HIV Infections
Conditions
Keywords
Healthy participants, GSK3640254, Human immunodeficiency virus, Relative Bioavailability
Brief summary
This is an open-label, 2 part, single-dose and crossover study conducted to assess the relative bioavailability of a tablet compared to a capsule of GSK3640254 and to assess the effect of food on the GSK3640254 tablet in healthy participants. This study will also evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the pharmacokinetics of the GSK3640254 mesylate tablet formulation. In Part 1, participants will be randomly assigned to 1 of 2 treatment sequences (AB or BA) in two sequential treatment periods; and in Part 2, participants will be randomly assigned to 1 of 3 treatment sequences (CDE, DEC, or ECD) in three sequential treatment periods. Participants will be randomized to receive a single dose of GSK3640254 200 milligram (mg) capsules under moderate fat conditions and GSK3640254 200 mg tablets under moderate fat, fasted and high fat conditions in each treatment period. Approximately 30 participants will be enrolled.
Interventions
GSK3640254 capsules will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open label study.
Intervention model description
Eligible participants will be randomly assigned to 1 of 2 treatment sequences (AB or BA) in Part 1 and 1 of 3 treatment sequences (CDE, DEC, or ECD) in Part 2.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be 18 to 55 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, laboratory tests, and cardiac monitoring (history and ECG). * Body weight \>=50.0 kilogram (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 kg 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 participants: Males shall 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. Female participants: 1. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: a. not a woman of childbearing potential (WOCBP); or Is a WOCBP and using a nonhormonal contraceptive method that is highly effective, with a failure rate of \<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. 2. A WOCBP must have a negative highly sensitive serum pregnancy test at Screening and Day -1. 3. Additional requirements for pregnancy testing during and after study intervention. * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions.
Exclusion criteria
* 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 (example \[e.g.\], gastroesophageal 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 surgery (prior appendectomy is acceptable). * 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 (\>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 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. * 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 and positive on reflex to hepatitis C ribonucleic acid (RNA). * Positive Human immunodeficiency virus (HIV)-1 and -2 antigen/antibody immunoassay at Screening. * 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 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 creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT (described above), 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. * A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at Screening or before the first dose of study intervention. * Unable to refrain from the use of prescription or nonprescription drugs including vitamins, herbal and dietary supplements (including Saint 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 excessive 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). * Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (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). * Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months, symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia, second-degree atrioventricular block Mobitz Type II, third-degree atrioventricular block, complete heart block, or conduction abnormality) which, in the opinion of the investigator or Medical Monitor, will interfere with the safety for the individual participant. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) for GSK3640254-Part 1 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were calculated using standard non-compartmental analysis. |
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Time t (AUC[0 to t]) for GSK3640254-Part 1 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| Maximum Observed Concentration (Cmax) for GSK3640254-Part 1 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| Time of Maximum Observed Concentration for GSK3640254-Part 1 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| AUC(0 to Inf) for GSK3640254-Part 2 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| AUC(0 to t) for GSK3640254-Part 2 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| Cmax for GSK3640254-Part 2 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| Time of Maximum Observed Concentration for GSK3640254-Part 2 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. |
| Absolute Values for Erythrocytes Count-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. |
| Absolute Values for Hemoglobin-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: hemoglobin. |
| Absolute Values for Hematocrit-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: hematocrit. |
| Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. |
| Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Erythrocytes Count-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Hemoglobin-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Hematocrit-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Erythrocytes Count-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Hemoglobin-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Hematocrit-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. |
| Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. |
| Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. |
| Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. |
| Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. |
| Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. |
| Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. |
| Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. |
| Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. |
| Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. |
| Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Absolute Values for Urine Parameter: Specific Gravity-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of 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, indicated as ratio of urine density to water density. |
| Absolute Values for Urine Parameter: Urobilinogen-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. |
| Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of urine pH. 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). |
| Absolute Values for Urine Parameter: Specific Gravity-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of 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, indicated as ratio of urine density to water density. |
| Absolute Values for Urine Parameter: Urobilinogen-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. |
| Absolute Values for Urine Parameter: pH-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of urine pH. 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). |
| Change From Baseline in Urine Parameter: Specific Gravity-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of 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, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Urine Parameter: Urobilinogen-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Urine Parameter: pH-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of urine pH. 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 is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Urine Parameter: Specific Gravity-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of 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, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Urine Parameter: Urobilinogen-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Urine Parameter: pH-Part 2 | Baseline (Day -1), Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of urine pH. 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 is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented. |
| Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Day 2 and Day 5 | Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented. |
| Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5 | Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. |
| Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5 | Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. |
| Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5 | Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5 | Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Absolute Values for Vital Sign: Pulse Rate-Part 1 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Absolute Values for Vital Sign: Temperature-Part 1 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Absolute Values for Vital Signs: DBP and SBP-Part 2 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Absolute Values for Vital Sign: Pulse Rate-Part 2 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Absolute Values for Vital Sign: Temperature-Part 2 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Change From Baseline in Vital Signs: SBP and DBP-Part 1 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Vital Sign: Pulse Rate-Part 1 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Change From Baseline in Vital Sign: Respiratory Rate-Part 1 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Vital Sign: Temperature-Part 1 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Vital Signs: SBP and DBP-Part 2 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Vital Sign: Temperature-Part 2 | Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5 | Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Lag Time for Absorption (Tlag) for GSK3640254-Part 1 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| Apparent Terminal Phase Half-life (t1/2) for GSK3640254-Part 1 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| Apparent Oral Clearance (CL/F) for GSK3640254-Part 1 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| Apparent Volume of Distribution (Vz/F) for GSK3640254-Part 1 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| Plasma Concentration of GSK3640254-Part 1 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 | Up to Day 12 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. |
| T1/2 for GSK3640254-Part 2 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| CL/F for GSK3640254-Part 2 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| Vz/F for GSK3640254-Part 2 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| Plasma Concentration of GSK3640254-Part 2 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. |
| Tlag for GSK3640254-Part 2 | pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. |
| Number of Participants With AEs and SAEs-Part 2 | Up to Day 19 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. |
| Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. |
| Absolute Values for Erythrocytes Count-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. |
| Absolute Values for Hemoglobin-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: hemoglobin. |
| Absolute Values for Hematocrit-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: hematocrit. |
| Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. |
| Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Baseline (Day -1), Day 2 and Day 5 | Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. |
Countries
United States
Participant flow
Recruitment details
This was a 2-part, randomized, single dose cross-over study conducted at a single center in the United States to assess the relative bioavailability and food effect of GSK3640254 tablet and capsule formulations in healthy participants.
Pre-assignment details
A total of 39 participants were enrolled in Part 1 (18 participants) and Part 2 (21 participants) of the study.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Treatment Sequence AB Participants were administered a single dose of GSK3640254 200 milligram (mg) capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg tablets (Treatment B- test), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention. | 9 |
| Part 1: Treatment Sequence BA Participants were administered a single dose of GSK3640254 200 mg tablets (Treatment B-test), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention. | 9 |
| Part 2: Treatment Sequence CDE Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. | 7 |
| Part 2: Treatment Sequence DEC Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. | 7 |
| Part 2: Treatment Sequence ECD Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 1; followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 2; followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. | 7 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Part 2 Period 1 (Day 1) | Adverse Event | 0 | 0 | 0 | 0 | 1 |
| Part 2 Period 2 (Day 1) | Physician Decision | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Part 1: Treatment Sequence AB | Part 1: Treatment Sequence BA | Part 2: Treatment Sequence CDE | Part 2: Treatment Sequence DEC | Part 2: Treatment Sequence ECD | Total |
|---|---|---|---|---|---|---|
| Age, Customized <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 19 to 64 years | 9 Participants | 9 Participants | 7 Participants | 7 Participants | 7 Participants | 39 Participants |
| Age, Customized >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 2 Participants | 3 Participants | 2 Participants | 4 Participants | 15 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White-Arabic/North African Heritage | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White-White/Caucasian/European Heritage | 4 Participants | 5 Participants | 4 Participants | 5 Participants | 3 Participants | 21 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 3 Participants | 1 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 4 Participants | 6 Participants | 2 Participants | 25 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 20 | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 0 / 18 | 1 / 18 | 0 / 20 | 0 / 19 | 2 / 21 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 20 | 0 / 19 | 0 / 21 |
Outcome results
Primary
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) for GSK3640254-Part 1
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population comprised of all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) for GSK3640254-Part 1 | 36.94 Hours*microgram per milliliter | Geometric Coefficient of Variation 42.7 |
| Part 1: GSK3640254 200 mg Tablets | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) for GSK3640254-Part 1 | 36.88 Hours*microgram per milliliter | Geometric Coefficient of Variation 40.3 |
90% CI: [0.9263, 1.0757]
Primary
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Time t (AUC[0 to t]) for GSK3640254-Part 1
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Time t (AUC[0 to t]) for GSK3640254-Part 1 | 33.72 Hours*microgram per milliliter | Geometric Coefficient of Variation 41.1 |
| Part 1: GSK3640254 200 mg Tablets | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Time t (AUC[0 to t]) for GSK3640254-Part 1 | 33.80 Hours*microgram per milliliter | Geometric Coefficient of Variation 40.2 |
90% CI: [0.9321, 1.0781]
Primary
AUC(0 to Inf) for GSK3640254-Part 2
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | AUC(0 to Inf) for GSK3640254-Part 2 | 41.00 Hours*micrograms per milliliter | Geometric Coefficient of Variation 42.2 |
| Part 1: GSK3640254 200 mg Tablets | AUC(0 to Inf) for GSK3640254-Part 2 | 13.46 Hours*micrograms per milliliter | Geometric Coefficient of Variation 58.2 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | AUC(0 to Inf) for GSK3640254-Part 2 | 36.92 Hours*micrograms per milliliter | Geometric Coefficient of Variation 35.9 |
90% CI: [2.3703, 3.6107]
90% CI: [2.1003, 3.2038]
Primary
AUC(0 to t) for GSK3640254-Part 2
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | AUC(0 to t) for GSK3640254-Part 2 | 37.91 Hours*micrograms per milliliter | Geometric Coefficient of Variation 41.5 |
| Part 1: GSK3640254 200 mg Tablets | AUC(0 to t) for GSK3640254-Part 2 | 11.37 Hours*micrograms per milliliter | Geometric Coefficient of Variation 65.6 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | AUC(0 to t) for GSK3640254-Part 2 | 34.08 Hours*micrograms per milliliter | Geometric Coefficient of Variation 34.9 |
90% CI: [2.5925, 3.8178]
90% CI: [2.2943, 3.3807]
Primary
Cmax for GSK3640254-Part 2
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Cmax for GSK3640254-Part 2 | 1.425 Micrograms per milliliter | Geometric Coefficient of Variation 35.6 |
| Part 1: GSK3640254 200 mg Tablets | Cmax for GSK3640254-Part 2 | 0.3544 Micrograms per milliliter | Geometric Coefficient of Variation 84.4 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Cmax for GSK3640254-Part 2 | 1.082 Micrograms per milliliter | Geometric Coefficient of Variation 38.6 |
90% CI: [3.2442, 5.183]
90% CI: [2.4359, 3.8935]
Primary
Maximum Observed Concentration (Cmax) for GSK3640254-Part 1
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Maximum Observed Concentration (Cmax) for GSK3640254-Part 1 | 1.201 Microgram per milliliter | Geometric Coefficient of Variation 33.4 |
| Part 1: GSK3640254 200 mg Tablets | Maximum Observed Concentration (Cmax) for GSK3640254-Part 1 | 1.313 Microgram per milliliter | Geometric Coefficient of Variation 45.3 |
90% CI: [0.9885, 1.208]
Primary
Time of Maximum Observed Concentration for GSK3640254-Part 1
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Time of Maximum Observed Concentration for GSK3640254-Part 1 | 5.000 Hours |
| Part 1: GSK3640254 200 mg Tablets | Time of Maximum Observed Concentration for GSK3640254-Part 1 | 4.000 Hours |
Primary
Time of Maximum Observed Concentration for GSK3640254-Part 2
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Time of Maximum Observed Concentration for GSK3640254-Part 2 | 5.000 Hours |
| Part 1: GSK3640254 200 mg Tablets | Time of Maximum Observed Concentration for GSK3640254-Part 2 | 4.000 Hours |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Time of Maximum Observed Concentration for GSK3640254-Part 2 | 5.000 Hours |
Secondary
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | ALT; Baseline; n=18, 18 | 22.1 International units per liter | Standard Deviation 12.44 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | ALT; Day 2; n=18, 18 | 21.8 International units per liter | Standard Deviation 13.38 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | ALT; Day 5; n=9, 9 | 20.6 International units per liter | Standard Deviation 14.51 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | ALP; Baseline; n=18, 18 | 54.6 International units per liter | Standard Deviation 11.32 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | ALP; Day 2; n=18, 18 | 52.1 International units per liter | Standard Deviation 11.59 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | ALP; Day 5; n=9, 9 | 55.2 International units per liter | Standard Deviation 12.34 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | AST; Baseline; n=18, 18 | 21.7 International units per liter | Standard Deviation 8.39 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | AST; Day 2; n=18, 18 | 19.1 International units per liter | Standard Deviation 6.65 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | AST; Day 5; n=9, 9 | 19.0 International units per liter | Standard Deviation 4.3 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | GGT; Baseline; n=18, 18 | 19.3 International units per liter | Standard Deviation 11.26 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | GGT; Day 2; n=18, 18 | 18.1 International units per liter | Standard Deviation 11.18 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | GGT; Day 5; n=9, 9 | 19.2 International units per liter | Standard Deviation 13.07 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | CK; Baseline; n=18, 18 | 126.9 International units per liter | Standard Deviation 62.61 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | CK; Day 2; n=18, 18 | 87.4 International units per liter | Standard Deviation 40.3 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | CK; Day 5; n=9, 9 | 86.0 International units per liter | Standard Deviation 35.27 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | LDH; Baseline; n=18, 18 | 136.4 International units per liter | Standard Deviation 20.82 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | LDH; Day 2; n=18, 18 | 117.7 International units per liter | Standard Deviation 21.06 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | LDH; Day 5; n=9, 9 | 122.0 International units per liter | Standard Deviation 20.91 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | CK; Day 2; n=18, 18 | 92.2 International units per liter | Standard Deviation 44.64 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | ALT; Baseline; n=18, 18 | 22.1 International units per liter | Standard Deviation 12.44 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | GGT; Baseline; n=18, 18 | 19.3 International units per liter | Standard Deviation 11.26 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | ALT; Day 2; n=18, 18 | 18.4 International units per liter | Standard Deviation 9.28 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | LDH; Day 5; n=9, 9 | 123.6 International units per liter | Standard Deviation 18.53 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | ALT; Day 5; n=9, 9 | 19.6 International units per liter | Standard Deviation 7.07 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | GGT; Day 2; n=18, 18 | 18.9 International units per liter | Standard Deviation 11.6 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | ALP; Baseline; n=18, 18 | 54.6 International units per liter | Standard Deviation 11.32 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | CK; Day 5; n=9, 9 | 98.3 International units per liter | Standard Deviation 50.21 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | ALP; Day 2; n=18, 18 | 52.1 International units per liter | Standard Deviation 10.96 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | GGT; Day 5; n=9, 9 | 15.8 International units per liter | Standard Deviation 6.85 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | ALP; Day 5; n=9, 9 | 50.3 International units per liter | Standard Deviation 5.87 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | LDH; Day 2; n=18, 18 | 120.4 International units per liter | Standard Deviation 21.17 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | AST; Baseline; n=18, 18 | 21.7 International units per liter | Standard Deviation 8.39 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | CK; Baseline; n=18, 18 | 126.9 International units per liter | Standard Deviation 62.61 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | AST; Day 2; n=18, 18 | 17.6 International units per liter | Standard Deviation 4.94 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | LDH; Baseline; n=18, 18 | 136.4 International units per liter | Standard Deviation 20.82 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 | AST; Day 5; n=9, 9 | 17.0 International units per liter | Standard Deviation 3.71 |
Secondary
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Albumin; Day 2; n=18, 18 | 43.8 Grams per liter | Standard Deviation 2.53 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Globulin; Day 5; n=9, 9 | 26.2 Grams per liter | Standard Deviation 4.58 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Globulin; Baseline; n=18, 18 | 27.5 Grams per liter | Standard Deviation 3.84 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Protein; Baseline; n=18, 18 | 71.2 Grams per liter | Standard Deviation 3.19 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Albumin; Day 5; n=9, 9 | 45.1 Grams per liter | Standard Deviation 2.85 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Protein; Day 2; n=18, 18 | 70.7 Grams per liter | Standard Deviation 5.07 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Globulin; Day 2; n=18, 18 | 26.9 Grams per liter | Standard Deviation 4.58 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Protein; Day 5; n=9, 9 | 71.3 Grams per liter | Standard Deviation 6.42 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Albumin; Baseline; n=18, 18 | 43.7 Grams per liter | Standard Deviation 2.52 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Protein; Day 5; n=9, 9 | 72.2 Grams per liter | Standard Deviation 4.74 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Albumin; Baseline; n=18, 18 | 43.7 Grams per liter | Standard Deviation 2.52 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Albumin; Day 2; n=18, 18 | 44.4 Grams per liter | Standard Deviation 2.96 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Albumin; Day 5; n=9, 9 | 44.2 Grams per liter | Standard Deviation 2.82 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Globulin; Baseline; n=18, 18 | 27.5 Grams per liter | Standard Deviation 3.84 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Globulin; Day 2; n=18, 18 | 27.8 Grams per liter | Standard Deviation 4.35 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Globulin; Day 5; n=9, 9 | 28.0 Grams per liter | Standard Deviation 4.97 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Protein; Baseline; n=18, 18 | 71.2 Grams per liter | Standard Deviation 3.19 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Protein; Day 2; n=18, 18 | 72.2 Grams per liter | Standard Deviation 5.43 |
Secondary
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Baseline; n=20, 19, 21 | 26.5 Grams per liter | Standard Deviation 3.19 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Day 5; n=7, 5, 7 | 71.6 Grams per liter | Standard Deviation 3.15 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Day 5; n=7, 5, 7 | 23.6 Grams per liter | Standard Deviation 1.51 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Day 2; n=20, 19, 21 | 26.6 Grams per liter | Standard Deviation 3.33 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Baseline; n=20, 19, 21 | 43.8 Grams per liter | Standard Deviation 2.9 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Day 2; n=20, 19, 21 | 72.2 Grams per liter | Standard Deviation 3.56 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Day 5; n=7, 5, 7 | 48.0 Grams per liter | Standard Deviation 2.58 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Day 2; n=20, 19, 21 | 45.6 Grams per liter | Standard Deviation 2.68 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Baseline; n=20, 19, 21 | 70.3 Grams per liter | Standard Deviation 4.23 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Day 2; n=20, 19, 21 | 26.0 Grams per liter | Standard Deviation 3.43 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Baseline; n=20, 19, 21 | 43.8 Grams per liter | Standard Deviation 2.9 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Day 2; n=20, 19, 21 | 45.4 Grams per liter | Standard Deviation 2.27 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Day 5; n=7, 5, 7 | 43.4 Grams per liter | Standard Deviation 2.07 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Baseline; n=20, 19, 21 | 26.5 Grams per liter | Standard Deviation 3.19 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Day 5; n=7, 5, 7 | 28.2 Grams per liter | Standard Deviation 2.49 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Baseline; n=20, 19, 21 | 70.3 Grams per liter | Standard Deviation 4.23 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Day 2; n=20, 19, 21 | 71.4 Grams per liter | Standard Deviation 3.2 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Day 5; n=7, 5, 7 | 71.6 Grams per liter | Standard Deviation 2.07 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Day 5; n=7, 5, 7 | 45.1 Grams per liter | Standard Deviation 2.97 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Baseline; n=20, 19, 21 | 43.8 Grams per liter | Standard Deviation 2.9 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Baseline; n=20, 19, 21 | 70.3 Grams per liter | Standard Deviation 4.23 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Day 2; n=20, 19, 21 | 45.7 Grams per liter | Standard Deviation 2.99 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Day 5; n=7, 5, 7 | 71.9 Grams per liter | Standard Deviation 2.85 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Day 2; n=20, 19, 21 | 26.4 Grams per liter | Standard Deviation 3.43 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Baseline; n=20, 19, 21 | 26.5 Grams per liter | Standard Deviation 3.19 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Day 2; n=20, 19, 21 | 72.1 Grams per liter | Standard Deviation 4.31 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Day 5; n=7, 5, 7 | 26.7 Grams per liter | Standard Deviation 1.25 |
Secondary
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Day 2; n=20, 19, 21 | 56.5 International units per liter | Standard Deviation 17.52 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Day 2; n=20, 19, 21 | 14.4 International units per liter | Standard Deviation 6.06 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Day 5; n=7, 5, 7 | 16.7 International units per liter | Standard Deviation 8.04 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Baseline; n=20, 19, 21 | 50.4 International units per liter | Standard Deviation 16.47 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Baseline; n=20, 19, 21 | 19.0 International units per liter | Standard Deviation 11.01 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Day 5; n=7, 5, 7 | 49.6 International units per liter | Standard Deviation 22.4 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Baseline; n=20, 19, 21 | 18.0 International units per liter | Standard Deviation 6.01 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Day 2; n=20, 19, 21 | 14.9 International units per liter | Standard Deviation 3.01 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Day 5; n=7, 5, 7 | 16.7 International units per liter | Standard Deviation 4.42 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Baseline; n=20, 19, 21 | 17.1 International units per liter | Standard Deviation 5.8 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Day 2; n=20, 19, 21 | 16.5 International units per liter | Standard Deviation 5.56 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Day 5; n=7, 5, 7 | 14.9 International units per liter | Standard Deviation 3.72 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Baseline; n=20, 19, 21 | 118.8 International units per liter | Standard Deviation 79.8 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Day 2; n=20, 19, 21 | 106.2 International units per liter | Standard Deviation 80.82 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Day 5; n=7, 5, 7 | 135.7 International units per liter | Standard Deviation 108.77 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Baseline; n=20, 19, 21 | 133.6 International units per liter | Standard Deviation 19.21 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Day 2; n=20, 19, 21 | 121.1 International units per liter | Standard Deviation 17.48 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Day 5; n=7, 5, 7 | 118.4 International units per liter | Standard Deviation 16.63 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Day 5; n=7, 5, 7 | 110.0 International units per liter | Standard Deviation 12.29 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Baseline; n=20, 19, 21 | 19.0 International units per liter | Standard Deviation 11.01 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Baseline; n=20, 19, 21 | 17.1 International units per liter | Standard Deviation 5.8 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Baseline; n=20, 19, 21 | 118.8 International units per liter | Standard Deviation 79.8 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Day 2; n=20, 19, 21 | 17.3 International units per liter | Standard Deviation 9.49 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Day 5; n=7, 5, 7 | 136.4 International units per liter | Standard Deviation 109.71 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Baseline; n=20, 19, 21 | 133.6 International units per liter | Standard Deviation 19.21 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Day 5; n=7, 5, 7 | 11.0 International units per liter | Standard Deviation 2.74 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Day 2; n=20, 19, 21 | 17.4 International units per liter | Standard Deviation 6.15 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Day 2; n=20, 19, 21 | 121.5 International units per liter | Standard Deviation 21.6 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Baseline; n=20, 19, 21 | 50.4 International units per liter | Standard Deviation 16.47 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Day 5; n=7, 5, 7 | 14.0 International units per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Day 2; n=20, 19, 21 | 114.9 International units per liter | Standard Deviation 101.61 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Day 2; n=20, 19, 21 | 57.4 International units per liter | Standard Deviation 17.03 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Day 2; n=20, 19, 21 | 15.8 International units per liter | Standard Deviation 4.29 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Day 5; n=7, 5, 7 | 14.8 International units per liter | Standard Deviation 0.45 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Day 5; n=7, 5, 7 | 56.4 International units per liter | Standard Deviation 9.58 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Baseline; n=20, 19, 21 | 18.0 International units per liter | Standard Deviation 6.01 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Day 5; n=7, 5, 7 | 55.0 International units per liter | Standard Deviation 13.69 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Baseline; n=20, 19, 21 | 18.0 International units per liter | Standard Deviation 6.01 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Day 2; n=20, 19, 21 | 16.0 International units per liter | Standard Deviation 4.11 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Day 5; n=7, 5, 7 | 145.4 International units per liter | Standard Deviation 170.9 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Day 5; n=7, 5, 7 | 16.6 International units per liter | Standard Deviation 3.78 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Day 5; n=7, 5, 7 | 126.0 International units per liter | Standard Deviation 22.84 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Baseline; n=20, 19, 21 | 17.1 International units per liter | Standard Deviation 5.8 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Day 2; n=20, 19, 21 | 17.3 International units per liter | Standard Deviation 7.67 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Baseline; n=20, 19, 21 | 133.6 International units per liter | Standard Deviation 19.21 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Day 5; n=7, 5, 7 | 21.6 International units per liter | Standard Deviation 13.31 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Baseline; n=20, 19, 21 | 19.0 International units per liter | Standard Deviation 11.01 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Day 2; n=20, 19, 21 | 16.8 International units per liter | Standard Deviation 9.2 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Baseline; n=20, 19, 21 | 118.8 International units per liter | Standard Deviation 79.8 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Day 5; n=7, 5, 7 | 22.7 International units per liter | Standard Deviation 14.36 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Baseline; n=20, 19, 21 | 50.4 International units per liter | Standard Deviation 16.47 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Day 2; n=20, 19, 21 | 56.7 International units per liter | Standard Deviation 18.33 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Day 2; n=20, 19, 21 | 106.2 International units per liter | Standard Deviation 81.94 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Day 2; n=20, 19, 21 | 122.1 International units per liter | Standard Deviation 18.56 |
Secondary
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1
Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Amylase; Day 2; n=18, 18 | 46.7 Units per liter | Standard Deviation 18.11 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Amylase; Baseline; n=18, 18 | 43.3 Units per liter | Standard Deviation 14.96 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Lipase; Day 2; n=18, 18 | 26.7 Units per liter | Standard Deviation 14.32 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Amylase; Day 5; n=9, 9 | 44.3 Units per liter | Standard Deviation 15.86 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Lipase; Day 5; n=9, 9 | 28.9 Units per liter | Standard Deviation 14.98 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Lipase; Baseline; n=18, 18 | 24.0 Units per liter | Standard Deviation 11.24 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Lipase; Day 5; n=9, 9 | 24.7 Units per liter | Standard Deviation 12.66 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Amylase; Baseline; n=18, 18 | 43.3 Units per liter | Standard Deviation 14.96 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Amylase; Day 2; n=18, 18 | 47.7 Units per liter | Standard Deviation 21.31 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Amylase; Day 5; n=9, 9 | 47.6 Units per liter | Standard Deviation 22.94 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Lipase; Baseline; n=18, 18 | 24.0 Units per liter | Standard Deviation 11.24 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 | Lipase; Day 2; n=18, 18 | 26.2 Units per liter | Standard Deviation 14.26 |
Secondary
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2
Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Day 2; n=20, 19, 21 | 48.3 Units per liter | Standard Deviation 15.91 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Day 5; n=7, 5, 7 | 49.6 Units per liter | Standard Deviation 22.33 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Day 5; n=7, 5, 7 | 21.9 Units per liter | Standard Deviation 9.39 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Baseline; n=20, 19, 21 | 49.3 Units per liter | Standard Deviation 16.33 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Baseline; n=20, 19, 21 | 23.8 Units per liter | Standard Deviation 17.88 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Day 2; n=20, 19, 21 | 20.4 Units per liter | Standard Deviation 10.04 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Baseline; n=20, 19, 21 | 23.8 Units per liter | Standard Deviation 17.88 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Day 2; n=20, 19, 21 | 22.2 Units per liter | Standard Deviation 12.81 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Day 5; n=7, 5, 7 | 17.6 Units per liter | Standard Deviation 8.23 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Day 2; n=20, 19, 21 | 49.4 Units per liter | Standard Deviation 18.86 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Baseline; n=20, 19, 21 | 49.3 Units per liter | Standard Deviation 16.33 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Day 5; n=7, 5, 7 | 48.8 Units per liter | Standard Deviation 8.53 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Day 5; n=7, 5, 7 | 24.1 Units per liter | Standard Deviation 13.26 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Baseline; n=20, 19, 21 | 49.3 Units per liter | Standard Deviation 16.33 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Day 2; n=20, 19, 21 | 50.1 Units per liter | Standard Deviation 18.22 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Day 5; n=7, 5, 7 | 43.6 Units per liter | Standard Deviation 14.89 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Day 2; n=20, 19, 21 | 24.1 Units per liter | Standard Deviation 11.45 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Baseline; n=20, 19, 21 | 23.8 Units per liter | Standard Deviation 17.88 |
Secondary
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Calcium; Day 2; n=18, 18 | 2.352 Millimoles per liter | Standard Deviation 0.0536 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Phosphate; Day 5; n=9, 9 | 1.173 Millimoles per liter | Standard Deviation 0.1413 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Sodium; Baseline; n=18, 18 | 136.9 Millimoles per liter | Standard Deviation 2.19 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | BUN; Baseline; n=18, 18 | 3.728 Millimoles per liter | Standard Deviation 1.0672 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Glucose; Day 5; n=9, 9 | 4.607 Millimoles per liter | Standard Deviation 0.2889 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | BUN; Day 2; n=18, 18 | 4.747 Millimoles per liter | Standard Deviation 0.8949 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Sodium; Day 2; n=18, 18 | 138.5 Millimoles per liter | Standard Deviation 1.54 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | BUN; Day 5; n=9, 9 | 5.053 Millimoles per liter | Standard Deviation 0.9143 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Glucose; Baseline; n=18, 18 | 4.987 Millimoles per liter | Standard Deviation 0.3833 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Triglycerides; Baseline; n=18, 18 | 1.026 Millimoles per liter | Standard Deviation 0.6064 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Sodium; Day 5; n=9, 9 | 138.2 Millimoles per liter | Standard Deviation 1.48 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Triglycerides; Day 2; n=18, 18 | 1.127 Millimoles per liter | Standard Deviation 0.3973 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Potassium; Baseline; n=18, 18 | 4.00 Millimoles per liter | Standard Deviation 0.23 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Triglycerides; Day 5; n=9, 9 | 1.029 Millimoles per liter | Standard Deviation 0.3389 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Chloride; Baseline; n=18, 18 | 102.3 Millimoles per liter | Standard Deviation 1.64 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Cholesterol; Baseline; n=18, 18 | 4.549 Millimoles per liter | Standard Deviation 0.9656 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Calcium; Day 5; n=9, 9 | 2.343 Millimoles per liter | Standard Deviation 0.0705 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Cholesterol; Day 2; n=18, 18 | 4.544 Millimoles per liter | Standard Deviation 0.8853 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Chloride; Day 2; n=18, 18 | 102.5 Millimoles per liter | Standard Deviation 1.69 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Cholesterol; Day 5; n=9, 9 | 4.519 Millimoles per liter | Standard Deviation 0.6212 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Potassium; Day 2; n=18, 18 | 4.27 Millimoles per liter | Standard Deviation 0.256 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Anion gap; Baseline; n=18, 18 | 9.5 Millimoles per liter | Standard Deviation 1.76 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Chloride; Day 5; n=9, 9 | 101.9 Millimoles per liter | Standard Deviation 1.76 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Anion gap; Day 2; n=18, 18 | 10.1 Millimoles per liter | Standard Deviation 1.28 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Glucose; Day 2; n=18, 18 | 4.842 Millimoles per liter | Standard Deviation 0.3451 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Anion gap; Day 5; n=9, 9 | 10.7 Millimoles per liter | Standard Deviation 0.87 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Phosphate; Baseline; n=18, 18 | 1.121 Millimoles per liter | Standard Deviation 0.1289 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Carbon dioxide; Baseline; n=18, 18 | 29.1 Millimoles per liter | Standard Deviation 2 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Potassium; Day 5; n=9, 9 | 4.18 Millimoles per liter | Standard Deviation 0.228 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Carbon dioxide; Day 2; n=18, 18 | 30.1 Millimoles per liter | Standard Deviation 1.86 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Phosphate; Day 2; n=18, 18 | 1.197 Millimoles per liter | Standard Deviation 0.1058 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Carbon dioxide; Day 5; n=9, 9 | 29.9 Millimoles per liter | Standard Deviation 1.36 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Calcium; Baseline; n=18, 18 | 2.327 Millimoles per liter | Standard Deviation 0.0451 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Carbon dioxide; Day 5; n=9, 9 | 31.0 Millimoles per liter | Standard Deviation 1.87 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Calcium; Baseline; n=18, 18 | 2.327 Millimoles per liter | Standard Deviation 0.0451 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Calcium; Day 2; n=18, 18 | 2.378 Millimoles per liter | Standard Deviation 0.083 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Calcium; Day 5; n=9, 9 | 2.313 Millimoles per liter | Standard Deviation 0.0559 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Glucose; Baseline; n=18, 18 | 4.987 Millimoles per liter | Standard Deviation 0.3833 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Glucose; Day 2; n=18, 18 | 4.706 Millimoles per liter | Standard Deviation 0.2996 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Glucose; Day 5; n=9, 9 | 4.600 Millimoles per liter | Standard Deviation 0.2182 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Potassium; Baseline; n=18, 18 | 4.00 Millimoles per liter | Standard Deviation 0.23 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Potassium; Day 2; n=18, 18 | 4.33 Millimoles per liter | Standard Deviation 0.379 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Potassium; Day 5; n=9, 9 | 4.13 Millimoles per liter | Standard Deviation 0.32 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Sodium; Baseline; n=18, 18 | 136.9 Millimoles per liter | Standard Deviation 2.19 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Sodium; Day 2; n=18, 18 | 138.9 Millimoles per liter | Standard Deviation 1.75 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Sodium; Day 5; n=9, 9 | 138.8 Millimoles per liter | Standard Deviation 1.48 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Chloride; Baseline; n=18, 18 | 102.3 Millimoles per liter | Standard Deviation 1.64 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Chloride; Day 2; n=18, 18 | 102.9 Millimoles per liter | Standard Deviation 1.66 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Chloride; Day 5; n=9, 9 | 101.8 Millimoles per liter | Standard Deviation 1.56 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Phosphate; Baseline; n=18, 18 | 1.121 Millimoles per liter | Standard Deviation 0.1289 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Phosphate; Day 2; n=18, 18 | 1.197 Millimoles per liter | Standard Deviation 0.1365 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Phosphate; Day 5; n=9, 9 | 1.234 Millimoles per liter | Standard Deviation 0.0963 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | BUN; Baseline; n=18, 18 | 3.728 Millimoles per liter | Standard Deviation 1.0672 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | BUN; Day 2; n=18, 18 | 4.654 Millimoles per liter | Standard Deviation 0.8997 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | BUN; Day 5; n=9, 9 | 4.729 Millimoles per liter | Standard Deviation 0.7928 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Triglycerides; Baseline; n=18, 18 | 1.026 Millimoles per liter | Standard Deviation 0.6064 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Triglycerides; Day 2; n=18, 18 | 1.036 Millimoles per liter | Standard Deviation 0.3982 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Triglycerides; Day 5; n=9, 9 | 0.904 Millimoles per liter | Standard Deviation 0.2605 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Cholesterol; Baseline; n=18, 18 | 4.549 Millimoles per liter | Standard Deviation 0.9656 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Cholesterol; Day 2; n=18, 18 | 4.632 Millimoles per liter | Standard Deviation 0.9164 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Cholesterol; Day 5; n=9, 9 | 4.330 Millimoles per liter | Standard Deviation 1.1611 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Anion gap; Baseline; n=18, 18 | 9.5 Millimoles per liter | Standard Deviation 1.76 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Anion gap; Day 2; n=18, 18 | 10.0 Millimoles per liter | Standard Deviation 1.08 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Anion gap; Day 5; n=9, 9 | 10.1 Millimoles per liter | Standard Deviation 0.93 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Carbon dioxide; Baseline; n=18, 18 | 29.1 Millimoles per liter | Standard Deviation 2 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Carbon dioxide; Day 2; n=18, 18 | 30.2 Millimoles per liter | Standard Deviation 1.58 |
Secondary
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Day 5; n=7, 5, 7 | 137.3 Millimoles per liter | Standard Deviation 1.11 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Day 2; n=20, 19, 21 | 4.716 Millimoles per liter | Standard Deviation 0.2093 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Baseline; n=20, 19, 21 | 0.828 Millimoles per liter | Standard Deviation 0.3752 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Baseline; n=20, 19, 21 | 102.4 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Day 2; n=20, 19, 21 | 29.6 Millimoles per liter | Standard Deviation 1.67 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Baseline; n=20, 19, 21 | 2.312 Millimoles per liter | Standard Deviation 0.0973 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Day 2; n=20, 19, 21 | 102.0 Millimoles per liter | Standard Deviation 1.81 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Day 2; n=20, 19, 21 | 10.6 Millimoles per liter | Standard Deviation 1.15 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Day 5; n=7, 5, 7 | 4.921 Millimoles per liter | Standard Deviation 0.9744 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Day 5; n=7, 5, 7 | 100.3 Millimoles per liter | Standard Deviation 1.38 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Day 5; n=7, 5, 7 | 4.574 Millimoles per liter | Standard Deviation 0.3675 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Day 2; n=20, 19, 21 | 4.526 Millimoles per liter | Standard Deviation 0.7144 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Baseline; n=20, 19, 21 | 1.100 Millimoles per liter | Standard Deviation 0.1813 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Day 5; n=7, 5, 7 | 2.446 Millimoles per liter | Standard Deviation 0.05 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Baseline; n=20, 19, 21 | 4.190 Millimoles per liter | Standard Deviation 0.9187 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Day 2; n=20, 19, 21 | 1.191 Millimoles per liter | Standard Deviation 0.1827 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Baseline; n=20, 19, 21 | 11.3 Millimoles per liter | Standard Deviation 1.53 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Day 5; n=7, 5, 7 | 1.297 Millimoles per liter | Standard Deviation 0.1577 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Baseline; n=20, 19, 21 | 4.16 Millimoles per liter | Standard Deviation 0.225 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Day 2; n=20, 19, 21 | 2.408 Millimoles per liter | Standard Deviation 0.067 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Day 5; n=7, 5, 7 | 4.520 Millimoles per liter | Standard Deviation 0.5269 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Day 2; n=20, 19, 21 | 4.26 Millimoles per liter | Standard Deviation 0.244 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Baseline; n=20, 19, 21 | 28.7 Millimoles per liter | Standard Deviation 2 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Day 2; n=20, 19, 21 | 4.652 Millimoles per liter | Standard Deviation 0.7742 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Day 5; n=7, 5, 7 | 3.84 Millimoles per liter | Standard Deviation 0.251 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Baseline; n=20, 19, 21 | 4.745 Millimoles per liter | Standard Deviation 0.316 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Baseline; n=20, 19, 21 | 4.533 Millimoles per liter | Standard Deviation 0.8776 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Baseline; n=20, 19, 21 | 138.4 Millimoles per liter | Standard Deviation 1.56 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Day 5; n=7, 5, 7 | 29.3 Millimoles per liter | Standard Deviation 1.5 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Day 5; n=7, 5, 7 | 0.894 Millimoles per liter | Standard Deviation 0.3072 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Day 2; n=20, 19, 21 | 137.9 Millimoles per liter | Standard Deviation 2 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Day 5; n=7, 5, 7 | 11.7 Millimoles per liter | Standard Deviation 2.43 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Day 2; n=20, 19, 21 | 0.957 Millimoles per liter | Standard Deviation 0.3872 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Day 5; n=7, 5, 7 | 4.768 Millimoles per liter | Standard Deviation 0.4098 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Baseline; n=20, 19, 21 | 2.312 Millimoles per liter | Standard Deviation 0.0973 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Day 2; n=20, 19, 21 | 2.369 Millimoles per liter | Standard Deviation 0.0671 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Day 5; n=7, 5, 7 | 2.324 Millimoles per liter | Standard Deviation 0.0439 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Baseline; n=20, 19, 21 | 4.745 Millimoles per liter | Standard Deviation 0.316 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Day 2; n=20, 19, 21 | 4.861 Millimoles per liter | Standard Deviation 0.225 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Day 5; n=7, 5, 7 | 4.608 Millimoles per liter | Standard Deviation 0.3518 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Baseline; n=20, 19, 21 | 4.16 Millimoles per liter | Standard Deviation 0.225 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Day 2; n=20, 19, 21 | 4.17 Millimoles per liter | Standard Deviation 0.281 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Day 5; n=7, 5, 7 | 3.94 Millimoles per liter | Standard Deviation 0.23 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Baseline; n=20, 19, 21 | 138.4 Millimoles per liter | Standard Deviation 1.56 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Day 2; n=20, 19, 21 | 137.9 Millimoles per liter | Standard Deviation 2.58 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Day 5; n=7, 5, 7 | 136.2 Millimoles per liter | Standard Deviation 2.59 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Baseline; n=20, 19, 21 | 102.4 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Day 2; n=20, 19, 21 | 102.2 Millimoles per liter | Standard Deviation 2.06 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Day 5; n=7, 5, 7 | 101.8 Millimoles per liter | Standard Deviation 2.28 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Baseline; n=20, 19, 21 | 1.100 Millimoles per liter | Standard Deviation 0.1813 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Day 2; n=20, 19, 21 | 1.177 Millimoles per liter | Standard Deviation 0.1535 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Day 5; n=7, 5, 7 | 1.158 Millimoles per liter | Standard Deviation 0.2958 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Baseline; n=20, 19, 21 | 4.190 Millimoles per liter | Standard Deviation 0.9187 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Day 2; n=20, 19, 21 | 4.531 Millimoles per liter | Standard Deviation 0.8261 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Baseline; n=20, 19, 21 | 0.828 Millimoles per liter | Standard Deviation 0.3752 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Day 2; n=20, 19, 21 | 0.994 Millimoles per liter | Standard Deviation 0.3875 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Day 5; n=7, 5, 7 | 0.774 Millimoles per liter | Standard Deviation 0.279 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Baseline; n=20, 19, 21 | 4.533 Millimoles per liter | Standard Deviation 0.8776 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Day 2; n=20, 19, 21 | 4.639 Millimoles per liter | Standard Deviation 0.9975 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Day 5; n=7, 5, 7 | 3.962 Millimoles per liter | Standard Deviation 0.8236 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Baseline; n=20, 19, 21 | 11.3 Millimoles per liter | Standard Deviation 1.53 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Day 2; n=20, 19, 21 | 10.4 Millimoles per liter | Standard Deviation 1.17 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Day 5; n=7, 5, 7 | 10.8 Millimoles per liter | Standard Deviation 0.84 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Baseline; n=20, 19, 21 | 28.7 Millimoles per liter | Standard Deviation 2 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Day 2; n=20, 19, 21 | 29.5 Millimoles per liter | Standard Deviation 1.78 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Day 5; n=7, 5, 7 | 27.6 Millimoles per liter | Standard Deviation 2.19 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Day 2; n=20, 19, 21 | 137.4 Millimoles per liter | Standard Deviation 1.24 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Day 2; n=20, 19, 21 | 28.6 Millimoles per liter | Standard Deviation 2.2 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Day 2; n=20, 19, 21 | 0.890 Millimoles per liter | Standard Deviation 0.4024 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Baseline; n=20, 19, 21 | 138.4 Millimoles per liter | Standard Deviation 1.56 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Day 5; n=7, 5, 7 | 11.9 Millimoles per liter | Standard Deviation 1.68 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Day 5; n=7, 5, 7 | 1.363 Millimoles per liter | Standard Deviation 0.6417 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Day 5; n=7, 5, 7 | 4.17 Millimoles per liter | Standard Deviation 0.236 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Day 5; n=7, 5, 7 | 2.367 Millimoles per liter | Standard Deviation 0.064 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Baseline; n=20, 19, 21 | 4.533 Millimoles per liter | Standard Deviation 0.8776 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Day 2; n=20, 19, 21 | 4.14 Millimoles per liter | Standard Deviation 0.24 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Baseline; n=20, 19, 21 | 2.312 Millimoles per liter | Standard Deviation 0.0973 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Day 2; n=20, 19, 21 | 4.610 Millimoles per liter | Standard Deviation 0.8031 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Baseline; n=20, 19, 21 | 4.16 Millimoles per liter | Standard Deviation 0.225 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Baseline; n=20, 19, 21 | 28.7 Millimoles per liter | Standard Deviation 2 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Day 5; n=7, 5, 7 | 4.454 Millimoles per liter | Standard Deviation 0.8948 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Day 5; n=7, 5, 7 | 4.926 Millimoles per liter | Standard Deviation 0.2224 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Day 2; n=20, 19, 21 | 2.390 Millimoles per liter | Standard Deviation 0.0695 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Baseline; n=20, 19, 21 | 11.3 Millimoles per liter | Standard Deviation 1.53 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Day 2; n=20, 19, 21 | 1.176 Millimoles per liter | Standard Deviation 0.173 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Day 2; n=20, 19, 21 | 4.775 Millimoles per liter | Standard Deviation 0.2039 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Day 5; n=7, 5, 7 | 1.117 Millimoles per liter | Standard Deviation 0.1612 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Baseline; n=20, 19, 21 | 1.100 Millimoles per liter | Standard Deviation 0.1813 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Day 5; n=7, 5, 7 | 28.1 Millimoles per liter | Standard Deviation 1.57 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Baseline; n=20, 19, 21 | 4.190 Millimoles per liter | Standard Deviation 0.9187 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Day 5; n=7, 5, 7 | 100.4 Millimoles per liter | Standard Deviation 2.37 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Day 2; n=20, 19, 21 | 10.8 Millimoles per liter | Standard Deviation 1.54 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Day 2; n=20, 19, 21 | 4.403 Millimoles per liter | Standard Deviation 0.8736 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Day 2; n=20, 19, 21 | 102.0 Millimoles per liter | Standard Deviation 2.09 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Baseline; n=20, 19, 21 | 102.4 Millimoles per liter | Standard Deviation 1.72 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Day 5; n=7, 5, 7 | 5.050 Millimoles per liter | Standard Deviation 1.2701 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Day 5; n=7, 5, 7 | 136.3 Millimoles per liter | Standard Deviation 1.89 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Baseline; n=20, 19, 21 | 4.745 Millimoles per liter | Standard Deviation 0.316 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Baseline; n=20, 19, 21 | 0.828 Millimoles per liter | Standard Deviation 0.3752 |
Secondary
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Creatinine; Baseline; n=18, 18 | 78.68 Micromoles per liter | Standard Deviation 15.983 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Creatinine; Day 2; n=18, 18 | 80.87 Micromoles per liter | Standard Deviation 15.104 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Creatinine; Day 5; n=9, 9 | 79.57 Micromoles per liter | Standard Deviation 17.196 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Total bilirubin; Baseline; n=18, 18 | 10.56 Micromoles per liter | Standard Deviation 3.578 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Total bilirubin; Day 2; n=18, 18 | 11.45 Micromoles per liter | Standard Deviation 4.334 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Total bilirubin; Day 5; n=9, 9 | 11.49 Micromoles per liter | Standard Deviation 1.59 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Direct bilirubin; Baseline; n=18, 18 | 1.96 Micromoles per liter | Standard Deviation 0.624 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Direct bilirubin; Day 2; n=18, 18 | 1.91 Micromoles per liter | Standard Deviation 0.643 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Direct bilirubin; Day 5; n=9, 9 | 1.86 Micromoles per liter | Standard Deviation 0.332 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Urate; Baseline; n=18, 18 | 306.7 Micromoles per liter | Standard Deviation 87.16 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Urate; Day 2; n=18, 18 | 283.2 Micromoles per liter | Standard Deviation 78.74 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Urate; Day 5; n=9, 9 | 281.4 Micromoles per liter | Standard Deviation 75.17 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Urate; Day 2; n=18, 18 | 282.5 Micromoles per liter | Standard Deviation 68.93 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Creatinine; Baseline; n=18, 18 | 78.68 Micromoles per liter | Standard Deviation 15.983 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Direct bilirubin; Baseline; n=18, 18 | 1.96 Micromoles per liter | Standard Deviation 0.624 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Creatinine; Day 2; n=18, 18 | 80.11 Micromoles per liter | Standard Deviation 14.243 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Urate; Baseline; n=18, 18 | 306.7 Micromoles per liter | Standard Deviation 87.16 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Creatinine; Day 5; n=9, 9 | 80.33 Micromoles per liter | Standard Deviation 11.925 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Direct bilirubin; Day 2; n=18, 18 | 1.86 Micromoles per liter | Standard Deviation 0.631 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Total bilirubin; Baseline; n=18, 18 | 10.56 Micromoles per liter | Standard Deviation 3.578 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Urate; Day 5; n=9, 9 | 282.9 Micromoles per liter | Standard Deviation 67.35 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Total bilirubin; Day 2; n=18, 18 | 10.91 Micromoles per liter | Standard Deviation 2.952 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Direct bilirubin; Day 5; n=9, 9 | 1.90 Micromoles per liter | Standard Deviation 0.752 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Total bilirubin; Day 5; n=9, 9 | 11.41 Micromoles per liter | Standard Deviation 3.867 |
Secondary
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Baseline; n=20, 19, 21 | 74.00 Micromoles per liter | Standard Deviation 13.855 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Day 2; n=20, 19, 21 | 81.95 Micromoles per liter | Standard Deviation 14.968 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Day 5; n=7, 5, 7 | 91.69 Micromoles per liter | Standard Deviation 7.992 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Baseline; n=20, 19, 21 | 9.05 Micromoles per liter | Standard Deviation 3.07 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Day 2; n=20, 19, 21 | 11.49 Micromoles per liter | Standard Deviation 4.185 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Day 5; n=7, 5, 7 | 13.34 Micromoles per liter | Standard Deviation 4.999 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Baseline; n=20, 19, 21 | 1.89 Micromoles per liter | Standard Deviation 0.66 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Day 2; n=20, 19, 21 | 2.12 Micromoles per liter | Standard Deviation 0.747 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Day 5; n=7, 5, 7 | 2.29 Micromoles per liter | Standard Deviation 0.76 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Baseline; n=20, 19, 21 | 289.2 Micromoles per liter | Standard Deviation 73.13 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Day 2; n=20, 19, 21 | 277.7 Micromoles per liter | Standard Deviation 72.39 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Day 5; n=7, 5, 7 | 286.3 Micromoles per liter | Standard Deviation 48.83 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Day 5; n=7, 5, 7 | 291.2 Micromoles per liter | Standard Deviation 96.66 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Baseline; n=20, 19, 21 | 74.00 Micromoles per liter | Standard Deviation 13.855 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Baseline; n=20, 19, 21 | 1.89 Micromoles per liter | Standard Deviation 0.66 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Day 5; n=7, 5, 7 | 2.38 Micromoles per liter | Standard Deviation 0.996 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Day 2; n=20, 19, 21 | 83.34 Micromoles per liter | Standard Deviation 11.078 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Day 5; n=7, 5, 7 | 14.30 Micromoles per liter | Standard Deviation 7.174 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Day 2; n=20, 19, 21 | 299.4 Micromoles per liter | Standard Deviation 68.62 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Day 5; n=7, 5, 7 | 76.04 Micromoles per liter | Standard Deviation 14.435 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Day 2; n=20, 19, 21 | 2.17 Micromoles per liter | Standard Deviation 0.732 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Day 2; n=20, 19, 21 | 11.88 Micromoles per liter | Standard Deviation 4.544 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Baseline; n=20, 19, 21 | 9.05 Micromoles per liter | Standard Deviation 3.07 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Baseline; n=20, 19, 21 | 289.2 Micromoles per liter | Standard Deviation 73.13 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Baseline; n=20, 19, 21 | 9.05 Micromoles per liter | Standard Deviation 3.07 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Day 2; n=20, 19, 21 | 11.11 Micromoles per liter | Standard Deviation 3.517 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Baseline; n=20, 19, 21 | 289.2 Micromoles per liter | Standard Deviation 73.13 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Day 5; n=7, 5, 7 | 10.46 Micromoles per liter | Standard Deviation 1.397 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Baseline; n=20, 19, 21 | 1.89 Micromoles per liter | Standard Deviation 0.66 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Day 2; n=20, 19, 21 | 2.07 Micromoles per liter | Standard Deviation 0.656 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Day 2; n=20, 19, 21 | 275.4 Micromoles per liter | Standard Deviation 77.75 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Baseline; n=20, 19, 21 | 74.00 Micromoles per liter | Standard Deviation 13.855 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Day 2; n=20, 19, 21 | 80.18 Micromoles per liter | Standard Deviation 13.533 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Day 5; n=7, 5, 7 | 1.87 Micromoles per liter | Standard Deviation 0.431 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Day 5; n=7, 5, 7 | 83.71 Micromoles per liter | Standard Deviation 15.52 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Day 5; n=7, 5, 7 | 313.6 Micromoles per liter | Standard Deviation 79.74 |
Secondary
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Baseline; n=18, 18 | 29.68 Picograms | Standard Deviation 1.858 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Day 2; n=18, 18 | 29.69 Picograms | Standard Deviation 1.74 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Day 5; n=9, 9 | 30.08 Picograms | Standard Deviation 1.737 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Baseline; n=18, 18 | 29.68 Picograms | Standard Deviation 1.858 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Day 2; n=18, 18 | 29.83 Picograms | Standard Deviation 1.772 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Day 5; n=9, 9 | 29.74 Picograms | Standard Deviation 1.938 |
Secondary
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Day 2; n=20, 19, 21 | 28.87 Picograms | Standard Deviation 2.415 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Baseline; n=20, 19, 21 | 29.05 Picograms | Standard Deviation 2.499 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Day 5; n=7, 5, 7 | 29.96 Picograms | Standard Deviation 3.365 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Day 2; n=20, 19, 21 | 28.92 Picograms | Standard Deviation 2.449 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Baseline; n=20, 19, 21 | 29.05 Picograms | Standard Deviation 2.499 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Day 5; n=7, 5, 7 | 28.14 Picograms | Standard Deviation 1.394 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Baseline; n=20, 19, 21 | 29.05 Picograms | Standard Deviation 2.499 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Day 5; n=7, 5, 7 | 28.93 Picograms | Standard Deviation 1.962 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Day 2; n=20, 19, 21 | 28.99 Picograms | Standard Deviation 2.411 |
Secondary
Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1 | Baseline; n=18, 18 | 88.80 Femtoliters | Standard Deviation 4.887 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1 | Day 2; n=18, 18 | 88.21 Femtoliters | Standard Deviation 4.48 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1 | Day 5; n=9, 9 | 88.17 Femtoliters | Standard Deviation 4.532 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1 | Baseline; n=18, 18 | 88.80 Femtoliters | Standard Deviation 4.887 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1 | Day 2; n=18, 18 | 88.61 Femtoliters | Standard Deviation 4.363 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1 | Day 5; n=9, 9 | 87.63 Femtoliters | Standard Deviation 4.971 |
Secondary
Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 | Day 2; n=20, 19, 21 | 86.37 Femtoliters | Standard Deviation 5.934 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 | Baseline; n=20, 19, 21 | 86.98 Femtoliters | Standard Deviation 5.931 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 | Day 5; n=7, 5, 7 | 88.47 Femtoliters | Standard Deviation 8.285 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 | Day 2; n=20, 19, 21 | 86.52 Femtoliters | Standard Deviation 6.038 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 | Baseline; n=20, 19, 21 | 86.98 Femtoliters | Standard Deviation 5.931 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 | Day 5; n=7, 5, 7 | 85.86 Femtoliters | Standard Deviation 4.453 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 | Baseline; n=20, 19, 21 | 86.98 Femtoliters | Standard Deviation 5.931 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 | Day 5; n=7, 5, 7 | 85.41 Femtoliters | Standard Deviation 4.401 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 | Day 2; n=20, 19, 21 | 86.57 Femtoliters | Standard Deviation 5.867 |
Secondary
Absolute Values for Erythrocytes Count-Part 1
Blood samples were collected for the assessment of following hematology parameter: erythrocytes count.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocytes Count-Part 1 | Baseline; n=18, 18 | 4.801 10^12 cells per liter | Standard Deviation 0.4605 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocytes Count-Part 1 | Day 2; n=18, 18 | 4.937 10^12 cells per liter | Standard Deviation 0.4896 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocytes Count-Part 1 | Day 5; n=9, 9 | 5.009 10^12 cells per liter | Standard Deviation 0.4786 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocytes Count-Part 1 | Baseline; n=18, 18 | 4.801 10^12 cells per liter | Standard Deviation 0.4605 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocytes Count-Part 1 | Day 2; n=18, 18 | 4.983 10^12 cells per liter | Standard Deviation 0.501 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocytes Count-Part 1 | Day 5; n=9, 9 | 5.061 10^12 cells per liter | Standard Deviation 0.3888 |
Secondary
Absolute Values for Erythrocytes Count-Part 2
Blood samples were collected for the assessment of following hematology parameter: erythrocytes count.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocytes Count-Part 2 | Day 2; n=20, 19, 21 | 4.893 10^12 cells per liter | Standard Deviation 0.5814 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocytes Count-Part 2 | Baseline; n=20, 19, 21 | 4.613 10^12 cells per liter | Standard Deviation 0.568 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Erythrocytes Count-Part 2 | Day 5; n=7, 5, 7 | 4.941 10^12 cells per liter | Standard Deviation 0.6086 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocytes Count-Part 2 | Day 2; n=20, 19, 21 | 4.899 10^12 cells per liter | Standard Deviation 0.5878 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocytes Count-Part 2 | Baseline; n=20, 19, 21 | 4.613 10^12 cells per liter | Standard Deviation 0.568 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Erythrocytes Count-Part 2 | Day 5; n=7, 5, 7 | 4.424 10^12 cells per liter | Standard Deviation 0.6683 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Erythrocytes Count-Part 2 | Baseline; n=20, 19, 21 | 4.613 10^12 cells per liter | Standard Deviation 0.568 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Erythrocytes Count-Part 2 | Day 5; n=7, 5, 7 | 4.957 10^12 cells per liter | Standard Deviation 0.6309 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Erythrocytes Count-Part 2 | Day 2; n=20, 19, 21 | 4.850 10^12 cells per liter | Standard Deviation 0.59 |
Secondary
Absolute Values for Hematocrit-Part 1
Blood samples were collected for the assessment of following hematology parameter: hematocrit.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Hematocrit-Part 1 | Baseline; n=18, 18 | 0.4252 Proportion of red blood cells in blood | Standard Deviation 0.03485 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Hematocrit-Part 1 | Day 2; n=18, 18 | 0.4346 Proportion of red blood cells in blood | Standard Deviation 0.03935 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Hematocrit-Part 1 | Day 5; n=9, 9 | 0.4410 Proportion of red blood cells in blood | Standard Deviation 0.04004 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Hematocrit-Part 1 | Baseline; n=18, 18 | 0.4252 Proportion of red blood cells in blood | Standard Deviation 0.03485 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Hematocrit-Part 1 | Day 2; n=18, 18 | 0.4405 Proportion of red blood cells in blood | Standard Deviation 0.03885 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Hematocrit-Part 1 | Day 5; n=9, 9 | 0.4430 Proportion of red blood cells in blood | Standard Deviation 0.03266 |
Secondary
Absolute Values for Hematocrit-Part 2
Blood samples were collected for the assessment of following hematology parameter: hematocrit.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Hematocrit-Part 2 | Day 2; n=20, 19, 21 | 0.4207 Proportion of red blood cells in blood | Standard Deviation 0.03989 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Hematocrit-Part 2 | Baseline; n=20, 19, 21 | 0.4010 Proportion of red blood cells in blood | Standard Deviation 0.03876 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Hematocrit-Part 2 | Day 5; n=7, 5, 7 | 0.4337 Proportion of red blood cells in blood | Standard Deviation 0.03499 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Hematocrit-Part 2 | Day 2; n=20, 19, 21 | 0.4219 Proportion of red blood cells in blood | Standard Deviation 0.04146 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Hematocrit-Part 2 | Baseline; n=20, 19, 21 | 0.4010 Proportion of red blood cells in blood | Standard Deviation 0.03876 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Hematocrit-Part 2 | Day 5; n=7, 5, 7 | 0.3786 Proportion of red blood cells in blood | Standard Deviation 0.04858 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematocrit-Part 2 | Baseline; n=20, 19, 21 | 0.4010 Proportion of red blood cells in blood | Standard Deviation 0.03876 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematocrit-Part 2 | Day 5; n=7, 5, 7 | 0.4216 Proportion of red blood cells in blood | Standard Deviation 0.03917 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematocrit-Part 2 | Day 2; n=20, 19, 21 | 0.4176 Proportion of red blood cells in blood | Standard Deviation 0.03777 |
Secondary
Absolute Values for Hemoglobin-Part 1
Blood samples were collected for the assessment of following hematology parameter: hemoglobin.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Hemoglobin-Part 1 | Baseline; n=18, 18 | 142.2 Grams per liter | Standard Deviation 13.46 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Hemoglobin-Part 1 | Day 2; n=18, 18 | 146.4 Grams per liter | Standard Deviation 13.74 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Hemoglobin-Part 1 | Day 5; n=9, 9 | 150.3 Grams per liter | Standard Deviation 15.74 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Hemoglobin-Part 1 | Baseline; n=18, 18 | 142.2 Grams per liter | Standard Deviation 13.46 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Hemoglobin-Part 1 | Day 2; n=18, 18 | 148.3 Grams per liter | Standard Deviation 14.29 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Hemoglobin-Part 1 | Day 5; n=9, 9 | 150.3 Grams per liter | Standard Deviation 13.13 |
Secondary
Absolute Values for Hemoglobin-Part 2
Blood samples were collected for the assessment of following hematology parameter: hemoglobin.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Hemoglobin-Part 2 | Day 5; n=7, 5, 7 | 146.9 Grams per liter | Standard Deviation 14.14 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Hemoglobin-Part 2 | Baseline; n=20, 19, 21 | 134.0 Grams per liter | Standard Deviation 15.37 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Hemoglobin-Part 2 | Day 2; n=20, 19, 21 | 140.6 Grams per liter | Standard Deviation 15.83 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Hemoglobin-Part 2 | Day 5; n=7, 5, 7 | 124.2 Grams per liter | Standard Deviation 15.74 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Hemoglobin-Part 2 | Baseline; n=20, 19, 21 | 134.0 Grams per liter | Standard Deviation 15.37 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Hemoglobin-Part 2 | Day 2; n=20, 19, 21 | 141.1 Grams per liter | Standard Deviation 16.19 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hemoglobin-Part 2 | Day 5; n=7, 5, 7 | 142.7 Grams per liter | Standard Deviation 14.42 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hemoglobin-Part 2 | Baseline; n=20, 19, 21 | 134.0 Grams per liter | Standard Deviation 15.37 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hemoglobin-Part 2 | Day 2; n=20, 19, 21 | 140.0 Grams per liter | Standard Deviation 15.37 |
Secondary
Absolute Values for Urine Parameter: pH-Part 2
Urine samples were collected at indicated time points for the assessment of urine pH. 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).
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: pH-Part 2 | Day 2; n=20, 19, 21 | 6.15 pH | Standard Deviation 0.69 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: pH-Part 2 | Baseline; n=20, 19, 21 | 6.36 pH | Standard Deviation 0.727 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: pH-Part 2 | Day 5; n=7, 5, 7 | 5.86 pH | Standard Deviation 0.627 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: pH-Part 2 | Day 2; n=20, 19, 21 | 6.08 pH | Standard Deviation 0.584 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: pH-Part 2 | Baseline; n=20, 19, 21 | 6.36 pH | Standard Deviation 0.727 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: pH-Part 2 | Day 5; n=7, 5, 7 | 5.60 pH | Standard Deviation 0.418 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: pH-Part 2 | Baseline; n=20, 19, 21 | 6.36 pH | Standard Deviation 0.727 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: pH-Part 2 | Day 5; n=7, 5, 7 | 6.21 pH | Standard Deviation 0.393 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: pH-Part 2 | Day 2; n=20, 19, 21 | 6.10 pH | Standard Deviation 0.718 |
Secondary
Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1
Urine samples were collected at indicated time points for the assessment of urine pH. 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).
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1 | Baseline; n=18, 18 | 6.03 pH | Standard Deviation 0.696 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1 | Day 2; n=18, 18 | 6.14 pH | Standard Deviation 0.682 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1 | Day 5; n=9, 9 | 5.72 pH | Standard Deviation 0.441 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1 | Baseline; n=18, 18 | 6.03 pH | Standard Deviation 0.696 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1 | Day 2; n=18, 18 | 6.25 pH | Standard Deviation 0.6 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1 | Day 5; n=9, 9 | 5.89 pH | Standard Deviation 0.697 |
Secondary
Absolute Values for Urine Parameter: Specific Gravity-Part 1
Urine samples were collected at indicated time points for the assessment of 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, indicated as ratio of urine density to water density.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Specific Gravity-Part 1 | Baseline; n=18, 18 | 1.0120 Ratio | Standard Deviation 0.00915 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Specific Gravity-Part 1 | Day 2; n=18, 18 | 1.0152 Ratio | Standard Deviation 0.00685 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Specific Gravity-Part 1 | Day 5; n=9, 9 | 1.0201 Ratio | Standard Deviation 0.00664 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Specific Gravity-Part 1 | Baseline; n=18, 18 | 1.0120 Ratio | Standard Deviation 0.00915 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Specific Gravity-Part 1 | Day 2; n=18, 18 | 1.0158 Ratio | Standard Deviation 0.00584 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Specific Gravity-Part 1 | Day 5; n=9, 9 | 1.0161 Ratio | Standard Deviation 0.00434 |
Secondary
Absolute Values for Urine Parameter: Specific Gravity-Part 2
Urine samples were collected at indicated time points for the assessment of 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, indicated as ratio of urine density to water density.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Specific Gravity-Part 2 | Day 2; n=20, 19, 21 | 1.0166 Ratio | Standard Deviation 0.00675 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Specific Gravity-Part 2 | Baseline; n=20, 19, 21 | 1.0080 Ratio | Standard Deviation 0.00735 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Specific Gravity-Part 2 | Day 5; n=7, 5, 7 | 1.0180 Ratio | Standard Deviation 0.00632 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Specific Gravity-Part 2 | Day 2; n=20, 19, 21 | 1.0151 Ratio | Standard Deviation 0.00552 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Specific Gravity-Part 2 | Baseline; n=20, 19, 21 | 1.0080 Ratio | Standard Deviation 0.00735 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Specific Gravity-Part 2 | Day 5; n=7, 5, 7 | 1.0248 Ratio | Standard Deviation 0.00526 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: Specific Gravity-Part 2 | Baseline; n=20, 19, 21 | 1.0080 Ratio | Standard Deviation 0.00735 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: Specific Gravity-Part 2 | Day 5; n=7, 5, 7 | 1.0171 Ratio | Standard Deviation 0.00999 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: Specific Gravity-Part 2 | Day 2; n=20, 19, 21 | 1.0163 Ratio | Standard Deviation 0.00419 |
Secondary
Absolute Values for Urine Parameter: Urobilinogen-Part 1
Urine samples were collected at indicated time points for the assessment of urine urobilinogen.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Urobilinogen-Part 1 | Baseline; n=18, 18 | 4.1384 Micromoles per liter | Standard Deviation 3.19235 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Urobilinogen-Part 1 | Day 2; n=18, 18 | 3.3860 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Urobilinogen-Part 1 | Day 5; n=9, 9 | 3.3860 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Urobilinogen-Part 1 | Day 5; n=9, 9 | 3.3860 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Urobilinogen-Part 1 | Baseline; n=18, 18 | 4.1384 Micromoles per liter | Standard Deviation 3.19235 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Urobilinogen-Part 1 | Day 2; n=18, 18 | 4.1384 Micromoles per liter | Standard Deviation 3.19235 |
Secondary
Absolute Values for Urine Parameter: Urobilinogen-Part 2
Urine samples were collected at indicated time points for the assessment of urine urobilinogen.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Urobilinogen-Part 2 | Day 2; n=20, 19, 21 | 4.0632 Micromoles per liter | Standard Deviation 3.02853 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Urobilinogen-Part 2 | Baseline; n=20, 19, 21 | 4.6759 Micromoles per liter | Standard Deviation 4.03794 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Urine Parameter: Urobilinogen-Part 2 | Day 5; n=7, 5, 7 | 3.3860 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Urobilinogen-Part 2 | Day 2; n=20, 19, 21 | 3.3860 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Urobilinogen-Part 2 | Baseline; n=20, 19, 21 | 4.6759 Micromoles per liter | Standard Deviation 4.03794 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Urine Parameter: Urobilinogen-Part 2 | Day 5; n=7, 5, 7 | 6.0948 Micromoles per liter | Standard Deviation 6.05706 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: Urobilinogen-Part 2 | Baseline; n=20, 19, 21 | 4.6759 Micromoles per liter | Standard Deviation 4.03794 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: Urobilinogen-Part 2 | Day 5; n=7, 5, 7 | 5.3209 Micromoles per liter | Standard Deviation 5.11915 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: Urobilinogen-Part 2 | Day 2; n=20, 19, 21 | 3.3860 Micromoles per liter | Standard Deviation 0 |
Secondary
Absolute Values for Vital Sign: Pulse Rate-Part 1
Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Pulse Rate-Part 1 | Day 4 | 67.4 Beats per minute | Standard Deviation 7.89 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Pulse Rate-Part 1 | Day 5 | 64.4 Beats per minute | Standard Deviation 6.97 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Pulse Rate-Part 1 | Baseline | 65.7 Beats per minute | Standard Deviation 5.27 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Pulse Rate-Part 1 | Day 2 | 66.7 Beats per minute | Standard Deviation 7.02 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Pulse Rate-Part 1 | Day 3 | 67.4 Beats per minute | Standard Deviation 7.79 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Pulse Rate-Part 1 | Day 3 | 68.6 Beats per minute | Standard Deviation 9.58 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Pulse Rate-Part 1 | Day 4 | 65.6 Beats per minute | Standard Deviation 9.37 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Pulse Rate-Part 1 | Day 2 | 68.4 Beats per minute | Standard Deviation 8.71 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Pulse Rate-Part 1 | Day 5 | 66.9 Beats per minute | Standard Deviation 8.39 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Pulse Rate-Part 1 | Baseline | 66.2 Beats per minute | Standard Deviation 10 |
Secondary
Absolute Values for Vital Sign: Pulse Rate-Part 2
Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Day 4 | 70.8 Beats per minute | Standard Deviation 12.9 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Day 3 | 66.7 Beats per minute | Standard Deviation 11.28 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Baseline | 65.4 Beats per minute | Standard Deviation 12.47 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Day 2 | 66.9 Beats per minute | Standard Deviation 12.76 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Day 5 | 67.6 Beats per minute | Standard Deviation 11.19 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Day 3 | 64.9 Beats per minute | Standard Deviation 14.16 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Baseline | 64.1 Beats per minute | Standard Deviation 7.7 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Day 2 | 64.0 Beats per minute | Standard Deviation 10.66 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Day 4 | 68.2 Beats per minute | Standard Deviation 11.25 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Day 5 | 69.1 Beats per minute | Standard Deviation 9.11 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Day 5 | 69.6 Beats per minute | Standard Deviation 13.99 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Day 4 | 72.6 Beats per minute | Standard Deviation 12.36 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Baseline | 63.8 Beats per minute | Standard Deviation 7.85 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Day 3 | 67.4 Beats per minute | Standard Deviation 11.04 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Pulse Rate-Part 2 | Day 2 | 64.1 Beats per minute | Standard Deviation 7.94 |
Secondary
Absolute Values for Vital Sign: Respiratory Rate-Part 1
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Day 2; n=17, 17 | 13.1 Breaths per minute | Standard Deviation 2.56 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Day 4; n=18, 18 | 13.9 Breaths per minute | Standard Deviation 2.87 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Day 3; n=17, 18 | 14.7 Breaths per minute | Standard Deviation 2.11 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Day 5; n=18, 18 | 14.0 Breaths per minute | Standard Deviation 2.47 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Baseline; n=18, 18 | 14.0 Breaths per minute | Standard Deviation 2.66 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Day 5; n=18, 18 | 14.1 Breaths per minute | Standard Deviation 1.75 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Baseline; n=18, 18 | 14.9 Breaths per minute | Standard Deviation 1.71 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Day 2; n=17, 17 | 13.9 Breaths per minute | Standard Deviation 2.69 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Day 3; n=17, 18 | 15.2 Breaths per minute | Standard Deviation 2.49 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Respiratory Rate-Part 1 | Day 4; n=18, 18 | 14.7 Breaths per minute | Standard Deviation 3.07 |
Secondary
Absolute Values for Vital Sign: Respiratory Rate-Part 2
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Day 4 | 14.9 Breaths per minute | Standard Deviation 2.38 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Day 3 | 15.0 Breaths per minute | Standard Deviation 2 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Baseline | 14.8 Breaths per minute | Standard Deviation 1.2 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Day 2 | 14.3 Breaths per minute | Standard Deviation 2.27 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Day 5 | 13.7 Breaths per minute | Standard Deviation 1.63 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Day 3 | 14.5 Breaths per minute | Standard Deviation 1.98 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Baseline | 15.3 Breaths per minute | Standard Deviation 2.02 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Day 2 | 15.4 Breaths per minute | Standard Deviation 1.64 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Day 4 | 14.0 Breaths per minute | Standard Deviation 3.06 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Day 5 | 14.5 Breaths per minute | Standard Deviation 1.61 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Day 5 | 14.6 Breaths per minute | Standard Deviation 1.8 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Day 4 | 14.3 Breaths per minute | Standard Deviation 2.22 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Baseline | 13.8 Breaths per minute | Standard Deviation 2.27 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Day 3 | 14.2 Breaths per minute | Standard Deviation 2.18 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Respiratory Rate-Part 2 | Day 2 | 14.2 Breaths per minute | Standard Deviation 2.36 |
Secondary
Absolute Values for Vital Signs: DBP and SBP-Part 2
Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Baseline | 120.8 Millimeters of mercury | Standard Deviation 17.53 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Day 2 | 117.4 Millimeters of mercury | Standard Deviation 11.84 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Day 3 | 115.8 Millimeters of mercury | Standard Deviation 10.63 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Day 4 | 119.0 Millimeters of mercury | Standard Deviation 12.75 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Day 5 | 118.2 Millimeters of mercury | Standard Deviation 12.92 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Baseline | 74.8 Millimeters of mercury | Standard Deviation 10.44 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Day 2 | 72.5 Millimeters of mercury | Standard Deviation 9.26 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Day 3 | 72.9 Millimeters of mercury | Standard Deviation 7.57 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Day 4 | 71.9 Millimeters of mercury | Standard Deviation 6.94 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Day 5 | 72.0 Millimeters of mercury | Standard Deviation 8.61 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Day 4 | 73.5 Millimeters of mercury | Standard Deviation 8.32 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Baseline | 115.2 Millimeters of mercury | Standard Deviation 11.46 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Baseline | 71.4 Millimeters of mercury | Standard Deviation 9.62 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Day 5 | 115.8 Millimeters of mercury | Standard Deviation 12.76 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Day 2 | 116.6 Millimeters of mercury | Standard Deviation 11.32 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Day 5 | 72.3 Millimeters of mercury | Standard Deviation 7.64 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Day 3 | 72.9 Millimeters of mercury | Standard Deviation 9.24 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Day 3 | 117.2 Millimeters of mercury | Standard Deviation 11.47 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Day 2 | 74.2 Millimeters of mercury | Standard Deviation 9.83 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Day 4 | 115.4 Millimeters of mercury | Standard Deviation 11.14 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Day 3 | 72.4 Millimeters of mercury | Standard Deviation 7.53 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Day 4 | 118.0 Millimeters of mercury | Standard Deviation 16.87 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Day 5 | 118.0 Millimeters of mercury | Standard Deviation 13.18 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Baseline | 71.8 Millimeters of mercury | Standard Deviation 7.51 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Day 4 | 70.5 Millimeters of mercury | Standard Deviation 9.26 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Day 2 | 71.1 Millimeters of mercury | Standard Deviation 7.48 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Baseline | 117.4 Millimeters of mercury | Standard Deviation 13.01 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Signs: DBP and SBP-Part 2 | DBP, Day 5 | 68.7 Millimeters of mercury | Standard Deviation 9.18 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Day 2 | 115.7 Millimeters of mercury | Standard Deviation 11.73 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Signs: DBP and SBP-Part 2 | SBP, Day 3 | 116.6 Millimeters of mercury | Standard Deviation 12.36 |
Secondary
Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1
Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | SBP; Day 3 | 113.6 Millimeters of mercury | Standard Deviation 12.13 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | DBP; Baseline | 72.1 Millimeters of mercury | Standard Deviation 8.35 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | DBP; Day 2 | 70.1 Millimeters of mercury | Standard Deviation 7.06 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | SBP; Day 4 | 112.2 Millimeters of mercury | Standard Deviation 11.11 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | DBP; Day 3 | 70.4 Millimeters of mercury | Standard Deviation 7.72 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | SBP; Day 2 | 113.8 Millimeters of mercury | Standard Deviation 10.32 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | DBP; Day 4 | 70.2 Millimeters of mercury | Standard Deviation 6.98 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | SBP; Day 5 | 112.2 Millimeters of mercury | Standard Deviation 9.62 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | DBP; Day 5 | 70.1 Millimeters of mercury | Standard Deviation 7.68 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | SBP; Baseline | 118.3 Millimeters of mercury | Standard Deviation 9.73 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | DBP; Day 5 | 68.9 Millimeters of mercury | Standard Deviation 5.76 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | SBP; Day 2 | 115.1 Millimeters of mercury | Standard Deviation 11.94 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | SBP; Baseline | 117.4 Millimeters of mercury | Standard Deviation 12.26 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | SBP; Day 3 | 113.3 Millimeters of mercury | Standard Deviation 9.71 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | SBP; Day 4 | 113.9 Millimeters of mercury | Standard Deviation 10.57 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | SBP; Day 5 | 113.8 Millimeters of mercury | Standard Deviation 8.91 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | DBP; Baseline | 73.4 Millimeters of mercury | Standard Deviation 8.51 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | DBP; Day 2 | 71.3 Millimeters of mercury | Standard Deviation 10.56 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | DBP; Day 3 | 69.1 Millimeters of mercury | Standard Deviation 8.46 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 | DBP; Day 4 | 68.7 Millimeters of mercury | Standard Deviation 6.77 |
Secondary
Absolute Values for Vital Sign: Temperature-Part 1
Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Temperature-Part 1 | Day 2 | 36.22 Degrees Celsius | Standard Deviation 0.426 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Temperature-Part 1 | Day 4 | 36.38 Degrees Celsius | Standard Deviation 0.402 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Temperature-Part 1 | Day 3 | 36.33 Degrees Celsius | Standard Deviation 0.42 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Temperature-Part 1 | Day 5 | 36.21 Degrees Celsius | Standard Deviation 0.555 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Temperature-Part 1 | Baseline | 36.24 Degrees Celsius | Standard Deviation 0.393 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Temperature-Part 1 | Day 5 | 36.27 Degrees Celsius | Standard Deviation 0.324 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Temperature-Part 1 | Baseline | 36.37 Degrees Celsius | Standard Deviation 0.361 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Temperature-Part 1 | Day 2 | 36.39 Degrees Celsius | Standard Deviation 0.407 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Temperature-Part 1 | Day 3 | 36.22 Degrees Celsius | Standard Deviation 0.383 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Temperature-Part 1 | Day 4 | 36.35 Degrees Celsius | Standard Deviation 0.385 |
Secondary
Absolute Values for Vital Sign: Temperature-Part 2
Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Temperature-Part 2 | Day 4 | 36.37 Degrees Celsius | Standard Deviation 0.404 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Temperature-Part 2 | Day 3 | 36.33 Degrees Celsius | Standard Deviation 0.351 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Temperature-Part 2 | Baseline | 36.24 Degrees Celsius | Standard Deviation 0.421 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Temperature-Part 2 | Day 2 | 36.29 Degrees Celsius | Standard Deviation 0.476 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values for Vital Sign: Temperature-Part 2 | Day 5 | 36.34 Degrees Celsius | Standard Deviation 0.345 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Temperature-Part 2 | Day 3 | 36.37 Degrees Celsius | Standard Deviation 0.425 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Temperature-Part 2 | Baseline | 36.50 Degrees Celsius | Standard Deviation 0.298 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Temperature-Part 2 | Day 2 | 36.40 Degrees Celsius | Standard Deviation 0.406 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Temperature-Part 2 | Day 4 | 36.37 Degrees Celsius | Standard Deviation 0.378 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values for Vital Sign: Temperature-Part 2 | Day 5 | 36.49 Degrees Celsius | Standard Deviation 0.375 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Temperature-Part 2 | Day 5 | 36.51 Degrees Celsius | Standard Deviation 0.459 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Temperature-Part 2 | Day 4 | 36.38 Degrees Celsius | Standard Deviation 0.495 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Temperature-Part 2 | Baseline | 36.37 Degrees Celsius | Standard Deviation 0.483 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Temperature-Part 2 | Day 3 | 36.29 Degrees Celsius | Standard Deviation 0.419 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Vital Sign: Temperature-Part 2 | Day 2 | 36.27 Degrees Celsius | Standard Deviation 0.508 |
Secondary
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals.
Time frame: Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 1 (2 hours); n=20, 19, 21 | 379.7 Milliseconds | Standard Deviation 25.7 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 1 (4 hours); n=20, 19, 21 | 165.2 Milliseconds | Standard Deviation 17.74 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 1 (4 hours); n=20, 19, 21 | 401.0 Milliseconds | Standard Deviation 25.84 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Baseline; n=20, 19, 21 | 391.8 Milliseconds | Standard Deviation 28.22 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 5; n=7, 5, 7 | 173.4 Milliseconds | Standard Deviation 19.16 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 1 (2 hours); n=20, 19, 21 | 88.9 Milliseconds | Standard Deviation 9.68 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 1 (4 hours); n=20, 19, 21 | 91.1 Milliseconds | Standard Deviation 10.63 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Baseline; n=20, 19, 21 | 92.1 Milliseconds | Standard Deviation 9.76 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 1 (2 hours); n=20, 19, 21 | 384.0 Milliseconds | Standard Deviation 19.91 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Baseline; n=20, 19, 21 | 395.3 Milliseconds | Standard Deviation 21.06 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 5; n=7, 5, 7 | 101.1 Milliseconds | Standard Deviation 7.1 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Baseline; n=20, 19, 21 | 166.4 Milliseconds | Standard Deviation 16.48 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 5; n=7, 5, 7 | 391.9 Milliseconds | Standard Deviation 30.45 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 5; n=7, 5, 7 | 401.7 Milliseconds | Standard Deviation 33.29 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 1 (2 hours); n=20, 19, 21 | 163.9 Milliseconds | Standard Deviation 18.45 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 1 (4 hours); n=20, 19, 21 | 396.8 Milliseconds | Standard Deviation 21.9 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Baseline; n=20, 19, 21 | 166.2 Milliseconds | Standard Deviation 15.4 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 1 (2 hours); n=20, 19, 21 | 399.2 Milliseconds | Standard Deviation 22.43 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 1 (4 hours); n=20, 19, 21 | 406.9 Milliseconds | Standard Deviation 22.25 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 1 (2 hours); n=20, 19, 21 | 391.7 Milliseconds | Standard Deviation 21.77 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Baseline; n=20, 19, 21 | 91.7 Milliseconds | Standard Deviation 9.02 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 1 (2 hours); n=20, 19, 21 | 166.8 Milliseconds | Standard Deviation 15.23 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 1 (4 hours); n=20, 19, 21 | 165.7 Milliseconds | Standard Deviation 15.29 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 5; n=7, 5, 7 | 171.6 Milliseconds | Standard Deviation 14.57 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 1 (2 hours); n=20, 19, 21 | 92.6 Milliseconds | Standard Deviation 9.82 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 1 (4 hours); n=20, 19, 21 | 93.2 Milliseconds | Standard Deviation 8.45 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 5; n=7, 5, 7 | 85.8 Milliseconds | Standard Deviation 8.07 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Baseline; n=20, 19, 21 | 388.5 Milliseconds | Standard Deviation 24.78 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 5; n=7, 5, 7 | 391.0 Milliseconds | Standard Deviation 10.27 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Baseline; n=20, 19, 21 | 392.4 Milliseconds | Standard Deviation 19.45 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 1 (4 hours); n=20, 19, 21 | 395.5 Milliseconds | Standard Deviation 20.75 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 5; n=7, 5, 7 | 402.4 Milliseconds | Standard Deviation 7.7 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 5; n=7, 5, 7 | 388.1 Milliseconds | Standard Deviation 22.81 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Baseline; n=20, 19, 21 | 389.7 Milliseconds | Standard Deviation 26.09 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 1 (2 hours); n=20, 19, 21 | 161.7 Milliseconds | Standard Deviation 16.82 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Baseline; n=20, 19, 21 | 166.8 Milliseconds | Standard Deviation 17.01 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 1 (4 hours); n=20, 19, 21 | 393.3 Milliseconds | Standard Deviation 20.78 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 5; n=7, 5, 7 | 378.9 Milliseconds | Standard Deviation 25.15 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Baseline; n=20, 19, 21 | 90.1 Milliseconds | Standard Deviation 10.42 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Baseline; n=20, 19, 21 | 391.9 Milliseconds | Standard Deviation 21.63 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 1 (4 hours); n=20, 19, 21 | 389.1 Milliseconds | Standard Deviation 25.95 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 1 (2 hours); n=20, 19, 21 | 89.7 Milliseconds | Standard Deviation 9.86 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 5; n=7, 5, 7 | 163.1 Milliseconds | Standard Deviation 12.36 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 1 (2 hours); n=20, 19, 21 | 388.3 Milliseconds | Standard Deviation 18.91 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 1 (4 hours); n=20, 19, 21 | 90.3 Milliseconds | Standard Deviation 8.69 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 1 (2 hours); n=20, 19, 21 | 376.2 Milliseconds | Standard Deviation 22.54 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 5; n=7, 5, 7 | 88.7 Milliseconds | Standard Deviation 5.28 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 1 (4 hours); n=20, 19, 21 | 162.6 Milliseconds | Standard Deviation 13.99 |
Secondary
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals.
Time frame: Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | PR interval, Day 1 (2 hours); n=18, 18 | 166.3 Milliseconds | Standard Deviation 21.55 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QRS duration, Day 1 (2 hours); n=18, 18 | 91.9 Milliseconds | Standard Deviation 8.76 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QT interval, Day 1 (2 hours); n=18, 18 | 383.3 Milliseconds | Standard Deviation 13.71 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QRS duration, Day 1 (4 hours); n=18, 18 | 94.1 Milliseconds | Standard Deviation 8.88 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | PR interval, Day 1 (4 hours); n=18, 18 | 160.6 Milliseconds | Standard Deviation 20.94 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QRS duration, Day 5; n=9, 9 | 94.3 Milliseconds | Standard Deviation 11.65 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QT interval, Baseline; n=18, 18 | 395.1 Milliseconds | Standard Deviation 14.22 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QT interval, Day 5; n=9, 9 | 393.4 Milliseconds | Standard Deviation 16.38 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | PR interval, Day 5; n=9, 9 | 161.8 Milliseconds | Standard Deviation 11.68 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QTcF interval, Baseline; n=18, 18 | 399.4 Milliseconds | Standard Deviation 9.76 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QTcF interval, Day 1 (2 hours); n=18, 18 | 389.5 Milliseconds | Standard Deviation 12.11 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QT interval, Day 1 (4 hours); n=18, 18 | 404.8 Milliseconds | Standard Deviation 16.36 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QTcF interval, Day 1 (4 hours); n=18, 18 | 398.7 Milliseconds | Standard Deviation 11.13 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QRS duration, Baseline; n=18, 18 | 93.4 Milliseconds | Standard Deviation 9.3 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QTcF interval, Day 5; n=9, 9 | 400.8 Milliseconds | Standard Deviation 13.34 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | PR interval, Baseline; n=18, 18 | 164.1 Milliseconds | Standard Deviation 22.81 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QTcF interval, Day 5; n=9, 9 | 399.4 Milliseconds | Standard Deviation 11.98 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QT interval, Baseline; n=18, 18 | 394.4 Milliseconds | Standard Deviation 24.04 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QT interval, Day 1 (2 hours); n=18, 18 | 383.6 Milliseconds | Standard Deviation 24.11 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QT interval, Day 1 (4 hours); n=18, 18 | 402.0 Milliseconds | Standard Deviation 27.67 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QTcF interval, Baseline; n=18, 18 | 401.9 Milliseconds | Standard Deviation 15.01 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | PR interval, Baseline; n=18, 18 | 162.3 Milliseconds | Standard Deviation 20.76 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | PR interval, Day 1 (2 hours); n=18, 18 | 158.7 Milliseconds | Standard Deviation 19.95 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | PR interval, Day 1 (4 hours); n=18, 18 | 158.9 Milliseconds | Standard Deviation 19.19 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | PR interval, Day 5; n=9, 9 | 169.3 Milliseconds | Standard Deviation 26.14 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QRS duration, Baseline; n=18, 18 | 92.5 Milliseconds | Standard Deviation 8.09 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QRS duration, Day 1 (2 hours); n=18, 18 | 92.6 Milliseconds | Standard Deviation 9 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QRS duration, Day 1 (4 hours); n=18, 18 | 93.8 Milliseconds | Standard Deviation 9.9 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QRS duration, Day 5; n=9, 9 | 92.4 Milliseconds | Standard Deviation 8.25 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QT interval, Day 5; n=9, 9 | 402.7 Milliseconds | Standard Deviation 18.71 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QTcF interval, Day 1 (2 hours); n=18, 18 | 392.8 Milliseconds | Standard Deviation 15.09 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 | QTcF interval, Day 1 (4 hours); n=18, 18 | 402.6 Milliseconds | Standard Deviation 19.46 |
Secondary
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Monocytes; Baseline; n=18, 18 | 0.403 10^9 cells per liter | Standard Deviation 0.0859 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Eosinophils; Day 2; n=18, 18 | 0.116 10^9 cells per liter | Standard Deviation 0.0911 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Monocytes; Day 2; n=18, 18 | 0.409 10^9 cells per liter | Standard Deviation 0.0955 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Basophils; Day 5; n=9, 9 | 0.027 10^9 cells per liter | Standard Deviation 0.0071 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Monocytes; Day 5; n=9, 9 | 0.386 10^9 cells per liter | Standard Deviation 0.11 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Eosinophils; Day 5; n=9, 9 | 0.133 10^9 cells per liter | Standard Deviation 0.1227 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Neutrophils; Baseline; n=18, 18 | 3.406 10^9 cells per liter | Standard Deviation 1.0436 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Lymphocytes; Baseline; n=18, 18 | 1.617 10^9 cells per liter | Standard Deviation 0.3975 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Neutrophils; Day 2; n=18, 18 | 2.925 10^9 cells per liter | Standard Deviation 0.6617 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Basophils; Day 2; n=18, 18 | 0.030 10^9 cells per liter | Standard Deviation 0.0137 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Neutrophils; Day 5; n=9, 9 | 2.864 10^9 cells per liter | Standard Deviation 0.7372 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Lymphocytes; Day 2; n=18, 18 | 1.726 10^9 cells per liter | Standard Deviation 0.3852 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Platelets; Baseline; n=18, 18 | 232.5 10^9 cells per liter | Standard Deviation 43.58 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Eosinophils; Baseline; n=18, 18 | 0.100 10^9 cells per liter | Standard Deviation 0.0832 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Platelets; Day 2; n=18, 18 | 238.2 10^9 cells per liter | Standard Deviation 49.37 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Lymphocytes; Day 5; n=9, 9 | 1.639 10^9 cells per liter | Standard Deviation 0.3536 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Platelets; Day 5; n=9, 9 | 267.1 10^9 cells per liter | Standard Deviation 52.86 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Basophils; Baseline; n=18, 18 | 0.032 10^9 cells per liter | Standard Deviation 0.0134 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Platelets; Day 5; n=9, 9 | 231.4 10^9 cells per liter | Standard Deviation 38.51 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Basophils; Baseline; n=18, 18 | 0.032 10^9 cells per liter | Standard Deviation 0.0134 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Basophils; Day 2; n=18, 18 | 0.030 10^9 cells per liter | Standard Deviation 0.077 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Basophils; Day 5; n=9, 9 | 0.030 10^9 cells per liter | Standard Deviation 0.0166 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Eosinophils; Baseline; n=18, 18 | 0.100 10^9 cells per liter | Standard Deviation 0.0832 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Eosinophils; Day 2; n=18, 18 | 0.122 10^9 cells per liter | Standard Deviation 0.1101 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Lymphocytes; Baseline; n=18, 18 | 1.617 10^9 cells per liter | Standard Deviation 0.3975 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Lymphocytes; Day 2; n=18, 18 | 1.744 10^9 cells per liter | Standard Deviation 0.4791 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Lymphocytes; Day 5; n=9, 9 | 2.074 10^9 cells per liter | Standard Deviation 0.6328 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Monocytes; Baseline; n=18, 18 | 0.403 10^9 cells per liter | Standard Deviation 0.0859 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Monocytes; Day 2; n=18, 18 | 0.412 10^9 cells per liter | Standard Deviation 0.1379 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Monocytes; Day 5; n=9, 9 | 0.411 10^9 cells per liter | Standard Deviation 0.1071 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Neutrophils; Baseline; n=18, 18 | 3.406 10^9 cells per liter | Standard Deviation 1.0436 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Neutrophils; Day 2; n=18, 18 | 2.723 10^9 cells per liter | Standard Deviation 0.9257 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Neutrophils; Day 5; n=9, 9 | 3.108 10^9 cells per liter | Standard Deviation 0.5724 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Platelets; Baseline; n=18, 18 | 232.5 10^9 cells per liter | Standard Deviation 43.58 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Platelets; Day 2; n=18, 18 | 241.5 10^9 cells per liter | Standard Deviation 48.56 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Eosinophils; Day 5; n=9, 9 | 0.118 10^9 cells per liter | Standard Deviation 0.0769 |
Secondary
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Day 2; n=20, 19, 21 | 0.136 10^9 cells per liter | Standard Deviation 0.0922 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Day 2; n=20, 19, 21 | 0.041 10^9 cells per liter | Standard Deviation 0.0276 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Day 5; n=7, 5, 7 | 0.047 10^9 cells per liter | Standard Deviation 0.0287 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Baseline; n=20, 19, 21 | 0.141 10^9 cells per liter | Standard Deviation 0.0879 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Baseline; n=20, 19, 21 | 0.042 10^9 cells per liter | Standard Deviation 0.026 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Day 5; n=7, 5, 7 | 0.146 10^9 cells per liter | Standard Deviation 0.105 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Baseline; n=20, 19, 21 | 1.650 10^9 cells per liter | Standard Deviation 0.4926 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Day 2; n=20, 19, 21 | 1.576 10^9 cells per liter | Standard Deviation 0.341 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Day 5; n=7, 5, 7 | 1.806 10^9 cells per liter | Standard Deviation 0.3577 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Baseline; n=20, 19, 21 | 0.469 10^9 cells per liter | Standard Deviation 0.1445 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Day 2; n=20, 19, 21 | 0.446 10^9 cells per liter | Standard Deviation 0.1589 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Day 5; n=7, 5, 7 | 0.530 10^9 cells per liter | Standard Deviation 0.1788 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Baseline; n=20, 19, 21 | 3.246 10^9 cells per liter | Standard Deviation 1.0719 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Day 2; n=20, 19, 21 | 2.908 10^9 cells per liter | Standard Deviation 1.166 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Day 5; n=7, 5, 7 | 2.464 10^9 cells per liter | Standard Deviation 0.9204 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Baseline; n=20, 19, 21 | 259.9 10^9 cells per liter | Standard Deviation 63.91 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Day 2; n=20, 19, 21 | 284.2 10^9 cells per liter | Standard Deviation 55.7 |
| Part 1: GSK3640254 200 mg Capsules | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Day 5; n=7, 5, 7 | 255.9 10^9 cells per liter | Standard Deviation 47.27 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Day 5; n=7, 5, 7 | 272.4 10^9 cells per liter | Standard Deviation 77.61 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Baseline; n=20, 19, 21 | 0.042 10^9 cells per liter | Standard Deviation 0.026 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Baseline; n=20, 19, 21 | 0.469 10^9 cells per liter | Standard Deviation 0.1445 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Baseline; n=20, 19, 21 | 3.246 10^9 cells per liter | Standard Deviation 1.0719 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Day 2; n=20, 19, 21 | 0.040 10^9 cells per liter | Standard Deviation 0.02 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Day 5; n=7, 5, 7 | 3.472 10^9 cells per liter | Standard Deviation 0.8987 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Baseline; n=20, 19, 21 | 259.9 10^9 cells per liter | Standard Deviation 63.91 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Day 5; n=7, 5, 7 | 0.036 10^9 cells per liter | Standard Deviation 0.0167 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Day 2; n=20, 19, 21 | 0.449 10^9 cells per liter | Standard Deviation 0.1171 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Day 2; n=20, 19, 21 | 270.6 10^9 cells per liter | Standard Deviation 60.8 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Baseline; n=20, 19, 21 | 0.141 10^9 cells per liter | Standard Deviation 0.0879 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Day 5; n=7, 5, 7 | 1.472 10^9 cells per liter | Standard Deviation 0.2765 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Day 2; n=20, 19, 21 | 2.904 10^9 cells per liter | Standard Deviation 0.8595 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Day 2; n=20, 19, 21 | 0.135 10^9 cells per liter | Standard Deviation 0.0837 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Day 2; n=20, 19, 21 | 1.684 10^9 cells per liter | Standard Deviation 0.4939 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Day 5; n=7, 5, 7 | 0.422 10^9 cells per liter | Standard Deviation 0.0669 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Day 5; n=7, 5, 7 | 0.090 10^9 cells per liter | Standard Deviation 0.0374 |
| Part 1: GSK3640254 200 mg Tablets | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Baseline; n=20, 19, 21 | 1.650 10^9 cells per liter | Standard Deviation 0.4926 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Day 5; n=7, 5, 7 | 0.151 10^9 cells per liter | Standard Deviation 0.0915 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Baseline; n=20, 19, 21 | 1.650 10^9 cells per liter | Standard Deviation 0.4926 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Day 2; n=20, 19, 21 | 1.583 10^9 cells per liter | Standard Deviation 0.3748 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Day 5; n=7, 5, 7 | 3.877 10^9 cells per liter | Standard Deviation 1.4452 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Day 5; n=7, 5, 7 | 1.923 10^9 cells per liter | Standard Deviation 0.4442 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Day 5; n=7, 5, 7 | 291.3 10^9 cells per liter | Standard Deviation 48.52 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Baseline; n=20, 19, 21 | 0.469 10^9 cells per liter | Standard Deviation 0.1445 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Day 2; n=20, 19, 21 | 0.446 10^9 cells per liter | Standard Deviation 0.1553 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Baseline; n=20, 19, 21 | 259.9 10^9 cells per liter | Standard Deviation 63.91 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Day 5; n=7, 5, 7 | 0.504 10^9 cells per liter | Standard Deviation 0.113 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Baseline; n=20, 19, 21 | 0.042 10^9 cells per liter | Standard Deviation 0.026 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Day 2; n=20, 19, 21 | 0.043 10^9 cells per liter | Standard Deviation 0.0215 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Baseline; n=20, 19, 21 | 3.246 10^9 cells per liter | Standard Deviation 1.0719 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Day 5; n=7, 5, 7 | 0.049 10^9 cells per liter | Standard Deviation 0.0219 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Baseline; n=20, 19, 21 | 0.141 10^9 cells per liter | Standard Deviation 0.0879 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Day 2; n=20, 19, 21 | 0.150 10^9 cells per liter | Standard Deviation 0.1109 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Day 2; n=20, 19, 21 | 2.947 10^9 cells per liter | Standard Deviation 1.0824 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Day 2; n=20, 19, 21 | 281.3 10^9 cells per liter | Standard Deviation 59.88 |
Secondary
Apparent Oral Clearance (CL/F) for GSK3640254-Part 1
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Apparent Oral Clearance (CL/F) for GSK3640254-Part 1 | 5.413 Liters per hour | Geometric Coefficient of Variation 42.7 |
| Part 1: GSK3640254 200 mg Tablets | Apparent Oral Clearance (CL/F) for GSK3640254-Part 1 | 5.423 Liters per hour | Geometric Coefficient of Variation 40.3 |
Secondary
Apparent Terminal Phase Half-life (t1/2) for GSK3640254-Part 1
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Apparent Terminal Phase Half-life (t1/2) for GSK3640254-Part 1 | 26.247 Hours | Geometric Coefficient of Variation 17.6 |
| Part 1: GSK3640254 200 mg Tablets | Apparent Terminal Phase Half-life (t1/2) for GSK3640254-Part 1 | 26.185 Hours | Geometric Coefficient of Variation 17.2 |
Secondary
Apparent Volume of Distribution (Vz/F) for GSK3640254-Part 1
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Apparent Volume of Distribution (Vz/F) for GSK3640254-Part 1 | 205.0 Liters | Geometric Coefficient of Variation 40 |
| Part 1: GSK3640254 200 mg Tablets | Apparent Volume of Distribution (Vz/F) for GSK3640254-Part 1 | 204.9 Liters | Geometric Coefficient of Variation 43 |
Secondary
Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Creatinine; Day 2; n=18, 18 | 2.19 Micromoles per liter | Standard Deviation 4.721 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Creatinine; Day 5; n=9, 9 | 3.64 Micromoles per liter | Standard Deviation 3.78 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Total bilirubin; Day 2; n=18, 18 | 0.89 Micromoles per liter | Standard Deviation 2.659 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Total bilirubin; Day 5; n=9, 9 | 0.59 Micromoles per liter | Standard Deviation 3.297 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Direct bilirubin; Day 2; n=18, 18 | -0.05 Micromoles per liter | Standard Deviation 0.399 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Direct bilirubin; Day 5; n=9, 9 | -0.12 Micromoles per liter | Standard Deviation 0.526 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Urate; Day 2; n=18, 18 | -23.5 Micromoles per liter | Standard Deviation 46.62 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Urate; Day 5; n=9, 9 | -29.8 Micromoles per liter | Standard Deviation 46.45 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Urate; Day 5; n=9, 9 | -19.3 Micromoles per liter | Standard Deviation 36.96 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Creatinine; Day 2; n=18, 18 | 1.43 Micromoles per liter | Standard Deviation 6.188 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Direct bilirubin; Day 2; n=18, 18 | -0.10 Micromoles per liter | Standard Deviation 0.387 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Creatinine; Day 5; n=9, 9 | -1.10 Micromoles per liter | Standard Deviation 5.169 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Urate; Day 2; n=18, 18 | -24.2 Micromoles per liter | Standard Deviation 43.16 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Total bilirubin; Day 2; n=18, 18 | 0.36 Micromoles per liter | Standard Deviation 2.632 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Direct bilirubin; Day 5; n=9, 9 | -0.04 Micromoles per liter | Standard Deviation 0.361 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 | Total bilirubin; Day 5; n=9, 9 | 1.20 Micromoles per liter | Standard Deviation 2.513 |
Secondary
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Albumin; Day 2; n=18, 18 | 0.1 Grams per liter | Standard Deviation 2.8 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Albumin; Day 5; n=9, 9 | 0.9 Grams per liter | Standard Deviation 3.37 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Globulin; Day 2; n=18, 18 | -0.6 Grams per liter | Standard Deviation 2.5 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Globulin; Day 5; n=9, 9 | -0.7 Grams per liter | Standard Deviation 2.78 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Protein; Day 2; n=18, 18 | -0.5 Grams per liter | Standard Deviation 4.82 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Protein; Day 5; n=9, 9 | 0.2 Grams per liter | Standard Deviation 5.93 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Protein; Day 2; n=18, 18 | 1.0 Grams per liter | Standard Deviation 4.79 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Albumin; Day 2; n=18, 18 | 0.7 Grams per liter | Standard Deviation 3.04 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Globulin; Day 5; n=9, 9 | -0.1 Grams per liter | Standard Deviation 1.76 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Albumin; Day 5; n=9, 9 | 1.0 Grams per liter | Standard Deviation 3 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Protein; Day 5; n=9, 9 | 0.9 Grams per liter | Standard Deviation 4.54 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 | Globulin; Day 2; n=18, 18 | 0.3 Grams per liter | Standard Deviation 2.37 |
Secondary
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Day 2; n=20, 19, 21 | 2.1 Grams per liter | Standard Deviation 3.01 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Day 2; n=20, 19, 21 | 2.0 Grams per liter | Standard Deviation 1.85 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Day 5; n=7, 5, 7 | 3.4 Grams per liter | Standard Deviation 1.4 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Day 2; n=20, 19, 21 | 0.2 Grams per liter | Standard Deviation 1.79 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Day 5; n=7, 5, 7 | 0.1 Grams per liter | Standard Deviation 1.86 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Day 5; n=7, 5, 7 | 3.6 Grams per liter | Standard Deviation 2.23 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Day 2; n=20, 19, 21 | 1.8 Grams per liter | Standard Deviation 2.57 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Day 5; n=7, 5, 7 | 1.8 Grams per liter | Standard Deviation 0.84 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Day 5; n=7, 5, 7 | 0.1 Grams per liter | Standard Deviation 3.39 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Day 2; n=20, 19, 21 | -0.1 Grams per liter | Standard Deviation 2.26 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Day 2; n=20, 19, 21 | 1.7 Grams per liter | Standard Deviation 4.28 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Day 5; n=7, 5, 7 | 2.8 Grams per liter | Standard Deviation 4.09 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Day 2; n=20, 19, 21 | -0.1 Grams per liter | Standard Deviation 1.76 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Day 2; n=20, 19, 21 | 1.9 Grams per liter | Standard Deviation 1.95 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Globulin; Day 5; n=7, 5, 7 | -1.3 Grams per liter | Standard Deviation 1.8 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Day 5; n=7, 5, 7 | -0.1 Grams per liter | Standard Deviation 3.02 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Albumin; Day 5; n=7, 5, 7 | 1.1 Grams per liter | Standard Deviation 1.46 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 | Protein; Day 2; n=20, 19, 21 | 1.8 Grams per liter | Standard Deviation 3.01 |
Secondary
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | ALT; Day 2; n=18, 18 | -0.2 International units per liter | Standard Deviation 5.34 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | ALT; Day 5; n=9, 9 | 1.3 International units per liter | Standard Deviation 7.87 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | ALP; Day 2; n=18, 18 | -2.4 International units per liter | Standard Deviation 5.25 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | ALP; Day 5; n=9, 9 | -1.7 International units per liter | Standard Deviation 7.4 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | AST; Day 2; n=18, 18 | -2.6 International units per liter | Standard Deviation 4.68 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | AST; Day 5; n=9, 9 | -1.4 International units per liter | Standard Deviation 3.84 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | GGT; Day 2; n=18, 18 | -1.2 International units per liter | Standard Deviation 1.93 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | GGT; Day 5; n=9, 9 | -2.1 International units per liter | Standard Deviation 2.47 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | CK; Day 2; n=18, 18 | -39.6 International units per liter | Standard Deviation 39.29 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | CK; Day 5; n=9, 9 | -23.3 International units per liter | Standard Deviation 28.33 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | LDH; Day 2; n=18, 18 | -18.7 International units per liter | Standard Deviation 11 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | LDH; Day 5; n=9, 9 | -13.9 International units per liter | Standard Deviation 16.12 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | LDH; Day 2; n=18, 18 | -16.0 International units per liter | Standard Deviation 11.86 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | ALT; Day 2; n=18, 18 | -3.6 International units per liter | Standard Deviation 8.39 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | GGT; Day 2; n=18, 18 | -0.4 International units per liter | Standard Deviation 2.94 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | ALT; Day 5; n=9, 9 | -5.3 International units per liter | Standard Deviation 12.32 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | CK; Day 5; n=9, 9 | -46.2 International units per liter | Standard Deviation 76.08 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | ALP; Day 2; n=18, 18 | -2.5 International units per liter | Standard Deviation 4.74 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | GGT; Day 5; n=9, 9 | -1.6 International units per liter | Standard Deviation 3.88 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | ALP; Day 5; n=9, 9 | -1.9 International units per liter | Standard Deviation 3.37 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | LDH; Day 5; n=9, 9 | -13.4 International units per liter | Standard Deviation 16.13 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | AST; Day 2; n=18, 18 | -4.2 International units per liter | Standard Deviation 6.57 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | CK; Day 2; n=18, 18 | -34.8 International units per liter | Standard Deviation 53.99 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 | AST; Day 5; n=9, 9 | -6.0 International units per liter | Standard Deviation 8.7 |
Secondary
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Day 2; n=20, 19, 21 | -4.9 International units per liter | Standard Deviation 8.61 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Day 5; n=7, 5, 7 | -9.7 International units per liter | Standard Deviation 13.03 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Day 2; n=20, 19, 21 | 6.1 International units per liter | Standard Deviation 5.61 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Day 5; n=7, 5, 7 | 3.9 International units per liter | Standard Deviation 6.69 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Day 2; n=20, 19, 21 | -3.3 International units per liter | Standard Deviation 5.18 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Day 5; n=7, 5, 7 | -5.1 International units per liter | Standard Deviation 6.26 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Day 2; n=20, 19, 21 | -1.1 International units per liter | Standard Deviation 2.65 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Day 5; n=7, 5, 7 | -2.4 International units per liter | Standard Deviation 3.31 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Day 2; n=20, 19, 21 | -15.4 International units per liter | Standard Deviation 27.15 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Day 5; n=7, 5, 7 | 1.1 International units per liter | Standard Deviation 78.79 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Day 2; n=20, 19, 21 | -12.2 International units per liter | Standard Deviation 10.28 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Day 5; n=7, 5, 7 | -17.3 International units per liter | Standard Deviation 14.95 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Day 5; n=7, 5, 7 | -17.8 International units per liter | Standard Deviation 3.27 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Day 2; n=20, 19, 21 | -2.6 International units per liter | Standard Deviation 4.4 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Day 2; n=20, 19, 21 | -2.5 International units per liter | Standard Deviation 4.06 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Day 2; n=20, 19, 21 | -0.4 International units per liter | Standard Deviation 1.8 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Day 2; n=20, 19, 21 | -10.7 International units per liter | Standard Deviation 40.57 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Day 5; n=7, 5, 7 | -3.4 International units per liter | Standard Deviation 4.39 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Day 5; n=7, 5, 7 | -2.8 International units per liter | Standard Deviation 4.66 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Day 2; n=20, 19, 21 | -12.4 International units per liter | Standard Deviation 12.05 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Day 2; n=20, 19, 21 | 5.9 International units per liter | Standard Deviation 5.91 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Day 5; n=7, 5, 7 | -1.4 International units per liter | Standard Deviation 2.7 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Day 5; n=7, 5, 7 | 9.4 International units per liter | Standard Deviation 92.62 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Day 5; n=7, 5, 7 | 2.2 International units per liter | Standard Deviation 6.22 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Day 2; n=20, 19, 21 | -11.5 International units per liter | Standard Deviation 11.97 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Day 2; n=20, 19, 21 | -2.0 International units per liter | Standard Deviation 4.88 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Day 5; n=7, 5, 7 | 29.9 International units per liter | Standard Deviation 152.85 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | AST; Day 5; n=7, 5, 7 | 0.6 International units per liter | Standard Deviation 3.36 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Day 2; n=20, 19, 21 | 0.2 International units per liter | Standard Deviation 3.09 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | GGT; Day 5; n=7, 5, 7 | 2.1 International units per liter | Standard Deviation 5.73 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Day 5; n=7, 5, 7 | -0.4 International units per liter | Standard Deviation 6.5 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Day 2; n=20, 19, 21 | -2.2 International units per liter | Standard Deviation 8.48 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALT; Day 5; n=7, 5, 7 | 5.7 International units per liter | Standard Deviation 9.23 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | CK; Day 2; n=20, 19, 21 | -12.6 International units per liter | Standard Deviation 31.5 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | ALP; Day 2; n=20, 19, 21 | 6.3 International units per liter | Standard Deviation 6.21 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 | LDH; Day 5; n=7, 5, 7 | -10.4 International units per liter | Standard Deviation 15.05 |
Secondary
Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1
Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1 | Amylase; Day 2; n=18, 18 | 3.3 Units per liter | Standard Deviation 5.66 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1 | Amylase; Day 5; n=9, 9 | 1.0 Units per liter | Standard Deviation 6.52 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1 | Lipase; Day 2; n=18, 18 | 2.7 Units per liter | Standard Deviation 8.27 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1 | Lipase; Day 5; n=9, 9 | 4.0 Units per liter | Standard Deviation 6.56 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1 | Lipase; Day 5; n=9, 9 | 1.6 Units per liter | Standard Deviation 3.28 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1 | Amylase; Day 2; n=18, 18 | 4.3 Units per liter | Standard Deviation 8.75 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1 | Lipase; Day 2; n=18, 18 | 2.2 Units per liter | Standard Deviation 5.15 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1 | Amylase; Day 5; n=9, 9 | 4.2 Units per liter | Standard Deviation 6.22 |
Secondary
Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2
Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Day 2; n=20, 19, 21 | 0.7 Units per liter | Standard Deviation 5.68 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Day 5; n=7, 5, 7 | 4.4 Units per liter | Standard Deviation 4.86 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Day 2; n=20, 19, 21 | -2.6 Units per liter | Standard Deviation 15.99 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Day 5; n=7, 5, 7 | 6.3 Units per liter | Standard Deviation 7.54 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Day 5; n=7, 5, 7 | -3.0 Units per liter | Standard Deviation 14.27 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Day 2; n=20, 19, 21 | 1.8 Units per liter | Standard Deviation 8.7 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Day 2; n=20, 19, 21 | -1.4 Units per liter | Standard Deviation 13.01 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Day 5; n=7, 5, 7 | -1.8 Units per liter | Standard Deviation 10.16 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Day 5; n=7, 5, 7 | -9.6 Units per liter | Standard Deviation 24.84 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Day 5; n=7, 5, 7 | -4.4 Units per liter | Standard Deviation 8.26 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Lipase; Day 2; n=20, 19, 21 | 0.3 Units per liter | Standard Deviation 17.39 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 | Amylase; Day 2; n=20, 19, 21 | 0.8 Units per liter | Standard Deviation 8.27 |
Secondary
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Cholesterol; Day 2; n=18, 18 | -0.005 Millimoles per liter | Standard Deviation 0.3983 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Calcium; Day 2; n=18, 18 | 0.025 Millimoles per liter | Standard Deviation 0.0534 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Calcium; Day 5; n=9, 9 | 0.019 Millimoles per liter | Standard Deviation 0.0762 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Glucose; Day 2; n=18, 18 | -0.145 Millimoles per liter | Standard Deviation 0.3134 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Glucose; Day 5; n=9, 9 | -0.252 Millimoles per liter | Standard Deviation 0.4474 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Potassium; Day 2; n=18, 18 | 0.27 Millimoles per liter | Standard Deviation 0.278 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Potassium; Day 5; n=9, 9 | 0.30 Millimoles per liter | Standard Deviation 0.296 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Sodium; Day 2; n=18, 18 | 1.6 Millimoles per liter | Standard Deviation 2.3 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Sodium; Day 5; n=9, 9 | 1.8 Millimoles per liter | Standard Deviation 2.77 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Chloride; Day 2; n=18, 18 | 0.2 Millimoles per liter | Standard Deviation 2.05 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Chloride; Day 5; n=9, 9 | -0.2 Millimoles per liter | Standard Deviation 2.33 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Phosphate; Day 2; n=18, 18 | 0.077 Millimoles per liter | Standard Deviation 0.1177 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Phosphate; Day 5; n=9, 9 | 0.077 Millimoles per liter | Standard Deviation 0.1331 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | BUN; Day 2; n=18, 18 | 1.019 Millimoles per liter | Standard Deviation 0.9553 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | BUN; Day 5; n=9, 9 | 1.178 Millimoles per liter | Standard Deviation 1.0554 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Triglycerides; Day 2; n=18, 18 | 0.101 Millimoles per liter | Standard Deviation 0.4182 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Triglycerides; Day 5; n=9, 9 | 0.102 Millimoles per liter | Standard Deviation 0.287 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Cholesterol; Day 5; n=9, 9 | -0.148 Millimoles per liter | Standard Deviation 0.4463 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Anion gap; Day 2; n=18, 18 | 0.6 Millimoles per liter | Standard Deviation 2.03 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Anion gap; Day 5; n=9, 9 | 0.8 Millimoles per liter | Standard Deviation 2.64 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Carbon dioxide; Day 2; n=18, 18 | 0.9 Millimoles per liter | Standard Deviation 2.6 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Carbon dioxide; Day 5; n=9, 9 | 1.4 Millimoles per liter | Standard Deviation 2.6 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Phosphate; Day 2; n=18, 18 | 0.077 Millimoles per liter | Standard Deviation 0.1223 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Cholesterol; Day 2; n=18, 18 | 0.082 Millimoles per liter | Standard Deviation 0.4981 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Calcium; Day 2; n=18, 18 | 0.051 Millimoles per liter | Standard Deviation 0.0828 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Phosphate; Day 5; n=9, 9 | 0.090 Millimoles per liter | Standard Deviation 0.1282 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Calcium; Day 5; n=9, 9 | -0.016 Millimoles per liter | Standard Deviation 0.0548 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Cholesterol; Day 5; n=9, 9 | -0.102 Millimoles per liter | Standard Deviation 0.6612 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Glucose; Day 2; n=18, 18 | -0.281 Millimoles per liter | Standard Deviation 0.4796 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | BUN; Day 2; n=18, 18 | 0.926 Millimoles per liter | Standard Deviation 1.0408 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Glucose; Day 5; n=9, 9 | -0.514 Millimoles per liter | Standard Deviation 0.3475 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Carbon dioxide; Day 5; n=9, 9 | 1.2 Millimoles per liter | Standard Deviation 1.56 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Potassium; Day 2; n=18, 18 | 0.33 Millimoles per liter | Standard Deviation 0.331 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | BUN; Day 5; n=9, 9 | 1.148 Millimoles per liter | Standard Deviation 0.6297 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Potassium; Day 5; n=9, 9 | 0.01 Millimoles per liter | Standard Deviation 0.247 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Anion gap; Day 2; n=18, 18 | 0.5 Millimoles per liter | Standard Deviation 1.95 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Sodium; Day 2; n=18, 18 | 2.0 Millimoles per liter | Standard Deviation 2.28 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Triglycerides; Day 2; n=18, 18 | 0.010 Millimoles per liter | Standard Deviation 0.4769 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Sodium; Day 5; n=9, 9 | 1.4 Millimoles per liter | Standard Deviation 1.33 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Carbon dioxide; Day 2; n=18, 18 | 1.1 Millimoles per liter | Standard Deviation 2.1 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Chloride; Day 2; n=18, 18 | 0.7 Millimoles per liter | Standard Deviation 2.22 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Triglycerides; Day 5; n=9, 9 | -0.221 Millimoles per liter | Standard Deviation 0.5382 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Chloride; Day 5; n=9, 9 | -0.7 Millimoles per liter | Standard Deviation 1.73 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 | Anion gap; Day 5; n=9, 9 | 1.0 Millimoles per liter | Standard Deviation 1.22 |
Secondary
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Day 5; n=7, 5, 7 | 1.0 Millimoles per liter | Standard Deviation 1.73 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Day 5; n=7, 5, 7 | 0.060 Millimoles per liter | Standard Deviation 0.0856 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Day 2; n=20, 19, 21 | -0.5 Millimoles per liter | Standard Deviation 2.06 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Day 2; n=20, 19, 21 | -0.8 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Day 2; n=20, 19, 21 | 0.307 Millimoles per liter | Standard Deviation 0.8732 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Day 5; n=7, 5, 7 | 0.021 Millimoles per liter | Standard Deviation 0.2874 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Day 5; n=7, 5, 7 | -0.033 Millimoles per liter | Standard Deviation 0.5333 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Day 5; n=7, 5, 7 | 0.783 Millimoles per liter | Standard Deviation 1.1942 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Day 5; n=7, 5, 7 | 0.097 Millimoles per liter | Standard Deviation 0.0663 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Day 2; n=20, 19, 21 | 0.103 Millimoles per liter | Standard Deviation 0.4625 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Day 2; n=20, 19, 21 | 0.115 Millimoles per liter | Standard Deviation 0.213 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Day 5; n=7, 5, 7 | -1.9 Millimoles per liter | Standard Deviation 0.69 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Day 5; n=7, 5, 7 | -0.207 Millimoles per liter | Standard Deviation 0.3073 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Day 2; n=20, 19, 21 | 0.098 Millimoles per liter | Standard Deviation 0.0777 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Day 2; n=20, 19, 21 | -0.5 Millimoles per liter | Standard Deviation 1.67 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Day 5; n=7, 5, 7 | -0.26 Millimoles per liter | Standard Deviation 0.27 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Day 5; n=7, 5, 7 | -1.0 Millimoles per liter | Standard Deviation 2 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Day 5; n=7, 5, 7 | -1.9 Millimoles per liter | Standard Deviation 0.9 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Day 2; n=20, 19, 21 | 0.08 Millimoles per liter | Standard Deviation 0.249 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Day 2; n=20, 19, 21 | 0.9 Millimoles per liter | Standard Deviation 1.59 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Day 2; n=20, 19, 21 | 0.087 Millimoles per liter | Standard Deviation 0.0836 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Day 2; n=20, 19, 21 | -0.036 Millimoles per liter | Standard Deviation 0.2823 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Day 5; n=7, 5, 7 | -0.100 Millimoles per liter | Standard Deviation 0.2547 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Day 2; n=20, 19, 21 | -0.01 Millimoles per liter | Standard Deviation 0.273 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Day 5; n=7, 5, 7 | -0.32 Millimoles per liter | Standard Deviation 0.377 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Day 2; n=20, 19, 21 | -0.5 Millimoles per liter | Standard Deviation 2.59 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Day 5; n=7, 5, 7 | -2.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Day 2; n=20, 19, 21 | -0.2 Millimoles per liter | Standard Deviation 1.78 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Day 5; n=7, 5, 7 | -2.2 Millimoles per liter | Standard Deviation 1.1 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Day 2; n=20, 19, 21 | 0.065 Millimoles per liter | Standard Deviation 0.0973 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Day 5; n=7, 5, 7 | 0.124 Millimoles per liter | Standard Deviation 0.0953 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Day 2; n=20, 19, 21 | 0.257 Millimoles per liter | Standard Deviation 0.9884 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Day 5; n=7, 5, 7 | 0.684 Millimoles per liter | Standard Deviation 0.7695 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Day 2; n=20, 19, 21 | 0.127 Millimoles per liter | Standard Deviation 0.275 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Day 5; n=7, 5, 7 | 0.226 Millimoles per liter | Standard Deviation 0.1254 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Day 2; n=20, 19, 21 | 0.078 Millimoles per liter | Standard Deviation 0.5175 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Day 5; n=7, 5, 7 | -0.286 Millimoles per liter | Standard Deviation 0.3791 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Day 2; n=20, 19, 21 | -0.9 Millimoles per liter | Standard Deviation 2.13 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Day 5; n=7, 5, 7 | 0.4 Millimoles per liter | Standard Deviation 1.67 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Day 2; n=20, 19, 21 | 0.8 Millimoles per liter | Standard Deviation 1.18 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Day 5; n=7, 5, 7 | -0.4 Millimoles per liter | Standard Deviation 2.3 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Day 2; n=20, 19, 21 | 0.063 Millimoles per liter | Standard Deviation 0.093 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Day 5; n=7, 5, 7 | 0.068 Millimoles per liter | Standard Deviation 0.0867 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Day 2; n=20, 19, 21 | 0.087 Millimoles per liter | Standard Deviation 0.2938 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Day 2; n=20, 19, 21 | -0.02 Millimoles per liter | Standard Deviation 0.27 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Day 2; n=20, 19, 21 | -0.5 Millimoles per liter | Standard Deviation 1.66 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Day 2; n=20, 19, 21 | 0.076 Millimoles per liter | Standard Deviation 0.0815 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Day 5; n=7, 5, 7 | 0.067 Millimoles per liter | Standard Deviation 0.0702 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Anion gap; Day 5; n=7, 5, 7 | -0.7 Millimoles per liter | Standard Deviation 1.98 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Day 5; n=7, 5, 7 | -1.0 Millimoles per liter | Standard Deviation 2.89 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Potassium; Day 5; n=7, 5, 7 | -0.04 Millimoles per liter | Standard Deviation 0.282 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Day 2; n=20, 19, 21 | -0.1 Millimoles per liter | Standard Deviation 2.1 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Chloride; Day 2; n=20, 19, 21 | -0.3 Millimoles per liter | Standard Deviation 2.29 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Day 5; n=7, 5, 7 | 0.113 Millimoles per liter | Standard Deviation 0.3935 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Carbon dioxide; Day 5; n=7, 5, 7 | 0.4 Millimoles per liter | Standard Deviation 1.81 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Day 5; n=7, 5, 7 | -1.4 Millimoles per liter | Standard Deviation 3.1 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Day 2; n=20, 19, 21 | 0.062 Millimoles per liter | Standard Deviation 0.2884 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Glucose; Day 2; n=20, 19, 21 | 0.030 Millimoles per liter | Standard Deviation 0.2588 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Triglycerides; Day 5; n=7, 5, 7 | 0.273 Millimoles per liter | Standard Deviation 0.5007 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Day 5; n=7, 5, 7 | 0.506 Millimoles per liter | Standard Deviation 0.9007 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Calcium; Day 2; n=20, 19, 21 | 0.078 Millimoles per liter | Standard Deviation 0.059 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Day 2; n=20, 19, 21 | 0.077 Millimoles per liter | Standard Deviation 0.4478 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | BUN; Day 2; n=20, 19, 21 | 0.213 Millimoles per liter | Standard Deviation 0.9258 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Sodium; Day 2; n=20, 19, 21 | -1.0 Millimoles per liter | Standard Deviation 2 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Cholesterol; Day 5; n=7, 5, 7 | -0.339 Millimoles per liter | Standard Deviation 0.3855 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 | Phosphate; Day 5; n=7, 5, 7 | 0.074 Millimoles per liter | Standard Deviation 0.082 |
Secondary
Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Day 2; n=20, 19, 21 | 2.29 Micromoles per liter | Standard Deviation 2.65 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Day 2; n=20, 19, 21 | 7.25 Micromoles per liter | Standard Deviation 5.306 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Day 5; n=7, 5, 7 | 3.89 Micromoles per liter | Standard Deviation 3.133 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Day 5; n=7, 5, 7 | -6.7 Micromoles per liter | Standard Deviation 29.86 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Day 5; n=7, 5, 7 | 10.10 Micromoles per liter | Standard Deviation 5.536 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Day 2; n=20, 19, 21 | 0.21 Micromoles per liter | Standard Deviation 0.524 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Day 2; n=20, 19, 21 | -16.5 Micromoles per liter | Standard Deviation 31.57 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Day 5; n=7, 5, 7 | 0.31 Micromoles per liter | Standard Deviation 0.495 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Day 5; n=7, 5, 7 | 8.86 Micromoles per liter | Standard Deviation 4.565 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Day 5; n=7, 5, 7 | 0.16 Micromoles per liter | Standard Deviation 0.611 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Day 2; n=20, 19, 21 | 7.41 Micromoles per liter | Standard Deviation 4.836 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Day 2; n=20, 19, 21 | -0.5 Micromoles per liter | Standard Deviation 29.49 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Day 5; n=7, 5, 7 | -4.0 Micromoles per liter | Standard Deviation 34.62 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Day 2; n=20, 19, 21 | 2.47 Micromoles per liter | Standard Deviation 3.448 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Day 5; n=7, 5, 7 | 4.04 Micromoles per liter | Standard Deviation 4.689 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Day 2; n=20, 19, 21 | 0.22 Micromoles per liter | Standard Deviation 0.55 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Day 5; n=7, 5, 7 | 1.69 Micromoles per liter | Standard Deviation 1.791 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Day 2; n=20, 19, 21 | 6.18 Micromoles per liter | Standard Deviation 4.833 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Creatinine; Day 5; n=7, 5, 7 | 7.19 Micromoles per liter | Standard Deviation 5.827 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Total bilirubin; Day 2; n=20, 19, 21 | 2.06 Micromoles per liter | Standard Deviation 2.729 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Day 5; n=7, 5, 7 | 3.3 Micromoles per liter | Standard Deviation 27.67 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Day 2; n=20, 19, 21 | 0.18 Micromoles per liter | Standard Deviation 0.494 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Direct bilirubin; Day 5; n=7, 5, 7 | 0.11 Micromoles per liter | Standard Deviation 0.389 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 | Urate; Day 2; n=20, 19, 21 | -13.8 Micromoles per liter | Standard Deviation 32.92 |
Secondary
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | PR interval, Day 1 (4 hours); n=18, 18 | -3.6 Milliseconds | Standard Deviation 11.61 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QRS duration, Day 1 (2 hours); n=18, 18 | -1.5 Milliseconds | Standard Deviation 2.81 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QT interval, Day 1 (2 hours); n=18, 18 | -11.8 Milliseconds | Standard Deviation 10.7 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QT interval, Day 5; n=9, 9 | -1.3 Milliseconds | Standard Deviation 10 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QTcF interval, Day 1 (2 hours); n=18, 18 | -9.9 Milliseconds | Standard Deviation 6.49 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QTcF interval, Day 1 (4 hours); n=18, 18 | -0.7 Milliseconds | Standard Deviation 7.71 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | PR interval, Day 1 (2 hours); n=18, 18 | 2.2 Milliseconds | Standard Deviation 8.35 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | PR interval, Day 5; n=9, 9 | -0.9 Milliseconds | Standard Deviation 13.72 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QRS duration, Day 1 (4 hours); n=18, 18 | 0.7 Milliseconds | Standard Deviation 3.63 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QRS duration, Day 5; n=9, 9 | -0.3 Milliseconds | Standard Deviation 3.74 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QT interval, Day 1 (4 hours); n=18, 18 | 9.7 Milliseconds | Standard Deviation 13.99 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QTcF interval, Day 5; n=9, 9 | -0.7 Milliseconds | Standard Deviation 7.19 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QT interval, Day 1 (4 hours); n=18, 18 | 7.6 Milliseconds | Standard Deviation 16.85 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | PR interval, Day 1 (4 hours); n=18, 18 | -3.3 Milliseconds | Standard Deviation 10.85 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | PR interval, Day 5; n=9, 9 | 3.2 Milliseconds | Standard Deviation 8.35 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QTcF interval, Day 1 (4 hours); n=18, 18 | 0.7 Milliseconds | Standard Deviation 9.23 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QRS duration, Day 1 (2 hours); n=18, 18 | 0.1 Milliseconds | Standard Deviation 6.06 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QRS duration, Day 1 (4 hours); n=18, 18 | 1.3 Milliseconds | Standard Deviation 4.92 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QRS duration, Day 5; n=9, 9 | 0.8 Milliseconds | Standard Deviation 3.46 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QTcF interval, Day 1 (2 hours); n=18, 18 | -9.1 Milliseconds | Standard Deviation 9.16 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QT interval, Day 1 (2 hours); n=18, 18 | -10.8 Milliseconds | Standard Deviation 11.18 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | PR interval, Day 1 (2 hours); n=18, 18 | -3.6 Milliseconds | Standard Deviation 10.01 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QT interval, Day 5; n=9, 9 | 5.0 Milliseconds | Standard Deviation 26.51 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 | QTcF interval, Day 5; n=9, 9 | 3.9 Milliseconds | Standard Deviation 7.93 |
Secondary
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 1 (2 hours); n=20, 19, 21 | -3.2 Milliseconds | Standard Deviation 3.44 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 1 (4 hours); n=20, 19, 21 | 1.6 Milliseconds | Standard Deviation 7.5 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 1 (2 hours); n=20, 19, 21 | -12.1 Milliseconds | Standard Deviation 18.05 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 5; n=7, 5, 7 | -0.4 Milliseconds | Standard Deviation 9.34 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 1 (2 hours); n=20, 19, 21 | -2.5 Milliseconds | Standard Deviation 7.02 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 5; n=7, 5, 7 | 0.4 Milliseconds | Standard Deviation 3.21 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 1 (2 hours); n=20, 19, 21 | -11.3 Milliseconds | Standard Deviation 7.04 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 1 (4 hours); n=20, 19, 21 | -1.2 Milliseconds | Standard Deviation 8.47 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 5; n=7, 5, 7 | 2.0 Milliseconds | Standard Deviation 4.08 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 5; n=7, 5, 7 | -2.1 Milliseconds | Standard Deviation 10.67 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 1 (4 hours); n=20, 19, 21 | -1.0 Milliseconds | Standard Deviation 4.18 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 1 (4 hours); n=20, 19, 21 | 9.2 Milliseconds | Standard Deviation 18.08 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 5; n=7, 5, 7 | -0.4 Milliseconds | Standard Deviation 3.13 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 1 (2 hours); n=20, 19, 21 | 0.7 Milliseconds | Standard Deviation 7.9 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 1 (4 hours); n=20, 19, 21 | -0.4 Milliseconds | Standard Deviation 11.52 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 5; n=7, 5, 7 | 1.6 Milliseconds | Standard Deviation 11.26 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 1 (2 hours); n=20, 19, 21 | 0.9 Milliseconds | Standard Deviation 3.9 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 1 (4 hours); n=20, 19, 21 | 1.5 Milliseconds | Standard Deviation 4.45 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 1 (2 hours); n=20, 19, 21 | 10.6 Milliseconds | Standard Deviation 12.36 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 1 (4 hours); n=20, 19, 21 | 18.4 Milliseconds | Standard Deviation 12.9 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 5; n=7, 5, 7 | -12.4 Milliseconds | Standard Deviation 13.28 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 1 (2 hours); n=20, 19, 21 | -0.6 Milliseconds | Standard Deviation 7.33 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 1 (4 hours); n=20, 19, 21 | 3.1 Milliseconds | Standard Deviation 7.75 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 5; n=7, 5, 7 | -1.4 Milliseconds | Standard Deviation 3.91 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 5; n=7, 5, 7 | -2.9 Milliseconds | Standard Deviation 7.95 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 1 (4 hours); n=20, 19, 21 | -0.6 Milliseconds | Standard Deviation 14.14 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 1 (4 hours); n=20, 19, 21 | -4.2 Milliseconds | Standard Deviation 6.79 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 5; n=7, 5, 7 | 1.7 Milliseconds | Standard Deviation 8.3 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 1 (2 hours); n=20, 19, 21 | -5.0 Milliseconds | Standard Deviation 8.29 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 1 (4 hours); n=20, 19, 21 | 1.4 Milliseconds | Standard Deviation 7.64 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 1 (4 hours); n=20, 19, 21 | 0.2 Milliseconds | Standard Deviation 4.12 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 5; n=7, 5, 7 | 0.4 Milliseconds | Standard Deviation 2.88 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QRS duration, Day 1 (2 hours); n=20, 19, 21 | -0.5 Milliseconds | Standard Deviation 3.03 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QTcF interval, Day 1 (2 hours); n=20, 19, 21 | -3.5 Milliseconds | Standard Deviation 8.7 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | QT interval, Day 1 (2 hours); n=20, 19, 21 | -13.4 Milliseconds | Standard Deviation 15.31 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 | PR interval, Day 5; n=7, 5, 7 | -2.7 Milliseconds | Standard Deviation 16.42 |
Secondary
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Day 2; n=18, 18 | 0.01 Picograms | Standard Deviation 0.344 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Day 5; n=9, 9 | 0.26 Picograms | Standard Deviation 0.343 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Day 2; n=18, 18 | 0.14 Picograms | Standard Deviation 0.365 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1 | Day 5; n=9, 9 | 0.20 Picograms | Standard Deviation 0.439 |
Secondary
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Day 2; n=20, 19, 21 | -0.05 Picograms | Standard Deviation 0.33 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Day 5; n=7, 5, 7 | 0.10 Picograms | Standard Deviation 0.365 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Day 2; n=20, 19, 21 | -0.05 Picograms | Standard Deviation 0.276 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Day 5; n=7, 5, 7 | 0.18 Picograms | Standard Deviation 0.536 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Day 2; n=20, 19, 21 | -0.06 Picograms | Standard Deviation 0.356 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2 | Day 5; n=7, 5, 7 | 0.13 Picograms | Standard Deviation 0.553 |
Secondary
Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1 | Day 2; n=18, 18 | -0.59 Femtoliters | Standard Deviation 0.984 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1 | Day 5; n=9, 9 | -0.84 Femtoliters | Standard Deviation 0.911 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1 | Day 2; n=18, 18 | -0.19 Femtoliters | Standard Deviation 1.05 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1 | Day 5; n=9, 9 | -0.96 Femtoliters | Standard Deviation 0.592 |
Secondary
Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2 | Day 2; n=20, 19, 21 | -0.35 Femtoliters | Standard Deviation 0.841 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2 | Day 5; n=7, 5, 7 | -0.06 Femtoliters | Standard Deviation 1.124 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2 | Day 2; n=20, 19, 21 | -0.28 Femtoliters | Standard Deviation 0.897 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2 | Day 5; n=7, 5, 7 | -0.02 Femtoliters | Standard Deviation 1.103 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2 | Day 2; n=20, 19, 21 | -0.41 Femtoliters | Standard Deviation 0.774 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2 | Day 5; n=7, 5, 7 | -0.33 Femtoliters | Standard Deviation 0.834 |
Secondary
Change From Baseline in Erythrocytes Count-Part 1
Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Erythrocytes Count-Part 1 | Day 2; n=18, 18 | 0.136 10^12 cells per liter | Standard Deviation 0.2431 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Erythrocytes Count-Part 1 | Day 5; n=9, 9 | 0.253 10^12 cells per liter | Standard Deviation 0.232 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Erythrocytes Count-Part 1 | Day 2; n=18, 18 | 0.182 10^12 cells per liter | Standard Deviation 0.2052 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Erythrocytes Count-Part 1 | Day 5; n=9, 9 | 0.214 10^12 cells per liter | Standard Deviation 0.1729 |
Secondary
Change From Baseline in Erythrocytes Count-Part 2
Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Erythrocytes Count-Part 2 | Day 2; n=20, 19, 21 | 0.256 10^12 cells per liter | Standard Deviation 0.1751 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Erythrocytes Count-Part 2 | Day 5; n=7, 5, 7 | 0.231 10^12 cells per liter | Standard Deviation 0.152 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Erythrocytes Count-Part 2 | Day 2; n=20, 19, 21 | 0.247 10^12 cells per liter | Standard Deviation 0.2564 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Erythrocytes Count-Part 2 | Day 5; n=7, 5, 7 | 0.172 10^12 cells per liter | Standard Deviation 0.1678 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Erythrocytes Count-Part 2 | Day 2; n=20, 19, 21 | 0.237 10^12 cells per liter | Standard Deviation 0.1682 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Erythrocytes Count-Part 2 | Day 5; n=7, 5, 7 | 0.077 10^12 cells per liter | Standard Deviation 0.2276 |
Secondary
Change From Baseline in Hematocrit-Part 1
Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematocrit-Part 1 | Day 2; n=18, 18 | 0.0094 Proportion of red blood cells in blood | Standard Deviation 0.02265 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematocrit-Part 1 | Day 5; n=9, 9 | 0.0189 Proportion of red blood cells in blood | Standard Deviation 0.02196 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematocrit-Part 1 | Day 2; n=18, 18 | 0.0153 Proportion of red blood cells in blood | Standard Deviation 0.01912 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematocrit-Part 1 | Day 5; n=9, 9 | 0.0147 Proportion of red blood cells in blood | Standard Deviation 0.01362 |
Secondary
Change From Baseline in Hematocrit-Part 2
Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematocrit-Part 2 | Day 2; n=20, 19, 21 | 0.0187 Proportion of red blood cells in blood | Standard Deviation 0.01477 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematocrit-Part 2 | Day 5; n=7, 5, 7 | 0.0179 Proportion of red blood cells in blood | Standard Deviation 0.01378 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematocrit-Part 2 | Day 2; n=20, 19, 21 | 0.0182 Proportion of red blood cells in blood | Standard Deviation 0.02179 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematocrit-Part 2 | Day 5; n=7, 5, 7 | 0.0106 Proportion of red blood cells in blood | Standard Deviation 0.01731 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematocrit-Part 2 | Day 2; n=20, 19, 21 | 0.0166 Proportion of red blood cells in blood | Standard Deviation 0.01313 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematocrit-Part 2 | Day 5; n=7, 5, 7 | 0.0046 Proportion of red blood cells in blood | Standard Deviation 0.01855 |
Secondary
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Basophils; Day 2; n=18, 18 | -0.002 10^9 cells per liter | Standard Deviation 0.0092 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Basophils; Day 5; n=9, 9 | -0.002 10^9 cells per liter | Standard Deviation 0.0083 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Eosinophils; Day 2; n=18, 18 | 0.016 10^9 cells per liter | Standard Deviation 0.0322 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Eosinophils; Day 5; n=9, 9 | 0.022 10^9 cells per liter | Standard Deviation 0.0441 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Lymphocytes; Day 2; n=18, 18 | 0.109 10^9 cells per liter | Standard Deviation 0.2237 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Lymphocytes; Day 5; n=9, 9 | 0.082 10^9 cells per liter | Standard Deviation 0.2124 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Monocytes; Day 2; n=18, 18 | 0.006 10^9 cells per liter | Standard Deviation 0.0581 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Monocytes; Day 5; n=9, 9 | -0.009 10^9 cells per liter | Standard Deviation 0.0821 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Neutrophils; Day 2; n=18, 18 | -0.481 10^9 cells per liter | Standard Deviation 0.7029 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Neutrophils; Day 5; n=9, 9 | -0.291 10^9 cells per liter | Standard Deviation 0.5628 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Platelets; Day 2; n=18, 18 | 5.7 10^9 cells per liter | Standard Deviation 21.18 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Platelets; Day 5; n=9, 9 | 20.8 10^9 cells per liter | Standard Deviation 15.16 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Platelets; Day 2; n=18, 18 | 9.0 10^9 cells per liter | Standard Deviation 18.89 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Basophils; Day 2; n=18, 18 | -0.002 10^9 cells per liter | Standard Deviation 0.0092 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Monocytes; Day 2; n=18, 18 | 0.008 10^9 cells per liter | Standard Deviation 0.1164 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Basophils; Day 5; n=9, 9 | -0.004 10^9 cells per liter | Standard Deviation 0.0073 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Neutrophils; Day 5; n=9, 9 | 0.549 10^9 cells per liter | Standard Deviation 0.7398 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Eosinophils; Day 2; n=18, 18 | 0.022 10^9 cells per liter | Standard Deviation 0.0387 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Monocytes; Day 5; n=9, 9 | -0.001 10^9 cells per liter | Standard Deviation 0.0637 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Eosinophils; Day 5; n=9, 9 | 0.029 10^9 cells per liter | Standard Deviation 0.0462 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Platelets; Day 5; n=9, 9 | 12.8 10^9 cells per liter | Standard Deviation 22.55 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Lymphocytes; Day 2; n=18, 18 | 0.127 10^9 cells per liter | Standard Deviation 0.235 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Neutrophils; Day 2; n=18, 18 | -0.683 10^9 cells per liter | Standard Deviation 0.8597 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 | Lymphocytes; Day 5; n=9, 9 | 0.398 10^9 cells per liter | Standard Deviation 0.3721 |
Secondary
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Day 2; n=20, 19, 21 | -0.001 10^9 cells per liter | Standard Deviation 0.0107 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Day 5; n=7, 5, 7 | 0.000 10^9 cells per liter | Standard Deviation 0.01 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Day 2; n=20, 19, 21 | 0.001 10^9 cells per liter | Standard Deviation 0.0424 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Day 5; n=7, 5, 7 | 0.007 10^9 cells per liter | Standard Deviation 0.0423 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Day 2; n=20, 19, 21 | -0.073 10^9 cells per liter | Standard Deviation 0.2828 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Day 5; n=7, 5, 7 | 0.257 10^9 cells per liter | Standard Deviation 0.2146 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Day 2; n=20, 19, 21 | -0.028 10^9 cells per liter | Standard Deviation 0.1055 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Day 5; n=7, 5, 7 | 0.024 10^9 cells per liter | Standard Deviation 0.1081 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Day 2; n=20, 19, 21 | -0.326 10^9 cells per liter | Standard Deviation 0.7627 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Day 5; n=7, 5, 7 | -0.216 10^9 cells per liter | Standard Deviation 0.6986 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Day 2; n=20, 19, 21 | 21.6 10^9 cells per liter | Standard Deviation 30.53 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Day 5; n=7, 5, 7 | 38.0 10^9 cells per liter | Standard Deviation 26.03 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Day 5; n=7, 5, 7 | -5.8 10^9 cells per liter | Standard Deviation 28.08 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Day 2; n=20, 19, 21 | -0.003 10^9 cells per liter | Standard Deviation 0.0129 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Day 2; n=20, 19, 21 | -0.022 10^9 cells per liter | Standard Deviation 0.0978 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Day 2; n=20, 19, 21 | -0.336 10^9 cells per liter | Standard Deviation 0.7377 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Day 5; n=7, 5, 7 | 0.006 10^9 cells per liter | Standard Deviation 0.0114 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Day 5; n=7, 5, 7 | -0.010 10^9 cells per liter | Standard Deviation 0.1454 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Day 2; n=20, 19, 21 | 9.4 10^9 cells per liter | Standard Deviation 25.64 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Day 2; n=20, 19, 21 | -0.006 10^9 cells per liter | Standard Deviation 0.0519 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Day 5; n=7, 5, 7 | 0.000 10^9 cells per liter | Standard Deviation 0.1058 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Day 2; n=20, 19, 21 | 0.006 10^9 cells per liter | Standard Deviation 0.3097 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Day 5; n=7, 5, 7 | -0.030 10^9 cells per liter | Standard Deviation 0.0738 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Day 5; n=7, 5, 7 | 0.154 10^9 cells per liter | Standard Deviation 0.8131 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Day 5; n=7, 5, 7 | -0.009 10^9 cells per liter | Standard Deviation 0.0402 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Day 2; n=20, 19, 21 | -0.068 10^9 cells per liter | Standard Deviation 0.2313 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Day 5; n=7, 5, 7 | 0.134 10^9 cells per liter | Standard Deviation 1.1111 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Lymphocytes; Day 5; n=7, 5, 7 | -0.024 10^9 cells per liter | Standard Deviation 0.4172 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Day 2; n=20, 19, 21 | -0.022 10^9 cells per liter | Standard Deviation 0.1272 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Monocytes; Day 5; n=7, 5, 7 | 0.034 10^9 cells per liter | Standard Deviation 0.1509 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Day 2; n=20, 19, 21 | 21.4 10^9 cells per liter | Standard Deviation 26.82 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Day 2; n=20, 19, 21 | 0.001 10^9 cells per liter | Standard Deviation 0.0128 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Basophils; Day 5; n=7, 5, 7 | 0.000 10^9 cells per liter | Standard Deviation 0.0129 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Neutrophils; Day 2; n=20, 19, 21 | -0.300 10^9 cells per liter | Standard Deviation 0.7173 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Eosinophils; Day 2; n=20, 19, 21 | 0.009 10^9 cells per liter | Standard Deviation 0.0464 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 | Platelets; Day 5; n=7, 5, 7 | -1.1 10^9 cells per liter | Standard Deviation 30.28 |
Secondary
Change From Baseline in Hemoglobin-Part 1
Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hemoglobin-Part 1 | Day 2; n=18, 18 | 4.2 Grams per liter | Standard Deviation 7.11 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hemoglobin-Part 1 | Day 5; n=9, 9 | 8.7 Grams per liter | Standard Deviation 7.66 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hemoglobin-Part 1 | Day 2; n=18, 18 | 6.1 Grams per liter | Standard Deviation 6.69 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hemoglobin-Part 1 | Day 5; n=9, 9 | 7.6 Grams per liter | Standard Deviation 6.04 |
Secondary
Change From Baseline in Hemoglobin-Part 2
Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hemoglobin-Part 2 | Day 2; n=20, 19, 21 | 6.5 Grams per liter | Standard Deviation 4.96 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Hemoglobin-Part 2 | Day 5; n=7, 5, 7 | 7.0 Grams per liter | Standard Deviation 3.11 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hemoglobin-Part 2 | Day 2; n=20, 19, 21 | 6.3 Grams per liter | Standard Deviation 7.39 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Hemoglobin-Part 2 | Day 5; n=7, 5, 7 | 4.2 Grams per liter | Standard Deviation 5.5 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hemoglobin-Part 2 | Day 2; n=20, 19, 21 | 6.0 Grams per liter | Standard Deviation 4.21 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hemoglobin-Part 2 | Day 5; n=7, 5, 7 | 2.4 Grams per liter | Standard Deviation 5.32 |
Secondary
Change From Baseline in Urine Parameter: pH-Part 1
Urine samples were collected at indicated time points for the assessment of urine pH. 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 is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Urine Parameter: pH-Part 1 | Day 2; n=18, 18 | 0.11 pH | Standard Deviation 1.008 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Urine Parameter: pH-Part 1 | Day 5; n=9, 9 | -0.17 pH | Standard Deviation 0.559 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Urine Parameter: pH-Part 1 | Day 2; n=18, 18 | 0.22 pH | Standard Deviation 0.974 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Urine Parameter: pH-Part 1 | Day 5; n=9, 9 | -0.28 pH | Standard Deviation 1.121 |
Secondary
Change From Baseline in Urine Parameter: pH-Part 2
Urine samples were collected at indicated time points for the assessment of urine pH. 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 is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Urine Parameter: pH-Part 2 | Day 2; n=20, 19, 21 | -0.18 pH | Standard Deviation 0.799 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Urine Parameter: pH-Part 2 | Day 5; n=7, 5, 7 | -0.43 pH | Standard Deviation 0.787 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Urine Parameter: pH-Part 2 | Day 2; n=20, 19, 21 | -0.18 pH | Standard Deviation 0.73 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Urine Parameter: pH-Part 2 | Day 5; n=7, 5, 7 | -0.80 pH | Standard Deviation 0.837 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Urine Parameter: pH-Part 2 | Day 2; n=20, 19, 21 | -0.26 pH | Standard Deviation 0.664 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Urine Parameter: pH-Part 2 | Day 5; n=7, 5, 7 | 0.07 pH | Standard Deviation 0.45 |
Secondary
Change From Baseline in Urine Parameter: Specific Gravity-Part 1
Urine samples were collected at indicated time points for the assessment of 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, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Urine Parameter: Specific Gravity-Part 1 | Day 2; n=18, 18 | 0.0032 Ratio | Standard Deviation 0.01242 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Urine Parameter: Specific Gravity-Part 1 | Day 5; n=9, 9 | 0.0088 Ratio | Standard Deviation 0.0121 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Urine Parameter: Specific Gravity-Part 1 | Day 2; n=18, 18 | 0.0038 Ratio | Standard Deviation 0.01043 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Urine Parameter: Specific Gravity-Part 1 | Day 5; n=9, 9 | 0.0034 Ratio | Standard Deviation 0.0118 |
Secondary
Change From Baseline in Urine Parameter: Specific Gravity-Part 2
Urine samples were collected at indicated time points for the assessment of 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, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Urine Parameter: Specific Gravity-Part 2 | Day 2; n=20, 19, 21 | 0.0084 Ratio | Standard Deviation 0.00942 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Urine Parameter: Specific Gravity-Part 2 | Day 5; n=7, 5, 7 | 0.0109 Ratio | Standard Deviation 0.00825 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Urine Parameter: Specific Gravity-Part 2 | Day 2; n=20, 19, 21 | 0.0066 Ratio | Standard Deviation 0.00718 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Urine Parameter: Specific Gravity-Part 2 | Day 5; n=7, 5, 7 | 0.0140 Ratio | Standard Deviation 0.01142 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Urine Parameter: Specific Gravity-Part 2 | Day 2; n=20, 19, 21 | 0.0083 Ratio | Standard Deviation 0.00728 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Urine Parameter: Specific Gravity-Part 2 | Day 5; n=7, 5, 7 | 0.0091 Ratio | Standard Deviation 0.00956 |
Secondary
Change From Baseline in Urine Parameter: Urobilinogen-Part 1
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Urine Parameter: Urobilinogen-Part 1 | Day 2; n=18, 18 | -0.7524 Micromoles per liter | Standard Deviation 3.19235 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Urine Parameter: Urobilinogen-Part 1 | Day 5; n=9, 9 | 0.0000 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Urine Parameter: Urobilinogen-Part 1 | Day 2; n=18, 18 | 0.0000 Micromoles per liter | Standard Deviation 4.64555 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Urine Parameter: Urobilinogen-Part 1 | Day 5; n=9, 9 | -1.5049 Micromoles per liter | Standard Deviation 4.51467 |
Secondary
Change From Baseline in Urine Parameter: Urobilinogen-Part 2
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1), Day 2 and Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Urine Parameter: Urobilinogen-Part 2 | Day 2; n=20, 19, 21 | -0.6772 Micromoles per liter | Standard Deviation 5.3368 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Urine Parameter: Urobilinogen-Part 2 | Day 5; n=7, 5, 7 | 0.0000 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Urine Parameter: Urobilinogen-Part 2 | Day 5; n=7, 5, 7 | -2.7088 Micromoles per liter | Standard Deviation 6.05706 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Urine Parameter: Urobilinogen-Part 2 | Day 2; n=20, 19, 21 | -1.4275 Micromoles per liter | Standard Deviation 4.27045 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Urine Parameter: Urobilinogen-Part 2 | Day 5; n=7, 5, 7 | 1.9349 Micromoles per liter | Standard Deviation 5.11915 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Urine Parameter: Urobilinogen-Part 2 | Day 2; n=20, 19, 21 | -1.2899 Micromoles per liter | Standard Deviation 4.07394 |
Secondary
Change From Baseline in Vital Sign: Pulse Rate-Part 1
Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Pulse Rate-Part 1 | Day 2 | 1.1 Beats per minute | Standard Deviation 5.76 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Pulse Rate-Part 1 | Day 3 | 1.8 Beats per minute | Standard Deviation 8.2 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Pulse Rate-Part 1 | Day 4 | 1.7 Beats per minute | Standard Deviation 6.93 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Pulse Rate-Part 1 | Day 5 | -1.3 Beats per minute | Standard Deviation 5.46 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Pulse Rate-Part 1 | Day 5 | 0.8 Beats per minute | Standard Deviation 10.7 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Pulse Rate-Part 1 | Day 2 | 2.2 Beats per minute | Standard Deviation 7.5 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Pulse Rate-Part 1 | Day 4 | -0.6 Beats per minute | Standard Deviation 7.88 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Pulse Rate-Part 1 | Day 3 | 2.4 Beats per minute | Standard Deviation 7.41 |
Secondary
Change From Baseline in Vital Sign: Pulse Rate-Part 2
Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Day 4 | 5.4 Beats per minute | Standard Deviation 10.17 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Day 2 | 1.5 Beats per minute | Standard Deviation 7.39 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Day 5 | 2.2 Beats per minute | Standard Deviation 6.39 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Day 3 | 1.3 Beats per minute | Standard Deviation 9.69 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Day 4 | 4.1 Beats per minute | Standard Deviation 9.64 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Day 3 | 0.9 Beats per minute | Standard Deviation 13.16 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Day 5 | 5.0 Beats per minute | Standard Deviation 8.37 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Day 2 | -0.1 Beats per minute | Standard Deviation 8.02 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Day 5 | 5.9 Beats per minute | Standard Deviation 8.43 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Day 2 | 0.3 Beats per minute | Standard Deviation 4.72 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Day 3 | 3.7 Beats per minute | Standard Deviation 6.59 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Sign: Pulse Rate-Part 2 | Day 4 | 8.9 Beats per minute | Standard Deviation 8.21 |
Secondary
Change From Baseline in Vital Sign: Respiratory Rate-Part 1
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Respiratory Rate-Part 1 | Day 2; n=17, 17 | -1.1 Breaths per minute | Standard Deviation 3.47 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Respiratory Rate-Part 1 | Day 3; n=17, 18 | 0.6 Breaths per minute | Standard Deviation 2.62 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Respiratory Rate-Part 1 | Day 4; n=18, 18 | -0.1 Breaths per minute | Standard Deviation 2.78 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Respiratory Rate-Part 1 | Day 5; n=18, 18 | 0.0 Breaths per minute | Standard Deviation 2.74 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Respiratory Rate-Part 1 | Day 5; n=18, 18 | -0.8 Breaths per minute | Standard Deviation 2.76 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Respiratory Rate-Part 1 | Day 2; n=17, 17 | -0.8 Breaths per minute | Standard Deviation 3 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Respiratory Rate-Part 1 | Day 4; n=18, 18 | -0.2 Breaths per minute | Standard Deviation 3.35 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Respiratory Rate-Part 1 | Day 3; n=17, 18 | 0.3 Breaths per minute | Standard Deviation 3.58 |
Secondary
Change From Baseline in Vital Sign: Respiratory Rate-Part 2
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Day 5 | -1.1 Breaths per minute | Standard Deviation 1.77 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Day 4 | 0.1 Breaths per minute | Standard Deviation 2.2 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Day 3 | 0.2 Breaths per minute | Standard Deviation 2.42 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Day 2 | -0.5 Breaths per minute | Standard Deviation 2.24 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Day 3 | -0.7 Breaths per minute | Standard Deviation 2.42 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Day 5 | -0.7 Breaths per minute | Standard Deviation 1.91 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Day 2 | 0.1 Breaths per minute | Standard Deviation 2.62 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Day 4 | -1.3 Breaths per minute | Standard Deviation 3.72 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Day 5 | 0.8 Breaths per minute | Standard Deviation 2.86 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Day 2 | 0.4 Breaths per minute | Standard Deviation 2.58 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Day 4 | 0.5 Breaths per minute | Standard Deviation 2.27 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Sign: Respiratory Rate-Part 2 | Day 3 | 0.4 Breaths per minute | Standard Deviation 3.61 |
Secondary
Change From Baseline in Vital Signs: SBP and DBP-Part 1
Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | SBP; Day 2 | -4.5 Millimeters of mercury | Standard Deviation 7.52 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | SBP; Day 3 | -4.7 Millimeters of mercury | Standard Deviation 9.63 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | SBP; Day 4 | -6.1 Millimeters of mercury | Standard Deviation 7.45 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | SBP; Day 5 | -6.1 Millimeters of mercury | Standard Deviation 7.49 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | DBP; Day 2 | -2.0 Millimeters of mercury | Standard Deviation 6.82 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | DBP; Day 3 | -1.7 Millimeters of mercury | Standard Deviation 7.46 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | DBP; Day 4 | -1.9 Millimeters of mercury | Standard Deviation 6.98 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | DBP; Day 5 | -2.1 Millimeters of mercury | Standard Deviation 7.46 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | DBP; Day 5 | -4.6 Millimeters of mercury | Standard Deviation 7.17 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | SBP; Day 2 | -2.3 Millimeters of mercury | Standard Deviation 7.22 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | DBP; Day 2 | -2.2 Millimeters of mercury | Standard Deviation 5.78 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | SBP; Day 3 | -4.1 Millimeters of mercury | Standard Deviation 9.63 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | DBP; Day 4 | -4.7 Millimeters of mercury | Standard Deviation 6.99 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | SBP; Day 4 | -3.4 Millimeters of mercury | Standard Deviation 10.18 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | DBP; Day 3 | -4.3 Millimeters of mercury | Standard Deviation 4.8 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 1 | SBP; Day 5 | -3.6 Millimeters of mercury | Standard Deviation 11.37 |
Secondary
Change From Baseline in Vital Signs: SBP and DBP-Part 2
Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | SBP, Day 3 | -5.1 Millimeters of mercury | Standard Deviation 12.99 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | DBP, Day 4 | -2.9 Millimeters of mercury | Standard Deviation 8.53 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | SBP, Day 5 | -2.6 Millimeters of mercury | Standard Deviation 11.23 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | SBP, Day 4 | -1.9 Millimeters of mercury | Standard Deviation 12.28 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | DBP, Day 5 | -2.9 Millimeters of mercury | Standard Deviation 6.19 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | SBP, Day 2 | -3.5 Millimeters of mercury | Standard Deviation 10.5 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | DBP, Day 2 | -2.4 Millimeters of mercury | Standard Deviation 6.1 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | DBP, Day 3 | -1.9 Millimeters of mercury | Standard Deviation 6.4 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | SBP, Day 5 | 0.7 Millimeters of mercury | Standard Deviation 8.28 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | DBP, Day 2 | 2.8 Millimeters of mercury | Standard Deviation 5.07 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | SBP, Day 2 | 1.5 Millimeters of mercury | Standard Deviation 6.59 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | SBP, Day 3 | 2.1 Millimeters of mercury | Standard Deviation 7.74 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | SBP, Day 4 | 0.3 Millimeters of mercury | Standard Deviation 6.1 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | DBP, Day 3 | 1.5 Millimeters of mercury | Standard Deviation 7.83 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | DBP, Day 4 | 2.2 Millimeters of mercury | Standard Deviation 6.27 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | DBP, Day 5 | 0.9 Millimeters of mercury | Standard Deviation 6.99 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | SBP, Day 2 | -1.7 Millimeters of mercury | Standard Deviation 7.65 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | DBP, Day 4 | -1.3 Millimeters of mercury | Standard Deviation 6.63 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | DBP, Day 3 | 0.6 Millimeters of mercury | Standard Deviation 4.95 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | SBP, Day 5 | 0.6 Millimeters of mercury | Standard Deviation 7.71 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | DBP, Day 5 | -3.0 Millimeters of mercury | Standard Deviation 7.92 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | SBP, Day 4 | 0.6 Millimeters of mercury | Standard Deviation 9.95 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | SBP, Day 3 | -0.9 Millimeters of mercury | Standard Deviation 9.11 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Signs: SBP and DBP-Part 2 | DBP, Day 2 | -0.7 Millimeters of mercury | Standard Deviation 4.9 |
Secondary
Change From Baseline in Vital Sign: Temperature-Part 1
Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Temperature-Part 1 | Day 2 | -0.03 Degrees Celsius | Standard Deviation 0.329 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Temperature-Part 1 | Day 3 | 0.09 Degrees Celsius | Standard Deviation 0.442 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Temperature-Part 1 | Day 4 | 0.13 Degrees Celsius | Standard Deviation 0.452 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Temperature-Part 1 | Day 5 | -0.04 Degrees Celsius | Standard Deviation 0.501 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Temperature-Part 1 | Day 5 | -0.11 Degrees Celsius | Standard Deviation 0.33 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Temperature-Part 1 | Day 2 | 0.02 Degrees Celsius | Standard Deviation 0.472 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Temperature-Part 1 | Day 4 | -0.02 Degrees Celsius | Standard Deviation 0.458 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Temperature-Part 1 | Day 3 | -0.15 Degrees Celsius | Standard Deviation 0.444 |
Secondary
Change From Baseline in Vital Sign: Temperature-Part 2
Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Temperature-Part 2 | Day 3 | 0.09 Degrees Celsius | Standard Deviation 0.302 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Temperature-Part 2 | Day 2 | 0.05 Degrees Celsius | Standard Deviation 0.477 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Temperature-Part 2 | Day 5 | 0.10 Degrees Celsius | Standard Deviation 0.426 |
| Part 1: GSK3640254 200 mg Capsules | Change From Baseline in Vital Sign: Temperature-Part 2 | Day 4 | 0.13 Degrees Celsius | Standard Deviation 0.49 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Temperature-Part 2 | Day 3 | -0.13 Degrees Celsius | Standard Deviation 0.245 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Temperature-Part 2 | Day 4 | -0.13 Degrees Celsius | Standard Deviation 0.268 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Temperature-Part 2 | Day 5 | -0.01 Degrees Celsius | Standard Deviation 0.375 |
| Part 1: GSK3640254 200 mg Tablets | Change From Baseline in Vital Sign: Temperature-Part 2 | Day 2 | -0.10 Degrees Celsius | Standard Deviation 0.325 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Sign: Temperature-Part 2 | Day 5 | 0.15 Degrees Celsius | Standard Deviation 0.437 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Sign: Temperature-Part 2 | Day 3 | -0.08 Degrees Celsius | Standard Deviation 0.453 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Sign: Temperature-Part 2 | Day 4 | 0.01 Degrees Celsius | Standard Deviation 0.399 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Vital Sign: Temperature-Part 2 | Day 2 | -0.10 Degrees Celsius | Standard Deviation 0.39 |
Secondary
CL/F for GSK3640254-Part 2
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | CL/F for GSK3640254-Part 2 | 4.878 Liter per hour | Geometric Coefficient of Variation 42.2 |
| Part 1: GSK3640254 200 mg Tablets | CL/F for GSK3640254-Part 2 | 14.85 Liter per hour | Geometric Coefficient of Variation 58.2 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | CL/F for GSK3640254-Part 2 | 5.417 Liter per hour | Geometric Coefficient of Variation 35.9 |
Secondary
Lag Time for Absorption (Tlag) for GSK3640254-Part 1
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Lag Time for Absorption (Tlag) for GSK3640254-Part 1 | 0.528 Hours | Standard Deviation 0.7568 |
| Part 1: GSK3640254 200 mg Tablets | Lag Time for Absorption (Tlag) for GSK3640254-Part 1 | 0.139 Hours | Standard Deviation 0.4132 |
Secondary
Number of Participants With Abnormal Urine Dipstick Results-Part 1
Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented.
Time frame: Day 2 and Day 5
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Leukocyte esterase, Day 2, 1+ | 1 Participants |
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Leukocyte esterase, Day 5, 1+ | 0 Participants |
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Leukocyte esterase, Day 2, Trace | 0 Participants |
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Occult blood, Day 2, Trace | 1 Participants |
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Leukocyte esterase, Day 5, Trace | 0 Participants |
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Occult blood, Day 2, 1+ | 1 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Leukocyte esterase, Day 5, Trace | 1 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Leukocyte esterase, Day 2, 1+ | 0 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Occult blood, Day 2, 1+ | 0 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Leukocyte esterase, Day 2, Trace | 1 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Leukocyte esterase, Day 5, 1+ | 1 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Abnormal Urine Dipstick Results-Part 1 | Occult blood, Day 2, Trace | 1 Participants |
Secondary
Number of Participants With Abnormal Urine Dipstick Results-Part 2
Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented.
Time frame: Day 2 and Day 5
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Occult blood; Day 2; Trace | 0 Participants |
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Occult blood; Day 2; 3+ | 0 Participants |
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Ketones; Day 5; Trace | 1 Participants |
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Occult blood; Day 2; 2+ | 1 Participants |
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Ketones; Day 5; 2+ | 0 Participants |
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Leukocyte esterase; Day 2; 1+ | 0 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Occult blood; Day 2; 2+ | 0 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Occult blood; Day 2; Trace | 0 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Ketones; Day 5; Trace | 0 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Leukocyte esterase; Day 2; 1+ | 0 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Occult blood; Day 2; 3+ | 0 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Ketones; Day 5; 2+ | 0 Participants |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Occult blood; Day 2; 3+ | 2 Participants |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Occult blood; Day 2; 2+ | 0 Participants |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Ketones; Day 5; Trace | 0 Participants |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Ketones; Day 5; 2+ | 1 Participants |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Leukocyte esterase; Day 2; 1+ | 1 Participants |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Number of Participants With Abnormal Urine Dipstick Results-Part 2 | Occult blood; Day 2; Trace | 1 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Time frame: Up to Day 12
Population: Safety Population comprised of all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 | AEs | 0 Participants |
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 | SAEs | 0 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 | AEs | 1 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 | SAEs | 0 Participants |
Secondary
Number of Participants With AEs and SAEs-Part 2
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Time frame: Up to Day 19
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With AEs and SAEs-Part 2 | AEs | 0 Participants |
| Part 1: GSK3640254 200 mg Capsules | Number of Participants With AEs and SAEs-Part 2 | SAEs | 0 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With AEs and SAEs-Part 2 | AEs | 0 Participants |
| Part 1: GSK3640254 200 mg Tablets | Number of Participants With AEs and SAEs-Part 2 | SAEs | 0 Participants |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Number of Participants With AEs and SAEs-Part 2 | AEs | 5 Participants |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Number of Participants With AEs and SAEs-Part 2 | SAEs | 0 Participants |
Secondary
Plasma Concentration of GSK3640254-Part 1
Blood samples were collected at indicated time points for PK analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Concentration Population comprised of all participants who underwent plasma PK sampling and had evaluable PK assay results.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 1 hour | 6.795 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 5 hours | 1047 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 3 hours | 563.5 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 6 hours | 1013 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 2 hours | 104.5 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 8 hours | 981.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 3.5 hours | 724.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 12 hours | 817.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 1.5 hours | 26.40 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 24 hours | 565.5 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 4 hours | 798.5 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 48 hours | 286.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 2.5 hours | 342.5 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 72 hours | 159.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 4.5 hours | 964.5 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | 96 hours | 78.10 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 1 | pre-dose | 1.910 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 96 hours | 72.80 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | pre-dose | 1.580 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 1 hour | 81.90 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 1.5 hours | 291.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 2 hours | 502.5 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 2.5 hours | 804.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 3 hours | 965.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 3.5 hours | 1105 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 4 hours | 1190 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 4.5 hours | 1270 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 5 hours | 1195 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 6 hours | 992.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 8 hours | 895.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 12 hours | 787.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 24 hours | 582.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 48 hours | 286.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 1 | 72 hours | 150.0 Nanograms per milliliter |
Secondary
Plasma Concentration of GSK3640254-Part 2
Blood samples were collected at indicated time points for PK analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 3.5 hours | 1250 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 1 hour | 39.25 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 24 hours | 627.5 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 3 hours | 1195 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 1.5 hours | 306.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 12 hours | 773.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 2.5 hours | 1075 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 2 hours | 733.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 48 hours | 335.5 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 4.5 hours | 1245 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 8 hours | 950.5 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 72 hours | 171.5 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 4 hours | 1305 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 5 hours | 1275 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 96 hours | 79.75 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | pre-dose | 6.370 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Capsules | Plasma Concentration of GSK3640254-Part 2 | 6 hours | 1195 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 12 hours | 217.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 4 hours | 358.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 6 hours | 290.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 48 hours | 98.60 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 72 hours | 52.50 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | pre-dose | 0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 1 hour | 38.70 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 1.5 hours | 84.10 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 2 hours | 121.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 2.5 hours | 194.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 3 hours | 270.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 3.5 hours | 326.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 4.5 hours | 324.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 5 hours | 322.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 8 hours | 255.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 24 hours | 177.0 Nanograms per milliliter |
| Part 1: GSK3640254 200 mg Tablets | Plasma Concentration of GSK3640254-Part 2 | 96 hours | 31.30 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 12 hours | 734.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 3.5 hours | 785.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 4 hours | 833.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 4.5 hours | 866.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 72 hours | 145.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 96 hours | 62.20 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 48 hours | 287.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 24 hours | 580.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 8 hours | 845.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 2 hours | 574.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 1.5 hours | 239.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 6 hours | 968.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 2.5 hours | 684.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 1 hour | 92.30 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 5 hours | 845.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | 3 hours | 724.0 Nanograms per milliliter |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Plasma Concentration of GSK3640254-Part 2 | pre-dose | NA Nanograms per milliliter |
Secondary
T1/2 for GSK3640254-Part 2
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | T1/2 for GSK3640254-Part 2 | 24.921 Hours | Geometric Coefficient of Variation 18 |
| Part 1: GSK3640254 200 mg Tablets | T1/2 for GSK3640254-Part 2 | 25.669 Hours | Geometric Coefficient of Variation 12.7 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | T1/2 for GSK3640254-Part 2 | 24.833 Hours | Geometric Coefficient of Variation 15.7 |
Secondary
Tlag for GSK3640254-Part 2
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Tlag for GSK3640254-Part 2 | 0.050 Hours | Standard Deviation 0.2236 |
| Part 1: GSK3640254 200 mg Tablets | Tlag for GSK3640254-Part 2 | 0.000 Hours | Standard Deviation 0 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Tlag for GSK3640254-Part 2 | 0.048 Hours | Standard Deviation 0.2182 |
Secondary
Vz/F for GSK3640254-Part 2
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 200 mg Capsules | Vz/F for GSK3640254-Part 2 | 175.4 Liters | Geometric Coefficient of Variation 43.4 |
| Part 1: GSK3640254 200 mg Tablets | Vz/F for GSK3640254-Part 2 | 550.1 Liters | Geometric Coefficient of Variation 66.3 |
| Part 2: GSK3640254 200 mg Tablet (High Fat) | Vz/F for GSK3640254-Part 2 | 194.1 Liters | Geometric Coefficient of Variation 35.9 |