Infection, Human Immunodeficiency Virus, HIV Infections
Conditions
Keywords
FTIH, Healthy, Tolerability, Dose-escalation, HIV-1, Safety, PK, GSK3640254, Maturation inhibitor
Brief summary
Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat throughout the world and development of medicines with new mechanism of action have an important role to play. GSK3640254 is a maturation inhibitor (MI) and can be effective in HIV-1 treatment. This randomized, 2-part, single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of in healthy subjects for GSK3640254. The information collected in this study will help in further clinical development of GSK3640254, including a Phase IIA Proof of Concept (PoC) study in HIV-infected subjects. Approximately 16 healthy subjects will be randomized to receive single oral dose of GSK3640254 and placebo in Part 1 and approximately 56 healthy subjects will be randomized to receive repeat oral dose of GSK3640254 or placebo in Part 2. All doses will be given immediately after a moderate fat meal. Maximum duration of study participation will be approximately 12 weeks.
Interventions
DRUGGSK3640254
GSK3640254 is a capsule available in 1 milligram (mg), 10 mg and 100 mg dosing strength. GSK3640254 capsule will be given via oral route during each dosing day with approximately 240 mL of water.
DRUGPlacebo
Placebo capsule matching to the study treatment will be given via oral route during each dosing day with approximately 240 mL of water.
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This will be a double-blind study with subjects and the site-staff blinded and sponsor unblinded.
Intervention model description
This is a dose-escalation study and dose will be escalated based on the safety data of the initial dose.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Subjects who are overtly healthy as determined by medical evaluation including medical history and psychiatric history, physical examination, laboratory tests, and 24 hour Holter monitoring. * Body weight \>=50.0 kilogram (kg) (110 pounds) for men and 45.0kg (99 pounds) for women and body mass index (BMI) within the range 18.5-32.0 kg per meter square (kg/m\^2) (inclusive). * Male or female subjects. A male subject must agree to use contraception during the treatment period and for at least 14 weeks following the last dose, corresponding to the time needed to eliminate study treatment for potential genotoxic and teratogenic study treatments plus an additional 90 days (spermatogenesis cycle). In addition, male subjects must refrain from donating sperm during this period. A female subject is eligible to participate if she is not a woman of childbearing potential (WOCBP). * Capable of giving signed informed consent.
Exclusion criteria
* Alanine transaminase (ALT) \>1.5 into upper limit of normal (ULN). * Bilirubin \>1.5 into ULN (isolated bilirubin \>1.5 into ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Current or chronic history of liver disease, or known hepatic or biliary abnormalities. * Pre-existing clinically relevant, in the opinion of the primary investigator (PI), gastro-intestinal pathology or diagnosis - example irritable bowel syndrome, inflammatory bowel disease, and/or significant Baseline signs and symptoms. * Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome. * Any known or suspected pre-existing psychiatric condition. * Any other clinical condition (including but not limited to active substance use) or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits; or a condition that could affect the absorption, distribution, metabolism or excretion of the drug. * Unable to refrain from the use of prescription or non-prescription drugs (with the exception of paracetamol), including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication and for the duration of the study, unless in the opinion of the Investigator and ViiV Healthcare Sponsor and medical monitor, the medication will not interfere with the study medications, procedures, or compromise subject safety. * Unwillingness to abstain from ingestion of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos within 7 days prior to the first dose of study treatment(s) or 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 investigational product (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. * Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. * A positive pre-study drug/alcohol screen. * A positive test for a diagnostic HIV-1 polymerase chain reaction (PCR). * Exposure to more than four new chemical entities within 12 months prior to the first dosing day. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Number of Participants With Abnormal ECG Findings | Day 1 (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5, 5.5, 6, 8, 12, 24 hours); Pre-dose on Days 3, 4, 6, 8, 10, 12; Day 14: Pre-dose, 1, 2, 4.5, 5, 6, 12, 24, 48, 72 and 96 hours post-dose and follow up (Day 28) | 12-lead ECG were obtained at given time points. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS).Results are presented treatment wise. |
| Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Baseline (Day -2) and Day 1 (96 hours) and Follow up (Day 15) | Blood samples were collected to analyze the chemistry parameter: cholesterol, glucose, HDL cholesterol, LDL cholesterol, triglycerides. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Change From Baseline in Chemistry Parameter: Glucose | Baseline (Day -2) and Day 1 (96 hours) and Follow up (Day 15) | Blood samples were collected to analyze the chemistry parameter: glucose . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15) | Blood samples were collected to analyze the chemistry parameter: Protein. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Part 1: Number of Participants With Abnormal Urinalysis | Up to Day 15 | Urine samples were collected at given time points to analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick. |
| Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15) | SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Change From Baseline in Vital Signs: Pulse Rate | Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15) | Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Change From Baseline in Vital Signs: Temperature | Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15) | Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Change From Baseline in Vital Sign: Respiratory Rate | Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15) | Respiratory rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline (Day 1 predose), 1,2,4,6,12,24,48,72,96 hours post dose and Follow up (Day 15) | 12-lead ECGs were measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). |
| Part 2: Number of Participants AEs and SAEs | Up to Day 28 | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. Results are presented treatment wise. |
| Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Baseline (Day -2), Pre dose on Days 2,4,6,8,10,12,14 Day 14 : 48 and 96 hours post dose, Follow up (Day 28) | Blood samples were collected at indicated time points to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day -2), Pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28) | Blood samples were collected at indicated time points to analyze the hematology parameters: Erythrocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28) | Blood samples were collected at indicated time points to analyze the hematology parameters: Erythrocyte MCV. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28) | Blood samples were collected at indicated time points to analyze the hematology parameter: Erythrocyte MCH. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28) | Blood samples were collected at indicated time points to analyze the hematology parameter: hematocrit. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28) | Blood samples were collected to analyze the hematology parameter: percentage of reticulocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 2: Change From Baseline in Hematology Parameter: Hb | Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28) | Blood samples were collected at indicated time points to analyze the hematology parameter: Hb. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day14: 48 and 96 hours post dose, Follow up (Day 28) | Blood samples were collected to analyze the chemistry parameter: ALT, AST,ALP. Day -2was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28) | Blood samples were collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, urea. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Baseline (Day -2), Day 8 (pre dose), Day 14 (48 hours) post dose and Follow up (Day 28) | Blood samples were collected at indicated time points to analyze the chemistry parameter: cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 2: Change From Baseline in Chemistry Parameter: Glucose | Baseline (Day -2), Day 8 (predose), Day 14 (48 hours) post dose and Follow up (Day 28) | Blood samples were collected at indicated time points to analyze the chemistry parameter: glucose . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28) | Blood samples were collected to analyze the chemistry parameter: bilirubin, creatinine, direct bilirubin . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 2: Change From Baseline in Chemistry Parameter: Protein | Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28) | Blood samples were collected to analyze the chemistry parameter: Protein. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 2: Number of Participants With Abnormal Urinalysis | Up to Day 28 | Urine samples were collected analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick. |
| Part 2: Change From Baseline in Vital Signs: SBP and DBP | Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12,and 14 (pre dose and 72 hours) and Follow up (Day 28) | SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 2: Change From Baseline in Vital Sign: Pulse Rate | Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12, and 14 (pre dose and 72 hours) and Follow up (Day 28) | Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Part 2: Change From Baseline in Vital Sign: Temperature | Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12, and 14 (pre dose and 72 hours) and Follow up (Day 28) | Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12 and 14 (pre dose and 72 hours) and Follow up (Day 28) | Respiratory rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15) | Blood samples were collected to analyze the chemistry parameter: bilirubin, creatinine, direct bilirubin . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Up to Day 15 | An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE. Results are presented treatment wise. |
| Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15) | Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15) | Blood samples were collected to analyze the hematology parameters: erythrocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.Results are presented treatment wise. |
| Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15) | Blood samples were collected to analyze the hematology parameters: erythrocyte MCV. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15) | Blood samples were collected to analyze the hematology parameter: Erythrocyte MCH. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.Results are presented treatment wise. |
| Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15) | Blood samples were collected to analyze the hematology parameter: hematocrit. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15) | Blood samples were collected to analyze the hematology parameter: percentage of reticulocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15) | Blood samples were collected to analyze the hematology parameter: Hb. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15) | Blood samples were collected to analyze the chemistry parameter: ALT, AST, and ALP. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
| Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15) | Blood samples were collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, urea. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254 | Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise. |
| Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254 | Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise. |
| Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 | Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Most of the concentrations were below limit of quantification (BLQ) at this dose group this value and/ or %AUC extrapolated was \>20% for all participants so this value should be used with caution. Results are presented treatment wise. |
| Part 1: Apparent Oral Clearance (CL/F) of GSK3640254 | Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise. |
| Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. |
| Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise. |
| Part 2: AUC(0-24) of GSK3640254: Day 1 | Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 and 24 hours post-dose on Day 1 | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise. |
| Part 2: Cmax, C24 of GSK3640254 on Day 1 | Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 hours post-dose on Day 1 | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise. |
| Part 2: Tmax, Tlag of GSK3640254 on Day 1 | Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 hours post-dose on Day 1 | Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. |
| Part 2: Tmax GSK3640254 on Day 14 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise. |
| Part 2: Cmax of GSK3640254 on Day 14 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise. |
| Part 2: AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]): Day 14 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours after Day 14 dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise. |
| Part 2: Plasma Trough Concentration (Ctau) of GSK3640254: Day 14 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose | Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The PK parameter name for Part 2 (Day 14) trough concentration was changed using Phoenix WinNonlin 8 from Ct to Ctrough. Day 15 Ctrough values were used for dose proportionality and time to steady-state assessments. |
| Part 2: T1/2 of GSK3640254: Day 14 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise. |
| Part 2: CL/F of GSK3640254: Day 14 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. |
| Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose | Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise. |
| Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours post dose | Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise. |
| Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose | Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise. |
| Part 2: Dose Proportionality (AUC0-tau) Following Repeated Dose of GSK3640254 on Day 14 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose | Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise. |
| Part 2: Dose Proportionality (Ctrough) Following Repeated Dose of GSK3640254 on Day 14 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose | Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise. |
| Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 on Day 14 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose | Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise. |
| Part 2: Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]) From Day 1 to Day 14 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 14 and Day 1, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise. |
| Part 2: Accumulation Ratio of Cmax (R [CMAX]) From Day 1 to Day 14 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 14 and Day 1, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise. |
| Part 2: Accumulation Ratio of C(Tau) (R[CTAU]) From Day 2 to Day 15 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 15 dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 15 and Day 2, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise. |
| Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Pre-dose on Days 2,3,4,6,8,10,12 and 14 | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. results are presented treatment wise. |
| Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 at Day 1 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose | Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise. |
| Part 2: Dose Proportionality (AUC0-24) Following Repeated Dose of GSK3640254 at Day 1 | Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose | Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise. |
| Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254 | Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24 hours post-dose | Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise. |
Countries
United Kingdom
Participant flow
Recruitment details
This study was conducted to evaluate safety, tolerability and pharmacokinetic (PK) of GSK3640254 in healthy participants at one center in United Kingdom from 19-September-2017 to 09-September-2018
Pre-assignment details
Total 78 participants were enrolled in the study. This was a two part study, Part 1 was single ascending dose (SAD) and Part 2 was multiple ascending dose (MAD).
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Cohort 1 Participants received GSK3640254 1mg, GSK3640254 10 mg, GSK3640254 100mg, GSK3640254 400mg as ascending single dose on Day 1 of each period, each participant received placebo in one of the four periods | 12 |
| Part 1: Cohort 2 Participants received GSK3640254 3mg, GSK3640254 30 mg, GSK3640254 200mg, GSK3640254 700mg as ascending single dose on Day 1 of each period, each participant received placebo in one of the four periods | 8 |
| Part 2: Repeated Dose GSK3640254 50 mg Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days | 6 |
| Part 2: Repeated Dose GSK3640254 100 mg Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days | 6 |
| Part 2: Repeated Dose GSK3640254 200 mg + Expansion Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days | 25 |
| Part 2: Repeated Dose GSK3640254 320 mg Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days | 7 |
| Part 2: Repeated Dose Placebo Participants received repeated dose of matching placebo once daily up to 14 days | 14 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1, Period 2 (up to Day 30) | Adverse Event | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1, Period 2 (up to Day 30) | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1, Period 3 (up to Day 45) | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 2 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Part 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Part 1: Cohort 2 | Part 2: Repeated Dose GSK3640254 50 mg | Part 2: Repeated Dose GSK3640254 100 mg | Part 1: Cohort 1 | Part 2: Repeated Dose GSK3640254 200 mg + Expansion | Part 2: Repeated Dose GSK3640254 320 mg | Part 2: Repeated Dose Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 6 Participants | 6 Participants | 12 Participants | 25 Participants | 7 Participants | 14 Participants | 78 Participants |
| Race/Ethnicity, Customized ASIAN - CENTRAL/SOUTH ASIAN HERITAGE | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized ASIAN - EAST ASIAN HERITAGE | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized ASIAN - SOUTH EAST ASIAN HERITAGE | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 2 Participants | 10 Participants |
| Race/Ethnicity, Customized MULTIPLE | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized WHITE - ARABIC/NORTH AFRICAN HERITAGE | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized WHITE-WHITE/CAUCASIAN/EUROPEAN HERITAGE | 6 Participants | 5 Participants | 5 Participants | 9 Participants | 20 Participants | 5 Participants | 11 Participants | 61 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 6 Participants | 12 Participants | 25 Participants | 7 Participants | 14 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 16 | 0 / 6 | 0 / 6 | 0 / 25 | 0 / 7 | 0 / 14 |
| other Total, other adverse events | 3 / 6 | 2 / 6 | 4 / 6 | 3 / 6 | 3 / 6 | 4 / 6 | 4 / 6 | 1 / 6 | 7 / 16 | 4 / 6 | 5 / 6 | 19 / 25 | 6 / 7 | 10 / 14 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 16 | 0 / 6 | 0 / 6 | 0 / 25 | 0 / 7 | 0 / 14 |
Outcome results
Primary
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Blood samples were collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, urea. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 12, predose, n=6,6,25,7,14 | 0.155 Millimoles per liter | Standard Deviation 0.1428 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 4, predose, n=6,6,25,7,14 | 0.057 Millimoles per liter | Standard Deviation 0.1091 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 4, predose, n=6,6,25,7,14 | 1.5 Millimoles per liter | Standard Deviation 1.87 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 6, predose, n=6,6,25,7,14 | 0.028 Millimoles per liter | Standard Deviation 0.1063 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 2, predose, n=6,6,25,7,14 | -0.583100 Millimoles per liter | Standard Deviation 1.7190989 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, 48 hours, n=6,6,24,6,14 | 0.040 Millimoles per liter | Standard Deviation 0.0555 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 28), n=6,6,25,7,14 | 0.05 Millimoles per liter | Standard Deviation 0.383 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 8 predose, n=6,6,25,7,14 | -0.7 Millimoles per liter | Standard Deviation 1.86 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 8 predose, n=6,6,25,7,14 | 0.005 Millimoles per liter | Standard Deviation 0.0528 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 12, predose, n=6,6,25,7,14 | -1.8 Millimoles per liter | Standard Deviation 1.6 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, predose, n=6,6,25,6,14 | -1.049580 Millimoles per liter | Standard Deviation 1.9204291 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 10, predose, n=6,6,25,7,14 | 0.000 Millimoles per liter | Standard Deviation 0.089 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, 96 hours, n=6,6,24,6,14 | -0.949620 Millimoles per liter | Standard Deviation 1.5674926 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 8 predose, n=6,6,25,7,14 | 0.150 Millimoles per liter | Standard Deviation 0.1145 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, 96 hours, n=6,6,24,6,14 | 0.07 Millimoles per liter | Standard Deviation 0.333 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 4, predose, n=6,6,25,7,14 | 1.8 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 12, predose, n=6,6,25,7,14 | -0.063 Millimoles per liter | Standard Deviation 0.0619 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU(Day 28), n=6,6,25,7,14 | 1.8 Millimoles per liter | Standard Deviation 2.48 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 10, predose, n=6,6,25,7,14 | -0.5 Millimoles per liter | Standard Deviation 2.81 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, 48 hours, n=6,6,24,6,14 | 0.27 Millimoles per liter | Standard Deviation 0.509 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 2, predose, n=6,6,25,7,14 | 0.068 Millimoles per liter | Standard Deviation 0.1636 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 10, predose, n=6,6,25,7,14 | 0.047 Millimoles per liter | Standard Deviation 0.0543 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 4, predose, n=6,6,25,7,14 | 0.063 Millimoles per liter | Standard Deviation 0.0472 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, predose, n=5,5,24,6,13 | -0.12 Millimoles per liter | Standard Deviation 0.277 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, 48 hours, n=6,6,24,6,14 | -0.017 Millimoles per liter | Standard Deviation 0.0592 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, 96 hours, n=6,6,24,6,14 | 1.5 Millimoles per liter | Standard Deviation 1.52 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 10, predose, n=6,6,25,7,14 | 0.150 Millimoles per liter | Standard Deviation 0.1848 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, predose, n=6,6,25,6,12 | -0.063 Millimoles per liter | Standard Deviation 0.0779 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 12, predose, n=6,6,25,7,14 | 0.38 Millimoles per liter | Standard Deviation 0.431 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, 96 hours, n=6,6,24,6,14 | 0.005 Millimoles per liter | Standard Deviation 0.0459 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 2, predose, n=6,6,25,7,14 | 0.055 Millimoles per liter | Standard Deviation 0.0596 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 2, predose, n=6,6,25,7,14 | 0.2 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, predose, n=6,6,25,6,12 | -1.2 Millimoles per liter | Standard Deviation 0.98 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 10, predose, n=6,6,25,7,14 | 0.32 Millimoles per liter | Standard Deviation 0.519 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU(Day 28), n=6,6,25,7,14 | -0.042 Millimoles per liter | Standard Deviation 0.0471 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 28), n=6,6,25,7,14 | 0.037 Millimoles per liter | Standard Deviation 0.0509 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, 48 hours, n=6,6,24,6,14 | -0.916300 Millimoles per liter | Standard Deviation 1.5165176 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, 48 hours, n=6,6,24,6,14 | 3.3 Millimoles per liter | Standard Deviation 1.75 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 8 predose, n=6,5,25,7,14 | 0.23 Millimoles per liter | Standard Deviation 0.216 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 2, predose, n=6,6,25,7,14 | 0.7 Millimoles per liter | Standard Deviation 1.03 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 12, predose, n=6,6,25,7,14 | 0.038 Millimoles per liter | Standard Deviation 0.0585 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 12, predose, n=6,6,25,7,14 | 1.2 Millimoles per liter | Standard Deviation 0.98 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, 48 hours, n=6,6,24,6,14 | 0.2 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 6, predose, n=6,6,25,7,14 | 0.30 Millimoles per liter | Standard Deviation 0.529 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 4, predose, n=6,6,25,7,14 | 0.7 Millimoles per liter | Standard Deviation 1.63 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU(Day 28), n=6,6,25,7,14 | 1.3 Millimoles per liter | Standard Deviation 1.21 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, predose, n=6,6,25,6,14 | 0.5 Millimoles per liter | Standard Deviation 1.52 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, 96 hours, n=6,6,24,6,14 | -1.2 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 4, predose, n=6,6,25,7,14 | 0.28 Millimoles per liter | Standard Deviation 0.279 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 6, predose, n=6,6,25,7,14 | -0.2 Millimoles per liter | Standard Deviation 1.17 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 4, predose, n=6,6,25,7,14 | -0.982940 Millimoles per liter | Standard Deviation 2.0645229 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 12, predose, n=6,6,25,7,14 | -1.032920 Millimoles per liter | Standard Deviation 1.708897 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 6, predose, n=6,6,25,7,14 | 0.100 Millimoles per liter | Standard Deviation 0.1324 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 2, predose, n=6,6,25,7,14 | 0.10 Millimoles per liter | Standard Deviation 0.39 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 8 predose, n=6,6,25,7,14 | 0.5 Millimoles per liter | Standard Deviation 1.38 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, 96 hours, n=6,6,24,6,14 | 0.025 Millimoles per liter | Standard Deviation 0.0485 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 10, predose, n=6,6,25,7,14 | 1.5 Millimoles per liter | Standard Deviation 1.22 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, FU (Day 28), n=6,6,25,7,14 | 0.3 Millimoles per liter | Standard Deviation 2.94 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 10, predose, n=6,6,25,7,14 | 2.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, predose, n=5,6,25,6,14 | 0.030 Millimoles per liter | Standard Deviation 0.0495 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 10, predose, n=6,6,25,7,14 | -0.866320 Millimoles per liter | Standard Deviation 1.6805969 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 28), n=6,6,25,7,14 | -0.013 Millimoles per liter | Standard Deviation 0.1363 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 12, predose, n=6,6,25,7,14 | 0.3 Millimoles per liter | Standard Deviation 1.75 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 6, predose, n=6,6,25,7,14 | 0.053 Millimoles per liter | Standard Deviation 0.0388 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 8 predose, n=6,6,25,7,14 | 0.5 Millimoles per liter | Standard Deviation 1.38 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 2, predose, n=6,6,25,7,14 | -0.005 Millimoles per liter | Standard Deviation 0.0497 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, 96 hours, n=6,6,24,6,14 | 0.178 Millimoles per liter | Standard Deviation 0.1869 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, predose, n=6,6,25,6,12 | 1.8 Millimoles per liter | Standard Deviation 2.14 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 6, predose, n=6,6,25,7,14 | 0.2 Millimoles per liter | Standard Deviation 2.4 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 8 predose, n=6,6,25,7,14 | 0.075 Millimoles per liter | Standard Deviation 0.0532 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, FU (Day 28), n=6,6,25,7,14 | -0.882980 Millimoles per liter | Standard Deviation 1.2603155 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, 48 hours, n=6,6,24,6,14 | 0.208 Millimoles per liter | Standard Deviation 0.1382 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, 48 hours, n=6,6,24,6,14 | 3.2 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 6, predose, n=6,6,25,7,14 | -0.3 Millimoles per liter | Standard Deviation 1.21 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 8 predose, n=6,6,25,7,14 | -0.716380 Millimoles per liter | Standard Deviation 1.4324888 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 4, predose, n=6,6,25,7,14 | 0.022 Millimoles per liter | Standard Deviation 0.0791 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, predose, n=5,6,25,6,14 | 0.212 Millimoles per liter | Standard Deviation 0.1587 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, 96 hours, n=6,6,24,6,14 | 1.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 6, predose, n=6,6,25,7,14 | -0.533120 Millimoles per liter | Standard Deviation 1.6805969 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 2, predose, n=6,6,25,7,14 | 0.7 Millimoles per liter | Standard Deviation 2.8 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, predose, n=6,6,25,6,12 | -0.034 Millimoles per liter | Standard Deviation 0.0404 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU(Day 28), n=6,6,25,7,14 | 0.5 Millimoles per liter | Standard Deviation 1.38 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 2, predose, n=6,6,25,7,14 | -1.3 Millimoles per liter | Standard Deviation 2.07 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 10, predose, n=6,6,25,7,14 | 0.118 Millimoles per liter | Standard Deviation 0.0937 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 2, predose, n=6,6,25,7,14 | -0.012 Millimoles per liter | Standard Deviation 0.0436 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 8 predose, n=6,6,25,7,14 | 0.075 Millimoles per liter | Standard Deviation 0.114 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 4, predose, n=6,6,25,7,14 | -0.027 Millimoles per liter | Standard Deviation 0.052 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 6, predose, n=6,6,25,7,14 | -0.566440 Millimoles per liter | Standard Deviation 1.0685283 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 6, predose, n=6,6,25,7,14 | 0.038 Millimoles per liter | Standard Deviation 0.108 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 6, predose, n=6,6,25,7,14 | -0.027 Millimoles per liter | Standard Deviation 0.0589 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 4, predose, n=6,6,25,7,14 | 0.017 Millimoles per liter | Standard Deviation 0.1237 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 2, predose, n=6,6,25,7,14 | 0.062 Millimoles per liter | Standard Deviation 0.076 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 10, predose, n=6,6,25,7,14 | -0.003 Millimoles per liter | Standard Deviation 0.0361 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 4, predose, n=6,6,25,7,14 | -0.616420 Millimoles per liter | Standard Deviation 0.8994549 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 28), n=6,6,25,7,14 | -0.027 Millimoles per liter | Standard Deviation 0.0589 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 12, predose, n=6,6,25,7,14 | 0.013 Millimoles per liter | Standard Deviation 0.0505 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, 96 hours, n=6,6,24,6,14 | -0.007 Millimoles per liter | Standard Deviation 0.0423 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, predose, n=5,6,25,6,14 | -0.013 Millimoles per liter | Standard Deviation 0.0653 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, 48 hours, n=6,6,24,6,14 | -0.022 Millimoles per liter | Standard Deviation 0.0445 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 6, predose, n=6,6,25,7,14 | -4.5 Millimoles per liter | Standard Deviation 1.22 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, 96 hours, n=6,6,24,6,14 | -0.483140 Millimoles per liter | Standard Deviation 0.9278887 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 2, predose, n=6,6,25,7,14 | -0.383180 Millimoles per liter | Standard Deviation 0.8994549 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 8 predose, n=6,6,25,7,14 | -1.5 Millimoles per liter | Standard Deviation 1.87 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU(Day 28), n=6,6,25,7,14 | 0.8 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 10, predose, n=6,6,25,7,14 | -0.2 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, FU (Day 28), n=6,6,25,7,14 | -1.166200 Millimoles per liter | Standard Deviation 0.9580876 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, 96 hours, n=6,6,24,6,14 | 2.3 Millimoles per liter | Standard Deviation 0.82 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 12, predose, n=6,6,25,7,14 | -0.5 Millimoles per liter | Standard Deviation 1.64 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, 48 hours, n=6,6,24,6,14 | 1.0 Millimoles per liter | Standard Deviation 0.89 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, predose, n=6,6,25,6,12 | -1.2 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, predose, n=6,6,25,6,14 | 2.2 Millimoles per liter | Standard Deviation 1.17 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, 48 hours, n=6,6,24,6,14 | 0.8 Millimoles per liter | Standard Deviation 0.98 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, 96 hours, n=6,6,24,6,14 | 1.0 Millimoles per liter | Standard Deviation 1.67 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, predose, n=6,6,25,6,14 | -1.166200 Millimoles per liter | Standard Deviation 1.6051804 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 10, predose, n=6,6,25,7,14 | 2.8 Millimoles per liter | Standard Deviation 0.98 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, FU (Day 28), n=6,6,25,7,14 | -1.0 Millimoles per liter | Standard Deviation 0.63 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 8 predose, n=6,6,25,7,14 | 1.8 Millimoles per liter | Standard Deviation 0.75 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 2, predose, n=6,6,25,7,14 | 0.012 Millimoles per liter | Standard Deviation 0.0354 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 6, predose, n=6,6,25,7,14 | 1.2 Millimoles per liter | Standard Deviation 1.17 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 4, predose, n=6,6,25,7,14 | 0.010 Millimoles per liter | Standard Deviation 0.0385 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 8 predose, n=6,6,25,7,14 | 0.000 Millimoles per liter | Standard Deviation 0.042 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 4, predose, n=6,6,25,7,14 | 1.5 Millimoles per liter | Standard Deviation 1.38 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 6, predose, n=6,6,25,7,14 | 0.003 Millimoles per liter | Standard Deviation 0.0505 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, 96 hours, n=6,6,24,6,14 | -0.13 Millimoles per liter | Standard Deviation 0.137 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 8 predose, n=6,6,25,7,14 | 0.003 Millimoles per liter | Standard Deviation 0.0378 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 10, predose, n=6,6,25,7,14 | 0.017 Millimoles per liter | Standard Deviation 0.0408 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 12, predose, n=6,6,25,7,14 | -0.466480 Millimoles per liter | Standard Deviation 1.1821793 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 12, predose, n=6,6,25,7,14 | -0.010 Millimoles per liter | Standard Deviation 0.0551 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, 48 hours, n=6,6,24,6,14 | -0.18 Millimoles per liter | Standard Deviation 0.204 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 12, predose, n=6,6,25,7,14 | 0.090 Millimoles per liter | Standard Deviation 0.0827 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 28), n=6,6,25,7,14 | -0.08 Millimoles per liter | Standard Deviation 0.16 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, predose, n=5,5,24,6,13 | -0.20 Millimoles per liter | Standard Deviation 0.3 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, 48 hours, n=6,6,24,6,14 | 0.012 Millimoles per liter | Standard Deviation 0.0462 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 4, predose, n=6,6,25,7,14 | -3.3 Millimoles per liter | Standard Deviation 1.97 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 12, predose, n=6,6,25,7,14 | -0.13 Millimoles per liter | Standard Deviation 0.28 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, 96 hours, n=6,6,24,6,14 | 0.027 Millimoles per liter | Standard Deviation 0.0472 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 10, predose, n=6,6,25,7,14 | -0.08 Millimoles per liter | Standard Deviation 0.194 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU(Day 28), n=6,6,25,7,14 | 0.003 Millimoles per liter | Standard Deviation 0.055 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 2, predose, n=6,6,25,7,14 | 1.2 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 8 predose, n=6,5,25,7,14 | -0.06 Millimoles per liter | Standard Deviation 0.152 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 2, predose, n=6,6,25,7,14 | 2.0 Millimoles per liter | Standard Deviation 2.1 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 6, predose, n=6,6,25,7,14 | 0.12 Millimoles per liter | Standard Deviation 0.264 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 4, predose, n=6,6,25,7,14 | 2.3 Millimoles per liter | Standard Deviation 1.63 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 12, predose, n=6,6,25,7,14 | 1.7 Millimoles per liter | Standard Deviation 1.03 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 4, predose, n=6,6,25,7,14 | -0.07 Millimoles per liter | Standard Deviation 0.216 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 6, predose, n=6,6,25,7,14 | 0.7 Millimoles per liter | Standard Deviation 1.21 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 2, predose, n=6,6,25,7,14 | -0.10 Millimoles per liter | Standard Deviation 0.19 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 8 predose, n=6,6,25,7,14 | 1.8 Millimoles per liter | Standard Deviation 1.33 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 10, predose, n=6,6,25,7,14 | -0.066640 Millimoles per liter | Standard Deviation 0.8843306 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 28), n=6,6,25,7,14 | -0.020 Millimoles per liter | Standard Deviation 0.1418 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 10, predose, n=6,6,25,7,14 | 1.7 Millimoles per liter | Standard Deviation 1.03 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 12, predose, n=6,6,25,7,14 | 2.0 Millimoles per liter | Standard Deviation 1.26 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, 48 hours, n=6,6,24,6,14 | -0.533120 Millimoles per liter | Standard Deviation 1.2237107 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, 96 hours, n=6,6,24,6,14 | 0.140 Millimoles per liter | Standard Deviation 0.1255 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, predose, n=6,6,25,6,12 | 2.2 Millimoles per liter | Standard Deviation 1.17 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 8 predose, n=6,6,25,7,14 | -0.982940 Millimoles per liter | Standard Deviation 1.2427511 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, 48 hours, n=6,6,24,6,14 | 0.063 Millimoles per liter | Standard Deviation 0.1516 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, 48 hours, n=6,6,24,6,14 | 1.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, predose, n=5,6,25,6,14 | 0.087 Millimoles per liter | Standard Deviation 0.1388 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, 96 hours, n=6,6,24,6,14 | 2.8 Millimoles per liter | Standard Deviation 1.33 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, 48 hours, n=6,6,24,6,14 | 0.07 Millimoles per liter | Standard Deviation 0.338 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, 48 hours, n=6,6,24,6,14 | 2.2 Millimoles per liter | Standard Deviation 2.3 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, FU (Day 28), n=6,6,25,7,14 | 0.3 Millimoles per liter | Standard Deviation 2.5 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 12, predose, n=6,6,25,7,14 | 0.024 Millimoles per liter | Standard Deviation 0.0667 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 28), n=6,6,25,7,14 | -0.06 Millimoles per liter | Standard Deviation 0.347 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 2, predose, n=6,6,25,7,14 | 0.2 Millimoles per liter | Standard Deviation 2.31 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 4, predose, n=6,6,25,7,14 | 1.0 Millimoles per liter | Standard Deviation 2.23 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 6, predose, n=6,6,25,7,14 | 1.0 Millimoles per liter | Standard Deviation 2.17 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 8 predose, n=6,6,25,7,14 | 1.0 Millimoles per liter | Standard Deviation 1.63 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 10, predose, n=6,6,25,7,14 | 2.4 Millimoles per liter | Standard Deviation 3.29 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 12, predose, n=6,6,25,7,14 | 1.3 Millimoles per liter | Standard Deviation 2.17 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, predose, n=6,6,25,6,12 | 0.1 Millimoles per liter | Standard Deviation 1.93 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, 96 hours, n=6,6,24,6,14 | 1.7 Millimoles per liter | Standard Deviation 1.55 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 2, predose, n=6,6,25,7,14 | 0.003 Millimoles per liter | Standard Deviation 0.0701 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 4, predose, n=6,6,25,7,14 | 0.013 Millimoles per liter | Standard Deviation 0.058 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 6, predose, n=6,6,25,7,14 | -0.020 Millimoles per liter | Standard Deviation 0.0607 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 8 predose, n=6,6,25,7,14 | 0.006 Millimoles per liter | Standard Deviation 0.0575 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 10, predose, n=6,6,25,7,14 | 0.014 Millimoles per liter | Standard Deviation 0.0699 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, predose, n=6,6,25,6,12 | -0.015 Millimoles per liter | Standard Deviation 0.0843 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, 48 hours, n=6,6,24,6,14 | 0.035 Millimoles per liter | Standard Deviation 0.0566 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, 96 hours, n=6,6,24,6,14 | 0.037 Millimoles per liter | Standard Deviation 0.0526 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU(Day 28), n=6,6,25,7,14 | -0.018 Millimoles per liter | Standard Deviation 0.0572 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 2, predose, n=6,6,25,7,14 | 0.4 Millimoles per liter | Standard Deviation 1.45 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 4, predose, n=6,6,25,7,14 | 0.1 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 6, predose, n=6,6,25,7,14 | 0.2 Millimoles per liter | Standard Deviation 2.01 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 8 predose, n=6,6,25,7,14 | -0.2 Millimoles per liter | Standard Deviation 1.67 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 10, predose, n=6,6,25,7,14 | 0.0 Millimoles per liter | Standard Deviation 1.99 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 12, predose, n=6,6,25,7,14 | 0.8 Millimoles per liter | Standard Deviation 1.8 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, predose, n=6,6,25,6,12 | 0.9 Millimoles per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, 48 hours, n=6,6,24,6,14 | 1.0 Millimoles per liter | Standard Deviation 1.76 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, 96 hours, n=6,6,24,6,14 | 0.6 Millimoles per liter | Standard Deviation 1.71 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU(Day 28), n=6,6,25,7,14 | 0.4 Millimoles per liter | Standard Deviation 1.55 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 2, predose, n=6,6,25,7,14 | -0.004 Millimoles per liter | Standard Deviation 0.0486 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 4, predose, n=6,6,25,7,14 | 0.005 Millimoles per liter | Standard Deviation 0.0415 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 6, predose, n=6,6,25,7,14 | 0.019 Millimoles per liter | Standard Deviation 0.0476 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 8 predose, n=6,6,25,7,14 | 0.002 Millimoles per liter | Standard Deviation 0.0426 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 10, predose, n=6,6,25,7,14 | 0.018 Millimoles per liter | Standard Deviation 0.0472 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 12, predose, n=6,6,25,7,14 | 0.014 Millimoles per liter | Standard Deviation 0.0401 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, predose, n=5,6,25,6,14 | 0.019 Millimoles per liter | Standard Deviation 0.0473 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, 48 hours, n=6,6,24,6,14 | 0.011 Millimoles per liter | Standard Deviation 0.0355 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, 96 hours, n=6,6,24,6,14 | 0.011 Millimoles per liter | Standard Deviation 0.036 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 28), n=6,6,25,7,14 | 0.001 Millimoles per liter | Standard Deviation 0.0387 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 2, predose, n=6,6,25,7,14 | -0.024 Millimoles per liter | Standard Deviation 0.1248 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 4, predose, n=6,6,25,7,14 | -0.003 Millimoles per liter | Standard Deviation 0.1382 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 6, predose, n=6,6,25,7,14 | -0.014 Millimoles per liter | Standard Deviation 0.1375 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 8 predose, n=6,6,25,7,14 | 0.021 Millimoles per liter | Standard Deviation 0.1285 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 10, predose, n=6,6,25,7,14 | 0.061 Millimoles per liter | Standard Deviation 0.1372 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 12, predose, n=6,6,25,7,14 | 0.085 Millimoles per liter | Standard Deviation 0.1704 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, predose, n=5,6,25,6,14 | 0.043 Millimoles per liter | Standard Deviation 0.1363 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, 48 hours, n=6,6,24,6,14 | 0.093 Millimoles per liter | Standard Deviation 0.1517 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, 96 hours, n=6,6,24,6,14 | 0.089 Millimoles per liter | Standard Deviation 0.151 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 28), n=6,6,25,7,14 | -0.047 Millimoles per liter | Standard Deviation 0.1837 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 2, predose, n=6,6,25,7,14 | 0.12 Millimoles per liter | Standard Deviation 0.34 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 4, predose, n=6,6,25,7,14 | 0.17 Millimoles per liter | Standard Deviation 0.369 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 6, predose, n=6,6,25,7,14 | 0.11 Millimoles per liter | Standard Deviation 0.396 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 8 predose, n=6,5,25,7,14 | 0.04 Millimoles per liter | Standard Deviation 0.364 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 10, predose, n=6,6,25,7,14 | 0.06 Millimoles per liter | Standard Deviation 0.406 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 12, predose, n=6,6,25,7,14 | 0.08 Millimoles per liter | Standard Deviation 0.384 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, predose, n=5,5,24,6,13 | -0.06 Millimoles per liter | Standard Deviation 0.388 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, 96 hours, n=6,6,24,6,14 | 0.00 Millimoles per liter | Standard Deviation 0.393 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 2, predose, n=6,6,25,7,14 | -0.5 Millimoles per liter | Standard Deviation 1.48 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 4, predose, n=6,6,25,7,14 | -0.3 Millimoles per liter | Standard Deviation 1.17 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 6, predose, n=6,6,25,7,14 | -0.7 Millimoles per liter | Standard Deviation 1.14 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 8 predose, n=6,6,25,7,14 | -1.0 Millimoles per liter | Standard Deviation 1.15 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 10, predose, n=6,6,25,7,14 | 0.3 Millimoles per liter | Standard Deviation 2.1 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 12, predose, n=6,6,25,7,14 | 0.2 Millimoles per liter | Standard Deviation 1.53 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, predose, n=6,6,25,6,14 | -1.1 Millimoles per liter | Standard Deviation 1.83 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, 48 hours, n=6,6,24,6,14 | 0.4 Millimoles per liter | Standard Deviation 1.35 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, 96 hours, n=6,6,24,6,14 | 0.6 Millimoles per liter | Standard Deviation 1.59 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU(Day 28), n=6,6,25,7,14 | -0.1 Millimoles per liter | Standard Deviation 1.58 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 2, predose, n=6,6,25,7,14 | -0.279888 Millimoles per liter | Standard Deviation 1.3039577 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 4, predose, n=6,6,25,7,14 | -0.415834 Millimoles per liter | Standard Deviation 1.2169831 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 6, predose, n=6,6,25,7,14 | -0.439824 Millimoles per liter | Standard Deviation 1.3090563 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 8 predose, n=6,6,25,7,14 | -0.287885 Millimoles per liter | Standard Deviation 1.1923207 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 10, predose, n=6,6,25,7,14 | -0.491803 Millimoles per liter | Standard Deviation 1.110831 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 12, predose, n=6,6,25,7,14 | -0.139944 Millimoles per liter | Standard Deviation 1.1809813 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, predose, n=6,6,25,6,14 | -0.399840 Millimoles per liter | Standard Deviation 1.2290067 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, 48 hours, n=6,6,24,6,14 | -0.703885 Millimoles per liter | Standard Deviation 1.1463627 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, 96 hours, n=6,6,24,6,14 | -0.749700 Millimoles per liter | Standard Deviation 1.1904312 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, FU (Day 28), n=6,6,25,7,14 | -0.411835 Millimoles per liter | Standard Deviation 1.0341231 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 12, predose, n=6,6,25,7,14 | 0.7 Millimoles per liter | Standard Deviation 2.29 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 6, predose, n=6,6,25,7,14 | -0.1 Millimoles per liter | Standard Deviation 1.07 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, 96 hours, n=6,6,24,6,14 | 0.078 Millimoles per liter | Standard Deviation 0.1042 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 10, predose, n=6,6,25,7,14 | -0.842520 Millimoles per liter | Standard Deviation 0.7064873 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, FU (Day 28), n=6,6,25,7,14 | 2.3 Millimoles per liter | Standard Deviation 2.56 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 2, predose, n=6,6,25,7,14 | 0.086 Millimoles per liter | Standard Deviation 0.1585 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 8 predose, n=6,6,25,7,14 | 0.4 Millimoles per liter | Standard Deviation 1.4 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 10, predose, n=6,6,25,7,14 | 0.21 Millimoles per liter | Standard Deviation 0.358 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 2, predose, n=6,6,25,7,14 | 0.41 Millimoles per liter | Standard Deviation 0.662 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, 96 hours, n=6,6,24,6,14 | 4.3 Millimoles per liter | Standard Deviation 2.16 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 10, predose, n=6,6,25,7,14 | 0.7 Millimoles per liter | Standard Deviation 2.43 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 10, predose, n=6,6,25,7,14 | 1.0 Millimoles per liter | Standard Deviation 1.63 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, 96 hours, n=6,6,24,6,14 | -0.499800 Millimoles per liter | Standard Deviation 0.8387115 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 12, predose, n=6,6,25,7,14 | 3.4 Millimoles per liter | Standard Deviation 2.82 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 12, predose, n=6,6,25,7,14 | 0.9 Millimoles per liter | Standard Deviation 1.57 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, 48 hours, n=6,6,24,6,14 | 0.072 Millimoles per liter | Standard Deviation 0.0806 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, 96 hours, n=6,6,24,6,14 | 0.085 Millimoles per liter | Standard Deviation 0.1536 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 12, predose, n=6,6,25,7,14 | 0.17 Millimoles per liter | Standard Deviation 0.399 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, predose, n=6,6,25,6,14 | -0.882980 Millimoles per liter | Standard Deviation 0.9192335 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, predose, n=6,6,25,6,14 | -0.5 Millimoles per liter | Standard Deviation 0.55 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 4, predose, n=6,6,25,7,14 | 0.0 Millimoles per liter | Standard Deviation 2.45 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, predose, n=6,6,25,6,12 | 1.5 Millimoles per liter | Standard Deviation 1.05 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, predose, n=6,6,25,6,12 | 0.2 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, predose, n=6,6,25,6,12 | 0.028 Millimoles per liter | Standard Deviation 0.0512 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, 48 hours, n=6,6,24,6,14 | 0.5 Millimoles per liter | Standard Deviation 0.84 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 10, predose, n=6,6,25,7,14 | 2.0 Millimoles per liter | Standard Deviation 1.63 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 8 predose, n=6,6,25,7,14 | 1.3 Millimoles per liter | Standard Deviation 1.7 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, 96 hours, n=6,6,24,6,14 | 0.3 Millimoles per liter | Standard Deviation 1.03 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, predose, n=5,5,24,6,13 | -0.05 Millimoles per liter | Standard Deviation 0.327 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 4, predose, n=6,6,25,7,14 | 0.20 Millimoles per liter | Standard Deviation 0.383 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 8 predose, n=6,6,25,7,14 | 1.3 Millimoles per liter | Standard Deviation 1.7 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, 48 hours, n=6,6,24,6,14 | -0.949620 Millimoles per liter | Standard Deviation 1.1991034 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU(Day 28), n=6,6,25,7,14 | 0.0 Millimoles per liter | Standard Deviation 1.73 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 12, predose, n=6,6,25,7,14 | 0.066 Millimoles per liter | Standard Deviation 0.0608 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, 48 hours, n=6,6,24,6,14 | 0.052 Millimoles per liter | Standard Deviation 0.1446 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 6, predose, n=6,6,25,7,14 | 0.4 Millimoles per liter | Standard Deviation 1.81 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, 48 hours, n=6,6,24,6,14 | -0.08 Millimoles per liter | Standard Deviation 0.331 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 2, predose, n=6,6,25,7,14 | 0.242760 Millimoles per liter | Standard Deviation 0.8615469 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 2, predose, n=6,6,25,7,14 | -0.1 Millimoles per liter | Standard Deviation 1.57 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 10, predose, n=6,6,25,7,14 | 0.079 Millimoles per liter | Standard Deviation 0.0763 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, predose, n=5,6,25,6,14 | -0.002 Millimoles per liter | Standard Deviation 0.0343 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 8 predose, n=6,6,25,7,14 | -0.257040 Millimoles per liter | Standard Deviation 0.7543661 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, 48 hours, n=6,6,24,6,14 | 0.020 Millimoles per liter | Standard Deviation 0.0603 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 6, predose, n=6,6,25,7,14 | 0.21 Millimoles per liter | Standard Deviation 0.285 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, 96 hours, n=6,6,24,6,14 | 0.08 Millimoles per liter | Standard Deviation 0.172 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 12, predose, n=6,6,25,7,14 | 0.007 Millimoles per liter | Standard Deviation 0.0446 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 4, predose, n=6,6,25,7,14 | 3.1 Millimoles per liter | Standard Deviation 3.08 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, 96 hours, n=6,6,24,6,14 | 0.022 Millimoles per liter | Standard Deviation 0.0331 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 28), n=6,6,25,7,14 | 0.010 Millimoles per liter | Standard Deviation 0.1795 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 6, predose, n=6,6,25,7,14 | 0.083 Millimoles per liter | Standard Deviation 0.0512 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 10, predose, n=6,6,25,7,14 | 0.017 Millimoles per liter | Standard Deviation 0.039 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 8 predose, n=6,6,25,7,14 | 0.074 Millimoles per liter | Standard Deviation 0.0387 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 28), n=6,6,25,7,14 | -0.003 Millimoles per liter | Standard Deviation 0.0415 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 28), n=6,6,25,7,14 | -0.13 Millimoles per liter | Standard Deviation 0.335 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, 48 hours, n=6,6,24,6,14 | 1.0 Millimoles per liter | Standard Deviation 2.53 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 8 predose, n=6,6,25,7,14 | 0.019 Millimoles per liter | Standard Deviation 0.0438 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 4, predose, n=6,6,25,7,14 | -0.157080 Millimoles per liter | Standard Deviation 0.7761282 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, 48 hours, n=6,6,24,6,14 | 2.5 Millimoles per liter | Standard Deviation 3.56 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 6, predose, n=6,6,25,7,14 | 0.017 Millimoles per liter | Standard Deviation 0.0399 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 2, predose, n=6,6,25,7,14 | -1.1 Millimoles per liter | Standard Deviation 1.86 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 4, predose, n=6,6,25,7,14 | 0.057 Millimoles per liter | Standard Deviation 0.1045 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU(Day 28), n=6,6,25,7,14 | 0.039 Millimoles per liter | Standard Deviation 0.0891 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, predose, n=5,6,25,6,14 | 0.170 Millimoles per liter | Standard Deviation 0.103 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 4, predose, n=6,6,25,7,14 | 0.027 Millimoles per liter | Standard Deviation 0.0577 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 2, predose, n=6,6,25,7,14 | 1.1 Millimoles per liter | Standard Deviation 1.57 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 6, predose, n=6,6,25,7,14 | 0.164 Millimoles per liter | Standard Deviation 0.1018 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 4, predose, n=6,6,25,7,14 | 0.117 Millimoles per liter | Standard Deviation 0.0574 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 12, predose, n=6,6,25,7,14 | -1.013880 Millimoles per liter | Standard Deviation 0.9698843 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 2, predose, n=6,6,25,7,14 | 0.016 Millimoles per liter | Standard Deviation 0.0624 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, FU (Day 28), n=6,6,25,7,14 | -0.571200 Millimoles per liter | Standard Deviation 0.6208106 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 8 predose, n=6,6,25,7,14 | 0.121 Millimoles per liter | Standard Deviation 0.1644 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 4, predose, n=6,6,25,7,14 | 0.9 Millimoles per liter | Standard Deviation 1.77 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 8 predose, n=6,5,25,7,14 | 0.20 Millimoles per liter | Standard Deviation 0.374 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU(Day 28), n=6,6,25,7,14 | 0.3 Millimoles per liter | Standard Deviation 2.43 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 6, predose, n=6,6,25,7,14 | -0.414120 Millimoles per liter | Standard Deviation 0.8948673 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 10, predose, n=6,6,25,7,14 | 0.140 Millimoles per liter | Standard Deviation 0.1344 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 6, predose, n=6,6,25,7,14 | 0.4 Millimoles per liter | Standard Deviation 1.4 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 2, predose, n=6,6,25,7,14 | 0.104 Millimoles per liter | Standard Deviation 0.0627 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, 96 hours, n=6,6,24,6,14 | -0.5 Millimoles per liter | Standard Deviation 1.87 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 12, predose, n=6,6,25,7,14 | 0.193 Millimoles per liter | Standard Deviation 0.1329 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 6, predose, n=6,6,25,7,14 | -0.606900 Millimoles per liter | Standard Deviation 1.0361954 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 12, predose, n=6,6,25,7,14 | 0.139 Millimoles per liter | Standard Deviation 0.2 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, 48 hours, n=6,6,24,6,14 | 1.1 Millimoles per liter | Standard Deviation 2.37 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, 48 hours, n=6,6,24,6,14 | -0.521220 Millimoles per liter | Standard Deviation 1.4681527 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, predose, n=5,6,25,6,14 | 0.101 Millimoles per liter | Standard Deviation 0.2161 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, predose, n=6,6,25,6,12 | 1.0 Millimoles per liter | Standard Deviation 2.11 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, 48 hours, n=6,6,24,6,14 | 0.082 Millimoles per liter | Standard Deviation 0.1873 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 12, predose, n=6,6,25,7,14 | 1.3 Millimoles per liter | Standard Deviation 2.23 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 14, 96 hours, n=6,6,24,6,14 | 0.119 Millimoles per liter | Standard Deviation 0.2051 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 10, predose, n=6,6,25,7,14 | 0.7 Millimoles per liter | Standard Deviation 1.77 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 8 predose, n=6,6,25,7,14 | 0.6 Millimoles per liter | Standard Deviation 2.14 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 28), n=6,6,25,7,14 | 0.010 Millimoles per liter | Standard Deviation 0.1741 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 6, predose, n=6,6,25,7,14 | 0.4 Millimoles per liter | Standard Deviation 2.1 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 8 predose, n=6,6,25,7,14 | -0.249900 Millimoles per liter | Standard Deviation 1.254488 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 2, predose, n=6,6,25,7,14 | 0.14 Millimoles per liter | Standard Deviation 0.203 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 4, predose, n=6,6,25,7,14 | 0.9 Millimoles per liter | Standard Deviation 1.9 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 4, predose, n=6,6,25,7,14 | -0.535500 Millimoles per liter | Standard Deviation 1.2302718 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 4, predose, n=6,6,25,7,14 | 0.19 Millimoles per liter | Standard Deviation 0.141 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 2, predose, n=6,6,25,7,14 | 1.1 Millimoles per liter | Standard Deviation 1.98 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, 48 hours, n=6,6,24,6,14 | 1.3 Millimoles per liter | Standard Deviation 2.27 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 6, predose, n=6,6,25,7,14 | 0.06 Millimoles per liter | Standard Deviation 0.234 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU(Day 28), n=6,6,25,7,14 | 0.019 Millimoles per liter | Standard Deviation 0.0827 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, 96 hours, n=6,6,24,6,14 | -0.556920 Millimoles per liter | Standard Deviation 1.1341178 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 8 predose, n=6,5,25,7,14 | 0.17 Millimoles per liter | Standard Deviation 0.307 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, 96 hours, n=6,6,24,6,14 | 0.046 Millimoles per liter | Standard Deviation 0.058 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 10, predose, n=6,6,25,7,14 | 0.09 Millimoles per liter | Standard Deviation 0.138 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, 48 hours, n=6,6,24,6,14 | 0.033 Millimoles per liter | Standard Deviation 0.077 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 10, predose, n=6,6,25,7,14 | -0.207060 Millimoles per liter | Standard Deviation 1.4392234 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 12, predose, n=6,6,25,7,14 | 0.22 Millimoles per liter | Standard Deviation 0.176 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 14, predose, n=6,6,25,6,12 | 0.008 Millimoles per liter | Standard Deviation 0.0715 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, predose, n=5,5,24,6,13 | 0.19 Millimoles per liter | Standard Deviation 0.348 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 12, predose, n=6,6,25,7,14 | 0.025 Millimoles per liter | Standard Deviation 0.0617 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 10, predose, n=6,6,25,7,14 | 0.024 Millimoles per liter | Standard Deviation 0.0628 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, 48 hours, n=6,6,24,6,14 | 0.04 Millimoles per liter | Standard Deviation 0.214 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 6, predose, n=6,6,25,7,14 | 0.011 Millimoles per liter | Standard Deviation 0.0578 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 2, predose, n=6,6,25,7,14 | 0.035 Millimoles per liter | Standard Deviation 0.2069 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, Day 14, 96 hours, n=6,6,24,6,14 | 0.13 Millimoles per liter | Standard Deviation 0.261 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 28), n=6,6,25,7,14 | 0.21 Millimoles per liter | Standard Deviation 0.53 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 2, predose, n=6,6,25,7,14 | 0.1 Millimoles per liter | Standard Deviation 2.11 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 4, predose, n=6,6,25,7,14 | 0.030 Millimoles per liter | Standard Deviation 0.0479 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 4, predose, n=6,6,25,7,14 | 0.8 Millimoles per liter | Standard Deviation 1.93 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 2, predose, n=6,6,25,7,14 | 0.003 Millimoles per liter | Standard Deviation 0.0722 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 12, predose, n=6,6,25,7,14 | -0.399840 Millimoles per liter | Standard Deviation 1.2423284 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 6, predose, n=6,6,25,7,14 | 0.5 Millimoles per liter | Standard Deviation 1.7 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, FU (Day 28), n=6,6,25,7,14 | 0.8 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 8 predose, n=6,6,25,7,14 | 0.7 Millimoles per liter | Standard Deviation 2.16 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, 96 hours, n=6,6,24,6,14 | 2.3 Millimoles per liter | Standard Deviation 2.05 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 10, predose, n=6,6,25,7,14 | 0.9 Millimoles per liter | Standard Deviation 2.07 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 12, predose, n=6,6,25,7,14 | 1.2 Millimoles per liter | Standard Deviation 1.89 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, 48 hours, n=6,6,24,6,14 | 3.0 Millimoles per liter | Standard Deviation 2.11 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 14, predose, n=6,6,25,6,12 | 1.0 Millimoles per liter | Standard Deviation 1.62 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, predose, n=6,6,25,6,14 | 0.1 Millimoles per liter | Standard Deviation 2.34 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 12, predose, n=6,6,25,7,14 | 1.6 Millimoles per liter | Standard Deviation 1.65 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 14, predose, n=6,6,25,6,14 | -0.271320 Millimoles per liter | Standard Deviation 1.2493792 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 10, predose, n=6,6,25,7,14 | 2.4 Millimoles per liter | Standard Deviation 2.24 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, Day 14, 96 hours, n=6,6,24,6,14 | 1.1 Millimoles per liter | Standard Deviation 2.59 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 8 predose, n=6,6,25,7,14 | 1.6 Millimoles per liter | Standard Deviation 1.91 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, FU (Day 28), n=6,6,25,7,14 | -0.778260 Millimoles per liter | Standard Deviation 0.9818953 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU(Day 28), n=6,6,25,7,14 | 0.9 Millimoles per liter | Standard Deviation 2.32 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 6, predose, n=6,6,25,7,14 | 1.8 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, Day 8 predose, n=6,6,25,7,14 | 0.028 Millimoles per liter | Standard Deviation 0.0641 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, Day 2, predose, n=6,6,25,7,14 | -0.221340 Millimoles per liter | Standard Deviation 1.056553 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, predose, n=5,6,25,6,14 | -0.001 Millimoles per liter | Standard Deviation 0.0551 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 4, predose, n=6,6,25,7,14 | 2.1 Millimoles per liter | Standard Deviation 2.09 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, 48 hours, n=6,6,24,6,14 | -0.001 Millimoles per liter | Standard Deviation 0.0363 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 12, predose, n=6,6,25,7,14 | 0.004 Millimoles per liter | Standard Deviation 0.039 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 14, 96 hours, n=6,6,24,6,14 | -0.002 Millimoles per liter | Standard Deviation 0.0662 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 10, predose, n=6,6,25,7,14 | 0.000 Millimoles per liter | Standard Deviation 0.0566 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 28), n=6,6,25,7,14 | -0.009 Millimoles per liter | Standard Deviation 0.0469 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 8 predose, n=6,6,25,7,14 | 0.004 Millimoles per liter | Standard Deviation 0.042 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 6, predose, n=6,6,25,7,14 | 0.008 Millimoles per liter | Standard Deviation 0.0556 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, Day 2, predose, n=6,6,25,7,14 | 0.4 Millimoles per liter | Standard Deviation 1.95 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 4, predose, n=6,6,25,7,14 | 0.036 Millimoles per liter | Standard Deviation 0.1835 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 4, predose, n=6,6,25,7,14 | 0.007 Millimoles per liter | Standard Deviation 0.0347 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 6, predose, n=6,6,25,7,14 | 0.060 Millimoles per liter | Standard Deviation 0.2119 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, Day 2, predose, n=6,6,25,7,14 | -0.006 Millimoles per liter | Standard Deviation 0.0422 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 8 predose, n=6,6,25,7,14 | 0.074 Millimoles per liter | Standard Deviation 0.2112 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU(Day 28), n=6,6,25,7,14 | 0.8 Millimoles per liter | Standard Deviation 1.89 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, Day 10, predose, n=6,6,25,7,14 | 0.129 Millimoles per liter | Standard Deviation 0.1626 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, Day 14, 96 hours, n=6,6,24,6,14 | 0.5 Millimoles per liter | Standard Deviation 2.21 |
Primary
Part 1: Change From Baseline in Chemistry Parameter: Glucose
Blood samples were collected to analyze the chemistry parameter: glucose . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2) and Day 1 (96 hours) and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | Day 1 (96 hours), n=5,6,6,6,6,6,6,6,14 | -0.16 Millimoles per liter | Standard Deviation 0.288 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.03 Millimoles per liter | Standard Deviation 0.513 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | Day 1 (96 hours), n=5,6,6,6,6,6,6,6,14 | -0.30 Millimoles per liter | Standard Deviation 0.11 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.05 Millimoles per liter | Standard Deviation 0.345 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | Day 1 (96 hours), n=5,6,6,6,6,6,6,6,14 | -0.25 Millimoles per liter | Standard Deviation 0.414 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.12 Millimoles per liter | Standard Deviation 0.605 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | Day 1 (96 hours), n=5,6,6,6,6,6,6,6,14 | -0.28 Millimoles per liter | Standard Deviation 0.527 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.22 Millimoles per liter | Standard Deviation 0.471 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | Day 1 (96 hours), n=5,6,6,6,6,6,6,6,14 | -0.17 Millimoles per liter | Standard Deviation 0.446 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.07 Millimoles per liter | Standard Deviation 0.582 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.27 Millimoles per liter | Standard Deviation 0.367 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | Day 1 (96 hours), n=5,6,6,6,6,6,6,6,14 | -0.08 Millimoles per liter | Standard Deviation 0.349 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.27 Millimoles per liter | Standard Deviation 0.745 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | Day 1 (96 hours), n=5,6,6,6,6,6,6,6,14 | -0.07 Millimoles per liter | Standard Deviation 0.432 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | Day 1 (96 hours), n=5,6,6,6,6,6,6,6,14 | -0.33 Millimoles per liter | Standard Deviation 0.175 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.00 Millimoles per liter | Standard Deviation 0.374 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Chemistry Parameter: Glucose | Day 1 (96 hours), n=5,6,6,6,6,6,6,6,14 | -0.21 Millimoles per liter | Standard Deviation 0.279 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.04 Millimoles per liter | Standard Deviation 0.379 |
Primary
Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides
Blood samples were collected to analyze the chemistry parameter: cholesterol, glucose, HDL cholesterol, LDL cholesterol, triglycerides. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2) and Day 1 (96 hours) and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol,Day1,96 hours,n=6,6,6,6,5,6,6,6,15 | -0.02 Millimoles per liter | Standard Deviation 0.041 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides, FU (Day 15),n=6,6,6,6,5,6,6,6,16 | -0.20 Millimoles per liter | Standard Deviation 0.297 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.28 Millimoles per liter | Standard Deviation 0.531 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.40 Millimoles per liter | Standard Deviation 0.324 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol, FU(Day 15), n=6,6,6,6,5,6,6,6,16 | 0.30 Millimoles per liter | Standard Deviation 0.21 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.25 Millimoles per liter | Standard Deviation 0.404 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol,Day1, 96hours,n=5,6,6,6,5,6,6,6,14 | 0.30 Millimoles per liter | Standard Deviation 0.122 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol, FU (Day 15), n=6,6,6,6,5,6,6,6,16 | 0.07 Millimoles per liter | Standard Deviation 0.137 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.32 Millimoles per liter | Standard Deviation 0.271 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol, FU(Day 15), n=6,6,6,6,5,6,6,6,16 | 0.15 Millimoles per liter | Standard Deviation 0.295 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol, FU (Day 15), n=6,6,6,6,5,6,6,6,16 | -0.05 Millimoles per liter | Standard Deviation 0.122 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol,Day1, 96hours,n=5,6,6,6,5,6,6,6,14 | 0.10 Millimoles per liter | Standard Deviation 0.562 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol,Day1,96 hours,n=6,6,6,6,5,6,6,6,15 | -0.05 Millimoles per liter | Standard Deviation 0.105 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.23 Millimoles per liter | Standard Deviation 0.327 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.60 Millimoles per liter | Standard Deviation 1.079 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides, FU (Day 15),n=6,6,6,6,5,6,6,6,16 | 0.32 Millimoles per liter | Standard Deviation 0.838 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol, FU (Day 15), n=6,6,6,6,5,6,6,6,16 | -0.02 Millimoles per liter | Standard Deviation 0.16 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | -0.05 Millimoles per liter | Standard Deviation 0.628 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides, FU (Day 15),n=6,6,6,6,5,6,6,6,16 | -0.30 Millimoles per liter | Standard Deviation 0.303 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol, FU(Day 15), n=6,6,6,6,5,6,6,6,16 | 0.22 Millimoles per liter | Standard Deviation 0.564 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.45 Millimoles per liter | Standard Deviation 0.468 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol,Day1,96 hours,n=6,6,6,6,5,6,6,6,15 | -0.15 Millimoles per liter | Standard Deviation 0.152 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol,Day1, 96hours,n=5,6,6,6,5,6,6,6,14 | -0.12 Millimoles per liter | Standard Deviation 0.519 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.07 Millimoles per liter | Standard Deviation 0.579 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol,Day1,96 hours,n=6,6,6,6,5,6,6,6,15 | -0.12 Millimoles per liter | Standard Deviation 0.147 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.02 Millimoles per liter | Standard Deviation 0.422 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.23 Millimoles per liter | Standard Deviation 0.493 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol, FU (Day 15), n=6,6,6,6,5,6,6,6,16 | 0.00 Millimoles per liter | Standard Deviation 0.179 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol,Day1, 96hours,n=5,6,6,6,5,6,6,6,14 | -0.13 Millimoles per liter | Standard Deviation 0.408 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol, FU(Day 15), n=6,6,6,6,5,6,6,6,16 | 0.07 Millimoles per liter | Standard Deviation 0.314 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.62 Millimoles per liter | Standard Deviation 1.026 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides, FU (Day 15),n=6,6,6,6,5,6,6,6,16 | 0.40 Millimoles per liter | Standard Deviation 0.94 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol,Day1,96 hours,n=6,6,6,6,5,6,6,6,15 | -0.22 Millimoles per liter | Standard Deviation 0.084 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.16 Millimoles per liter | Standard Deviation 0.59 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol, FU (Day 15), n=6,6,6,6,5,6,6,6,16 | -0.18 Millimoles per liter | Standard Deviation 0.148 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol,Day1, 96hours,n=5,6,6,6,5,6,6,6,14 | -0.04 Millimoles per liter | Standard Deviation 0.428 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides, FU (Day 15),n=6,6,6,6,5,6,6,6,16 | 0.40 Millimoles per liter | Standard Deviation 0.831 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.52 Millimoles per liter | Standard Deviation 0.931 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | -0.06 Millimoles per liter | Standard Deviation 0.699 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol, FU(Day 15), n=6,6,6,6,5,6,6,6,16 | -0.14 Millimoles per liter | Standard Deviation 0.472 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol, FU (Day 15), n=6,6,6,6,5,6,6,6,16 | -0.05 Millimoles per liter | Standard Deviation 0.105 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol,Day1,96 hours,n=6,6,6,6,5,6,6,6,15 | -0.12 Millimoles per liter | Standard Deviation 0.098 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.40 Millimoles per liter | Standard Deviation 0.562 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides, FU (Day 15),n=6,6,6,6,5,6,6,6,16 | 0.02 Millimoles per liter | Standard Deviation 0.279 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol,Day1, 96hours,n=5,6,6,6,5,6,6,6,14 | -0.03 Millimoles per liter | Standard Deviation 0.361 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.13 Millimoles per liter | Standard Deviation 0.516 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol, FU(Day 15), n=6,6,6,6,5,6,6,6,16 | -0.35 Millimoles per liter | Standard Deviation 0.451 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.60 Millimoles per liter | Standard Deviation 0.883 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.45 Millimoles per liter | Standard Deviation 0.373 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol, FU(Day 15), n=6,6,6,6,5,6,6,6,16 | 0.37 Millimoles per liter | Standard Deviation 0.308 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol, FU (Day 15), n=6,6,6,6,5,6,6,6,16 | -0.02 Millimoles per liter | Standard Deviation 0.264 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides, FU (Day 15),n=6,6,6,6,5,6,6,6,16 | -0.55 Millimoles per liter | Standard Deviation 0.501 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.03 Millimoles per liter | Standard Deviation 0.468 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol,Day1, 96hours,n=5,6,6,6,5,6,6,6,14 | 0.43 Millimoles per liter | Standard Deviation 0.441 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.08 Millimoles per liter | Standard Deviation 0.445 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol,Day1,96 hours,n=6,6,6,6,5,6,6,6,15 | -0.02 Millimoles per liter | Standard Deviation 0.133 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol,Day1,96 hours,n=6,6,6,6,5,6,6,6,15 | -0.13 Millimoles per liter | Standard Deviation 0.103 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.22 Millimoles per liter | Standard Deviation 0.496 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.43 Millimoles per liter | Standard Deviation 0.641 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol,Day1, 96hours,n=5,6,6,6,5,6,6,6,14 | 0.25 Millimoles per liter | Standard Deviation 0.281 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol, FU(Day 15), n=6,6,6,6,5,6,6,6,16 | 0.07 Millimoles per liter | Standard Deviation 0.327 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides, FU (Day 15),n=6,6,6,6,5,6,6,6,16 | 0.40 Millimoles per liter | Standard Deviation 0.41 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.70 Millimoles per liter | Standard Deviation 0.834 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol, FU (Day 15), n=6,6,6,6,5,6,6,6,16 | -0.03 Millimoles per liter | Standard Deviation 0.103 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.49 Millimoles per liter | Standard Deviation 0.36 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol, FU(Day 15), n=6,6,6,6,5,6,6,6,16 | 0.13 Millimoles per liter | Standard Deviation 0.491 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Triglycerides, FU (Day 15),n=6,6,6,6,5,6,6,6,16 | 0.05 Millimoles per liter | Standard Deviation 0.588 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | LDL cholesterol,Day1, 96hours,n=5,6,6,6,5,6,6,6,14 | 0.16 Millimoles per liter | Standard Deviation 0.386 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol,Day1,96 hours,n=5,6,6,6,5,6,6,6,14 | 0.30 Millimoles per liter | Standard Deviation 0.445 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol, FU (Day 15), n=6,6,6,6,5,6,6,6,16 | 0.00 Millimoles per liter | Standard Deviation 0.219 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | Cholesterol, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.16 Millimoles per liter | Standard Deviation 0.566 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides | HDL cholesterol,Day1,96 hours,n=6,6,6,6,5,6,6,6,15 | -0.08 Millimoles per liter | Standard Deviation 0.174 |
Primary
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
Blood samples were collected to analyze the chemistry parameter: ALT, AST, and ALP. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.3 International units per liter | Standard Deviation 10.01 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.7 International units per liter | Standard Deviation 4.55 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 48 hours, n=6,6,6,6,6,6,6,5,16 | -4.3 International units per liter | Standard Deviation 7.5 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 24 hours, n=6,6,6,6,6,6,6,6,16 | -5.7 International units per liter | Standard Deviation 7.63 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.5 International units per liter | Standard Deviation 5.75 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 3.3 International units per liter | Standard Deviation 4.18 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 96 hours, n=6,6,6,6,6,6,6,6,15 | -4.2 International units per liter | Standard Deviation 8.57 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.3 International units per liter | Standard Deviation 1.37 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.5 International units per liter | Standard Deviation 5.01 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 24 hours, n=6,6,6,6,6,6,6,6,16 | 2.8 International units per liter | Standard Deviation 4.54 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -1.5 International units per liter | Standard Deviation 8.53 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 48 hours, n=6,6,6,6,6,6,6,5,16 | 3.3 International units per liter | Standard Deviation 4.93 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 48 hours, n=6,6,6,6,6,6,6,5,16 | 1.7 International units per liter | Standard Deviation 5.13 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.7 International units per liter | Standard Deviation 3.2 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 48 hours, n=6,6,6,6,6,6,6,5,16 | -2.3 International units per liter | Standard Deviation 3.83 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 5.2 International units per liter | Standard Deviation 2.93 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.5 International units per liter | Standard Deviation 3.27 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.3 International units per liter | Standard Deviation 3.39 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.2 International units per liter | Standard Deviation 4.49 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 24 hours, n=6,6,6,6,6,6,6,6,16 | 6.0 International units per liter | Standard Deviation 3.74 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 96 hours, n=6,6,6,6,6,6,6,6,15 | 4.0 International units per liter | Standard Deviation 3.9 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 4.5 International units per liter | Standard Deviation 9.57 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 2.3 International units per liter | Standard Deviation 4.32 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.4 International units per liter | Standard Deviation 3.13 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 24 hours, n=6,6,6,6,6,6,6,6,16 | 1.2 International units per liter | Standard Deviation 8.28 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 48 hours, n=6,6,6,6,6,6,6,5,16 | -3.0 International units per liter | Standard Deviation 2.1 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 24 hours, n=6,6,6,6,6,6,6,6,16 | -2.5 International units per liter | Standard Deviation 2.88 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 2.3 International units per liter | Standard Deviation 3.56 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 96 hours, n=6,6,6,6,6,6,6,6,15 | -4.2 International units per liter | Standard Deviation 3.97 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.3 International units per liter | Standard Deviation 4.68 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.5 International units per liter | Standard Deviation 4.81 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.8 International units per liter | Standard Deviation 3.6 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 48 hours, n=6,6,6,6,6,6,6,5,16 | 2.2 International units per liter | Standard Deviation 6.24 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 3.5 International units per liter | Standard Deviation 10.09 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.0 International units per liter | Standard Deviation 5.18 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.3 International units per liter | Standard Deviation 4.37 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 48 hours, n=6,6,6,6,6,6,6,5,16 | -2.2 International units per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 48 hours, n=6,6,6,6,6,6,6,5,16 | 1.2 International units per liter | Standard Deviation 2.23 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.3 International units per liter | Standard Deviation 2.73 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.0 International units per liter | Standard Deviation 5.18 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 96 hours, n=6,6,6,6,6,6,6,6,15 | 2.2 International units per liter | Standard Deviation 3.19 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.5 International units per liter | Standard Deviation 2.88 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 24 hours, n=6,6,6,6,6,6,6,6,16 | -4.2 International units per liter | Standard Deviation 1.94 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 9.5 International units per liter | Standard Deviation 14.46 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 2.2 International units per liter | Standard Deviation 6.62 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.8 International units per liter | Standard Deviation 5.31 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.0 International units per liter | Standard Deviation 6.66 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 24 hours, n=6,6,6,6,6,6,6,6,16 | -3.8 International units per liter | Standard Deviation 2.04 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.5 International units per liter | Standard Deviation 4.85 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 96 hours, n=6,6,6,6,6,6,6,6,15 | 2.5 International units per liter | Standard Deviation 5.47 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 96 hours, n=6,6,6,6,6,6,6,6,15 | -3.3 International units per liter | Standard Deviation 4.89 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.5 International units per liter | Standard Deviation 4.93 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.5 International units per liter | Standard Deviation 4.04 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 5.2 International units per liter | Standard Deviation 9.95 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 24 hours, n=6,6,6,6,6,6,6,6,16 | -3.5 International units per liter | Standard Deviation 4.72 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.7 International units per liter | Standard Deviation 4.8 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 4.5 International units per liter | Standard Deviation 5.36 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 24 hours, n=6,6,6,6,6,6,6,6,16 | -2.8 International units per liter | Standard Deviation 6.15 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.7 International units per liter | Standard Deviation 6.65 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -1.2 International units per liter | Standard Deviation 6.97 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.5 International units per liter | Standard Deviation 8.29 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 24 hours, n=6,6,6,6,6,6,6,6,16 | -4.7 International units per liter | Standard Deviation 6.74 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -1.8 International units per liter | Standard Deviation 6.01 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -1.7 International units per liter | Standard Deviation 2.8 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 96 hours, n=6,6,6,6,6,6,6,6,15 | -3.5 International units per liter | Standard Deviation 8.26 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.2 International units per liter | Standard Deviation 8.42 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 96 hours, n=6,6,6,6,6,6,6,6,15 | -4.5 International units per liter | Standard Deviation 4.85 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 48 hours, n=6,6,6,6,6,6,6,5,16 | -2.5 International units per liter | Standard Deviation 3.33 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 96 hours, n=6,6,6,6,6,6,6,6,15 | -4.8 International units per liter | Standard Deviation 9.11 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 48 hours, n=6,6,6,6,6,6,6,5,16 | -2.7 International units per liter | Standard Deviation 6.25 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.3 International units per liter | Standard Deviation 14.35 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 24 hours, n=6,6,6,6,6,6,6,6,16 | -3.8 International units per liter | Standard Deviation 3.49 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 48 hours, n=6,6,6,6,6,6,6,5,16 | -2.0 International units per liter | Standard Deviation 3.85 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.7 International units per liter | Standard Deviation 3.72 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.8 International units per liter | Standard Deviation 4.31 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.5 International units per liter | Standard Deviation 4.85 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 2.2 International units per liter | Standard Deviation 8.26 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 48 hours, n=6,6,6,6,6,6,6,5,16 | -2.7 International units per liter | Standard Deviation 4.89 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.8 International units per liter | Standard Deviation 5.98 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.0 International units per liter | Standard Deviation 5.44 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.8 International units per liter | Standard Deviation 5.31 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.2 International units per liter | Standard Deviation 4.67 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.5 International units per liter | Standard Deviation 6.19 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.0 International units per liter | Standard Deviation 4.34 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 96 hours, n=6,6,6,6,6,6,6,6,15 | 3.8 International units per liter | Standard Deviation 10.76 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.2 International units per liter | Standard Deviation 3.49 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.3 International units per liter | Standard Deviation 2.94 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 5.3 International units per liter | Standard Deviation 6.06 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.7 International units per liter | Standard Deviation 3.78 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.9 International units per liter | Standard Deviation 5.87 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.6 International units per liter | Standard Deviation 2.97 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 48 hours, n=6,6,6,6,6,6,6,5,16 | 5.0 International units per liter | Standard Deviation 10.17 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 48 hours, n=6,6,6,6,6,6,6,5,16 | 1.4 International units per liter | Standard Deviation 5.86 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.3 International units per liter | Standard Deviation 1.97 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.5 International units per liter | Standard Deviation 4.89 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.3 International units per liter | Standard Deviation 5.05 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 48 hours, n=6,6,6,6,6,6,6,5,16 | -2.6 International units per liter | Standard Deviation 4.11 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 48 hours, n=6,6,6,6,6,6,6,5,16 | -2.4 International units per liter | Standard Deviation 4.84 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 96 hours, n=6,6,6,6,6,6,6,6,15 | 2.5 International units per liter | Standard Deviation 8.08 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 24 hours, n=6,6,6,6,6,6,6,6,16 | -2.9 International units per liter | Standard Deviation 4.1 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.4 International units per liter | Standard Deviation 6.37 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.4 International units per liter | Standard Deviation 3.48 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, 24 hours, n=6,6,6,6,6,6,6,6,16 | -3.0 International units per liter | Standard Deviation 3.6 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALP, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.1 International units per liter | Standard Deviation 4.16 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | AST, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.9 International units per liter | Standard Deviation 5.87 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.1 International units per liter | Standard Deviation 4.94 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.8 International units per liter | Standard Deviation 4.68 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) | ALT, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 5.1 International units per liter | Standard Deviation 15.95 |
Primary
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameter: bilirubin, creatinine, direct bilirubin . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -2.5 Grams per liter | Standard Deviation 2.88 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.8 Grams per liter | Standard Deviation 1.48 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 96 hours, n=6,6,6,6,6,6,6,6,15 | -2.5 Grams per liter | Standard Deviation 7.34 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -2.2 Grams per liter | Standard Deviation 3.19 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | -0.7 Grams per liter | Standard Deviation 1.21 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -3.2 Grams per liter | Standard Deviation 2.32 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 24 hours, n=6,6,6,6,6,6,6,6,16 | -7.0 Grams per liter | Standard Deviation 7.13 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | -0.8 Grams per liter | Standard Deviation 3.43 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.0 Grams per liter | Standard Deviation 1.26 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -2.5 Grams per liter | Standard Deviation 6.38 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.0 Grams per liter | Standard Deviation 1.55 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 48 hours, n=6,6,6,6,6,6,6,5,16 | -6.7 Grams per liter | Standard Deviation 7.15 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.5 Grams per liter | Standard Deviation 1.29 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 1.0 Grams per liter | Standard Deviation 1.22 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.8 Grams per liter | Standard Deviation 4.26 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 24 hours, n=6,6,6,6,6,6,6,6,16 | 3.2 Grams per liter | Standard Deviation 5.85 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -2.5 Grams per liter | Standard Deviation 4.04 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.2 Grams per liter | Standard Deviation 3.37 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 9.3 Grams per liter | Standard Deviation 7.76 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 3.3 Grams per liter | Standard Deviation 4.13 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.0 Grams per liter | Standard Deviation 1.15 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.8 Grams per liter | Standard Deviation 1.26 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 96 hours, n=6,6,6,6,6,6,6,6,15 | 8.7 Grams per liter | Standard Deviation 4.89 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 48 hours, n=6,6,6,6,6,6,6,5,16 | 7.2 Grams per liter | Standard Deviation 4.96 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.6 Grams per liter | Standard Deviation 1.14 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 0.2 Grams per liter | Standard Deviation 0.75 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.2 Grams per liter | Standard Deviation 2.14 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.5 Grams per liter | Standard Deviation 3.62 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -1.3 Grams per liter | Standard Deviation 5.09 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -4.7 Grams per liter | Standard Deviation 3.2 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 96 hours, n=6,6,6,6,6,6,6,6,15 | 3.2 Grams per liter | Standard Deviation 4.71 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.2 Grams per liter | Standard Deviation 1.3 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | -0.8 Grams per liter | Standard Deviation 2.56 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -3.8 Grams per liter | Standard Deviation 3.6 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -5.3 Grams per liter | Standard Deviation 3.33 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.2 Grams per liter | Standard Deviation 0.75 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.2 Grams per liter | Standard Deviation 5.49 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.3 Grams per liter | Standard Deviation 4.8 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.2 Grams per liter | Standard Deviation 1.48 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.0 Grams per liter | Standard Deviation 5.33 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.3 Grams per liter | Standard Deviation 1.03 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 2.5 Grams per liter | Standard Deviation 2.88 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.3 Grams per liter | Standard Deviation 1.37 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 48 hours, n=6,6,6,6,6,6,6,5,16 | -3.8 Grams per liter | Standard Deviation 5.34 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.7 Grams per liter | Standard Deviation 4.13 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -1.7 Grams per liter | Standard Deviation 7.2 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 1.0 Grams per liter | Standard Deviation 0.89 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.5 Grams per liter | Standard Deviation 5.32 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.0 Grams per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.2 Grams per liter | Standard Deviation 1.1 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.2 Grams per liter | Standard Deviation 3.19 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.3 Grams per liter | Standard Deviation 2.5 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.7 Grams per liter | Standard Deviation 3.14 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 1.0 Grams per liter | Standard Deviation 5.1 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.3 Grams per liter | Standard Deviation 0.5 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.2 Grams per liter | Standard Deviation 1.83 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 0.8 Grams per liter | Standard Deviation 0.96 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.8 Grams per liter | Standard Deviation 4.92 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.0 Grams per liter | Standard Deviation 8.72 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 2.5 Grams per liter | Standard Deviation 4.97 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.7 Grams per liter | Standard Deviation 2.94 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 96 hours, n=6,6,6,6,6,6,6,6,15 | 7.2 Grams per liter | Standard Deviation 4.36 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 48 hours, n=6,6,6,6,6,6,6,5,16 | 6.5 Grams per liter | Standard Deviation 6.25 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 24 hours, n=6,6,6,6,6,6,6,6,16 | 6.8 Grams per liter | Standard Deviation 4.62 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | -1.0 Grams per liter | Standard Deviation 3.1 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.2 Grams per liter | Standard Deviation 0.84 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.2 Grams per liter | Standard Deviation 2.23 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.3 Grams per liter | Standard Deviation 1.51 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.0 Grams per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 3.0 Grams per liter | Standard Deviation 3.95 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.2 Grams per liter | Standard Deviation 0.45 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 0.0 Grams per liter | Standard Deviation 1.41 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -2.5 Grams per liter | Standard Deviation 1.97 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 96 hours, n=6,6,6,6,6,6,6,6,15 | -5.3 Grams per liter | Standard Deviation 6.44 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.5 Grams per liter | Standard Deviation 2.35 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -2.2 Grams per liter | Standard Deviation 2.79 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 2.2 Grams per liter | Standard Deviation 4.92 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.7 Grams per liter | Standard Deviation 6.12 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.7 Grams per liter | Standard Deviation 7.39 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.8 Grams per liter | Standard Deviation 7.05 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.0 Grams per liter | Standard Deviation 0.63 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.5 Grams per liter | Standard Deviation 0.55 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.8 Grams per liter | Standard Deviation 0.45 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 0.5 Grams per liter | Standard Deviation 1.52 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 48 hours, n=6,6,6,6,6,6,6,5,16 | -2.8 Grams per liter | Standard Deviation 8.76 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 0.7 Grams per liter | Standard Deviation 1.37 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.8 Grams per liter | Standard Deviation 0.5 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.8 Grams per liter | Standard Deviation 0.96 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.5 Grams per liter | Standard Deviation 9.03 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.7 Grams per liter | Standard Deviation 5.47 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.3 Grams per liter | Standard Deviation 1.37 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.05 Grams per liter | Standard Deviation 1.05 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.6 Grams per liter | Standard Deviation 2.07 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 2.0 Grams per liter | Standard Deviation 2.97 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.3 Grams per liter | Standard Deviation 0.82 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -11.2 Grams per liter | Standard Deviation 9.02 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.9 Grams per liter | Standard Deviation 6.69 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 96 hours, n=6,6,6,6,6,6,6,6,15 | 4.6 Grams per liter | Standard Deviation 7.56 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.8 Grams per liter | Standard Deviation 6.69 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 0.4 Grams per liter | Standard Deviation 1.36 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.5 Grams per liter | Standard Deviation 1.1 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.6 Grams per liter | Standard Deviation 6.83 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 1.2 Grams per liter | Standard Deviation 4.2 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.6 Grams per liter | Standard Deviation 2.61 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.3 Grams per liter | Standard Deviation 0.9 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.6 Grams per liter | Standard Deviation 2.97 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.2 Grams per liter | Standard Deviation 3.19 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.3 Grams per liter | Standard Deviation 1.23 |
Primary
Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein
Blood samples were collected to analyze the chemistry parameter: Protein. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.3 Grams per liter | Standard Deviation 3.39 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.7 Grams per liter | Standard Deviation 5.16 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.2 Grams per liter | Standard Deviation 3.6 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | FU (Day 15),n=6,6,6,6,6,6,6,6,16 | -0.5 Grams per liter | Standard Deviation 3.62 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 0.7 Grams per liter | Standard Deviation 2.25 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 24 hours, n=6,6,6,6,6,6,6,6,16 | 2.5 Grams per liter | Standard Deviation 0.84 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.0 Grams per liter | Standard Deviation 1.26 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.5 Grams per liter | Standard Deviation 3.39 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 48 hours, n=6,6,6,6,6,6,6,5,16 | -4.0 Grams per liter | Standard Deviation 4.05 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | FU (Day 15),n=6,6,6,6,6,6,6,6,16 | -1.3 Grams per liter | Standard Deviation 6.31 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 96 hours, n=6,6,6,6,6,6,6,6,15 | -2.0 Grams per liter | Standard Deviation 4.73 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 24 hours, n=6,6,6,6,6,6,6,6,16 | -5.2 Grams per liter | Standard Deviation 3.76 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.0 Grams per liter | Standard Deviation 3.16 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 48 hours, n=6,6,6,6,6,6,6,5,16 | -2.3 Grams per liter | Standard Deviation 2.42 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.0 Grams per liter | Standard Deviation 4.1 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 0.2 Grams per liter | Standard Deviation 3.66 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.7 Grams per liter | Standard Deviation 5.2 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.3 Grams per liter | Standard Deviation 1.51 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.2 Grams per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | FU (Day 15),n=6,6,6,6,6,6,6,6,16 | -2.7 Grams per liter | Standard Deviation 3.2 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 1.7 Grams per liter | Standard Deviation 2.42 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.7 Grams per liter | Standard Deviation 1.21 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.8 Grams per liter | Standard Deviation 1.94 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 48 hours, n=6,6,6,6,6,6,6,5,16 | 2.2 Grams per liter | Standard Deviation 1.33 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.3 Grams per liter | Standard Deviation 2.94 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.3 Grams per liter | Standard Deviation 3.88 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | FU (Day 15),n=6,6,6,6,6,6,6,6,16 | -1.7 Grams per liter | Standard Deviation 3.98 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.3 Grams per liter | Standard Deviation 2.73 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 48 hours, n=6,6,6,6,6,6,6,5,16 | 1.8 Grams per liter | Standard Deviation 2.28 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 1.7 Grams per liter | Standard Deviation 1.86 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.8 Grams per liter | Standard Deviation 3.6 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 24 hours, n=6,6,6,6,6,6,6,6,16 | 2.3 Grams per liter | Standard Deviation 2.25 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.8 Grams per liter | Standard Deviation 2.37 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | FU (Day 15),n=6,6,6,6,6,6,6,6,16 | 1.5 Grams per liter | Standard Deviation 3.85 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.3 Grams per liter | Standard Deviation 3.75 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein | 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.2 Grams per liter | Standard Deviation 3.31 |
Primary
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Blood samples were collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, urea. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.3 Millimoles per liter | Standard Deviation 1.86 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 1.0 Millimoles per liter | Standard Deviation 1.1 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.045 Millimoles per liter | Standard Deviation 0.0931 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.043 Millimoles per liter | Standard Deviation 0.0983 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.7 Millimoles per liter | Standard Deviation 1.86 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.018 Millimoles per liter | Standard Deviation 0.0483 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.7 Millimoles per liter | Standard Deviation 1.21 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 24 hours, n=6,6,6,6,6,6,6,6,16 | 1.8 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.2 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.077 Millimoles per liter | Standard Deviation 0.1084 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.2 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.7 Millimoles per liter | Standard Deviation 1.37 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.0 Millimoles per liter | Standard Deviation 1.26 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.12 Millimoles per liter | Standard Deviation 0.436 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.047 Millimoles per liter | Standard Deviation 0.0997 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.28 Millimoles per liter | Standard Deviation 0.417 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.116620 Millimoles per liter | Standard Deviation 0.7274909 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.483140 Millimoles per liter | Standard Deviation 0.9491815 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.148 Millimoles per liter | Standard Deviation 0.0679 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.03 Millimoles per liter | Standard Deviation 0.647 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.316540 Millimoles per liter | Standard Deviation 0.8081731 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.088 Millimoles per liter | Standard Deviation 0.1074 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.005 Millimoles per liter | Standard Deviation 0.0909 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.107 Millimoles per liter | Standard Deviation 0.1224 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.8 Millimoles per liter | Standard Deviation 2.14 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.008 Millimoles per liter | Standard Deviation 0.0643 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.003 Millimoles per liter | Standard Deviation 0.0686 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 48 hours, n=6,6,6,6,6,6,6,5,16 | 1.8 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.033320 Millimoles per liter | Standard Deviation 0.3443425 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.010 Millimoles per liter | Standard Deviation 0.0525 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.00 Millimoles per liter | Standard Deviation 0.525 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.8 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.042 Millimoles per liter | Standard Deviation 0.0581 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.43 Millimoles per liter | Standard Deviation 0.413 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.2 Millimoles per liter | Standard Deviation 2.14 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.0 Millimoles per liter | Standard Deviation 1.9 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.233240 Millimoles per liter | Standard Deviation 0.9476011 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.416500 Millimoles per liter | Standard Deviation 0.8769556 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.283220 Millimoles per liter | Standard Deviation 1.039616 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 24 hours, n=6,6,6,6,6,6,6,6,16 | 3.0 Millimoles per liter | Standard Deviation 3.03 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.017 Millimoles per liter | Standard Deviation 0.035 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 48 hours, n=6,6,6,6,6,6,6,5,16 | 3.5 Millimoles per liter | Standard Deviation 2.66 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.30 Millimoles per liter | Standard Deviation 0.31 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 96 hours, n=6,6,6,6,6,6,6,6,15 | 2.0 Millimoles per liter | Standard Deviation 3.41 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.3 Millimoles per liter | Standard Deviation 2.25 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.2 Millimoles per liter | Standard Deviation 2.99 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.5 Millimoles per liter | Standard Deviation 1.05 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.005 Millimoles per liter | Standard Deviation 0.0513 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.8 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.038 Millimoles per liter | Standard Deviation 0.0627 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.30 Millimoles per liter | Standard Deviation 0.335 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 24 hours, n=6,6,6,6,6,6,6,6,16 | -2.2 Millimoles per liter | Standard Deviation 2.04 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.022 Millimoles per liter | Standard Deviation 0.0488 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.060 Millimoles per liter | Standard Deviation 0.062 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.035 Millimoles per liter | Standard Deviation 0.0367 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.466480 Millimoles per liter | Standard Deviation 0.9929136 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.070 Millimoles per liter | Standard Deviation 0.0687 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.117 Millimoles per liter | Standard Deviation 0.1777 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.022 Millimoles per liter | Standard Deviation 0.1713 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.122 Millimoles per liter | Standard Deviation 0.1854 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.3 Millimoles per liter | Standard Deviation 2.07 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.018 Millimoles per liter | Standard Deviation 0.123 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.42 Millimoles per liter | Standard Deviation 0.313 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.5 Millimoles per liter | Standard Deviation 1.64 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 24 hours, n=6,6,6,6,6,6,6,6,16 | 2.7 Millimoles per liter | Standard Deviation 2.07 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.3 Millimoles per liter | Standard Deviation 2.42 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.1230 Millimoles per liter | Standard Deviation 0.1378 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.037 Millimoles per liter | Standard Deviation 0.0866 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.023 Millimoles per liter | Standard Deviation 0.0393 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.037 Millimoles per liter | Standard Deviation 0.0535 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.25 Millimoles per liter | Standard Deviation 0.217 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.008 Millimoles per liter | Standard Deviation 0.1194 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.7 Millimoles per liter | Standard Deviation 1.21 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 24 hours, n=6,6,6,6,6,6,6,6,16 | -3.2 Millimoles per liter | Standard Deviation 3.06 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.05 Millimoles per liter | Standard Deviation 0.207 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.020 Millimoles per liter | Standard Deviation 0.0583 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.38 Millimoles per liter | Standard Deviation 0.306 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.012 Millimoles per liter | Standard Deviation 0.0838 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.33 Millimoles per liter | Standard Deviation 0.327 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.299880 Millimoles per liter | Standard Deviation 0.6630596 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.098 Millimoles per liter | Standard Deviation 0.1843 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.032 Millimoles per liter | Standard Deviation 0.0731 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.107 Millimoles per liter | Standard Deviation 0.154 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.116620 Millimoles per liter | Standard Deviation 0.7701895 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.3 Millimoles per liter | Standard Deviation 2.16 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.098 Millimoles per liter | Standard Deviation 0.1485 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.2 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.0 Millimoles per liter | Standard Deviation 2 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 1.0 Millimoles per liter | Standard Deviation 1.67 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 96 hours, n=6,6,6,6,6,6,6,6,15 | -2.0 Millimoles per liter | Standard Deviation 2.76 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.316540 Millimoles per liter | Standard Deviation 1.0510863 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -1.8 Millimoles per liter | Standard Deviation 2.64 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.5 Millimoles per liter | Standard Deviation 1.64 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.035 Millimoles per liter | Standard Deviation 0.0468 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.466480 Millimoles per liter | Standard Deviation 0.3828177 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 48 hours, n=6,6,6,6,6,6,6,5,16 | 2.3 Millimoles per liter | Standard Deviation 1.63 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.03 Millimoles per liter | Standard Deviation 0.356 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.733040 Millimoles per liter | Standard Deviation 1.1736967 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.063 Millimoles per liter | Standard Deviation 0.1528 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.683060 Millimoles per liter | Standard Deviation 1.010371 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.5 Millimoles per liter | Standard Deviation 1.87 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.090 Millimoles per liter | Standard Deviation 0.1485 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.07 Millimoles per liter | Standard Deviation 0.258 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.023 Millimoles per liter | Standard Deviation 0.0398 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.3 Millimoles per liter | Standard Deviation 3.01 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.033 Millimoles per liter | Standard Deviation 0.0987 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.015 Millimoles per liter | Standard Deviation 0.0568 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.2 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.003 Millimoles per liter | Standard Deviation 0.0709 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.7 Millimoles per liter | Standard Deviation 1.63 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.12 Millimoles per liter | Standard Deviation 0.232 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 24 hours, n=6,6,6,6,6,6,6,6,16 | 2.2 Millimoles per liter | Standard Deviation 2.04 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.7 Millimoles per liter | Standard Deviation 1.75 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.055 Millimoles per liter | Standard Deviation 0.1934 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.012 Millimoles per liter | Standard Deviation 0.0349 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.010 Millimoles per liter | Standard Deviation 0.0502 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.499800 Millimoles per liter | Standard Deviation 0.5930586 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.027 Millimoles per liter | Standard Deviation 0.0747 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.7 Millimoles per liter | Standard Deviation 1.37 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.3 Millimoles per liter | Standard Deviation 2.5 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.0 Millimoles per liter | Standard Deviation 1.79 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.649740 Millimoles per liter | Standard Deviation 1.0517198 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.20 Millimoles per liter | Standard Deviation 0.29 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.3 Millimoles per liter | Standard Deviation 2.07 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.080 Millimoles per liter | Standard Deviation 0.137 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.008 Millimoles per liter | Standard Deviation 0.0808 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 48 hours, n=6,6,6,6,6,6,6,5,16 | -2.0 Millimoles per liter | Standard Deviation 1.9 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 48 hours, n=6,6,6,6,6,6,6,5,16 | 2.7 Millimoles per liter | Standard Deviation 1.86 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.5 Millimoles per liter | Standard Deviation 0.55 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.003 Millimoles per liter | Standard Deviation 0.1279 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.2 Millimoles per liter | Standard Deviation 2.14 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 48 hours, n=6,6,6,6,6,6,6,5,16 | 2.2 Millimoles per liter | Standard Deviation 1.94 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.2 Millimoles per liter | Standard Deviation 4.31 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.2 Millimoles per liter | Standard Deviation 1.94 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.017 Millimoles per liter | Standard Deviation 0.0476 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.002 Millimoles per liter | Standard Deviation 0.0264 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.017 Millimoles per liter | Standard Deviation 0.0361 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.043 Millimoles per liter | Standard Deviation 0.1499 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.028 Millimoles per liter | Standard Deviation 0.0995 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.042 Millimoles per liter | Standard Deviation 0.1865 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.20 Millimoles per liter | Standard Deviation 0.276 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.20 Millimoles per liter | Standard Deviation 0.352 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.07 Millimoles per liter | Standard Deviation 0.25 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.8 Millimoles per liter | Standard Deviation 1.6 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.7 Millimoles per liter | Standard Deviation 1.86 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.8 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.012 Millimoles per liter | Standard Deviation 0.0492 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.008 Millimoles per liter | Standard Deviation 0.0736 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.015 Millimoles per liter | Standard Deviation 0.068 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.047 Millimoles per liter | Standard Deviation 0.0528 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.2 Millimoles per liter | Standard Deviation 3.06 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.2 Millimoles per liter | Standard Deviation 2.32 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.5 Millimoles per liter | Standard Deviation 2.88 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.3 Millimoles per liter | Standard Deviation 3.39 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.003 Millimoles per liter | Standard Deviation 0.0393 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.166600 Millimoles per liter | Standard Deviation 0.8450414 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.233240 Millimoles per liter | Standard Deviation 0.9601712 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.433160 Millimoles per liter | Standard Deviation 0.5986483 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.233240 Millimoles per liter | Standard Deviation 2.0187631 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.20 Millimoles per liter | Standard Deviation 0.253 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.8 Millimoles per liter | Standard Deviation 1.94 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.7 Millimoles per liter | Standard Deviation 2.07 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.20 Millimoles per liter | Standard Deviation 0.316 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.3 Millimoles per liter | Standard Deviation 2.42 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.027 Millimoles per liter | Standard Deviation 0.1645 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 48 hours, n=6,6,6,6,6,6,6,5,16 | 5.8 Millimoles per liter | Standard Deviation 3.71 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.048 Millimoles per liter | Standard Deviation 0.0204 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.649740 Millimoles per liter | Standard Deviation 0.717348 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.043 Millimoles per liter | Standard Deviation 0.0753 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.5 Millimoles per liter | Standard Deviation 1.76 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.010 Millimoles per liter | Standard Deviation 0.1803 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.599760 Millimoles per liter | Standard Deviation 0.7717016 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.049980 Millimoles per liter | Standard Deviation 0.5955804 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.145 Millimoles per liter | Standard Deviation 0.0568 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.058 Millimoles per liter | Standard Deviation 0.1816 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.5 Millimoles per liter | Standard Deviation 2.66 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.18 Millimoles per liter | Standard Deviation 0.183 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.30 Millimoles per liter | Standard Deviation 0.228 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.8 Millimoles per liter | Standard Deviation 2.48 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.060 Millimoles per liter | Standard Deviation 0.0369 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 1.2 Millimoles per liter | Standard Deviation 2.23 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.055 Millimoles per liter | Standard Deviation 0.1407 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.7 Millimoles per liter | Standard Deviation 3.08 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.017 Millimoles per liter | Standard Deviation 0.0367 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.0 Millimoles per liter | Standard Deviation 0.2 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.033 Millimoles per liter | Standard Deviation 0.0398 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.2 Millimoles per liter | Standard Deviation 2.93 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.097 Millimoles per liter | Standard Deviation 0.0625 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.316540 Millimoles per liter | Standard Deviation 0.6366649 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.060 Millimoles per liter | Standard Deviation 0.0562 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.22 Millimoles per liter | Standard Deviation 0.313 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.3 Millimoles per liter | Standard Deviation 2.94 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.025 Millimoles per liter | Standard Deviation 0.0497 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.133280 Millimoles per liter | Standard Deviation 0.3880028 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 96 hours, n=6,6,6,6,6,6,6,6,15 | -2.2 Millimoles per liter | Standard Deviation 2.04 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.8 Millimoles per liter | Standard Deviation 1.83 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.5 Millimoles per liter | Standard Deviation 1.38 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.017 Millimoles per liter | Standard Deviation 0.0476 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.8 Millimoles per liter | Standard Deviation 2.48 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 24 hours, n=6,6,6,6,6,6,6,6,16 | -2.2 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.003 Millimoles per liter | Standard Deviation 0.0339 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.5 Millimoles per liter | Standard Deviation 2.17 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.032 Millimoles per liter | Standard Deviation 0.1647 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.08 Millimoles per liter | Standard Deviation 0.232 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.3 Millimoles per liter | Standard Deviation 2.25 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.05 Millimoles per liter | Standard Deviation 0.339 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.013 Millimoles per liter | Standard Deviation 0.055 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.07 Millimoles per liter | Standard Deviation 0.163 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.035 Millimoles per liter | Standard Deviation 0.0731 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.092 Millimoles per liter | Standard Deviation 0.124 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 24 hours, n=6,6,6,6,6,6,6,6,16 | -1.3 Millimoles per liter | Standard Deviation 1.21 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.033 Millimoles per liter | Standard Deviation 0.0308 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.017 Millimoles per liter | Standard Deviation 0.1134 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.10 Millimoles per liter | Standard Deviation 0.245 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.166600 Millimoles per liter | Standard Deviation 0.924112 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.7 Millimoles per liter | Standard Deviation 2.16 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.033320 Millimoles per liter | Standard Deviation 1.0907403 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.7 Millimoles per liter | Standard Deviation 2.16 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.025 Millimoles per liter | Standard Deviation 0.0459 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.3 Millimoles per liter | Standard Deviation 2.88 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.025 Millimoles per liter | Standard Deviation 0.1801 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.7 Millimoles per liter | Standard Deviation 2.73 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.063 Millimoles per liter | Standard Deviation 0.1138 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.083300 Millimoles per liter | Standard Deviation 0.710818 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.05 Millimoles per liter | Standard Deviation 0.423 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.3 Millimoles per liter | Standard Deviation 1.03 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.076 Millimoles per liter | Standard Deviation 0.0963 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.3 Millimoles per liter | Standard Deviation 2.73 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.002 Millimoles per liter | Standard Deviation 0.0454 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.018 Millimoles per liter | Standard Deviation 0.0968 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.018 Millimoles per liter | Standard Deviation 0.0349 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.015 Millimoles per liter | Standard Deviation 0.0468 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.045 Millimoles per liter | Standard Deviation 0.0836 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.007 Millimoles per liter | Standard Deviation 0.0476 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.027 Millimoles per liter | Standard Deviation 0.0455 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.034 Millimoles per liter | Standard Deviation 0.0513 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -1.332800 Millimoles per liter | Standard Deviation 1.423041 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.6 Millimoles per liter | Standard Deviation 1.95 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 96 hours, n=6,6,6,6,6,6,6,6,15 | -2.2 Millimoles per liter | Standard Deviation 2.32 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.3 Millimoles per liter | Standard Deviation 1.97 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.8 Millimoles per liter | Standard Deviation 1.64 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.7 Millimoles per liter | Standard Deviation 3.27 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.0 Millimoles per liter | Standard Deviation 1.67 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.8 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.0 Millimoles per liter | Standard Deviation 2.19 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.012 Millimoles per liter | Standard Deviation 0.056 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.12 Millimoles per liter | Standard Deviation 0.204 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.849660 Millimoles per liter | Standard Deviation 1.3570283 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.002 Millimoles per liter | Standard Deviation 0.1341 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.06 Millimoles per liter | Standard Deviation 0.251 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 48 hours, n=6,6,6,6,6,6,6,5,16 | -1.099560 Millimoles per liter | Standard Deviation 0.8242913 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.042 Millimoles per liter | Standard Deviation 0.1144 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.916300 Millimoles per liter | Standard Deviation 1.5178348 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.27 Millimoles per liter | Standard Deviation 0.314 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.5 Millimoles per liter | Standard Deviation 2.26 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.8 Millimoles per liter | Standard Deviation 1.92 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.099960 Millimoles per liter | Standard Deviation 0.6590288 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.022 Millimoles per liter | Standard Deviation 0.1285 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.046648 Millimoles per liter | Standard Deviation 1.2598057 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.1 Millimoles per liter | Standard Deviation 2.47 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.014 Millimoles per liter | Standard Deviation 0.0495 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.029 Millimoles per liter | Standard Deviation 0.1391 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 48 hours, n=6,6,6,6,6,6,6,5,16 | -0.187425 Millimoles per liter | Standard Deviation 1.0590572 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.5 Millimoles per liter | Standard Deviation 1.75 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.5 Millimoles per liter | Standard Deviation 2.42 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.022 Millimoles per liter | Standard Deviation 0.1561 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Phosphate, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.020 Millimoles per liter | Standard Deviation 0.1363 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.6 Millimoles per liter | Standard Deviation 2 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate,FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.1 Millimoles per liter | Standard Deviation 1.65 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.034 Millimoles per liter | Standard Deviation 0.0626 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.6 Millimoles per liter | Standard Deviation 1.75 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.10 Millimoles per liter | Standard Deviation 0.379 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.8 Millimoles per liter | Standard Deviation 1.8 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.042 Millimoles per liter | Standard Deviation 0.0507 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.034 Millimoles per liter | Standard Deviation 0.0687 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.25 Millimoles per liter | Standard Deviation 0.316 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.3 Millimoles per liter | Standard Deviation 1.95 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Sodium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.4 Millimoles per liter | Standard Deviation 1.82 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Magnesium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.002 Millimoles per liter | Standard Deviation 0.0489 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.30 Millimoles per liter | Standard Deviation 0.314 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.031 Millimoles per liter | Standard Deviation 0.0762 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 48 hours, n=6,6,6,6,6,6,6,5,16 | 2.1 Millimoles per liter | Standard Deviation 3.57 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Bicarbonate, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.8 Millimoles per liter | Standard Deviation 2.59 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Chloride, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.1 Millimoles per liter | Standard Deviation 2.76 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.033 Millimoles per liter | Standard Deviation 0.0694 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Urea, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.187425 Millimoles per liter | Standard Deviation 0.9102217 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Potassium, 48 hours, n=6,6,6,6,6,6,6,5,16 | 0.16 Millimoles per liter | Standard Deviation 0.278 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea | Calcium, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.005 Millimoles per liter | Standard Deviation 0.0647 |
Primary
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Blood samples were collected to analyze the hematology parameter: Erythrocyte MCH. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.Results are presented treatment wise.
Time frame: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.12 Picograms | Standard Deviation 0.337 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.15 Picograms | Standard Deviation 0.464 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.47 Picograms | Standard Deviation 0.339 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Follow up, Day 15,n=6,6,6,6,6,6,6,6,16 | -0.07 Picograms | Standard Deviation 0.266 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Follow up, Day 15,n=6,6,6,6,6,6,6,6,16 | -0.27 Picograms | Standard Deviation 0.459 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.18 Picograms | Standard Deviation 0.147 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.08 Picograms | Standard Deviation 0.271 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.02 Picograms | Standard Deviation 0.194 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.14 Picograms | Standard Deviation 0.321 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Follow up, Day 15,n=6,6,6,6,6,6,6,6,16 | 0.35 Picograms | Standard Deviation 0.66 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 96 hours,n=6,6,6,6,6,6,6,6,15 | -0.33 Picograms | Standard Deviation 0.301 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.00 Picograms | Standard Deviation 0.438 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.15 Picograms | Standard Deviation 0.596 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.37 Picograms | Standard Deviation 0.779 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.17 Picograms | Standard Deviation 1.111 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Follow up, Day 15,n=6,6,6,6,6,6,6,6,16 | 0.03 Picograms | Standard Deviation 0.665 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.63 Picograms | Standard Deviation 0.589 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.73 Picograms | Standard Deviation 0.45 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.25 Picograms | Standard Deviation 0.485 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Follow up, Day 15,n=6,6,6,6,6,6,6,6,16 | 0.92 Picograms | Standard Deviation 0.741 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Follow up, Day 15,n=6,6,6,6,6,6,6,6,16 | -0.40 Picograms | Standard Deviation 0.514 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.15 Picograms | Standard Deviation 0.339 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 96 hours,n=6,6,6,6,6,6,6,6,15 | -0.02 Picograms | Standard Deviation 0.319 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.18 Picograms | Standard Deviation 0.397 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 96 hours,n=6,6,6,6,6,6,6,6,15 | -0.13 Picograms | Standard Deviation 0.459 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.03 Picograms | Standard Deviation 0.821 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Follow up, Day 15,n=6,6,6,6,6,6,6,6,16 | -0.03 Picograms | Standard Deviation 0.207 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.08 Picograms | Standard Deviation 0.963 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.13 Picograms | Standard Deviation 0.446 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Follow up, Day 15,n=6,6,6,6,6,6,6,6,16 | 0.02 Picograms | Standard Deviation 0.319 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 96 hours,n=6,6,6,6,6,6,6,6,15 | -0.13 Picograms | Standard Deviation 0.497 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.07 Picograms | Standard Deviation 0.7 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.01 Picograms | Standard Deviation 0.635 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Follow up, Day 15,n=6,6,6,6,6,6,6,6,16 | 0.03 Picograms | Standard Deviation 0.639 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.17 Picograms | Standard Deviation 0.442 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.18 Picograms | Standard Deviation 0.583 |
Primary
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.0080 Percentage of red blood cells in blood | Standard Deviation 0.02666 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.0032 Percentage of red blood cells in blood | Standard Deviation 0.02247 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.0123 Percentage of red blood cells in blood | Standard Deviation 0.02767 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.0223 Percentage of red blood cells in blood | Standard Deviation 0.01896 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.0198 Percentage of red blood cells in blood | Standard Deviation 0.01771 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.0222 Percentage of red blood cells in blood | Standard Deviation 0.01879 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.0143 Percentage of red blood cells in blood | Standard Deviation 0.01521 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.0288 Percentage of red blood cells in blood | Standard Deviation 0.0115 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.0003 Percentage of red blood cells in blood | Standard Deviation 0.01791 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.0078 Percentage of red blood cells in blood | Standard Deviation 0.02337 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.0018 Percentage of red blood cells in blood | Standard Deviation 0.02255 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.0025 Percentage of red blood cells in blood | Standard Deviation 0.02848 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.0145 Percentage of red blood cells in blood | Standard Deviation 0.02346 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.0163 Percentage of red blood cells in blood | Standard Deviation 0.02526 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.0102 Percentage of red blood cells in blood | Standard Deviation 0.02851 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.0012 Percentage of red blood cells in blood | Standard Deviation 0.03201 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.0128 Percentage of red blood cells in blood | Standard Deviation 0.02031 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.0103 Percentage of red blood cells in blood | Standard Deviation 0.01256 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 96 hours,n=6,6,6,6,6,6,6,6,15 | -0.0072 Percentage of red blood cells in blood | Standard Deviation 0.02753 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.0185 Percentage of red blood cells in blood | Standard Deviation 0.01816 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.0070 Percentage of red blood cells in blood | Standard Deviation 0.01534 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.0155 Percentage of red blood cells in blood | Standard Deviation 0.01058 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.0252 Percentage of red blood cells in blood | Standard Deviation 0.0097 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.0108 Percentage of red blood cells in blood | Standard Deviation 0.00947 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.0045 Percentage of red blood cells in blood | Standard Deviation 0.02345 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.0013 Percentage of red blood cells in blood | Standard Deviation 0.01739 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.0038 Percentage of red blood cells in blood | Standard Deviation 0.01333 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.0265 Percentage of red blood cells in blood | Standard Deviation 0.01852 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.0250 Percentage of red blood cells in blood | Standard Deviation 0.01416 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.0200 Percentage of red blood cells in blood | Standard Deviation 0.02265 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.0148 Percentage of red blood cells in blood | Standard Deviation 0.02179 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.0007 Percentage of red blood cells in blood | Standard Deviation 0.01945 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.0035 Percentage of red blood cells in blood | Standard Deviation 0.02603 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.0174 Percentage of red blood cells in blood | Standard Deviation 0.0174 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.0163 Percentage of red blood cells in blood | Standard Deviation 0.0163 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.0177 Percentage of red blood cells in blood | Standard Deviation 0.0177 |
Primary
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb)
Blood samples were collected to analyze the hematology parameter: Hb. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 4.2 Grams per liter | Standard Deviation 8.93 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 5.7 Grams per liter | Standard Deviation 10.65 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 96 hours, n=6,6,6,6,6,6,6,6,15 | 6.8 Grams per liter | Standard Deviation 6.27 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.5 Grams per liter | Standard Deviation 5.75 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 3.0 Grams per liter | Standard Deviation 7.24 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 10.8 Grams per liter | Standard Deviation 3.43 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 4.7 Grams per liter | Standard Deviation 5.89 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 96 hours, n=6,6,6,6,6,6,6,6,15 | 6.0 Grams per liter | Standard Deviation 5.33 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.0 Grams per liter | Standard Deviation 6.6 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.0 Grams per liter | Standard Deviation 11.05 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.8 Grams per liter | Standard Deviation 6.49 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.0 Grams per liter | Standard Deviation 5.51 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 3.5 Grams per liter | Standard Deviation 7.34 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 5.2 Grams per liter | Standard Deviation 6.88 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 96 hours, n=6,6,6,6,6,6,6,6,15 | 6.3 Grams per liter | Standard Deviation 7 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.0 Grams per liter | Standard Deviation 7.97 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 96 hours, n=6,6,6,6,6,6,6,6,15 | 2.3 Grams per liter | Standard Deviation 7.97 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 8.3 Grams per liter | Standard Deviation 3.2 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 7.7 Grams per liter | Standard Deviation 5.82 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -1.5 Grams per liter | Standard Deviation 7.06 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.5 Grams per liter | Standard Deviation 3.39 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 6.8 Grams per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 96 hours, n=6,6,6,6,6,6,6,6,15 | 3.2 Grams per liter | Standard Deviation 2.71 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 7.7 Grams per liter | Standard Deviation 3.72 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.2 Grams per liter | Standard Deviation 9.13 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 2.5 Grams per liter | Standard Deviation 6.35 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -9.2 Grams per liter | Standard Deviation 6.82 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 3.0 Grams per liter | Standard Deviation 6.04 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 6.2 Grams per liter | Standard Deviation 7.88 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.2 Grams per liter | Standard Deviation 6.37 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 96 hours, n=6,6,6,6,6,6,6,6,15 | 6.5 Grams per liter | Standard Deviation 9.67 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 8.8 Grams per liter | Standard Deviation 7.91 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 24 hours, n=6,6,6,6,6,6,5,6,16 | 5.9 Grams per liter | Standard Deviation 7.29 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.0 Grams per liter | Standard Deviation 8.25 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 96 hours, n=6,6,6,6,6,6,6,6,15 | 6.6 Grams per liter | Standard Deviation 5.51 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) | 48 hours, n=6,6,5,6,6,6,6,6,16 | 6.0 Grams per liter | Standard Deviation 7.85 |
Primary
Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Blood samples were collected to analyze the hematology parameter: percentage of reticulocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.00050 10^12 cells per liter | Standard Deviation 0.00139 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.00082 10^12 cells per liter | Standard Deviation 0.001496 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 96 hours,n=6,6,6,6,6,6,6,6,15 | -0.00005 10^12 cells per liter | Standard Deviation 0.00204 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.00018 10^12 cells per liter | Standard Deviation 0.001273 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.00435 10^12 cells per liter | Standard Deviation 0.001628 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.00055 10^12 cells per liter | Standard Deviation 0.001608 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.00123 10^12 cells per liter | Standard Deviation 0.001334 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.00160 10^12 cells per liter | Standard Deviation 0.001615 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.00154 10^12 cells per liter | Standard Deviation 0.00179 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.00077 10^12 cells per liter | Standard Deviation 0.002293 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.00095 10^12 cells per liter | Standard Deviation 0.002517 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.00118 10^12 cells per liter | Standard Deviation 0.001955 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.00023 10^12 cells per liter | Standard Deviation 0.002223 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.00017 10^12 cells per liter | Standard Deviation 0.002028 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.00023 10^12 cells per liter | Standard Deviation 0.001965 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.00042 10^12 cells per liter | Standard Deviation 0.002832 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.00138 10^12 cells per liter | Standard Deviation 0.001841 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.00070 10^12 cells per liter | Standard Deviation 0.001451 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.00022 10^12 cells per liter | Standard Deviation 0.001694 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.00092 10^12 cells per liter | Standard Deviation 0.002495 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.00015 10^12 cells per liter | Standard Deviation 0.00164 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.00015 10^12 cells per liter | Standard Deviation 0.001276 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.00060 10^12 cells per liter | Standard Deviation 0.001663 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.00075 10^12 cells per liter | Standard Deviation 0.001838 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.00265 10^12 cells per liter | Standard Deviation 0.002867 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.00260 10^12 cells per liter | Standard Deviation 0.002924 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.00002 10^12 cells per liter | Standard Deviation 0.001841 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.00156 10^12 cells per liter | Standard Deviation 0.00249 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.00117 10^12 cells per liter | Standard Deviation 0.001859 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.00055 10^12 cells per liter | Standard Deviation 0.00223 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.00175 10^12 cells per liter | Standard Deviation 0.002019 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.00057 10^12 cells per liter | Standard Deviation 0.000579 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.00071 10^12 cells per liter | Standard Deviation 0.001808 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.00061 10^12 cells per liter | Standard Deviation 0.003329 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 96 hours,n=6,6,6,6,6,6,6,6,15 | 0.00162 10^12 cells per liter | Standard Deviation 0.002889 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.00118 10^12 cells per liter | Standard Deviation 0.002221 |
Primary
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | 0.398 10^9 cells /Liter | Standard Deviation 0.6349 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 96 hours, n=6,6,6,6,6,6,6,6,15 | -8.2 10^9 cells /Liter | Standard Deviation 15.75 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.3 10^9 cells /Liter | Standard Deviation 11.4 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 48 hours, n=6,6,5,6,6,6,6,6,16 | -1.5 10^9 cells /Liter | Standard Deviation 15.95 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.142 10^9 cells /Liter | Standard Deviation 0.2643 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 48 hour, 6,6,5,6,6,6,6,6,16 | -0.032 10^9 cells /Liter | Standard Deviation 0.1982 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.023 10^9 cells /Liter | Standard Deviation 0.1328 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 48 hours, 6,6,5,6,6,6,6,6,16 | 0.048 10^9 cells /Liter | Standard Deviation 0.1052 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes,FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | -0.003 10^9 cells /Liter | Standard Deviation 0.0771 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 15,n=6,6,6,6,6,6,6,6,16 | 0.002 10^9 cells /Liter | Standard Deviation 0.0133 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.015 10^9 cells /Liter | Standard Deviation 0.1266 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.528 10^9 cells /Liter | Standard Deviation 0.5383 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.693 10^9 cells /Liter | Standard Deviation 1.1514 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.003 10^9 cells /Liter | Standard Deviation 0.0103 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.002 10^9 cells /Liter | Standard Deviation 0.0098 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.017 10^9 cells /Liter | Standard Deviation 0.0755 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.348 10^9 cells /Liter | Standard Deviation 1.0652 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.507 10^9 cells /Liter | Standard Deviation 0.8878 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.592 10^9 cells /Liter | Standard Deviation 0.9839 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.002 10^9 cells /Liter | Standard Deviation 0.0075 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.022 10^9 cells /Liter | Standard Deviation 0.1876 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.587 10^9 cells /Liter | Standard Deviation 0.7991 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.603 10^9 cells /Liter | Standard Deviation 1.3012 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.073 10^9 cells /Liter | Standard Deviation 0.3189 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.082 10^9 cells /Liter | Standard Deviation 0.3344 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.027 10^9 cells /Liter | Standard Deviation 0.4607 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.052 10^9 cells /Liter | Standard Deviation 0.197 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -10.4 10^9 cells /Liter | Standard Deviation 21.59 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | 0.345 10^9 cells /Liter | Standard Deviation 0.9399 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.035 10^9 cells /Liter | Standard Deviation 0.0575 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.243 10^9 cells /Liter | Standard Deviation 0.1888 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 96 hours, n=6,6,6,6,6,6,6,6,15 | 7.3 10^9 cells /Liter | Standard Deviation 14.65 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.583 10^9 cells /Liter | Standard Deviation 0.6552 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.320 10^9 cells /Liter | Standard Deviation 0.2909 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.388 10^9 cells /Liter | Standard Deviation 0.8506 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.207 10^9 cells /Liter | Standard Deviation 0.2388 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.502 10^9 cells /Liter | Standard Deviation 1.2216 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 24 hours, n=6,6,6,6,6,6,5,6,16 | 9.7 10^9 cells /Liter | Standard Deviation 30.29 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 15,n=6,6,6,6,6,6,6,6,16 | 0.012 10^9 cells /Liter | Standard Deviation 0.0117 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 48 hours, n=6,6,5,6,6,6,6,6,16 | -3.2 10^9 cells /Liter | Standard Deviation 17.33 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.082 10^9 cells /Liter | Standard Deviation 0.1219 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.012 10^9 cells /Liter | Standard Deviation 0.0117 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 48 hour, 6,6,5,6,6,6,6,6,16 | 0.018 10^9 cells /Liter | Standard Deviation 0.0731 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.002 10^9 cells /Liter | Standard Deviation 0.0147 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.012 10^9 cells /Liter | Standard Deviation 0.0534 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.040 10^9 cells /Liter | Standard Deviation 0.0846 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 48 hours, 6,6,5,6,6,6,6,6,16 | 0.043 10^9 cells /Liter | Standard Deviation 0.1198 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.628 10^9 cells /Liter | Standard Deviation 0.6082 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 19.2 10^9 cells /Liter | Standard Deviation 14.66 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes,FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | 0.048 10^9 cells /Liter | Standard Deviation 0.0826 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.877 10^9 cells /Liter | Standard Deviation 0.7228 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.082 10^9 cells /Liter | Standard Deviation 0.2491 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.003 10^9 cells /Liter | Standard Deviation 0.5852 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.953 10^9 cells /Liter | Standard Deviation 0.8659 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.000 10^9 cells /Liter | Standard Deviation 0.0155 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.012 10^9 cells /Liter | Standard Deviation 0.0376 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.910 10^9 cells /Liter | Standard Deviation 1.1691 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 48 hour, 6,6,5,6,6,6,6,6,16 | 0.008 10^9 cells /Liter | Standard Deviation 0.0497 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 48 hours, 6,6,5,6,6,6,6,6,16 | -0.104 10^9 cells /Liter | Standard Deviation 0.1146 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.000 10^9 cells /Liter | Standard Deviation 0.0335 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes,FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | -0.022 10^9 cells /Liter | Standard Deviation 0.1309 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.107 10^9 cells /Liter | Standard Deviation 0.1405 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.562 10^9 cells /Liter | Standard Deviation 0.7714 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.546 10^9 cells /Liter | Standard Deviation 0.6919 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.165 10^9 cells /Liter | Standard Deviation 0.6984 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.575 10^9 cells /Liter | Standard Deviation 0.6277 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.012 10^9 cells /Liter | Standard Deviation 0.0591 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | 0.077 10^9 cells /Liter | Standard Deviation 1.0609 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.215 10^9 cells /Liter | Standard Deviation 0.3661 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 24 hours, n=6,6,6,6,6,6,5,6,16 | -8.5 10^9 cells /Liter | Standard Deviation 16.11 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 48 hours, n=6,6,5,6,6,6,6,6,16 | -11.0 10^9 cells /Liter | Standard Deviation 21.13 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.244 10^9 cells /Liter | Standard Deviation 0.4865 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 96 hours, n=6,6,6,6,6,6,6,6,15 | -6.8 10^9 cells /Liter | Standard Deviation 14.99 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.248 10^9 cells /Liter | Standard Deviation 0.3124 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -16.7 10^9 cells /Liter | Standard Deviation 36.59 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.005 10^9 cells /Liter | Standard Deviation 0.0084 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.113 10^9 cells /Liter | Standard Deviation 1.8444 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.010 10^9 cells /Liter | Standard Deviation 0.0187 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.897 10^9 cells /Liter | Standard Deviation 0.9192 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.003 10^9 cells /Liter | Standard Deviation 0.0103 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.090 10^9 cells /Liter | Standard Deviation 0.1307 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.878 10^9 cells /Liter | Standard Deviation 1.2611 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 15,n=6,6,6,6,6,6,6,6,16 | 0.000 10^9 cells /Liter | Standard Deviation 0.011 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.005 10^9 cells /Liter | Standard Deviation 0.065 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.107 10^9 cells /Liter | Standard Deviation 0.9821 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 48 hour, 6,6,5,6,6,6,6,6,16 | 0.010 10^9 cells /Liter | Standard Deviation 0.0544 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.230 10^9 cells /Liter | Standard Deviation 0.8517 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.045 10^9 cells /Liter | Standard Deviation 0.0505 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.015 10^9 cells /Liter | Standard Deviation 0.0489 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.002 10^9 cells /Liter | Standard Deviation 0.0147 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 13.0 10^9 cells /Liter | Standard Deviation 15.85 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.140 10^9 cells /Liter | Standard Deviation 0.2305 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.003 10^9 cells /Liter | Standard Deviation 0.0602 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.3 10^9 cells /Liter | Standard Deviation 17.29 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.007 10^9 cells /Liter | Standard Deviation 0.9485 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes,FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | 0.020 10^9 cells /Liter | Standard Deviation 0.1619 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.027 10^9 cells /Liter | Standard Deviation 0.9432 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.058 10^9 cells /Liter | Standard Deviation 0.8437 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | -0.037 10^9 cells /Liter | Standard Deviation 0.971 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.238 10^9 cells /Liter | Standard Deviation 0.2739 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.007 10^9 cells /Liter | Standard Deviation 1.0958 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 24 hours, n=6,6,6,6,6,6,5,6,16 | -17.5 10^9 cells /Liter | Standard Deviation 27.9 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 15,n=6,6,6,6,6,6,6,6,16 | 0.002 10^9 cells /Liter | Standard Deviation 0.0098 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 48 hours, n=6,6,5,6,6,6,6,6,16 | -1.7 10^9 cells /Liter | Standard Deviation 13.08 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.012 10^9 cells /Liter | Standard Deviation 0.4303 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.007 10^9 cells /Liter | Standard Deviation 0.0103 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.035 10^9 cells /Liter | Standard Deviation 0.1747 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 48 hours, 6,6,5,6,6,6,6,6,16 | -0.050 10^9 cells /Liter | Standard Deviation 0.0885 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.292 10^9 cells /Liter | Standard Deviation 0.9476 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.020 10^9 cells /Liter | Standard Deviation 0.0921 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.002 10^9 cells /Liter | Standard Deviation 0.0075 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.047 10^9 cells /Liter | Standard Deviation 0.0579 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.008 10^9 cells /Liter | Standard Deviation 0.0508 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.000 10^9 cells /Liter | Standard Deviation 0.3509 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.513 10^9 cells /Liter | Standard Deviation 0.9082 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 6.5 10^9 cells /Liter | Standard Deviation 22.64 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.292 10^9 cells /Liter | Standard Deviation 0.624 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.132 10^9 cells /Liter | Standard Deviation 0.8528 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.007 10^9 cells /Liter | Standard Deviation 0.0103 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.342 10^9 cells /Liter | Standard Deviation 0.9186 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.018 10^9 cells /Liter | Standard Deviation 0.0542 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.067 10^9 cells /Liter | Standard Deviation 0.402 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 48 hours, 6,6,5,6,6,6,6,6,16 | -0.002 10^9 cells /Liter | Standard Deviation 0.0854 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.342 10^9 cells /Liter | Standard Deviation 0.4796 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 48 hour, 6,6,5,6,6,6,6,6,16 | 0.010 10^9 cells /Liter | Standard Deviation 0.0544 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.005 10^9 cells /Liter | Standard Deviation 0.0055 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes,FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | 0.045 10^9 cells /Liter | Standard Deviation 0.0896 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.503 10^9 cells /Liter | Standard Deviation 1.1885 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.005 10^9 cells /Liter | Standard Deviation 0.0152 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.022 10^9 cells /Liter | Standard Deviation 0.1342 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.307 10^9 cells /Liter | Standard Deviation 1.1555 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.018 10^9 cells /Liter | Standard Deviation 0.1184 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.013 10^9 cells /Liter | Standard Deviation 0.0207 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.050 10^9 cells /Liter | Standard Deviation 0.2748 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 24 hours, n=6,6,6,6,6,6,5,6,16 | -2.8 10^9 cells /Liter | Standard Deviation 14.48 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.7 10^9 cells /Liter | Standard Deviation 14.98 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 15,n=6,6,6,6,6,6,6,6,16 | -0.007 10^9 cells /Liter | Standard Deviation 0.0082 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.188 10^9 cells /Liter | Standard Deviation 0.3172 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | 0.302 10^9 cells /Liter | Standard Deviation 0.6797 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 96 hours, n=6,6,6,6,6,6,6,6,15 | 2.3 10^9 cells /Liter | Standard Deviation 24.57 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.143 10^9 cells /Liter | Standard Deviation 0.1766 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 24 hours, n=6,6,6,6,6,6,5,6,16 | 7.2 10^9 cells /Liter | Standard Deviation 9.54 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.078 10^9 cells /Liter | Standard Deviation 0.1242 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes,FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | 0.115 10^9 cells /Liter | Standard Deviation 0.0789 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.500 10^9 cells /Liter | Standard Deviation 2.0326 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.455 10^9 cells /Liter | Standard Deviation 1.685 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.218 10^9 cells /Liter | Standard Deviation 2.3225 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | -0.643 10^9 cells /Liter | Standard Deviation 1.4316 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 48 hours, n=6,6,5,6,6,6,6,6,16 | 9.5 10^9 cells /Liter | Standard Deviation 11.64 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 96 hours, n=6,6,6,6,6,6,6,6,15 | 6.7 10^9 cells /Liter | Standard Deviation 15.02 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 13.0 10^9 cells /Liter | Standard Deviation 29.48 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.002 10^9 cells /Liter | Standard Deviation 0.0098 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.007 10^9 cells /Liter | Standard Deviation 0.0082 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.002 10^9 cells /Liter | Standard Deviation 0.0098 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 15,n=6,6,6,6,6,6,6,6,16 | 0.010 10^9 cells /Liter | Standard Deviation 0.0063 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.017 10^9 cells /Liter | Standard Deviation 0.0186 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 48 hour, 6,6,5,6,6,6,6,6,16 | 0.020 10^9 cells /Liter | Standard Deviation 0.0346 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.018 10^9 cells /Liter | Standard Deviation 0.0382 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.012 10^9 cells /Liter | Standard Deviation 0.0471 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.742 10^9 cells /Liter | Standard Deviation 2.2552 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.673 10^9 cells /Liter | Standard Deviation 1.8656 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.458 10^9 cells /Liter | Standard Deviation 2.3501 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.835 10^9 cells /Liter | Standard Deviation 1.6488 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.158 10^9 cells /Liter | Standard Deviation 0.1659 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.110 10^9 cells /Liter | Standard Deviation 0.2873 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.097 10^9 cells /Liter | Standard Deviation 0.4866 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.068 10^9 cells /Liter | Standard Deviation 0.2099 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 48 hours, 6,6,5,6,6,6,6,6,16 | 0.083 10^9 cells /Liter | Standard Deviation 0.1533 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.028 10^9 cells /Liter | Standard Deviation 0.0861 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.088 10^9 cells /Liter | Standard Deviation 0.4219 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.142 10^9 cells /Liter | Standard Deviation 1.5163 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.020 10^9 cells /Liter | Standard Deviation 0.1655 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.093 10^9 cells /Liter | Standard Deviation 0.3449 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -13.0 10^9 cells /Liter | Standard Deviation 48.17 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | 0.120 10^9 cells /Liter | Standard Deviation 1.1397 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | 1.220 10^9 cells /Liter | Standard Deviation 2.6559 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 96 hours, n=6,6,6,6,6,6,6,6,15 | -13.2 10^9 cells /Liter | Standard Deviation 44.37 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 24 hours, n=6,6,6,6,6,6,5,6,16 | -9.0 10^9 cells /Liter | Standard Deviation 37.33 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.124 10^9 cells /Liter | Standard Deviation 0.0727 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 48 hour, 6,6,5,6,6,6,6,6,16 | -0.030 10^9 cells /Liter | Standard Deviation 0.0443 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 48 hours, n=6,6,5,6,6,6,6,6,16 | -14.7 10^9 cells /Liter | Standard Deviation 36.62 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.303 10^9 cells /Liter | Standard Deviation 0.4113 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.042 10^9 cells /Liter | Standard Deviation 0.1252 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 48 hours, 6,6,5,6,6,6,6,6,16 | 0.083 10^9 cells /Liter | Standard Deviation 0.2224 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.007 10^9 cells /Liter | Standard Deviation 0.0052 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes,FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | 0.008 10^9 cells /Liter | Standard Deviation 0.1439 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.032 10^9 cells /Liter | Standard Deviation 0.096 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.000 10^9 cells /Liter | Standard Deviation 0.0167 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.110 10^9 cells /Liter | Standard Deviation 0.2985 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.390 10^9 cells /Liter | Standard Deviation 1.3833 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.032 10^9 cells /Liter | Standard Deviation 0.0642 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.232 10^9 cells /Liter | Standard Deviation 0.3513 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | 1.425 10^9 cells /Liter | Standard Deviation 2.7042 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 15,n=6,6,6,6,6,6,6,6,16 | -0.005 10^9 cells /Liter | Standard Deviation 0.0207 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.002 10^9 cells /Liter | Standard Deviation 0.0148 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.440 10^9 cells /Liter | Standard Deviation 1.1395 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.130 10^9 cells /Liter | Standard Deviation 0.3107 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.023 10^9 cells /Liter | Standard Deviation 0.0266 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.033 10^9 cells /Liter | Standard Deviation 0.0572 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.078 10^9 cells /Liter | Standard Deviation 0.6916 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 15,n=6,6,6,6,6,6,6,6,16 | -0.005 10^9 cells /Liter | Standard Deviation 0.0084 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.002 10^9 cells /Liter | Standard Deviation 0.0147 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.312 10^9 cells /Liter | Standard Deviation 0.6725 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.000 10^9 cells /Liter | Standard Deviation 0.011 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.557 10^9 cells /Liter | Standard Deviation 0.5838 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.007 10^9 cells /Liter | Standard Deviation 0.0121 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -4.0 10^9 cells /Liter | Standard Deviation 18.64 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.005 10^9 cells /Liter | Standard Deviation 0.2375 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.327 10^9 cells /Liter | Standard Deviation 0.9991 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.3 10^9 cells /Liter | Standard Deviation 24.34 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 48 hours, n=6,6,5,6,6,6,6,6,16 | -2.8 10^9 cells /Liter | Standard Deviation 18.97 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 24 hours, n=6,6,6,6,6,6,5,6,16 | -1.7 10^9 cells /Liter | Standard Deviation 31.17 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.082 10^9 cells /Liter | Standard Deviation 0.249 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | 0.475 10^9 cells /Liter | Standard Deviation 0.7676 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.218 10^9 cells /Liter | Standard Deviation 0.4922 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.285 10^9 cells /Liter | Standard Deviation 0.2741 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.153 10^9 cells /Liter | Standard Deviation 0.5704 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 48 hours, 6,6,5,6,6,6,6,6,16 | 0.037 10^9 cells /Liter | Standard Deviation 0.0441 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.035 10^9 cells /Liter | Standard Deviation 0.6405 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes,FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | -0.003 10^9 cells /Liter | Standard Deviation 0.0855 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.028 10^9 cells /Liter | Standard Deviation 0.0643 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.022 10^9 cells /Liter | Standard Deviation 0.0256 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 48 hour, 6,6,5,6,6,6,6,6,16 | 0.012 10^9 cells /Liter | Standard Deviation 0.0796 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.012 10^9 cells /Liter | Standard Deviation 0.0354 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -1.6 10^9 cells /Liter | Standard Deviation 32.94 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.085 10^9 cells /Liter | Standard Deviation 0.7056 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.004 10^9 cells /Liter | Standard Deviation 0.0118 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.001 10^9 cells /Liter | Standard Deviation 0.0106 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.059 10^9 cells /Liter | Standard Deviation 0.7913 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 48 hour, 6,6,5,6,6,6,6,6,16 | 0.037 10^9 cells /Liter | Standard Deviation 0.0266 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.272 10^9 cells /Liter | Standard Deviation 0.8542 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.005 10^9 cells /Liter | Standard Deviation 0.0648 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.005 10^9 cells /Liter | Standard Deviation 0.3483 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.015 10^9 cells /Liter | Standard Deviation 0.0791 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.027 10^9 cells /Liter | Standard Deviation 0.2972 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes,FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | -0.002 10^9 cells /Liter | Standard Deviation 0.0878 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.020 10^9 cells /Liter | Standard Deviation 0.089 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.005 10^9 cells /Liter | Standard Deviation 0.0115 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 48 hours, 6,6,5,6,6,6,6,6,16 | 0.002 10^9 cells /Liter | Standard Deviation 0.0795 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.104 10^9 cells /Liter | Standard Deviation 0.8442 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 24 hours, n=6,6,6,6,6,6,5,6,16 | -3.3 10^9 cells /Liter | Standard Deviation 34.99 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.079 10^9 cells /Liter | Standard Deviation 0.87 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.164 10^9 cells /Liter | Standard Deviation 0.3759 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.8 10^9 cells /Liter | Standard Deviation 22.54 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 15), n= 6,6,6,6,6,6,6,6,16 | -0.107 10^9 cells /Liter | Standard Deviation 0.7009 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.014 10^9 cells /Liter | Standard Deviation 0.087 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.7 10^9 cells /Liter | Standard Deviation 22.98 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.055 10^9 cells /Liter | Standard Deviation 0.6401 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.013 10^9 cells /Liter | Standard Deviation 0.0656 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.111 10^9 cells /Liter | Standard Deviation 0.7964 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 15,n=6,6,6,6,6,6,6,6,16 | 0.007 10^9 cells /Liter | Standard Deviation 0.0178 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.181 10^9 cells /Liter | Standard Deviation 0.4474 |
Primary
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes.
Blood samples were collected to analyze the hematology parameters: erythrocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.Results are presented treatment wise.
Time frame: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.118 10^12 cells/Liter | Standard Deviation 0.2576 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.162 10^12 cells/Liter | Standard Deviation 0.2899 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.155 10^12 cells/Liter | Standard Deviation 0.229 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | Follow Up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.027 10^12 cells/Liter | Standard Deviation 0.1876 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | Follow Up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.145 10^12 cells/Liter | Standard Deviation 0.2041 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.338 10^12 cells/Liter | Standard Deviation 0.115 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.142 10^12 cells/Liter | Standard Deviation 0.1607 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.202 10^12 cells/Liter | Standard Deviation 0.1683 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 48 hours, n=6,6,5,6,6,6,6,6,16 | -0.024 10^12 cells/Liter | Standard Deviation 0.2501 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | Follow Up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.060 10^12 cells/Liter | Standard Deviation 0.3138 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.083 10^12 cells/Liter | Standard Deviation 0.2499 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 24 hours, n=6,6,6,6,6,6,5,6,16 | -0.005 10^12 cells/Liter | Standard Deviation 0.1747 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.147 10^12 cells/Liter | Standard Deviation 0.2925 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.108 10^12 cells/Liter | Standard Deviation 0.3252 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.178 10^12 cells/Liter | Standard Deviation 0.232 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | Follow Up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.023 10^12 cells/Liter | Standard Deviation 0.337 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.035 10^12 cells/Liter | Standard Deviation 0.2672 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.152 10^12 cells/Liter | Standard Deviation 0.1528 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.212 10^12 cells/Liter | Standard Deviation 0.2335 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | Follow Up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.205 10^12 cells/Liter | Standard Deviation 0.1639 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | Follow Up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.053 10^12 cells/Liter | Standard Deviation 0.1549 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.198 10^12 cells/Liter | Standard Deviation 0.0933 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.112 10^12 cells/Liter | Standard Deviation 0.0674 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.288 10^12 cells/Liter | Standard Deviation 0.1082 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.062 10^12 cells/Liter | Standard Deviation 0.2528 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.087 10^12 cells/Liter | Standard Deviation 0.2295 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | Follow Up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.295 10^12 cells/Liter | Standard Deviation 0.2001 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.084 10^12 cells/Liter | Standard Deviation 0.1928 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.180 10^12 cells/Liter | Standard Deviation 0.244 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | Follow Up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.007 10^12 cells/Liter | Standard Deviation 0.2067 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.237 10^12 cells/Liter | Standard Deviation 0.253 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.302 10^12 cells/Liter | Standard Deviation 0.1447 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 24 hours, n=6,6,6,6,6,6,5,6,16 | 0.197 10^12 cells/Liter | Standard Deviation 0.2148 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | Follow Up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.032 10^12 cells/Liter | Standard Deviation 0.2691 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.189 10^12 cells/Liter | Standard Deviation 0.1834 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes. | 48 hours, n=6,6,5,6,6,6,6,6,16 | 0.171 10^12 cells/Liter | Standard Deviation 0.2112 |
Primary
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV).
Blood samples were collected to analyze the hematology parameters: erythrocyte MCV. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 24 hour, n=6,6,6,6,6,6,5,6,16 | -0.50 Femtoliter | Standard Deviation 1.39 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 48 hour, n=6,6,5,6,6,6,6,6,16 | -0.42 Femtoliter | Standard Deviation 0.966 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 96 hour,n=6,6,6,6,6,6,6,6,15 | 1.75 Femtoliter | Standard Deviation 0.619 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.15 Femtoliter | Standard Deviation 1.263 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.83 Femtoliter | Standard Deviation 0.505 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 24 hour, n=6,6,6,6,6,6,5,6,16 | -0.03 Femtoliter | Standard Deviation 0.497 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 48 hour, n=6,6,5,6,6,6,6,6,16 | 0.35 Femtoliter | Standard Deviation 1.231 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 96 hour,n=6,6,6,6,6,6,6,6,15 | 0.43 Femtoliter | Standard Deviation 0.95 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 48 hour, n=6,6,5,6,6,6,6,6,16 | 0.06 Femtoliter | Standard Deviation 0.673 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.53 Femtoliter | Standard Deviation 0.85 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 96 hour,n=6,6,6,6,6,6,6,6,15 | 0.02 Femtoliter | Standard Deviation 0.979 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 24 hour, n=6,6,6,6,6,6,5,6,16 | 0.17 Femtoliter | Standard Deviation 0.689 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 24 hour, n=6,6,6,6,6,6,5,6,16 | 0.70 Femtoliter | Standard Deviation 0.494 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 48 hour, n=6,6,5,6,6,6,6,6,16 | 0.13 Femtoliter | Standard Deviation 0.659 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 96 hour,n=6,6,6,6,6,6,6,6,15 | -0.22 Femtoliter | Standard Deviation 1.03 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.20 Femtoliter | Standard Deviation 1.241 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 96 hour,n=6,6,6,6,6,6,6,6,15 | -0.85 Femtoliter | Standard Deviation 1.214 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 48 hour, n=6,6,5,6,6,6,6,6,16 | -0.57 Femtoliter | Standard Deviation 0.843 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 24 hour, n=6,6,6,6,6,6,5,6,16 | -1.07 Femtoliter | Standard Deviation 0.575 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.15 Femtoliter | Standard Deviation 1.253 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.42 Femtoliter | Standard Deviation 1.339 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 24 hour, n=6,6,6,6,6,6,5,6,16 | -0.28 Femtoliter | Standard Deviation 1.192 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 96 hour,n=6,6,6,6,6,6,6,6,15 | 0.28 Femtoliter | Standard Deviation 1.177 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 48 hour, n=6,6,5,6,6,6,6,6,16 | 0.10 Femtoliter | Standard Deviation 1.135 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 96 hour,n=6,6,6,6,6,6,6,6,15 | -0.15 Femtoliter | Standard Deviation 0.616 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 48 hour, n=6,6,5,6,6,6,6,6,16 | -1.18 Femtoliter | Standard Deviation 0.703 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.10 Femtoliter | Standard Deviation 1.567 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 24 hour, n=6,6,6,6,6,6,5,6,16 | -0.64 Femtoliter | Standard Deviation 0.754 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 48 hour, n=6,6,5,6,6,6,6,6,16 | -0.18 Femtoliter | Standard Deviation 0.725 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.28 Femtoliter | Standard Deviation 0.84 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 96 hour,n=6,6,6,6,6,6,6,6,15 | -0.13 Femtoliter | Standard Deviation 0.388 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 24 hour, n=6,6,6,6,6,6,5,6,16 | -0.25 Femtoliter | Standard Deviation 0.853 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 24 hour, n=6,6,6,6,6,6,5,6,16 | 0.05 Femtoliter | Standard Deviation 0.797 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | Follow up (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.14 Femtoliter | Standard Deviation 1.153 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 96 hour,n=6,6,6,6,6,6,6,6,15 | 0.20 Femtoliter | Standard Deviation 1.196 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV). | 48 hour, n=6,6,5,6,6,6,6,6,16 | 0.24 Femtoliter | Standard Deviation 0.932 |
Primary
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
Respiratory rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 1 hour, n=6,6,6,6,6,6,6,6,16 | 1.5 Breaths per minute | Standard Deviation 1.52 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.7 Breaths per minute | Standard Deviation 1.97 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,15 | 0.2 Breaths per minute | Standard Deviation 2.71 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.2 Breaths per minute | Standard Deviation 1.47 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.3 Breaths per minute | Standard Deviation 1.97 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 1.7 Breaths per minute | Standard Deviation 1.51 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 1.8 Breaths per minute | Standard Deviation 1.72 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.7 Breaths per minute | Standard Deviation 1.51 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 0.7 Breaths per minute | Standard Deviation 1.97 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 2.2 Breaths per minute | Standard Deviation 2.14 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.3 Breaths per minute | Standard Deviation 2.34 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.0 Breaths per minute | Standard Deviation 2.19 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.8 Breaths per minute | Standard Deviation 3.31 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.8 Breaths per minute | Standard Deviation 2.14 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 2.8 Breaths per minute | Standard Deviation 4.26 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,15 | -0.8 Breaths per minute | Standard Deviation 2.48 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | -0.2 Breaths per minute | Standard Deviation 2.32 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.5 Breaths per minute | Standard Deviation 2.07 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 1.3 Breaths per minute | Standard Deviation 3.27 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.3 Breaths per minute | Standard Deviation 1.03 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.7 Breaths per minute | Standard Deviation 2.8 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 2.2 Breaths per minute | Standard Deviation 4.36 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 1 hour, n=6,6,6,6,6,6,6,6,16 | -0.3 Breaths per minute | Standard Deviation 1.97 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.0 Breaths per minute | Standard Deviation 2 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 1.0 Breaths per minute | Standard Deviation 2.19 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.3 Breaths per minute | Standard Deviation 2.58 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 1.7 Breaths per minute | Standard Deviation 3.2 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,15 | 0.5 Breaths per minute | Standard Deviation 3.27 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 0.5 Breaths per minute | Standard Deviation 3.08 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 6 hours, n=6,6,6,6,6,6,6,6,16 | -1.7 Breaths per minute | Standard Deviation 1.86 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.3 Breaths per minute | Standard Deviation 2.8 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.7 Breaths per minute | Standard Deviation 3.5 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 6 hours, n=6,6,6,6,6,6,6,6,16 | 2.3 Breaths per minute | Standard Deviation 2.8 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.7 Breaths per minute | Standard Deviation 1.37 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.0 Breaths per minute | Standard Deviation 2.37 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,15 | 0.0 Breaths per minute | Standard Deviation 2.9 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 2.7 Breaths per minute | Standard Deviation 2.34 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.8 Breaths per minute | Standard Deviation 1.33 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 1 hour, n=6,6,6,6,6,6,6,6,16 | 1.0 Breaths per minute | Standard Deviation 0.89 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 1.2 Breaths per minute | Standard Deviation 2.04 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.2 Breaths per minute | Standard Deviation 4.02 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 1 hour, n=6,6,6,6,6,6,6,6,16 | -1.0 Breaths per minute | Standard Deviation 2.37 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.5 Breaths per minute | Standard Deviation 1.38 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.3 Breaths per minute | Standard Deviation 1.21 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 6 hours, n=6,6,6,6,6,6,6,6,16 | -0.2 Breaths per minute | Standard Deviation 2.04 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | -1.7 Breaths per minute | Standard Deviation 2.88 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | -2.0 Breaths per minute | Standard Deviation 1.67 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 0.0 Breaths per minute | Standard Deviation 1.26 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | -0.5 Breaths per minute | Standard Deviation 2.35 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,15 | 0.5 Breaths per minute | Standard Deviation 2.43 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.7 Breaths per minute | Standard Deviation 2.73 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 1.0 Breaths per minute | Standard Deviation 2.61 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.7 Breaths per minute | Standard Deviation 1.63 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 1.7 Breaths per minute | Standard Deviation 1.21 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.8 Breaths per minute | Standard Deviation 2.14 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,15 | -1.2 Breaths per minute | Standard Deviation 2.64 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | -0.3 Breaths per minute | Standard Deviation 1.97 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.3 Breaths per minute | Standard Deviation 1.51 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.0 Breaths per minute | Standard Deviation 1.26 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | -0.2 Breaths per minute | Standard Deviation 1.33 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | -1.0 Breaths per minute | Standard Deviation 2.68 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.2 Breaths per minute | Standard Deviation 0.98 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | -0.5 Breaths per minute | Standard Deviation 3.08 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,15 | -0.5 Breaths per minute | Standard Deviation 1.87 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 1.0 Breaths per minute | Standard Deviation 1.41 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 1.3 Breaths per minute | Standard Deviation 2.34 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | -1.5 Breaths per minute | Standard Deviation 2.35 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 1.7 Breaths per minute | Standard Deviation 1.37 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.5 Breaths per minute | Standard Deviation 1.38 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.5 Breaths per minute | Standard Deviation 1.97 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 0.3 Breaths per minute | Standard Deviation 2.25 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 1.3 Breaths per minute | Standard Deviation 2.25 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.3 Breaths per minute | Standard Deviation 2.58 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 6 hours, n=6,6,6,6,6,6,6,6,16 | 1.3 Breaths per minute | Standard Deviation 1.75 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 1.5 Breaths per minute | Standard Deviation 2.07 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.5 Breaths per minute | Standard Deviation 4.14 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,15 | 1.2 Breaths per minute | Standard Deviation 2.86 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.7 Breaths per minute | Standard Deviation 2.16 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 1.0 Breaths per minute | Standard Deviation 2.53 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.8 Breaths per minute | Standard Deviation 2.04 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.3 Breaths per minute | Standard Deviation 2.37 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | -0.3 Breaths per minute | Standard Deviation 3.15 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.3 Breaths per minute | Standard Deviation 2.02 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 2.2 Breaths per minute | Standard Deviation 2.59 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | -0.3 Breaths per minute | Standard Deviation 2.73 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.1 Breaths per minute | Standard Deviation 2.69 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 6 hours, n=6,6,6,6,6,6,6,6,16 | 1.0 Breaths per minute | Standard Deviation 3.35 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.9 Breaths per minute | Standard Deviation 2.66 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 1.9 Breaths per minute | Standard Deviation 2.31 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,15 | 0.3 Breaths per minute | Standard Deviation 2.74 |
Primary
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | -4.8 Millimeters of mercury (mmHg) | Standard Deviation 6.91 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 24 hours n=6,6,6,6,6,6,6,6,16 | -1.5 Millimeters of mercury (mmHg) | Standard Deviation 5.54 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 11.67 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 48 hours, n=6,6,6,6,6,6,6,6,16 | -3.0 Millimeters of mercury (mmHg) | Standard Deviation 6.29 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 0.7 Millimeters of mercury (mmHg) | Standard Deviation 12.56 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 2 hours, n=6,6,6,6,6,6,6,6,16 | -7.5 Millimeters of mercury (mmHg) | Standard Deviation 8.96 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 8.23 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 1.8 Millimeters of mercury (mmHg) | Standard Deviation 7.22 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 96 hours n=6,6,6,6,6,6,6,6,15 | 1.8 Millimeters of mercury (mmHg) | Standard Deviation 5.42 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.3 Millimeters of mercury (mmHg) | Standard Deviation 3.01 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 12 hours n=6,6,6,6,6,6,6,6,16 | 3.8 Millimeters of mercury (mmHg) | Standard Deviation 6.24 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 6.7 Millimeters of mercury (mmHg) | Standard Deviation 9.18 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 6 hours n=6,6,6,6,6,6,6,6,16 | 4.7 Millimeters of mercury (mmHg) | Standard Deviation 5.75 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 96 hours, n=6,6,6,6,6,6,6,6,15 | -2.1 Millimeters of mercury (mmHg) | Standard Deviation 6.59 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP,72 hours n=6,6,6,6,6,6,6,6,16 | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 5.66 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 6 hours, n=6,6,6,6,6,6,6,6,16 | -3.5 Millimeters of mercury (mmHg) | Standard Deviation 4.42 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 2 hours n=6,6,6,6,6,6,6,6,16 | -0.7 Millimeters of mercury (mmHg) | Standard Deviation 7.84 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP,72 hours, n=6,6,6,6,6,6,6,6,16 | -3.2 Millimeters of mercury (mmHg) | Standard Deviation 6.08 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 48 hours n=6,6,6,6,6,6,6,6,16 | -4.3 Millimeters of mercury (mmHg) | Standard Deviation 6.59 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 1 hour n=6,6,6,6,6,6,6,6,16 | -3.2 Millimeters of mercury (mmHg) | Standard Deviation 8.84 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 2.3 Millimeters of mercury (mmHg) | Standard Deviation 6.44 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 3.2 Millimeters of mercury (mmHg) | Standard Deviation 4.45 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP,72 hours, n=6,6,6,6,6,6,6,6,16 | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 6 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 1 hour n=6,6,6,6,6,6,6,6,16 | -3.7 Millimeters of mercury (mmHg) | Standard Deviation 2.07 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 24 hours n=6,6,6,6,6,6,6,6,16 | 3.2 Millimeters of mercury (mmHg) | Standard Deviation 2.79 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | -4.5 Millimeters of mercury (mmHg) | Standard Deviation 5.5 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 3.1 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 6 hours, n=6,6,6,6,6,6,6,6,16 | -3.7 Millimeters of mercury (mmHg) | Standard Deviation 4.93 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 48 hours, n=6,6,6,6,6,6,6,6,16 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 6.56 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 48 hours n=6,6,6,6,6,6,6,6,16 | 1.3 Millimeters of mercury (mmHg) | Standard Deviation 5.35 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 2 hours, n=6,6,6,6,6,6,6,6,16 | -1.3 Millimeters of mercury (mmHg) | Standard Deviation 3.27 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 5.3 Millimeters of mercury (mmHg) | Standard Deviation 5.2 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 6 hours n=6,6,6,6,6,6,6,6,16 | 4.7 Millimeters of mercury (mmHg) | Standard Deviation 6.41 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP,72 hours n=6,6,6,6,6,6,6,6,16 | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 7.24 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 2.58 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 12 hours n=6,6,6,6,6,6,6,6,16 | 8.7 Millimeters of mercury (mmHg) | Standard Deviation 6.77 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 2 hours n=6,6,6,6,6,6,6,6,16 | 2.2 Millimeters of mercury (mmHg) | Standard Deviation 4.17 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 3.78 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 96 hours n=6,6,6,6,6,6,6,6,15 | 1.3 Millimeters of mercury (mmHg) | Standard Deviation 5.35 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 7.69 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 12 hours n=6,6,6,6,6,6,6,6,16 | 10.2 Millimeters of mercury (mmHg) | Standard Deviation 5.04 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP,72 hours n=6,6,6,6,6,6,6,6,16 | -0.8 Millimeters of mercury (mmHg) | Standard Deviation 5.49 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 48 hours n=6,6,6,6,6,6,6,6,16 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 8.22 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 12 hours, n=6,6,6,6,6,6,6,6,16 | 4.2 Millimeters of mercury (mmHg) | Standard Deviation 3.76 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 24 hours, n=6,6,6,6,6,6,6,6,16 | 4.7 Millimeters of mercury (mmHg) | Standard Deviation 5.35 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.2 Millimeters of mercury (mmHg) | Standard Deviation 5.71 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 48 hours, n=6,6,6,6,6,6,6,6,16 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 5.29 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP,72 hours, n=6,6,6,6,6,6,6,6,16 | 1.7 Millimeters of mercury (mmHg) | Standard Deviation 7.17 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 6.7 Millimeters of mercury (mmHg) | Standard Deviation 6.77 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 5.0 Millimeters of mercury (mmHg) | Standard Deviation 6.69 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 2 hours, n=6,6,6,6,6,6,6,6,16 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 4.24 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 6.8 Millimeters of mercury (mmHg) | Standard Deviation 4.88 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 6.18 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 6.3 Millimeters of mercury (mmHg) | Standard Deviation 6.22 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 2 hours n=6,6,6,6,6,6,6,6,16 | 8.8 Millimeters of mercury (mmHg) | Standard Deviation 3.06 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 11.5 Millimeters of mercury (mmHg) | Standard Deviation 7.92 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 6 hours n=6,6,6,6,6,6,6,6,16 | 3.7 Millimeters of mercury (mmHg) | Standard Deviation 4.63 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 24 hours n=6,6,6,6,6,6,6,6,16 | 9.0 Millimeters of mercury (mmHg) | Standard Deviation 6.32 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 8.8 Millimeters of mercury (mmHg) | Standard Deviation 5.6 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 96 hours n=6,6,6,6,6,6,6,6,15 | 6.0 Millimeters of mercury (mmHg) | Standard Deviation 11.4 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 5.3 Millimeters of mercury (mmHg) | Standard Deviation 6.12 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 6 hours, n=6,6,6,6,6,6,6,6,16 | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 3.74 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 4.7 Millimeters of mercury (mmHg) | Standard Deviation 6.77 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP,72 hours, n=6,6,6,6,6,6,6,6,16 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 6.84 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 96 hours n=6,6,6,6,6,6,6,6,15 | 5.3 Millimeters of mercury (mmHg) | Standard Deviation 12.71 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 24 hours, n=6,6,6,6,6,6,6,6,16 | 2.8 Millimeters of mercury (mmHg) | Standard Deviation 7.44 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 6.8 Millimeters of mercury (mmHg) | Standard Deviation 7.22 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 1.7 Millimeters of mercury (mmHg) | Standard Deviation 6.83 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 12 hours n=6,6,6,6,6,6,6,6,16 | 8.2 Millimeters of mercury (mmHg) | Standard Deviation 6.62 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 48 hours n=6,6,6,6,6,6,6,6,16 | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 9.79 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 2 hours n=6,6,6,6,6,6,6,6,16 | 10.7 Millimeters of mercury (mmHg) | Standard Deviation 6.62 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 24 hours n=6,6,6,6,6,6,6,6,16 | 3.3 Millimeters of mercury (mmHg) | Standard Deviation 7.58 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 12 hours, n=6,6,6,6,6,6,6,6,16 | 4.3 Millimeters of mercury (mmHg) | Standard Deviation 9.09 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 8.02 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 2 hours, n=6,6,6,6,6,6,6,6,16 | -1.3 Millimeters of mercury (mmHg) | Standard Deviation 6.83 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 48 hours, n=6,6,6,6,6,6,6,6,16 | -2.5 Millimeters of mercury (mmHg) | Standard Deviation 7.56 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 1.7 Millimeters of mercury (mmHg) | Standard Deviation 7.37 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP,72 hours n=6,6,6,6,6,6,6,6,16 | 2.2 Millimeters of mercury (mmHg) | Standard Deviation 8.52 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 6 hours n=6,6,6,6,6,6,6,6,16 | 9.5 Millimeters of mercury (mmHg) | Standard Deviation 7.06 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 1 hour n=6,6,6,6,6,6,6,6,16 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 5.53 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 6 hours n=6,6,6,6,6,6,6,6,16 | 2.8 Millimeters of mercury (mmHg) | Standard Deviation 7.73 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 6.7 Millimeters of mercury (mmHg) | Standard Deviation 7.42 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 6.2 Millimeters of mercury (mmHg) | Standard Deviation 7.63 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 48 hours, n=6,6,6,6,6,6,6,6,16 | 3.7 Millimeters of mercury (mmHg) | Standard Deviation 5.65 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP,72 hours, n=6,6,6,6,6,6,6,6,16 | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 5.09 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 4.5 Millimeters of mercury (mmHg) | Standard Deviation 10.21 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 2.2 Millimeters of mercury (mmHg) | Standard Deviation 3.06 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP,72 hours n=6,6,6,6,6,6,6,6,16 | -3.0 Millimeters of mercury (mmHg) | Standard Deviation 6.57 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 12 hours n=6,6,6,6,6,6,6,6,16 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 8.29 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 4 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 96 hours n=6,6,6,6,6,6,6,6,15 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 5.8 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 6 hours, n=6,6,6,6,6,6,6,6,16 | -2.2 Millimeters of mercury (mmHg) | Standard Deviation 5.15 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 12 hours, n=6,6,6,6,6,6,6,6,16 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 5.1 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 2 hours n=6,6,6,6,6,6,6,6,16 | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 7.5 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 48 hours n=6,6,6,6,6,6,6,6,16 | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 11.45 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 2.7 Millimeters of mercury (mmHg) | Standard Deviation 3.78 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 1 hour n=6,6,6,6,6,6,6,6,16 | -0.3 Millimeters of mercury (mmHg) | Standard Deviation 4.32 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 24 hours n=6,6,6,6,6,6,6,6,16 | -0.3 Millimeters of mercury (mmHg) | Standard Deviation 4.46 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 6.19 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 2 hours, n=6,6,6,6,6,6,6,6,16 | -2.7 Millimeters of mercury (mmHg) | Standard Deviation 3.08 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 48 hours n=6,6,6,6,6,6,6,6,16 | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 7.5 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 2 hours n=6,6,6,6,6,6,6,6,16 | 5.5 Millimeters of mercury (mmHg) | Standard Deviation 8.46 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 12 hours, n=6,6,6,6,6,6,6,6,16 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 6.1 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 5.56 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 48 hours, n=6,6,6,6,6,6,6,6,16 | -1.3 Millimeters of mercury (mmHg) | Standard Deviation 5.43 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP,72 hours, n=6,6,6,6,6,6,6,6,16 | 1.7 Millimeters of mercury (mmHg) | Standard Deviation 2.73 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 10.8 Millimeters of mercury (mmHg) | Standard Deviation 9.81 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 2.3 Millimeters of mercury (mmHg) | Standard Deviation 6.06 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 3.7 Millimeters of mercury (mmHg) | Standard Deviation 5.2 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 2.2 Millimeters of mercury (mmHg) | Standard Deviation 11.07 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 6 hours n=6,6,6,6,6,6,6,6,16 | 4.0 Millimeters of mercury (mmHg) | Standard Deviation 10.47 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 12 hours n=6,6,6,6,6,6,6,6,16 | 3.3 Millimeters of mercury (mmHg) | Standard Deviation 7.23 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 24 hours n=6,6,6,6,6,6,6,6,16 | 2.7 Millimeters of mercury (mmHg) | Standard Deviation 5.72 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP,72 hours n=6,6,6,6,6,6,6,6,16 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 6 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 96 hours n=6,6,6,6,6,6,6,6,15 | 6.3 Millimeters of mercury (mmHg) | Standard Deviation 7.53 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 4.5 Millimeters of mercury (mmHg) | Standard Deviation 6.02 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 1 hour n=6,6,6,6,6,6,6,6,16 | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 4.56 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 2 hours, n=6,6,6,6,6,6,6,6,16 | -3.3 Millimeters of mercury (mmHg) | Standard Deviation 3.93 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 1.5 Millimeters of mercury (mmHg) | Standard Deviation 4.55 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 6 hours, n=6,6,6,6,6,6,6,6,16 | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 6.48 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP,72 hours n=6,6,6,6,6,6,6,6,16 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 11.93 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 12 hours n=6,6,6,6,6,6,6,6,16 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 17.62 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 96 hours n=6,6,6,6,6,6,6,6,15 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 14.34 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 6 hours n=6,6,6,6,6,6,6,6,16 | 5.8 Millimeters of mercury (mmHg) | Standard Deviation 12.81 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 2 hours n=6,6,6,6,6,6,6,6,16 | 5.7 Millimeters of mercury (mmHg) | Standard Deviation 14.02 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 11.5 Millimeters of mercury (mmHg) | Standard Deviation 3.33 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 5.8 Millimeters of mercury (mmHg) | Standard Deviation 10.57 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 7.3 Millimeters of mercury (mmHg) | Standard Deviation 3.83 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 1.3 Millimeters of mercury (mmHg) | Standard Deviation 9.87 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 1.5 Millimeters of mercury (mmHg) | Standard Deviation 12.63 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 8.7 Millimeters of mercury (mmHg) | Standard Deviation 11.04 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 12 hours, n=6,6,6,6,6,6,6,6,16 | 1.5 Millimeters of mercury (mmHg) | Standard Deviation 12.61 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 2 hours, n=6,6,6,6,6,6,6,6,16 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 10.45 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP,72 hours, n=6,6,6,6,6,6,6,6,16 | 2.3 Millimeters of mercury (mmHg) | Standard Deviation 8.71 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 2.2 Millimeters of mercury (mmHg) | Standard Deviation 6.31 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 48 hours, n=6,6,6,6,6,6,6,6,16 | 1.7 Millimeters of mercury (mmHg) | Standard Deviation 8.71 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 24 hours, n=6,6,6,6,6,6,6,6,16 | 6.2 Millimeters of mercury (mmHg) | Standard Deviation 8.04 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 48 hours n=6,6,6,6,6,6,6,6,16 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 6.98 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 24 hours n=6,6,6,6,6,6,6,6,16 | 5.8 Millimeters of mercury (mmHg) | Standard Deviation 8.3 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 6 hours, n=6,6,6,6,6,6,6,6,16 | 1.8 Millimeters of mercury (mmHg) | Standard Deviation 9.15 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 24 hours n=6,6,6,6,6,6,6,6,16 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 7.57 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP,72 hours n=6,6,6,6,6,6,6,6,16 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 12.02 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 4.0 Millimeters of mercury (mmHg) | Standard Deviation 6.84 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 2.88 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 12 hours n=6,6,6,6,6,6,6,6,16 | 6.3 Millimeters of mercury (mmHg) | Standard Deviation 3.39 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 12 hours, n=6,6,6,6,6,6,6,6,16 | 5.3 Millimeters of mercury (mmHg) | Standard Deviation 3.83 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.2 Millimeters of mercury (mmHg) | Standard Deviation 5.42 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 6 hours n=6,6,6,6,6,6,6,6,16 | 6.5 Millimeters of mercury (mmHg) | Standard Deviation 6.09 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 6 hours, n=6,6,6,6,6,6,6,6,16 | 3.2 Millimeters of mercury (mmHg) | Standard Deviation 7.78 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 48 hours, n=6,6,6,6,6,6,6,6,16 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 4.73 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 96 hours n=6,6,6,6,6,6,6,6,15 | 0.7 Millimeters of mercury (mmHg) | Standard Deviation 6.19 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 2.35 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 7.8 Millimeters of mercury (mmHg) | Standard Deviation 4.22 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 2 hours n=6,6,6,6,6,6,6,6,16 | 6.2 Millimeters of mercury (mmHg) | Standard Deviation 6.11 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 48 hours n=6,6,6,6,6,6,6,6,16 | 2.2 Millimeters of mercury (mmHg) | Standard Deviation 9.24 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 24 hours, n=6,6,6,6,6,6,6,6,16 | 3.3 Millimeters of mercury (mmHg) | Standard Deviation 4.63 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 3.5 Millimeters of mercury (mmHg) | Standard Deviation 4.93 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 7.3 Millimeters of mercury (mmHg) | Standard Deviation 5.35 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 6.3 Millimeters of mercury (mmHg) | Standard Deviation 8.16 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP,72 hours, n=6,6,6,6,6,6,6,6,16 | 4.7 Millimeters of mercury (mmHg) | Standard Deviation 6.56 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 7.3 Millimeters of mercury (mmHg) | Standard Deviation 10.2 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16 | 7.1 Millimeters of mercury (mmHg) | Standard Deviation 9.92 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 48 hours n=6,6,6,6,6,6,6,6,16 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 8.68 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 96 hours, n=6,6,6,6,6,6,6,6,15 | 4.0 Millimeters of mercury (mmHg) | Standard Deviation 7.39 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 24 hours, n=6,6,6,6,6,6,6,6,16 | 3.7 Millimeters of mercury (mmHg) | Standard Deviation 9.16 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 8.62 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 7.4 Millimeters of mercury (mmHg) | Standard Deviation 11.04 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 24 hours n=6,6,6,6,6,6,6,6,16 | 5.1 Millimeters of mercury (mmHg) | Standard Deviation 10.68 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 12 hours, n=6,6,6,6,6,6,6,6,16 | 4.8 Millimeters of mercury (mmHg) | Standard Deviation 7.64 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 2 hours n=6,6,6,6,6,6,6,6,16 | 4.4 Millimeters of mercury (mmHg) | Standard Deviation 8.05 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 8.42 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP,72 hours, n=6,6,6,6,6,6,6,6,16 | 4.3 Millimeters of mercury (mmHg) | Standard Deviation 8.02 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP,72 hours n=6,6,6,6,6,6,6,6,16 | 2.4 Millimeters of mercury (mmHg) | Standard Deviation 6.13 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 12 hours n=6,6,6,6,6,6,6,6,16 | 7.6 Millimeters of mercury (mmHg) | Standard Deviation 7.9 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 48 hours, n=6,6,6,6,6,6,6,6,16 | 4.3 Millimeters of mercury (mmHg) | Standard Deviation 8.9 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 6 hours n=6,6,6,6,6,6,6,6,16 | 8.3 Millimeters of mercury (mmHg) | Standard Deviation 10.97 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 96 hours n=6,6,6,6,6,6,6,6,15 | 4.5 Millimeters of mercury (mmHg) | Standard Deviation 9.02 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, 1 hour n=6,6,6,6,6,6,6,6,16 | 8.1 Millimeters of mercury (mmHg) | Standard Deviation 7.25 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 6 hours, n=6,6,6,6,6,6,6,6,16 | 2.4 Millimeters of mercury (mmHg) | Standard Deviation 9.76 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 6.8 Millimeters of mercury (mmHg) | Standard Deviation 10.1 |
Primary
Part 1: Change From Baseline in Vital Signs: Pulse Rate
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 6 hours,n=6,6,6,6,6,6,6,6,16 | 16.8 Beats per minute | Standard Deviation 7.41 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | 2.0 Beats per minute | Standard Deviation 8.58 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 12.5 Beats per minute | Standard Deviation 12.93 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 0.8 Beats per minute | Standard Deviation 5.67 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 6.2 Beats per minute | Standard Deviation 4.71 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 6.5 Beats per minute | Standard Deviation 6.72 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 10.2 Beats per minute | Standard Deviation 4.4 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 7.3 Beats per minute | Standard Deviation 4.89 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 5.2 Beats per minute | Standard Deviation 4.58 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 1 hour n=6,6,6,6,6,6,6,6,16 | 13.3 Beats per minute | Standard Deviation 6.71 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 5.7 Beats per minute | Standard Deviation 7.55 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 6 hours,n=6,6,6,6,6,6,6,6,16 | 7.7 Beats per minute | Standard Deviation 5.85 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | 3.8 Beats per minute | Standard Deviation 5 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 4.8 Beats per minute | Standard Deviation 4.83 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 2.0 Beats per minute | Standard Deviation 7.56 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 3.3 Beats per minute | Standard Deviation 8.07 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 3.5 Beats per minute | Standard Deviation 7.31 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 1 hour n=6,6,6,6,6,6,6,6,16 | 5.2 Beats per minute | Standard Deviation 2.48 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 3.3 Beats per minute | Standard Deviation 4.37 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 3.2 Beats per minute | Standard Deviation 4.96 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 3.2 Beats per minute | Standard Deviation 4.58 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 6 hours,n=6,6,6,6,6,6,6,6,16 | 9.7 Beats per minute | Standard Deviation 3.98 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | 2.8 Beats per minute | Standard Deviation 4.31 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 2.3 Beats per minute | Standard Deviation 6.56 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 11.8 Beats per minute | Standard Deviation 6.85 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 4.8 Beats per minute | Standard Deviation 5.15 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 3.2 Beats per minute | Standard Deviation 6.52 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 6.8 Beats per minute | Standard Deviation 4.75 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 3.7 Beats per minute | Standard Deviation 1.97 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 1 hour n=6,6,6,6,6,6,6,6,16 | 14.5 Beats per minute | Standard Deviation 4.04 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 4.5 Beats per minute | Standard Deviation 6.89 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 6 hours,n=6,6,6,6,6,6,6,6,16 | 11.3 Beats per minute | Standard Deviation 6.02 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 4.5 Beats per minute | Standard Deviation 9.48 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 9.0 Beats per minute | Standard Deviation 5.83 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 1 hour n=6,6,6,6,6,6,6,6,16 | 13.7 Beats per minute | Standard Deviation 5.05 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | 6.8 Beats per minute | Standard Deviation 4.49 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 6.3 Beats per minute | Standard Deviation 10.07 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 10.7 Beats per minute | Standard Deviation 9.09 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 9.2 Beats per minute | Standard Deviation 6.88 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 5.8 Beats per minute | Standard Deviation 4.4 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 12.8 Beats per minute | Standard Deviation 6.05 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 6.7 Beats per minute | Standard Deviation 10.15 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 11.0 Beats per minute | Standard Deviation 4.9 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 4.8 Beats per minute | Standard Deviation 6.46 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 6 hours,n=6,6,6,6,6,6,6,6,16 | 11.2 Beats per minute | Standard Deviation 6.65 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 3.5 Beats per minute | Standard Deviation 3.99 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 8.2 Beats per minute | Standard Deviation 11.97 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 1 hour n=6,6,6,6,6,6,6,6,16 | 11.3 Beats per minute | Standard Deviation 4.8 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | 2.0 Beats per minute | Standard Deviation 3.29 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 5.7 Beats per minute | Standard Deviation 4.37 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 6 hours,n=6,6,6,6,6,6,6,6,16 | 7.7 Beats per minute | Standard Deviation 3.88 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | -0.3 Beats per minute | Standard Deviation 6.19 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 4.0 Beats per minute | Standard Deviation 2.45 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.7 Beats per minute | Standard Deviation 11.93 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 1 hour n=6,6,6,6,6,6,6,6,16 | 7.5 Beats per minute | Standard Deviation 3.67 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 6.0 Beats per minute | Standard Deviation 3.22 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 5.5 Beats per minute | Standard Deviation 3.94 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 6.5 Beats per minute | Standard Deviation 8.96 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 2.5 Beats per minute | Standard Deviation 5.68 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | -2.3 Beats per minute | Standard Deviation 6.83 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 4.2 Beats per minute | Standard Deviation 8.08 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 1 hour n=6,6,6,6,6,6,6,6,16 | 9.0 Beats per minute | Standard Deviation 3.85 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 4.8 Beats per minute | Standard Deviation 6.97 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 7.0 Beats per minute | Standard Deviation 5.8 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 5.8 Beats per minute | Standard Deviation 10.38 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | 4.5 Beats per minute | Standard Deviation 6.28 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 8.0 Beats per minute | Standard Deviation 11.26 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 6 hours,n=6,6,6,6,6,6,6,6,16 | 8.3 Beats per minute | Standard Deviation 4.72 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 10.8 Beats per minute | Standard Deviation 15.89 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 2.8 Beats per minute | Standard Deviation 4.54 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 3.7 Beats per minute | Standard Deviation 9.65 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 6.2 Beats per minute | Standard Deviation 6.85 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 6.0 Beats per minute | Standard Deviation 7.51 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 1 hour n=6,6,6,6,6,6,6,6,16 | 7.0 Beats per minute | Standard Deviation 2.97 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 6.3 Beats per minute | Standard Deviation 8.24 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 1.0 Beats per minute | Standard Deviation 4.86 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 8.0 Beats per minute | Standard Deviation 4.47 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 1.5 Beats per minute | Standard Deviation 6.35 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | -0.2 Beats per minute | Standard Deviation 7.14 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 6 hours,n=6,6,6,6,6,6,6,6,16 | 8.0 Beats per minute | Standard Deviation 3.16 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 72 hours, n=6,6,6,6,6,6,6,6,16 | 1.4 Beats per minute | Standard Deviation 5.4 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 2 hours, n=6,6,6,6,6,6,6,6,16 | 8.2 Beats per minute | Standard Deviation 3.99 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 12 hours, n=6,6,6,6,6,6,6,6,16 | 7.3 Beats per minute | Standard Deviation 5.61 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 6.4 Beats per minute | Standard Deviation 5.94 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 48 hours, n=6,6,6,6,6,6,6,6,16 | 1.5 Beats per minute | Standard Deviation 3.88 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 6 hours,n=6,6,6,6,6,6,6,6,16 | 10.4 Beats per minute | Standard Deviation 6.59 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.2 Beats per minute | Standard Deviation 3.89 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Pulse Rate | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 1.3 Beats per minute | Standard Deviation 5.74 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 96 hours, n=6,6,6,6,6,6,6,6,15 | 2.5 Beats per minute | Standard Deviation 4.29 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 1 hour n=6,6,6,6,6,6,6,6,16 | 9.6 Beats per minute | Standard Deviation 6.97 |
Primary
Part 1: Change From Baseline in Vital Signs: Temperature
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.45 Degree Celsius | Standard Deviation 0.274 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.33 Degree Celsius | Standard Deviation 0.186 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.02 Degree Celsius | Standard Deviation 0.232 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 48 hours, n=6,6,6,6,6,6,6,6,16 | -0.03 Degree Celsius | Standard Deviation 0.234 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Temperature | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.05 Degree Celsius | Standard Deviation 0.327 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 24 hours, n=6,6,6,6,6,6,6,6,16 | -0.13 Degree Celsius | Standard Deviation 0.266 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.10 Degree Celsius | Standard Deviation 0.11 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 12 hours, n=6,6,6,6,6,6,6,6,16 | 0.30 Degree Celsius | Standard Deviation 0.219 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.35 Degree Celsius | Standard Deviation 0.308 |
| Part 1: GSK3640254 1 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.20 Degree Celsius | Standard Deviation 0.237 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.23 Degree Celsius | Standard Deviation 0.356 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.27 Degree Celsius | Standard Deviation 0.234 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Temperature | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | -0.03 Degree Celsius | Standard Deviation 0.344 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.10 Degree Celsius | Standard Deviation 0.255 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.23 Degree Celsius | Standard Deviation 0.427 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.00 Degree Celsius | Standard Deviation 0.322 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 48 hours, n=6,6,6,6,6,6,6,6,16 | 0.10 Degree Celsius | Standard Deviation 0.46 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.10 Degree Celsius | Standard Deviation 0.21 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 12 hours, n=6,6,6,6,6,6,6,6,16 | 0.20 Degree Celsius | Standard Deviation 0.261 |
| Part 1: GSK3640254 3 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.15 Degree Celsius | Standard Deviation 0.378 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.15 Degree Celsius | Standard Deviation 0.378 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.03 Degree Celsius | Standard Deviation 0.333 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.03 Degree Celsius | Standard Deviation 0.35 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.15 Degree Celsius | Standard Deviation 0.339 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 12 hours, n=6,6,6,6,6,6,6,6,16 | 0.17 Degree Celsius | Standard Deviation 0.35 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.07 Degree Celsius | Standard Deviation 0.175 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 48 hours, n=6,6,6,6,6,6,6,6,16 | -0.18 Degree Celsius | Standard Deviation 0.214 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.00 Degree Celsius | Standard Deviation 0.316 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.12 Degree Celsius | Standard Deviation 0.16 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Vital Signs: Temperature | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.12 Degree Celsius | Standard Deviation 0.331 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Temperature | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.00 Degree Celsius | Standard Deviation 0.518 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Temperature | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.18 Degree Celsius | Standard Deviation 0.306 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Temperature | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.28 Degree Celsius | Standard Deviation 0.256 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Temperature | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.18 Degree Celsius | Standard Deviation 0.376 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Temperature | 12 hours, n=6,6,6,6,6,6,6,6,16 | 0.20 Degree Celsius | Standard Deviation 0.283 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Temperature | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.07 Degree Celsius | Standard Deviation 0.28 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Temperature | 48 hours, n=6,6,6,6,6,6,6,6,16 | 0.07 Degree Celsius | Standard Deviation 0.356 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Temperature | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.42 Degree Celsius | Standard Deviation 0.223 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Temperature | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.05 Degree Celsius | Standard Deviation 0.105 |
| Part 1: GSK3640254 30mg | Part 1: Change From Baseline in Vital Signs: Temperature | 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.18 Degree Celsius | Standard Deviation 0.214 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.05 Degree Celsius | Standard Deviation 0.596 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.17 Degree Celsius | Standard Deviation 0.628 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.02 Degree Celsius | Standard Deviation 0.256 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 48 hours, n=6,6,6,6,6,6,6,6,16 | -0.17 Degree Celsius | Standard Deviation 0.25 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 12 hours, n=6,6,6,6,6,6,6,6,16 | 0.27 Degree Celsius | Standard Deviation 0.493 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.20 Degree Celsius | Standard Deviation 0.21 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.10 Degree Celsius | Standard Deviation 0.303 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 72 hours, n=6,6,6,6,6,6,6,6,16 | -0.12 Degree Celsius | Standard Deviation 0.488 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Temperature | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.20 Degree Celsius | Standard Deviation 0.506 |
| Part 1: GSK3640254 100 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.12 Degree Celsius | Standard Deviation 0.36 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 48 hours, n=6,6,6,6,6,6,6,6,16 | -0.03 Degree Celsius | Standard Deviation 0.463 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.00 Degree Celsius | Standard Deviation 0.245 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.17 Degree Celsius | Standard Deviation 0.446 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.45 Degree Celsius | Standard Deviation 0.321 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 12 hours, n=6,6,6,6,6,6,6,6,16 | 0.18 Degree Celsius | Standard Deviation 0.426 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.45 Degree Celsius | Standard Deviation 0.394 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.27 Degree Celsius | Standard Deviation 0.25 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.10 Degree Celsius | Standard Deviation 0.31 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.22 Degree Celsius | Standard Deviation 0.402 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Vital Signs: Temperature | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.13 Degree Celsius | Standard Deviation 0.344 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 48 hours, n=6,6,6,6,6,6,6,6,16 | 0.42 Degree Celsius | Standard Deviation 0.694 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.38 Degree Celsius | Standard Deviation 0.264 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 12 hours, n=6,6,6,6,6,6,6,6,16 | 0.07 Degree Celsius | Standard Deviation 0.175 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.17 Degree Celsius | Standard Deviation 0.388 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.17 Degree Celsius | Standard Deviation 0.103 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Temperature | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.18 Degree Celsius | Standard Deviation 0.293 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.25 Degree Celsius | Standard Deviation 0.217 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.28 Degree Celsius | Standard Deviation 0.256 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.17 Degree Celsius | Standard Deviation 0.216 |
| Part 1: GSK3640254 400 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.33 Degree Celsius | Standard Deviation 0.308 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.15 Degree Celsius | Standard Deviation 0.362 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 48 hours, n=6,6,6,6,6,6,6,6,16 | 0.27 Degree Celsius | Standard Deviation 0.489 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Temperature | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.47 Degree Celsius | Standard Deviation 0.398 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.23 Degree Celsius | Standard Deviation 0.427 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 96 hours, n=6,6,6,6,6,6,6,6,15 | 0.08 Degree Celsius | Standard Deviation 0.24 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 12 hours, n=6,6,6,6,6,6,6,6,16 | 0.53 Degree Celsius | Standard Deviation 0.398 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.52 Degree Celsius | Standard Deviation 0.279 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.75 Degree Celsius | Standard Deviation 0.217 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.22 Degree Celsius | Standard Deviation 0.407 |
| Part 1: GSK3640254 700 mg | Part 1: Change From Baseline in Vital Signs: Temperature | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.42 Degree Celsius | Standard Deviation 0.426 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Temperature | 96 hours, n=6,6,6,6,6,6,6,6,15 | -0.07 Degree Celsius | Standard Deviation 0.313 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Temperature | 72 hours, n=6,6,6,6,6,6,6,6,16 | 0.03 Degree Celsius | Standard Deviation 0.317 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Temperature | 4.5 hours, n=6,6,6,6,6,6,6,6,16 | 0.22 Degree Celsius | Standard Deviation 0.299 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Temperature | 12 hours, n=6,6,6,6,6,6,6,6,16 | 0.12 Degree Celsius | Standard Deviation 0.259 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Temperature | 1 hour, n=6,6,6,6,6,6,6,6,16 | 0.19 Degree Celsius | Standard Deviation 0.267 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Temperature | FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0.11 Degree Celsius | Standard Deviation 0.344 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Temperature | 24 hours, n=6,6,6,6,6,6,6,6,16 | 0.03 Degree Celsius | Standard Deviation 0.244 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Temperature | 48 hours, n=6,6,6,6,6,6,6,6,16 | 0.04 Degree Celsius | Standard Deviation 0.301 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Temperature | 6 hours, n=6,6,6,6,6,6,6,6,16 | 0.29 Degree Celsius | Standard Deviation 0.39 |
| Part 1: Single Dose Placebo | Part 1: Change From Baseline in Vital Signs: Temperature | 2 hours, n=6,6,6,6,6,6,6,6,16 | 0.23 Degree Celsius | Standard Deviation 0.322 |
Primary
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
12-lead ECGs were measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS).
Time frame: Baseline (Day 1 predose), 1,2,4,6,12,24,48,72,96 hours post dose and Follow up (Day 15)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS,Day 1, 48 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 48 hours n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS,Day 1, 48 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 48 hours n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS,Day 1, 48 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 48 hours n=6,6,6,6,6,6,6,6,16 | 1 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 1 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS,Day 1, 48 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 1 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 48 hours n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS,Day 1, 48 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 48 hours n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 48 hours n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS,Day 1, 48 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS,Day 1, 48 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 48 hours n=6,6,6,6,6,6,6,6,16 | 1 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 2 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 48 hours n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS,Day 1, 48 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, FU (Day 15), n=6,6,6,6,6,6,6,6,16 | 1 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS,Day 1, 48 hours n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS,Day 1, 48 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | NCS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | CS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16 | 0 Participants |
Primary
Part 1: Number of Participants With Abnormal Urinalysis
Urine samples were collected at given time points to analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
Time frame: Up to Day 15
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Number of Participants With Abnormal Urinalysis | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1: Number of Participants With Abnormal Urinalysis | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Abnormal Urinalysis | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1: Number of Participants With Abnormal Urinalysis | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1: Number of Participants With Abnormal Urinalysis | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Abnormal Urinalysis | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1: Number of Participants With Abnormal Urinalysis | 0 Participants |
| Part 1: GSK3640254 700 mg | Part 1: Number of Participants With Abnormal Urinalysis | 0 Participants |
| Part 1: Single Dose Placebo | Part 1: Number of Participants With Abnormal Urinalysis | 0 Participants |
Primary
Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE. Results are presented treatment wise.
Time frame: Up to Day 15
Population: Safety Population. It is comprised of all participants who received at least one dose of a study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE | 3 Participants |
| Part 1: GSK3640254 1 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE | 2 Participants |
| Part 1: GSK3640254 3 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE | 4 Participants |
| Part 1: GSK3640254 10 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE | 0 Participants |
| Part 1: GSK3640254 30mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE | 3 Participants |
| Part 1: GSK3640254 30mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE | 3 Participants |
| Part 1: GSK3640254 100 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE | 4 Participants |
| Part 1: GSK3640254 400 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE | 0 Participants |
| Part 1: GSK3640254 400 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE | 4 Participants |
| Part 1: GSK3640254 700 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE | 1 Participants |
| Part 1: GSK3640254 700 mg | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE | 0 Participants |
| Part 1: Single Dose Placebo | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE | 7 Participants |
| Part 1: Single Dose Placebo | Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE | 0 Participants |
Primary
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Blood samples were collected at indicated time points to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), Pre dose on Days 2,4,6,8,10,12,14 Day 14 : 48 and 96 hours post dose, Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 28), n=6,6,25,7,14 | -0.490 10^9 cells/Liter | Standard Deviation 0.3072 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 2, predose, n=6,6,25,7,14 | 0.178 10^9 cells/Liter | Standard Deviation 0.55 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, predose, n=6,6,25,6,14 | -0.078 10^9 cells/Liter | Standard Deviation 0.5286 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 8 predose, n=6,6,25,7,14 | 0.043 10^9 cells/Liter | Standard Deviation 0.85 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 6, predose, n=6,6,25,7,14 | 0.043 10^9 cells/Liter | Standard Deviation 0.0665 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 10, predose, n=6,6,25,7,14 | 3.7 10^9 cells/Liter | Standard Deviation 16.38 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 4, predose, n=6,6,25,7,14 | 0.188 10^9 cells/Liter | Standard Deviation 0.3853 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 2, predose, n=6,6,25,7,14 | 0.003 10^9 cells/Liter | Standard Deviation 0.0103 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, predose, n=6,6,25,6,14 | 5.3 10^9 cells/Liter | Standard Deviation 23.52 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 6, predose, n=6,6,25,7,14 | 0.177 10^9 cells/Liter | Standard Deviation 0.4173 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, 48 hours, n=6,6,24,6,14 | 0.002 10^9 cells/Liter | Standard Deviation 0.0075 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 10, predose, n=6,6,25,7,14 | 0.005 10^9 cells/Liter | Standard Deviation 0.0055 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 8 predose, n=6,5,25,7,14 | 0.8 10^9 cells/Liter | Standard Deviation 8.82 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 8 predose, n=6,6,25,7,14 | 0.038 10^9 cells/Liter | Standard Deviation 0.2525 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 8 predose, n=6,6,25,7,14 | 0.005 10^9 cells/Liter | Standard Deviation 0.0138 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 2, predose, n=6,6,25,7,14 | 0.003 10^9 cells/Liter | Standard Deviation 0.4892 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, predose, n=6,6,25,6,14 | 0.037 10^9 cells/Liter | Standard Deviation 0.1084 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 12, predose, n=6,6,25,7,14 | 0.328 10^9 cells/Liter | Standard Deviation 0.3414 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 10, predose, n=6,6,25,7,14 | 0.053 10^9 cells/Liter | Standard Deviation 0.732 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 4, predose, n=6,6,25,7,14 | -0.008 10^9 cells/Liter | Standard Deviation 0.6814 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 28), n=6,6,25,7,14 | -1.148 10^9 cells/Liter | Standard Deviation 0.7008 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 6, predose, n=6,6,25,7,14 | 0.002 10^9 cells/Liter | Standard Deviation 0.0075 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, 96 hours, n=6,6,24,6,14 | 0.035 10^9 cells/Liter | Standard Deviation 0.0961 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 6, predose, n=6,6,25,7,14 | -0.035 10^9 cells/Liter | Standard Deviation 0.7416 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 2, predose, n=6,6,25,7,14 | 0.203 10^9 cells/Liter | Standard Deviation 0.8721 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 12, predose, n=6,6,25,7,14 | 0.008 10^9 cells/Liter | Standard Deviation 0.0768 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 6, predose, n=6,6,25,7,14 | 0.158 10^9 cells/Liter | Standard Deviation 1.1274 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, predose, n=6,6,25,6,14 | 0.200 10^9 cells/Liter | Standard Deviation 0.8402 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 8 predose, n=6,6,25,7,14 | -0.035 10^9 cells/Liter | Standard Deviation 0.6427 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, predose, n=6,6,25,6,14 | 0.222 10^9 cells/Liter | Standard Deviation 0.454 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 12, predose, n=6,6,25,7,14 | 4.5 10^9 cells/Liter | Standard Deviation 27.4 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 10, predose, n=6,6,25,7,14 | 0.028 10^9 cells/Liter | Standard Deviation 0.0426 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, 96 hours, n=6,6,24,6,14 | 0.060 10^9 cells/Liter | Standard Deviation 0.5114 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 6, predose, n=6,6,25,7,14 | 11.2 10^9 cells/Liter | Standard Deviation 20.61 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, 48 hours, n=6,6,24,6,14 | -0.005 10^9 cells/Liter | Standard Deviation 0.1093 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, 96 hours, n=6,6,24,6,14 | 0.438 10^9 cells/Liter | Standard Deviation 1.0624 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 2, predose, n=6,6,25,7,14 | 0.015 10^9 cells/Liter | Standard Deviation 0.0176 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 10, predose, n=6,6,25,7,14 | 0.003 10^9 cells/Liter | Standard Deviation 0.1204 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, predose, n=6,6,25,6,14 | 0.017 10^9 cells/Liter | Standard Deviation 0.0602 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 10, predose, n=6,6,25,7,14 | 0.028 10^9 cells/Liter | Standard Deviation 0.1317 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, 48 hours, n=6,6,24,6,14 | 0.048 10^9 cells/Liter | Standard Deviation 0.3746 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, 48 hours, n=6,6,24,6,14 | 0.028 10^9 cells/Liter | Standard Deviation 0.7348 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 28), n=6,6,25,7,14 | -8.7 10^9 cells/Liter | Standard Deviation 10.75 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, 48 hours, n=6,6,24,6,14 | 0.003 10^9 cells/Liter | Standard Deviation 0.0468 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, predose, n=6,6,25,6,14 | 0.003 10^9 cells/Liter | Standard Deviation 0.0052 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 2, predose, n=6,5,25,7,14 | -0.7 10^9 cells/Liter | Standard Deviation 18.78 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.002 10^9 cells/Liter | Standard Deviation 0.0075 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 28), n=6,6,25,7,14 | -0.055 10^9 cells/Liter | Standard Deviation 0.0373 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.045 10^9 cells/Liter | Standard Deviation 0.0647 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 4, predose, n=6,6,25,7,14 | 0.170 10^9 cells/Liter | Standard Deviation 0.8864 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 12, predose, n=6,6,25,7,14 | 0.538 10^9 cells/Liter | Standard Deviation 1.0626 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, 96 hours, n=6,6,24,6,14 | -4.3 10^9 cells/Liter | Standard Deviation 9.93 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 8 predose, n=6,6,25,7,14 | 0.012 10^9 cells/Liter | Standard Deviation 0.1068 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 28), n=6,6,25,7,14 | -0.512 10^9 cells/Liter | Standard Deviation 0.5189 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 4, predose, n=6,6,25,7,14 | -0.002 10^9 cells/Liter | Standard Deviation 0.0117 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 6, predose, n=6,6,25,7,14 | -0.030 10^9 cells/Liter | Standard Deviation 0.1489 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, FU(Day 28), n=6,6,25,7,14 | -0.007 10^9 cells/Liter | Standard Deviation 0.0103 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.292 10^9 cells/Liter | Standard Deviation 0.571 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 2, predose, n=6,6,25,7,14 | 0.003 10^9 cells/Liter | Standard Deviation 0.1046 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, 48 hours, n=6,6,24,6,14 | -0.022 10^9 cells/Liter | Standard Deviation 0.5561 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 12, predose, n=6,6,25,7,14 | 0.177 10^9 cells/Liter | Standard Deviation 0.7096 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 4, predose, n=6,6,25,7,14 | 0.015 10^9 cells/Liter | Standard Deviation 0.0536 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 12, predose, n=6,6,25,7,14 | 0.023 10^9 cells/Liter | Standard Deviation 0.0942 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 4, predose, n=6,6,25,7,14 | -0.023 10^9 cells/Liter | Standard Deviation 0.0804 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 12, predose, n=6,6,25,7,14 | 0.002 10^9 cells/Liter | Standard Deviation 0.0075 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, 48 hours, n=6,6,24,6,14 | -3.0 10^9 cells/Liter | Standard Deviation 13.73 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, FU (Day 28), n=6,6,25,7,14 | -0.083 10^9 cells/Liter | Standard Deviation 0.1037 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 8 predose, n=6,6,25,7,14 | 0.027 10^9 cells/Liter | Standard Deviation 0.0516 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 10, predose, n=6,6,25,7,14 | 0.117 10^9 cells/Liter | Standard Deviation 0.8565 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 4, predose, n=6,5,25,7,14 | 2.5 10^9 cells/Liter | Standard Deviation 12.76 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 12, predose, n=6,6,25,7,14 | 0.017 10^9 cells/Liter | Standard Deviation 0.0163 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, 96 hours, n=6,6,24,6,14 | -0.030 10^9 cells/Liter | Standard Deviation 0.1077 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, FU(Day 28), n=6,6,25,7,14 | 0.003 10^9 cells/Liter | Standard Deviation 0.0137 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, 48 hours, n=6,6,24,6,14 | 0.135 10^9 cells/Liter | Standard Deviation 0.3746 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 4, predose, n=6,6,25,7,14 | 0.123 10^9 cells/Liter | Standard Deviation 0.5792 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 2, predose, n=6,6,25,7,14 | 0.032 10^9 cells/Liter | Standard Deviation 0.0147 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 4, predose, n=6,5,25,7,14 | -11.2 10^9 cells/Liter | Standard Deviation 8.23 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 8 predose, n=6,6,25,7,14 | 0.030 10^9 cells/Liter | Standard Deviation 0.0529 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 2, predose, n=6,6,25,7,14 | 0.275 10^9 cells/Liter | Standard Deviation 0.4329 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 8 predose, n=6,6,25,7,14 | 0.097 10^9 cells/Liter | Standard Deviation 0.3894 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, 96 hours, n=6,6,24,6,14 | -3.3 10^9 cells/Liter | Standard Deviation 20.74 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 12, predose, n=6,6,25,7,14 | 0.067 10^9 cells/Liter | Standard Deviation 0.0472 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, 96 hours, n=6,6,24,6,14 | 0.255 10^9 cells/Liter | Standard Deviation 0.4602 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, predose, n=6,6,25,6,14 | 0.013 10^9 cells/Liter | Standard Deviation 0.0468 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 28), n=6,6,25,7,14 | 0.017 10^9 cells/Liter | Standard Deviation 0.0659 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, 48 hours, n=6,6,24,6,14 | 0.047 10^9 cells/Liter | Standard Deviation 0.0513 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.043 10^9 cells/Liter | Standard Deviation 0.0437 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 28), n=6,6,25,7,14 | -0.280 10^9 cells/Liter | Standard Deviation 0.5637 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 2, predose, n=6,6,25,7,14 | -0.038 10^9 cells/Liter | Standard Deviation 0.0791 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, 48 hours, n=6,6,24,6,14 | -2.8 10^9 cells/Liter | Standard Deviation 13.7 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 4, predose, n=6,6,25,7,14 | 0.013 10^9 cells/Liter | Standard Deviation 0.0455 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, FU (Day 28), n=6,6,25,7,14 | -0.030 10^9 cells/Liter | Standard Deviation 0.1188 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 2, predose, n=6,6,25,7,14 | 0.190 10^9 cells/Liter | Standard Deviation 0.5981 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, predose, n=6,6,25,6,14 | -6.2 10^9 cells/Liter | Standard Deviation 19.3 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 6, predose, n=6,6,25,7,14 | 0.135 10^9 cells/Liter | Standard Deviation 0.3031 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 6, predose, n=6,6,25,7,14 | 0.007 10^9 cells/Liter | Standard Deviation 0.0528 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 2, predose, n=6,6,25,7,14 | 0.092 10^9 cells/Liter | Standard Deviation 0.4111 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 4, predose, n=6,6,25,7,14 | -0.067 10^9 cells/Liter | Standard Deviation 0.523 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 4, predose, n=6,6,25,7,14 | 0.207 10^9 cells/Liter | Standard Deviation 0.3747 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 6, predose, n=6,6,25,7,14 | -0.017 10^9 cells/Liter | Standard Deviation 0.5384 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 12, predose, n=6,6,25,7,14 | 9.8 10^9 cells/Liter | Standard Deviation 19.02 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 8 predose, n=6,6,25,7,14 | 0.100 10^9 cells/Liter | Standard Deviation 0.5655 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 10, predose, n=6,6,25,7,14 | 0.185 10^9 cells/Liter | Standard Deviation 0.5404 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 10, predose, n=6,6,25,7,14 | 0.053 10^9 cells/Liter | Standard Deviation 0.0539 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 10, predose, n=6,6,25,7,14 | 14.7 10^9 cells/Liter | Standard Deviation 11.34 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 6, predose, n=6,6,25,7,14 | 0.052 10^9 cells/Liter | Standard Deviation 0.4839 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 4, predose, n=6,6,25,7,14 | 0.005 10^9 cells/Liter | Standard Deviation 0.0217 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 6, predose, n=6,6,25,7,14 | 0.003 10^9 cells/Liter | Standard Deviation 0.0151 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, predose, n=6,6,25,6,14 | -0.053 10^9 cells/Liter | Standard Deviation 0.423 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 8 predose, n=6,5,25,7,14 | 4.4 10^9 cells/Liter | Standard Deviation 13.87 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 10, predose, n=6,6,25,7,14 | 0.013 10^9 cells/Liter | Standard Deviation 0.0163 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 6, predose, n=6,6,25,7,14 | 10.3 10^9 cells/Liter | Standard Deviation 14.73 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 28), n=6,6,25,7,14 | 0.555 10^9 cells/Liter | Standard Deviation 1.9413 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 8 predose, n=6,6,25,7,14 | 0.178 10^9 cells/Liter | Standard Deviation 0.6011 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.017 10^9 cells/Liter | Standard Deviation 0.5775 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 10, predose, n=6,6,25,7,14 | 0.515 10^9 cells/Liter | Standard Deviation 0.4821 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 12, predose, n=6,6,25,7,14 | 0.332 10^9 cells/Liter | Standard Deviation 0.3874 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 4, predose, n=6,6,25,7,14 | -0.037 10^9 cells/Liter | Standard Deviation 0.0905 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 2, predose, n=6,6,25,7,14 | 0.000 10^9 cells/Liter | Standard Deviation 0.011 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 6, predose, n=6,6,25,7,14 | -0.075 10^9 cells/Liter | Standard Deviation 0.0817 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, 48 hours, n=6,6,24,6,14 | 0.035 10^9 cells/Liter | Standard Deviation 0.7028 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 8 predose, n=6,6,25,7,14 | -0.057 10^9 cells/Liter | Standard Deviation 0.1063 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 12, predose, n=6,6,25,7,14 | 0.810 10^9 cells/Liter | Standard Deviation 0.4692 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, 48 hours, n=6,6,24,6,14 | 0.187 10^9 cells/Liter | Standard Deviation 0.4774 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 2, predose, n=6,5,25,7,14 | 9.8 10^9 cells/Liter | Standard Deviation 6.94 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, predose, n=6,6,25,6,14 | -0.007 10^9 cells/Liter | Standard Deviation 0.462 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, 96 hours, n=6,6,24,6,14 | 0.300 10^9 cells/Liter | Standard Deviation 0.4367 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 10, predose, n=6,6,25,7,14 | 0.020 10^9 cells/Liter | Standard Deviation 0.1115 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 28), n=6,6,25,7,14 | -11.8 10^9 cells/Liter | Standard Deviation 20.02 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 28), n=6,6,25,7,14 | 0.263 10^9 cells/Liter | Standard Deviation 1.6261 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 8 predose, n=6,6,25,7,14 | 0.012 10^9 cells/Liter | Standard Deviation 0.0214 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 12, predose, n=6,6,25,7,14 | 0.022 10^9 cells/Liter | Standard Deviation 0.1269 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 12, predose, n=6,6,25,7,14 | 0.373 10^9 cells/Liter | Standard Deviation 0.369 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, predose, n=6,6,25,6,14 | 0.002 10^9 cells/Liter | Standard Deviation 0.0214 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, predose, n=6,6,25,6,14 | -0.008 10^9 cells/Liter | Standard Deviation 0.0773 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, predose, n=6,6,25,6,14 | -0.055 10^9 cells/Liter | Standard Deviation 0.4773 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 10, predose, n=6,6,25,7,14 | 0.240 10^9 cells/Liter | Standard Deviation 0.3099 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, 48 hours, n=6,6,24,6,14 | 0.010 10^9 cells/Liter | Standard Deviation 0.019 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.010 10^9 cells/Liter | Standard Deviation 0.0228 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, 48 hours, n=6,6,24,6,14 | -0.040 10^9 cells/Liter | Standard Deviation 0.0947 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, 96 hours, n=6,6,24,6,14 | 1.0 10^9 cells/Liter | Standard Deviation 23.54 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 2, predose, n=6,6,25,7,14 | 0.011 10^9 cells/Liter | Standard Deviation 0.169 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 12, predose, n=6,6,25,7,14 | 0.008 10^9 cells/Liter | Standard Deviation 0.0121 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 4, predose, n=6,6,25,7,14 | 0.012 10^9 cells/Liter | Standard Deviation 0.0867 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 10, predose, n=6,6,25,7,14 | 0.296 10^9 cells/Liter | Standard Deviation 0.8216 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 28), n=6,6,25,7,14 | -0.024 10^9 cells/Liter | Standard Deviation 0.7404 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 12, predose, n=6,6,25,7,14 | 0.180 10^9 cells/Liter | Standard Deviation 0.4106 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, 48 hours, n=6,6,24,6,14 | -0.019 10^9 cells/Liter | Standard Deviation 0.1158 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 4, predose, n=6,6,25,7,14 | -0.001 10^9 cells/Liter | Standard Deviation 0.1085 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, 48 hours, n=6,6,24,6,14 | 0.180 10^9 cells/Liter | Standard Deviation 0.3403 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, 48 hours, n=6,6,24,6,14 | 1.3 10^9 cells/Liter | Standard Deviation 21.79 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 28), n=6,6,25,7,14 | -0.144 10^9 cells/Liter | Standard Deviation 0.4368 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 12, predose, n=6,6,25,7,14 | -0.002 10^9 cells/Liter | Standard Deviation 0.0926 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 6, predose, n=6,6,25,7,14 | -0.019 10^9 cells/Liter | Standard Deviation 0.1169 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 28), n=6,6,25,7,14 | -3.9 10^9 cells/Liter | Standard Deviation 21.61 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, 48 hours, n=6,6,24,6,14 | -0.072 10^9 cells/Liter | Standard Deviation 0.9007 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 2, predose, n=6,6,25,7,14 | 0.006 10^9 cells/Liter | Standard Deviation 0.0728 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.004 10^9 cells/Liter | Standard Deviation 0.1167 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 10, predose, n=6,6,25,7,14 | 0.012 10^9 cells/Liter | Standard Deviation 0.8357 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, predose, n=6,6,25,6,14 | 0.180 10^9 cells/Liter | Standard Deviation 1.0249 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 8 predose, n=6,6,25,7,14 | -0.018 10^9 cells/Liter | Standard Deviation 0.1006 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, FU(Day 28), n=6,6,25,7,14 | -0.003 10^9 cells/Liter | Standard Deviation 0.0124 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, 48 hours, n=6,6,24,6,14 | 0.000 10^9 cells/Liter | Standard Deviation 0.1193 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, 96 hours, n=6,6,24,6,14 | 0.247 10^9 cells/Liter | Standard Deviation 0.3308 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, 48 hours, n=6,6,24,6,14 | 0.007 10^9 cells/Liter | Standard Deviation 0.0137 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, predose, n=6,6,25,6,14 | 0.019 10^9 cells/Liter | Standard Deviation 0.1192 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, 48 hours, n=6,6,24,6,14 | 0.097 10^9 cells/Liter | Standard Deviation 1.0672 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, predose, n=6,6,25,6,14 | 0.186 10^9 cells/Liter | Standard Deviation 0.2944 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, predose, n=6,6,25,6,14 | -0.023 10^9 cells/Liter | Standard Deviation 0.1044 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 28), n=6,6,25,7,14 | -0.003 10^9 cells/Liter | Standard Deviation 0.1617 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 12, predose, n=6,6,25,7,14 | 0.021 10^9 cells/Liter | Standard Deviation 0.1075 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 4, predose, n=6,6,25,7,14 | -0.096 10^9 cells/Liter | Standard Deviation 0.9361 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 8 predose, n=6,6,25,7,14 | 0.140 10^9 cells/Liter | Standard Deviation 0.2862 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 10, predose, n=6,6,25,7,14 | 8.0 10^9 cells/Liter | Standard Deviation 30.98 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, predose, n=6,6,25,6,14 | 0.007 10^9 cells/Liter | Standard Deviation 0.014 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 2, predose, n=6,6,25,7,14 | -0.004 10^9 cells/Liter | Standard Deviation 0.0111 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, 96 hours, n=6,6,24,6,14 | 0.336 10^9 cells/Liter | Standard Deviation 1.1083 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 10, predose, n=6,6,25,7,14 | 0.016 10^9 cells/Liter | Standard Deviation 0.0881 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 2, predose, n=6,5,25,7,14 | 5.4 10^9 cells/Liter | Standard Deviation 13.46 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 8 predose, n=6,6,25,7,14 | -0.132 10^9 cells/Liter | Standard Deviation 0.8619 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 6, predose, n=6,6,25,7,14 | 0.100 10^9 cells/Liter | Standard Deviation 1.3054 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 10, predose, n=6,6,25,7,14 | 0.025 10^9 cells/Liter | Standard Deviation 0.1057 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 4, predose, n=6,6,25,7,14 | -0.001 10^9 cells/Liter | Standard Deviation 0.0108 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 6, predose, n=6,6,25,7,14 | 0.147 10^9 cells/Liter | Standard Deviation 0.3174 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 8 predose, n=6,5,25,7,14 | 8.6 10^9 cells/Liter | Standard Deviation 19.14 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 10, predose, n=6,6,25,7,14 | 0.232 10^9 cells/Liter | Standard Deviation 0.358 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 4, predose, n=6,6,25,7,14 | 0.000 10^9 cells/Liter | Standard Deviation 0.3242 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 12, predose, n=6,6,25,7,14 | 0.165 10^9 cells/Liter | Standard Deviation 0.8511 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 6, predose, n=6,6,25,7,14 | 0.001 10^9 cells/Liter | Standard Deviation 0.0124 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.004 10^9 cells/Liter | Standard Deviation 0.011 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 2, predose, n=6,6,25,7,14 | 0.013 10^9 cells/Liter | Standard Deviation 0.3249 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 8 predose, n=6,6,25,7,14 | -0.005 10^9 cells/Liter | Standard Deviation 0.0838 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 12, predose, n=6,6,25,7,14 | 3.6 10^9 cells/Liter | Standard Deviation 34.68 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 8 predose, n=6,6,25,7,14 | 0.004 10^9 cells/Liter | Standard Deviation 0.0147 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 4, predose, n=6,5,25,7,14 | 2.5 10^9 cells/Liter | Standard Deviation 16.28 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 28), n=6,6,25,7,14 | -0.209 10^9 cells/Liter | Standard Deviation 0.899 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 6, predose, n=6,6,25,7,14 | -0.030 10^9 cells/Liter | Standard Deviation 1.1214 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 12, predose, n=6,6,25,7,14 | -0.042 10^9 cells/Liter | Standard Deviation 0.7593 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 10, predose, n=6,6,25,7,14 | 0.010 10^9 cells/Liter | Standard Deviation 0.0108 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, predose, n=6,6,25,6,14 | -0.011 10^9 cells/Liter | Standard Deviation 0.9244 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 6, predose, n=6,6,25,7,14 | 3.4 10^9 cells/Liter | Standard Deviation 18.67 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 4, predose, n=6,6,25,7,14 | -0.107 10^9 cells/Liter | Standard Deviation 0.8863 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 2, predose, n=6,6,25,7,14 | 0.355 10^9 cells/Liter | Standard Deviation 1.6576 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 6, predose, n=6,6,25,7,14 | 0.000 10^9 cells/Liter | Standard Deviation 0.0876 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 2, predose, n=6,6,25,7,14 | 0.328 10^9 cells/Liter | Standard Deviation 1.5779 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, 96 hours, n=6,6,24,6,14 | 0.006 10^9 cells/Liter | Standard Deviation 0.1323 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 8 predose, n=6,6,25,7,14 | -0.011 10^9 cells/Liter | Standard Deviation 0.9496 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, predose, n=6,6,25,6,14 | 8.3 10^9 cells/Liter | Standard Deviation 25.49 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.075 10^9 cells/Liter | Standard Deviation 0.9796 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, FU (Day 28), n=6,6,25,7,14 | -0.036 10^9 cells/Liter | Standard Deviation 0.0937 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.050 10^9 cells/Liter | Standard Deviation 0.0851 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 4, predose, n=6,6,25,7,14 | -0.153 10^9 cells/Liter | Standard Deviation 1.0017 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 6, predose, n=6,6,25,7,14 | 0.034 10^9 cells/Liter | Standard Deviation 0.0832 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 8 predose, n=6,6,25,7,14 | 0.024 10^9 cells/Liter | Standard Deviation 0.0683 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 12, predose, n=6,6,25,7,14 | -0.831 10^9 cells/Liter | Standard Deviation 1.1224 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, 96 hours, n=6,6,24,6,14 | -0.497 10^9 cells/Liter | Standard Deviation 1.0625 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 28), n=6,6,25,7,14 | -0.509 10^9 cells/Liter | Standard Deviation 1.3465 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 12, predose, n=6,6,25,7,14 | 0.231 10^9 cells/Liter | Standard Deviation 0.5225 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, predose, n=6,6,25,6,14 | 0.125 10^9 cells/Liter | Standard Deviation 0.4923 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, 48 hours, n=6,6,24,6,14 | 0.072 10^9 cells/Liter | Standard Deviation 0.4776 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, 96 hours, n=6,6,24,6,14 | 0.193 10^9 cells/Liter | Standard Deviation 0.7185 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 28), n=6,6,25,7,14 | -0.237 10^9 cells/Liter | Standard Deviation 0.3583 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 2, predose, n=6,6,25,7,14 | -0.026 10^9 cells/Liter | Standard Deviation 0.0948 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, 96 hours, n=6,6,24,6,14 | -0.002 10^9 cells/Liter | Standard Deviation 0.145 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, FU (Day 28), n=6,6,25,7,14 | 0.013 10^9 cells/Liter | Standard Deviation 0.1883 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 2, predose, n=6,6,25,7,14 | -0.273 10^9 cells/Liter | Standard Deviation 0.6049 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 28), n=6,6,25,7,14 | -0.709 10^9 cells/Liter | Standard Deviation 1.279 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 2, predose, n=6,6,25,7,14 | 0.163 10^9 cells/Liter | Standard Deviation 0.3174 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 4, predose, n=6,6,25,7,14 | 0.194 10^9 cells/Liter | Standard Deviation 0.45 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 6, predose, n=6,6,25,7,14 | 0.210 10^9 cells/Liter | Standard Deviation 0.5157 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 8 predose, n=6,6,25,7,14 | 0.229 10^9 cells/Liter | Standard Deviation 0.4557 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 2, predose, n=6,6,25,7,14 | 0.001 10^9 cells/Liter | Standard Deviation 0.0069 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 4, predose, n=6,6,25,7,14 | 0.001 10^9 cells/Liter | Standard Deviation 0.0107 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 6, predose, n=6,6,25,7,14 | 0.009 10^9 cells/Liter | Standard Deviation 0.0135 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 10, predose, n=6,6,25,7,14 | 0.190 10^9 cells/Liter | Standard Deviation 0.5199 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 8 predose, n=6,6,25,7,14 | 0.014 10^9 cells/Liter | Standard Deviation 0.0098 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 10, predose, n=6,6,25,7,14 | 0.011 10^9 cells/Liter | Standard Deviation 0.0121 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 6, predose, n=6,6,25,7,14 | -0.347 10^9 cells/Liter | Standard Deviation 0.6065 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 8 predose, n=6,6,25,7,14 | -0.481 10^9 cells/Liter | Standard Deviation 1.2 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 10, predose, n=6,6,25,7,14 | -0.584 10^9 cells/Liter | Standard Deviation 1.1299 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 4, predose, n=6,6,25,7,14 | -0.023 10^9 cells/Liter | Standard Deviation 0.1052 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 6, predose, n=6,6,25,7,14 | -0.067 10^9 cells/Liter | Standard Deviation 0.0808 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 8 predose, n=6,6,25,7,14 | -0.001 10^9 cells/Liter | Standard Deviation 0.1192 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, 48 hours, n=6,6,24,6,14 | -0.597 10^9 cells/Liter | Standard Deviation 1.2776 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, 96 hours, n=6,6,24,6,14 | -0.248 10^9 cells/Liter | Standard Deviation 1.6414 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 10, predose, n=6,6,25,7,14 | -0.021 10^9 cells/Liter | Standard Deviation 0.1122 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 12, predose, n=6,6,25,7,14 | 0.010 10^9 cells/Liter | Standard Deviation 0.0082 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 12, predose, n=6,6,25,7,14 | -0.011 10^9 cells/Liter | Standard Deviation 0.153 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, predose, n=6,6,25,6,14 | -0.027 10^9 cells/Liter | Standard Deviation 0.1226 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, predose, n=6,6,25,6,14 | 0.017 10^9 cells/Liter | Standard Deviation 0.0082 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, 48 hours, n=6,6,24,6,14 | 0.005 10^9 cells/Liter | Standard Deviation 0.0138 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, 48 hours, n=6,6,24,6,14 | -0.050 10^9 cells/Liter | Standard Deviation 0.1352 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.007 10^9 cells/Liter | Standard Deviation 0.0121 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 6, predose, n=6,6,25,7,14 | -0.533 10^9 cells/Liter | Standard Deviation 0.6285 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, FU(Day 28), n=6,6,25,7,14 | -0.001 10^9 cells/Liter | Standard Deviation 0.0069 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 2, predose, n=6,6,25,7,14 | 0.050 10^9 cells/Liter | Standard Deviation 0.0663 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 4, predose, n=6,6,25,7,14 | 0.043 10^9 cells/Liter | Standard Deviation 0.0605 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 12, predose, n=6,6,25,7,14 | -0.567 10^9 cells/Liter | Standard Deviation 1.2112 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 10, predose, n=6,6,25,7,14 | 0.026 10^9 cells/Liter | Standard Deviation 0.0824 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 12, predose, n=6,6,25,7,14 | 0.033 10^9 cells/Liter | Standard Deviation 0.0862 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, predose, n=6,6,25,6,14 | 0.048 10^9 cells/Liter | Standard Deviation 0.0794 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, 48 hours, n=6,6,24,6,14 | 0.048 10^9 cells/Liter | Standard Deviation 0.0893 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, predose, n=6,6,25,6,14 | -0.433 10^9 cells/Liter | Standard Deviation 0.9609 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 28), n=6,6,25,7,14 | 0.023 10^9 cells/Liter | Standard Deviation 0.0804 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 2, predose, n=6,6,25,7,14 | -0.081 10^9 cells/Liter | Standard Deviation 0.4831 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 4, predose, n=6,6,25,7,14 | 0.063 10^9 cells/Liter | Standard Deviation 0.96 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 8 predose, n=6,6,25,7,14 | -0.746 10^9 cells/Liter | Standard Deviation 1.2632 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 10, predose, n=6,6,25,7,14 | -0.791 10^9 cells/Liter | Standard Deviation 1.1634 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, predose, n=6,6,25,6,14 | -0.598 10^9 cells/Liter | Standard Deviation 0.945 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, 48 hours, n=6,6,24,6,14 | -0.673 10^9 cells/Liter | Standard Deviation 1.2453 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 6, predose, n=6,6,25,7,14 | 17.1 10^9 cells/Liter | Standard Deviation 13.28 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 8 predose, n=6,5,25,7,14 | 16.7 10^9 cells/Liter | Standard Deviation 21.66 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 10, predose, n=6,6,25,7,14 | 14.3 10^9 cells/Liter | Standard Deviation 12.38 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 12, predose, n=6,6,25,7,14 | 6.1 10^9 cells/Liter | Standard Deviation 15 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, predose, n=6,6,25,6,14 | 7.8 10^9 cells/Liter | Standard Deviation 19.74 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, 48 hours, n=6,6,24,6,14 | -2.2 10^9 cells/Liter | Standard Deviation 17.99 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, 96 hours, n=6,6,24,6,14 | -17.3 10^9 cells/Liter | Standard Deviation 33.99 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 28), n=6,6,25,7,14 | -4.0 10^9 cells/Liter | Standard Deviation 28.3 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 2, predose, n=6,5,25,7,14 | 17.9 10^9 cells/Liter | Standard Deviation 18.89 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 4, predose, n=6,5,25,7,14 | 17.6 10^9 cells/Liter | Standard Deviation 31.86 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, 48 hours, n=6,6,24,6,14 | 0.004 10^9 cells/Liter | Standard Deviation 0.0756 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, 96 hours, n=6,6,24,6,14 | -5.4 10^9 cells/Liter | Standard Deviation 25.19 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 8 predose, n=6,6,25,7,14 | -0.141 10^9 cells/Liter | Standard Deviation 1.0976 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, predose, n=6,6,25,6,14 | 0.003 10^9 cells/Liter | Standard Deviation 0.1007 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, predose, n=6,6,25,6,14 | -0.003 10^9 cells/Liter | Standard Deviation 0.0114 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 12, predose, n=6,6,25,7,14 | -0.009 10^9 cells/Liter | Standard Deviation 0.1244 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 12, predose, n=6,6,25,7,14 | 0.054 10^9 cells/Liter | Standard Deviation 0.5013 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 10, predose, n=6,6,25,7,14 | -0.008 10^9 cells/Liter | Standard Deviation 1.3122 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 12, predose, n=6,6,25,7,14 | -0.001 10^9 cells/Liter | Standard Deviation 0.01 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 10, predose, n=6,6,25,7,14 | -0.001 10^9 cells/Liter | Standard Deviation 0.1356 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 12, predose, n=6,6,25,7,14 | -0.083 10^9 cells/Liter | Standard Deviation 1.1305 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, 96 hours, n=6,6,24,6,14 | 0.347 10^9 cells/Liter | Standard Deviation 1.3089 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, 48 hours, n=6,6,24,6,14 | 0.104 10^9 cells/Liter | Standard Deviation 1.2821 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 8 predose, n=6,5,25,7,14 | 0.4 10^9 cells/Liter | Standard Deviation 31.14 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, predose, n=6,6,25,6,14 | -0.026 10^9 cells/Liter | Standard Deviation 1.1249 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 8 predose, n=6,6,25,7,14 | -0.005 10^9 cells/Liter | Standard Deviation 0.1005 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 10, predose, n=6,6,25,7,14 | 0.064 10^9 cells/Liter | Standard Deviation 1.5507 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 6, predose, n=6,6,25,7,14 | -0.021 10^9 cells/Liter | Standard Deviation 0.1045 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, FU (Day 28), n=6,6,25,7,14 | 0.235 10^9 cells/Liter | Standard Deviation 1.3115 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, 48 hours, n=6,6,24,6,14 | 0.049 10^9 cells/Liter | Standard Deviation 1.1598 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 4, predose, n=6,6,25,7,14 | -0.029 10^9 cells/Liter | Standard Deviation 0.1018 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 10, predose, n=6,6,25,7,14 | 0.085 10^9 cells/Liter | Standard Deviation 0.4055 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 8 predose, n=6,6,25,7,14 | -0.144 10^9 cells/Liter | Standard Deviation 1.3225 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.255 10^9 cells/Liter | Standard Deviation 1.1764 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 14, predose, n=6,6,25,6,14 | 0.046 10^9 cells/Liter | Standard Deviation 1.3461 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 6, predose, n=6,6,25,7,14 | -0.026 10^9 cells/Liter | Standard Deviation 1.3748 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 10, predose, n=6,6,25,7,14 | 0.001 10^9 cells/Liter | Standard Deviation 0.0123 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 4, predose, n=6,6,25,7,14 | -0.003 10^9 cells/Liter | Standard Deviation 0.4739 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 6, predose, n=6,6,25,7,14 | 3.3 10^9 cells/Liter | Standard Deviation 25.28 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 8 predose, n=6,6,25,7,14 | -0.002 10^9 cells/Liter | Standard Deviation 0.0105 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 6, predose, n=6,6,25,7,14 | -0.002 10^9 cells/Liter | Standard Deviation 0.0105 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 4, predose, n=6,6,25,7,14 | -0.002 10^9 cells/Liter | Standard Deviation 0.0119 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, FU (Day 28), n=6,6,25,7,14 | -5.3 10^9 cells/Liter | Standard Deviation 39.09 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 2, predose, n=6,6,25,7,14 | -0.004 10^9 cells/Liter | Standard Deviation 0.0108 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 4, predose, n=6,6,25,7,14 | -0.250 10^9 cells/Liter | Standard Deviation 1.3609 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 8 predose, n=6,6,25,7,14 | -0.007 10^9 cells/Liter | Standard Deviation 0.0395 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 10, predose, n=6,6,25,7,14 | 4.8 10^9 cells/Liter | Standard Deviation 31.48 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 8 predose, n=6,6,25,7,14 | 0.013 10^9 cells/Liter | Standard Deviation 0.466 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 6, predose, n=6,6,25,7,14 | 0.112 10^9 cells/Liter | Standard Deviation 0.3739 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, FU (Day 28), n=6,6,25,7,14 | -0.049 10^9 cells/Liter | Standard Deviation 1.1939 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 4, predose, n=6,5,25,7,14 | -3.6 10^9 cells/Liter | Standard Deviation 21.81 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 12, predose, n=6,6,25,7,14 | 2.9 10^9 cells/Liter | Standard Deviation 28.62 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 4, predose, n=6,6,25,7,14 | -0.209 10^9 cells/Liter | Standard Deviation 1.0416 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 2, predose, n=6,6,25,7,14 | -0.128 10^9 cells/Liter | Standard Deviation 1.0189 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, FU (Day 28), n=6,6,25,7,14 | -0.051 10^9 cells/Liter | Standard Deviation 0.0778 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 2, predose, n=6,5,25,7,14 | 1.3 10^9 cells/Liter | Standard Deviation 20.45 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, predose, n=6,6,25,6,14 | -2.9 10^9 cells/Liter | Standard Deviation 31.9 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 14, 96 hours, n=6,6,24,6,14 | 0.038 10^9 cells/Liter | Standard Deviation 0.1207 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Monocytes, Day 2, predose, n=6,6,25,7,14 | -0.042 10^9 cells/Liter | Standard Deviation 0.0982 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, FU (Day 28), n=6,6,25,7,14 | -0.184 10^9 cells/Liter | Standard Deviation 0.2858 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 4, predose, n=6,6,25,7,14 | -0.006 10^9 cells/Liter | Standard Deviation 0.052 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Platelets, Day 14, 48 hours, n=6,6,24,6,14 | -1.1 10^9 cells/Liter | Standard Deviation 34.32 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, 96 hours, n=6,6,24,6,14 | 0.059 10^9 cells/Liter | Standard Deviation 0.4478 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 2, predose, n=6,6,25,7,14 | -0.026 10^9 cells/Liter | Standard Deviation 0.4478 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, 96 hours, n=6,6,24,6,14 | 0.001 10^9 cells/Liter | Standard Deviation 0.0584 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, 48 hours, n=6,6,24,6,14 | 0.009 10^9 cells/Liter | Standard Deviation 0.077 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 14, predose, n=6,6,25,6,14 | 0.011 10^9 cells/Liter | Standard Deviation 0.0589 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 12, predose, n=6,6,25,7,14 | -0.012 10^9 cells/Liter | Standard Deviation 0.0519 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, 48 hours, n=6,6,24,6,14 | 0.044 10^9 cells/Liter | Standard Deviation 0.4554 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 10, predose, n=6,6,25,7,14 | -0.012 10^9 cells/Liter | Standard Deviation 0.0437 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, FU (Day 28), n=6,6,25,7,14 | -0.041 10^9 cells/Liter | Standard Deviation 0.0618 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 12, predose, n=6,6,25,7,14 | -0.052 10^9 cells/Liter | Standard Deviation 1.4813 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Neutrophils, Day 6, predose, n=6,6,25,7,14 | -0.114 10^9 cells/Liter | Standard Deviation 1.1418 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 6, predose, n=6,6,25,7,14 | 0.000 10^9 cells/Liter | Standard Deviation 0.0411 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Lymphocytes, Day 14, predose, n=6,6,25,6,14 | 0.061 10^9 cells/Liter | Standard Deviation 0.4643 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Leukocytes, Day 2, predose, n=6,6,25,7,14 | -0.202 10^9 cells/Liter | Standard Deviation 1.2439 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Eosinophils, Day 2, predose, n=6,6,25,7,14 | -0.001 10^9 cells/Liter | Standard Deviation 0.0438 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, FU(Day 28), n=6,6,25,7,14 | -0.006 10^9 cells/Liter | Standard Deviation 0.015 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, 96 hours, n=6,6,24,6,14 | -0.004 10^9 cells/Liter | Standard Deviation 0.0165 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. | Basophils, Day 14, 48 hours, n=6,6,24,6,14 | -0.001 10^9 cells/Liter | Standard Deviation 0.0103 |
Primary
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
Blood samples were collected to analyze the chemistry parameter: ALT, AST,ALP. Day -2was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day14: 48 and 96 hours post dose, Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, 96 hours, n=6,6,24,6,14 | 2.7 International units per liter | Standard Deviation 5.13 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, 48 hours, n=6,6,24,6,14 | -1.3 International units per liter | Standard Deviation 4.93 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 6, predose, n=6,6,25,7,14 | 3.3 International units per liter | Standard Deviation 7.28 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, 48 hours, n=6,6,24,6,14 | 5.8 International units per liter | Standard Deviation 15.54 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, predose, n=5,5,25,6,14 | -3.6 International units per liter | Standard Deviation 7.13 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 12, predose, n=6,6,25,7,14 | -1.2 International units per liter | Standard Deviation 3.92 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 10, predose, n=6,6,25,7,14 | 0.8 International units per liter | Standard Deviation 4.92 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 8 predose, n=6,5,25,7,14 | 1.0 International units per liter | Standard Deviation 4.52 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, predose, n=5,5,25,6,14 | 1.4 International units per liter | Standard Deviation 9.26 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 12, predose, n=5,6,25,7,14 | 0.2 International units per liter | Standard Deviation 4.32 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 10, predose, n=5,6,25,7,14 | 0.0 International units per liter | Standard Deviation 3.24 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 8 predose, n=5,5,25,7,14 | 0.6 International units per liter | Standard Deviation 4.34 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, 96 hours, n=6,6,24,6,14 | 6.0 International units per liter | Standard Deviation 10.35 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, 96 hours, n=5,6,24,6,14 | 2.4 International units per liter | Standard Deviation 4.22 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 6, predose, n=5,6,25,7,14 | 0.0 International units per liter | Standard Deviation 4.18 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 4, predose, n=5,6,25,7,14 | 0.6 International units per liter | Standard Deviation 2.88 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 2, predose, n=5,6,24,7,14 | -1.4 International units per liter | Standard Deviation 3.58 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, FU (Day 28), n=6,6,25,7,14 | 2.5 International units per liter | Standard Deviation 5.09 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, 48 hours, n=5,6,24,6,14 | 0.8 International units per liter | Standard Deviation 4.44 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, FU (Day 28), n=6,6,25,7,14 | 1.5 International units per liter | Standard Deviation 5.75 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 12, predose, n=6,6,25,7,14 | 4.8 International units per liter | Standard Deviation 10.85 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 10, predose, n=6,6,25,7,14 | 2.2 International units per liter | Standard Deviation 8.04 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 2, predose, n=6,6,25,7,14 | -0.7 International units per liter | Standard Deviation 1.37 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, predose, n=4,5,23,5,12 | 2.8 International units per liter | Standard Deviation 3.3 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 8 predose, n=6,6,25,7,14 | 3.0 International units per liter | Standard Deviation 7.62 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 6, predose, n=6,6,25,7,14 | 3.2 International units per liter | Standard Deviation 6.55 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 4, predose, n=6,6,25,7,14 | 0.0 International units per liter | Standard Deviation 5.44 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 4, predose, n=6,6,25,7,14 | 3.7 International units per liter | Standard Deviation 3.67 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, FU (Day 28), n=6,6,25,7,14 | 2.0 International units per liter | Standard Deviation 6.67 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 2, predose, n=6,6,25,7,14 | -1.2 International units per liter | Standard Deviation 5.08 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 4, predose, n=6,6,25,7,14 | -1.3 International units per liter | Standard Deviation 6.35 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, predose, n=5,5,25,6,14 | -2.6 International units per liter | Standard Deviation 12.97 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, 48 hours, n=6,6,24,6,14 | 1.7 International units per liter | Standard Deviation 13.69 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, 96 hours, n=6,6,24,6,14 | -0.3 International units per liter | Standard Deviation 13.34 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, FU (Day 28), n=6,6,25,7,14 | 7.0 International units per liter | Standard Deviation 20.39 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 2, predose, n=6,6,25,7,14 | -3.7 International units per liter | Standard Deviation 4.97 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 4, predose, n=6,6,25,7,14 | -7.2 International units per liter | Standard Deviation 5.23 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 6, predose, n=6,6,25,7,14 | -5.2 International units per liter | Standard Deviation 4.62 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 8 predose, n=6,5,25,7,14 | -4.4 International units per liter | Standard Deviation 4.51 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 10, predose, n=6,6,25,7,14 | -6.2 International units per liter | Standard Deviation 3.19 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 12, predose, n=6,6,25,7,14 | -5.7 International units per liter | Standard Deviation 3.39 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, predose, n=5,5,25,6,14 | -8.8 International units per liter | Standard Deviation 6.1 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, 48 hours, n=6,6,24,6,14 | -6.0 International units per liter | Standard Deviation 4.73 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 2, predose, n=6,6,25,7,14 | 1.0 International units per liter | Standard Deviation 4.56 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 6, predose, n=6,6,25,7,14 | -0.2 International units per liter | Standard Deviation 7.86 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 8 predose, n=6,6,25,7,14 | -6.4 International units per liter | Standard Deviation 9.66 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 10, predose, n=6,6,25,7,14 | 0.8 International units per liter | Standard Deviation 11.75 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, 96 hours, n=6,6,24,6,14 | -6.8 International units per liter | Standard Deviation 6.01 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 12, predose, n=6,6,25,7,14 | 1.8 International units per liter | Standard Deviation 13.76 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, FU (Day 28), n=6,6,25,7,14 | -6.2 International units per liter | Standard Deviation 5.91 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 2, predose, n=5,6,24,7,14 | -1.2 International units per liter | Standard Deviation 2.79 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 4, predose, n=5,6,25,7,14 | -3.0 International units per liter | Standard Deviation 3.1 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 6, predose, n=5,6,25,7,14 | -1.3 International units per liter | Standard Deviation 3.88 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 8 predose, n=5,5,25,7,14 | -6.4 International units per liter | Standard Deviation 4.04 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 10, predose, n=5,6,25,7,14 | -2.8 International units per liter | Standard Deviation 3.6 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 12, predose, n=5,6,25,7,14 | -3.3 International units per liter | Standard Deviation 5.09 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, FU (Day 28), n=6,6,25,7,14 | 2.5 International units per liter | Standard Deviation 5.89 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, predose, n=4,5,23,5,12 | -5.6 International units per liter | Standard Deviation 6.02 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, 48 hours, n=5,6,24,6,14 | -3.0 International units per liter | Standard Deviation 4.69 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, 96 hours, n=5,6,24,6,14 | -2.8 International units per liter | Standard Deviation 4.45 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 2, predose, n=6,6,25,7,14 | 0.5 International units per liter | Standard Deviation 3.43 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 4, predose, n=6,6,25,7,14 | 1.4 International units per liter | Standard Deviation 4.66 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, 96 hours, n=6,6,24,6,14 | -1.8 International units per liter | Standard Deviation 5.67 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 6, predose, n=6,6,25,7,14 | 0.9 International units per liter | Standard Deviation 4.95 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 8 predose, n=5,5,25,7,14 | -0.8 International units per liter | Standard Deviation 4.64 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, FU (Day 28), n=6,6,25,7,14 | 4.6 International units per liter | Standard Deviation 9.22 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, predose, n=5,5,25,6,14 | 2.6 International units per liter | Standard Deviation 6.37 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, 96 hours, n=5,6,24,6,14 | -2.0 International units per liter | Standard Deviation 3.93 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, FU (Day 28), n=6,6,25,7,14 | -2.4 International units per liter | Standard Deviation 5.41 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, 48 hours, n=6,6,24,6,14 | -1.6 International units per liter | Standard Deviation 5.06 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 6, predose, n=5,6,25,7,14 | -1.7 International units per liter | Standard Deviation 3.79 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, 96 hours, n=6,6,24,6,14 | 3.9 International units per liter | Standard Deviation 6.98 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, predose, n=4,5,23,5,12 | -2.0 International units per liter | Standard Deviation 3.42 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 2, predose, n=5,6,24,7,14 | -1.5 International units per liter | Standard Deviation 3.51 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 10, predose, n=6,6,25,7,14 | -0.3 International units per liter | Standard Deviation 5.53 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 4, predose, n=5,6,25,7,14 | -1.4 International units per liter | Standard Deviation 4.22 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 2, predose, n=6,6,25,7,14 | -0.9 International units per liter | Standard Deviation 4.66 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 12, predose, n=5,6,25,7,14 | -2.0 International units per liter | Standard Deviation 4.63 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 8 predose, n=6,6,25,7,14 | 1.8 International units per liter | Standard Deviation 6.22 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, predose, n=5,5,25,6,14 | -2.2 International units per liter | Standard Deviation 4.87 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 8 predose, n=6,5,25,7,14 | -0.1 International units per liter | Standard Deviation 5.33 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, 48 hours, n=5,6,24,6,14 | -1.8 International units per liter | Standard Deviation 3.95 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 6, predose, n=6,6,25,7,14 | 0.3 International units per liter | Standard Deviation 5.41 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 10, predose, n=6,6,25,7,14 | 3.5 International units per liter | Standard Deviation 6.85 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 4, predose, n=6,6,25,7,14 | 0.3 International units per liter | Standard Deviation 5.01 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, 48 hours, n=6,6,24,6,14 | 3.7 International units per liter | Standard Deviation 6.19 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 12, predose, n=6,6,25,7,14 | 0.2 International units per liter | Standard Deviation 5.8 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 10, predose, n=5,6,25,7,14 | -1.6 International units per liter | Standard Deviation 4.24 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, FU (Day 28), n=6,6,25,7,14 | 2.8 International units per liter | Standard Deviation 5.75 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 12, predose, n=6,6,25,7,14 | 1.8 International units per liter | Standard Deviation 6.08 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 12, predose, n=5,6,25,7,14 | -4.1 International units per liter | Standard Deviation 4.38 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 4, predose, n=6,6,25,7,14 | 1.6 International units per liter | Standard Deviation 6.75 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 2, predose, n=6,6,25,7,14 | 1.7 International units per liter | Standard Deviation 2.63 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 4, predose, n=6,6,25,7,14 | 3.4 International units per liter | Standard Deviation 5.32 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 2, predose, n=6,6,25,7,14 | -0.1 International units per liter | Standard Deviation 3.67 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, FU (Day 28), n=6,6,25,7,14 | 0.6 International units per liter | Standard Deviation 6.55 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 6, predose, n=6,6,25,7,14 | 0.3 International units per liter | Standard Deviation 4.07 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 8 predose, n=6,6,25,7,14 | 1.7 International units per liter | Standard Deviation 4.68 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, 48 hours, n=6,6,24,6,14 | 1.2 International units per liter | Standard Deviation 5.53 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 10, predose, n=6,6,25,7,14 | 0.7 International units per liter | Standard Deviation 4.89 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, FU (Day 28), n=6,6,25,7,14 | -1.3 International units per liter | Standard Deviation 3.3 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, predose, n=5,5,25,6,14 | -1.0 International units per liter | Standard Deviation 4.1 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 12, predose, n=6,6,25,7,14 | 0.1 International units per liter | Standard Deviation 4.49 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, 96 hours, n=6,6,24,6,14 | 1.2 International units per liter | Standard Deviation 3.31 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, FU (Day 28), n=6,6,25,7,14 | -2.4 International units per liter | Standard Deviation 8.36 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 2, predose, n=5,6,24,7,14 | -1.3 International units per liter | Standard Deviation 4.89 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, 96 hours, n=6,6,24,6,14 | 1.8 International units per liter | Standard Deviation 6.85 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, predose, n=4,5,23,5,12 | -1.6 International units per liter | Standard Deviation 5.68 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 4, predose, n=5,6,25,7,14 | -2.4 International units per liter | Standard Deviation 4.24 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, 96 hours, n=5,6,24,6,14 | -2.2 International units per liter | Standard Deviation 6.43 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 6, predose, n=5,6,25,7,14 | -3.6 International units per liter | Standard Deviation 2.94 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 8 predose, n=5,5,25,7,14 | -3.1 International units per liter | Standard Deviation 4.06 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, 48 hours, n=6,6,24,6,14 | -0.3 International units per liter | Standard Deviation 3.5 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 10, predose, n=5,6,25,7,14 | -3.6 International units per liter | Standard Deviation 3.15 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 8 predose, n=6,5,25,7,14 | -0.4 International units per liter | Standard Deviation 7.41 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 10, predose, n=6,6,25,7,14 | -1.0 International units per liter | Standard Deviation 8.85 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 6, predose, n=6,6,25,7,14 | 0.9 International units per liter | Standard Deviation 5.52 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 12, predose, n=6,6,25,7,14 | -0.1 International units per liter | Standard Deviation 11.44 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, predose, n=5,5,25,6,14 | 0.8 International units per liter | Standard Deviation 3.19 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, 48 hours, n=5,6,24,6,14 | -3.5 International units per liter | Standard Deviation 2.88 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 12, predose, n=6,6,25,7,14 | -1.4 International units per liter | Standard Deviation 6.12 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 8 predose, n=5,5,25,7,14 | -1.1 International units per liter | Standard Deviation 6.28 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 2, predose, n=6,6,25,7,14 | -2.3 International units per liter | Standard Deviation 5.74 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 12, predose, n=6,6,25,7,14 | -0.4 International units per liter | Standard Deviation 14.7 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 12, predose, n=5,6,25,7,14 | -1.6 International units per liter | Standard Deviation 7.53 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, predose, n=5,5,25,6,14 | -1.2 International units per liter | Standard Deviation 13.45 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 10, predose, n=5,6,25,7,14 | -1.5 International units per liter | Standard Deviation 7.62 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 10, predose, n=6,6,25,7,14 | 0.4 International units per liter | Standard Deviation 11.55 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, FU (Day 28), n=6,6,25,7,14 | 0.3 International units per liter | Standard Deviation 8.41 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 8 predose, n=6,6,25,7,14 | -0.4 International units per liter | Standard Deviation 7.51 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 2, predose, n=6,6,25,7,14 | -0.4 International units per liter | Standard Deviation 3.71 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 8 predose, n=6,5,25,7,14 | -1.4 International units per liter | Standard Deviation 5.96 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 6, predose, n=6,6,25,7,14 | -0.6 International units per liter | Standard Deviation 4.88 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, FU (Day 28), n=6,6,25,7,14 | 0.7 International units per liter | Standard Deviation 4.7 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 6, predose, n=6,6,25,7,14 | 0.9 International units per liter | Standard Deviation 7.45 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, 48 hours, n=6,6,24,6,14 | -1.5 International units per liter | Standard Deviation 6.02 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 10, predose, n=6,6,25,7,14 | -1.2 International units per liter | Standard Deviation 5.94 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, predose, n=5,5,25,6,14 | -4.2 International units per liter | Standard Deviation 6.17 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 2, predose, n=5,6,24,7,14 | -2.5 International units per liter | Standard Deviation 3.01 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, 96 hours, n=5,6,24,6,14 | -1.2 International units per liter | Standard Deviation 9.22 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 4, predose, n=5,6,25,7,14 | -1.5 International units per liter | Standard Deviation 4.29 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, 96 hours, n=6,6,24,6,14 | 1.1 International units per liter | Standard Deviation 15.54 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, predose, n=4,5,23,5,12 | -2.8 International units per liter | Standard Deviation 7.38 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 4, predose, n=6,6,25,7,14 | 0.3 International units per liter | Standard Deviation 4.01 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, FU (Day 28), n=6,6,25,7,14 | -1.9 International units per liter | Standard Deviation 7.29 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 4, predose, n=6,6,25,7,14 | -2.1 International units per liter | Standard Deviation 4.31 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 6, predose, n=5,6,25,7,14 | -1.9 International units per liter | Standard Deviation 5.4 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALT, Day 14, 48 hours, n=6,6,24,6,14 | 1.0 International units per liter | Standard Deviation 13.94 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | AST, Day 14, 48 hours, n=5,6,24,6,14 | -2.4 International units per liter | Standard Deviation 7.67 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP | ALP, Day 14, 96 hours, n=6,6,24,6,14 | -1.3 International units per liter | Standard Deviation 6.09 |
Primary
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Blood samples were collected to analyze the chemistry parameter: bilirubin, creatinine, direct bilirubin . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, predose, n=6,6,25,6,14 | 0.0 Micromoles per liter | Standard Deviation 0.82 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 4, predose, n=6,6,25,7,14 | 4.7 Micromoles per liter | Standard Deviation 4.72 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 12, predose, n=6,6,25,7,14 | -0.4 Micromoles per liter | Standard Deviation 0.55 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 6, predose, n=6,6,25,7,14 | 3.3 Micromoles per liter | Standard Deviation 5.72 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 8 predose, n=6,6,25,7,14 | -0.4 Micromoles per liter | Standard Deviation 0.89 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, 96 hours, n=6,6,24,6,14 | 6.0 Micromoles per liter | Standard Deviation 5.1 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 8 predose, n=6,6,25,7,14 | 2.7 Micromoles per liter | Standard Deviation 7.74 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 8 predose, n=6,6,25,7,14 | -1.7 Micromoles per liter | Standard Deviation 2.07 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 10, predose, n=6,6,25,7,14 | 5.8 Micromoles per liter | Standard Deviation 8.66 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 28), n=6,6,25,7,14 | 0.8 Micromoles per liter | Standard Deviation 0.84 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 10, predose, n=6,6,25,7,14 | -0.4 Micromoles per liter | Standard Deviation 0.89 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 12, predose, n=6,6,25,7,14 | 4.5 Micromoles per liter | Standard Deviation 7.29 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 28), n=6,6,25,7,14 | -0.7 Micromoles per liter | Standard Deviation 8.91 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, 48 hours, n=6,6,24,6,14 | 4.2 Micromoles per liter | Standard Deviation 6.88 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, predose, n=6,6,25,6,14 | -2.3 Micromoles per liter | Standard Deviation 3.83 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, 48 hours, n=6,6,24,6,14 | -0.8 Micromoles per liter | Standard Deviation 0.45 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 10, predose, n=6,6,25,7,14 | -1.8 Micromoles per liter | Standard Deviation 2.64 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 12, predose, n=6,6,25,7,14 | -1.8 Micromoles per liter | Standard Deviation 1.83 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 6, predose, n=6,6,25,7,14 | -0.8 Micromoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, predose, n=6,6,25,6,14 | -0.3 Micromoles per liter | Standard Deviation 1.37 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, 96 hours, n=6,6,24,6,14 | -0.4 Micromoles per liter | Standard Deviation 0.55 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 2, predose, n=6,6,25,7,14 | -0.6 Micromoles per liter | Standard Deviation 0.55 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, 96 hours, n=6,6,24,6,14 | -1.2 Micromoles per liter | Standard Deviation 1.17 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 4, predose, n=6,6,25,7,14 | -1.5 Micromoles per liter | Standard Deviation 2.59 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 28), n=6,6,25,7,14 | 1.2 Micromoles per liter | Standard Deviation 2.04 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, 48 hours, n=6,6,24,6,14 | -1.7 Micromoles per liter | Standard Deviation 2.07 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 6, predose, n=6,6,25,7,14 | -0.4 Micromoles per liter | Standard Deviation 0.55 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 2, predose, n=6,6,25,7,14 | 0.7 Micromoles per liter | Standard Deviation 2.5 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 4, predose, n=6,6,25,7,14 | -0.8 Micromoles per liter | Standard Deviation 0.45 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 2, predose, n=6,6,25,7,14 | -1.3 Micromoles per liter | Standard Deviation 1.97 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 28), n=6,6,25,7,14 | 1.8 Micromoles per liter | Standard Deviation 2.4 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 10, predose, n=6,6,25,7,14 | -0.2 Micromoles per liter | Standard Deviation 2.04 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 4, predose, n=6,6,25,7,14 | 1.8 Micromoles per liter | Standard Deviation 3.43 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 4, predose, n=6,6,25,7,14 | -0.3 Micromoles per liter | Standard Deviation 0.82 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 2, predose, n=6,6,25,7,14 | -0.8 Micromoles per liter | Standard Deviation 2.14 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 28), n=6,6,25,7,14 | 4.5 Micromoles per liter | Standard Deviation 4.89 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, 48 hours, n=6,6,24,6,14 | 7.8 Micromoles per liter | Standard Deviation 5.46 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 6, predose, n=6,6,25,7,14 | 3.3 Micromoles per liter | Standard Deviation 4.41 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, 96 hours, n=6,6,24,6,14 | 15.3 Micromoles per liter | Standard Deviation 6.53 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, 96 hours, n=6,6,24,6,14 | 1.0 Micromoles per liter | Standard Deviation 1.79 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 12, predose, n=6,6,25,7,14 | 0.2 Micromoles per liter | Standard Deviation 2.48 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 2, predose, n=6,6,25,7,14 | 0.0 Micromoles per liter | Standard Deviation 1 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 8 predose, n=6,6,25,7,14 | 13.8 Micromoles per liter | Standard Deviation 4.67 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, 48 hours, n=6,6,24,6,14 | -0.2 Micromoles per liter | Standard Deviation 0.98 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 28), n=6,6,25,7,14 | 0.3 Micromoles per liter | Standard Deviation 1.21 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 10, predose, n=6,6,25,7,14 | 0.0 Micromoles per liter | Standard Deviation 1.26 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, predose, n=6,6,25,6,14 | 0.0 Micromoles per liter | Standard Deviation 0.82 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 10, predose, n=6,6,25,7,14 | 7.5 Micromoles per liter | Standard Deviation 5.39 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 8 predose, n=6,6,25,7,14 | -0.5 Micromoles per liter | Standard Deviation 1.38 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, 96 hours, n=6,6,24,6,14 | -0.2 Micromoles per liter | Standard Deviation 0.84 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, predose, n=6,6,25,6,14 | -0.3 Micromoles per liter | Standard Deviation 1.86 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 6, predose, n=6,6,25,7,14 | -1.0 Micromoles per liter | Standard Deviation 0.82 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 12, predose, n=6,6,25,7,14 | 6.8 Micromoles per liter | Standard Deviation 5.74 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 2, predose, n=6,6,25,7,14 | 8.2 Micromoles per liter | Standard Deviation 3.87 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 4, predose, n=6,6,25,7,14 | 0.2 Micromoles per liter | Standard Deviation 0.98 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, 48 hours, n=6,6,24,6,14 | 1.2 Micromoles per liter | Standard Deviation 2.64 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 6, predose, n=6,6,25,7,14 | -2.2 Micromoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, predose, n=6,6,25,6,14 | 1.7 Micromoles per liter | Standard Deviation 3.83 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 12, predose, n=6,6,25,7,14 | -0.4 Micromoles per liter | Standard Deviation 1.14 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 8 predose, n=6,6,25,7,14 | 0.2 Micromoles per liter | Standard Deviation 1.1 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 4, predose, n=6,6,25,7,14 | -0.7 Micromoles per liter | Standard Deviation 3.53 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, 48 hours, n=6,6,24,6,14 | 1.5 Micromoles per liter | Standard Deviation 7.08 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, 96 hours, n=6,6,24,6,14 | 5.5 Micromoles per liter | Standard Deviation 8.81 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, 48 hours, n=6,6,24,6,14 | -0.2 Micromoles per liter | Standard Deviation 1.14 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 6, predose, n=6,6,25,7,14 | -0.4 Micromoles per liter | Standard Deviation 1.2 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 28), n=6,6,25,7,14 | -0.3 Micromoles per liter | Standard Deviation 7.66 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 2, predose, n=6,6,25,7,14 | -0.4 Micromoles per liter | Standard Deviation 1.18 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 4, predose, n=6,6,25,7,14 | -0.4 Micromoles per liter | Standard Deviation 1.03 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 6, predose, n=6,6,25,7,14 | -1.0 Micromoles per liter | Standard Deviation 3.67 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 8 predose, n=6,6,25,7,14 | -0.9 Micromoles per liter | Standard Deviation 3.73 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 10, predose, n=6,6,25,7,14 | 0.0 Micromoles per liter | Standard Deviation 3.52 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, predose, n=6,6,25,6,14 | -0.4 Micromoles per liter | Standard Deviation 1.26 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 12, predose, n=6,6,25,7,14 | -1.3 Micromoles per liter | Standard Deviation 3.31 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, predose, n=6,6,25,6,14 | -1.0 Micromoles per liter | Standard Deviation 3.65 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, 48 hours, n=6,6,24,6,14 | 0.1 Micromoles per liter | Standard Deviation 3.71 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, 96 hours, n=6,6,24,6,14 | -0.4 Micromoles per liter | Standard Deviation 4.71 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 28), n=6,6,25,7,14 | 2.3 Micromoles per liter | Standard Deviation 7.28 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, 96 hours, n=6,6,24,6,14 | -0.2 Micromoles per liter | Standard Deviation 1.4 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 12, predose, n=6,6,25,7,14 | -0.5 Micromoles per liter | Standard Deviation 0.99 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 2, predose, n=6,6,25,7,14 | -3.0 Micromoles per liter | Standard Deviation 5.3 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 4, predose, n=6,6,25,7,14 | 1.9 Micromoles per liter | Standard Deviation 6.05 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 6, predose, n=6,6,25,7,14 | -2.2 Micromoles per liter | Standard Deviation 6.13 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 2, predose, n=6,6,25,7,14 | -0.7 Micromoles per liter | Standard Deviation 4.03 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 10, predose, n=6,6,25,7,14 | 0.0 Micromoles per liter | Standard Deviation 1.13 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 8 predose, n=6,6,25,7,14 | 2.6 Micromoles per liter | Standard Deviation 6.31 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 28), n=6,6,25,7,14 | 0.7 Micromoles per liter | Standard Deviation 2.17 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 10, predose, n=6,6,25,7,14 | 0.8 Micromoles per liter | Standard Deviation 6.16 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 12, predose, n=6,6,25,7,14 | 2.0 Micromoles per liter | Standard Deviation 8.62 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 8 predose, n=6,6,25,7,14 | -0.3 Micromoles per liter | Standard Deviation 1.19 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, predose, n=6,6,25,6,14 | 1.2 Micromoles per liter | Standard Deviation 6.31 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 12, predose, n=6,6,25,7,14 | -0.6 Micromoles per liter | Standard Deviation 1.52 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, 48 hours, n=6,6,24,6,14 | -0.8 Micromoles per liter | Standard Deviation 3.6 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 2, predose, n=6,6,25,7,14 | -2.6 Micromoles per liter | Standard Deviation 2.94 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 4, predose, n=6,6,25,7,14 | 0.3 Micromoles per liter | Standard Deviation 1.5 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 6, predose, n=6,6,25,7,14 | -1.1 Micromoles per liter | Standard Deviation 3.63 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 8 predose, n=6,6,25,7,14 | -1.3 Micromoles per liter | Standard Deviation 3.64 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 10, predose, n=6,6,25,7,14 | -0.6 Micromoles per liter | Standard Deviation 4.2 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 12, predose, n=6,6,25,7,14 | -1.4 Micromoles per liter | Standard Deviation 3.69 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, predose, n=6,6,25,6,14 | -1.8 Micromoles per liter | Standard Deviation 3.54 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, 96 hours, n=6,6,24,6,14 | -1.0 Micromoles per liter | Standard Deviation 3.74 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 28), n=6,6,25,7,14 | 0.6 Micromoles per liter | Standard Deviation 4.35 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 2, predose, n=6,6,25,7,14 | 6.1 Micromoles per liter | Standard Deviation 8.3 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 4, predose, n=6,6,25,7,14 | 3.1 Micromoles per liter | Standard Deviation 3.24 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 6, predose, n=6,6,25,7,14 | 5.6 Micromoles per liter | Standard Deviation 7.23 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 8 predose, n=6,6,25,7,14 | 6.9 Micromoles per liter | Standard Deviation 6.52 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 10, predose, n=6,6,25,7,14 | 6.4 Micromoles per liter | Standard Deviation 3.46 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 12, predose, n=6,6,25,7,14 | 3.0 Micromoles per liter | Standard Deviation 3.96 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, predose, n=6,6,25,6,14 | 4.3 Micromoles per liter | Standard Deviation 5.05 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, 48 hours, n=6,6,24,6,14 | 8.5 Micromoles per liter | Standard Deviation 6.83 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, 96 hours, n=6,6,24,6,14 | 10.2 Micromoles per liter | Standard Deviation 5.56 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 28), n=6,6,25,7,14 | 3.6 Micromoles per liter | Standard Deviation 3.55 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 2, predose, n=6,6,25,7,14 | -1.5 Micromoles per liter | Standard Deviation 1.73 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 4, predose, n=6,6,25,7,14 | -0.2 Micromoles per liter | Standard Deviation 0.41 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 6, predose, n=6,6,25,7,14 | -0.5 Micromoles per liter | Standard Deviation 1.22 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 8 predose, n=6,6,25,7,14 | -0.3 Micromoles per liter | Standard Deviation 1.03 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 10, predose, n=6,6,25,7,14 | -0.6 Micromoles per liter | Standard Deviation 1.52 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, predose, n=6,6,25,6,14 | -2.5 Micromoles per liter | Standard Deviation 0.71 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, 48 hours, n=6,6,24,6,14 | -0.2 Micromoles per liter | Standard Deviation 1.3 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, 96 hours, n=6,6,24,6,14 | -0.6 Micromoles per liter | Standard Deviation 0.89 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 28), n=6,6,25,7,14 | 0.4 Micromoles per liter | Standard Deviation 1.52 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 12, predose, n=6,6,25,7,14 | 3.6 Micromoles per liter | Standard Deviation 7.44 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, 96 hours, n=6,6,24,6,14 | -0.3 Micromoles per liter | Standard Deviation 1.48 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 8 predose, n=6,6,25,7,14 | -0.3 Micromoles per liter | Standard Deviation 1.37 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 10, predose, n=6,6,25,7,14 | 4.7 Micromoles per liter | Standard Deviation 5.8 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 8 predose, n=6,6,25,7,14 | 3.6 Micromoles per liter | Standard Deviation 9.71 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 6, predose, n=6,6,25,7,14 | 0.5 Micromoles per liter | Standard Deviation 7.47 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 2, predose, n=6,6,25,7,14 | -0.9 Micromoles per liter | Standard Deviation 4.01 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 10, predose, n=6,6,25,7,14 | -0.3 Micromoles per liter | Standard Deviation 1.14 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 4, predose, n=6,6,25,7,14 | 1.4 Micromoles per liter | Standard Deviation 8.9 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 2, predose, n=6,6,25,7,14 | 0.4 Micromoles per liter | Standard Deviation 3.23 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, FU (Day 28), n=6,6,25,7,14 | -0.1 Micromoles per liter | Standard Deviation 3.9 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, 96 hours, n=6,6,24,6,14 | 0.2 Micromoles per liter | Standard Deviation 4.02 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 12, predose, n=6,6,25,7,14 | -0.4 Micromoles per liter | Standard Deviation 1.24 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, 48 hours, n=6,6,24,6,14 | 0.0 Micromoles per liter | Standard Deviation 3.35 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 12, predose, n=6,6,25,7,14 | -1.1 Micromoles per liter | Standard Deviation 3.17 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 10, predose, n=6,6,25,7,14 | -0.1 Micromoles per liter | Standard Deviation 3.41 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 4, predose, n=6,6,25,7,14 | 0.0 Micromoles per liter | Standard Deviation 0.95 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, predose, n=6,6,25,6,14 | -0.4 Micromoles per liter | Standard Deviation 1.43 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 8 predose, n=6,6,25,7,14 | -0.1 Micromoles per liter | Standard Deviation 3.65 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 6, predose, n=6,6,25,7,14 | -0.7 Micromoles per liter | Standard Deviation 3.58 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 4, predose, n=6,6,25,7,14 | 0.3 Micromoles per liter | Standard Deviation 3.5 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Bilirubin, Day 14, predose, n=6,6,25,6,14 | -0.4 Micromoles per liter | Standard Deviation 3.75 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 14, 48 hours, n=6,6,24,6,14 | -0.3 Micromoles per liter | Standard Deviation 1.3 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 2, predose, n=6,6,25,7,14 | -0.5 Micromoles per liter | Standard Deviation 1.31 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, FU (Day 28), n=6,6,25,7,14 | 1.7 Micromoles per liter | Standard Deviation 5.17 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, 96 hours, n=6,6,24,6,14 | 8.8 Micromoles per liter | Standard Deviation 6.22 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct bilirubin, FU (Day 28), n=6,6,25,7,14 | 0.2 Micromoles per liter | Standard Deviation 1.54 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Direct Bilirubin, Day 6, predose, n=6,6,25,7,14 | -0.3 Micromoles per liter | Standard Deviation 1.36 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, 48 hours, n=6,6,24,6,14 | 4.0 Micromoles per liter | Standard Deviation 7.92 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin | Creatinine, Day 14, predose, n=6,6,25,6,14 | 3.6 Micromoles per liter | Standard Deviation 8.31 |
Primary
Part 2: Change From Baseline in Chemistry Parameter: Glucose
Blood samples were collected at indicated time points to analyze the chemistry parameter: glucose . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), Day 8 (predose), Day 14 (48 hours) post dose and Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | Day 8, (predose) n=5,6,25,7,13 | 0.02 Millimoles per liter | Standard Deviation 0.55 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 28), n= 6,6,25,7,14 | 0.05 Millimoles per liter | Standard Deviation 0.824 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | Day 14 (48 hours), n= 6,6,24,6,14 | 0.15 Millimoles per liter | Standard Deviation 0.532 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | Day 14 (48 hours), n= 6,6,24,6,14 | 0.03 Millimoles per liter | Standard Deviation 0.35 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | Day 8, (predose) n=5,6,25,7,13 | 0.20 Millimoles per liter | Standard Deviation 0.237 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 28), n= 6,6,25,7,14 | 0.15 Millimoles per liter | Standard Deviation 0.389 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | Day 14 (48 hours), n= 6,6,24,6,14 | -0.23 Millimoles per liter | Standard Deviation 0.275 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | Day 8, (predose) n=5,6,25,7,13 | -0.10 Millimoles per liter | Standard Deviation 0.278 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 28), n= 6,6,25,7,14 | -0.12 Millimoles per liter | Standard Deviation 0.375 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | Day 8, (predose) n=5,6,25,7,13 | -0.09 Millimoles per liter | Standard Deviation 0.398 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 28), n= 6,6,25,7,14 | 0.20 Millimoles per liter | Standard Deviation 0.507 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | Day 14 (48 hours), n= 6,6,24,6,14 | 0.00 Millimoles per liter | Standard Deviation 0.329 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | Day 14 (48 hours), n= 6,6,24,6,14 | -0.21 Millimoles per liter | Standard Deviation 0.405 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | Day 8, (predose) n=5,6,25,7,13 | -0.12 Millimoles per liter | Standard Deviation 0.394 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Glucose | FU (Day 28), n= 6,6,25,7,14 | -0.02 Millimoles per liter | Standard Deviation 0.458 |
Primary
Part 2: Change From Baseline in Chemistry Parameter: Protein
Blood samples were collected to analyze the chemistry parameter: Protein. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, predose, n=6,6,25,6,14 | -2.5 Grams per liter | Standard Deviation 4.32 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 12, predose, n=6,6,25,7,14 | -2.7 Grams per liter | Standard Deviation 3.08 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 6, predose, n=6,6,25,7,14 | 0.7 Grams per liter | Standard Deviation 5.61 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | FU (Day 28), n=6,6,25,7,14 | -1.0 Grams per liter | Standard Deviation 2.28 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 10, predose, n=6,6,25,7,14 | -0.5 Grams per liter | Standard Deviation 4.04 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, 96 hours, n=6,6,24,6,14 | 0.0 Grams per liter | Standard Deviation 2.53 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, 48 hours, n=6,6,24,6,14 | -2.2 Grams per liter | Standard Deviation 3.31 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 4, predose, n=6,6,25,7,14 | 1.5 Grams per liter | Standard Deviation 3.02 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 8 predose, n=6,6,25,7,14 | -1.0 Grams per liter | Standard Deviation 3.03 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 2, predose, n=6,6,25,7,14 | -0.5 Grams per liter | Standard Deviation 2.35 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, predose, n=6,6,25,6,14 | -3.5 Grams per liter | Standard Deviation 1.87 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 8 predose, n=6,6,25,7,14 | -0.8 Grams per liter | Standard Deviation 2.48 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 2, predose, n=6,6,25,7,14 | -1.0 Grams per liter | Standard Deviation 2.19 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 4, predose, n=6,6,25,7,14 | 0.0 Grams per liter | Standard Deviation 2.37 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 6, predose, n=6,6,25,7,14 | -1.3 Grams per liter | Standard Deviation 1.75 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 10, predose, n=6,6,25,7,14 | 0.7 Grams per liter | Standard Deviation 1.97 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 12, predose, n=6,6,25,7,14 | -1.0 Grams per liter | Standard Deviation 2.45 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, 48 hours, n=6,6,24,6,14 | -1.7 Grams per liter | Standard Deviation 2.5 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, 96 hours, n=6,6,24,6,14 | -0.8 Grams per liter | Standard Deviation 2.64 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | FU (Day 28), n=6,6,25,7,14 | -1.2 Grams per liter | Standard Deviation 1.94 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 2, predose, n=6,6,25,7,14 | 0.2 Grams per liter | Standard Deviation 3.34 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 4, predose, n=6,6,25,7,14 | -0.3 Grams per liter | Standard Deviation 2.78 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, predose, n=6,6,25,6,14 | -2.0 Grams per liter | Standard Deviation 4.14 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 8 predose, n=6,6,25,7,14 | -0.5 Grams per liter | Standard Deviation 2.69 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 10, predose, n=6,6,25,7,14 | -0.6 Grams per liter | Standard Deviation 3.12 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, 96 hours, n=6,6,24,6,14 | -1.1 Grams per liter | Standard Deviation 3.9 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | FU (Day 28), n=6,6,25,7,14 | -0.5 Grams per liter | Standard Deviation 3.43 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, 48 hours, n=6,6,24,6,14 | -1.8 Grams per liter | Standard Deviation 3.57 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 6, predose, n=6,6,25,7,14 | -0.1 Grams per liter | Standard Deviation 2.53 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 12, predose, n=6,6,25,7,14 | -0.3 Grams per liter | Standard Deviation 2.72 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 4, predose, n=6,6,25,7,14 | 5.9 Grams per liter | Standard Deviation 3.53 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | FU (Day 28), n=6,6,25,7,14 | 0.4 Grams per liter | Standard Deviation 3.26 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, 96 hours, n=6,6,24,6,14 | 2.7 Grams per liter | Standard Deviation 2.42 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 12, predose, n=6,6,25,7,14 | 2.9 Grams per liter | Standard Deviation 2.12 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 6, predose, n=6,6,25,7,14 | 2.1 Grams per liter | Standard Deviation 2.48 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 8 predose, n=6,6,25,7,14 | 1.4 Grams per liter | Standard Deviation 2.15 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 2, predose, n=6,6,25,7,14 | 1.7 Grams per liter | Standard Deviation 2.14 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, predose, n=6,6,25,6,14 | 0.2 Grams per liter | Standard Deviation 1.94 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 10, predose, n=6,6,25,7,14 | 1.7 Grams per liter | Standard Deviation 1.98 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, 48 hours, n=6,6,24,6,14 | 2.0 Grams per liter | Standard Deviation 2 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 8 predose, n=6,6,25,7,14 | 0.1 Grams per liter | Standard Deviation 2.56 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 10, predose, n=6,6,25,7,14 | 0.0 Grams per liter | Standard Deviation 4.08 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 4, predose, n=6,6,25,7,14 | -0.6 Grams per liter | Standard Deviation 2.82 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | FU (Day 28), n=6,6,25,7,14 | 0.4 Grams per liter | Standard Deviation 4.05 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 12, predose, n=6,6,25,7,14 | -0.3 Grams per liter | Standard Deviation 3.36 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, predose, n=6,6,25,6,14 | -1.8 Grams per liter | Standard Deviation 3.85 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 2, predose, n=6,6,25,7,14 | -0.9 Grams per liter | Standard Deviation 3.32 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, 48 hours, n=6,6,24,6,14 | -0.2 Grams per liter | Standard Deviation 3.79 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 14, 96 hours, n=6,6,24,6,14 | 0.6 Grams per liter | Standard Deviation 3.9 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Chemistry Parameter: Protein | Day 6, predose, n=6,6,25,7,14 | 0.0 Grams per liter | Standard Deviation 2.86 |
Primary
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
Blood samples were collected at indicated time points to analyze the chemistry parameter: cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), Day 8 (pre dose), Day 14 (48 hours) post dose and Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, FU (Day 28), n= 6,6,25,7,14 | -0.12 Millimoles per liter | Standard Deviation 0.471 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, FU (Day 28), n= 6,6,25,7,14 | -0.28 Millimoles per liter | Standard Deviation 0.147 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, Day 8, (predose) n=5,6,25,7,13 | 0.08 Millimoles per liter | Standard Deviation 0.192 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, Day 8, (predose) n=5,6,25,7,13 | 0.12 Millimoles per liter | Standard Deviation 0.492 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, FU (Day 28),n= 6,6,25,7,14 | -0.23 Millimoles per liter | Standard Deviation 0.216 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | -0.03 Millimoles per liter | Standard Deviation 0.234 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, Day 8, (predose) n=5,6,25,7,13 | 0.08 Millimoles per liter | Standard Deviation 0.217 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | -0.08 Millimoles per liter | Standard Deviation 0.075 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, FU (Day 28), n= 6,6,25,7,14 | 0.02 Millimoles per liter | Standard Deviation 0.041 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, Day 8, (predose) n=5,6,25,7,14 | -0.03 Millimoles per liter | Standard Deviation 0.121 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | -0.05 Millimoles per liter | Standard Deviation 0.373 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, Day 14 (48 hours), n= 6,6,24,6,14 | 0.20 Millimoles per liter | Standard Deviation 0.502 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, FU (Day 28),n= 6,6,25,7,14 | 0.12 Millimoles per liter | Standard Deviation 0.556 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, Day 8, (predose) n=5,6,25,7,13 | 0.07 Millimoles per liter | Standard Deviation 0.137 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, FU (Day 28), n= 6,6,25,7,14 | 0.07 Millimoles per liter | Standard Deviation 0.356 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, Day 8, (predose) n=5,6,25,7,13 | 0.07 Millimoles per liter | Standard Deviation 0.631 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | 0.23 Millimoles per liter | Standard Deviation 0.589 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, FU (Day 28), n= 6,6,25,7,14 | 0.15 Millimoles per liter | Standard Deviation 0.619 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, Day 8, (predose) n=5,6,25,7,14 | 0.00 Millimoles per liter | Standard Deviation 0.167 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | -0.10 Millimoles per liter | Standard Deviation 0.179 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, FU (Day 28), n= 6,6,25,7,14 | 0.00 Millimoles per liter | Standard Deviation 0.179 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, Day 8, (predose) n=5,6,25,7,13 | 0.03 Millimoles per liter | Standard Deviation 0.463 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | 0.27 Millimoles per liter | Standard Deviation 0.388 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, Day 14 (48 hours), n= 6,6,24,6,14 | 0.15 Millimoles per liter | Standard Deviation 0.266 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, Day 8, (predose) n=5,6,25,7,13 | 0.27 Millimoles per liter | Standard Deviation 0.407 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, Day 14 (48 hours), n= 6,6,24,6,14 | 0.18 Millimoles per liter | Standard Deviation 0.4 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, Day 8, (predose) n=5,6,25,7,14 | -0.14 Millimoles per liter | Standard Deviation 0.235 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | -0.18 Millimoles per liter | Standard Deviation 0.129 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, FU (Day 28), n= 6,6,25,7,14 | -0.12 Millimoles per liter | Standard Deviation 0.277 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, FU (Day 28), n= 6,6,25,7,14 | -0.06 Millimoles per liter | Standard Deviation 0.349 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | 0.33 Millimoles per liter | Standard Deviation 0.442 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, Day 8, (predose) n=5,6,25,7,13 | 0.16 Millimoles per liter | Standard Deviation 0.466 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, FU (Day 28),n= 6,6,25,7,14 | 0.12 Millimoles per liter | Standard Deviation 0.456 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, Day 8, (predose) n=5,6,25,7,13 | 0.08 Millimoles per liter | Standard Deviation 0.314 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | 0.23 Millimoles per liter | Standard Deviation 0.531 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, FU (Day 28), n= 6,6,25,7,14 | -0.04 Millimoles per liter | Standard Deviation 0.461 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, FU (Day 28), n= 6,6,25,7,14 | -0.29 Millimoles per liter | Standard Deviation 0.955 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, Day 8, (predose) n=5,6,25,7,13 | 0.36 Millimoles per liter | Standard Deviation 0.369 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, Day 8, (predose) n=5,6,25,7,13 | -0.04 Millimoles per liter | Standard Deviation 0.424 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, Day 14 (48 hours), n= 6,6,24,6,14 | 0.28 Millimoles per liter | Standard Deviation 0.479 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | 0.33 Millimoles per liter | Standard Deviation 0.615 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | -0.08 Millimoles per liter | Standard Deviation 0.194 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, Day 8, (predose) n=5,6,25,7,13 | 0.49 Millimoles per liter | Standard Deviation 0.453 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, FU (Day 28), n= 6,6,25,7,14 | 0.01 Millimoles per liter | Standard Deviation 0.372 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, Day 8, (predose) n=5,6,25,7,14 | -0.13 Millimoles per liter | Standard Deviation 0.15 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, FU (Day 28), n= 6,6,25,7,14 | 0.06 Millimoles per liter | Standard Deviation 0.538 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | 0.40 Millimoles per liter | Standard Deviation 0.696 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, FU (Day 28),n= 6,6,25,7,14 | -0.33 Millimoles per liter | Standard Deviation 0.565 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, Day 8, (predose) n=5,6,25,7,14 | -0.14 Millimoles per liter | Standard Deviation 0.203 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, Day 8, (predose) n=5,6,25,7,13 | 0.42 Millimoles per liter | Standard Deviation 0.42 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | 0.47 Millimoles per liter | Standard Deviation 0.517 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, FU (Day 28), n= 6,6,25,7,14 | -0.04 Millimoles per liter | Standard Deviation 0.434 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, FU (Day 28), n= 6,6,25,7,14 | 0.14 Millimoles per liter | Standard Deviation 0.665 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | 0.38 Millimoles per liter | Standard Deviation 0.647 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, Day 8, (predose) n=5,6,25,7,13 | 0.22 Millimoles per liter | Standard Deviation 0.215 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14 | -0.20 Millimoles per liter | Standard Deviation 0.26 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Triglycerides, Day 14 (48 hours), n= 6,6,24,6,14 | 0.26 Millimoles per liter | Standard Deviation 0.285 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | Cholesterol, Day 8, (predose) n=5,6,25,7,13 | 0.38 Millimoles per liter | Standard Deviation 0.44 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | HDL Cholesterol, FU (Day 28), n= 6,6,25,7,14 | -0.14 Millimoles per liter | Standard Deviation 0.195 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides | LDL Cholesterol, FU (Day 28),n= 6,6,25,7,14 | 0.06 Millimoles per liter | Standard Deviation 0.455 |
Primary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time points to analyze the hematology parameters: Erythrocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -2), Pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 6, predose, n=6,6,25,7,14 | 0.197 10^12 cells/Liter | Standard Deviation 0.3267 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | FU (Day 28),n=6,6,25,7,14 | -0.187 10^12 cells/Liter | Standard Deviation 0.1632 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 8 predose, n=6,6,25,7,14 | 0.035 10^12 cells/Liter | Standard Deviation 0.3056 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, 96 hours, n=6,6,24,6,14 | 0.042 10^12 cells/Liter | Standard Deviation 0.1597 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, 48 hours, n=6,6,24,6,14 | -0.002 10^12 cells/Liter | Standard Deviation 0.2416 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 4, predose, n=6,6,25,7,14 | 0.193 10^12 cells/Liter | Standard Deviation 0.2322 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 2, predose, n=6,6,25,7,14 | 0.135 10^12 cells/Liter | Standard Deviation 0.2601 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, predose, n=6,6,25,6,14 | 0.017 10^12 cells/Liter | Standard Deviation 0.2243 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 12, predose, n=6,6,25,7,14 | 0.078 10^12 cells/Liter | Standard Deviation 0.2423 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 10, predose, n=6,6,25,7,14 | 0.082 10^12 cells/Liter | Standard Deviation 0.3415 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 4, predose, n=6,6,25,7,14 | 0.112 10^12 cells/Liter | Standard Deviation 0.1057 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 2, predose, n=6,6,25,7,14 | 0.200 10^12 cells/Liter | Standard Deviation 0.1411 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 6, predose, n=6,6,25,7,14 | 0.230 10^12 cells/Liter | Standard Deviation 0.0994 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 8 predose, n=6,6,25,7,14 | 0.272 10^12 cells/Liter | Standard Deviation 0.1685 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 10, predose, n=6,6,25,7,14 | 0.293 10^12 cells/Liter | Standard Deviation 0.2238 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 12, predose, n=6,6,25,7,14 | 0.387 10^12 cells/Liter | Standard Deviation 0.1643 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, predose, n=6,6,25,6,14 | 0.037 10^12 cells/Liter | Standard Deviation 0.1394 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, 48 hours, n=6,6,24,6,14 | 0.177 10^12 cells/Liter | Standard Deviation 0.2253 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, 96 hours, n=6,6,24,6,14 | 0.215 10^12 cells/Liter | Standard Deviation 0.2095 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | FU (Day 28),n=6,6,25,7,14 | -0.123 10^12 cells/Liter | Standard Deviation 0.1835 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 12, predose, n=6,6,25,7,14 | 0.139 10^12 cells/Liter | Standard Deviation 0.2004 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, 96 hours, n=6,6,24,6,14 | 0.068 10^12 cells/Liter | Standard Deviation 0.2039 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 6, predose, n=6,6,25,7,14 | 0.088 10^12 cells/Liter | Standard Deviation 0.216 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 8 predose, n=6,6,25,7,14 | 0.088 10^12 cells/Liter | Standard Deviation 0.2352 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 4, predose, n=6,6,25,7,14 | 0.086 10^12 cells/Liter | Standard Deviation 0.2099 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 10, predose, n=6,6,25,7,14 | 0.179 10^12 cells/Liter | Standard Deviation 0.1861 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, predose, n=6,6,25,6,14 | 0.031 10^12 cells/Liter | Standard Deviation 0.2429 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 2, predose, n=6,6,25,7,14 | 0.128 10^12 cells/Liter | Standard Deviation 0.2539 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | FU (Day 28),n=6,6,25,7,14 | -0.093 10^12 cells/Liter | Standard Deviation 0.2015 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, 48 hours, n=6,6,24,6,14 | 0.109 10^12 cells/Liter | Standard Deviation 0.2116 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 4, predose, n=6,6,25,7,14 | 0.544 10^12 cells/Liter | Standard Deviation 0.1318 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | FU (Day 28),n=6,6,25,7,14 | 0.050 10^12 cells/Liter | Standard Deviation 0.2484 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 2, predose, n=6,6,25,7,14 | 0.440 10^12 cells/Liter | Standard Deviation 0.1458 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 6, predose, n=6,6,25,7,14 | 0.323 10^12 cells/Liter | Standard Deviation 0.1614 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 12, predose, n=6,6,25,7,14 | 0.296 10^12 cells/Liter | Standard Deviation 0.1049 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, 48 hours, n=6,6,24,6,14 | 0.323 10^12 cells/Liter | Standard Deviation 0.2219 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, 96 hours, n=6,6,24,6,14 | 0.327 10^12 cells/Liter | Standard Deviation 0.1159 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, predose, n=6,6,25,6,14 | 0.385 10^12 cells/Liter | Standard Deviation 0.2288 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 8 predose, n=6,6,25,7,14 | 0.327 10^12 cells/Liter | Standard Deviation 0.194 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 10, predose, n=6,6,25,7,14 | 0.306 10^12 cells/Liter | Standard Deviation 0.1334 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 8 predose, n=6,6,25,7,14 | 0.115 10^12 cells/Liter | Standard Deviation 0.1816 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, 96 hours, n=6,6,24,6,14 | 0.156 10^12 cells/Liter | Standard Deviation 0.1938 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 10, predose, n=6,6,25,7,14 | 0.206 10^12 cells/Liter | Standard Deviation 0.1637 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 12, predose, n=6,6,25,7,14 | 0.179 10^12 cells/Liter | Standard Deviation 0.1372 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | FU (Day 28),n=6,6,25,7,14 | -0.081 10^12 cells/Liter | Standard Deviation 0.2517 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, predose, n=6,6,25,6,14 | 0.005 10^12 cells/Liter | Standard Deviation 0.1931 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 2, predose, n=6,6,25,7,14 | 0.131 10^12 cells/Liter | Standard Deviation 0.21 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 14, 48 hours, n=6,6,24,6,14 | 0.182 10^12 cells/Liter | Standard Deviation 0.2198 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 6, predose, n=6,6,25,7,14 | 0.146 10^12 cells/Liter | Standard Deviation 0.148 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 4, predose, n=6,6,25,7,14 | 0.091 10^12 cells/Liter | Standard Deviation 0.1589 |
Primary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
Blood samples were collected at indicated time points to analyze the hematology parameters: Erythrocyte MCV. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 2, predose, n=6,6,25,7,14 | -0.20 Femtoliter | Standard Deviation 0.559 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | FU (Day 28), n=6,6,25,7,14 | 0.00 Femtoliter | Standard Deviation 0.678 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 6, predose, n=6,6,25,7,14 | -0.25 Femtoliter | Standard Deviation 0.683 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 12, predose, n=6,6,25,7,14 | -0.33 Femtoliter | Standard Deviation 0.838 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 8 predose, n=6,6,25,7,14 | 0.03 Femtoliter | Standard Deviation 0.308 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, predose, n=6,6,25,6,14 | -0.73 Femtoliter | Standard Deviation 0.864 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, 48 hours, n=6,6,24,6,14 | 0.52 Femtoliter | Standard Deviation 0.56 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 4, predose, n=6,6,25,7,14 | -0.50 Femtoliter | Standard Deviation 0.777 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, 96 hours, n=6,6,24,6,14 | -0.55 Femtoliter | Standard Deviation 0.409 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 10, predose, n=6,6,25,7,14 | -0.02 Femtoliter | Standard Deviation 0.534 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 2, predose, n=6,6,25,7,14 | -0.63 Femtoliter | Standard Deviation 0.989 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, predose, n=6,6,25,6,14 | 0.72 Femtoliter | Standard Deviation 0.995 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | FU (Day 28), n=6,6,25,7,14 | 0.63 Femtoliter | Standard Deviation 0.459 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, 48 hours, n=6,6,24,6,14 | -0.40 Femtoliter | Standard Deviation 1.322 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 4, predose, n=6,6,25,7,14 | -1.05 Femtoliter | Standard Deviation 1.009 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 6, predose, n=6,6,25,7,14 | 0.10 Femtoliter | Standard Deviation 1.368 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 8 predose, n=6,6,25,7,14 | -0.60 Femtoliter | Standard Deviation 1.226 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 10, predose, n=6,6,25,7,14 | -0.73 Femtoliter | Standard Deviation 1.025 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, 96 hours, n=6,6,24,6,14 | -0.25 Femtoliter | Standard Deviation 1.122 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 12, predose, n=6,6,25,7,14 | -0.55 Femtoliter | Standard Deviation 1.017 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 4, predose, n=6,6,25,7,14 | -0.18 Femtoliter | Standard Deviation 1.321 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 12, predose, n=6,6,25,7,14 | -0.34 Femtoliter | Standard Deviation 0.908 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 10, predose, n=6,6,25,7,14 | -0.70 Femtoliter | Standard Deviation 1.635 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 2, predose, n=6,6,25,7,14 | -0.27 Femtoliter | Standard Deviation 1.223 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | FU (Day 28), n=6,6,25,7,14 | -0.65 Femtoliter | Standard Deviation 1.447 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, predose, n=6,6,25,6,14 | -0.86 Femtoliter | Standard Deviation 1.693 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, 96 hours, n=6,6,24,6,14 | -0.53 Femtoliter | Standard Deviation 1.361 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 6, predose, n=6,6,25,7,14 | -0.02 Femtoliter | Standard Deviation 1.422 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, 48 hours, n=6,6,24,6,14 | -0.67 Femtoliter | Standard Deviation 1.209 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 8 predose, n=6,6,25,7,14 | -0.53 Femtoliter | Standard Deviation 1.39 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, 96 hours, n=6,6,24,6,14 | -0.50 Femtoliter | Standard Deviation 0.738 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 2, predose, n=6,6,25,7,14 | -1.13 Femtoliter | Standard Deviation 1.28 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 4, predose, n=6,6,25,7,14 | -0.19 Femtoliter | Standard Deviation 1.227 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 6, predose, n=6,6,25,7,14 | -1.30 Femtoliter | Standard Deviation 1.39 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 10, predose, n=6,6,25,7,14 | -0.90 Femtoliter | Standard Deviation 0.933 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 12, predose, n=6,6,25,7,14 | -0.99 Femtoliter | Standard Deviation 0.747 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, predose, n=6,6,25,6,14 | -1.92 Femtoliter | Standard Deviation 1.059 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, 48 hours, n=6,6,24,6,14 | -1.30 Femtoliter | Standard Deviation 0.629 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 8 predose, n=6,6,25,7,14 | -0.67 Femtoliter | Standard Deviation 1.566 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | FU (Day 28), n=6,6,25,7,14 | -1.19 Femtoliter | Standard Deviation 0.832 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, 48 hours, n=6,6,24,6,14 | 0.01 Femtoliter | Standard Deviation 1.21 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 10, predose, n=6,6,25,7,14 | 0.21 Femtoliter | Standard Deviation 1.278 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 6, predose, n=6,6,25,7,14 | 0.62 Femtoliter | Standard Deviation 1.188 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | FU (Day 28), n=6,6,25,7,14 | 0.61 Femtoliter | Standard Deviation 1.215 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, 96 hours, n=6,6,24,6,14 | 0.14 Femtoliter | Standard Deviation 1.329 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 4, predose, n=6,6,25,7,14 | 0.17 Femtoliter | Standard Deviation 0.675 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 2, predose, n=6,6,25,7,14 | -0.16 Femtoliter | Standard Deviation 1.126 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 14, predose, n=6,6,25,6,14 | 0.26 Femtoliter | Standard Deviation 1.585 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 12, predose, n=6,6,25,7,14 | 0.16 Femtoliter | Standard Deviation 1.161 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV | Day 8 predose, n=6,6,25,7,14 | 0.79 Femtoliter | Standard Deviation 1.299 |
Primary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Blood samples were collected at indicated time points to analyze the hematology parameter: Erythrocyte MCH. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | FU, (Day 28), n=6,6,25,7,14 | 0.03 Picograms | Standard Deviation 0.427 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 12, predose, n=6,6,25,7,14 | 0.00 Picograms | Standard Deviation 0.522 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, 48 hours, n=6,6,24,6,14 | 0.08 Picograms | Standard Deviation 0.504 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 6, predose, n=6,6,25,7,14 | -0.43 Picograms | Standard Deviation 0.413 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, 96 hours, n=6,6,24,6,14 | -0.25 Picograms | Standard Deviation 0.647 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 2, predose, n=6,6,25,7,14 | -0.10 Picograms | Standard Deviation 0.443 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 4, predose, n=6,6,25,7,14 | -0.32 Picograms | Standard Deviation 0.306 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, predose, n=6,6,25,6,14 | 0.00 Picograms | Standard Deviation 0.31 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 8 predose, n=6,6,25,7,14 | -0.23 Picograms | Standard Deviation 0.602 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 10, predose, n=6,6,25,7,14 | -0.22 Picograms | Standard Deviation 0.571 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 8 predose, n=6,6,25,7,14 | -0.55 Picograms | Standard Deviation 0.226 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 12, predose, n=6,6,25,7,14 | -0.68 Picograms | Standard Deviation 0.248 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 10, predose, n=6,6,25,7,14 | -0.67 Picograms | Standard Deviation 0.339 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | FU, (Day 28), n=6,6,25,7,14 | -0.60 Picograms | Standard Deviation 0.237 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, 96 hours, n=6,6,24,6,14 | -0.87 Picograms | Standard Deviation 0.216 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 4, predose, n=6,6,25,7,14 | -0.03 Picograms | Standard Deviation 0.367 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, 48 hours, n=6,6,24,6,14 | -0.68 Picograms | Standard Deviation 0.293 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 6, predose, n=6,6,25,7,14 | -0.78 Picograms | Standard Deviation 0.172 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, predose, n=6,6,25,6,14 | -0.72 Picograms | Standard Deviation 0.264 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 2, predose, n=6,6,25,7,14 | -0.35 Picograms | Standard Deviation 0.217 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 10, predose, n=6,6,25,7,14 | -0.08 Picograms | Standard Deviation 0.573 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 2, predose, n=6,6,25,7,14 | -0.08 Picograms | Standard Deviation 0.578 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 4, predose, n=6,6,25,7,14 | 0.06 Picograms | Standard Deviation 0.607 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 6, predose, n=6,6,25,7,14 | 0.06 Picograms | Standard Deviation 0.788 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 8 predose, n=6,6,25,7,14 | 0.08 Picograms | Standard Deviation 0.785 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | FU, (Day 28), n=6,6,25,7,14 | -0.04 Picograms | Standard Deviation 0.644 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 12, predose, n=6,6,25,7,14 | 0.00 Picograms | Standard Deviation 0.45 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, predose, n=6,6,25,6,14 | -0.02 Picograms | Standard Deviation 0.724 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, 48 hours, n=6,6,24,6,14 | -0.12 Picograms | Standard Deviation 0.598 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, 96 hours, n=6,6,24,6,14 | -0.20 Picograms | Standard Deviation 0.52 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, 96 hours, n=6,6,24,6,14 | -0.65 Picograms | Standard Deviation 0.74 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 12, predose, n=6,6,25,7,14 | -0.10 Picograms | Standard Deviation 0.742 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 6, predose, n=6,6,25,7,14 | -0.30 Picograms | Standard Deviation 0.606 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, predose, n=6,6,25,6,14 | -0.57 Picograms | Standard Deviation 0.728 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 4, predose, n=6,6,25,7,14 | -0.40 Picograms | Standard Deviation 0.408 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, 48 hours, n=6,6,24,6,14 | -0.17 Picograms | Standard Deviation 0.698 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 2, predose, n=6,6,25,7,14 | -0.46 Picograms | Standard Deviation 0.67 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | FU, (Day 28), n=6,6,25,7,14 | -0.36 Picograms | Standard Deviation 0.412 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 10, predose, n=6,6,25,7,14 | -0.26 Picograms | Standard Deviation 0.544 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 8 predose, n=6,6,25,7,14 | -0.43 Picograms | Standard Deviation 0.577 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | FU, (Day 28), n=6,6,25,7,14 | 0.01 Picograms | Standard Deviation 0.637 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 10, predose, n=6,6,25,7,14 | 0.01 Picograms | Standard Deviation 0.617 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 12, predose, n=6,6,25,7,14 | -0.06 Picograms | Standard Deviation 0.557 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 6, predose, n=6,6,25,7,14 | -0.06 Picograms | Standard Deviation 0.677 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, 48 hours, n=6,6,24,6,14 | -0.15 Picograms | Standard Deviation 0.557 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, 96 hours, n=6,6,24,6,14 | 0.00 Picograms | Standard Deviation 0.477 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 2, predose, n=6,6,25,7,14 | -0.14 Picograms | Standard Deviation 0.759 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 14, predose, n=6,6,25,6,14 | -0.04 Picograms | Standard Deviation 0.637 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 4, predose, n=6,6,25,7,14 | 0.09 Picograms | Standard Deviation 0.684 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH) | Day 8 predose, n=6,6,25,7,14 | 0.21 Picograms | Standard Deviation 0.673 |
Primary
Part 2: Change From Baseline in Hematology Parameter: Hb
Blood samples were collected at indicated time points to analyze the hematology parameter: Hb. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 10, predose, n=6,6,25,7,14 | 1.2 Grams per liter | Standard Deviation 8.45 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | FU (Day 28), n=6,6,25,7,14 | -5.3 Grams per liter | Standard Deviation 4.18 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, 48 hours, n=6,6,24,6,14 | 0.2 Grams per liter | Standard Deviation 4.92 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 8 predose, n=6,6,25,7,14 | -0.3 Grams per liter | Standard Deviation 6.95 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 4, predose, n=6,6,25,7,14 | 3.8 Grams per liter | Standard Deviation 5.49 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, 96 hours, n=6,6,24,6,14 | -0.2 Grams per liter | Standard Deviation 3.13 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 2, predose, n=6,6,25,7,14 | 3.3 Grams per liter | Standard Deviation 6.28 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, predose, n=6,6,25,6,14 | 0.3 Grams per liter | Standard Deviation 5.2 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 12, predose, n=6,6,25,7,14 | 2.3 Grams per liter | Standard Deviation 6.62 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 6, predose, n=6,6,25,7,14 | 3.5 Grams per liter | Standard Deviation 8.57 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 2, predose, n=6,6,25,7,14 | 4.3 Grams per liter | Standard Deviation 4.13 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 10, predose, n=6,6,25,7,14 | 5.5 Grams per liter | Standard Deviation 6.22 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 8 predose, n=6,6,25,7,14 | 5.3 Grams per liter | Standard Deviation 5.89 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | FU (Day 28), n=6,6,25,7,14 | -6.5 Grams per liter | Standard Deviation 5.82 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 12, predose, n=6,6,25,7,14 | 8.0 Grams per liter | Standard Deviation 5.83 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, 48 hours, n=6,6,24,6,14 | 1.8 Grams per liter | Standard Deviation 7.39 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 6, predose, n=6,6,25,7,14 | 2.8 Grams per liter | Standard Deviation 3.19 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, predose, n=6,6,25,6,14 | -2.5 Grams per liter | Standard Deviation 4.23 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 4, predose, n=6,6,25,7,14 | 3.2 Grams per liter | Standard Deviation 2.48 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, 96 hours, n=6,6,24,6,14 | 2.2 Grams per liter | Standard Deviation 5.98 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 8 predose, n=6,6,25,7,14 | 3.1 Grams per liter | Standard Deviation 5.93 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 12, predose, n=6,6,25,7,14 | 4.1 Grams per liter | Standard Deviation 5.7 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | FU (Day 28), n=6,6,25,7,14 | -2.9 Grams per liter | Standard Deviation 5.51 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 2, predose, n=6,6,25,7,14 | 3.4 Grams per liter | Standard Deviation 7.18 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 4, predose, n=6,6,25,7,14 | 2.8 Grams per liter | Standard Deviation 6.28 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 6, predose, n=6,6,25,7,14 | 3.0 Grams per liter | Standard Deviation 5.91 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 10, predose, n=6,6,25,7,14 | 4.9 Grams per liter | Standard Deviation 6.56 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, predose, n=6,6,25,6,14 | 0.9 Grams per liter | Standard Deviation 7.16 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, 48 hours, n=6,6,24,6,14 | 2.8 Grams per liter | Standard Deviation 6.37 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, 96 hours, n=6,6,24,6,14 | 1.1 Grams per liter | Standard Deviation 6.52 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, 96 hours, n=6,6,24,6,14 | 6.5 Grams per liter | Standard Deviation 2.88 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 12, predose, n=6,6,25,7,14 | 8.1 Grams per liter | Standard Deviation 3.08 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 4, predose, n=6,6,25,7,14 | 13.9 Grams per liter | Standard Deviation 3.02 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, predose, n=6,6,25,6,14 | 8.3 Grams per liter | Standard Deviation 3.33 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 2, predose, n=6,6,25,7,14 | 10.6 Grams per liter | Standard Deviation 3.31 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hb | FU (Day 28), n=6,6,25,7,14 | -0.3 Grams per liter | Standard Deviation 7.54 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 8 predose, n=6,6,25,7,14 | 7.3 Grams per liter | Standard Deviation 4.31 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, 48 hours, n=6,6,24,6,14 | 8.8 Grams per liter | Standard Deviation 4.58 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 6, predose, n=6,6,25,7,14 | 7.7 Grams per liter | Standard Deviation 3.77 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 10, predose, n=6,6,25,7,14 | 7.7 Grams per liter | Standard Deviation 3.5 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, 48 hours, n=6,6,24,6,14 | 4.5 Grams per liter | Standard Deviation 6.42 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 10, predose, n=6,6,25,7,14 | 6.3 Grams per liter | Standard Deviation 5.8 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 4, predose, n=6,6,25,7,14 | 3.1 Grams per liter | Standard Deviation 4.71 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | FU (Day 28), n=6,6,25,7,14 | -2.6 Grams per liter | Standard Deviation 7.42 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 12, predose, n=6,6,25,7,14 | 4.9 Grams per liter | Standard Deviation 4.1 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 8 predose, n=6,6,25,7,14 | 4.2 Grams per liter | Standard Deviation 5.91 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 2, predose, n=6,6,25,7,14 | 3.4 Grams per liter | Standard Deviation 5.73 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, 96 hours, n=6,6,24,6,14 | 4.7 Grams per liter | Standard Deviation 5.09 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 6, predose, n=6,6,25,7,14 | 3.9 Grams per liter | Standard Deviation 3.87 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hb | Day 14, predose, n=6,6,25,6,14 | 0.2 Grams per liter | Standard Deviation 6.15 |
Primary
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected at indicated time points to analyze the hematology parameter: hematocrit. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, 96 hours, n=6,6,24,6,14 | 0.0003 Percentage of red blood cells in blood | Standard Deviation 0.01419 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 4, predose, n=6,6,25,7,14 | 0.0133 Percentage of red blood cells in blood | Standard Deviation 0.0227 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 10, predose, n=6,6,25,7,14 | 0.0063 Percentage of red blood cells in blood | Standard Deviation 0.03144 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, 48 hours, n=6,6,24,6,14 | 0.0018 Percentage of red blood cells in blood | Standard Deviation 0.01969 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 12, predose, n=6,6,25,7,14 | 0.0047 Percentage of red blood cells in blood | Standard Deviation 0.02439 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, predose, n=6,6,25,6,14 | -0.0027 Percentage of red blood cells in blood | Standard Deviation 0.02276 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 2, predose, n=6,6,25,7,14 | 0.0102 Percentage of red blood cells in blood | Standard Deviation 0.023 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 6, predose, n=6,6,25,7,14 | 0.0148 Percentage of red blood cells in blood | Standard Deviation 0.03205 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | FU (Day 28), n=6,6,25,7,14 | -0.0158 Percentage of red blood cells in blood | Standard Deviation 0.01587 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 8 predose, n=6,6,25,7,14 | 0.0025 Percentage of red blood cells in blood | Standard Deviation 0.02788 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 8 predose, n=6,6,25,7,14 | 0.0203 Percentage of red blood cells in blood | Standard Deviation 0.0125 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | FU (Day 28), n=6,6,25,7,14 | -0.0070 Percentage of red blood cells in blood | Standard Deviation 0.01628 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, 96 hours, n=6,6,24,6,14 | 0.0170 Percentage of red blood cells in blood | Standard Deviation 0.01665 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 10, predose, n=6,6,25,7,14 | 0.0217 Percentage of red blood cells in blood | Standard Deviation 0.01697 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 4, predose, n=6,6,25,7,14 | 0.0043 Percentage of red blood cells in blood | Standard Deviation 0.01154 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, 48 hours, n=6,6,24,6,14 | 0.0133 Percentage of red blood cells in blood | Standard Deviation 0.01375 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 6, predose, n=6,6,25,7,14 | 0.0202 Percentage of red blood cells in blood | Standard Deviation 0.01304 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, predose, n=6,6,25,6,14 | 0.0070 Percentage of red blood cells in blood | Standard Deviation 0.01053 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 12, predose, n=6,6,25,7,14 | 0.0302 Percentage of red blood cells in blood | Standard Deviation 0.01396 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 2, predose, n=6,6,25,7,14 | 0.0140 Percentage of red blood cells in blood | Standard Deviation 0.01425 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 12, predose, n=6,6,25,7,14 | 0.0102 Percentage of red blood cells in blood | Standard Deviation 0.01872 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, predose, n=6,6,25,6,14 | -0.0014 Percentage of red blood cells in blood | Standard Deviation 0.02132 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | FU (Day 28), n=6,6,25,7,14 | -0.0110 Percentage of red blood cells in blood | Standard Deviation 0.01675 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 4, predose, n=6,6,25,7,14 | 0.0066 Percentage of red blood cells in blood | Standard Deviation 0.01855 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 6, predose, n=6,6,25,7,14 | 0.0075 Percentage of red blood cells in blood | Standard Deviation 0.01857 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 8 predose, n=6,6,25,7,14 | 0.0049 Percentage of red blood cells in blood | Standard Deviation 0.01827 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 2, predose, n=6,6,25,7,14 | 0.0096 Percentage of red blood cells in blood | Standard Deviation 0.01995 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, 48 hours, n=6,6,24,6,14 | 0.0060 Percentage of red blood cells in blood | Standard Deviation 0.01664 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 10, predose, n=6,6,25,7,14 | 0.0119 Percentage of red blood cells in blood | Standard Deviation 0.02108 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, 96 hours, n=6,6,24,6,14 | 0.0032 Percentage of red blood cells in blood | Standard Deviation 0.01808 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, 48 hours, n=6,6,24,6,14 | 0.0212 Percentage of red blood cells in blood | Standard Deviation 0.01734 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 2, predose, n=6,6,25,7,14 | 0.0314 Percentage of red blood cells in blood | Standard Deviation 0.01122 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 4, predose, n=6,6,25,7,14 | 0.0453 Percentage of red blood cells in blood | Standard Deviation 0.01067 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 6, predose, n=6,6,25,7,14 | 0.0206 Percentage of red blood cells in blood | Standard Deviation 0.01397 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 8 predose, n=6,6,25,7,14 | 0.0241 Percentage of red blood cells in blood | Standard Deviation 0.01378 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 10, predose, n=6,6,25,7,14 | 0.0216 Percentage of red blood cells in blood | Standard Deviation 0.00872 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, predose, n=6,6,25,6,14 | 0.0227 Percentage of red blood cells in blood | Standard Deviation 0.01825 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, 96 hours, n=6,6,24,6,14 | 0.0255 Percentage of red blood cells in blood | Standard Deviation 0.01086 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 12, predose, n=6,6,25,7,14 | 0.0203 Percentage of red blood cells in blood | Standard Deviation 0.00739 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | FU (Day 28), n=6,6,25,7,14 | -0.0013 Percentage of red blood cells in blood | Standard Deviation 0.01739 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, 96 hours, n=6,6,24,6,14 | 0.0145 Percentage of red blood cells in blood | Standard Deviation 0.01594 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 10, predose, n=6,6,25,7,14 | 0.0191 Percentage of red blood cells in blood | Standard Deviation 0.01466 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 8 predose, n=6,6,25,7,14 | 0.0137 Percentage of red blood cells in blood | Standard Deviation 0.01431 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | FU (Day 28), n=6,6,25,7,14 | -0.0046 Percentage of red blood cells in blood | Standard Deviation 0.0204 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, 48 hours, n=6,6,24,6,14 | 0.0157 Percentage of red blood cells in blood | Standard Deviation 0.01601 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 6, predose, n=6,6,25,7,14 | 0.0155 Percentage of red blood cells in blood | Standard Deviation 0.01108 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 4, predose, n=6,6,25,7,14 | 0.0085 Percentage of red blood cells in blood | Standard Deviation 0.01459 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 14, predose, n=6,6,25,6,14 | 0.0019 Percentage of red blood cells in blood | Standard Deviation 0.01499 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 12, predose, n=6,6,25,7,14 | 0.0159 Percentage of red blood cells in blood | Standard Deviation 0.01201 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 2, predose, n=6,6,25,7,14 | 0.0108 Percentage of red blood cells in blood | Standard Deviation 0.01712 |
Primary
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Blood samples were collected to analyze the hematology parameter: percentage of reticulocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 8 predose, n=6,6,25,7,14 | 0.00173 10^12 cells per liter | Standard Deviation 0.001143 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 12, predose, n=6,6,25,7,14 | 0.00220 10^12 cells per liter | Standard Deviation 0.001075 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 10, predose, n=6,6,25,7,14 | 0.00203 10^12 cells per liter | Standard Deviation 0.000804 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 2, predose, n=6,6,25,7,14 | 0.00093 10^12 cells per liter | Standard Deviation 0.001204 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | FU, (Day 28), n=6,6,25,7,14 | 0.00177 10^12 cells per liter | Standard Deviation 0.001581 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 4, predose, n=6,6,25,7,14 | 0.00215 10^12 cells per liter | Standard Deviation 0.001099 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, 48 hours, n=6,6,24,6,14 | 0.00270 10^12 cells per liter | Standard Deviation 0.001788 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 6, predose, n=6,6,25,7,14 | 0.00232 10^12 cells per liter | Standard Deviation 0.000999 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, 96 hours, n=6,6,24,6,14 | 0.00222 10^12 cells per liter | Standard Deviation 0.001766 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, predose, n=6,6,25,6,14 | 0.00287 10^12 cells per liter | Standard Deviation 0.00181 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 6, predose, n=6,6,25,7,14 | 0.00138 10^12 cells per liter | Standard Deviation 0.001118 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, 48 hours, n=6,6,24,6,14 | 0.00295 10^12 cells per liter | Standard Deviation 0.001524 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 4, predose, n=6,6,25,7,14 | -0.00032 10^12 cells per liter | Standard Deviation 0.00144 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 12, predose, n=6,6,25,7,14 | 0.00313 10^12 cells per liter | Standard Deviation 0.001468 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 10, predose, n=6,6,25,7,14 | 0.00255 10^12 cells per liter | Standard Deviation 0.00145 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, predose, n=6,6,25,6,14 | 0.00318 10^12 cells per liter | Standard Deviation 0.000842 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 2, predose, n=6,6,25,7,14 | -0.00103 10^12 cells per liter | Standard Deviation 0.001214 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 8 predose, n=6,6,25,7,14 | 0.00213 10^12 cells per liter | Standard Deviation 0.000894 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | FU, (Day 28), n=6,6,25,7,14 | 0.00212 10^12 cells per liter | Standard Deviation 0.002369 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, 96 hours, n=6,6,24,6,14 | 0.00163 10^12 cells per liter | Standard Deviation 0.00178 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 10, predose, n=6,6,25,7,14 | 0.00153 10^12 cells per liter | Standard Deviation 0.002881 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 2, predose, n=6,6,25,7,14 | 0.00088 10^12 cells per liter | Standard Deviation 0.001818 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 4, predose, n=6,6,25,7,14 | 0.00131 10^12 cells per liter | Standard Deviation 0.002263 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 6, predose, n=6,6,25,7,14 | 0.00125 10^12 cells per liter | Standard Deviation 0.002761 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 8 predose, n=6,6,25,7,14 | 0.00154 10^12 cells per liter | Standard Deviation 0.002999 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 12, predose, n=6,6,25,7,14 | 0.00205 10^12 cells per liter | Standard Deviation 0.002889 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, predose, n=6,6,25,6,14 | 0.00212 10^12 cells per liter | Standard Deviation 0.002924 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, 48 hours, n=6,6,24,6,14 | 0.00205 10^12 cells per liter | Standard Deviation 0.003168 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, 96 hours, n=6,6,24,6,14 | 0.00195 10^12 cells per liter | Standard Deviation 0.003251 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | FU, (Day 28), n=6,6,25,7,14 | 0.00095 10^12 cells per liter | Standard Deviation 0.003073 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, 48 hours, n=6,6,24,6,14 | 0.00063 10^12 cells per liter | Standard Deviation 0.001429 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 2, predose, n=6,6,25,7,14 | -0.00037 10^12 cells per liter | Standard Deviation 0.00119 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | FU, (Day 28), n=6,6,25,7,14 | -0.00084 10^12 cells per liter | Standard Deviation 0.003085 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, 96 hours, n=6,6,24,6,14 | 0.00013 10^12 cells per liter | Standard Deviation 0.00168 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, predose, n=6,6,25,6,14 | -0.00015 10^12 cells per liter | Standard Deviation 0.001621 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 6, predose, n=6,6,25,7,14 | 0.00106 10^12 cells per liter | Standard Deviation 0.002192 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 10, predose, n=6,6,25,7,14 | -0.00023 10^12 cells per liter | Standard Deviation 0.001186 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 4, predose, n=6,6,25,7,14 | 0.00124 10^12 cells per liter | Standard Deviation 0.001996 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 8 predose, n=6,6,25,7,14 | 0.00031 10^12 cells per liter | Standard Deviation 0.00178 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 12, predose, n=6,6,25,7,14 | 0.00007 10^12 cells per liter | Standard Deviation 0.001643 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 6, predose, n=6,6,25,7,14 | 0.00208 10^12 cells per liter | Standard Deviation 0.001785 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 12, predose, n=6,6,25,7,14 | 0.00161 10^12 cells per liter | Standard Deviation 0.002094 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 4, predose, n=6,6,25,7,14 | 0.00157 10^12 cells per liter | Standard Deviation 0.001778 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, predose, n=6,6,25,6,14 | 0.00171 10^12 cells per liter | Standard Deviation 0.002176 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | FU, (Day 28), n=6,6,25,7,14 | 0.00104 10^12 cells per liter | Standard Deviation 0.002853 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, 48 hours, n=6,6,24,6,14 | 0.00184 10^12 cells per liter | Standard Deviation 0.003189 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 14, 96 hours, n=6,6,24,6,14 | 0.00111 10^12 cells per liter | Standard Deviation 0.002838 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 8 predose, n=6,6,25,7,14 | 0.00243 10^12 cells per liter | Standard Deviation 0.002265 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 10, predose, n=6,6,25,7,14 | 0.00154 10^12 cells per liter | Standard Deviation 0.002233 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes | Day 2, predose, n=6,6,25,7,14 | 0.00117 10^12 cells per liter | Standard Deviation 0.001333 |
Primary
Part 2: Change From Baseline in Vital Sign: Pulse Rate
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12, and 14 (pre dose and 72 hours) and Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 1, predose, n=6,6,25,7,14 | -0.3 Beats per minute | Standard Deviation 4.27 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 14, 72 hours, n=6,6,25,6,14 | 7.0 Beats per minute | Standard Deviation 7.62 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 4, predose, n=6,6,25,7,14 | 1.5 Beats per minute | Standard Deviation 3.27 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 14, predose, n=6,6,25,6,14 | 3.5 Beats per minute | Standard Deviation 3.62 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 6, predose, n=6,6,25,7,14 | 3.8 Beats per minute | Standard Deviation 3.6 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 12, predose, n=6,6,25,7,14 | 3.5 Beats per minute | Standard Deviation 4.51 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | FU (Day 28), n=6,6,25,7,14 | 6.3 Beats per minute | Standard Deviation 6.62 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 10, predose, n=6,6,25,7,14 | 0.5 Beats per minute | Standard Deviation 3.94 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 2, predose, n=6,6,25,7,14 | 0.3 Beats per minute | Standard Deviation 4.18 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 8, predose, n=6,6,25,7,14 | -0.5 Beats per minute | Standard Deviation 3.94 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 14, 72 hours, n=6,6,25,6,14 | 1.8 Beats per minute | Standard Deviation 4.4 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 12, predose, n=6,6,25,7,14 | 2.5 Beats per minute | Standard Deviation 7.87 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 14, predose, n=6,6,25,6,14 | -0.2 Beats per minute | Standard Deviation 5.12 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 2, predose, n=6,6,25,7,14 | 0.5 Beats per minute | Standard Deviation 4.93 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | FU (Day 28), n=6,6,25,7,14 | -1.3 Beats per minute | Standard Deviation 10.63 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 4, predose, n=6,6,25,7,14 | 1.5 Beats per minute | Standard Deviation 5.96 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 1, predose, n=6,6,25,7,14 | 0.6 Beats per minute | Standard Deviation 1.86 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 6, predose, n=6,6,25,7,14 | 2.5 Beats per minute | Standard Deviation 5.47 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 8, predose, n=6,6,25,7,14 | 1.3 Beats per minute | Standard Deviation 4.89 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 10, predose, n=6,6,25,7,14 | 3.3 Beats per minute | Standard Deviation 5.79 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 1, predose, n=6,6,25,7,14 | 1.6 Beats per minute | Standard Deviation 4.98 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | FU (Day 28), n=6,6,25,7,14 | 0.8 Beats per minute | Standard Deviation 9.36 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 8, predose, n=6,6,25,7,14 | 1.4 Beats per minute | Standard Deviation 8.02 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 2, predose, n=6,6,25,7,14 | 2.5 Beats per minute | Standard Deviation 7.22 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 14, 72 hours, n=6,6,25,6,14 | 2.9 Beats per minute | Standard Deviation 6.91 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 14, predose, n=6,6,25,6,14 | -0.2 Beats per minute | Standard Deviation 7.4 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 12, predose, n=6,6,25,7,14 | -0.1 Beats per minute | Standard Deviation 8.02 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 4, predose, n=6,6,25,7,14 | 0.2 Beats per minute | Standard Deviation 6.17 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 10, predose, n=6,6,25,7,14 | 1.0 Beats per minute | Standard Deviation 7.21 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 6, predose, n=6,6,25,7,14 | 0.8 Beats per minute | Standard Deviation 6.55 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 14, 72 hours, n=6,6,25,6,14 | 4.2 Beats per minute | Standard Deviation 4.31 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 1, predose, n=6,6,25,7,14 | -3.4 Beats per minute | Standard Deviation 3.31 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 2, predose, n=6,6,25,7,14 | 2.1 Beats per minute | Standard Deviation 5.79 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 4, predose, n=6,6,25,7,14 | 2.7 Beats per minute | Standard Deviation 7.63 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 6, predose, n=6,6,25,7,14 | 3.4 Beats per minute | Standard Deviation 4.43 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 8, predose, n=6,6,25,7,14 | 2.7 Beats per minute | Standard Deviation 6.7 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 10, predose, n=6,6,25,7,14 | 0.4 Beats per minute | Standard Deviation 5.62 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 12, predose, n=6,6,25,7,14 | 3.1 Beats per minute | Standard Deviation 10.64 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 14, predose, n=6,6,25,6,14 | 1.5 Beats per minute | Standard Deviation 3.83 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | FU (Day 28), n=6,6,25,7,14 | 9.6 Beats per minute | Standard Deviation 7.96 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 12, predose, n=6,6,25,7,14 | 2.5 Beats per minute | Standard Deviation 8.12 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 10, predose, n=6,6,25,7,14 | 1.8 Beats per minute | Standard Deviation 6.93 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 8, predose, n=6,6,25,7,14 | 2.1 Beats per minute | Standard Deviation 5.34 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 6, predose, n=6,6,25,7,14 | 3.2 Beats per minute | Standard Deviation 7.16 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 14, 72 hours, n=6,6,25,6,14 | 5.0 Beats per minute | Standard Deviation 6.82 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 4, predose, n=6,6,25,7,14 | 4.1 Beats per minute | Standard Deviation 6.34 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 2, predose, n=6,6,25,7,14 | 3.1 Beats per minute | Standard Deviation 5.66 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 1, predose, n=6,6,25,7,14 | 5.3 Beats per minute | Standard Deviation 5.61 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | FU (Day 28), n=6,6,25,7,14 | 6.3 Beats per minute | Standard Deviation 7.33 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Pulse Rate | Day 14, predose, n=6,6,25,6,14 | 0.3 Beats per minute | Standard Deviation 4.61 |
Primary
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
Respiratory rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12 and 14 (pre dose and 72 hours) and Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 10, predose, n=6,6,25,7,14 | -0.3 Breaths per minute | Standard Deviation 3.2 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 1, predose, n=6,6,25,7,14 | -1.0 Breaths per minute | Standard Deviation 2.37 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 12, predose, n=6,6,25,7,14 | -0.7 Breaths per minute | Standard Deviation 2.25 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 2, predose, n=6,6,25,7,14 | -0.5 Breaths per minute | Standard Deviation 2.88 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 14, predose, n=6,6,25,6,14 | -0.8 Breaths per minute | Standard Deviation 2.14 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 28), n=6,6,25,7,14 | -0.5 Breaths per minute | Standard Deviation 2.95 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 4, predose, n=6,6,25,7,14 | -0.5 Breaths per minute | Standard Deviation 2.17 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 6, predose, n=6,6,25,7,14 | 0.7 Breaths per minute | Standard Deviation 2.25 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 14, 72 hours, n=6,6,25,6,14 | -1.0 Breaths per minute | Standard Deviation 1.41 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 8, predose, n=6,6,25,7,14 | -1.2 Breaths per minute | Standard Deviation 3.06 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 1, predose, n=6,6,25,7,14 | 2.2 Breaths per minute | Standard Deviation 3.49 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 28), n=6,6,25,7,14 | 0.8 Breaths per minute | Standard Deviation 1.72 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 8, predose, n=6,6,25,7,14 | 1.7 Breaths per minute | Standard Deviation 1.03 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 2, predose, n=6,6,25,7,14 | 2.3 Breaths per minute | Standard Deviation 1.21 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 14, 72 hours, n=6,6,25,6,14 | 2.7 Breaths per minute | Standard Deviation 1.63 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 6, predose, n=6,6,25,7,14 | 0.2 Breaths per minute | Standard Deviation 1.47 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 14, predose, n=6,6,25,6,14 | 2.7 Breaths per minute | Standard Deviation 1.51 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 4, predose, n=6,6,25,7,14 | 2.2 Breaths per minute | Standard Deviation 1.94 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 12, predose, n=6,6,25,7,14 | 2.3 Breaths per minute | Standard Deviation 2.8 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 10, predose, n=6,6,25,7,14 | 1.5 Breaths per minute | Standard Deviation 2.35 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 1, predose, n=6,6,25,7,14 | 0.2 Breaths per minute | Standard Deviation 2.15 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 4, predose, n=6,6,25,7,14 | -0.2 Breaths per minute | Standard Deviation 1.5 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 10, predose, n=6,6,25,7,14 | 0.9 Breaths per minute | Standard Deviation 1.69 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 2, predose, n=6,6,25,7,14 | 0.4 Breaths per minute | Standard Deviation 2 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 14, 72 hours, n=6,6,25,6,14 | 0.5 Breaths per minute | Standard Deviation 1.56 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 6, predose, n=6,6,25,7,14 | 0.1 Breaths per minute | Standard Deviation 1.73 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 8, predose, n=6,6,25,7,14 | 0.0 Breaths per minute | Standard Deviation 2.37 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 12, predose, n=6,6,25,7,14 | 0.4 Breaths per minute | Standard Deviation 1.96 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 14, predose, n=6,6,25,6,14 | 0.6 Breaths per minute | Standard Deviation 1.98 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 28), n=6,6,25,7,14 | 1.1 Breaths per minute | Standard Deviation 2.38 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 12, predose, n=6,6,25,7,14 | -0.1 Breaths per minute | Standard Deviation 1.35 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 14, 72 hours, n=6,6,25,6,14 | -0.5 Breaths per minute | Standard Deviation 1.97 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 28), n=6,6,25,7,14 | 0.1 Breaths per minute | Standard Deviation 0.69 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 1, predose, n=6,6,25,7,14 | 0.1 Breaths per minute | Standard Deviation 2.27 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 2, predose, n=6,6,25,7,14 | 1.6 Breaths per minute | Standard Deviation 1.72 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 4, predose, n=6,6,25,7,14 | 0.6 Breaths per minute | Standard Deviation 2.44 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 6, predose, n=6,6,25,7,14 | 0.0 Breaths per minute | Standard Deviation 1.91 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 8, predose, n=6,6,25,7,14 | 0.6 Breaths per minute | Standard Deviation 1.9 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 10, predose, n=6,6,25,7,14 | 0.6 Breaths per minute | Standard Deviation 0.98 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 14, predose, n=6,6,25,6,14 | -0.2 Breaths per minute | Standard Deviation 2.23 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 10, predose, n=6,6,25,7,14 | 0.5 Breaths per minute | Standard Deviation 1.74 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 8, predose, n=6,6,25,7,14 | 0.5 Breaths per minute | Standard Deviation 1.91 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | FU (Day 28), n=6,6,25,7,14 | 0.6 Breaths per minute | Standard Deviation 2.1 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 14, predose, n=6,6,25,6,14 | 0.4 Breaths per minute | Standard Deviation 2.24 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 6, predose, n=6,6,25,7,14 | -0.4 Breaths per minute | Standard Deviation 1.65 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 4, predose, n=6,6,25,7,14 | 0.2 Breaths per minute | Standard Deviation 1.53 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 14, 72 hours, n=6,6,25,6,14 | -0.4 Breaths per minute | Standard Deviation 1.98 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 2, predose, n=6,6,25,7,14 | 0.5 Breaths per minute | Standard Deviation 1.95 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 1, predose, n=6,6,25,7,14 | 0.8 Breaths per minute | Standard Deviation 2.22 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Respiratory Rate | Day 12, predose, n=6,6,25,7,14 | 0.4 Breaths per minute | Standard Deviation 2.62 |
Primary
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12,and 14 (pre dose and 72 hours) and Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, FU (Day 28), n=6,6,25,7,14 | -3.0 Millimeters of mercury (mmHg) | Standard Deviation 8.56 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 14, predose, n=6,6,25,7,14 | -0.8 Millimeters of mercury (mmHg) | Standard Deviation 3.97 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 12, n=6,6,25,7,14 | 0.7 Millimeters of mercury (mmHg) | Standard Deviation 1.86 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 4, predose, n=6,6,25,7,14 | -0.3 Millimeters of mercury (mmHg) | Standard Deviation 5.79 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 14, 72 hours n=6,6,24,6,14 | -0.3 Millimeters of mercury (mmHg) | Standard Deviation 2.88 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 10, predose, n=6,6,25,7,14 | -3.2 Millimeters of mercury (mmHg) | Standard Deviation 6.27 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 1, predose, n=6,6,25,7,14 | -2.7 Millimeters of mercury (mmHg) | Standard Deviation 5.65 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 8, predose, n=6,6,25,7,14 | -2.5 Millimeters of mercury (mmHg) | Standard Deviation 7.89 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 6, predose, n=6,6,25,7,14 | -2.7 Millimeters of mercury (mmHg) | Standard Deviation 5.09 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 1, predose, n=6,6,25,7,14 | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 4.76 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 6, predose, n=6,6,25,7,14 | -4.7 Millimeters of mercury (mmHg) | Standard Deviation 7.17 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 8, predose, n=6,6,25,7,14 | -2.5 Millimeters of mercury (mmHg) | Standard Deviation 3.73 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, follow up, n=6,6,25,7,14 | -3.0 Millimeters of mercury (mmHg) | Standard Deviation 8.56 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 14, 72 hours, n=6,6,25,7,14 | 1.3 Millimeters of mercury (mmHg) | Standard Deviation 3.33 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 14, predose, n=6,6,24,6,14 | 0.2 Millimeters of mercury (mmHg) | Standard Deviation 3.13 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 4, predose, n=6,6,25,7,14 | -2.7 Millimeters of mercury (mmHg) | Standard Deviation 5.85 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 10, predose, n=6,6,25,7,14 | -2.8 Millimeters of mercury (mmHg) | Standard Deviation 3.06 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 2, predose, n=6,6,25,7,14 | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 2.88 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 12, predose, n=6,6,25,7,14 | -2.8 Millimeters of mercury (mmHg) | Standard Deviation 2.64 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 2, predose, n=6,6,25,7,14 | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 3.03 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 2, predose, n=6,6,25,7,14 | -0.3 Millimeters of mercury (mmHg) | Standard Deviation 5.2 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 1, predose, n=6,6,25,7,14 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 2.76 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 14, predose, n=6,6,25,7,14 | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 14 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, follow up, n=6,6,25,7,14 | 1.3 Millimeters of mercury (mmHg) | Standard Deviation 1.75 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 14, 72 hours, n=6,6,25,7,14 | 0.2 Millimeters of mercury (mmHg) | Standard Deviation 10.98 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 14, 72 hours n=6,6,24,6,14 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 2.42 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 12, predose, n=6,6,25,7,14 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 10.15 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 1, predose, n=6,6,25,7,14 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 9.87 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 14, predose, n=6,6,24,6,14 | -0.8 Millimeters of mercury (mmHg) | Standard Deviation 2.56 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 2, predose, n=6,6,25,7,14 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 10.3 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, FU (Day 28), n=6,6,25,7,14 | 1.3 Millimeters of mercury (mmHg) | Standard Deviation 1.75 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 12, n=6,6,25,7,14 | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 4.85 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 4, predose, n=6,6,25,7,14 | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 9.2 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 8, predose, n=6,6,25,7,14 | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 3.73 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 6, predose, n=6,6,25,7,14 | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 2.19 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 8, predose, n=6,6,25,7,14 | 3.3 Millimeters of mercury (mmHg) | Standard Deviation 9.85 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 10, predose, n=6,6,25,7,14 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 4.71 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 4, predose, n=6,6,25,7,14 | -0.3 Millimeters of mercury (mmHg) | Standard Deviation 5.68 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 10, predose, n=6,6,25,7,14 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 9.37 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 6, predose, n=6,6,25,7,14 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 9.87 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 10, predose, n=6,6,25,7,14 | -1.9 Millimeters of mercury (mmHg) | Standard Deviation 6.66 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 6, predose, n=6,6,25,7,14 | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 5.72 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 12, predose, n=6,6,25,7,14 | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 5.7 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 4, predose, n=6,6,25,7,14 | -1.6 Millimeters of mercury (mmHg) | Standard Deviation 7.18 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 14, predose, n=6,6,24,6,14 | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 6.93 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 1, predose, n=6,6,25,7,14 | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 4.68 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 2, predose, n=6,6,25,7,14 | 0.6 Millimeters of mercury (mmHg) | Standard Deviation 6.47 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 4, predose, n=6,6,25,7,14 | -2.2 Millimeters of mercury (mmHg) | Standard Deviation 6.33 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 8, predose, n=6,6,25,7,14 | -1.4 Millimeters of mercury (mmHg) | Standard Deviation 6.19 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 14, predose, n=6,6,25,7,14 | -1.3 Millimeters of mercury (mmHg) | Standard Deviation 7.31 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 14, 72 hours, n=6,6,25,7,14 | -2.3 Millimeters of mercury (mmHg) | Standard Deviation 6.21 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, follow up, n=6,6,25,7,14 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 6.43 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 1, predose, n=6,6,25,7,14 | -0.9 Millimeters of mercury (mmHg) | Standard Deviation 5.78 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 2, predose, n=6,6,25,7,14 | 0.9 Millimeters of mercury (mmHg) | Standard Deviation 6.93 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 6, predose, n=6,6,25,7,14 | 0.2 Millimeters of mercury (mmHg) | Standard Deviation 5.21 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 8, predose, n=6,6,25,7,14 | -1.3 Millimeters of mercury (mmHg) | Standard Deviation 6.52 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 10, predose, n=6,6,25,7,14 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 5.79 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 12, n=6,6,25,7,14 | -1.9 Millimeters of mercury (mmHg) | Standard Deviation 6.16 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 14, 72 hours n=6,6,24,6,14 | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 6.03 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, FU (Day 28), n=6,6,25,7,14 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 6.43 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, FU (Day 28), n=6,6,25,7,14 | 7 Millimeters of mercury (mmHg) | Standard Deviation 4.1 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 1, predose, n=6,6,25,7,14 | 2.3 Millimeters of mercury (mmHg) | Standard Deviation 5.41 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 10, predose, n=6,6,25,7,14 | 3.7 Millimeters of mercury (mmHg) | Standard Deviation 4.11 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 14, 72 hours n=6,6,24,6,14 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 4.67 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 2, predose, n=6,6,25,7,14 | 2.2 Millimeters of mercury (mmHg) | Standard Deviation 4.28 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 8, predose, n=6,6,25,7,14 | 4.3 Millimeters of mercury (mmHg) | Standard Deviation 5.65 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 6, predose, n=6,6,25,7,14 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 7.48 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 6, predose, n=6,6,25,7,14 | 1.9 Millimeters of mercury (mmHg) | Standard Deviation 4.06 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 4, predose, n=6,6,25,7,14 | 3.0 Millimeters of mercury (mmHg) | Standard Deviation 5.42 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 12, n=6,6,25,7,14 | 0.9 Millimeters of mercury (mmHg) | Standard Deviation 5.01 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 8, predose, n=6,6,25,7,14 | 0.1 Millimeters of mercury (mmHg) | Standard Deviation 4.63 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 4, predose, n=6,6,25,7,14 | 3.1 Millimeters of mercury (mmHg) | Standard Deviation 3.8 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 10, predose, n=6,6,25,7,14 | 3.3 Millimeters of mercury (mmHg) | Standard Deviation 4.96 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 2, predose, n=6,6,25,7,14 | 2.6 Millimeters of mercury (mmHg) | Standard Deviation 3.4 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 1, predose, n=6,6,25,7,14 | 2.9 Millimeters of mercury (mmHg) | Standard Deviation 5.76 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 14, predose, n=6,6,24,6,14 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 3.76 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 14, 72 hours, n=6,6,25,7,14 | 0.2 Millimeters of mercury (mmHg) | Standard Deviation 6.85 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 14, predose, n=6,6,25,7,14 | 3.8 Millimeters of mercury (mmHg) | Standard Deviation 5.56 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, follow up, n=6,6,25,7,14 | 4.1 Millimeters of mercury (mmHg) | Standard Deviation 7.6 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 12, predose, n=6,6,25,7,14 | 3.3 Millimeters of mercury (mmHg) | Standard Deviation 5.71 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 8, predose, n=6,6,25,7,14 | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 4.7 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 12, predose, n=6,6,25,7,14 | -4.6 Millimeters of mercury (mmHg) | Standard Deviation 11.88 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 1, predose, n=6,6,25,7,14 | -0.8 Millimeters of mercury (mmHg) | Standard Deviation 5.73 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 10, predose, n=6,6,25,7,14 | -5.2 Millimeters of mercury (mmHg) | Standard Deviation 12.77 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 14, 72 hours, n=6,6,25,7,14 | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 11.07 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 10, predose, n=6,6,25,7,14 | -2.1 Millimeters of mercury (mmHg) | Standard Deviation 7.13 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 2, predose, n=6,6,25,7,14 | -2.6 Millimeters of mercury (mmHg) | Standard Deviation 7.84 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 2, predose, n=6,6,25,7,14 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 4.76 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 8, predose, n=6,6,25,7,14 | -1.4 Millimeters of mercury (mmHg) | Standard Deviation 11.8 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 14, predose, n=6,6,25,7,14 | -4.1 Millimeters of mercury (mmHg) | Standard Deviation 12.33 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 4, predose, n=6,6,25,7,14 | -1.3 Millimeters of mercury (mmHg) | Standard Deviation 4.94 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 6, predose, n=6,6,25,7,14 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 12.94 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, FU (Day 28), n=6,6,25,7,14 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 7.03 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 14, 72 hours n=6,6,24,6,14 | -1.6 Millimeters of mercury (mmHg) | Standard Deviation 4.5 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 1, predose, n=6,6,25,7,14 | -1.1 Millimeters of mercury (mmHg) | Standard Deviation 8.48 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 6, predose, n=6,6,25,7,14 | -1.6 Millimeters of mercury (mmHg) | Standard Deviation 4.62 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 4, predose, n=6,6,25,7,14 | -3.3 Millimeters of mercury (mmHg) | Standard Deviation 12.67 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, follow up, n=6,6,25,7,14 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 7.03 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 14, predose, n=6,6,24,6,14 | -1.9 Millimeters of mercury (mmHg) | Standard Deviation 7.07 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 12, n=6,6,25,7,14 | -2.3 Millimeters of mercury (mmHg) | Standard Deviation 7.45 |
Primary
Part 2: Change From Baseline in Vital Sign: Temperature
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Time frame: Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12, and 14 (pre dose and 72 hours) and Follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 12, predose, n=6,6,25,7,14 | 0.23 Degree Celsius | Standard Deviation 0.489 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 10, predose, n=6,6,25,7,14 | 0.30 Degree Celsius | Standard Deviation 0.498 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Temperature | FU (Day 28), n=6,6,25,7,14 | 0.42 Degree Celsius | Standard Deviation 0.264 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 1, predose, n=6,6,25,7,14 | 0.38 Degree Celsius | Standard Deviation 0.313 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 14, 72 hours, n=6,6,25,6,14 | 0.30 Degree Celsius | Standard Deviation 0.31 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 4, predose, n=6,6,25,7,14 | 0.44 Degree Celsius | Standard Deviation 0.512 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 2, predose, n=6,6,25,7,14 | 0.25 Degree Celsius | Standard Deviation 0.281 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 14, predose, n=6,6,25,6,14 | 0.30 Degree Celsius | Standard Deviation 0.29 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 6, predose, n=6,6,25,7,14 | 0.33 Degree Celsius | Standard Deviation 0.489 |
| Part 1: GSK3640254 1 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 8, predose, n=6,6,25,7,14 | 0.05 Degree Celsius | Standard Deviation 0.373 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 12, predose, n=6,6,25,7,14 | 0.23 Degree Celsius | Standard Deviation 0.314 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 8, predose, n=6,6,25,7,14 | 0.20 Degree Celsius | Standard Deviation 0.322 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 2, predose, n=6,6,25,7,14 | 0.18 Degree Celsius | Standard Deviation 0.331 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 10, predose, n=6,6,25,7,14 | 0.10 Degree Celsius | Standard Deviation 0.593 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 4, predose, n=6,6,25,7,14 | 0.28 Degree Celsius | Standard Deviation 0.271 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Temperature | FU (Day 28), n=6,6,25,7,14 | 0.37 Degree Celsius | Standard Deviation 0.441 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 6, predose, n=6,6,25,7,14 | 0.25 Degree Celsius | Standard Deviation 0.226 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 14, predose, n=6,6,25,6,14 | 0.13 Degree Celsius | Standard Deviation 0.258 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 14, 72 hours, n=6,6,25,6,14 | 0.15 Degree Celsius | Standard Deviation 0.302 |
| Part 1: GSK3640254 3 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 1, predose, n=6,6,25,7,14 | 0.08 Degree Celsius | Standard Deviation 0.222 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 4, predose, n=6,6,25,7,14 | 0.04 Degree Celsius | Standard Deviation 0.425 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 1, predose, n=6,6,25,7,14 | 0.11 Degree Celsius | Standard Deviation 0.414 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 2, predose, n=6,6,25,7,14 | -0.04 Degree Celsius | Standard Deviation 0.507 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 6, predose, n=6,6,25,7,14 | -0.04 Degree Celsius | Standard Deviation 0.342 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 8, predose, n=6,6,25,7,14 | 0.05 Degree Celsius | Standard Deviation 0.255 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 10, predose, n=6,6,25,7,14 | -0.01 Degree Celsius | Standard Deviation 0.355 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 12, predose, n=6,6,25,7,14 | -0.02 Degree Celsius | Standard Deviation 0.415 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 14, predose, n=6,6,25,6,14 | 0.05 Degree Celsius | Standard Deviation 0.309 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 14, 72 hours, n=6,6,25,6,14 | 0.06 Degree Celsius | Standard Deviation 0.33 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Vital Sign: Temperature | FU (Day 28), n=6,6,25,7,14 | 0.04 Degree Celsius | Standard Deviation 0.586 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 1, predose, n=6,6,25,7,14 | 0.11 Degree Celsius | Standard Deviation 0.308 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 2, predose, n=6,6,25,7,14 | -0.11 Degree Celsius | Standard Deviation 0.279 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Temperature | FU (Day 28), n=6,6,25,7,14 | 0.23 Degree Celsius | Standard Deviation 0.364 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 14, 72 hours, n=6,6,25,6,14 | 0.22 Degree Celsius | Standard Deviation 0.256 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 4, predose, n=6,6,25,7,14 | 0.11 Degree Celsius | Standard Deviation 0.204 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 12, predose, n=6,6,25,7,14 | 0.03 Degree Celsius | Standard Deviation 0.32 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 8, predose, n=6,6,25,7,14 | -0.09 Degree Celsius | Standard Deviation 0.372 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 14, predose, n=6,6,25,6,14 | 0.05 Degree Celsius | Standard Deviation 0.266 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 10, predose, n=6,6,25,7,14 | -0.10 Degree Celsius | Standard Deviation 0.289 |
| Part 1: GSK3640254 30mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 6, predose, n=6,6,25,7,14 | -0.11 Degree Celsius | Standard Deviation 0.491 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 10, predose, n=6,6,25,7,14 | 0.09 Degree Celsius | Standard Deviation 0.455 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 12, predose, n=6,6,25,7,14 | 0.06 Degree Celsius | Standard Deviation 0.393 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 4, predose, n=6,6,25,7,14 | 0.14 Degree Celsius | Standard Deviation 0.374 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Temperature | FU (Day 28), n=6,6,25,7,14 | 0.21 Degree Celsius | Standard Deviation 0.317 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 14, predose, n=6,6,25,6,14 | -0.02 Degree Celsius | Standard Deviation 0.395 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 2, predose, n=6,6,25,7,14 | 0.14 Degree Celsius | Standard Deviation 0.367 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 14, 72 hours, n=6,6,25,6,14 | 0.06 Degree Celsius | Standard Deviation 0.363 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 8, predose, n=6,6,25,7,14 | -0.02 Degree Celsius | Standard Deviation 0.379 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 1, predose, n=6,6,25,7,14 | 0.09 Degree Celsius | Standard Deviation 0.276 |
| Part 1: GSK3640254 100 mg | Part 2: Change From Baseline in Vital Sign: Temperature | Day 6, predose, n=6,6,25,7,14 | 0.14 Degree Celsius | Standard Deviation 0.405 |
Primary
Part 2: Number of Participants AEs and SAEs
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. Results are presented treatment wise.
Time frame: Up to Day 28
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants AEs and SAEs | AE | 4 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants AEs and SAEs | SAE | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants AEs and SAEs | AE | 5 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants AEs and SAEs | SAE | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants AEs and SAEs | SAE | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants AEs and SAEs | AE | 19 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants AEs and SAEs | SAE | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants AEs and SAEs | AE | 6 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants AEs and SAEs | AE | 10 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants AEs and SAEs | SAE | 0 Participants |
Primary
Part 2: Number of Participants With Abnormal ECG Findings
12-lead ECG were obtained at given time points. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS).Results are presented treatment wise.
Time frame: Day 1 (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5, 5.5, 6, 8, 12, 24 hours); Pre-dose on Days 3, 4, 6, 8, 10, 12; Day 14: Pre-dose, 1, 2, 4.5, 5, 6, 12, 24, 48, 72 and 96 hours post-dose and follow up (Day 28)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 3.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 2hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 4.5 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 4, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 5hours n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1,5.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 8, Predose, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 6hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 96 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 8 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 12 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, Predose, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 2.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 6, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 3, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 4, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 3 hours n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 3.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 72 hours, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 4.5 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 5hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1,5.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 48 hours, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 6hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 10, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 8 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 12 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 24hours, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 24 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 3, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 12 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 6, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 8, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 72 hours, n=6,6,24, 6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 14, 6 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 12, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, Predose, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 14, 1hour, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 1.5 hours, n=4,0,0,0,1 | 1 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 2 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 4.5 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 4.5hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 6 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 2 hours, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 12 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 0.5 hours, n=4,0,0,0,2 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 24 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, FU (Day 28), n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 48 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1,1 hour, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 14, 1hour, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 96 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, FU (Day 28), n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1,0.5 hours, n=4,0,0,0,2 | 1 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1,1 hour, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 12, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 2hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 1.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 2.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS Day 1, 3 hours n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 10, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 72 hours, n=6,6,24, 6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 2 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 8, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS Day 1, 3 hours n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 6, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 6 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 12 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 14, 1hour, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 6, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 12 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 12, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, FU (Day 28), n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 3, Predose, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 4.5 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 96 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 2 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 12 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 4, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 14, 6 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 72 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1,1 hour, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, FU (Day 28), n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 3, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 4.5 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 4.5 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 4, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 2hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 24 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 48 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 12, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1,1 hour, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 14, 1hour, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 6hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 4.5hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 8, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 10, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, Predose, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 48 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 24hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1,5.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 10, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 96 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 2hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 24 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, Predose, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 12 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 6hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 12 hours, n=6,6,24,6,14 | 2 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 4, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 2hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, Predose, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 6, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, FU (Day 28), n=6,6,24,6,14 | 2 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 14, 6 hours, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 2hours, n=6,6,25,7,14 | 2 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 8, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 96 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1,1 hour, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 12, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, Predose, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 4.5 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 14, 1hour, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, FU (Day 28), n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 2 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 12 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 4.5 hours, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 12, Predose, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 8, Predose, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 4.5hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1,5.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 2 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 6hours, n=6,6,25,7,14 | 2 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 6, Predose, n=6,6,25,7,14 | 2 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 10, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 12 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 6 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS Day 1, 3 hours n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 3, Predose, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 72 hours, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 4, Predose, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 12 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 14, 1hour, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1,1 hour, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 4.5 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 48 hours, n=6,6,24,6,14 | 3 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 24 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 96 hours, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 3, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 6hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 24hours, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 48 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 24 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 10, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 72 hours, n=6,6,24, 6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 8, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 10, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 12, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1,5.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1,1 hour, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 2hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 4.5 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 6hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 12 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 24 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 3, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 4, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 6, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 8, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, Predose, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 14, 1hour, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 2 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 4.5hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 6 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 12 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 24 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 48 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 72 hours, n=6,6,24, 6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 96 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, FU (Day 28), n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1,1 hour, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 2hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS Day 1, 3 hours n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 4.5 hours, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 6hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 12 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 3, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 4, Predose, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 6, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 10, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 12, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, Predose, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 14, 1hour, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 2 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 4.5 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 14, 6 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 12 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 24hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 48 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 72 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 96 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, FU (Day 28), n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 2hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 2.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 10, Predose, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1,1 hour, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1,0.5 hours, n=4,0,0,0,2 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, FU (Day 28), n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 12, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 12, Predose, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 96 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 72 hours, n=6,6,24, 6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 72 hours, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, Predose, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 48 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 24 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 12 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 2hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 14, 1hour, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 6 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 5hours, n=0,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 4.5hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 1.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 2 hours, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, 2 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 14, 1hour, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 14, Predose, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1,1 hour, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 4.5 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 5hours, n=0,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 10, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 8, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 6, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, FU (Day 28), n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 14, 6 hours, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 4, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 3, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 24 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 96 hours, n=6,6,24,6,14 | 2 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 12 hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 12 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 8 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 6hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 0.5 hours, n=4,0,0,0,2 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 24hours, n=6,6,24,6,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1,5.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 5hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 4.5 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 1.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 14, 48 hours, n=6,6,24,6,14 | 1 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 3, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS,Day 1, 3.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 4, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 12 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 8 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 6hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | CS, Day 1, 3 hours n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 6, Predose, n=6,6,25,7,14 | 1 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1,5.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 5hours n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS, Day 1, 4.5 hours, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 3.5 hours, n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 8, Predose, n=6,6,25,7,14 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS Day 1, 3 hours n=4,0,0,0,1 | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal ECG Findings | NCS,Day 1, 2.5 hours, n=4,0,0,0,1 | 0 Participants |
Primary
Part 2: Number of Participants With Abnormal Urinalysis
Urine samples were collected analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
Time frame: Up to Day 28
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Number of Participants With Abnormal Urinalysis | 0 Participants |
| Part 1: GSK3640254 3 mg | Part 2: Number of Participants With Abnormal Urinalysis | 0 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Abnormal Urinalysis | 0 Participants |
| Part 1: GSK3640254 30mg | Part 2: Number of Participants With Abnormal Urinalysis | 0 Participants |
| Part 1: GSK3640254 100 mg | Part 2: Number of Participants With Abnormal Urinalysis | 0 Participants |
Secondary
Part 1: Apparent Oral Clearance (CL/F) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Apparent Oral Clearance (CL/F) of GSK3640254 | 17.685 Liters/hour |
| Part 1: GSK3640254 3 mg | Part 1: Apparent Oral Clearance (CL/F) of GSK3640254 | 9.119 Liters/hour |
| Part 1: GSK3640254 10 mg | Part 1: Apparent Oral Clearance (CL/F) of GSK3640254 | 8.152 Liters/hour |
| Part 1: GSK3640254 30mg | Part 1: Apparent Oral Clearance (CL/F) of GSK3640254 | 10.027 Liters/hour |
| Part 1: GSK3640254 100 mg | Part 1: Apparent Oral Clearance (CL/F) of GSK3640254 | 11.711 Liters/hour |
| Part 1: GSK3640254 200 mg | Part 1: Apparent Oral Clearance (CL/F) of GSK3640254 | 13.376 Liters/hour |
| Part 1: GSK3640254 400 mg | Part 1: Apparent Oral Clearance (CL/F) of GSK3640254 | 9.305 Liters/hour |
| Part 1: GSK3640254 700 mg | Part 1: Apparent Oral Clearance (CL/F) of GSK3640254 | 17.636 Liters/hour |
Secondary
Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Most of the concentrations were below limit of quantification (BLQ) at this dose group this value and/ or %AUC extrapolated was \>20% for all participants so this value should be used with caution. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 | 7.886 Hour |
| Part 1: GSK3640254 3 mg | Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 | 20.486 Hour |
| Part 1: GSK3640254 10 mg | Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 | 25.332 Hour |
| Part 1: GSK3640254 30mg | Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 | 21.221 Hour |
| Part 1: GSK3640254 100 mg | Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 | 22.838 Hour |
| Part 1: GSK3640254 200 mg | Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 | 22.620 Hour |
| Part 1: GSK3640254 400 mg | Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 | 23.737 Hour |
| Part 1: GSK3640254 700 mg | Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 | 20.761 Hour |
Secondary
Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24 hours post-dose
Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254 | 0.056 Hour*microgram per milliliter |
| Part 1: GSK3640254 3 mg | Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254 | 0.171 Hour*microgram per milliliter |
| Part 1: GSK3640254 10 mg | Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254 | 0.576 Hour*microgram per milliliter |
| Part 1: GSK3640254 30mg | Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254 | 1.546 Hour*microgram per milliliter |
| Part 1: GSK3640254 100 mg | Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254 | 4.177 Hour*microgram per milliliter |
| Part 1: GSK3640254 200 mg | Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254 | 7.334 Hour*microgram per milliliter |
| Part 1: GSK3640254 400 mg | Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254 | 21.666 Hour*microgram per milliliter |
| Part 1: GSK3640254 700 mg | Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254 | 20.743 Hour*microgram per milliliter |
Secondary
Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254 | 0.057 Hour*microgram per milliliter |
| Part 1: GSK3640254 3 mg | Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254 | 0.329 Hour*microgram per milliliter |
| Part 1: GSK3640254 10 mg | Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254 | 1.227 Hour*microgram per milliliter |
| Part 1: GSK3640254 30mg | Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254 | 2.992 Hour*microgram per milliliter |
| Part 1: GSK3640254 100 mg | Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254 | 8.539 Hour*microgram per milliliter |
| Part 1: GSK3640254 200 mg | Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254 | 14.952 Hour*microgram per milliliter |
| Part 1: GSK3640254 400 mg | Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254 | 42.989 Hour*microgram per milliliter |
| Part 1: GSK3640254 700 mg | Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254 | 39.692 Hour*microgram per milliliter |
Secondary
Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254 | 0.020 Hour*microgram per milliliter |
| Part 1: GSK3640254 3 mg | Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254 | 0.184 Hour*microgram per milliliter |
| Part 1: GSK3640254 10 mg | Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254 | 1.082 Hour*microgram per milliliter |
| Part 1: GSK3640254 30mg | Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254 | 2.816 Hour*microgram per milliliter |
| Part 1: GSK3640254 100 mg | Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254 | 8.060 Hour*microgram per milliliter |
| Part 1: GSK3640254 200 mg | Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254 | 14.068 Hour*microgram per milliliter |
| Part 1: GSK3640254 400 mg | Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254 | 40.238 Hour*microgram per milliliter |
| Part 1: GSK3640254 700 mg | Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254 | 37.626 Hour*microgram per milliliter |
Secondary
Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours post dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1 | 0.056 hour*micrograms per mililiter |
| Part 1: GSK3640254 3 mg | Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1 | 0.171 hour*micrograms per mililiter |
| Part 1: GSK3640254 10 mg | Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1 | 0.576 hour*micrograms per mililiter |
| Part 1: GSK3640254 30mg | Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1 | 1.546 hour*micrograms per mililiter |
| Part 1: GSK3640254 100 mg | Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1 | 4.177 hour*micrograms per mililiter |
| Part 1: GSK3640254 200 mg | Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1 | 7.334 hour*micrograms per mililiter |
| Part 1: GSK3640254 400 mg | Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1 | 21.666 hour*micrograms per mililiter |
| Part 1: GSK3640254 700 mg | Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1 | 20.743 hour*micrograms per mililiter |
90% CI: [0.8877, 0.9683]
Secondary
Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1 | 0.057 hour*micrograms per mililiter |
| Part 1: GSK3640254 3 mg | Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1 | 0.329 hour*micrograms per mililiter |
| Part 1: GSK3640254 10 mg | Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1 | 1.1227 hour*micrograms per mililiter |
| Part 1: GSK3640254 30mg | Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1 | 2.992 hour*micrograms per mililiter |
| Part 1: GSK3640254 100 mg | Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1 | 8.539 hour*micrograms per mililiter |
| Part 1: GSK3640254 200 mg | Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1 | 14.952 hour*micrograms per mililiter |
| Part 1: GSK3640254 400 mg | Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1 | 42.989 hour*micrograms per mililiter |
| Part 1: GSK3640254 700 mg | Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1 | 39.692 hour*micrograms per mililiter |
90% CI: [0.8982, 0.9971]
Secondary
Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1 | 0.005 Micrograms per mililiter |
| Part 1: GSK3640254 3 mg | Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1 | 0.014 Micrograms per mililiter |
| Part 1: GSK3640254 10 mg | Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1 | 0.047 Micrograms per mililiter |
| Part 1: GSK3640254 30mg | Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1 | 0.130 Micrograms per mililiter |
| Part 1: GSK3640254 100 mg | Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1 | 0.372 Micrograms per mililiter |
| Part 1: GSK3640254 200 mg | Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1 | 0.579 Micrograms per mililiter |
| Part 1: GSK3640254 400 mg | Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1 | 1.881 Micrograms per mililiter |
| Part 1: GSK3640254 700 mg | Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1 | 1.724 Micrograms per mililiter |
90% CI: [0.897, 0.9734]
Secondary
Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Time frame: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Cmax | 0.005 Micrograms per milliliter |
| Part 1: GSK3640254 1 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Clast | 0.004 Micrograms per milliliter |
| Part 1: GSK3640254 1 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | C24 | 0.001 Micrograms per milliliter |
| Part 1: GSK3640254 3 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Clast | 0.005 Micrograms per milliliter |
| Part 1: GSK3640254 3 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | C24 | 0.005 Micrograms per milliliter |
| Part 1: GSK3640254 3 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Cmax | 0.014 Micrograms per milliliter |
| Part 1: GSK3640254 10 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Clast | 0.004 Micrograms per milliliter |
| Part 1: GSK3640254 10 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Cmax | 0.047 Micrograms per milliliter |
| Part 1: GSK3640254 10 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | C24 | 0.017 Micrograms per milliliter |
| Part 1: GSK3640254 30mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Cmax | 0.130 Micrograms per milliliter |
| Part 1: GSK3640254 30mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | C24 | 0.043 Micrograms per milliliter |
| Part 1: GSK3640254 30mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Clast | 0.005 Micrograms per milliliter |
| Part 1: GSK3640254 100 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | C24 | 0.126 Micrograms per milliliter |
| Part 1: GSK3640254 100 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Cmax | 0.372 Micrograms per milliliter |
| Part 1: GSK3640254 100 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Clast | 0.014 Micrograms per milliliter |
| Part 1: GSK3640254 200 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | C24 | 0.245 Micrograms per milliliter |
| Part 1: GSK3640254 200 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Cmax | 0.579 Micrograms per milliliter |
| Part 1: GSK3640254 200 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Clast | 0.024 Micrograms per milliliter |
| Part 1: GSK3640254 400 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | C24 | 0.610 Micrograms per milliliter |
| Part 1: GSK3640254 400 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Cmax | 1.881 Micrograms per milliliter |
| Part 1: GSK3640254 400 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Clast | 0.072 Micrograms per milliliter |
| Part 1: GSK3640254 700 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Cmax | 1.724 Micrograms per milliliter |
| Part 1: GSK3640254 700 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | C24 | 0.579 Micrograms per milliliter |
| Part 1: GSK3640254 700 mg | Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254 | Clast | 0.054 Micrograms per milliliter |
Secondary
Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose
Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlast | 6.017 Hour |
| Part 1: GSK3640254 1 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlag | 2.000 Hour |
| Part 1: GSK3640254 1 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tmax | 3.500 Hour |
| Part 1: GSK3640254 3 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlag | 1.250 Hour |
| Part 1: GSK3640254 3 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tmax | 4.500 Hour |
| Part 1: GSK3640254 3 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlast | 24.017 Hour |
| Part 1: GSK3640254 10 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlag | 0.750 Hour |
| Part 1: GSK3640254 10 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tmax | 3.500 Hour |
| Part 1: GSK3640254 10 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlast | 72.008 Hour |
| Part 1: GSK3640254 30mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlag | 0.500 Hour |
| Part 1: GSK3640254 30mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tmax | 4.000 Hour |
| Part 1: GSK3640254 30mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlast | 96.000 Hour |
| Part 1: GSK3640254 100 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlag | 0.750 Hour |
| Part 1: GSK3640254 100 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tmax | 3.750 Hour |
| Part 1: GSK3640254 100 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlast | 96.000 Hour |
| Part 1: GSK3640254 200 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlag | 0.500 Hour |
| Part 1: GSK3640254 200 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tmax | 3.000 Hour |
| Part 1: GSK3640254 200 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlast | 95.667 Hour |
| Part 1: GSK3640254 400 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlag | 0.500 Hour |
| Part 1: GSK3640254 400 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tmax | 3.250 Hour |
| Part 1: GSK3640254 400 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlast | 95.667 Hour |
| Part 1: GSK3640254 700 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tmax | 3.250 Hour |
| Part 1: GSK3640254 700 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlag | 0.500 Hour |
| Part 1: GSK3640254 700 mg | Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254 | Tlast | 95.542 Hour |
Secondary
Part 2: Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]) From Day 1 to Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 14 and Day 1, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]) From Day 1 to Day 14 | 2.2005 Ratio of AUC(0-tau) |
| Part 1: GSK3640254 3 mg | Part 2: Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]) From Day 1 to Day 14 | 2.5739 Ratio of AUC(0-tau) |
| Part 1: GSK3640254 10 mg | Part 2: Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]) From Day 1 to Day 14 | 2.6167 Ratio of AUC(0-tau) |
| Part 1: GSK3640254 30mg | Part 2: Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]) From Day 1 to Day 14 | 2.3634 Ratio of AUC(0-tau) |
Secondary
Part 2: Accumulation Ratio of Cmax (R [CMAX]) From Day 1 to Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 14 and Day 1, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Accumulation Ratio of Cmax (R [CMAX]) From Day 1 to Day 14 | 1.9276 Ratio of Cmax |
| Part 1: GSK3640254 3 mg | Part 2: Accumulation Ratio of Cmax (R [CMAX]) From Day 1 to Day 14 | 2.2069 Ratio of Cmax |
| Part 1: GSK3640254 10 mg | Part 2: Accumulation Ratio of Cmax (R [CMAX]) From Day 1 to Day 14 | 2.2994 Ratio of Cmax |
| Part 1: GSK3640254 30mg | Part 2: Accumulation Ratio of Cmax (R [CMAX]) From Day 1 to Day 14 | 2.0650 Ratio of Cmax |
Secondary
Part 2: Accumulation Ratio of C(Tau) (R[CTAU]) From Day 2 to Day 15
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 15 and Day 2, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 15 dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Accumulation Ratio of C(Tau) (R[CTAU]) From Day 2 to Day 15 | 2.1408 Ratio of Ctau |
| Part 1: GSK3640254 3 mg | Part 2: Accumulation Ratio of C(Tau) (R[CTAU]) From Day 2 to Day 15 | 2.5847 Ratio of Ctau |
| Part 1: GSK3640254 10 mg | Part 2: Accumulation Ratio of C(Tau) (R[CTAU]) From Day 2 to Day 15 | 2.5335 Ratio of Ctau |
| Part 1: GSK3640254 30mg | Part 2: Accumulation Ratio of C(Tau) (R[CTAU]) From Day 2 to Day 15 | 2.1666 Ratio of Ctau |
Secondary
Part 2: AUC(0-24) of GSK3640254: Day 1
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 and 24 hours post-dose on Day 1
Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: AUC(0-24) of GSK3640254: Day 1 | 2.855 Hour*micrograms per milliliter | Geometric Coefficient of Variation 29.621 |
| Part 1: GSK3640254 3 mg | Part 2: AUC(0-24) of GSK3640254: Day 1 | 6.801 Hour*micrograms per milliliter | Geometric Coefficient of Variation 22.97 |
| Part 1: GSK3640254 10 mg | Part 2: AUC(0-24) of GSK3640254: Day 1 | 8.257 Hour*micrograms per milliliter | Geometric Coefficient of Variation 49.782 |
| Part 1: GSK3640254 30mg | Part 2: AUC(0-24) of GSK3640254: Day 1 | 13.456 Hour*micrograms per milliliter | Geometric Coefficient of Variation 23.743 |
Secondary
Part 2: AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]): Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours after Day 14 dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]): Day 14 | 6.282 hour* micrograms per milliliter | Geometric Coefficient of Variation 34.01 |
| Part 1: GSK3640254 3 mg | Part 2: AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]): Day 14 | 17.506 hour* micrograms per milliliter | Geometric Coefficient of Variation 13.794 |
| Part 1: GSK3640254 10 mg | Part 2: AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]): Day 14 | 21.501 hour* micrograms per milliliter | Geometric Coefficient of Variation 34.205 |
| Part 1: GSK3640254 30mg | Part 2: AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]): Day 14 | 31.954 hour* micrograms per milliliter | Geometric Coefficient of Variation 35.38 |
Secondary
Part 2: CL/F of GSK3640254: Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: CL/F of GSK3640254: Day 14 | 7.959 Liter per hour | Geometric Coefficient of Variation 34.01 |
| Part 1: GSK3640254 3 mg | Part 2: CL/F of GSK3640254: Day 14 | 5.712 Liter per hour | Geometric Coefficient of Variation 13.794 |
| Part 1: GSK3640254 10 mg | Part 2: CL/F of GSK3640254: Day 14 | 9.302 Liter per hour | Geometric Coefficient of Variation 34.205 |
| Part 1: GSK3640254 30mg | Part 2: CL/F of GSK3640254: Day 14 | 10.014 Liter per hour | Geometric Coefficient of Variation 35.38 |
Secondary
Part 2: Cmax, C24 of GSK3640254 on Day 1
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 hours post-dose on Day 1
Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Cmax, C24 of GSK3640254 on Day 1 | Cmax | 0.215 Micrograms per milliliter | Geometric Coefficient of Variation 24.412 |
| Part 1: GSK3640254 1 mg | Part 2: Cmax, C24 of GSK3640254 on Day 1 | C24 | 0.082 Micrograms per milliliter | Geometric Coefficient of Variation 33.583 |
| Part 1: GSK3640254 3 mg | Part 2: Cmax, C24 of GSK3640254 on Day 1 | C24 | 0.207 Micrograms per milliliter | Geometric Coefficient of Variation 22.856 |
| Part 1: GSK3640254 3 mg | Part 2: Cmax, C24 of GSK3640254 on Day 1 | Cmax | 0.536 Micrograms per milliliter | Geometric Coefficient of Variation 22.959 |
| Part 1: GSK3640254 10 mg | Part 2: Cmax, C24 of GSK3640254 on Day 1 | Cmax | 0.614 Micrograms per milliliter | Geometric Coefficient of Variation 44.354 |
| Part 1: GSK3640254 10 mg | Part 2: Cmax, C24 of GSK3640254 on Day 1 | C24 | 0.238 Micrograms per milliliter | Geometric Coefficient of Variation 58.452 |
| Part 1: GSK3640254 30mg | Part 2: Cmax, C24 of GSK3640254 on Day 1 | Cmax | 1.044 Micrograms per milliliter | Geometric Coefficient of Variation 29.225 |
| Part 1: GSK3640254 30mg | Part 2: Cmax, C24 of GSK3640254 on Day 1 | C24 | 0.417 Micrograms per milliliter | Geometric Coefficient of Variation 39.681 |
Secondary
Part 2: Cmax of GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Cmax of GSK3640254 on Day 14 | 0.414 Micrograms per milliliter | Geometric Coefficient of Variation 31.556 |
| Part 1: GSK3640254 3 mg | Part 2: Cmax of GSK3640254 on Day 14 | 1.182 Micrograms per milliliter | Geometric Coefficient of Variation 10.264 |
| Part 1: GSK3640254 10 mg | Part 2: Cmax of GSK3640254 on Day 14 | 1.402 Micrograms per milliliter | Geometric Coefficient of Variation 30.839 |
| Part 1: GSK3640254 30mg | Part 2: Cmax of GSK3640254 on Day 14 | 2.156 Micrograms per milliliter | Geometric Coefficient of Variation 20.36 |
Secondary
Part 2: Dose Proportionality (AUC0-24) Following Repeated Dose of GSK3640254 at Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Dose Proportionality (AUC0-24) Following Repeated Dose of GSK3640254 at Day 1 | 2.855 hour*micrograms per mililiter | Geometric Coefficient of Variation 29.621 |
| Part 1: GSK3640254 3 mg | Part 2: Dose Proportionality (AUC0-24) Following Repeated Dose of GSK3640254 at Day 1 | 6.801 hour*micrograms per mililiter | Geometric Coefficient of Variation 22.97 |
| Part 1: GSK3640254 10 mg | Part 2: Dose Proportionality (AUC0-24) Following Repeated Dose of GSK3640254 at Day 1 | 8.257 hour*micrograms per mililiter | Geometric Coefficient of Variation 49.782 |
| Part 1: GSK3640254 30mg | Part 2: Dose Proportionality (AUC0-24) Following Repeated Dose of GSK3640254 at Day 1 | 13.456 hour*micrograms per mililiter | Geometric Coefficient of Variation 23.743 |
90% CI: [0.5576, 0.9218]
Secondary
Part 2: Dose Proportionality (AUC0-tau) Following Repeated Dose of GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Dose Proportionality (AUC0-tau) Following Repeated Dose of GSK3640254 on Day 14 | 6.282 hour*microgram per milliliter | Geometric Coefficient of Variation 34.01 |
| Part 1: GSK3640254 3 mg | Part 2: Dose Proportionality (AUC0-tau) Following Repeated Dose of GSK3640254 on Day 14 | 17.506 hour*microgram per milliliter | Geometric Coefficient of Variation 13.794 |
| Part 1: GSK3640254 10 mg | Part 2: Dose Proportionality (AUC0-tau) Following Repeated Dose of GSK3640254 on Day 14 | 21.501 hour*microgram per milliliter | Geometric Coefficient of Variation 34.205 |
| Part 1: GSK3640254 30mg | Part 2: Dose Proportionality (AUC0-tau) Following Repeated Dose of GSK3640254 on Day 14 | 31.954 hour*microgram per milliliter | Geometric Coefficient of Variation 35.38 |
90% CI: [0.6424, 0.9512]
Secondary
Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 at Day 1
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 at Day 1 | 0.215 Microgram per milliliter | Geometric Coefficient of Variation 24.412 |
| Part 1: GSK3640254 3 mg | Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 at Day 1 | 0.536 Microgram per milliliter | Geometric Coefficient of Variation 22.959 |
| Part 1: GSK3640254 10 mg | Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 at Day 1 | 0.614 Microgram per milliliter | Geometric Coefficient of Variation 44.354 |
| Part 1: GSK3640254 30mg | Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 at Day 1 | 1.044 Microgram per milliliter | Geometric Coefficient of Variation 29.225 |
90% CI: [0.5649, 0.9091]
Secondary
Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 on Day 14 | 0.414 Microgram per milliliter | Geometric Coefficient of Variation 31.556 |
| Part 1: GSK3640254 3 mg | Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 on Day 14 | 1.182 Microgram per milliliter | Geometric Coefficient of Variation 10.264 |
| Part 1: GSK3640254 10 mg | Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 on Day 14 | 1.402 Microgram per milliliter | Geometric Coefficient of Variation 30.839 |
| Part 1: GSK3640254 30mg | Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 on Day 14 | 2.156 Microgram per milliliter | Geometric Coefficient of Variation 20.36 |
90% CI: [0.6562, 0.9349]
Secondary
Part 2: Dose Proportionality (Ctrough) Following Repeated Dose of GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Dose Proportionality (Ctrough) Following Repeated Dose of GSK3640254 on Day 14 | 0.205 Micrograms per milliliter | Geometric Coefficient of Variation 33.414 |
| Part 1: GSK3640254 3 mg | Part 2: Dose Proportionality (Ctrough) Following Repeated Dose of GSK3640254 on Day 14 | 0.593 Micrograms per milliliter | Geometric Coefficient of Variation 16.359 |
| Part 1: GSK3640254 10 mg | Part 2: Dose Proportionality (Ctrough) Following Repeated Dose of GSK3640254 on Day 14 | 0.615 Micrograms per milliliter | Geometric Coefficient of Variation 74.191 |
| Part 1: GSK3640254 30mg | Part 2: Dose Proportionality (Ctrough) Following Repeated Dose of GSK3640254 on Day 14 | 1.255 Micrograms per milliliter | Geometric Coefficient of Variation 37.22 |
90% CI: [0.6149, 0.9631]
Secondary
Part 2: Plasma Trough Concentration (Ctau) of GSK3640254: Day 14
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The PK parameter name for Part 2 (Day 14) trough concentration was changed using Phoenix WinNonlin 8 from Ct to Ctrough. Day 15 Ctrough values were used for dose proportionality and time to steady-state assessments.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Plasma Trough Concentration (Ctau) of GSK3640254: Day 14 | 0.186 micrograms per milliliter | Geometric Coefficient of Variation 35.128 |
| Part 1: GSK3640254 3 mg | Part 2: Plasma Trough Concentration (Ctau) of GSK3640254: Day 14 | 0.558 micrograms per milliliter | Geometric Coefficient of Variation 21.407 |
| Part 1: GSK3640254 10 mg | Part 2: Plasma Trough Concentration (Ctau) of GSK3640254: Day 14 | 0.630 micrograms per milliliter | Geometric Coefficient of Variation 37.814 |
| Part 1: GSK3640254 30mg | Part 2: Plasma Trough Concentration (Ctau) of GSK3640254: Day 14 | 0.980 micrograms per milliliter | Geometric Coefficient of Variation 41.815 |
Secondary
Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. results are presented treatment wise.
Time frame: Pre-dose on Days 2,3,4,6,8,10,12 and 14
Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 2 Predose | 90.20 Nanogram per milliliter | Standard Deviation 25.312 |
| Part 1: GSK3640254 1 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 3 Predose | 155.93 Nanogram per milliliter | Standard Deviation 41.869 |
| Part 1: GSK3640254 1 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 4 Predose | 196.25 Nanogram per milliliter | Standard Deviation 55.807 |
| Part 1: GSK3640254 1 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 6 Predose | 214.64 Nanogram per milliliter | Standard Deviation 75.891 |
| Part 1: GSK3640254 1 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 8 Predose | 230.50 Nanogram per milliliter | Standard Deviation 77.819 |
| Part 1: GSK3640254 1 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 10 Predose | 218.97 Nanogram per milliliter | Standard Deviation 74.858 |
| Part 1: GSK3640254 1 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 12 predose | 221.10 Nanogram per milliliter | Standard Deviation 75.744 |
| Part 1: GSK3640254 1 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 14 predose | 214.16 Nanogram per milliliter | Standard Deviation 66.98 |
| Part 1: GSK3640254 3 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 10 Predose | 604.52 Nanogram per milliliter | Standard Deviation 137.121 |
| Part 1: GSK3640254 3 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 8 Predose | 595.26 Nanogram per milliliter | Standard Deviation 151.167 |
| Part 1: GSK3640254 3 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 3 Predose | 449.82 Nanogram per milliliter | Standard Deviation 68.287 |
| Part 1: GSK3640254 3 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 14 predose | 599.45 Nanogram per milliliter | Standard Deviation 97.262 |
| Part 1: GSK3640254 3 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 12 predose | 628.86 Nanogram per milliliter | Standard Deviation 114.448 |
| Part 1: GSK3640254 3 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 6 Predose | 550.48 Nanogram per milliliter | Standard Deviation 125.873 |
| Part 1: GSK3640254 3 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 4 Predose | 524.87 Nanogram per milliliter | Standard Deviation 120.723 |
| Part 1: GSK3640254 3 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 2 Predose | 221.55 Nanogram per milliliter | Standard Deviation 55.722 |
| Part 1: GSK3640254 10 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 12 predose | 726.13 Nanogram per milliliter | Standard Deviation 300.263 |
| Part 1: GSK3640254 10 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 4 Predose | 667.45 Nanogram per milliliter | Standard Deviation 295.479 |
| Part 1: GSK3640254 10 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 6 Predose | 701.98 Nanogram per milliliter | Standard Deviation 349.091 |
| Part 1: GSK3640254 10 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 8 Predose | 712.79 Nanogram per milliliter | Standard Deviation 342.941 |
| Part 1: GSK3640254 10 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 10 Predose | 802.81 Nanogram per milliliter | Standard Deviation 272 |
| Part 1: GSK3640254 10 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 14 predose | 706.76 Nanogram per milliliter | Standard Deviation 299.45 |
| Part 1: GSK3640254 10 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 2 Predose | 283.37 Nanogram per milliliter | Standard Deviation 137.243 |
| Part 1: GSK3640254 10 mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 3 Predose | 517.96 Nanogram per milliliter | Standard Deviation 239.825 |
| Part 1: GSK3640254 30mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 4 Predose | 926.40 Nanogram per milliliter | Standard Deviation 235.884 |
| Part 1: GSK3640254 30mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 6 Predose | 969.06 Nanogram per milliliter | Standard Deviation 225.6 |
| Part 1: GSK3640254 30mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 3 Predose | 753.02 Nanogram per milliliter | Standard Deviation 174.186 |
| Part 1: GSK3640254 30mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 2 Predose | 476.58 Nanogram per milliliter | Standard Deviation 197.909 |
| Part 1: GSK3640254 30mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 8 Predose | 936.45 Nanogram per milliliter | Standard Deviation 278.866 |
| Part 1: GSK3640254 30mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 14 predose | 1324.29 Nanogram per milliliter | Standard Deviation 470.703 |
| Part 1: GSK3640254 30mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 12 predose | 1182.80 Nanogram per milliliter | Standard Deviation 354.948 |
| Part 1: GSK3640254 30mg | Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14 | Day 10 Predose | 1051.91 Nanogram per milliliter | Standard Deviation 375.261 |
Secondary
Part 2: T1/2 of GSK3640254: Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: T1/2 of GSK3640254: Day 14 | 24.847 Hour | Geometric Coefficient of Variation 5.087 |
| Part 1: GSK3640254 3 mg | Part 2: T1/2 of GSK3640254: Day 14 | 28.358 Hour | Geometric Coefficient of Variation 19.199 |
| Part 1: GSK3640254 10 mg | Part 2: T1/2 of GSK3640254: Day 14 | 22.125 Hour | Geometric Coefficient of Variation 14.515 |
| Part 1: GSK3640254 30mg | Part 2: T1/2 of GSK3640254: Day 14 | 22.350 Hour | Geometric Coefficient of Variation 12.641 |
Secondary
Part 2: Tmax GSK3640254 on Day 14
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Time frame: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose
Population: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Tmax GSK3640254 on Day 14 | 3.775 Hour |
| Part 1: GSK3640254 3 mg | Part 2: Tmax GSK3640254 on Day 14 | 4.000 Hour |
| Part 1: GSK3640254 10 mg | Part 2: Tmax GSK3640254 on Day 14 | 3.750 Hour |
| Part 1: GSK3640254 30mg | Part 2: Tmax GSK3640254 on Day 14 | 4.250 Hour |
Secondary
Part 2: Tmax, Tlag of GSK3640254 on Day 1
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Time frame: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 hours post-dose on Day 1
Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: GSK3640254 1 mg | Part 2: Tmax, Tlag of GSK3640254 on Day 1 | Tmax | 3.750 Hour |
| Part 1: GSK3640254 1 mg | Part 2: Tmax, Tlag of GSK3640254 on Day 1 | Tlag | 0.508 Hour |
| Part 1: GSK3640254 3 mg | Part 2: Tmax, Tlag of GSK3640254 on Day 1 | Tlag | 0.500 Hour |
| Part 1: GSK3640254 3 mg | Part 2: Tmax, Tlag of GSK3640254 on Day 1 | Tmax | 4.250 Hour |
| Part 1: GSK3640254 10 mg | Part 2: Tmax, Tlag of GSK3640254 on Day 1 | Tmax | 4.000 Hour |
| Part 1: GSK3640254 10 mg | Part 2: Tmax, Tlag of GSK3640254 on Day 1 | Tlag | 0.500 Hour |
| Part 1: GSK3640254 30mg | Part 2: Tmax, Tlag of GSK3640254 on Day 1 | Tmax | 4.000 Hour |
| Part 1: GSK3640254 30mg | Part 2: Tmax, Tlag of GSK3640254 on Day 1 | Tlag | 0.500 Hour |