HIV Infections
Conditions
Keywords
Healthy participants, GSK3640254, Human immunodeficiency virus (HIV), Safety
Brief summary
This is an open-label, single-dose, four-period, four sequential, and crossover study conducted to assess the relative bioavailability of GSK3640254 mesylate tablets and GSK3640254 mesylate capsules (in the presence of a moderate fat meal). This study will also evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the pharmacokinetics of GSK3640254 mesylate tablet formulation. 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 16 participants will be enrolled and the duration of the study will be approximately 54 days.
Interventions
GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
GSK3640254 capsules 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 4 treatment sequences (ABCD, BADC, CDAB, or DCBA) in each treatment period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant 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 (m\^2) (inclusive). * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male or female: 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. * 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. * Positive Human immunodeficiency virus-1 and -2 antigen/antibody immunoassay at Screening. * ALT \>1.5 × upper limit of normal (ULN). A single repeat of ALT is allowed within a single Screening period to determine eligibility. * Bilirubin \>1.5 x ULN (isolated bilirubin \>1.5 x 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 and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT, 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 non-prescription 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-infinity]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B) | Pre-dose and at 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 analysis of GSK3640254. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. |
| AUC(0-infinity) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D) | Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B) | Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| AUC(0-t) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D) | Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Maximum Observed Concentration (Cmax) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B) | Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Cmax for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D) | Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Time of Cmax (Tmax) for GSK3640254 200 mg Capsules Under Fed Condition (Treatment A) | Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Time of Cmax (Tmax) for GSK3640254 200 mg Tablets Under Fed, Fasted and High Fat Condition (Treatment B, C and D) | Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Day 2 | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. |
| Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Day 2 | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. |
| Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Day 2 | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. |
| Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 2 | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. |
| Absolute Values for Urine Parameter: Specific Gravity | Day 2 | Urine samples were collected to analyze the urine parameter: 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. |
| Absolute Values for Urine Parameter: Urobilinogen | Day 2 | Urine samples were collected to analyze the urine parameter: urobilinogen. |
| Absolute Values for Urine Parameter: Potential of Hydrogen (pH) | Day 2 | Urine samples were collected to analyze the urine parameter: 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 Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | Day 1: 2 hours and 4 hours | Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. |
| Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Days 2, 3, 4, and 5 | SBP and DBP were measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. |
| Absolute Values for Pulse Rate | Days 2, 3, 4, and 5 | Pulse rate was measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. |
| Absolute Values for Respiratory Rate | Days 2, 3, 4, and 5 | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Absolute Values for Body Temperature | Days 2, 3, 4, and 5 | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Baseline (Day -1) and at Day 2 | Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Hematology Parameter: Hemoglobin | Baseline (Day -1) and at Day 2 | Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day -1) and at Day 2 | Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day -1) and at Day 2 | Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day -1) and at Day 2 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day -1) and at Day 2 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Baseline (Day -1) and at Day 2 | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Baseline (Day -1) and at Day 2 | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Baseline (Day -1) and at Day 2 | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Baseline (Day -1) and at Day 2 | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Chemistry Parameters: Amylase, Lipase | Baseline (Day -1) and at Day 2 | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Urinalysis Parameter: Specific Gravity | Baseline (Day -1) and at Day 2 | Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 14 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication. |
| Change From Baseline in Urinalysis Parameter: pH | Baseline (Day -1) and at Day 2 | Urine samples were collected to analyze the urinalysis parameter: 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 was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Baseline (Day 1, Pre-dose), Day 1: 2 hours and 4 hours | Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in SBP and DBP | Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5 | SBP and DBP were measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Pulse Rate | Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5 | Pulse rate was measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Respiratory Rate | Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5 | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Change From Baseline in Body Temperature | Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5 | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Lag Time for Absorption (Tlag) for GSK3640254 | Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Apparent Terminal Phase Half-life (t1/2) for GSK3640254 | Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Apparent Oral Clearance (CL/F) for GSK3640254 | Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Apparent Volume of Distribution (Vz/F) for GSK3640254 | Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Plasma Pharmacokinetic Concentration of GSK3640254 | Pre-dose and at 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 analysis of GSK3640254. The PK Concentration Population included all participants who underwent plasma PK sampling and had evaluable PK assay results. |
| Change From Baseline in Urinalysis Parameter: Urobilinogen | Baseline (Day -1) and at Day 2 | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Day 2 | Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. |
| Absolute Values for Hematology Parameter: Hemoglobin | Day 2 | Blood samples were collected to analyze the hematology parameter: hemoglobin. |
| Absolute Values for Hematology Parameter: Hematocrit | Day 2 | Blood samples were collected to analyze the hematology parameter: hematocrit. |
| Absolute Values for Hematology Parameter: Erythrocytes | Day 2 | Blood samples were collected to analyze the hematology parameter: erythrocytes. |
| Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 2 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. |
| Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 2 | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. |
| Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Day 2 | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. |
Countries
United States
Participant flow
Recruitment details
This was a randomized, open-label, single dose, 4 period crossover study in healthy participants conducted at a single center in the United States.
Pre-assignment details
A total of 16 participants were enrolled in this study. The study was early terminated by sponsor due to a potential contamination issue in the study drug after completion of treatment Period 2. Hence, treatment Periods 3 and 4 were not conducted.
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1 - Treatment ABCD Participants received a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-test) on Day 1 in treatment Period 4. Treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study. | 4 |
| Sequence 2 - Treatment BADC Participants received a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between two treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study. | 4 |
| Sequence 3 - Treatment CDAB Participants received a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study. | 4 |
| Sequence 4 - Treatment DCBA Participants received a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment D-Test) on Day 1 in treatment Period 1; followed by a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment C-Reference) on Day 1 in treatment Period 2. There was a washout period of at least 7 days between 2 treatment periods. Participants were planned to receive a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment B-Test) on Day 1 in treatment Period 3; and a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions (Treatment A-Reference) on Day 1 in treatment Period 4. The treatment Periods 3 and 4 were planned but no participants were enrolled due to early termination of the study. | 4 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Washout Period 2 (Up to 7 Days) | Study Closed/Terminated | 4 | 4 | 4 | 4 |
Baseline characteristics
| Characteristic | Sequence 1 - Treatment ABCD | Sequence 2 - Treatment BADC | Sequence 3 - Treatment CDAB | Sequence 4 - Treatment DCBA | Total |
|---|---|---|---|---|---|
| Age, Continuous | 33.8 Years STANDARD_DEVIATION 8.46 | 33.8 Years STANDARD_DEVIATION 10.21 | 31.3 Years STANDARD_DEVIATION 7.68 | 38.0 Years STANDARD_DEVIATION 11.66 | 34.2 Years STANDARD_DEVIATION 8.97 |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 10 Participants |
| Race/Ethnicity, Customized White-White/Caucasian/European Heritage | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 3 Participants | 3 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 1 / 8 | 0 / 8 | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
Time frame: Pre-dose and at 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 |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B) | 35.51 Hours*microgram per milliliter | Geometric Coefficient of Variation 16.7 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B) | 31.16 Hours*microgram per milliliter | Geometric Coefficient of Variation 37.4 |
90% CI: [0.7585, 1.0152]
Primary
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose and at 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 |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B) | 33.05 Hours*microgram per milliliter | Geometric Coefficient of Variation 18.2 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B) | 29.50 Hours*microgram per milliliter | Geometric Coefficient of Variation 37.7 |
90% CI: [0.7778, 1.0239]
Primary
AUC(0-infinity) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose and at 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 indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | AUC(0-infinity) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D) | 15.54 Hours*microgram per milliliter | Geometric Coefficient of Variation 49.4 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | AUC(0-infinity) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D) | 37.85 Hours*microgram per milliliter | Geometric Coefficient of Variation 30.1 |
Primary
AUC(0-t) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose and at 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 indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | AUC(0-t) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D) | 14.43 Hours*microgram per milliliter | Geometric Coefficient of Variation 52.3 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | AUC(0-t) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D) | 34.99 Hours*microgram per milliliter | Geometric Coefficient of Variation 29.1 |
Primary
Cmax for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose and at 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 indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Cmax for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D) | 0.5557 Microgram per milliliter | Geometric Coefficient of Variation 71.3 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Cmax for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D) | 1.168 Microgram per milliliter | Geometric Coefficient of Variation 30 |
Primary
Maximum Observed Concentration (Cmax) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose and at 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 |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Maximum Observed Concentration (Cmax) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B) | 1.151 Microgram per milliliter | Geometric Coefficient of Variation 16.8 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Maximum Observed Concentration (Cmax) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B) | 1.088 Microgram per milliliter | Geometric Coefficient of Variation 23.3 |
90% CI: [0.8594, 1.0404]
Primary
Time of Cmax (Tmax) for GSK3640254 200 mg Capsules Under Fed Condition (Treatment A)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose and at 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) |
|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Time of Cmax (Tmax) for GSK3640254 200 mg Capsules Under Fed Condition (Treatment A) | 6.000 Hours |
Primary
Time of Cmax (Tmax) for GSK3640254 200 mg Tablets Under Fed, Fasted and High Fat Condition (Treatment B, C and D)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose and at 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 indicated time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Time of Cmax (Tmax) for GSK3640254 200 mg Tablets Under Fed, Fasted and High Fat Condition (Treatment B, C and D) | 5.033 Hours |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Time of Cmax (Tmax) for GSK3640254 200 mg Tablets Under Fed, Fasted and High Fat Condition (Treatment B, C and D) | 4.250 Hours |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Time of Cmax (Tmax) for GSK3640254 200 mg Tablets Under Fed, Fasted and High Fat Condition (Treatment B, C and D) | 4.500 Hours |
p-value: 0.425290% CI: [-1, 2]Wilcoxon signed-rank test
p-value: 0.312590% CI: [-0.75, 5.25]Wilcoxon rank sum test
Secondary
Absolute Values for Body Temperature
Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Days 2, 3, 4, and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Body Temperature | Day 3 | 36.13 Degrees Celsius | Standard Deviation 0.219 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Body Temperature | Day 2 | 36.15 Degrees Celsius | Standard Deviation 0.378 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Body Temperature | Day 4 | 36.21 Degrees Celsius | Standard Deviation 0.295 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Body Temperature | Day 5 | 36.33 Degrees Celsius | Standard Deviation 0.238 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Body Temperature | Day 2 | 36.28 Degrees Celsius | Standard Deviation 0.292 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Body Temperature | Day 4 | 36.09 Degrees Celsius | Standard Deviation 0.242 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Body Temperature | Day 5 | 36.41 Degrees Celsius | Standard Deviation 0.309 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Body Temperature | Day 3 | 36.34 Degrees Celsius | Standard Deviation 0.297 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Body Temperature | Day 4 | 36.26 Degrees Celsius | Standard Deviation 0.407 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Body Temperature | Day 3 | 36.19 Degrees Celsius | Standard Deviation 0.23 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Body Temperature | Day 5 | 36.24 Degrees Celsius | Standard Deviation 0.213 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Body Temperature | Day 2 | 36.15 Degrees Celsius | Standard Deviation 0.548 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Body Temperature | Day 5 | 36.36 Degrees Celsius | Standard Deviation 0.385 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Body Temperature | Day 4 | 36.21 Degrees Celsius | Standard Deviation 0.253 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Body Temperature | Day 3 | 36.11 Degrees Celsius | Standard Deviation 0.429 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Body Temperature | Day 2 | 36.16 Degrees Celsius | Standard Deviation 0.407 |
Secondary
Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Albumin | 45.8 Grams per liter | Standard Deviation 1.49 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Protein | 73.5 Grams per liter | Standard Deviation 2.56 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Globulin | 27.8 Grams per liter | Standard Deviation 3.2 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Albumin | 44.0 Grams per liter | Standard Deviation 1.77 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Protein | 71.1 Grams per liter | Standard Deviation 3.36 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Globulin | 27.1 Grams per liter | Standard Deviation 4.02 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Globulin | 25.3 Grams per liter | Standard Deviation 3.11 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Albumin | 45.9 Grams per liter | Standard Deviation 2.85 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Protein | 71.1 Grams per liter | Standard Deviation 3.98 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Albumin | 46.4 Grams per liter | Standard Deviation 3.2 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Protein | 72.1 Grams per liter | Standard Deviation 5.06 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Globulin | 25.8 Grams per liter | Standard Deviation 2.92 |
Secondary
Absolute Values for Chemistry Parameters: Amylase, Lipase
Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Amylase, Lipase | Amylase | 53.8 Units per liter | Standard Deviation 11.51 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Amylase, Lipase | Lipase | 19.6 Units per liter | Standard Deviation 10 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Amylase, Lipase | Lipase | 21.6 Units per liter | Standard Deviation 13.67 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Amylase, Lipase | Amylase | 54.3 Units per liter | Standard Deviation 14.39 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Amylase, Lipase | Amylase | 66.3 Units per liter | Standard Deviation 26.29 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Amylase, Lipase | Lipase | 21.6 Units per liter | Standard Deviation 11.69 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Amylase, Lipase | Amylase | 68.8 Units per liter | Standard Deviation 24.84 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Amylase, Lipase | Lipase | 22.9 Units per liter | Standard Deviation 10.08 |
Secondary
Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Creatine kinase | 116.1 International units per liter | Standard Deviation 36.01 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Lactate dehydrogenase | 125.8 International units per liter | Standard Deviation 9.54 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | ALT | 18.1 International units per liter | Standard Deviation 3.09 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | ALP | 61.1 International units per liter | Standard Deviation 8.89 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | AST | 15.5 International units per liter | Standard Deviation 2.39 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Gamma-glutamyl transferase | 18.3 International units per liter | Standard Deviation 7.74 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Gamma-glutamyl transferase | 17.5 International units per liter | Standard Deviation 7.54 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | ALP | 58.3 International units per liter | Standard Deviation 8.07 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Creatine kinase | 116.8 International units per liter | Standard Deviation 48.18 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | ALT | 15.0 International units per liter | Standard Deviation 3.46 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Lactate dehydrogenase | 122.1 International units per liter | Standard Deviation 20.33 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | AST | 14.4 International units per liter | Standard Deviation 2.56 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Lactate dehydrogenase | 120.1 International units per liter | Standard Deviation 18.18 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | ALT | 17.9 International units per liter | Standard Deviation 14.22 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | ALP | 57.5 International units per liter | Standard Deviation 14.82 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Gamma-glutamyl transferase | 28.4 International units per liter | Standard Deviation 24.07 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | AST | 15.6 International units per liter | Standard Deviation 3.11 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Creatine kinase | 94.8 International units per liter | Standard Deviation 44.83 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | AST | 16.1 International units per liter | Standard Deviation 3.56 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Gamma-glutamyl transferase | 28.3 International units per liter | Standard Deviation 21.26 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Lactate dehydrogenase | 122.3 International units per liter | Standard Deviation 17.77 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | ALP | 60.8 International units per liter | Standard Deviation 20.15 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Creatine kinase | 111.9 International units per liter | Standard Deviation 55.35 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | ALT | 18.5 International units per liter | Standard Deviation 15.32 |
Secondary
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose | 4.774 Millimoles per liter | Standard Deviation 0.2447 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap | 9.8 Millimoles per liter | Standard Deviation 1.58 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate | 1.173 Millimoles per liter | Standard Deviation 0.1278 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol | 4.853 Millimoles per liter | Standard Deviation 1.0266 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride | 101.1 Millimoles per liter | Standard Deviation 0.99 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium | 2.473 Millimoles per liter | Standard Deviation 0.0453 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides | 1.048 Millimoles per liter | Standard Deviation 0.5887 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood urea nitrogen | 4.785 Millimoles per liter | Standard Deviation 0.9271 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium | 138.1 Millimoles per liter | Standard Deviation 0.99 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide | 31.8 Millimoles per liter | Standard Deviation 1.16 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium | 4.56 Millimoles per liter | Standard Deviation 0.334 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide | 31.3 Millimoles per liter | Standard Deviation 1.04 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium | 4.50 Millimoles per liter | Standard Deviation 0.239 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride | 101.0 Millimoles per liter | Standard Deviation 1.6 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate | 1.201 Millimoles per liter | Standard Deviation 0.0606 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides | 0.989 Millimoles per liter | Standard Deviation 0.6469 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood urea nitrogen | 4.509 Millimoles per liter | Standard Deviation 1.1031 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap | 9.9 Millimoles per liter | Standard Deviation 1.25 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium | 137.5 Millimoles per liter | Standard Deviation 2 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium | 2.430 Millimoles per liter | Standard Deviation 0.0609 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol | 4.630 Millimoles per liter | Standard Deviation 0.8081 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose | 4.780 Millimoles per liter | Standard Deviation 0.1336 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium | 138.5 Millimoles per liter | Standard Deviation 1.31 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose | 4.843 Millimoles per liter | Standard Deviation 0.3617 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol | 5.028 Millimoles per liter | Standard Deviation 1.5207 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides | 1.509 Millimoles per liter | Standard Deviation 1.1537 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap | 11.1 Millimoles per liter | Standard Deviation 2.03 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium | 2.421 Millimoles per liter | Standard Deviation 0.1025 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide | 30.1 Millimoles per liter | Standard Deviation 2.3 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride | 101.5 Millimoles per liter | Standard Deviation 2.14 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate | 1.199 Millimoles per liter | Standard Deviation 0.1929 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium | 4.28 Millimoles per liter | Standard Deviation 0.282 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood urea nitrogen | 4.351 Millimoles per liter | Standard Deviation 1.0179 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide | 30.5 Millimoles per liter | Standard Deviation 1.93 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood urea nitrogen | 4.096 Millimoles per liter | Standard Deviation 0.8941 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium | 4.36 Millimoles per liter | Standard Deviation 0.272 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium | 2.431 Millimoles per liter | Standard Deviation 0.1005 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap | 10.9 Millimoles per liter | Standard Deviation 1.64 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides | 1.379 Millimoles per liter | Standard Deviation 0.866 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium | 138.4 Millimoles per liter | Standard Deviation 1.19 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol | 4.960 Millimoles per liter | Standard Deviation 1.3009 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose | 4.838 Millimoles per liter | Standard Deviation 0.2467 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate | 1.230 Millimoles per liter | Standard Deviation 0.1292 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride | 101.6 Millimoles per liter | Standard Deviation 1.92 |
Secondary
Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Urate | 289.9 Micromoles per liter | Standard Deviation 60.74 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Creatinine | 92.84 Micromoles per liter | Standard Deviation 12.612 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Bilirubin | 10.85 Micromoles per liter | Standard Deviation 2.838 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Direct bilirubin | 2.04 Micromoles per liter | Standard Deviation 0.526 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Direct bilirubin | 2.13 Micromoles per liter | Standard Deviation 0.607 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Bilirubin | 10.78 Micromoles per liter | Standard Deviation 3.283 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Creatinine | 92.71 Micromoles per liter | Standard Deviation 12.136 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Urate | 282.6 Micromoles per liter | Standard Deviation 60.69 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Bilirubin | 12.24 Micromoles per liter | Standard Deviation 5.172 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Direct bilirubin | 2.29 Micromoles per liter | Standard Deviation 1.241 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Creatinine | 84.95 Micromoles per liter | Standard Deviation 13.2 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Urate | 287.0 Micromoles per liter | Standard Deviation 72.44 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Creatinine | 82.78 Micromoles per liter | Standard Deviation 13.843 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Urate | 276.6 Micromoles per liter | Standard Deviation 60.99 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Direct bilirubin | 2.14 Micromoles per liter | Standard Deviation 1.041 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Bilirubin | 11.09 Micromoles per liter | Standard Deviation 4.149 |
Secondary
Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)
Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.
Time frame: Day 1: 2 hours and 4 hours
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | PR Interval: Day 1, 2 hours | 173.3 Milliseconds | Standard Deviation 9.62 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | PR Interval: Day 1, 4 hours | 174.4 Milliseconds | Standard Deviation 11.25 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QRS Duration: Day 1, 2 hours | 90.9 Milliseconds | Standard Deviation 6.6 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QRS Duration: Day 1, 4 hours | 90.5 Milliseconds | Standard Deviation 5.88 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QT Interval: Day 1, 2 hours | 372.1 Milliseconds | Standard Deviation 22.03 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QT Interval: Day 1, 4 hours | 393.0 Milliseconds | Standard Deviation 22.55 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcF Interval: Day 1, 2 hours | 374.8 Milliseconds | Standard Deviation 14.41 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcF Interval: Day 1, 4 hours | 380.9 Milliseconds | Standard Deviation 18 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcB Interval: Day 1, 2 hours | 376.3 Milliseconds | Standard Deviation 13.54 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcB Interval: Day 1, 4 hours | 375.1 Milliseconds | Standard Deviation 18.55 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QRS Duration: Day 1, 2 hours | 94.3 Milliseconds | Standard Deviation 6.02 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcB Interval: Day 1, 2 hours | 377.9 Milliseconds | Standard Deviation 20.92 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QRS Duration: Day 1, 4 hours | 91.4 Milliseconds | Standard Deviation 7.95 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QT Interval: Day 1, 2 hours | 372.8 Milliseconds | Standard Deviation 21.74 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QT Interval: Day 1, 4 hours | 391.0 Milliseconds | Standard Deviation 25.95 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcF Interval: Day 1, 2 hours | 376.0 Milliseconds | Standard Deviation 20.09 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcB Interval: Day 1, 4 hours | 376.5 Milliseconds | Standard Deviation 12.93 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcF Interval: Day 1, 4 hours | 381.1 Milliseconds | Standard Deviation 15.37 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | PR Interval: Day 1, 2 hours | 173.4 Milliseconds | Standard Deviation 11.07 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | PR Interval: Day 1, 4 hours | 173.0 Milliseconds | Standard Deviation 9.55 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcF Interval: Day 1, 4 hours | 406.5 Milliseconds | Standard Deviation 24.6 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcF Interval: Day 1, 2 hours | 406.1 Milliseconds | Standard Deviation 23.12 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcB Interval: Day 1, 4 hours | 404.5 Milliseconds | Standard Deviation 28.43 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | PR Interval: Day 1, 2 hours | 158.3 Milliseconds | Standard Deviation 17.85 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QRS Duration: Day 1, 4 hours | 91.3 Milliseconds | Standard Deviation 9.13 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QT Interval: Day 1, 4 hours | 411.5 Milliseconds | Standard Deviation 30.29 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcB Interval: Day 1, 2 hours | 406.6 Milliseconds | Standard Deviation 26.45 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | PR Interval: Day 1, 4 hours | 157.5 Milliseconds | Standard Deviation 14.29 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QT Interval: Day 1, 2 hours | 405.8 Milliseconds | Standard Deviation 25.73 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QRS Duration: Day 1, 2 hours | 91.5 Milliseconds | Standard Deviation 11.1 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QT Interval: Day 1, 2 hours | 387.6 Milliseconds | Standard Deviation 29.34 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcF Interval: Day 1, 4 hours | 410.6 Milliseconds | Standard Deviation 20.85 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QT Interval: Day 1, 4 hours | 398.3 Milliseconds | Standard Deviation 23.92 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcB Interval: Day 1, 4 hours | 417.4 Milliseconds | Standard Deviation 24.86 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcF Interval: Day 1, 2 hours | 399.9 Milliseconds | Standard Deviation 19.79 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | PR Interval: Day 1, 4 hours | 149.6 Milliseconds | Standard Deviation 17.07 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QRS Duration: Day 1, 2 hours | 92.6 Milliseconds | Standard Deviation 10.68 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QRS Duration: Day 1, 4 hours | 92.1 Milliseconds | Standard Deviation 6.58 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | PR Interval: Day 1, 2 hours | 156.9 Milliseconds | Standard Deviation 18.37 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB) | QTcB Interval: Day 1, 2 hours | 406.8 Milliseconds | Standard Deviation 24.77 |
Secondary
Absolute Values for Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: erythrocytes.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Hematology Parameter: Erythrocytes | 5.199 10^12 cells per liter | Standard Deviation 0.3468 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Hematology Parameter: Erythrocytes | 5.120 10^12 cells per liter | Standard Deviation 0.3829 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameter: Erythrocytes | 5.013 10^12 cells per liter | Standard Deviation 0.5337 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameter: Erythrocytes | 5.066 10^12 cells per liter | Standard Deviation 0.4719 |
Secondary
Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | 28.01 Picograms | Standard Deviation 1.864 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | 28.06 Picograms | Standard Deviation 1.905 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | 28.94 Picograms | Standard Deviation 1.614 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | 28.73 Picograms | Standard Deviation 1.424 |
Secondary
Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 84.88 Femtoliter | Standard Deviation 4.055 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 85.00 Femtoliter | Standard Deviation 4.184 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 85.84 Femtoliter | Standard Deviation 4.373 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 85.90 Femtoliter | Standard Deviation 4.178 |
Secondary
Absolute Values for Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Hematology Parameter: Hematocrit | 0.4406 Proportion of red blood cells in blood | Standard Deviation 0.02272 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Hematology Parameter: Hematocrit | 0.4344 Proportion of red blood cells in blood | Standard Deviation 0.02477 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameter: Hematocrit | 0.4294 Proportion of red blood cells in blood | Standard Deviation 0.04147 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameter: Hematocrit | 0.4345 Proportion of red blood cells in blood | Standard Deviation 0.03691 |
Secondary
Absolute Values for Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Hematology Parameter: Hemoglobin | 145.1 Grams per liter | Standard Deviation 8.61 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Hematology Parameter: Hemoglobin | 143.1 Grams per liter | Standard Deviation 8.63 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameter: Hemoglobin | 144.8 Grams per liter | Standard Deviation 14.5 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameter: Hemoglobin | 145.5 Grams per liter | Standard Deviation 12.81 |
Secondary
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Basophils | 0.024 10^9 cells per liter | Standard Deviation 0.0092 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Eosinophils | 0.086 10^9 cells per liter | Standard Deviation 0.0472 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Lymphocytes | 1.673 10^9 cells per liter | Standard Deviation 0.3314 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Monocytes | 0.365 10^9 cells per liter | Standard Deviation 0.0849 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Neutrophils | 2.324 10^9 cells per liter | Standard Deviation 0.6459 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Platelet count | 252.1 10^9 cells per liter | Standard Deviation 22.64 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Platelet count | 241.5 10^9 cells per liter | Standard Deviation 28.91 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Monocytes | 0.384 10^9 cells per liter | Standard Deviation 0.0968 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Basophils | 0.028 10^9 cells per liter | Standard Deviation 0.0175 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Lymphocytes | 1.689 10^9 cells per liter | Standard Deviation 0.2283 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Eosinophils | 0.096 10^9 cells per liter | Standard Deviation 0.091 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Neutrophils | 2.403 10^9 cells per liter | Standard Deviation 0.6452 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Eosinophils | 0.126 10^9 cells per liter | Standard Deviation 0.0761 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Lymphocytes | 1.890 10^9 cells per liter | Standard Deviation 0.4366 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Monocytes | 0.434 10^9 cells per liter | Standard Deviation 0.1492 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Platelet count | 271.8 10^9 cells per liter | Standard Deviation 44.08 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Neutrophils | 2.470 10^9 cells per liter | Standard Deviation 0.6709 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Basophils | 0.036 10^9 cells per liter | Standard Deviation 0.0119 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Neutrophils | 2.403 10^9 cells per liter | Standard Deviation 0.6713 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Platelet count | 270.9 10^9 cells per liter | Standard Deviation 40.47 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Eosinophils | 0.128 10^9 cells per liter | Standard Deviation 0.074 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Monocytes | 0.410 10^9 cells per liter | Standard Deviation 0.161 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Basophils | 0.038 10^9 cells per liter | Standard Deviation 0.0139 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Lymphocytes | 1.753 10^9 cells per liter | Standard Deviation 0.4307 |
Secondary
Absolute Values for Pulse Rate
Pulse rate was measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions.
Time frame: Days 2, 3, 4, and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Pulse Rate | Day 2 | 60.0 Beats per minute | Standard Deviation 6.19 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Pulse Rate | Day 3 | 62.5 Beats per minute | Standard Deviation 7.54 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Pulse Rate | Day 4 | 62.9 Beats per minute | Standard Deviation 9.51 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Pulse Rate | Day 5 | 60.4 Beats per minute | Standard Deviation 8.47 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Pulse Rate | Day 3 | 61.4 Beats per minute | Standard Deviation 9.07 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Pulse Rate | Day 4 | 61.9 Beats per minute | Standard Deviation 7.2 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Pulse Rate | Day 5 | 62.8 Beats per minute | Standard Deviation 11.21 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Pulse Rate | Day 2 | 61.3 Beats per minute | Standard Deviation 9.79 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Pulse Rate | Day 4 | 67.1 Beats per minute | Standard Deviation 8.39 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Pulse Rate | Day 3 | 63.4 Beats per minute | Standard Deviation 8.94 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Pulse Rate | Day 5 | 67.4 Beats per minute | Standard Deviation 5.76 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Pulse Rate | Day 2 | 66.0 Beats per minute | Standard Deviation 11.75 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Pulse Rate | Day 5 | 65.8 Beats per minute | Standard Deviation 9.27 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Pulse Rate | Day 3 | 67.9 Beats per minute | Standard Deviation 9.57 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Pulse Rate | Day 2 | 64.5 Beats per minute | Standard Deviation 7.91 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Pulse Rate | Day 4 | 64.5 Beats per minute | Standard Deviation 10.84 |
Secondary
Absolute Values for Respiratory Rate
Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time frame: Days 2, 3, 4, and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Respiratory Rate | Day 2 | 14.3 Breaths per minute | Standard Deviation 2.71 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Respiratory Rate | Day 3 | 15.8 Breaths per minute | Standard Deviation 1.98 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Respiratory Rate | Day 4 | 16.0 Breaths per minute | Standard Deviation 0 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Respiratory Rate | Day 5 | 15.8 Breaths per minute | Standard Deviation 3.62 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Respiratory Rate | Day 3 | 15.5 Breaths per minute | Standard Deviation 2.33 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Respiratory Rate | Day 4 | 16.0 Breaths per minute | Standard Deviation 1.07 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Respiratory Rate | Day 5 | 15.3 Breaths per minute | Standard Deviation 3.01 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Respiratory Rate | Day 2 | 13.8 Breaths per minute | Standard Deviation 2.25 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Respiratory Rate | Day 4 | 14.5 Breaths per minute | Standard Deviation 1.41 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Respiratory Rate | Day 3 | 14.3 Breaths per minute | Standard Deviation 1.98 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Respiratory Rate | Day 5 | 15.8 Breaths per minute | Standard Deviation 2.25 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Respiratory Rate | Day 2 | 14.0 Breaths per minute | Standard Deviation 2.83 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Respiratory Rate | Day 5 | 14.5 Breaths per minute | Standard Deviation 3.51 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Respiratory Rate | Day 3 | 14.3 Breaths per minute | Standard Deviation 2.25 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Respiratory Rate | Day 2 | 14.0 Breaths per minute | Standard Deviation 3.55 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Respiratory Rate | Day 4 | 14.3 Breaths per minute | Standard Deviation 2.25 |
Secondary
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions.
Time frame: Days 2, 3, 4, and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 2 | 116.0 Millimeters of mercury | Standard Deviation 8.05 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 3 | 116.4 Millimeters of mercury | Standard Deviation 8.85 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 4 | 114.6 Millimeters of mercury | Standard Deviation 8.45 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 5 | 113.4 Millimeters of mercury | Standard Deviation 8.58 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 2 | 69.4 Millimeters of mercury | Standard Deviation 6.61 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 3 | 65.3 Millimeters of mercury | Standard Deviation 7.52 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 4 | 68.8 Millimeters of mercury | Standard Deviation 9.71 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 5 | 70.0 Millimeters of mercury | Standard Deviation 10.09 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 3 | 66.3 Millimeters of mercury | Standard Deviation 9.75 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 2 | 69.6 Millimeters of mercury | Standard Deviation 6.61 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 3 | 115.6 Millimeters of mercury | Standard Deviation 10.34 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 5 | 68.3 Millimeters of mercury | Standard Deviation 11.65 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 4 | 68.9 Millimeters of mercury | Standard Deviation 10.76 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 5 | 113.9 Millimeters of mercury | Standard Deviation 10.58 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 4 | 117.6 Millimeters of mercury | Standard Deviation 13.1 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 2 | 115.1 Millimeters of mercury | Standard Deviation 6.77 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 4 | 72.0 Millimeters of mercury | Standard Deviation 9.38 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 4 | 113.6 Millimeters of mercury | Standard Deviation 11.33 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 5 | 113.8 Millimeters of mercury | Standard Deviation 9.29 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 2 | 71.0 Millimeters of mercury | Standard Deviation 8.16 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 3 | 68.6 Millimeters of mercury | Standard Deviation 7.13 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 5 | 72.4 Millimeters of mercury | Standard Deviation 7.95 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 2 | 116.4 Millimeters of mercury | Standard Deviation 10.25 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 3 | 117.1 Millimeters of mercury | Standard Deviation 7.57 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 4 | 116.5 Millimeters of mercury | Standard Deviation 12.25 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 5 | 113.6 Millimeters of mercury | Standard Deviation 7.01 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 3 | 115.6 Millimeters of mercury | Standard Deviation 9.66 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Day 2 | 118.3 Millimeters of mercury | Standard Deviation 15 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 2 | 71.0 Millimeters of mercury | Standard Deviation 12.73 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 5 | 70.6 Millimeters of mercury | Standard Deviation 6.7 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 4 | 73.4 Millimeters of mercury | Standard Deviation 9.55 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Day 3 | 71.9 Millimeters of mercury | Standard Deviation 9.28 |
Secondary
Absolute Values for Urine Parameter: Potential of Hydrogen (pH)
Urine samples were collected to analyze the urine parameter: 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: Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Urine Parameter: Potential of Hydrogen (pH) | 6.38 pH | Standard Deviation 0.518 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Urine Parameter: Potential of Hydrogen (pH) | 6.31 pH | Standard Deviation 0.704 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: Potential of Hydrogen (pH) | 6.31 pH | Standard Deviation 0.53 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: Potential of Hydrogen (pH) | 6.13 pH | Standard Deviation 0.641 |
Secondary
Absolute Values for Urine Parameter: Specific Gravity
Urine samples were collected to analyze the urine parameter: 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.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Urine Parameter: Specific Gravity | 1.0169 Ratio | Standard Deviation 0.00666 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Urine Parameter: Specific Gravity | 1.0108 Ratio | Standard Deviation 0.00774 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: Specific Gravity | 1.0165 Ratio | Standard Deviation 0.0059 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: Specific Gravity | 1.0150 Ratio | Standard Deviation 0.00632 |
Secondary
Absolute Values for Urine Parameter: Urobilinogen
Urine samples were collected to analyze the urine parameter: urobilinogen.
Time frame: Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Absolute Values for Urine Parameter: Urobilinogen | 3.3860 Micromoles per liter | Standard Deviation 0 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Absolute Values for Urine Parameter: Urobilinogen | 5.0790 Micromoles per liter | Standard Deviation 4.78853 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: Urobilinogen | 8.4650 Micromoles per liter | Standard Deviation 7.00969 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Absolute Values for Urine Parameter: Urobilinogen | 5.0790 Micromoles per liter | Standard Deviation 4.78853 |
Secondary
Apparent Oral Clearance (CL/F) for GSK3640254
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose and at 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 indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Apparent Oral Clearance (CL/F) for GSK3640254 | 5.632 Liters per hour | Geometric Coefficient of Variation 16.7 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Apparent Oral Clearance (CL/F) for GSK3640254 | 6.418 Liters per hour | Geometric Coefficient of Variation 37.4 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Apparent Oral Clearance (CL/F) for GSK3640254 | 12.87 Liters per hour | Geometric Coefficient of Variation 49.4 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Apparent Oral Clearance (CL/F) for GSK3640254 | 5.284 Liters per hour | Geometric Coefficient of Variation 30.1 |
Secondary
Apparent Terminal Phase Half-life (t1/2) for GSK3640254
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose and at 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 indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Apparent Terminal Phase Half-life (t1/2) for GSK3640254 | 23.607 Hours | Geometric Coefficient of Variation 18.7 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Apparent Terminal Phase Half-life (t1/2) for GSK3640254 | 22.001 Hours | Geometric Coefficient of Variation 12.3 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Apparent Terminal Phase Half-life (t1/2) for GSK3640254 | 22.948 Hours | Geometric Coefficient of Variation 29.2 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Apparent Terminal Phase Half-life (t1/2) for GSK3640254 | 24.448 Hours | Geometric Coefficient of Variation 22.3 |
Secondary
Apparent Volume of Distribution (Vz/F) for GSK3640254
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose and at 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 indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Apparent Volume of Distribution (Vz/F) for GSK3640254 | 191.8 Liters | Geometric Coefficient of Variation 30.8 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Apparent Volume of Distribution (Vz/F) for GSK3640254 | 203.7 Liters | Geometric Coefficient of Variation 42.7 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Apparent Volume of Distribution (Vz/F) for GSK3640254 | 426.1 Liters | Geometric Coefficient of Variation 70.7 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Apparent Volume of Distribution (Vz/F) for GSK3640254 | 186.4 Liters | Geometric Coefficient of Variation 33.5 |
Secondary
Change From Baseline in Body Temperature
Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Body Temperature | Day 2 | -0.10 Degrees Celsius | Standard Deviation 0.374 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Body Temperature | Day 3 | -0.13 Degrees Celsius | Standard Deviation 0.433 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Body Temperature | Day 4 | -0.04 Degrees Celsius | Standard Deviation 0.262 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Body Temperature | Day 5 | 0.08 Degrees Celsius | Standard Deviation 0.354 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Body Temperature | Day 3 | -0.04 Degrees Celsius | Standard Deviation 0.311 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Body Temperature | Day 4 | -0.29 Degrees Celsius | Standard Deviation 0.429 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Body Temperature | Day 5 | 0.04 Degrees Celsius | Standard Deviation 0.256 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Body Temperature | Day 2 | -0.10 Degrees Celsius | Standard Deviation 0.227 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Body Temperature | Day 4 | -0.04 Degrees Celsius | Standard Deviation 0.45 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Body Temperature | Day 3 | -0.11 Degrees Celsius | Standard Deviation 0.253 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Body Temperature | Day 5 | -0.06 Degrees Celsius | Standard Deviation 0.25 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Body Temperature | Day 2 | -0.15 Degrees Celsius | Standard Deviation 0.469 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Body Temperature | Day 5 | 0.10 Degrees Celsius | Standard Deviation 0.342 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Body Temperature | Day 3 | -0.15 Degrees Celsius | Standard Deviation 0.389 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Body Temperature | Day 2 | -0.10 Degrees Celsius | Standard Deviation 0.417 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Body Temperature | Day 4 | -0.05 Degrees Celsius | Standard Deviation 0.288 |
Secondary
Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Albumin | 1.5 Grams per liter | Standard Deviation 2.83 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Protein | 2.0 Grams per liter | Standard Deviation 4.6 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Globulin | 0.5 Grams per liter | Standard Deviation 1.85 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Albumin | -0.3 Grams per liter | Standard Deviation 2.38 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Protein | -0.4 Grams per liter | Standard Deviation 3.78 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Globulin | -0.1 Grams per liter | Standard Deviation 2.3 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Globulin | -0.4 Grams per liter | Standard Deviation 2.13 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Albumin | 0.1 Grams per liter | Standard Deviation 1.55 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Protein | -0.3 Grams per liter | Standard Deviation 2.87 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Albumin | 0.6 Grams per liter | Standard Deviation 2.67 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Protein | 0.8 Grams per liter | Standard Deviation 4.77 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein | Globulin | 0.1 Grams per liter | Standard Deviation 2.42 |
Secondary
Change From Baseline in Chemistry Parameters: Amylase, Lipase
Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase | 1.0 Units per liter | Standard Deviation 9.29 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase | -9.5 Units per liter | Standard Deviation 16.34 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase | -7.5 Units per liter | Standard Deviation 9.93 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase | 1.5 Units per liter | Standard Deviation 10.21 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase | 4.0 Units per liter | Standard Deviation 5.98 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase | -3.9 Units per liter | Standard Deviation 3.87 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase | 6.5 Units per liter | Standard Deviation 6.32 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase | -2.6 Units per liter | Standard Deviation 6.25 |
Secondary
Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Creatine kinase | -54.3 International units per liter | Standard Deviation 60.14 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALP | -0.9 International units per liter | Standard Deviation 8.11 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | AST | -1.1 International units per liter | Standard Deviation 2.03 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Lactate dehydrogenase | -9.6 International units per liter | Standard Deviation 16.62 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALT | 1.0 International units per liter | Standard Deviation 2.56 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Gamma-glutamyl transferase | 1.4 International units per liter | Standard Deviation 2.13 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | AST | -2.3 International units per liter | Standard Deviation 2.38 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Gamma-glutamyl transferase | 0.6 International units per liter | Standard Deviation 1.77 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALP | -3.8 International units per liter | Standard Deviation 4.77 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALT | -2.1 International units per liter | Standard Deviation 3 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Lactate dehydrogenase | -13.3 International units per liter | Standard Deviation 19.02 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Creatine kinase | -53.6 International units per liter | Standard Deviation 72.2 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Lactate dehydrogenase | -12.9 International units per liter | Standard Deviation 8.22 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALP | -3.0 International units per liter | Standard Deviation 5.58 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | AST | -0.5 International units per liter | Standard Deviation 1.07 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Creatine kinase | -24.5 International units per liter | Standard Deviation 24.18 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Gamma-glutamyl transferase | -1.1 International units per liter | Standard Deviation 1.46 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALT | 0.4 International units per liter | Standard Deviation 2.5 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Gamma-glutamyl transferase | -1.3 International units per liter | Standard Deviation 6.45 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Creatine kinase | -7.4 International units per liter | Standard Deviation 34.16 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALP | 0.3 International units per liter | Standard Deviation 3.73 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Lactate dehydrogenase | -10.8 International units per liter | Standard Deviation 7.81 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | AST | 0.0 International units per liter | Standard Deviation 2.73 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | ALT | 1.0 International units per liter | Standard Deviation 2 |
Secondary
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose | -0.055 Millimoles per liter | Standard Deviation 0.3778 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap | -0.9 Millimoles per liter | Standard Deviation 1.89 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate | -0.006 Millimoles per liter | Standard Deviation 0.1165 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol | 0.498 Millimoles per liter | Standard Deviation 0.7449 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride | 0.3 Millimoles per liter | Standard Deviation 1.49 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium | 0.095 Millimoles per liter | Standard Deviation 0.0674 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides | 0.026 Millimoles per liter | Standard Deviation 0.1434 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood urea nitrogen | -0.049 Millimoles per liter | Standard Deviation 0.864 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium | 0.4 Millimoles per liter | Standard Deviation 1.6 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide | 1.4 Millimoles per liter | Standard Deviation 1.19 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium | 0.33 Millimoles per liter | Standard Deviation 0.238 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide | 0.9 Millimoles per liter | Standard Deviation 1.46 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium | 0.26 Millimoles per liter | Standard Deviation 0.226 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride | 0.1 Millimoles per liter | Standard Deviation 2.17 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate | 0.023 Millimoles per liter | Standard Deviation 0.1499 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides | -0.033 Millimoles per liter | Standard Deviation 0.1849 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood urea nitrogen | -0.325 Millimoles per liter | Standard Deviation 0.7951 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap | -0.8 Millimoles per liter | Standard Deviation 2.25 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium | -0.3 Millimoles per liter | Standard Deviation 2.25 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium | 0.053 Millimoles per liter | Standard Deviation 0.0794 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol | 0.275 Millimoles per liter | Standard Deviation 0.4277 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose | -0.049 Millimoles per liter | Standard Deviation 0.2568 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium | 0.4 Millimoles per liter | Standard Deviation 1.3 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose | -0.168 Millimoles per liter | Standard Deviation 0.253 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol | 0.310 Millimoles per liter | Standard Deviation 0.4079 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides | 0.013 Millimoles per liter | Standard Deviation 0.5576 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap | -0.6 Millimoles per liter | Standard Deviation 1.41 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium | 0.026 Millimoles per liter | Standard Deviation 0.0713 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide | 1.3 Millimoles per liter | Standard Deviation 0.89 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride | -0.1 Millimoles per liter | Standard Deviation 1.25 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate | 0.044 Millimoles per liter | Standard Deviation 0.1327 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium | 0.08 Millimoles per liter | Standard Deviation 0.198 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood urea nitrogen | 0.090 Millimoles per liter | Standard Deviation 1.7057 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Carbon dioxide | 1.6 Millimoles per liter | Standard Deviation 1.51 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood urea nitrogen | -0.165 Millimoles per liter | Standard Deviation 1.439 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Potassium | 0.16 Millimoles per liter | Standard Deviation 0.239 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Calcium | 0.036 Millimoles per liter | Standard Deviation 0.0965 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Anion gap | -0.9 Millimoles per liter | Standard Deviation 2.17 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Triglycerides | -0.118 Millimoles per liter | Standard Deviation 0.4461 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Sodium | 0.3 Millimoles per liter | Standard Deviation 1.58 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Cholesterol | 0.243 Millimoles per liter | Standard Deviation 0.3383 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Glucose | -0.173 Millimoles per liter | Standard Deviation 0.3159 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Phosphate | 0.075 Millimoles per liter | Standard Deviation 0.1144 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Chloride | 0.0 Millimoles per liter | Standard Deviation 1.85 |
Secondary
Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Urate | -6.3 Micromoles per liter | Standard Deviation 18.71 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Creatinine | 1.66 Micromoles per liter | Standard Deviation 6.736 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Bilirubin | 3.13 Micromoles per liter | Standard Deviation 2.364 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Direct bilirubin | 0.43 Micromoles per liter | Standard Deviation 0.59 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Creatinine | 1.54 Micromoles per liter | Standard Deviation 6.292 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Bilirubin | 3.05 Micromoles per liter | Standard Deviation 2.117 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Direct bilirubin | 0.51 Micromoles per liter | Standard Deviation 0.449 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Urate | -13.5 Micromoles per liter | Standard Deviation 28.1 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Bilirubin | 1.13 Micromoles per liter | Standard Deviation 4.318 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Creatinine | 1.75 Micromoles per liter | Standard Deviation 8.188 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Direct bilirubin | 0.06 Micromoles per liter | Standard Deviation 0.609 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Urate | -14.1 Micromoles per liter | Standard Deviation 37.84 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Direct bilirubin | -0.09 Micromoles per liter | Standard Deviation 0.762 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Creatinine | -0.43 Micromoles per liter | Standard Deviation 7.123 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Urate | -24.5 Micromoles per liter | Standard Deviation 50.08 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Bilirubin | -0.03 Micromoles per liter | Standard Deviation 4.639 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Hematology Parameter: Erythrocytes | 0.241 10^12 cells per liter | Standard Deviation 0.1604 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Hematology Parameter: Erythrocytes | 0.163 10^12 cells per liter | Standard Deviation 0.1521 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameter: Erythrocytes | 0.100 10^12 cells per liter | Standard Deviation 0.2321 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameter: Erythrocytes | 0.154 10^12 cells per liter | Standard Deviation 0.2329 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.10 Picograms | Standard Deviation 0.245 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.05 Picograms | Standard Deviation 0.22 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | 0.09 Picograms | Standard Deviation 0.387 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.13 Picograms | Standard Deviation 0.306 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | -0.61 Femtoliter | Standard Deviation 0.416 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | -0.49 Femtoliter | Standard Deviation 0.582 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | -0.45 Femtoliter | Standard Deviation 0.672 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | -0.39 Femtoliter | Standard Deviation 0.34 |
Secondary
Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Hematology Parameter: Hematocrit | 0.0179 Proportion of red blood cells in blood | Standard Deviation 0.01374 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Hematology Parameter: Hematocrit | 0.0116 Proportion of red blood cells in blood | Standard Deviation 0.0143 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameter: Hematocrit | 0.0063 Proportion of red blood cells in blood | Standard Deviation 0.01884 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameter: Hematocrit | 0.0114 Proportion of red blood cells in blood | Standard Deviation 0.01963 |
Secondary
Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Hematology Parameter: Hemoglobin | 6.0 Grams per liter | Standard Deviation 4.34 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Hematology Parameter: Hemoglobin | 4.0 Grams per liter | Standard Deviation 4.93 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameter: Hemoglobin | 3.3 Grams per liter | Standard Deviation 6.5 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameter: Hemoglobin | 4.0 Grams per liter | Standard Deviation 7.33 |
Secondary
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Basophils | -0.001 10^9 cells per liter | Standard Deviation 0.0099 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Eosinophils | -0.005 10^9 cells per liter | Standard Deviation 0.0338 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Lymphocytes | -0.170 10^9 cells per liter | Standard Deviation 0.3945 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Monocytes | -0.015 10^9 cells per liter | Standard Deviation 0.0487 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Neutrophils | -0.214 10^9 cells per liter | Standard Deviation 0.4939 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Platelet count | 18.3 10^9 cells per liter | Standard Deviation 22.63 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Platelet count | 7.6 10^9 cells per liter | Standard Deviation 11.84 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Monocytes | 0.004 10^9 cells per liter | Standard Deviation 0.0721 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Basophils | 0.003 10^9 cells per liter | Standard Deviation 0.0149 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Lymphocytes | -0.154 10^9 cells per liter | Standard Deviation 0.5025 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Eosinophils | 0.005 10^9 cells per liter | Standard Deviation 0.0278 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Neutrophils | -0.135 10^9 cells per liter | Standard Deviation 0.2945 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Eosinophils | 0.009 10^9 cells per liter | Standard Deviation 0.0259 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Lymphocytes | 0.015 10^9 cells per liter | Standard Deviation 0.1927 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Monocytes | 0.019 10^9 cells per liter | Standard Deviation 0.0884 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Platelet count | 6.1 10^9 cells per liter | Standard Deviation 18.76 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Neutrophils | -0.166 10^9 cells per liter | Standard Deviation 0.7631 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Basophils | -0.004 10^9 cells per liter | Standard Deviation 0.0074 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Neutrophils | -0.234 10^9 cells per liter | Standard Deviation 0.5199 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Platelet count | 5.3 10^9 cells per liter | Standard Deviation 18.38 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Eosinophils | 0.010 10^9 cells per liter | Standard Deviation 0.0169 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Monocytes | -0.005 10^9 cells per liter | Standard Deviation 0.0767 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Basophils | -0.003 10^9 cells per liter | Standard Deviation 0.0071 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Lymphocytes | -0.123 10^9 cells per liter | Standard Deviation 0.1959 |
Secondary
Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose), Day 1: 2 hours and 4 hours
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 2 hours | -10.9 Milliseconds | Standard Deviation 11.37 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 4 hours | -5.1 Milliseconds | Standard Deviation 4.79 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 4 hours | 1.0 Milliseconds | Standard Deviation 5.37 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 2 hours | 1.4 Milliseconds | Standard Deviation 3.81 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 4 hours | -0.8 Milliseconds | Standard Deviation 11.34 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 2 hours | -6.3 Milliseconds | Standard Deviation 3.81 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 4 hours | 10.0 Milliseconds | Standard Deviation 16.4 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 2 hours | -4.8 Milliseconds | Standard Deviation 14.38 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 2 hours | -6.9 Milliseconds | Standard Deviation 8.92 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 4 hours | -5.9 Milliseconds | Standard Deviation 16.44 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 2 hours | -15.6 Milliseconds | Standard Deviation 12.64 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 4 hours | 0.6 Milliseconds | Standard Deviation 4.44 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 4 hours | 1.9 Milliseconds | Standard Deviation 6.24 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 2 hours | 2.3 Milliseconds | Standard Deviation 8.24 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 4 hours | -9.5 Milliseconds | Standard Deviation 9.81 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 2 hours | -8.1 Milliseconds | Standard Deviation 13.15 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 2 hours | 3.5 Milliseconds | Standard Deviation 6.74 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 4 hours | 2.6 Milliseconds | Standard Deviation 10.69 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 2 hours | -10.5 Milliseconds | Standard Deviation 6.57 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 4 hours | -5.4 Milliseconds | Standard Deviation 6.67 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 4 hours | 11.3 Milliseconds | Standard Deviation 13.72 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 2 hours | -0.3 Milliseconds | Standard Deviation 5.85 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 2 hours | -0.1 Milliseconds | Standard Deviation 6.36 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 4 hours | 0.3 Milliseconds | Standard Deviation 7.74 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 2 hours | -3.1 Milliseconds | Standard Deviation 8.79 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 4 hours | -5.3 Milliseconds | Standard Deviation 11.66 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 4 hours | -1.0 Milliseconds | Standard Deviation 7.21 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 2 hours | 0.3 Milliseconds | Standard Deviation 4.46 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 4 hours | 0.0 Milliseconds | Standard Deviation 4.44 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 2 hours | 5.5 Milliseconds | Standard Deviation 7.96 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 2 hours | 5.4 Milliseconds | Standard Deviation 14.35 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 2 hours | -7.5 Milliseconds | Standard Deviation 8 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 4 hours | 1.1 Milliseconds | Standard Deviation 3.14 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 4 hours | 6.0 Milliseconds | Standard Deviation 5.37 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcB Interval: Day 1, 2 hours | -4.6 Milliseconds | Standard Deviation 11.84 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 4 hours | -2.0 Milliseconds | Standard Deviation 15.3 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QT Interval: Day 1, 2 hours | -12.6 Milliseconds | Standard Deviation 13.98 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QTcF Interval: Day 1, 4 hours | 3.3 Milliseconds | Standard Deviation 4.89 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | QRS Duration: Day 1, 2 hours | 1.6 Milliseconds | Standard Deviation 5.29 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | PR Interval: Day 1, 4 hours | -1.9 Milliseconds | Standard Deviation 15.87 |
Secondary
Change From Baseline in Pulse Rate
Pulse rate was measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Pulse Rate | Day 2 | -2.0 Beats per minute | Standard Deviation 4.84 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Pulse Rate | Day 3 | 0.5 Beats per minute | Standard Deviation 6.07 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Pulse Rate | Day 4 | 0.9 Beats per minute | Standard Deviation 5.44 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Pulse Rate | Day 5 | -1.6 Beats per minute | Standard Deviation 5.6 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Pulse Rate | Day 3 | -0.5 Beats per minute | Standard Deviation 4.38 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Pulse Rate | Day 4 | 0.0 Beats per minute | Standard Deviation 7.93 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Pulse Rate | Day 5 | 0.9 Beats per minute | Standard Deviation 4.94 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Pulse Rate | Day 2 | -0.6 Beats per minute | Standard Deviation 6.67 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Pulse Rate | Day 4 | 2.5 Beats per minute | Standard Deviation 4.34 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Pulse Rate | Day 3 | -1.3 Beats per minute | Standard Deviation 5.55 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Pulse Rate | Day 5 | 2.8 Beats per minute | Standard Deviation 3.2 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Pulse Rate | Day 2 | 1.4 Beats per minute | Standard Deviation 6.95 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Pulse Rate | Day 5 | 2.6 Beats per minute | Standard Deviation 7.85 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Pulse Rate | Day 3 | 4.8 Beats per minute | Standard Deviation 5.97 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Pulse Rate | Day 2 | 1.4 Beats per minute | Standard Deviation 3.85 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Pulse Rate | Day 4 | 1.4 Beats per minute | Standard Deviation 6.25 |
Secondary
Change From Baseline in Respiratory Rate
Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Respiratory Rate | Day 2 | -0.3 Breaths per minute | Standard Deviation 4.83 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Respiratory Rate | Day 3 | 1.3 Breaths per minute | Standard Deviation 2.12 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Respiratory Rate | Day 4 | 1.5 Breaths per minute | Standard Deviation 2.56 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Respiratory Rate | Day 5 | 1.3 Breaths per minute | Standard Deviation 5.65 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Respiratory Rate | Day 3 | 2.0 Breaths per minute | Standard Deviation 3.21 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Respiratory Rate | Day 4 | 2.5 Breaths per minute | Standard Deviation 2.07 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Respiratory Rate | Day 5 | 1.8 Breaths per minute | Standard Deviation 4.06 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Respiratory Rate | Day 2 | 0.3 Breaths per minute | Standard Deviation 2.71 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Respiratory Rate | Day 4 | 0.0 Breaths per minute | Standard Deviation 2.14 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Respiratory Rate | Day 3 | -0.3 Breaths per minute | Standard Deviation 1.98 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Respiratory Rate | Day 5 | 1.3 Breaths per minute | Standard Deviation 1.83 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Respiratory Rate | Day 2 | -0.5 Breaths per minute | Standard Deviation 2.33 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Respiratory Rate | Day 5 | 0.8 Breaths per minute | Standard Deviation 3.37 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Respiratory Rate | Day 3 | 0.5 Breaths per minute | Standard Deviation 2.56 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Respiratory Rate | Day 2 | 0.3 Breaths per minute | Standard Deviation 3.62 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Respiratory Rate | Day 4 | 0.5 Breaths per minute | Standard Deviation 3.16 |
Secondary
Change From Baseline in SBP and DBP
SBP and DBP were measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in SBP and DBP | SBP: Day 2 | -0.1 Millimeters of mercury | Standard Deviation 3.87 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in SBP and DBP | SBP: Day 3 | 0.3 Millimeters of mercury | Standard Deviation 3.2 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in SBP and DBP | SBP: Day 4 | -1.5 Millimeters of mercury | Standard Deviation 8.96 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in SBP and DBP | SBP: Day 5 | -2.8 Millimeters of mercury | Standard Deviation 6.41 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in SBP and DBP | DBP: Day 2 | -2.3 Millimeters of mercury | Standard Deviation 4.65 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in SBP and DBP | DBP: Day 3 | -6.4 Millimeters of mercury | Standard Deviation 7.98 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in SBP and DBP | DBP: Day 4 | -2.9 Millimeters of mercury | Standard Deviation 7 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in SBP and DBP | DBP: Day 5 | -1.6 Millimeters of mercury | Standard Deviation 4.75 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in SBP and DBP | DBP: Day 3 | -6.4 Millimeters of mercury | Standard Deviation 5.78 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in SBP and DBP | DBP: Day 2 | -3.0 Millimeters of mercury | Standard Deviation 6.5 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in SBP and DBP | SBP: Day 3 | -1.5 Millimeters of mercury | Standard Deviation 7.31 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in SBP and DBP | DBP: Day 5 | -4.4 Millimeters of mercury | Standard Deviation 7.56 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in SBP and DBP | DBP: Day 4 | -3.8 Millimeters of mercury | Standard Deviation 7.76 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in SBP and DBP | SBP: Day 5 | -3.3 Millimeters of mercury | Standard Deviation 7.09 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in SBP and DBP | SBP: Day 4 | 0.5 Millimeters of mercury | Standard Deviation 9.21 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in SBP and DBP | SBP: Day 2 | -2.0 Millimeters of mercury | Standard Deviation 4.54 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | DBP: Day 4 | -0.9 Millimeters of mercury | Standard Deviation 6.53 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | SBP: Day 4 | -4.5 Millimeters of mercury | Standard Deviation 7.54 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | SBP: Day 5 | -4.4 Millimeters of mercury | Standard Deviation 9.29 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | DBP: Day 2 | -1.9 Millimeters of mercury | Standard Deviation 4.55 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | DBP: Day 3 | -4.3 Millimeters of mercury | Standard Deviation 4.83 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | DBP: Day 5 | -0.5 Millimeters of mercury | Standard Deviation 4.69 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | SBP: Day 2 | -1.8 Millimeters of mercury | Standard Deviation 6.94 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | SBP: Day 3 | -1.0 Millimeters of mercury | Standard Deviation 6.7 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | SBP: Day 4 | 1.6 Millimeters of mercury | Standard Deviation 6.59 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | SBP: Day 5 | -1.3 Millimeters of mercury | Standard Deviation 6.36 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | SBP: Day 3 | 0.8 Millimeters of mercury | Standard Deviation 4.74 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | SBP: Day 2 | 3.4 Millimeters of mercury | Standard Deviation 10.42 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | DBP: Day 2 | -0.9 Millimeters of mercury | Standard Deviation 6.56 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | DBP: Day 5 | -1.3 Millimeters of mercury | Standard Deviation 5.28 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | DBP: Day 4 | 1.5 Millimeters of mercury | Standard Deviation 5.78 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in SBP and DBP | DBP: Day 3 | 0.0 Millimeters of mercury | Standard Deviation 3.38 |
Secondary
Change From Baseline in Urinalysis Parameter: pH
Urine samples were collected to analyze the urinalysis parameter: 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 was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Urinalysis Parameter: pH | 0.25 pH | Standard Deviation 0.463 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Urinalysis Parameter: pH | 0.19 pH | Standard Deviation 0.651 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Urinalysis Parameter: pH | 0.44 pH | Standard Deviation 0.623 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Urinalysis Parameter: pH | 0.25 pH | Standard Deviation 0.926 |
Secondary
Change From Baseline in Urinalysis Parameter: Specific Gravity
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Urinalysis Parameter: Specific Gravity | 0.0034 Ratio | Standard Deviation 0.01006 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Urinalysis Parameter: Specific Gravity | -0.0028 Ratio | Standard Deviation 0.01341 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Urinalysis Parameter: Specific Gravity | -0.0009 Ratio | Standard Deviation 0.01284 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Urinalysis Parameter: Specific Gravity | -0.0024 Ratio | Standard Deviation 0.01097 |
Secondary
Change From Baseline in Urinalysis Parameter: Urobilinogen
Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day -1) and at Day 2
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Change From Baseline in Urinalysis Parameter: Urobilinogen | -1.6930 Micromoles per liter | Standard Deviation 4.78853 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Change From Baseline in Urinalysis Parameter: Urobilinogen | 0.0000 Micromoles per liter | Standard Deviation 7.23957 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Urinalysis Parameter: Urobilinogen | 1.6930 Micromoles per liter | Standard Deviation 8.67994 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Change From Baseline in Urinalysis Parameter: Urobilinogen | -1.6930 Micromoles per liter | Standard Deviation 4.78853 |
Secondary
Lag Time for Absorption (Tlag) for GSK3640254
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose and at 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 indicated time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Lag Time for Absorption (Tlag) for GSK3640254 | 0.000 Hours |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Lag Time for Absorption (Tlag) for GSK3640254 | 0.000 Hours |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Lag Time for Absorption (Tlag) for GSK3640254 | 0.000 Hours |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Lag Time for Absorption (Tlag) for GSK3640254 | 0.000 Hours |
Secondary
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication.
Time frame: Up to Day 14
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 0 Participants |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 1 Participants |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 0 Participants |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 1 Participants |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
Secondary
Plasma Pharmacokinetic Concentration of GSK3640254
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK Concentration Population included all participants who underwent plasma PK sampling and had evaluable PK assay results.
Time frame: Pre-dose and at 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 indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | Pre-dose | NA Nanogram per milliliter | — |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 12 hours | 793.1 Nanogram per milliliter | Standard Deviation 134.74 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 8 hours | 1020 Nanogram per milliliter | Standard Deviation 201.61 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 3 hours | 490.3 Nanogram per milliliter | Standard Deviation 384.97 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 6 hours | 1129 Nanogram per milliliter | Standard Deviation 204.39 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 2 hours | 148.5 Nanogram per milliliter | Standard Deviation 176.3 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 48 hours | 268.0 Nanogram per milliliter | Standard Deviation 52.285 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 3.5 hours | 647.1 Nanogram per milliliter | Standard Deviation 375.9 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 5 hours | 1057 Nanogram per milliliter | Standard Deviation 172.77 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 96 hours | 67.26 Nanogram per milliliter | Standard Deviation 18.506 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 1 hour | 14.83 Nanogram per milliliter | — |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 4 hours | 759.3 Nanogram per milliliter | Standard Deviation 334.79 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 72 hours | 131.0 Nanogram per milliliter | Standard Deviation 26.34 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 1.5 hours | 62.30 Nanogram per milliliter | Standard Deviation 87.234 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 24 hours | 581.8 Nanogram per milliliter | Standard Deviation 156.89 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 4.5 hours | 919.1 Nanogram per milliliter | Standard Deviation 287.7 |
| Treatment A- GSK3640254 200 mg Capsules (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 2.5 hours | 293.4 Nanogram per milliliter | Standard Deviation 267.01 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 4.5 hours | 1027 Nanogram per milliliter | Standard Deviation 320.44 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 12 hours | 713.6 Nanogram per milliliter | Standard Deviation 247.97 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 5 hours | 1024 Nanogram per milliliter | Standard Deviation 278.55 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 96 hours | 52.96 Nanogram per milliliter | Standard Deviation 17.846 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 6 hours | 1006 Nanogram per milliliter | Standard Deviation 231.01 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 8 hours | 890.6 Nanogram per milliliter | Standard Deviation 277.11 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 72 hours | 116.5 Nanogram per milliliter | Standard Deviation 38.362 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 2 hours | 486.0 Nanogram per milliliter | Standard Deviation 352.74 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 2.5 hours | 746.1 Nanogram per milliliter | Standard Deviation 448.03 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 1 hour | 68.15 Nanogram per milliliter | Standard Deviation 70.107 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 48 hours | 240.5 Nanogram per milliliter | Standard Deviation 84.134 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 3 hours | 893.4 Nanogram per milliliter | Standard Deviation 398.47 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | Pre-dose | 7.863 Nanogram per milliliter | — |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 3.5 hours | 926.3 Nanogram per milliliter | Standard Deviation 194.74 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 24 hours | 519.8 Nanogram per milliliter | Standard Deviation 184.9 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 4 hours | 955.8 Nanogram per milliliter | Standard Deviation 253.23 |
| Treatment B- GSK3640254 200 mg Tablet (Fed) | Plasma Pharmacokinetic Concentration of GSK3640254 | 1.5 hours | 291.1 Nanogram per milliliter | Standard Deviation 304.32 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 6 hours | 523.5 Nanogram per milliliter | Standard Deviation 319.4 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | Pre-dose | 3.227 Nanogram per milliliter | — |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 1 hour | 61.22 Nanogram per milliliter | Standard Deviation 75.133 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 1.5 hours | 145.5 Nanogram per milliliter | Standard Deviation 121.2 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 2 hours | 273.2 Nanogram per milliliter | Standard Deviation 206.53 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 2.5 hours | 371.0 Nanogram per milliliter | Standard Deviation 261.44 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 3 hours | 412.4 Nanogram per milliliter | Standard Deviation 286 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 3.5 hours | 477.2 Nanogram per milliliter | Standard Deviation 345.06 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 4 hours | 541.0 Nanogram per milliliter | Standard Deviation 463.54 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 4.5 hours | 624.0 Nanogram per milliliter | Standard Deviation 475.1 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 5 hours | 560.3 Nanogram per milliliter | Standard Deviation 407.61 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 8 hours | 471.8 Nanogram per milliliter | Standard Deviation 294.06 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 12 hours | 359.5 Nanogram per milliliter | Standard Deviation 226.8 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 24 hours | 262.7 Nanogram per milliliter | Standard Deviation 140.32 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 48 hours | 124.2 Nanogram per milliliter | Standard Deviation 50.302 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 72 hours | 56.97 Nanogram per milliliter | Standard Deviation 16.732 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 96 hours | 28.18 Nanogram per milliliter | Standard Deviation 11.7 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 12 hours | 795.3 Nanogram per milliliter | Standard Deviation 206.96 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 4 hours | 1024 Nanogram per milliliter | Standard Deviation 350.97 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 3.5 hours | 976.3 Nanogram per milliliter | Standard Deviation 339.08 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 1 hour | 443.0 Nanogram per milliliter | Standard Deviation 456.37 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 24 hours | 597.5 Nanogram per milliliter | Standard Deviation 175.9 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 3 hours | 1009 Nanogram per milliliter | Standard Deviation 402.66 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 2.5 hours | 946.3 Nanogram per milliliter | Standard Deviation 477.31 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | Pre-dose | NA Nanogram per milliliter | — |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 48 hours | 281.6 Nanogram per milliliter | Standard Deviation 75.989 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 2 hours | 837.6 Nanogram per milliliter | Standard Deviation 602.91 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 1.5 hours | 696.0 Nanogram per milliliter | Standard Deviation 627.36 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 6 hours | 1001 Nanogram per milliliter | Standard Deviation 245.94 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 96 hours | 78.38 Nanogram per milliliter | Standard Deviation 39.314 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 8 hours | 922.1 Nanogram per milliliter | Standard Deviation 238.72 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 5 hours | 1067 Nanogram per milliliter | Standard Deviation 321.21 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 4.5 hours | 1027 Nanogram per milliliter | Standard Deviation 290.12 |
| Treatment D- GSK3640254 200 mg Tablet (High Fat) | Plasma Pharmacokinetic Concentration of GSK3640254 | 72 hours | 147.8 Nanogram per milliliter | Standard Deviation 56.122 |