (Day -2) | 5.31 10^9 cells per liter | Standard Deviation 1.325 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 8 | 5.11 10^9 cells per liter | Standard Deviation 1.151 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 9 | 4.78 10^9 cells per liter | Standard Deviation 1.411 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 14 | 5.05 10^9 cells per liter | Standard Deviation 1.054 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 8 | 0.501 10^9 cells per liter | Standard Deviation 0.1609 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Baseline (Day -2) | 0.429 10^9 cells per liter | Standard Deviation 0.1476 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 9 | 0.025 10^9 cells per liter | Standard Deviation 0.0108 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 8 | 224.7 10^9 cells per liter | Standard Deviation 41.97 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 14 | 1.755 10^9 cells per liter | Standard Deviation 0.5892 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 9 | 1.540 10^9 cells per liter | Standard Deviation 0.555 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 14 | 5.14 10^9 cells per liter | Standard Deviation 1.023 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 9 | 235.4 10^9 cells per liter | Standard Deviation 30.8 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 8 | 1.688 10^9 cells per liter | Standard Deviation 0.462 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Baseline (Day -2) | 1.677 10^9 cells per liter | Standard Deviation 0.4789 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 9 | 4.53 10^9 cells per liter | Standard Deviation 0.85 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 14 | 226.7 10^9 cells per liter | Standard Deviation 46.75 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 14 | 0.141 10^9 cells per liter | Standard Deviation 0.0737 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 9 | 0.081 10^9 cells per liter | Standard Deviation 0.0418 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 8 | 0.039 10^9 cells per liter | Standard Deviation 0.0157 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes, Baseline (Day -2) | 5.08 10^9 cells per liter | Standard Deviation 1.092 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 8 | 0.135 10^9 cells per liter | Standard Deviation 0.0725 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Baseline (Day -2) | 0.123 10^9 cells per liter | Standard Deviation 0.0716 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Baseline (Day -2) | 0.031 10^9 cells per liter | Standard Deviation 0.0121 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 9 | 2.530 10^9 cells per liter | Standard Deviation 0.501 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 8 | 2.952 10^9 cells per liter | Standard Deviation 0.9562 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils, Baseline (Day -2) | 2.829 10^9 cells per liter | Standard Deviation 0.8172 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 8 | 5.32 10^9 cells per liter | Standard Deviation 1.172 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 14 | 2.750 10^9 cells per liter | Standard Deviation 0.7833 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 14 | 0.448 10^9 cells per liter | Standard Deviation 0.1402 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 9 | 0.350 10^9 cells per liter | Standard Deviation 0.104 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 14 | 0.040 10^9 cells per liter | Standard Deviation 0.0242 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets,Baseline (Day -2) | 230.8 10^9 cells per liter | Standard Deviation 48.34 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time points to analyze Erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 8 | 4.775 10^12 cells per liter | Standard Deviation 0.4512 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 14 | 4.782 10^12 cells per liter | Standard Deviation 0.4689 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -2) | 4.859 10^12 cells per liter | Standard Deviation 0.4614 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 9 | 4.890 10^12 cells per liter | Standard Deviation 0.601 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -2) | 4.815 10^12 cells per liter | Standard Deviation 0.4808 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 14 | 4.780 10^12 cells per liter | Standard Deviation 0.4388 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 8 | 4.833 10^12 cells per liter | Standard Deviation 0.4585 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 9 | 4.737 10^12 cells per liter | Standard Deviation 0.4416 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -2) | 4.829 10^12 cells per liter | Standard Deviation 0.4842 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 14 | 4.866 10^12 cells per liter | Standard Deviation 0.5418 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 9 | 5.023 10^12 cells per liter | Standard Deviation 0.3646 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 8 | 4.794 10^12 cells per liter | Standard Deviation 0.5278 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 14 | 4.910 10^12 cells per liter | Standard Deviation 0.5078 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 8 | 4.927 10^12 cells per liter | Standard Deviation 0.5074 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 9 | 4.632 10^12 cells per liter | Standard Deviation 0.3654 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day -2) | 4.864 10^12 cells per liter | Standard Deviation 0.5017 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 8, Day 9, Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 8 | 29.34 Picograms | Standard Deviation 1.603 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -2) | 29.27 Picograms | Standard Deviation 2.308 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | 28.67 Picograms | Standard Deviation 3.417 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 | 29.45 Picograms | Standard Deviation 1.487 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 8 | 29.13 Picograms | Standard Deviation 2.325 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | 29.56 Picograms | Standard Deviation 1.551 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -2) | 29.23 Picograms | Standard Deviation 2.077 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 | 29.40 Picograms | Standard Deviation 2.449 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -2) | 29.37 Picograms | Standard Deviation 2.062 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 8 | 29.39 Picograms | Standard Deviation 2.273 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 | 29.29 Picograms | Standard Deviation 2.227 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | 28.62 Picograms | Standard Deviation 1.362 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 | 29.02 Picograms | Standard Deviation 2.137 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | 29.79 Picograms | Standard Deviation 1.516 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 8 | 29.17 Picograms | Standard Deviation 2.189 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -2) | 29.21 Picograms | Standard Deviation 2.005 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits
Time frame: Baseline (Day -2), Day 8, Day 9, Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -2) | 85.93 Femtoliter | Standard Deviation 5.041 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 8 | 85.95 Femtoliter | Standard Deviation 3.851 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | 85.00 Femtoliter | Standard Deviation 7.113 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 14 | 86.25 Femtoliter | Standard Deviation 3.841 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 8 | 85.57 Femtoliter | Standard Deviation 5.391 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | 86.42 Femtoliter | Standard Deviation 3.592 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 14 | 86.17 Femtoliter | Standard Deviation 5.378 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -2) | 85.96 Femtoliter | Standard Deviation 5.039 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | 84.61 Femtoliter | Standard Deviation 2.623 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 8 | 86.29 Femtoliter | Standard Deviation 5.417 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 14 | 86.05 Femtoliter | Standard Deviation 5.265 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -2) | 86.26 Femtoliter | Standard Deviation 4.971 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 14 | 85.53 Femtoliter | Standard Deviation 4.993 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 8 | 84.91 Femtoliter | Standard Deviation 4.948 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -2) | 85.92 Femtoliter | Standard Deviation 4.767 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | 87.08 Femtoliter | Standard Deviation 4.109 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Hematocrit
Blood samples were collected at indicated time points to analyze hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits
Time frame: Baseline (Day -2), Day 8, Day 9, Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day -2) | 0.4163 Proportion of red blood cells in blood | Standard Deviation 0.03226 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 8 | 0.4099 Proportion of red blood cells in blood | Standard Deviation 0.037 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 9 | 0.4134 Proportion of red blood cells in blood | Standard Deviation 0.04315 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 14 | 0.4118 Proportion of red blood cells in blood | Standard Deviation 0.03753 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 8 | 0.4120 Proportion of red blood cells in blood | Standard Deviation 0.03334 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 9 | 0.4086 Proportion of red blood cells in blood | Standard Deviation 0.03431 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 14 | 0.4107 Proportion of red blood cells in blood | Standard Deviation 0.03242 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day -2) | 0.4131 Proportion of red blood cells in blood | Standard Deviation 0.03985 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 9 | 0.4247 Proportion of red blood cells in blood | Standard Deviation 0.02835 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 8 | 0.4123 Proportion of red blood cells in blood | Standard Deviation 0.03874 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 14 | 0.4175 Proportion of red blood cells in blood | Standard Deviation 0.04266 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day -2) | 0.4157 Proportion of red blood cells in blood | Standard Deviation 0.04031 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 14 | 0.4189 Proportion of red blood cells in blood | Standard Deviation 0.0396 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 8 | 0.4171 Proportion of red blood cells in blood | Standard Deviation 0.03831 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day -2) | 0.4167 Proportion of red blood cells in blood | Standard Deviation 0.03829 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 9 | 0.4029 Proportion of red blood cells in blood | Standard Deviation 0.03272 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -2) | 141.8 Grams per liter | Standard Deviation 12.9 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 8 | 139.9 Grams per liter | Standard Deviation 14.26 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 9 | 139.4 Grams per liter | Standard Deviation 18.82 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 14 | 140.7 Grams per liter | Standard Deviation 14.01 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 8 | 140.3 Grams per liter | Standard Deviation 13.45 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 9 | 140.0 Grams per liter | Standard Deviation 13.6 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 14 | 140.1 Grams per liter | Standard Deviation 12.91 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -2) | 140.5 Grams per liter | Standard Deviation 15.05 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 9 | 143.7 Grams per liter | Standard Deviation 10.15 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 8 | 140.4 Grams per liter | Standard Deviation 14.81 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 14 | 142.1 Grams per liter | Standard Deviation 16.28 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -2) | 141.6 Grams per liter | Standard Deviation 15.47 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 14 | 142.2 Grams per liter | Standard Deviation 15.27 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 8 | 143.4 Grams per liter | Standard Deviation 15 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day -2) | 141.7 Grams per liter | Standard Deviation 14.37 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 9 | 137.7 Grams per liter | Standard Deviation 11.49 |
Secondary
Part 2: Absolute Values for Urinalysis Parameter: pH
Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Baseline (Day -2) | 6.10 pH | Standard Deviation 0.386 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 8 | 5.90 pH | Standard Deviation 0.327 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 9 | 5.75 pH | Standard Deviation 0.264 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 14 | 6.00 pH | Standard Deviation 0.491 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 8 | 5.88 pH | Standard Deviation 0.415 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 9 | 5.91 pH | Standard Deviation 0.625 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 14 | 6.00 pH | Standard Deviation 0.378 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Baseline (Day -2) | 6.19 pH | Standard Deviation 0.574 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 9 | 6.06 pH | Standard Deviation 0.527 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 8 | 5.98 pH | Standard Deviation 0.302 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 14 | 6.13 pH | Standard Deviation 0.447 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: pH | Baseline (Day -2) | 6.09 pH | Standard Deviation 0.479 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 14 | 6.12 pH | Standard Deviation 0.475 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 8 | 6.02 pH | Standard Deviation 0.278 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Baseline (Day -2) | 6.13 pH | Standard Deviation 0.596 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 9 | 6.20 pH | Standard Deviation 0.483 |
Secondary
Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity
Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -2) | 1.0152 Ratio | Standard Deviation 0.00779 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 8 | 1.0180 Ratio | Standard Deviation 0.00761 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 9 | 1.0189 Ratio | Standard Deviation 0.00973 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 14 | 1.0165 Ratio | Standard Deviation 0.00779 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 14 | 1.0170 Ratio | Standard Deviation 0.00804 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 9 | 1.0219 Ratio | Standard Deviation 0.00762 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 8 | 1.0164 Ratio | Standard Deviation 0.00846 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -2) | 1.0153 Ratio | Standard Deviation 0.0093 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 9 | 1.0179 Ratio | Standard Deviation 0.00595 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 14 | 1.0165 Ratio | Standard Deviation 0.00782 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 8 | 1.0179 Ratio | Standard Deviation 0.00767 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -2) | 1.0167 Ratio | Standard Deviation 0.00894 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 14 | 1.0175 Ratio | Standard Deviation 0.00872 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day -2) | 1.0161 Ratio | Standard Deviation 0.0085 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 8 | 1.0188 Ratio | Standard Deviation 0.0059 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 9 | 1.0136 Ratio | Standard Deviation 0.0084 |
Secondary
Part 2: Absolute Values for Vital Parameter: Pulse Rate
Pulse rate was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Time frame: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 14 | 63.6 Beats per minute | Standard Deviation 9.47 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 8 | 63.9 Beats per minute | Standard Deviation 8.98 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 6 | 62.0 Beats per minute | Standard Deviation 6.87 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 7 | 63.4 Beats per minute | Standard Deviation 7.36 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 2 | 61.9 Beats per minute | Standard Deviation 8.37 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Baseline (Pre-dose, Day 1) | 62.5 Beats per minute | Standard Deviation 9.32 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 3 | 63.4 Beats per minute | Standard Deviation 9.67 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 9 | 69.2 Beats per minute | Standard Deviation 7.48 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 4 | 63.4 Beats per minute | Standard Deviation 8.59 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 5 | 64.4 Beats per minute | Standard Deviation 8.57 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 14 | 63.6 Beats per minute | Standard Deviation 8.18 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 3 | 63.0 Beats per minute | Standard Deviation 6.76 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Baseline (Pre-dose, Day 1) | 60.4 Beats per minute | Standard Deviation 7.68 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 6 | 63.0 Beats per minute | Standard Deviation 7.17 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 8 | 63.9 Beats per minute | Standard Deviation 6.75 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 7 | 61.6 Beats per minute | Standard Deviation 6.77 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 5 | 62.4 Beats per minute | Standard Deviation 7.52 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 2 | 62.4 Beats per minute | Standard Deviation 8.04 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 4 | 63.0 Beats per minute | Standard Deviation 7.38 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 9 | 66.8 Beats per minute | Standard Deviation 8.89 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 6 | 63.7 Beats per minute | Standard Deviation 8.89 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Baseline (Pre-dose, Day 1) | 61.8 Beats per minute | Standard Deviation 9.46 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 2 | 61.6 Beats per minute | Standard Deviation 7.22 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 3 | 62.2 Beats per minute | Standard Deviation 6.46 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 4 | 63.5 Beats per minute | Standard Deviation 7.88 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 5 | 63.3 Beats per minute | Standard Deviation 8.32 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 7 | 62.7 Beats per minute | Standard Deviation 7.4 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 8 | 63.9 Beats per minute | Standard Deviation 7.21 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 9 | 70.3 Beats per minute | Standard Deviation 12.72 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 14 | 63.6 Beats per minute | Standard Deviation 6.49 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 6 | 66.5 Beats per minute | Standard Deviation 7.13 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 8 | 65.7 Beats per minute | Standard Deviation 6.92 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 3 | 63.9 Beats per minute | Standard Deviation 7.81 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 2 | 63.2 Beats per minute | Standard Deviation 9.05 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 14 | 61.1 Beats per minute | Standard Deviation 7.33 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 9 | 70.4 Beats per minute | Standard Deviation 10.19 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Baseline (Pre-dose, Day 1) | 61.0 Beats per minute | Standard Deviation 6.85 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 7 | 65.8 Beats per minute | Standard Deviation 7.4 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 5 | 66.0 Beats per minute | Standard Deviation 7.08 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Pulse Rate | Day 4 | 64.5 Beats per minute | Standard Deviation 7.76 |
Secondary
Part 2: Absolute Values for Vital Parameters: SBP and DBP
SBP and DBP were measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Time frame: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 6 | 60.3 Millimeters of mercury | Standard Deviation 5.69 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 2 | 59.6 Millimeters of mercury | Standard Deviation 6.27 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 4 | 103.1 Millimeters of mercury | Standard Deviation 9.37 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 5 | 60.3 Millimeters of mercury | Standard Deviation 8.15 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 3 | 60.9 Millimeters of mercury | Standard Deviation 7.26 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Baseline (Pre-dose, Day 1) | 106.0 Millimeters of mercury | Standard Deviation 9.39 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 4 | 59.8 Millimeters of mercury | Standard Deviation 7.61 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 2 | 103.9 Millimeters of mercury | Standard Deviation 8.18 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 9 | 66.2 Millimeters of mercury | Standard Deviation 5.67 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 5 | 105.7 Millimeters of mercury | Standard Deviation 9.5 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 6 | 105.2 Millimeters of mercury | Standard Deviation 8.8 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 8 | 62.3 Millimeters of mercury | Standard Deviation 6.72 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 7 | 107.6 Millimeters of mercury | Standard Deviation 10.34 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 14 | 61.6 Millimeters of mercury | Standard Deviation 7.86 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 8 | 109.9 Millimeters of mercury | Standard Deviation 9.03 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 3 | 104.3 Millimeters of mercury | Standard Deviation 9.82 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 7 | 61.0 Millimeters of mercury | Standard Deviation 6.14 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | ,SBP, Day 9 | 115.9 Millimeters of mercury | Standard Deviation 9.72 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 14 | 105.6 Millimeters of mercury | Standard Deviation 9.51 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Baseline (Pre-dose, Day 1) | 61.1 Millimeters of mercury | Standard Deviation 7.04 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 6 | 60.1 Millimeters of mercury | Standard Deviation 6.46 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Baseline (Pre-dose, Day 1) | 60.9 Millimeters of mercury | Standard Deviation 6.61 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 9 | 56.6 Millimeters of mercury | Standard Deviation 3.83 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 5 | 59.3 Millimeters of mercury | Standard Deviation 6.23 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 6 | 104.7 Millimeters of mercury | Standard Deviation 8.6 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 2 | 59.3 Millimeters of mercury | Standard Deviation 6.32 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Baseline (Pre-dose, Day 1) | 106.7 Millimeters of mercury | Standard Deviation 11.69 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 14 | 62.8 Millimeters of mercury | Standard Deviation 6.65 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 14 | 108.0 Millimeters of mercury | Standard Deviation 10.02 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 3 | 60.0 Millimeters of mercury | Standard Deviation 7.46 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 7 | 106.7 Millimeters of mercury | Standard Deviation 9.23 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 4 | 60.0 Millimeters of mercury | Standard Deviation 7.36 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | ,SBP, Day 9 | 104.2 Millimeters of mercury | Standard Deviation 11.58 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 4 | 103.5 Millimeters of mercury | Standard Deviation 11.25 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 7 | 59.6 Millimeters of mercury | Standard Deviation 6.89 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 3 | 103.8 Millimeters of mercury | Standard Deviation 8.53 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 8 | 108.1 Millimeters of mercury | Standard Deviation 9.4 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 5 | 103.3 Millimeters of mercury | Standard Deviation 10.24 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 2 | 104.5 Millimeters of mercury | Standard Deviation 9.05 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 8 | 62.6 Millimeters of mercury | Standard Deviation 7.23 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 3 | 61.0 Millimeters of mercury | Standard Deviation 7.23 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Baseline (Pre-dose, Day 1) | 106.8 Millimeters of mercury | Standard Deviation 9.03 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 2 | 105.6 Millimeters of mercury | Standard Deviation 9.78 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 3 | 105.1 Millimeters of mercury | Standard Deviation 9.41 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 4 | 105.3 Millimeters of mercury | Standard Deviation 8.73 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 5 | 103.7 Millimeters of mercury | Standard Deviation 8.65 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 6 | 105.7 Millimeters of mercury | Standard Deviation 8.42 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 7 | 107.4 Millimeters of mercury | Standard Deviation 8.68 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 8 | 109.4 Millimeters of mercury | Standard Deviation 8.95 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | ,SBP, Day 9 | 109.0 Millimeters of mercury | Standard Deviation 7.48 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 14 | 107.8 Millimeters of mercury | Standard Deviation 9.38 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Baseline (Pre-dose, Day 1) | 62.1 Millimeters of mercury | Standard Deviation 7.12 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 2 | 60.9 Millimeters of mercury | Standard Deviation 6.65 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 4 | 61.0 Millimeters of mercury | Standard Deviation 5.4 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 5 | 59.1 Millimeters of mercury | Standard Deviation 5.88 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 6 | 61.6 Millimeters of mercury | Standard Deviation 6.99 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 7 | 61.1 Millimeters of mercury | Standard Deviation 6.71 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 8 | 61.4 Millimeters of mercury | Standard Deviation 7.18 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 9 | 61.3 Millimeters of mercury | Standard Deviation 5.41 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 14 | 61.8 Millimeters of mercury | Standard Deviation 6.47 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 14 | 106.3 Millimeters of mercury | Standard Deviation 10.43 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | ,SBP, Day 9 | 105.8 Millimeters of mercury | Standard Deviation 8.61 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 9 | 65.8 Millimeters of mercury | Standard Deviation 5.37 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 6 | 62.4 Millimeters of mercury | Standard Deviation 7 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 8 | 109.1 Millimeters of mercury | Standard Deviation 9.24 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 7 | 107.4 Millimeters of mercury | Standard Deviation 7.9 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 2 | 105.7 Millimeters of mercury | Standard Deviation 10.1 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 7 | 62.3 Millimeters of mercury | Standard Deviation 6.28 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 6 | 108.4 Millimeters of mercury | Standard Deviation 9.44 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 5 | 106.8 Millimeters of mercury | Standard Deviation 8.82 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Baseline (Pre-dose, Day 1) | 105.4 Millimeters of mercury | Standard Deviation 9.79 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 8 | 62.7 Millimeters of mercury | Standard Deviation 7.03 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 4 | 105.7 Millimeters of mercury | Standard Deviation 10.05 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 3 | 63.0 Millimeters of mercury | Standard Deviation 7.8 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | SBP, Day 3 | 105.3 Millimeters of mercury | Standard Deviation 11.3 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 4 | 62.8 Millimeters of mercury | Standard Deviation 6.1 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 2 | 60.9 Millimeters of mercury | Standard Deviation 6.1 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Baseline (Pre-dose, Day 1) | 61.4 Millimeters of mercury | Standard Deviation 6.18 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 14 | 61.2 Millimeters of mercury | Standard Deviation 6.91 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameters: SBP and DBP | DBP, Day 5 | 61.7 Millimeters of mercury | Standard Deviation 5.44 |
Secondary
Part 2: Absolute Values for Vital Parameter: Temperature
Temperature was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Time frame: Baseline (Pre-dose, Day 1), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, and Day 14
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Baseline (Pre-dose, Day 1) | 36.25 Degrees Celsius | Standard Deviation 0.304 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 11 | 36.05 Degrees Celsius | Standard Deviation 0.276 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 8 | 36.28 Degrees Celsius | Standard Deviation 0.368 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 2 | 36.22 Degrees Celsius | Standard Deviation 0.333 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 9 | 36.16 Degrees Celsius | Standard Deviation 0.431 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 10 | 36.05 Degrees Celsius | Standard Deviation 0.353 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 3 | 36.20 Degrees Celsius | Standard Deviation 0.449 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 1 | 36.14 Degrees Celsius | Standard Deviation 0.302 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 13 | 36.12 Degrees Celsius | Standard Deviation 0.327 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 4 | 36.21 Degrees Celsius | Standard Deviation 0.378 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 5 | 36.26 Degrees Celsius | Standard Deviation 0.407 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 12 | 36.10 Degrees Celsius | Standard Deviation 0.35 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 6 | 36.21 Degrees Celsius | Standard Deviation 0.364 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 14 | 36.25 Degrees Celsius | Standard Deviation 0.261 |
| Part 1: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 7 | 36.20 Degrees Celsius | Standard Deviation 0.315 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 7 | 36.19 Degrees Celsius | Standard Deviation 0.303 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 11 | 36.22 Degrees Celsius | Standard Deviation 0.333 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 4 | 36.13 Degrees Celsius | Standard Deviation 0.353 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 8 | 36.25 Degrees Celsius | Standard Deviation 0.312 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 1 | 36.29 Degrees Celsius | Standard Deviation 0.313 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 10 | 36.10 Degrees Celsius | Standard Deviation 0.323 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 12 | 36.14 Degrees Celsius | Standard Deviation 0.285 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 9 | 36.18 Degrees Celsius | Standard Deviation 0.363 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 2 | 36.17 Degrees Celsius | Standard Deviation 0.266 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 6 | 36.21 Degrees Celsius | Standard Deviation 0.393 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 14 | 36.31 Degrees Celsius | Standard Deviation 0.328 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 13 | 36.25 Degrees Celsius | Standard Deviation 0.314 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 5 | 36.08 Degrees Celsius | Standard Deviation 0.326 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 3 | 36.09 Degrees Celsius | Standard Deviation 0.283 |
| Part 1 : GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Baseline (Pre-dose, Day 1) | 36.28 Degrees Celsius | Standard Deviation 0.335 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 7 | 36.22 Degrees Celsius | Standard Deviation 0.31 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Baseline (Pre-dose, Day 1) | 36.22 Degrees Celsius | Standard Deviation 0.379 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 1 | 36.25 Degrees Celsius | Standard Deviation 0.245 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 2 | 36.18 Degrees Celsius | Standard Deviation 0.309 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 3 | 36.14 Degrees Celsius | Standard Deviation 0.353 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 4 | 36.18 Degrees Celsius | Standard Deviation 0.288 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 5 | 36.16 Degrees Celsius | Standard Deviation 0.272 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 6 | 36.17 Degrees Celsius | Standard Deviation 0.32 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 8 | 36.32 Degrees Celsius | Standard Deviation 0.344 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 9 | 36.23 Degrees Celsius | Standard Deviation 0.327 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 10 | 36.17 Degrees Celsius | Standard Deviation 0.296 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 11 | 36.28 Degrees Celsius | Standard Deviation 0.397 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 12 | 36.26 Degrees Celsius | Standard Deviation 0.333 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 13 | 36.20 Degrees Celsius | Standard Deviation 0.308 |
| Part 2: Placebo | Part 2: Absolute Values for Vital Parameter: Temperature | Day 14 | 36.36 Degrees Celsius | Standard Deviation 0.224 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 6 | 36.16 Degrees Celsius | Standard Deviation 0.304 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 1 | 36.21 Degrees Celsius | Standard Deviation 0.378 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 11 | 36.19 Degrees Celsius | Standard Deviation 0.327 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 5 | 36.18 Degrees Celsius | Standard Deviation 0.289 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 4 | 36.23 Degrees Celsius | Standard Deviation 0.344 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Baseline (Pre-dose, Day 1) | 36.32 Degrees Celsius | Standard Deviation 0.303 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 12 | 36.07 Degrees Celsius | Standard Deviation 0.333 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 3 | 36.15 Degrees Celsius | Standard Deviation 0.344 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 2 | 36.18 Degrees Celsius | Standard Deviation 0.331 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 14 | 36.31 Degrees Celsius | Standard Deviation 0.368 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 9 | 36.12 Degrees Celsius | Standard Deviation 0.349 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 8 | 36.34 Degrees Celsius | Standard Deviation 0.271 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 13 | 36.21 Degrees Celsius | Standard Deviation 0.397 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 10 | 36.13 Degrees Celsius | Standard Deviation 0.36 |
| Part 2: GSK3640254 500 mg | Part 2: Absolute Values for Vital Parameter: Temperature | Day 7 | 36.22 Degrees Celsius | Standard Deviation 0.305 |
Secondary
Part 2: AUC(0-tau) of GSK3640254 100 mg and GSK3640254 500 mg
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: AUC(0-tau) of GSK3640254 100 mg and GSK3640254 500 mg | 13830 Hours*nanograms per milliliter | Geometric Coefficient of Variation 37.2 |
| Part 1 : GSK3640254 500 mg | Part 2: AUC(0-tau) of GSK3640254 100 mg and GSK3640254 500 mg | 67490 Hours*nanograms per milliliter | Geometric Coefficient of Variation 42.9 |
Secondary
Part 2: AUC(0-t) of GSK3640254 100 mg and GSK3640254 500 mg
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods .
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: AUC(0-t) of GSK3640254 100 mg and GSK3640254 500 mg | 13840 Hours*nanograms per milliliter | Geometric Coefficient of Variation 37.2 |
| Part 1 : GSK3640254 500 mg | Part 2: AUC(0-t) of GSK3640254 100 mg and GSK3640254 500 mg | 67520 Hours*nanograms per milliliter | Geometric Coefficient of Variation 42.9 |
Secondary
Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein
Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 8 | -3.1 Grams per liter | Standard Deviation 4.31 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 14 | -0.4 Grams per liter | Standard Deviation 1.99 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 14 | -1.3 Grams per liter | Standard Deviation 4.32 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 8 | -0.6 Grams per liter | Standard Deviation 1.8 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 14 | -0.9 Grams per liter | Standard Deviation 2.82 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 9 | 0.4 Grams per liter | Standard Deviation 2.07 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 9 | 0.4 Grams per liter | Standard Deviation 3.86 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 9 | 0.0 Grams per liter | Standard Deviation 2.11 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 8 | -2.5 Grams per liter | Standard Deviation 3 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 9 | -0.5 Grams per liter | Standard Deviation 2.38 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 8 | -2.1 Grams per liter | Standard Deviation 3.86 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 14 | 0.1 Grams per liter | Standard Deviation 1.88 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 9 | -0.5 Grams per liter | Standard Deviation 3.14 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 8 | -2.0 Grams per liter | Standard Deviation 2.58 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 14 | -1.2 Grams per liter | Standard Deviation 2.32 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 14 | -1.1 Grams per liter | Standard Deviation 3.41 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 9 | -0.9 Grams per liter | Standard Deviation 5.19 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 8 | -0.1 Grams per liter | Standard Deviation 1.96 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 9 | 0.4 Grams per liter | Standard Deviation 1.94 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 8 | -1.6 Grams per liter | Standard Deviation 1.89 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 9 | 1.1 Grams per liter | Standard Deviation 2.15 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 14 | 0.1 Grams per liter | Standard Deviation 2.72 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 8 | -0.2 Grams per liter | Standard Deviation 2.12 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 14 | 0.6 Grams per liter | Standard Deviation 1.7 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 8 | -1.8 Grams per liter | Standard Deviation 3.38 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 9 | 1.6 Grams per liter | Standard Deviation 3.91 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 14 | 0.7 Grams per liter | Standard Deviation 4.05 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 8 | -2.2 Grams per liter | Standard Deviation 3.45 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 8 | -0.1 Grams per liter | Standard Deviation 1.96 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 14 | -2.3 Grams per liter | Standard Deviation 2.21 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 14 | -2.6 Grams per liter | Standard Deviation 2.98 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Total protein, Day 9 | 0.7 Grams per liter | Standard Deviation 3.95 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 9 | 0.7 Grams per liter | Standard Deviation 2.45 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 14 | -0.2 Grams per liter | Standard Deviation 1.46 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Globulin, Day 9 | 0.0 Grams per liter | Standard Deviation 1.63 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein | Albumin, Day 8 | -2.2 Grams per liter | Standard Deviation 2.05 |
Secondary
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 8 | -0.5 International units per liter | Standard Deviation 2.42 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 14 | -1.5 International units per liter | Standard Deviation 3.42 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 14 | -1.8 International units per liter | Standard Deviation 6.18 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 8 | -2.1 International units per liter | Standard Deviation 4.76 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 9 | 0.9 International units per liter | Standard Deviation 2.38 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 8 | -1.6 International units per liter | Standard Deviation 3.66 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 8 | -11.2 International units per liter | Standard Deviation 15.99 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 14 | 8.8 International units per liter | Standard Deviation 90.46 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 14 | -2.3 International units per liter | Standard Deviation 5.67 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 9 | 0.7 International units per liter | Standard Deviation 6.09 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 9 | 39.7 International units per liter | Standard Deviation 69.36 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 8 | -18.9 International units per liter | Standard Deviation 24.04 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 8 | -2.2 International units per liter | Standard Deviation 7.77 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 14 | -5.4 International units per liter | Standard Deviation 15.88 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 14 | -1.0 International units per liter | Standard Deviation 3.23 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 9 | -0.1 International units per liter | Standard Deviation 1.97 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 9 | -3.6 International units per liter | Standard Deviation 7.29 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 9 | 1.9 International units per liter | Standard Deviation 13.49 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 14 | 0.6 International units per liter | Standard Deviation 8.68 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 8 | -0.9 International units per liter | Standard Deviation 6.65 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 9 | -0.9 International units per liter | Standard Deviation 2.34 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 8 | -0.7 International units per liter | Standard Deviation 4.55 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 9 | -0.1 International units per liter | Standard Deviation 5.82 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 14 | -1.1 International units per liter | Standard Deviation 7.33 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 8 | 0.0 International units per liter | Standard Deviation 11.09 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 9 | -0.3 International units per liter | Standard Deviation 1.62 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 14 | -0.7 International units per liter | Standard Deviation 4.26 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 8 | -1.0 International units per liter | Standard Deviation 2.44 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 9 | -0.4 International units per liter | Standard Deviation 1.03 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 14 | -1.3 International units per liter | Standard Deviation 2.74 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 8 | 28.2 International units per liter | Standard Deviation 446.48 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 9 | -5.7 International units per liter | Standard Deviation 18.29 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 14 | -30.8 International units per liter | Standard Deviation 80.07 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 8 | -12.5 International units per liter | Standard Deviation 20.51 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 9 | -11.6 International units per liter | Standard Deviation 12.66 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 14 | -10.8 International units per liter | Standard Deviation 20.17 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 9 | 2.1 International units per liter | Standard Deviation 5.84 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 8 | -0.7 International units per liter | Standard Deviation 1.85 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 9 | 0.3 International units per liter | Standard Deviation 1.22 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 8 | -1.2 International units per liter | Standard Deviation 4.94 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 14 | -3.3 International units per liter | Standard Deviation 16.67 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 14 | -0.8 International units per liter | Standard Deviation 2.33 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 9 | 0.0 International units per liter | Standard Deviation 6.78 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 8 | -31.7 International units per liter | Standard Deviation 89.14 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 14 | -1.6 International units per liter | Standard Deviation 6.24 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 9 | 63.9 International units per liter | Standard Deviation 126.8 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 8 | -2.5 International units per liter | Standard Deviation 4.9 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 14 | -22.5 International units per liter | Standard Deviation 88.7 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 9 | -0.6 International units per liter | Standard Deviation 2.24 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 8 | -1.9 International units per liter | Standard Deviation 2.49 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 14 | 0.5 International units per liter | Standard Deviation 6.83 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 9 | 0.7 International units per liter | Standard Deviation 2.4 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 8 | -11.9 International units per liter | Standard Deviation 14.29 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 14 | -1.2 International units per liter | Standard Deviation 3.36 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 8 | -0.2 International units per liter | Standard Deviation 3.73 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 8 | -13.4 International units per liter | Standard Deviation 17.89 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 9 | 15.8 International units per liter | Standard Deviation 29.26 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 8 | -0.1 International units per liter | Standard Deviation 3.51 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 8 | -1.7 International units per liter | Standard Deviation 4.71 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 8 | 2.0 International units per liter | Standard Deviation 8.06 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 9 | 3.8 International units per liter | Standard Deviation 9.87 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 9 | 0.3 International units per liter | Standard Deviation 0.67 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 9 | 1.1 International units per liter | Standard Deviation 3.63 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 14 | -8.1 International units per liter | Standard Deviation 15 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 14 | -22.0 International units per liter | Standard Deviation 100.57 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | GGT, Day 14 | -1.3 International units per liter | Standard Deviation 4.28 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALT, Day 14 | 1.7 International units per liter | Standard Deviation 4.19 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | ALP, Day 14 | -2.0 International units per liter | Standard Deviation 6.55 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 14 | 0.0 International units per liter | Standard Deviation 3.11 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Creatine kinase, Day 8 | -45.0 International units per liter | Standard Deviation 97.35 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | AST, Day 9 | 1.1 International units per liter | Standard Deviation 3.98 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase | Lactate dehydrogenase, Day 9 | 4.0 International units per liter | Standard Deviation 9.72 |
Secondary
Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Blood samples were collected at indicated timepoints to analyze amylase, lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase, Day 8 | -0.8 Units per liter | Standard Deviation 9.9 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase, Day 9 | 3.1 Units per liter | Standard Deviation 7.87 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase, Day 14 | -2.3 Units per liter | Standard Deviation 7.59 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase, Day 8 | 4.4 Units per liter | Standard Deviation 27.2 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase, Day 9 | 0.9 Units per liter | Standard Deviation 3.63 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase, Day 14 | -1.5 Units per liter | Standard Deviation 5.66 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase, Day 14 | -0.5 Units per liter | Standard Deviation 7.71 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase, Day 8 | -0.7 Units per liter | Standard Deviation 7.57 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase, Day 8 | -0.1 Units per liter | Standard Deviation 11.55 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase, Day 14 | -0.7 Units per liter | Standard Deviation 9.91 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase, Day 9 | 2.1 Units per liter | Standard Deviation 7.61 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase, Day 9 | -0.9 Units per liter | Standard Deviation 5.28 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase, Day 9 | -1.0 Units per liter | Standard Deviation 7.09 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase, Day 14 | -4.1 Units per liter | Standard Deviation 16.3 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase, Day 8 | -1.5 Units per liter | Standard Deviation 9.36 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase, Day 14 | -1.8 Units per liter | Standard Deviation 8.08 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase, Day 9 | 0.2 Units per liter | Standard Deviation 5.52 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase, Day 8 | -3.6 Units per liter | Standard Deviation 11.84 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase, Day 9 | 1.7 Units per liter | Standard Deviation 3.86 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase, Day 14 | -2.6 Units per liter | Standard Deviation 9.97 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase, Day 9 | 0.4 Units per liter | Standard Deviation 2.84 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase, Day 8 | -3.0 Units per liter | Standard Deviation 9.31 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase, Day 8 | -2.5 Units per liter | Standard Deviation 10.69 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase, Day 14 | -2.3 Units per liter | Standard Deviation 11 |
Secondary
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 8 | -0.33 Micromoles per liter | Standard Deviation 0.621 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 14 | -0.12 Micromoles per liter | Standard Deviation 0.492 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 9 | -0.52 Micromoles per liter | Standard Deviation 3.082 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 8 | -0.03 Micromoles per liter | Standard Deviation 5.326 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 14 | -0.65 Micromoles per liter | Standard Deviation 2.832 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 14 | 0.67 Micromoles per liter | Standard Deviation 6.049 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 8 | -6.0 Micromoles per liter | Standard Deviation 31.24 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 9 | 1.59 Micromoles per liter | Standard Deviation 7.022 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 9 | -0.12 Micromoles per liter | Standard Deviation 0.512 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 9 | -4.7 Micromoles per liter | Standard Deviation 12.04 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 14 | -4.1 Micromoles per liter | Standard Deviation 30.4 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 8 | -2.15 Micromoles per liter | Standard Deviation 3.823 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 9 | 3.23 Micromoles per liter | Standard Deviation 4.312 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 8 | -1.16 Micromoles per liter | Standard Deviation 2.946 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 8 | 2.7 Micromoles per liter | Standard Deviation 23.18 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 14 | 1.36 Micromoles per liter | Standard Deviation 3.546 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 8 | -0.17 Micromoles per liter | Standard Deviation 0.581 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 9 | 1.21 Micromoles per liter | Standard Deviation 2.806 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 8 | 7.07 Micromoles per liter | Standard Deviation 7.515 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 14 | -6.3 Micromoles per liter | Standard Deviation 28.01 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 9 | 13.4 Micromoles per liter | Standard Deviation 24.46 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 14 | 2.71 Micromoles per liter | Standard Deviation 5.478 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 14 | 0.14 Micromoles per liter | Standard Deviation 0.582 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 9 | 0.15 Micromoles per liter | Standard Deviation 0.589 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 9 | 1.10 Micromoles per liter | Standard Deviation 3.561 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 8 | -1.15 Micromoles per liter | Standard Deviation 6.209 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 9 | -0.48 Micromoles per liter | Standard Deviation 7.226 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 14 | -0.37 Micromoles per liter | Standard Deviation 5.89 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 8 | -8.1 Micromoles per liter | Standard Deviation 27.06 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 9 | 17.7 Micromoles per liter | Standard Deviation 16.53 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 14 | -4.6 Micromoles per liter | Standard Deviation 36.43 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 8 | -0.17 Micromoles per liter | Standard Deviation 3.235 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 14 | 1.54 Micromoles per liter | Standard Deviation 3.563 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 8 | -0.06 Micromoles per liter | Standard Deviation 0.578 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 9 | 0.19 Micromoles per liter | Standard Deviation 0.625 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 14 | 0.19 Micromoles per liter | Standard Deviation 0.618 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 14 | -15.7 Micromoles per liter | Standard Deviation 26.94 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 9 | -17.1 Micromoles per liter | Standard Deviation 24.15 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 8 | 1.74 Micromoles per liter | Standard Deviation 5.394 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 8 | 0.14 Micromoles per liter | Standard Deviation 0.821 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Urate, Day 8 | -23.4 Micromoles per liter | Standard Deviation 26.58 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 14 | 1.30 Micromoles per liter | Standard Deviation 4.255 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 14 | 0.00 Micromoles per liter | Standard Deviation 0.582 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Direct Bilirubin, Day 9 | 0.22 Micromoles per liter | Standard Deviation 0.503 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 9 | -0.07 Micromoles per liter | Standard Deviation 2.873 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 8 | -0.06 Micromoles per liter | Standard Deviation 3.984 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Creatinine, Day 9 | 2.13 Micromoles per liter | Standard Deviation 6.927 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin | Total Bilirubin, Day 14 | 0.01 Micromoles per liter | Standard Deviation 3.193 |
Secondary
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen.Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 8 | -1.0 Millimoles per liter | Standard Deviation 1.95 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 9 | -0.5 Millimoles per liter | Standard Deviation 1.9 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 14 | -0.102 Millimoles per liter | Standard Deviation 0.509 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 14 | 0.027 Millimoles per liter | Standard Deviation 0.1225 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 14 | -0.2 Millimoles per liter | Standard Deviation 1.46 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 8 | 0.7 Millimoles per liter | Standard Deviation 1.92 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 9 | 0.016 Millimoles per liter | Standard Deviation 0.0819 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 9 | -0.6 Millimoles per liter | Standard Deviation 1.71 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 8 | -0.041 Millimoles per liter | Standard Deviation 0.282 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 14 | 1.0 Millimoles per liter | Standard Deviation 1.81 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 8 | 0.751 Millimoles per liter | Standard Deviation 1.0248 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 8 | -0.009 Millimoles per liter | Standard Deviation 0.106 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 8 | -0.017 Millimoles per liter | Standard Deviation 0.0443 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 14 | 0.098 Millimoles per liter | Standard Deviation 0.8195 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 9 | -0.020 Millimoles per liter | Standard Deviation 0.0389 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 14 | -0.033 Millimoles per liter | Standard Deviation 0.3197 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 14 | 0.5 Millimoles per liter | Standard Deviation 2.24 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 14 | -0.013 Millimoles per liter | Standard Deviation 0.0431 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 8 | -0.019 Millimoles per liter | Standard Deviation 0.333 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 9 | -0.4 Millimoles per liter | Standard Deviation 0.97 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 9 | -0.050 Millimoles per liter | Standard Deviation 0.3006 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 14 | -0.052 Millimoles per liter | Standard Deviation 0.2523 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 8 | -0.148 Millimoles per liter | Standard Deviation 0.4156 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 8 | -0.4 Millimoles per liter | Standard Deviation 2.23 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 8 | -0.2 Millimoles per liter | Standard Deviation 2.02 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 9 | 0.8 Millimoles per liter | Standard Deviation 1.55 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 9 | 0.023 Millimoles per liter | Standard Deviation 0.3045 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 14 | 0.07 Millimoles per liter | Standard Deviation 0.448 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 14 | -0.4 Millimoles per liter | Standard Deviation 1.63 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 9 | 0.557 Millimoles per liter | Standard Deviation 0.2739 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 8 | -0.059 Millimoles per liter | Standard Deviation 0.0737 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 9 | -0.036 Millimoles per liter | Standard Deviation 0.3198 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 9 | -0.05 Millimoles per liter | Standard Deviation 0.299 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 9 | 0.001 Millimoles per liter | Standard Deviation 0.0798 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 14 | -0.010 Millimoles per liter | Standard Deviation 0.0754 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 8 | -0.02 Millimoles per liter | Standard Deviation 0.458 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 8 | -0.08 Millimoles per liter | Standard Deviation 0.302 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 8 | -0.6 Millimoles per liter | Standard Deviation 1.62 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 8 | 0.890 Millimoles per liter | Standard Deviation 0.784 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 14 | 0.000 Millimoles per liter | Standard Deviation 0.0961 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 8 | -0.111 Millimoles per liter | Standard Deviation 0.3637 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 9 | -1.1 Millimoles per liter | Standard Deviation 1.45 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 14 | 0.173 Millimoles per liter | Standard Deviation 0.9149 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 9 | -0.119 Millimoles per liter | Standard Deviation 0.3171 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 14 | -0.003 Millimoles per liter | Standard Deviation 0.0555 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 14 | 0.2 Millimoles per liter | Standard Deviation 1.92 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 14 | -0.181 Millimoles per liter | Standard Deviation 0.4539 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 9 | -0.001 Millimoles per liter | Standard Deviation 0.0641 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 9 | -0.097 Millimoles per liter | Standard Deviation 0.2744 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 8 | -0.6 Millimoles per liter | Standard Deviation 1.62 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 8 | 0.029 Millimoles per liter | Standard Deviation 0.3396 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 9 | 0.631 Millimoles per liter | Standard Deviation 0.5449 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 8 | -0.9 Millimoles per liter | Standard Deviation 1.96 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 9 | -0.2 Millimoles per liter | Standard Deviation 1.4 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 14 | -0.3 Millimoles per liter | Standard Deviation 1.51 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 8 | 0.031 Millimoles per liter | Standard Deviation 0.0971 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 14 | -0.127 Millimoles per liter | Standard Deviation 0.3297 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 14 | 0.2 Millimoles per liter | Standard Deviation 1.85 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 9 | -0.025 Millimoles per liter | Standard Deviation 0.1053 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 9 | -0.18 Millimoles per liter | Standard Deviation 0.343 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 9 | 0.005 Millimoles per liter | Standard Deviation 0.4131 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 8 | -0.018 Millimoles per liter | Standard Deviation 0.0379 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 8 | 0.1 Millimoles per liter | Standard Deviation 1.35 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 14 | -0.1 Millimoles per liter | Standard Deviation 1.87 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 8 | -0.116 Millimoles per liter | Standard Deviation 0.4323 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 9 | -0.001 Millimoles per liter | Standard Deviation 0.037 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 14 | 0.07 Millimoles per liter | Standard Deviation 0.373 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 8 | -0.037 Millimoles per liter | Standard Deviation 0.0795 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 9 | 1.0 Millimoles per liter | Standard Deviation 1.1 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 14 | 0.002 Millimoles per liter | Standard Deviation 0.0334 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 14 | 0.057 Millimoles per liter | Standard Deviation 0.2787 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 9 | -0.4 Millimoles per liter | Standard Deviation 1.12 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 9 | -1.0 Millimoles per liter | Standard Deviation 1.58 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 8 | -0.023 Millimoles per liter | Standard Deviation 0.3001 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 9 | 0.040 Millimoles per liter | Standard Deviation 0.1949 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 14 | -0.109 Millimoles per liter | Standard Deviation 0.322 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 8 | -0.054 Millimoles per liter | Standard Deviation 0.3518 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 9 | 0.081 Millimoles per liter | Standard Deviation 0.4041 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 14 | 0.032 Millimoles per liter | Standard Deviation 0.4605 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 8 | -0.011 Millimoles per liter | Standard Deviation 0.0364 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 9 | -0.013 Millimoles per liter | Standard Deviation 0.02 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 14 | 0.008 Millimoles per liter | Standard Deviation 0.0379 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 8 | -0.002 Millimoles per liter | Standard Deviation 0.2699 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 9 | -0.153 Millimoles per liter | Standard Deviation 0.1572 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 14 | 0.031 Millimoles per liter | Standard Deviation 0.3383 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 8 | 0.0 Millimoles per liter | Standard Deviation 1.92 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 9 | 1.2 Millimoles per liter | Standard Deviation 0.83 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 14 | 0.1 Millimoles per liter | Standard Deviation 1.77 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 8 | -0.034 Millimoles per liter | Standard Deviation 0.0744 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 9 | 0.050 Millimoles per liter | Standard Deviation 0.0825 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 14 | 0.042 Millimoles per liter | Standard Deviation 0.0671 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 8 | -1.2 Millimoles per liter | Standard Deviation 1.63 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 9 | -0.8 Millimoles per liter | Standard Deviation 1.86 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 14 | 0.1 Millimoles per liter | Standard Deviation 2.05 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 8 | -0.2 Millimoles per liter | Standard Deviation 1.83 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 14 | 0.5 Millimoles per liter | Standard Deviation 1.79 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 8 | 0.018 Millimoles per liter | Standard Deviation 0.0966 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 9 | -0.016 Millimoles per liter | Standard Deviation 0.0985 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 14 | 0.054 Millimoles per liter | Standard Deviation 0.1156 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 8 | -0.12 Millimoles per liter | Standard Deviation 0.401 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 9 | -0.03 Millimoles per liter | Standard Deviation 0.346 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 14 | 0.12 Millimoles per liter | Standard Deviation 0.343 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 8 | -0.9 Millimoles per liter | Standard Deviation 2.25 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 9 | -0.4 Millimoles per liter | Standard Deviation 2.07 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 14 | 0.8 Millimoles per liter | Standard Deviation 2.13 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 8 | 0.385 Millimoles per liter | Standard Deviation 0.9919 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 9 | 0.154 Millimoles per liter | Standard Deviation 0.7635 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 14 | 0.008 Millimoles per liter | Standard Deviation 1.003 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 14 | -0.020 Millimoles per liter | Standard Deviation 0.0584 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 9 | -0.032 Millimoles per liter | Standard Deviation 0.078 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 8 | 0.225 Millimoles per liter | Standard Deviation 1.1465 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 8 | -0.24 Millimoles per liter | Standard Deviation 0.455 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium, Day 8 | -0.063 Millimoles per liter | Standard Deviation 0.0617 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 14 | -0.8 Millimoles per liter | Standard Deviation 1.75 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 8 | -0.201 Millimoles per liter | Standard Deviation 0.3767 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 9 | -0.16 Millimoles per liter | Standard Deviation 0.295 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 9 | 0.4 Millimoles per liter | Standard Deviation 1.65 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap, Day 8 | -0.4 Millimoles per liter | Standard Deviation 2.1 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 14 | 0.046 Millimoles per liter | Standard Deviation 0.2481 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium, Day 14 | 0.14 Millimoles per liter | Standard Deviation 0.393 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 14 | 0.035 Millimoles per liter | Standard Deviation 0.2705 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 9 | -0.151 Millimoles per liter | Standard Deviation 0.1979 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 14 | 0.010 Millimoles per liter | Standard Deviation 1.1314 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 8 | -1.7 Millimoles per liter | Standard Deviation 1.68 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides, Day 8 | -0.100 Millimoles per liter | Standard Deviation 0.3027 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 14 | 0.003 Millimoles per liter | Standard Deviation 0.0353 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood Urea Nitrogen, Day 9 | -0.060 Millimoles per liter | Standard Deviation 0.7601 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 9 | -0.4 Millimoles per liter | Standard Deviation 2.01 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 9 | 0.009 Millimoles per liter | Standard Deviation 0.0328 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Magnesium, Day 8 | 0.005 Millimoles per liter | Standard Deviation 0.0394 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 9 | -0.139 Millimoles per liter | Standard Deviation 0.2262 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium, Day 14 | 0.1 Millimoles per liter | Standard Deviation 2.12 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 14 | 0.7 Millimoles per liter | Standard Deviation 2.22 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 9 | -1.1 Millimoles per liter | Standard Deviation 2.28 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 14 | -0.273 Millimoles per liter | Standard Deviation 0.4303 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 8 | 0.004 Millimoles per liter | Standard Deviation 0.1388 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride, Day 8 | -0.4 Millimoles per liter | Standard Deviation 2.03 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 14 | 0.3 Millimoles per liter | Standard Deviation 1.79 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol, Day 9 | -0.186 Millimoles per liter | Standard Deviation 0.3427 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 9 | -0.005 Millimoles per liter | Standard Deviation 0.0593 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 9 | -0.1 Millimoles per liter | Standard Deviation 1.1 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide, Day 8 | -1.2 Millimoles per liter | Standard Deviation 2.12 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose, Day 8 | -0.024 Millimoles per liter | Standard Deviation 0.2263 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate, Day 14 | 0.047 Millimoles per liter | Standard Deviation 0.1375 |
Secondary
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose
Population: QT/QTc Population comprised of all participants in the safety population with measurements at baseline as well as on-treatment with at least 1 post-dose time point with a valid change from Baseline in QTc value. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 8 Hour Post-dose | 7.3 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 3.5 Hour Post-dose | 4.5 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 1 Hour Post-dose | 5.4 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 6 Hour Post-dose | 9.6 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4 Hour Post-dose | 3.7 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 0.5 Hour Post-dose | 4.4 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 5 Hour Post-dose | 5.0 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4.5 Hour Post-dose | 5.4 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 10 Hour Post-dose | 2.6 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 2 Hour Post-dose | 5.9 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 24 Hour Post-dose | 2.0 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, Predose | 0.0 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 3 Hour Post-dose | 4.1 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 12 Hour Post-dose | 8.5 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 8 Hour Post-dose | 10.5 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, Predose | 2.8 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 0.5 Hour Post-dose | 8.5 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 1 Hour Post-dose | 9.1 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 2 Hour Post-dose | 7.0 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 3 Hour Post-dose | 5.6 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 3.5 Hour Post-dose | 6.0 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4 Hour Post-dose | 5.9 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4.5 Hour Post-dose | 6.9 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 5 Hour Post-dose | 7.5 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 6 Hour Post-dose | 12.7 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 10 Hour Post-dose | 7.0 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 12 Hour Post-dose | 9.2 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 24 Hour Post-dose | 3.3 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 12 Hour Post-dose | 8.1 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 6 Hour Post-dose | 8.6 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 3 Hour Post-dose | 2.7 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 2 Hour Post-dose | 4.5 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 8 Hour Post-dose | 6.3 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 1 Hour Post-dose | 5.2 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, Predose | 0.3 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 10 Hour Post-dose | 1.9 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 0.5 Hour Post-dose | 4.6 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4.5 Hour Post-dose | 3.7 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4 Hour Post-dose | 2.6 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 24 Hour Post-dose | -0.6 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 5 Hour Post-dose | 3.4 Beats per minute |
| Part 2: Placebo | Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 3.5 Hour Post-dose | 2.8 Beats per minute |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 8 | -0.002 10^9 cells per liter | Standard Deviation 0.0141 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 9 | 0.002 10^9 cells per liter | Standard Deviation 0.0123 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 14 | -0.005 10^9 cells per liter | Standard Deviation 0.0178 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 8 | 0.002 10^9 cells per liter | Standard Deviation 0.0363 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 9 | 0.008 10^9 cells per liter | Standard Deviation 0.0339 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 14 | -0.004 10^9 cells per liter | Standard Deviation 0.0382 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 8 | -0.129 10^9 cells per liter | Standard Deviation 0.3091 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 9 | 0.122 10^9 cells per liter | Standard Deviation 0.1852 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 14 | -0.066 10^9 cells per liter | Standard Deviation 0.2859 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 8 | 0.001 10^9 cells per liter | Standard Deviation 0.1206 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 9 | 0.047 10^9 cells per liter | Standard Deviation 0.0638 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 14 | -0.015 10^9 cells per liter | Standard Deviation 0.1347 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 8 | 0.018 10^9 cells per liter | Standard Deviation 0.8722 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 9 | 0.332 10^9 cells per liter | Standard Deviation 0.3485 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 14 | -0.155 10^9 cells per liter | Standard Deviation 0.5886 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 8 | -7.4 10^9 cells per liter | Standard Deviation 23.57 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 9 | -8.4 10^9 cells per liter | Standard Deviation 21.44 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 14 | -3.2 10^9 cells per liter | Standard Deviation 34.31 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 8 | -0.11 10^9 cells per liter | Standard Deviation 1.122 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 9 | 0.50 10^9 cells per liter | Standard Deviation 0.406 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 14 | -0.24 10^9 cells per liter | Standard Deviation 0.669 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 14 | -10.1 10^9 cells per liter | Standard Deviation 31.76 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 8 | -0.003 10^9 cells per liter | Standard Deviation 0.0111 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 9 | -0.092 10^9 cells per liter | Standard Deviation 0.3865 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 14 | -0.022 10^9 cells per liter | Standard Deviation 0.1413 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 8 | -0.161 10^9 cells per liter | Standard Deviation 0.3238 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 8 | -10.8 10^9 cells per liter | Standard Deviation 30.25 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 14 | -0.437 10^9 cells per liter | Standard Deviation 0.7038 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 8 | -0.272 10^9 cells per liter | Standard Deviation 0.6668 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 14 | -0.004 10^9 cells per liter | Standard Deviation 0.0105 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 9 | -0.32 10^9 cells per liter | Standard Deviation 1.138 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 9 | -3.5 10^9 cells per liter | Standard Deviation 22.1 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 9 | -0.174 10^9 cells per liter | Standard Deviation 0.8246 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 14 | -0.160 10^9 cells per liter | Standard Deviation 0.2649 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 9 | -0.004 10^9 cells per liter | Standard Deviation 0.0347 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 14 | 0.002 10^9 cells per liter | Standard Deviation 0.0641 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 14 | -0.63 10^9 cells per liter | Standard Deviation 0.864 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 8 | 0.014 10^9 cells per liter | Standard Deviation 0.09 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 8 | 0.007 10^9 cells per liter | Standard Deviation 0.0405 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 9 | -0.003 10^9 cells per liter | Standard Deviation 0.0101 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 8 | -0.42 10^9 cells per liter | Standard Deviation 0.858 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 9 | -0.030 10^9 cells per liter | Standard Deviation 0.1627 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 9 | -0.010 10^9 cells per liter | Standard Deviation 0.024 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 14 | -0.012 10^9 cells per liter | Standard Deviation 0.0528 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 8 | -0.071 10^9 cells per liter | Standard Deviation 0.3535 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 14 | -2.5 10^9 cells per liter | Standard Deviation 31.02 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 9 | -0.067 10^9 cells per liter | Standard Deviation 0.2649 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 14 | -0.041 10^9 cells per liter | Standard Deviation 0.3457 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 8 | -0.015 10^9 cells per liter | Standard Deviation 0.1119 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 9 | 0.010 10^9 cells per liter | Standard Deviation 0.0332 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 8 | -0.41 10^9 cells per liter | Standard Deviation 0.943 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 14 | -0.040 10^9 cells per liter | Standard Deviation 0.0967 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 8 | -0.319 10^9 cells per liter | Standard Deviation 0.7755 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 14 | -0.47 10^9 cells per liter | Standard Deviation 0.856 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 9 | 0.306 10^9 cells per liter | Standard Deviation 0.4508 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 14 | -0.386 10^9 cells per liter | Standard Deviation 0.6994 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 9 | 0.20 10^9 cells per liter | Standard Deviation 0.505 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 8 | -2.2 10^9 cells per liter | Standard Deviation 28.56 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 8 | -0.004 10^9 cells per liter | Standard Deviation 0.0088 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 14 | -0.001 10^9 cells per liter | Standard Deviation 0.0116 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 9 | 0.7 10^9 cells per liter | Standard Deviation 25.99 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 8 | -0.008 10^9 cells per liter | Standard Deviation 0.0525 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 9 | -0.011 10^9 cells per liter | Standard Deviation 0.0285 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 8 | -4.5 10^9 cells per liter | Standard Deviation 24.1 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 9 | 0.038 10^9 cells per liter | Standard Deviation 0.0382 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 9 | 7.9 10^9 cells per liter | Standard Deviation 28.29 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 8 | 0.005 10^9 cells per liter | Standard Deviation 0.0107 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 9 | 0.21 10^9 cells per liter | Standard Deviation 0.626 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 8 | 0.034 10^9 cells per liter | Standard Deviation 0.1148 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 14 | 0.014 10^9 cells per liter | Standard Deviation 0.3589 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 9 | 0.002 10^9 cells per liter | Standard Deviation 0.0103 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelets, Day 14 | -6.7 10^9 cells per liter | Standard Deviation 28.8 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 9 | 0.015 10^9 cells per liter | Standard Deviation 0.2089 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 14 | 0.006 10^9 cells per liter | Standard Deviation 0.0507 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophils,Day 14 | 0.007 10^9 cells per liter | Standard Deviation 0.0245 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 14 | -0.24 10^9 cells per liter | Standard Deviation 0.721 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 9 | 0.136 10^9 cells per liter | Standard Deviation 0.4495 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 8 | -0.022 10^9 cells per liter | Standard Deviation 0.704 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocytes,Day 8 | -0.01 10^9 cells per liter | Standard Deviation 0.837 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocytes,Day 8 | -0.039 10^9 cells per liter | Standard Deviation 0.2684 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophils,Day 14 | -0.262 10^9 cells per liter | Standard Deviation 0.5618 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 9 | -0.002 10^9 cells per liter | Standard Deviation 0.0204 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocytes,Day 14 | -0.022 10^9 cells per liter | Standard Deviation 0.1388 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophils,Day 8 | -0.001 10^9 cells per liter | Standard Deviation 0.0367 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time points to analyze erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 8 | -0.049 10^12 cells per liter | Standard Deviation 0.2246 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14 | -0.043 10^12 cells per liter | Standard Deviation 0.2695 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 9 | -0.023 10^12 cells per liter | Standard Deviation 0.1546 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 8 | 0.022 10^12 cells per liter | Standard Deviation 0.216 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14 | -0.031 10^12 cells per liter | Standard Deviation 0.213 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 9 | -0.090 10^12 cells per liter | Standard Deviation 0.2291 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 9 | 0.044 10^12 cells per liter | Standard Deviation 0.2637 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 8 | 0.008 10^12 cells per liter | Standard Deviation 0.2079 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14 | 0.081 10^12 cells per liter | Standard Deviation 0.2488 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 8 | -0.015 10^12 cells per liter | Standard Deviation 0.1855 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14 | -0.031 10^12 cells per liter | Standard Deviation 0.1956 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 9 | 0.004 10^12 cells per liter | Standard Deviation 0.2052 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 8 | -0.25 Picograms | Standard Deviation 1.052 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 | -0.15 Picograms | Standard Deviation 1.188 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | -0.05 Picograms | Standard Deviation 0.635 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 8 | -0.08 Picograms | Standard Deviation 0.379 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 | 0.19 Picograms | Standard Deviation 1.186 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | 0.27 Picograms | Standard Deviation 0.469 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | -0.06 Picograms | Standard Deviation 0.617 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 8 | -0.18 Picograms | Standard Deviation 0.417 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 | -0.28 Picograms | Standard Deviation 1.073 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 8 | 0.15 Picograms | Standard Deviation 1.042 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 14 | -0.01 Picograms | Standard Deviation 1.113 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 9 | 0.01 Picograms | Standard Deviation 0.486 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 8 | -0.57 Femtoliter | Standard Deviation 2.043 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 14 | -0.33 Femtoliter | Standard Deviation 2.255 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | 0.15 Femtoliter | Standard Deviation 0.438 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 8 | -0.26 Femtoliter | Standard Deviation 0.748 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 14 | 0.35 Femtoliter | Standard Deviation 2.379 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | 0.10 Femtoliter | Standard Deviation 0.559 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | -0.01 Femtoliter | Standard Deviation 0.695 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 8 | -0.45 Femtoliter | Standard Deviation 0.72 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 14 | -0.69 Femtoliter | Standard Deviation 2.122 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 8 | -0.55 Femtoliter | Standard Deviation 2.011 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 14 | -0.02 Femtoliter | Standard Deviation 2.074 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 9 | -0.20 Femtoliter | Standard Deviation 0.785 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected at indicated time points to analyze hematocrit . Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 8 | -0.0068 Proportion of red blood cells in blood | Standard Deviation 0.01715 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14 | -0.0052 Proportion of red blood cells in blood | Standard Deviation 0.01837 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 9 | -0.0009 Proportion of red blood cells in blood | Standard Deviation 0.0129 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 8 | 0.0002 Proportion of red blood cells in blood | Standard Deviation 0.01915 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14 | -0.0012 Proportion of red blood cells in blood | Standard Deviation 0.01728 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 9 | -0.0076 Proportion of red blood cells in blood | Standard Deviation 0.01928 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 9 | 0.0036 Proportion of red blood cells in blood | Standard Deviation 0.02174 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 8 | -0.0018 Proportion of red blood cells in blood | Standard Deviation 0.01861 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14 | 0.0035 Proportion of red blood cells in blood | Standard Deviation 0.02158 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 8 | -0.0040 Proportion of red blood cells in blood | Standard Deviation 0.01256 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14 | -0.0026 Proportion of red blood cells in blood | Standard Deviation 0.01427 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 9 | -0.0007 Proportion of red blood cells in blood | Standard Deviation 0.01843 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 8 | -2.7 Grams per liter | Standard Deviation 5.58 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 14 | -1.9 Grams per liter | Standard Deviation 6.15 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 9 | -0.6 Grams per liter | Standard Deviation 5.17 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 8 | 0.1 Grams per liter | Standard Deviation 6.08 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 14 | -0.2 Grams per liter | Standard Deviation 5.43 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 9 | -1.3 Grams per liter | Standard Deviation 5.87 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 9 | 1.0 Grams per liter | Standard Deviation 6.54 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 8 | -0.9 Grams per liter | Standard Deviation 6.2 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 14 | 0.8 Grams per liter | Standard Deviation 7.32 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 8 | 0.3 Grams per liter | Standard Deviation 4.45 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 14 | -0.9 Grams per liter | Standard Deviation 4.53 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 9 | 0.0 Grams per liter | Standard Deviation 4.78 |
Secondary
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose
Population: QT/QTc Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 8 Hour Post-dose | -5.6 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 3.5 Hour Post-dose | -3.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 1 Hour Post-dose | 0.7 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 6 Hour Post-dose | -3.8 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4 Hour Post-dose | -3.4 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 0.5 Hour Post-dose | 3.6 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 5 Hour Post-dose | -3.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4.5 Hour Post-dose | -4.7 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 10 Hour Post-dose | -3.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 2 Hour Post-dose | -3.6 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 24 Hour Post-dose | -0.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, Predose | 2.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 3 Hour Post-dose | -4.3 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 12 Hour Post-dose | -3.0 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 8 Hour Post-dose | -4.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, Predose | 3.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 0.5 Hour Post-dose | 5.7 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 1 Hour Post-dose | -0.3 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 2 Hour Post-dose | -1.2 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 3 Hour Post-dose | -2.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 3.5 Hour Post-dose | -1.5 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4 Hour Post-dose | -2.9 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4.5 Hour Post-dose | -4.3 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 5 Hour Post-dose | -3.7 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 6 Hour Post-dose | -3.9 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 10 Hour Post-dose | -3.9 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 12 Hour Post-dose | -1.8 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 24 Hour Post-dose | -0.9 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 12 Hour Post-dose | -3.6 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 6 Hour Post-dose | -4.1 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 3 Hour Post-dose | -4.7 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 2 Hour Post-dose | -2.8 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 8 Hour Post-dose | -5.3 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 1 Hour Post-dose | -0.4 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, Predose | 1.1 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 10 Hour Post-dose | -5.0 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 0.5 Hour Post-dose | 3.2 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4.5 Hour Post-dose | -5.3 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4 Hour Post-dose | -4.6 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 24 Hour Post-dose | 0.9 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 5 Hour Post-dose | -3.9 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 3.5 Hour Post-dose | -4.7 Milliseconds |
Secondary
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose
Population: QT/QTc Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 8 Hour Post-dose | 0.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 3.5 Hour Post-dose | 0.6 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 1 Hour Post-dose | 0.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 6 Hour Post-dose | 1.3 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4 Hour Post-dose | 0.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 0.5 Hour Post-dose | 0.7 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 5 Hour Post-dose | 1.3 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4.5 Hour Post-dose | 1.1 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 10 Hour Post-dose | 1.1 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 2 Hour Post-dose | 0.4 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 24 Hour Post-dose | 0.4 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, Predose | 0.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 3 Hour Post-dose | 0.6 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 12 Hour Post-dose | 0.8 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 8 Hour Post-dose | 0.9 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, Predose | 1.0 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 0.5 Hour Post-dose | 1.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 1 Hour Post-dose | 0.8 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 2 Hour Post-dose | 0.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 3 Hour Post-dose | 0.5 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 3.5 Hour Post-dose | 0.9 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4 Hour Post-dose | 1.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4.5 Hour Post-dose | 1.3 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 5 Hour Post-dose | 1.5 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 6 Hour Post-dose | 1.3 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 10 Hour Post-dose | 1.2 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 12 Hour Post-dose | 0.7 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 24 Hour Post-dose | 0.9 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 12 Hour Post-dose | 0.2 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 6 Hour Post-dose | 1.2 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 3 Hour Post-dose | 0.1 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 2 Hour Post-dose | -0.1 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 8 Hour Post-dose | 0.2 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 1 Hour Post-dose | 0.1 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, Predose | 0.4 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 10 Hour Post-dose | 0.6 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 0.5 Hour Post-dose | 0.5 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4.5 Hour Post-dose | 0.9 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4 Hour Post-dose | 0.6 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 24 Hour Post-dose | -0.5 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 5 Hour Post-dose | 1.0 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 3.5 Hour Post-dose | 0.3 Milliseconds |
Secondary
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Twelve-lead ECGs were recorded in participant using automated ECG machine & performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated by subtracting Baseline value from post dose value.
Time frame: Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose
Population: QT/QTc Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 8 Hour Post-dose | -8.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 3.5 Hour Post-dose | -2.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 1 Hour Post-dose | 0.4 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 6 Hour Post-dose | -1.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4 Hour Post-dose | -2.0 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 0.5 Hour Post-dose | -0.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 5 Hour Post-dose | -1.1 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4.5 Hour Post-dose | -1.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 10 Hour Post-dose | -4.0 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 2 Hour Post-dose | -2.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 24 Hour Post-dose | -0.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, Predose | 4.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 3 Hour Post-dose | -2.8 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 12 Hour Post-dose | -1.5 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 8 Hour Post-dose | 0.4 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, Predose | 9.8 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 0.5 Hour Post-dose | 5.3 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 1 Hour Post-dose | 3.8 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 2 Hour Post-dose | 2.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 3 Hour Post-dose | 3.7 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 3.5 Hour Post-dose | 4.8 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4 Hour Post-dose | 5.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4.5 Hour Post-dose | 8.0 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 5 Hour Post-dose | 8.3 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 6 Hour Post-dose | 5.7 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 10 Hour Post-dose | 4.4 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 12 Hour Post-dose | 4.0 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 24 Hour Post-dose | 7.1 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 12 Hour Post-dose | -2.0 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 6 Hour Post-dose | -2.9 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 3 Hour Post-dose | -4.3 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 2 Hour Post-dose | -3.9 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 8 Hour Post-dose | -7.7 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, 1 Hour Post-dose | -0.3 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day 7, Predose | 2.7 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 10 Hour Post-dose | -4.2 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 0.5 Hour Post-dose | -1.9 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4.5 Hour Post-dose | -2.6 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 4 Hour Post-dose | -3.0 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 24 Hour Post-dose | -0.6 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 5 Hour Post-dose | -1.3 Milliseconds |
| Part 2: Placebo | Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms | Day7, 3.5 Hour Post-dose | -4.4 Milliseconds |
Secondary
Part 2: Change From Baseline in Urinalysis Parameter: pH
Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: pH | Day 8 | -0.19 pH | Standard Deviation 0.441 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: pH | Day 14 | -0.13 pH | Standard Deviation 0.49 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: pH | Day 9 | -0.35 pH | Standard Deviation 0.337 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: pH | Day 8 | -0.33 pH | Standard Deviation 0.539 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: pH | Day 14 | -0.21 pH | Standard Deviation 0.59 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: pH | Day 9 | -0.23 pH | Standard Deviation 0.344 |
| Part 2: Placebo | Part 2: Change From Baseline in Urinalysis Parameter: pH | Day 9 | -0.11 pH | Standard Deviation 0.546 |
| Part 2: Placebo | Part 2: Change From Baseline in Urinalysis Parameter: pH | Day 8 | -0.08 pH | Standard Deviation 0.389 |
| Part 2: Placebo | Part 2: Change From Baseline in Urinalysis Parameter: pH | Day 14 | 0.06 pH | Standard Deviation 0.442 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: pH | Day 8 | -0.18 pH | Standard Deviation 0.676 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: pH | Day 14 | -0.09 pH | Standard Deviation 0.708 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: pH | Day 9 | 0.30 pH | Standard Deviation 0.35 |
Secondary
Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -2), Day 8, Day 9, and Day 14
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 8 | 0.0034 Ratio | Standard Deviation 0.00849 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 14 | 0.0022 Ratio | Standard Deviation 0.00747 |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 9 | 0.0015 Ratio | Standard Deviation 0.00619 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 8 | 0.0030 Ratio | Standard Deviation 0.00875 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 14 | 0.0037 Ratio | Standard Deviation 0.00838 |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 9 | 0.0015 Ratio | Standard Deviation 0.00708 |
| Part 2: Placebo | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 9 | -0.0011 Ratio | Standard Deviation 0.0108 |
| Part 2: Placebo | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 8 | 0.0019 Ratio | Standard Deviation 0.00727 |
| Part 2: Placebo | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 14 | 0.0005 Ratio | Standard Deviation 0.00922 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 8 | 0.0026 Ratio | Standard Deviation 0.01037 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 14 | 0.0016 Ratio | Standard Deviation 0.01055 |
| Part 2: GSK3640254 500 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Day 9 | -0.0020 Ratio | Standard Deviation 0.0085 |
Secondary
Part 2: Cmax of GSK3640254 100 mg and GSK3640254 500 mg
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Cmax of GSK3640254 100 mg and GSK3640254 500 mg | 830.3 Nanograms per milliliter | Geometric Coefficient of Variation 37.9 |
| Part 1 : GSK3640254 500 mg | Part 2: Cmax of GSK3640254 100 mg and GSK3640254 500 mg | 4261 Nanograms per milliliter | Geometric Coefficient of Variation 41.8 |
Secondary
Part 2: Cmax of Moxifloxacin 400 mg
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Cmax of Moxifloxacin 400 mg | 1964 Nanograms per milliliter | Geometric Coefficient of Variation 20.2 |
Secondary
Part 2: Ctau of GSK3640254 100 mg and GSK3640254 500 mg
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Ctau of GSK3640254 100 mg and GSK3640254 500 mg | 459.9 Nanograms per milliliter | Geometric Coefficient of Variation 40.3 |
| Part 1 : GSK3640254 500 mg | Part 2: Ctau of GSK3640254 100 mg and GSK3640254 500 mg | 2137 Nanograms per milliliter | Geometric Coefficient of Variation 46.6 |
Secondary
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
A 12-lead ECG was recorded with the participant in a supine position. 12-lead ECGs were obtained by using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal 12-Lead ECG findings has reported.
Time frame: Baseline(Day-2), Day1: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours; Day 2: 24 Hours, Day 4: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, Day 5: 24 Hours; Day 7: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours; Day 8: 24 Hours; Day 9 and Day 14
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Baseline (Day -2) | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 1 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 2 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 3 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 4 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 6 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 2: 24 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 1 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 2 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 3 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 4 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 6 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 5: 24 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 1 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 2 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 3 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 4 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 6 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 8: 24 Hours | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 9 | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 14 | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 6 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Baseline (Day -2) | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 1 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 6 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 2: 24 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 3 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 2 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 5: 24 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 2 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 9 | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 4 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 1 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 2 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 4 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 6 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 14 | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 3 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 3 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 1 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 8: 24 Hours | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 4 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 1 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 6 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 2: 24 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 6 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 1 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 2 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 3 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 4 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 8: 24 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 6 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 5: 24 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 14 | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 1 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 2 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 9 | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 3 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Baseline (Day -2) | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 2 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 4 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 3 Hours | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 4 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 3 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 4 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 4 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Baseline (Day -2) | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 9 | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 3 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 2 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 1 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 6 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 1 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 6 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 2 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 14 | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 1 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 5: 24 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 8: 24 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 2: 24 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 7: 2 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 4 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 4: 6 Hours | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings | Day 1: 3 Hours | 0 Participants |
Secondary
Part 2: Number of Participants With Non-SAEs 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 defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.
Time frame: Up to Day 51
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Non-SAEs and SAEs | Non SAE | 7 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Non-SAEs and SAEs | SAE | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Non-SAEs and SAEs | SAE | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Non-SAEs and SAEs | Non SAE | 4 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Non-SAEs and SAEs | Non SAE | 5 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Non-SAEs and SAEs | SAE | 0 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Non-SAEs and SAEs | Non SAE | 10 Participants |
| Part 2: GSK3640254 500 mg | Part 2: Number of Participants With Non-SAEs and SAEs | SAE | 0 Participants |
Secondary
Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg
Twelve-lead ECGs were recorded using an automated ECG machine with participant in a supine position after a rest of at least 10 minutes. Number of participants with outlier results for HR, QTcF, ΔQTcF, PR interval and QRS interval were summarized.Categorical outlier criteria was as follows:change from Baseline in QTcF (ΔQTcF) \>60 ms: Increase of QTc from Baseline \> 60 ms, QTcF \> 500 ms:Treatment-emergent value of \> 500 ms when not present at Baseline (new onset), HR \< 50 bpm with a decrease in change from Baseline in heart rate (ΔHR) \> 25%:Decrease of HR from Baseline \>25% resulting in HR \< 50 bpm, HR \> 100 bpm with an increase in ΔHR \> 25% :Increase of HR from Baseline \>25% resulting in HR \> 100 bpm, PR \> 200 ms with an increase in change from Baseline in PR interval (ΔPR) \> 25%:Increase of PR from Baseline \> 25% resulting in PR \> 200 ms, QRS \> 120 ms with an increase in change from Baseline in QRS interval (ΔQRS) \> 25%:Increase of QRS from Baseline \> 25% resulting in QRS \> 120 ms.
Time frame: Up to Day 51
Population: QT/QTc Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | ΔQTcF >60 ms | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | QTcF >500 ms | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | HR <50 bpm with a decrease in ΔHR > 25% | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | HR >100 bpm with an increase in ΔHR > 25% | 1 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | PR >200 ms with an increase in ΔPR > 25% | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | QRS >120 ms an increase in ΔQRS > 25% | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | PR >200 ms with an increase in ΔPR > 25% | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | ΔQTcF >60 ms | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | HR >100 bpm with an increase in ΔHR > 25% | 1 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | QTcF >500 ms | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | QRS >120 ms an increase in ΔQRS > 25% | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg | HR <50 bpm with a decrease in ΔHR > 25% | 0 Participants |
Secondary
Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Twelve-lead ECGs were recorded using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Flat T-wave=T-amplitude \< 1 mm (either positive \[+\] or negative \[-\]), including flat isoelectric line, Notched T-wave (+)=Presence of notch(es) of at least 0.05 millivolt (mV) amplitude on ascending or descending arm of the positive T-wave, Biphasic= T-wave that contains a second component with an opposite phase that is at least 0.1 mV deep (both positive/negative and negative/positive and polyphasic T-waves included), Normal T-wave (-)=T-amplitude that is negative, without biphasic T-wave or notches, Notched T-wave (-): Presence of notch(es) of at least 0.05 mV amplitude on descending or ascending arm of the negative T-wave, U-waves= Presence of abnormal U-waves. Data has been reported for Flat T-wave, Notched T-wave (Positive), Biphasic, Normal T-wave (Negative), Notched T-wave (Negative) and T-U wave Fusion.
Time frame: Up to Day 51
Population: QT/QTc Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Flat T-wave | 2 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Notched T-wave (Positive) | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Biphasic | 1 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Normal T-wave (Negative) | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Notched T-wave (Negative) | 0 Participants |
| Part 1: GSK3640254 500 mg | Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | T-U wave Fusion | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Notched T-wave (Negative) | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Flat T-wave | 1 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Normal T-wave (Negative) | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Notched T-wave (Positive) | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | T-U wave Fusion | 0 Participants |
| Part 1 : GSK3640254 500 mg | Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Biphasic | 0 Participants |
Secondary
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in HR was calculated as model-predicted mean change from Baseline in HR in GSK3640254 group minus model-predicted mean change from Baseline in HR in the placebo group.
Time frame: Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose
Population: QT/QTc Population. Only those participants with data available at specified time points were analyzed. This outcome measure is intended to provide Placebo-corrected data. Placebo and treatment wise change from Baseline data is provided in outcome measure number 42.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 2 Hour Post-dose | 1.4 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 4.5 Hour Post-dose | 1.8 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, Predose | -0.3 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 5 Hour Post-dose | 1.6 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 3 Hour Post-dose | 1.4 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 6 Hour Post-dose | 1.0 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 1 Hour Post-dose | 0.2 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 3.5 Hour Post-dose | 1.7 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 10 Hour Post-dose | 0.8 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 0.5 Hour Post-dose | -0.2 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 12 Hour Post-dose | 0.4 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 4 Hour Post-dose | 1.1 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 24 Hour Post-dose | 2.6 Beats per minute |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 8 Hour Post-dose | 1.1 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 24 Hour Post-dose | 3.9 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, Predose | 2.5 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 0.5 Hour Post-dose | 3.9 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 1 Hour Post-dose | 4.0 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 2 Hour Post-dose | 2.5 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 3 Hour Post-dose | 2.9 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 3.5 Hour Post-dose | 3.2 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 4 Hour Post-dose | 3.3 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 4.5 Hour Post-dose | 3.2 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 5 Hour Post-dose | 4.1 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 6 Hour Post-dose | 4.1 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 8 Hour Post-dose | 4.2 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 10 Hour Post-dose | 5.1 Beats per minute |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 12 Hour Post-dose | 1.1 Beats per minute |
Secondary
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in PR was calculated as model-predicted mean change from Baseline in PR interval in GSK3640254 group minus model-predicted mean change from Baseline in PR interval in the placebo group.
Time frame: Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose
Population: QT/QTc Population. Only those participants with data available at the specified time points were analyzed. This outcome measure is intended to provide Placebo-corrected data. Placebo and treatment wise change from Baseline data is provided in outcome measure number 44.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, Predose | 1.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 0.5 Hour Post-dose | 0.4 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 1 Hour Post-dose | 1.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 2 Hour Post-dose | -0.8 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 3 Hour Post-dose | 0.4 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 3.5 Hour Post-dose | 0.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 4 Hour Post-dose | 1.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 4.5 Hour Post-dose | 0.7 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 5 Hour Post-dose | 0.0 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 6 Hour Post-dose | 0.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 8 Hour Post-dose | -0.3 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 10 Hour Post-dose | 1.1 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 12 Hour Post-dose | 0.6 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 24 Hour Post-dose | -1.4 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 8 Hour Post-dose | 1.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, Predose | 2.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 4.5 Hour Post-dose | 1.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 0.5 Hour Post-dose | 2.5 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 12 Hour Post-dose | 1.8 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 1 Hour Post-dose | 0.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 5 Hour Post-dose | 0.3 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 2 Hour Post-dose | 1.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 10 Hour Post-dose | 1.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 3 Hour Post-dose | 2.0 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 6 Hour Post-dose | 0.2 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 3.5 Hour Post-dose | 3.2 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 24 Hour Post-dose | -1.8 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 4 Hour Post-dose | 1.7 Milliseconds |
Secondary
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in QRS was calculated as model-predicted mean change from Baseline in QRS interval in GSK3640254 group minus model-predicted mean change from Baseline in QRS interval in the placebo group.
Time frame: Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose
Population: QT/QTc Population. Only those participants with data available at the specified time points were analyzed. This outcome measure is intended to provide Placebo-corrected data. Placebo and treatment wise change from Baseline data is provided in outcome measure number 45.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 2 Hour Post-dose | 0.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 4.5 Hour Post-dose | 0.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, Predose | 0.1 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 5 Hour Post-dose | 0.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 3 Hour Post-dose | 0.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 6 Hour Post-dose | 0.1 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 1 Hour Post-dose | 0.3 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 8 Hour Post-dose | 0.3 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 3.5 Hour Post-dose | 0.3 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 10 Hour Post-dose | 0.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 0.5 Hour Post-dose | 0.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 12 Hour Post-dose | 0.6 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 4 Hour Post-dose | 0.3 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 24 Hour Post-dose | 0.9 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 24 Hour Post-dose | 1.4 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, Predose | 0.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 0.5 Hour Post-dose | 0.5 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 1 Hour Post-dose | 0.7 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 2 Hour Post-dose | 0.7 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 3 Hour Post-dose | 0.4 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 3.5 Hour Post-dose | 0.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 4 Hour Post-dose | 0.5 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 4.5 Hour Post-dose | 0.4 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 5 Hour Post-dose | 0.4 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 6 Hour Post-dose | 0.2 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 8 Hour Post-dose | 0.7 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 10 Hour Post-dose | 0.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg | Day7, 12 Hour Post-dose | 0.5 Milliseconds |
Secondary
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in QTcF was calculated as model-predicted mean change from Baseline in QTcF in moxifloxacin group minus model-predicted mean change from Baseline in QTcF in the placebo group.
Time frame: Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose
Population: QT/QTc Population. Only those participants with data available at specified time points were analyzed. This outcome measure is intended to provide Placebo-corrected data. Placebo and treatment wise change from Baseline data is provided in outcome measure number 91.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day 7, Predose | 0.6 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day7, 0.5 Hour Post-dose | -0.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day 7, 1 Hour Post-dose | -0.8 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day7, 2 Hour Post-dose | 5.6 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day 7, 3 Hour Post-dose | 7.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day7, 3.5 Hour Post-dose | 8.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day7, 4 Hour Post-dose | 8.6 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day7, 4.5 Hour Post-dose | 8.4 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day7, 5 Hour Post-dose | 8.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day7, 6 Hour Post-dose | 8.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day7, 8 Hour Post-dose | 6.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day7, 10 Hour Post-dose | 6.8 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day7, 12 Hour Post-dose | 5.3 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin | Day7, 24 Hour Post-dose | 6.8 Milliseconds |
Secondary
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Twelve-lead ECGs were recorded in participant using automated ECG machine & performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline was calculated by subtracting Baseline value from post dose value. Placebo-corrected change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated as model-predicted mean change from Baseline in QTcF in GSK3640254 group minus model-predicted mean change from Baseline in QTcF in the placebo group (by-time point analysis). Time point analysis was performed based on a linear mixed-effects model: Change from Baseline in QTcF = Time + Treatment + Time\*Treatment +Baseline QTcF + Period + Sequence. An unstructured covariance structure was used to specify the repeated measures (time within participant and period). A random intercept per participant was also included.
Time frame: Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose
Population: QT/QTc Population. Only those participants with data available at specified time points were analyzed. This outcome measure is intended to provide Placebo-corrected data. Placebo and treatment wise change from Baseline data is provided in outcome measure number 43.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, Predose | 1.4 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 0.5 Hour Post-dose | 1.0 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 1 Hour Post-dose | 0.6 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 2 Hour Post-dose | 1.7 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 3 Hour Post-dose | 1.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 3.5 Hour Post-dose | 1.4 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 4 Hour Post-dose | 1.0 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 4.5 Hour Post-dose | 1.0 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 5 Hour Post-dose | 0.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 6 Hour Post-dose | 1.7 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 8 Hour Post-dose | -0.8 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 10 Hour Post-dose | 0.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 12 Hour Post-dose | 0.5 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 24 Hour Post-dose | 0.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 8 Hour Post-dose | 8.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, Predose | 7.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 4.5 Hour Post-dose | 10.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 0.5 Hour Post-dose | 7.2 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 12 Hour Post-dose | 6.0 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 1 Hour Post-dose | 4.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 5 Hour Post-dose | 9.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 2 Hour Post-dose | 6.5 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 10 Hour Post-dose | 8.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 3 Hour Post-dose | 8.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 6 Hour Post-dose | 8.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 3.5 Hour Post-dose | 9.2 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 24 Hour Post-dose | 7.7 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis | Day7, 4 Hour Post-dose | 8.6 Milliseconds |
Secondary
Part 2: Tmax of GSK3640254 100 mg and GSK3640254 500 mg
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Tmax of GSK3640254 100 mg and GSK3640254 500 mg | 5.008 Hours |
| Part 1 : GSK3640254 500 mg | Part 2: Tmax of GSK3640254 100 mg and GSK3640254 500 mg | 5.000 Hours |
Secondary
Part 2: Tmax of Moxifloxacin 400 mg
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Tmax of Moxifloxacin 400 mg | 4.000 Hours |
Other Pre-specified
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value
Time frame: Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose
Population: QT/QTc Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day 7, Predose | 2.7 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 0.5 Hour Post-dose | -1.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day 7, 1 Hour Post-dose | -0.3 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day 7, 2 Hour Post-dose | -3.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day 7, 3 Hour Post-dose | -4.3 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 3.5 Hour Post-dose | -4.4 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 4 Hour Post-dose | -3.0 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 4.5 Hour Post-dose | -2.6 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 5 Hour Post-dose | -1.3 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 6 Hour Post-dose | -2.9 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 8 Hour Post-dose | -7.7 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 10 Hour Post-dose | -4.2 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 12 Hour Post-dose | -2.0 Milliseconds |
| Part 1: GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 24 Hour Post-dose | -0.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 8 Hour Post-dose | -0.8 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day 7, Predose | 3.3 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 4.5 Hour Post-dose | 5.9 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 0.5 Hour Post-dose | -2.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 12 Hour Post-dose | 3.3 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day 7, 1 Hour Post-dose | -1.1 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 5 Hour Post-dose | 6.9 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day 7, 2 Hour Post-dose | 1.7 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 10 Hour Post-dose | 2.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day 7, 3 Hour Post-dose | 3.6 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 6 Hour Post-dose | 5.3 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 3.5 Hour Post-dose | 4.5 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 24 Hour Post-dose | 6.2 Milliseconds |
| Part 1 : GSK3640254 500 mg | Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm | Day7, 4 Hour Post-dose | 5.6 Milliseconds |