HIV Infections
Conditions
Keywords
HIV-1, Antiviral Effect, GSK3640254, Proof of Concept
Brief summary
Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic exposure to combination anti-retroviral therapy identified anti-retroviral associated long-term toxicities. Hence, there is a need to prevent these co-morbidities. GSK3640254 is a next-generation HIV-1 Maturation Inhibitor (MI) which may be effective for HIV-1 infection. This study will evaluate the antiviral effect, safety, tolerability and pharmacokinetics/ pharmacodynamics of GSK3640254 in HIV-1 infected treatment-naive adults. This study will consists of two parts; Part 1 and Part 2. Part 1 will evaluate two active doses of GSK3640254, 200 milligrams (mg) (Cohort 1) and 10 mg (Cohort 2) along with placebo to match GSK3640254 Mesylate salt. Part 2 will evaluate three active doses of GSK3640254. Dose level 1 of GSK3640254 that can provide at least 30 percent of the maximum effect (Cohort 1), dose level 2 of GSK3640254 that can provide at least 75 percent of the maximum effect (Cohort 2) and dose level 3 of GSK3640254 that can provide at least 90 percent of the maximum effect (Cohort 3). These doses are anticipated to be 5 mg, 40 mg and 100 mg respectively, but could be modified based on data obtained in Part 1. Subjects will also receive placebo to match GSK3640254 Mesylate salt in Part 2 of the study. All doses will be administered after a moderate fat meal. This study will consist of Screening period (up to 14 days), Treatment period (Day 1- Day 10), post-dose Follow-up (Day 11- Day 17) and final Follow-up (Day 18-24). A total of approximately 34 subjects will be enrolled, of which, 14 subjects will be randomized in Part 1 and 20 in Part 2 of the study. Six subjects will be enrolled in each of the active dose cohorts and 2 subjects will be enrolled in each of the placebo cohorts.
Interventions
DRUGGSK3640254
GSK3640254 will be available with dosing strengths of 5 mg, 20 mg, and 100 mg to be administered as an oral capsule along with 240 mL of water.
DRUGPlacebo matching GSK3640254 Mesylate salt
Placebo to match GSK3640254 Mesylate salt will be given as an oral capsule along with 240 mL of water
Sponsors
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. Subjects and investigator will be blinded.
Intervention model description
Eligible subjects will be randomized to receive two active doses of GSK3640254 along with placebo in Part 1 of the study. In Part 2, subjects will receive three active doses of GSK3640254 along with placebo depending upon the data obtained in Part 1.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent. * Subjects who are healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, laboratory tests, and cardiac monitoring. * Screening Cluster of designation 4 positive (CD4+) T-cell count \>=350 cells per millimeter cube (cells/mm\^3). * Documented HIV infection and Screening plasma HIV-1 RNA \>=5000 copies/milliliter (mL). A single repeat of this test is allowed within a single Screening period to determine eligibility. * Treatment-naive: No anti-retrovirals (in combination or monotherapy) received after the diagnosis of HIV-1 infection. * Body weight \>=50.0 kilograms (kg) (110 Pounds) for men and \>=45.0 kg (99 pounds) for women and body mass index (BMI) within the range 18.5-31.0 kg/meter square (kg/m\^2) (inclusive). * A female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP). * Capable of giving signed informed consent. * For subjects enrolled in France: a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria
* Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to starting study treatment. * Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study treatment and positive on reflex to Hepatitis C RNA. * ALT \>2 times upper limit of normal (ULN). A single repeat of ALT is allowed within a single Screening period to determine eligibility. * Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent). * Subjects with primary HIV infection, evidenced by acute retroviral syndrome (example given \[e.g.\], fever, malaise, fatigue, etc) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion. * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones); * A pre-existing condition interfering with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease \[GERD\], gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs or render the subject unable to take oral study treatment. * Any acute laboratory abnormality at screen which, in the opinion of the investigator, should preclude participation in the study of an investigational compound. * Any Grade 2-4 laboratory abnormality at screen, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides, etc), and ALT (described above), will exclude a subject from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any lab abnormality is allowed within a single screening period to determine eligibility. * Any history of significant underlying psychiatric disorder, including but not limited to schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder. * Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (\>6 months) outpatient treatment. Subjects with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (\<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the ViiV Medical Monitor. * Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the subject's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the subject. * Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome. * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. * The subject has participated in a clinical trial and has received an investigational product within the 30 days prior to the first dosing day in the current study. * Any positive (abnormal) response confirmed by the investigator on a Screening clinician- (or qualified designee-) administered Columbia Suicide Severity Rating Scale (CSSRS). * Any positive result for illicit drug use (e.g., cocaine, heroin) at Screening. A positive screen for marijuana is not exclusionary, though if positive for delta-9-tetrahydrocannabinol (THC). * Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days. * Exposure to more than four new investigational drugs or vaccines within 12 months prior to the first dosing day. * Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 30 days of study drug administration or anticipated need for such treatment within the study. * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; or other localized malignancies require agreement between the investigator and the study medical monitor for inclusion of the subject prior to randomization. * Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of study drug administration. * An active Center for Disease Control and Prevention (CDC) Category C disease except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial. * Treatment with any vaccine within 30 days prior to receiving study medication. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11 | Baseline (Day 1) and Day 11 | Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. A HIV-1 RNA polymerase chain reaction (PCR) assay with a lower limit of detection (LLOD) of 50 copies per milliliter was used. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Maximum Change From Baseline in Plasma HIV-1 RNA at Day 8 | Baseline (Day 1) and Day 8 | Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. An HIV-1 RNA PCR assay with an LLOD of 50 copies per milliliter was used. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Number of Participants With Non-SAEs and SAEs | Up to Day 12 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per Medical or scientific judgment. |
| Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocyte | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: reticulocytes/erythrocyte (erythro). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Hematology Parameter: Reticulocytes/Erythro | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameter: reticulocytes/erythro. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Chemistry Parameters: Protein | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Baseline (Day 1) and Visit 6 (Day 11) | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Chemistry Parameters: Protein | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Urinalysis Parameter: Urobilinogen | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | Baseline (Day 1) and Visit 5 (Day 7) | Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urinalysis Parameter: Urobilinogen | Baseline (Day 1) and Visit 5 (Day 7) | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urinalysis Parameter: pH | Baseline (Day 1) and Visit 5 (Day 7) | Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1) and Visit 5 (Days 8 to 10) | SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Respiratory Rate | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Pulse Rate | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in SBP and DBP | Baseline (Day 1) and Visit 5 (Day 7) | SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Respiratory Rate | Baseline (Day 1) and Visit 5 (Day 7) | Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Pulse Rate | Baseline (Day 1) and Visit 5 (Day 7) | Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | Baseline (Day 1), Visit 5 (Days 8 to 10: Pre-dose, 2, 4 and 6 hours) | Twelve lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcB Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | Baseline (Day 1), Visit 5 (Day 7: Pre-dose, 2, 4 and 6 hours) | Twelve lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcB Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: reticulocytes/erythro. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the hematology parameter: reticulocytes/erythro. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Chemistry Parameters: Protein | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase | Baseline (Day 1) and Visit 6 (Day 11) | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Chemistry Parameters: Protein | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Baseline (Day 1) and Visit 5 (Day 7) | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Urinalysis Parameter: pH | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day 1) and Visit 5 (Day 7) | Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen | Baseline (Day 1) and Visit 5 (Day 7) | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Urinalysis Parameter: pH | Baseline (Day 1) and Visit 5 (Day 7) | Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for SBP and DBP | Baseline (Day 1) and Visit 5 (Days 8 to 10) | SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Respiratory Rate | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for Pulse Rate | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for SBP and DBP | Baseline (Day 1) and Visit 5 (Day 7) | SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Respiratory Rate | Baseline (Day 1) and Visit 5 (Day 7) | Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for Pulse Rate | Baseline (Day 1) and Visit 5 (Day 7) | Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | Baseline (Day 1), Visit 5 (Days 8 to 10: Pre-dose, 2, 4 and 6 hours) | Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval and QTcB interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | Baseline (Day 1), Visit 5 (Day 7: Pre-dose, 2, 4 and 6 hours) | Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval and QTcB interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Part 1: Area Under the Plasma Concentration Time Curve From Zero to 24 (AUC[0-24]) Following Administration of GSK3640254 on Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Pharmacokinetic (PK) Population consisted of all participants who received GSK3640254 and underwent plasma PK sampling during the study. |
| Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK3640254 on Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1: Time to Maximum Observed Concentration (Tmax) Following Administration of GSK3640254 on Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1: Concentration at 24 Hours Post-dose (C24) Following Administration of GSK3640254 on Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1: Absorption Lag Time (Tlag) Following Administration of GSK3640254 on Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 2: AUC(0-24) Following Administration of GSK3640254 on Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 2: Cmax Following Administration of GSK3640254 on Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 2: Tmax Following Administration of GSK3640254 on Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 2: C24 Following Administration of GSK3640254 on Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 2: Tlag Following Administration of GSK3640254 on Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1: Area Under the Plasma Drug Concentration-time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1: Cmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1: Tmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1: Pre-dose Concentration (C0) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | Days 8 to 10: Pre-dose | Blood sample was collected at indicated time point for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1: Concentration at End of Dosing Interval (Ctau) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1: Apparent Terminal Phase Half-life (t1/2) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1: Apparent Oral Clearance (CL/F) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 2: AUC(0-tau) Following Repeat Dose Administration of GSK3640254 on Day 7 | Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 2: Cmax Following Repeat Dose Administration of GSK3640254 on Day 7 | Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 2: Tmax Following Repeat Dose Administration of GSK3640254 on Day 7 | Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 2: C0 Following Repeat Dose Administration of GSK3640254 on Day 7 | Day 7: Pre-dose | Blood sample was collected at indicated time point for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 2: Ctau Following Repeat Dose Administration of GSK3640254 on Day 7 | Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1) and Visit 5 (Days 8 to 10) | Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. |
| Part 2: CL/F Following Repeat Dose Administration of GSK3640254 on Day 7 | Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 AUC(0-tau) | Baseline (Day 1) and Day 8 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Statistical analysis for relationship between PK parameters (AUC) and PD measures (Change from Baseline in plasma HIV-1 RNA) were explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: maximum response (Emax), PK parameter value that attains 50 percent (%) of the maximal effect (EC50) and residual variability (s2e). PK/PD Population consisted of participants who met criteria for Per-Protocol and Pharmacokinetic Population analysis sets and who underwent PD sampling during the study. |
| Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Cmax | Baseline (Day 1) and Day 8 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Statistical analysis for relationship between PK parameters (Cmax) and PD measures (Change from Baseline in plasma HIV-1 RNA) were explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: Emax, EC50 and s2e. |
| Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Ctau | Baseline (Day 1) and Day 8 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Statistical analysis for relationship between PK parameters (Ctau) and PD measures (Change from Baseline in plasma HIV-1 RNA) were explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: Emax, EC50 and s2e. |
| Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The accumulation ratios (Ro) were calculated as Ro\_AUC equal to (=) AUC(0-tau) Days 8 to 10 divided by (/) AUC(0-24) Day 1; Ro\_Cmax=Cmax Days 8 to 10/Cmax Day 1; and Ro\_Ctau=Ctau Days 8 to 10/C24 Day 1. |
| Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Days 1 and 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The accumulation ratios (Ro) were calculated as Ro\_AUC=AUC(0-tau) Day 7/AUC(0-24) Day 1; Ro\_Cmax=Cmax Day 7/Cmax Day 1; and Ro\_Ctau=Ctau Day 7/C24 Day 1. |
| Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on AUC(0-24) | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented. |
| Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on Cmax | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented. |
| Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on C24 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented. |
| Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on AUC(0-tau) | Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented. |
| Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Cmax | Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented. |
| Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Ctau | Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented. |
| Part 2: t1/2 Following Repeat Dose Administration of GSK3640254 on Day 7 | Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. |
| Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Up to Day 24 | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per Medical or scientific judgment. Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment. |
Countries
France, Germany, Italy, South Africa, Spain, United States
Participant flow
Recruitment details
This was a randomized, double-blind, placebo-controlled, adaptive clinical trial to evaluate the antiviral effect, safety, tolerability and pharmacokinetic (PK)/pharmacodynamics (PD) of GSK3640254 over 10 days in study Part 1 and over 7 days in study Part 2.
Pre-assignment details
A total of 34 participants (14 participants in Part 1 and 20 participants in Part 2) were enrolled in this study. This study was conducted in France, Germany, Italy, South Africa and Spain.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: GSK3640254 10 mg Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment. | 6 |
| Part 1: GSK3640254 200 mg Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment. | 6 |
| Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment. | 2 |
| Part 2: GSK3640254 40 mg Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment. | 6 |
| Part 2: GSK3640254 80 mg Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment. | 6 |
| Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment. | 6 |
| Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment. | 2 |
| Total | 34 |
Baseline characteristics
| Characteristic | Part 1: GSK3640254 10 mg | Part 1: GSK3640254 200 mg | Part 1: Placebo | Part 2: GSK3640254 40 mg | Part 2: GSK3640254 80 mg | Part 2: GSK3640254 140 mg | Part 2: Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Customized <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 19-64 years | 6 Participants | 6 Participants | 2 Participants | 6 Participants | 6 Participants | 6 Participants | 2 Participants | 34 Participants |
| Age, Customized >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian: South East Asian Heritage | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Multiple: American Indian or Alaska Native & White | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White: White/Caucasian/European Heritage | 2 Participants | 5 Participants | 2 Participants | 5 Participants | 4 Participants | 5 Participants | 1 Participants | 24 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 2 Participants | 5 Participants | 6 Participants | 5 Participants | 2 Participants | 32 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 2 |
| other Total, other adverse events | 3 / 6 | 5 / 6 | 0 / 2 | 5 / 6 | 4 / 6 | 4 / 6 | 0 / 2 |
| serious Total, serious adverse events | 1 / 6 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 6 | 1 / 6 | 0 / 2 |
Outcome results
Primary
Part 1: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. A HIV-1 RNA polymerase chain reaction (PCR) assay with a lower limit of detection (LLOD) of 50 copies per milliliter was used. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Day 11
Population: Intent-To-Treat Exposed Population consisted of all participants who met study criteria and were enrolled into the study with documented evidence of having received at least 1 dose of treatment and at least one post-Baseline HIV-1 RNA measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11 | -8605.8 Copies per milliliter | Standard Deviation 4604.4 |
| Part 1: GSK3640254 200 mg | Part 1: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11 | -100719.8 Copies per milliliter | Standard Deviation 89182.99 |
| Part 1: Placebo | Part 1: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11 | -3406.5 Copies per milliliter | Standard Deviation 2591.55 |
Primary
Part 2: Maximum Change From Baseline in Plasma HIV-1 RNA at Day 8
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. An HIV-1 RNA PCR assay with an LLOD of 50 copies per milliliter was used. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Day 8
Population: Intent-To-Treat Exposed Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Maximum Change From Baseline in Plasma HIV-1 RNA at Day 8 | -48655.0 Copies per milliliter | Standard Deviation 26269.41 |
| Part 1: GSK3640254 200 mg | Part 2: Maximum Change From Baseline in Plasma HIV-1 RNA at Day 8 | -37904.3 Copies per milliliter | Standard Deviation 38814.54 |
| Part 1: Placebo | Part 2: Maximum Change From Baseline in Plasma HIV-1 RNA at Day 8 | -64904.2 Copies per milliliter | Standard Deviation 83798.67 |
| Part 2: Placebo | Part 2: Maximum Change From Baseline in Plasma HIV-1 RNA at Day 8 | -123478.5 Copies per milliliter | Standard Deviation 175276.92 |
Secondary
Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALT | 31.3 International units per liter | Standard Deviation 15.67 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Days 8 to 10: ALT | 34.0 International units per liter | Standard Deviation 21.58 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALP | 62.0 International units per liter | Standard Deviation 10.55 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Days 8 to 10: ALP | 72.5 International units per liter | Standard Deviation 27.68 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): AST | 26.7 International units per liter | Standard Deviation 9.42 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Days 8 to 10: AST | 26.2 International units per liter | Standard Deviation 11.27 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Days 8 to 10: AST | 21.3 International units per liter | Standard Deviation 4.63 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALT | 19.7 International units per liter | Standard Deviation 15.82 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Days 8 to 10: ALP | 58.8 International units per liter | Standard Deviation 16.46 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): AST | 23.3 International units per liter | Standard Deviation 10.76 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Days 8 to 10: ALT | 18.0 International units per liter | Standard Deviation 11.85 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALP | 62.3 International units per liter | Standard Deviation 19.13 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Days 8 to 10: ALT | 29.5 International units per liter | Standard Deviation 14.85 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALP | 63.0 International units per liter | Standard Deviation 2.83 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Days 8 to 10: AST | 24.5 International units per liter | Standard Deviation 10.61 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Days 8 to 10: ALP | 59.0 International units per liter | Standard Deviation 1.41 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALT | 20.0 International units per liter | Standard Deviation 8.49 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): AST | 20.0 International units per liter | Standard Deviation 8.49 |
Secondary
Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase
Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 6 (Day 11)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed. Amylase and lipase results were collected for two participants in GSK3640254 10 mg arm during Part 1 of the study. No data were collected for Placebo and GSK3640254 200 mg arms at Visit 6 (Day 11) due to delays in approval of Protocol Amendment 02 into which testing for amylase and lipase was added.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase | Baseline (Day 1): Amylase | 57.0 Units per liter | Standard Deviation 11.31 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 11: Amylase | 57.0 Units per liter | Standard Deviation 0 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase | Baseline (Day 1): Lipase | 28.5 Units per liter | Standard Deviation 4.95 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 11: Lipase | 26.5 Units per liter | Standard Deviation 7.78 |
Secondary
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Creatinine | 82.05 Micromoles per liter | Standard Deviation 11.319 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Days 8 to 10: Creatinine | 83.82 Micromoles per liter | Standard Deviation 13.674 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Bilirubin | 11.7 Micromoles per liter | Standard Deviation 6.38 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Days 8 to 10: Bilirubin | 11.3 Micromoles per liter | Standard Deviation 3.5 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Days 8 to 10: Bilirubin | 6.0 Micromoles per liter | Standard Deviation 1.79 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Creatinine | 81.35 Micromoles per liter | Standard Deviation 3.861 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Bilirubin | 8.0 Micromoles per liter | Standard Deviation 2.83 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Days 8 to 10: Creatinine | 80.02 Micromoles per liter | Standard Deviation 6.239 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Days 8 to 10: Bilirubin | 18.0 Micromoles per liter | Standard Deviation 8.49 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Days 8 to 10: Creatinine | 88.40 Micromoles per liter | Standard Deviation 3.818 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Bilirubin | 15.0 Micromoles per liter | Standard Deviation 1.41 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Creatinine | 88.40 Micromoles per liter | Standard Deviation 3.818 |
Secondary
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Magnesium, n=6,6,2 | 0.847 Millimoles per liter | Standard Deviation 0.0393 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Triglycerides, n=6,6,2 | 1.070 Millimoles per liter | Standard Deviation 0.4527 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Urea, n=6,6,2 | 5.25 Millimoles per liter | Standard Deviation 1.037 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Phosphate, n=6,6,2 | 1.158 Millimoles per liter | Standard Deviation 0.1882 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Cholesterol, n=6,6,2 | 4.700 Millimoles per liter | Standard Deviation 1.2345 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): HDL cholesterol, n=6,6,2 | 1.192 Millimoles per liter | Standard Deviation 0.196 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Chloride, n=6,6,2 | 104.2 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Glucose, n=6,6,2 | 5.08 Millimoles per liter | Standard Deviation 0.618 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): LDL cholesterol, n=6,6,2 | 3.017 Millimoles per liter | Standard Deviation 1.0452 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Magnesium, n=6,6,2 | 0.847 Millimoles per liter | Standard Deviation 0.0561 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Glucose, n=6,6,2 | 5.28 Millimoles per liter | Standard Deviation 0.556 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Potassium, n=6,6,2 | 4.12 Millimoles per liter | Standard Deviation 0.349 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Chloride, n=6,6,2 | 104.2 Millimoles per liter | Standard Deviation 0.41 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Sodium, n=6,6,2 | 138.3 Millimoles per liter | Standard Deviation 2.25 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Potassium, n=6,6,2 | 4.10 Millimoles per liter | Standard Deviation 0.21 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Calcium, n=6,6,2 | 2.293 Millimoles per liter | Standard Deviation 0.0816 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Sodium, n=6,6,2 | 138.5 Millimoles per liter | Standard Deviation 2.17 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Phosphate, n=6,6,2 | 1.117 Millimoles per liter | Standard Deviation 0.1835 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Calcium, n=6,6,2 | 2.300 Millimoles per liter | Standard Deviation 0.1073 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Urea, n=6,6,2 | 5.33 Millimoles per liter | Standard Deviation 0.516 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Phosphate, n=6,6,2 | 1.142 Millimoles per liter | Standard Deviation 0.2245 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Potassium, n=6,6,2 | 4.30 Millimoles per liter | Standard Deviation 0.276 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Potassium, n=6,6,2 | 4.27 Millimoles per liter | Standard Deviation 0.216 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Magnesium, n=6,6,2 | 0.853 Millimoles per liter | Standard Deviation 0.045 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Magnesium, n=6,6,2 | 0.847 Millimoles per liter | Standard Deviation 0.0393 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Sodium, n=6,6,2 | 139.8 Millimoles per liter | Standard Deviation 0.75 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Sodium, n=6,6,2 | 139.0 Millimoles per liter | Standard Deviation 0.89 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Urea, n=6,6,2 | 5.83 Millimoles per liter | Standard Deviation 1.169 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Urea, n=6,6,2 | 5.75 Millimoles per liter | Standard Deviation 0.524 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): HDL cholesterol, n=6,6,2 | 1.025 Millimoles per liter | Standard Deviation 0.0612 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): LDL cholesterol, n=6,6,2 | 2.507 Millimoles per liter | Standard Deviation 0.7842 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Glucose, n=6,6,2 | 4.88 Millimoles per liter | Standard Deviation 0.546 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Glucose, n=6,6,2 | 5.17 Millimoles per liter | Standard Deviation 0.528 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Cholesterol, n=6,6,2 | 4.058 Millimoles per liter | Standard Deviation 0.9641 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Triglycerides, n=6,6,2 | 1.150 Millimoles per liter | Standard Deviation 0.5114 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Calcium, n=6,6,2 | 2.313 Millimoles per liter | Standard Deviation 0.0961 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Calcium, n=6,6,2 | 2.287 Millimoles per liter | Standard Deviation 0.0561 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Chloride, n=6,6,2 | 105.8 Millimoles per liter | Standard Deviation 2.48 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Chloride, n=6,6,2 | 106.7 Millimoles per liter | Standard Deviation 1.21 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Phosphate, n=6,6,2 | 1.083 Millimoles per liter | Standard Deviation 0.1889 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Urea, n=6,6,2 | 5.00 Millimoles per liter | Standard Deviation 0.707 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Chloride, n=6,6,2 | 104.5 Millimoles per liter | Standard Deviation 0.71 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Triglycerides, n=6,6,2 | 0.950 Millimoles per liter | Standard Deviation 0.4101 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Sodium, n=6,6,2 | 138.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Potassium, n=6,6,2 | 4.05 Millimoles per liter | Standard Deviation 0.212 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Calcium, n=6,6,2 | 2.330 Millimoles per liter | Standard Deviation 0.0141 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Sodium, n=6,6,2 | 139.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Phosphate, n=6,6,2 | 1.125 Millimoles per liter | Standard Deviation 0.1768 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Calcium, n=6,6,2 | 2.350 Millimoles per liter | Standard Deviation 0.0424 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Magnesium, n=6,6,2 | 0.860 Millimoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Phosphate, n=6,6,2 | 1.200 Millimoles per liter | Standard Deviation 0.0707 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): LDL cholesterol, n=6,6,2 | 2.840 Millimoles per liter | Standard Deviation 0.4808 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Chloride, n=6,6,2 | 105.0 Millimoles per liter | Standard Deviation 2.83 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Glucose, n=6,6,2 | 5.40 Millimoles per liter | Standard Deviation 0.141 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): HDL cholesterol, n=6,6,2 | 1.075 Millimoles per liter | Standard Deviation 0.0354 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Magnesium, n=6,6,2 | 0.880 Millimoles per liter | Standard Deviation 0.0283 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Glucose, n=6,6,2 | 5.40 Millimoles per liter | Standard Deviation 0.283 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Days 8 to 10: Urea, n=6,6,2 | 6.00 Millimoles per liter | Standard Deviation 0.707 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Potassium, n=6,6,2 | 4.15 Millimoles per liter | Standard Deviation 0.212 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Cholesterol, n=6,6,2 | 4.350 Millimoles per liter | Standard Deviation 0.6364 |
Secondary
Part 1: Absolute Values for Chemistry Parameters: Protein
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Protein | Baseline (Day 1) | 72.2 Grams per liter | Standard Deviation 3.06 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Chemistry Parameters: Protein | Days 8 to 10 | 70.8 Grams per liter | Standard Deviation 3.6 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Protein | Baseline (Day 1) | 70.3 Grams per liter | Standard Deviation 2.34 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Chemistry Parameters: Protein | Days 8 to 10 | 69.3 Grams per liter | Standard Deviation 5.05 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Protein | Baseline (Day 1) | 69.0 Grams per liter | Standard Deviation 1.41 |
| Part 1: Placebo | Part 1: Absolute Values for Chemistry Parameters: Protein | Days 8 to 10 | 70.0 Grams per liter | Standard Deviation 1.41 |
Secondary
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval and QTcB interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1), Visit 5 (Days 8 to 10: Pre-dose, 2, 4 and 6 hours)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Days 8 to 10: 4 hours | 136.5 Milliseconds | Standard Deviation 12.1 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Days 8 to 10: Pre-dose | 413.80 Milliseconds | Standard Deviation 42.176 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Days 8 to 10: 6 hours | 89.5 Milliseconds | Standard Deviation 7.04 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Days 8 to 10: 6 hours | 400.2 Milliseconds | Standard Deviation 19.22 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Baseline (Day 1) | 136.6 Milliseconds | Standard Deviation 14.49 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Baseline (Day 1) | 367.6 Milliseconds | Standard Deviation 26.04 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Days 8 to 10: Pre-dose | 397.3 Milliseconds | Standard Deviation 25.34 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Baseline (Day 1) | 412.15 Milliseconds | Standard Deviation 31.539 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Days 8 to 10: Pre-dose | 368.3 Milliseconds | Standard Deviation 23.35 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Days 8 to 10: 6 hours | 138.0 Milliseconds | Standard Deviation 9.1 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Days 8 to 10: 6 hours | 373.3 Milliseconds | Standard Deviation 26.48 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Days 8 to 10: 2 hours | 365.2 Milliseconds | Standard Deviation 25.39 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Days 8 to 10: 4 hours | 399.8 Milliseconds | Standard Deviation 25.87 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Days 8 to 10: 4 hours | 376.3 Milliseconds | Standard Deviation 22.7 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Baseline (Day 1) | 396.2 Milliseconds | Standard Deviation 17.67 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Baseline (Day 1) | 93.1 Milliseconds | Standard Deviation 4.54 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Days 8 to 10: 2 hours | 138.0 Milliseconds | Standard Deviation 14.46 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Days 8 to 10: 6 hours | 414.80 Milliseconds | Standard Deviation 34.569 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Days 8 to 10: Pre-dose | 90.0 Milliseconds | Standard Deviation 7.46 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Days 8 to 10: Pre-dose | 136.2 Milliseconds | Standard Deviation 15.26 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Days 8 to 10: 4 hours | 412.92 Milliseconds | Standard Deviation 42.143 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Days 8 to 10: 2 hours | 91.0 Milliseconds | Standard Deviation 6.36 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Days 8 to 10: 2 hours | 388.7 Milliseconds | Standard Deviation 22.72 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Days 8 to 10: 2 hours | 401.70 Milliseconds | Standard Deviation 37.316 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Days 8 to 10: 4 hours | 89.8 Milliseconds | Standard Deviation 5.91 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Baseline (Day 1) | 397.75 Milliseconds | Standard Deviation 22.914 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Baseline (Day 1) | 168.4 Milliseconds | Standard Deviation 15.48 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Days 8 to 10: Pre-dose | 160.8 Milliseconds | Standard Deviation 19.6 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Days 8 to 10: 2 hours | 162.2 Milliseconds | Standard Deviation 11.53 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Days 8 to 10: 4 hours | 168.7 Milliseconds | Standard Deviation 13.81 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Days 8 to 10: 6 hours | 162.5 Milliseconds | Standard Deviation 15.06 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Baseline (Day 1) | 95.7 Milliseconds | Standard Deviation 6.85 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Days 8 to 10: Pre-dose | 92.3 Milliseconds | Standard Deviation 7.74 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Days 8 to 10: 2 hours | 96.2 Milliseconds | Standard Deviation 7.17 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Days 8 to 10: 4 hours | 94.0 Milliseconds | Standard Deviation 6.42 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Days 8 to 10: 6 hours | 92.8 Milliseconds | Standard Deviation 10.11 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Baseline (Day 1) | 378.7 Milliseconds | Standard Deviation 26.75 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Days 8 to 10: Pre-dose | 376.0 Milliseconds | Standard Deviation 31.46 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Days 8 to 10: 2 hours | 383.2 Milliseconds | Standard Deviation 26.84 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Days 8 to 10: 4 hours | 387.7 Milliseconds | Standard Deviation 29.34 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Days 8 to 10: 6 hours | 384.5 Milliseconds | Standard Deviation 25.37 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Days 8 to 10: Pre-dose | 401.35 Milliseconds | Standard Deviation 22.923 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Days 8 to 10: 2 hours | 393.15 Milliseconds | Standard Deviation 26.29 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Days 8 to 10: 4 hours | 387.38 Milliseconds | Standard Deviation 24.454 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Days 8 to 10: 6 hours | 388.60 Milliseconds | Standard Deviation 23.893 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Baseline (Day 1) | 391.2 Milliseconds | Standard Deviation 19.11 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Days 8 to 10: Pre-dose | 392.3 Milliseconds | Standard Deviation 20.64 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Days 8 to 10: 2 hours | 389.8 Milliseconds | Standard Deviation 22.89 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Days 8 to 10: 4 hours | 387.5 Milliseconds | Standard Deviation 21.27 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Days 8 to 10: 6 hours | 387.3 Milliseconds | Standard Deviation 22.03 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Days 8 to 10: Pre-dose | 387.05 Milliseconds | Standard Deviation 33.163 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Days 8 to 10: 2 hours | 86.0 Milliseconds | Standard Deviation 7.07 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Baseline (Day 1) | 176.5 Milliseconds | Standard Deviation 27.58 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Days 8 to 10: 2 hours | 361.05 Milliseconds | Standard Deviation 7.283 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Days 8 to 10: Pre-dose | 80.5 Milliseconds | Standard Deviation 7.78 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Days 8 to 10: 2 hours | 355.5 Milliseconds | Standard Deviation 13.44 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Days 8 to 10: 4 hours | 358.20 Milliseconds | Standard Deviation 12.162 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Baseline (Day 1) | 85.8 Milliseconds | Standard Deviation 11.08 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Days 8 to 10: Pre-dose | 174.0 Milliseconds | Standard Deviation 29.7 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Days 8 to 10: 6 hours | 383.55 Milliseconds | Standard Deviation 28.496 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Days 8 to 10: 6 hours | 151.5 Milliseconds | Standard Deviation 23.33 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Days 8 to 10: 6 hours | 371.0 Milliseconds | Standard Deviation 21.21 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Baseline (Day 1) | 383.2 Milliseconds | Standard Deviation 36.06 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Days 8 to 10: 4 hours | 173.0 Milliseconds | Standard Deviation 28.28 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Days 8 to 10: 2 hours | 344.0 Milliseconds | Standard Deviation 25.46 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Days 8 to 10: 4 hours | 354.5 Milliseconds | Standard Deviation 4.95 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Days 8 to 10: 4 hours | 347.5 Milliseconds | Standard Deviation 10.61 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Days 8 to 10: Pre-dose | 353.0 Milliseconds | Standard Deviation 8.49 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Days 8 to 10: Pre-dose | 375.5 Milliseconds | Standard Deviation 24.75 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Days 8 to 10: 6 hours | 348.5 Milliseconds | Standard Deviation 7.78 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Baseline (Day 1) | 372.7 Milliseconds | Standard Deviation 29.7 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Days 8 to 10: 6 hours | 83.5 Milliseconds | Standard Deviation 2.12 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Baseline (Day 1) | 388.43 Milliseconds | Standard Deviation 39.598 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Days 8 to 10: 4 hours | 84.5 Milliseconds | Standard Deviation 14.85 |
| Part 1: Placebo | Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Days 8 to 10: 2 hours | 165.0 Milliseconds | Standard Deviation 28.28 |
Secondary
Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day 1): n=6,5,2 | 4.90 10^12 cells per liter | Standard Deviation 0.228 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Days 8 to 10: n=6,6,2 | 4.80 10^12 cells per liter | Standard Deviation 0.29 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Days 8 to 10: n=6,6,2 | 4.63 10^12 cells per liter | Standard Deviation 0.327 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day 1): n=6,5,2 | 4.58 10^12 cells per liter | Standard Deviation 0.259 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day 1): n=6,5,2 | 4.90 10^12 cells per liter | Standard Deviation 0.283 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | Days 8 to 10: n=6,6,2 | 4.90 10^12 cells per liter | Standard Deviation 0.424 |
Secondary
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1): n=6,5,2 | 29.38 Picograms | Standard Deviation 1.78 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Days 8 to 10: n=6,6,2 | 29.30 Picograms | Standard Deviation 1.747 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1): n=6,5,2 | 29.64 Picograms | Standard Deviation 0.879 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Days 8 to 10: n=6,6,2 | 29.97 Picograms | Standard Deviation 0.942 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1): n=6,5,2 | 30.25 Picograms | Standard Deviation 0.636 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Days 8 to 10: n=6,6,2 | 30.10 Picograms | Standard Deviation 0.707 |
Secondary
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1): n=6,5,2 | 88.5 Femtoliter | Standard Deviation 3.67 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Days 8 to 10: n=6,6,2 | 88.5 Femtoliter | Standard Deviation 4.09 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1): n=6,5,2 | 90.2 Femtoliter | Standard Deviation 3.49 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Days 8 to 10: n=6,6,2 | 90.0 Femtoliter | Standard Deviation 2.28 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1): n=6,5,2 | 90.0 Femtoliter | Standard Deviation 1.41 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Days 8 to 10: n=6,6,2 | 90.0 Femtoliter | Standard Deviation 1.41 |
Secondary
Part 1: Absolute Values for Hematology Parameter: Hematocrit
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day 1): n=6,5,2 | 0.4338 Proportion of red blood cells in blood | Standard Deviation 0.02709 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Days 8 to 10: n=6,6,2 | 0.4222 Proportion of red blood cells in blood | Standard Deviation 0.03456 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day 1): n=6,5,2 | 0.4112 Proportion of red blood cells in blood | Standard Deviation 0.02523 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Days 8 to 10: n=6,6,2 | 0.4158 Proportion of red blood cells in blood | Standard Deviation 0.02827 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day 1): n=6,5,2 | 0.4395 Proportion of red blood cells in blood | Standard Deviation 0.01344 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameter: Hematocrit | Days 8 to 10: n=6,6,2 | 0.4385 Proportion of red blood cells in blood | Standard Deviation 0.03182 |
Secondary
Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Days 8 to 10: n=6,6,2 | 140.0 Grams per liter | Standard Deviation 12.18 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day 1): n=6,5,2 | 144.2 Grams per liter | Standard Deviation 11.55 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day 1): n=6,5,2 | 135.4 Grams per liter | Standard Deviation 9.42 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Days 8 to 10: n=6,6,2 | 138.7 Grams per liter | Standard Deviation 12.72 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day 1): n=6,5,2 | 148.0 Grams per liter | Standard Deviation 4.24 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | Days 8 to 10: n=6,6,2 | 147.0 Grams per liter | Standard Deviation 9.9 |
Secondary
Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: reticulocytes/erythro. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Baseline (Day 1): n=6,5,2 | 0.0137 Percentage of reticulocytes in erythro | Standard Deviation 0.00726 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Days 8 to 10: n=6,6,2 | 0.0178 Percentage of reticulocytes in erythro | Standard Deviation 0.01139 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Baseline (Day 1): n=6,5,2 | 0.0078 Percentage of reticulocytes in erythro | Standard Deviation 0.00349 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Days 8 to 10: n=6,6,2 | 0.0088 Percentage of reticulocytes in erythro | Standard Deviation 0.00264 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Baseline (Day 1): n=6,5,2 | 0.0110 Percentage of reticulocytes in erythro | Standard Deviation 0.00424 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Days 8 to 10: n=6,6,2 | 0.0130 Percentage of reticulocytes in erythro | Standard Deviation 0.00424 |
Secondary
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Leukocytes, n=6,5,2 | 6.05 10^9 cells per liter | Standard Deviation 1.071 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Lymphocytes, n=6,6,2 | 2.277 10^9 cells per liter | Standard Deviation 0.4484 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Eosinophils, n=6,5,2 | 0.212 10^9 cells per liter | Standard Deviation 0.1783 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Neutrophils, n=6,6,2 | 2.890 10^9 cells per liter | Standard Deviation 0.6049 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Monocytes, n=6,5,2 | 0.552 10^9 cells per liter | Standard Deviation 0.2033 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Basophils, n=6,6,2 | 0.057 10^9 cells per liter | Standard Deviation 0.0266 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Neutrophils, n=6,5,2 | 2.935 10^9 cells per liter | Standard Deviation 0.4803 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Monocytes, n=6,6,2 | 0.652 10^9 cells per liter | Standard Deviation 0.1907 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Leukocytes, n=6,6,2 | 6.07 10^9 cells per liter | Standard Deviation 0.929 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Eosinophils, n=6,6,2 | 0.188 10^9 cells per liter | Standard Deviation 0.0873 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Platelet count, n=6,6,2 | 233.8 10^9 cells per liter | Standard Deviation 70.34 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Basophils, n=6,5,2 | 0.052 10^9 cells per liter | Standard Deviation 0.0279 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Lymphocytes, n=6,5,2 | 2.303 10^9 cells per liter | Standard Deviation 0.5431 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Platelet count, n=6,5,2 | 208.8 10^9 cells per liter | Standard Deviation 38.48 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Leukocytes, n=6,5,2 | 5.64 10^9 cells per liter | Standard Deviation 1.172 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Basophils, n=6,5,2 | 0.056 10^9 cells per liter | Standard Deviation 0.0321 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Basophils, n=6,6,2 | 0.037 10^9 cells per liter | Standard Deviation 0.0186 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Eosinophils, n=6,5,2 | 0.150 10^9 cells per liter | Standard Deviation 0.0616 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Eosinophils, n=6,6,2 | 0.202 10^9 cells per liter | Standard Deviation 0.1003 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Lymphocytes, n=6,5,2 | 1.810 10^9 cells per liter | Standard Deviation 0.4341 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Lymphocytes, n=6,6,2 | 2.217 10^9 cells per liter | Standard Deviation 0.6693 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Monocytes, n=6,5,2 | 0.530 10^9 cells per liter | Standard Deviation 0.1814 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Monocytes, n=6,6,2 | 0.508 10^9 cells per liter | Standard Deviation 0.2088 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Neutrophils, n=6,5,2 | 3.094 10^9 cells per liter | Standard Deviation 0.7279 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Neutrophils, n=6,6,2 | 2.635 10^9 cells per liter | Standard Deviation 0.4068 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Leukocytes, n=6,6,2 | 5.60 10^9 cells per liter | Standard Deviation 1.158 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Platelet count, n=6,5,2 | 202.0 10^9 cells per liter | Standard Deviation 39.26 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Platelet count, n=6,6,2 | 205.0 10^9 cells per liter | Standard Deviation 43.38 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Platelet count, n=6,5,2 | 195.5 10^9 cells per liter | Standard Deviation 12.02 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Neutrophils, n=6,6,2 | 2.185 10^9 cells per liter | Standard Deviation 0.2616 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Lymphocytes, n=6,5,2 | 2.010 10^9 cells per liter | Standard Deviation 0.0707 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Eosinophils, n=6,6,2 | 0.080 10^9 cells per liter | Standard Deviation 0.0424 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Leukocytes, n=6,5,2 | 4.45 10^9 cells per liter | Standard Deviation 0.495 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Eosinophils, n=6,5,2 | 0.105 10^9 cells per liter | Standard Deviation 0.0212 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Basophils, n=6,5,2 | 0.030 10^9 cells per liter | Standard Deviation 0 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Leukocytes, n=6,6,2 | 4.90 10^9 cells per liter | Standard Deviation 0.283 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Basophils, n=6,6,2 | 0.045 10^9 cells per liter | Standard Deviation 0.0212 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Monocytes, n=6,6,2 | 0.515 10^9 cells per liter | Standard Deviation 0.0212 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Monocytes, n=6,5,2 | 0.460 10^9 cells per liter | Standard Deviation 0 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Platelet count, n=6,6,2 | 208.5 10^9 cells per liter | Standard Deviation 14.85 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Neutrophils, n=6,5,2 | 1.840 10^9 cells per liter | Standard Deviation 0.4101 |
| Part 1: Placebo | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Days 8 to 10: Lymphocytes, n=6,6,2 | 2.080 10^9 cells per liter | Standard Deviation 0.1273 |
Secondary
Part 1: Absolute Values for Pulse Rate
Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Pulse Rate | Baseline (Day 1) | 81.8 Beats per minute | Standard Deviation 18.25 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Pulse Rate | Days 8 to 10 | 76.7 Beats per minute | Standard Deviation 21.13 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Pulse Rate | Baseline (Day 1) | 65.8 Beats per minute | Standard Deviation 14.22 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Pulse Rate | Days 8 to 10 | 71.3 Beats per minute | Standard Deviation 11.93 |
| Part 1: Placebo | Part 1: Absolute Values for Pulse Rate | Baseline (Day 1) | 60.0 Beats per minute | Standard Deviation 2.83 |
| Part 1: Placebo | Part 1: Absolute Values for Pulse Rate | Days 8 to 10 | 66.0 Beats per minute | Standard Deviation 5.66 |
Secondary
Part 1: Absolute Values for Respiratory Rate
Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Respiratory Rate | Baseline (Day 1) | 16.0 Breaths per minute | Standard Deviation 2.61 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Respiratory Rate | Days 8 to 10 | 15.0 Breaths per minute | Standard Deviation 1.26 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Respiratory Rate | Baseline (Day 1) | 16.2 Breaths per minute | Standard Deviation 3.31 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Respiratory Rate | Days 8 to 10 | 16.3 Breaths per minute | Standard Deviation 2.73 |
| Part 1: Placebo | Part 1: Absolute Values for Respiratory Rate | Baseline (Day 1) | 15.0 Breaths per minute | Standard Deviation 4.24 |
| Part 1: Placebo | Part 1: Absolute Values for Respiratory Rate | Days 8 to 10 | 14.0 Breaths per minute | Standard Deviation 2.83 |
Secondary
Part 1: Absolute Values for SBP and DBP
SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for SBP and DBP | Baseline (Day 1): SBP | 120.2 Millimeters of mercury | Standard Deviation 13.36 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for SBP and DBP | Days 8 to 10: SBP | 117.7 Millimeters of mercury | Standard Deviation 8.87 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for SBP and DBP | Baseline (Day 1): DBP | 70.3 Millimeters of mercury | Standard Deviation 17.32 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for SBP and DBP | Days 8 to 10: DBP | 70.0 Millimeters of mercury | Standard Deviation 6.81 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for SBP and DBP | Days 8 to 10: DBP | 67.5 Millimeters of mercury | Standard Deviation 9.91 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for SBP and DBP | Baseline (Day 1): SBP | 121.8 Millimeters of mercury | Standard Deviation 12.25 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for SBP and DBP | Baseline (Day 1): DBP | 66.7 Millimeters of mercury | Standard Deviation 10.8 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for SBP and DBP | Days 8 to 10: SBP | 122.3 Millimeters of mercury | Standard Deviation 7.94 |
| Part 1: Placebo | Part 1: Absolute Values for SBP and DBP | Days 8 to 10: DBP | 64.5 Millimeters of mercury | Standard Deviation 4.95 |
| Part 1: Placebo | Part 1: Absolute Values for SBP and DBP | Days 8 to 10: SBP | 104.5 Millimeters of mercury | Standard Deviation 7.78 |
| Part 1: Placebo | Part 1: Absolute Values for SBP and DBP | Baseline (Day 1): DBP | 64.0 Millimeters of mercury | Standard Deviation 5.66 |
| Part 1: Placebo | Part 1: Absolute Values for SBP and DBP | Baseline (Day 1): SBP | 106.0 Millimeters of mercury | Standard Deviation 11.31 |
Secondary
Part 1: Absolute Values for Urinalysis Parameter: pH
Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Urinalysis Parameter: pH | Baseline (Day 1) | 5.67 pH | Standard Deviation 0.931 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Urinalysis Parameter: pH | Days 8 to 10 | 5.83 pH | Standard Deviation 0.753 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Urinalysis Parameter: pH | Baseline (Day 1) | 5.75 pH | Standard Deviation 0.689 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Urinalysis Parameter: pH | Days 8 to 10 | 5.42 pH | Standard Deviation 0.585 |
| Part 1: Placebo | Part 1: Absolute Values for Urinalysis Parameter: pH | Baseline (Day 1) | 5.75 pH | Standard Deviation 0.354 |
| Part 1: Placebo | Part 1: Absolute Values for Urinalysis Parameter: pH | Days 8 to 10 | 5.25 pH | Standard Deviation 0.354 |
Secondary
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day 1) | 1.0238 Ratio | Standard Deviation 0.00677 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Days 8 to 10 | 1.0240 Ratio | Standard Deviation 0.00533 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day 1) | 1.0233 Ratio | Standard Deviation 0.0032 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Days 8 to 10 | 1.0242 Ratio | Standard Deviation 0.00279 |
| Part 1: Placebo | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day 1) | 1.0240 Ratio | Standard Deviation 0.00283 |
| Part 1: Placebo | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | Days 8 to 10 | 1.0240 Ratio | Standard Deviation 0 |
Secondary
Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen
Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen | Baseline (Day 1) | 3.40 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 10 mg | Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen | Days 8 to 10 | 7.90 Micromoles per liter | Standard Deviation 6.971 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen | Baseline (Day 1) | 3.40 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 200 mg | Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen | Days 8 to 10 | 3.40 Micromoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen | Baseline (Day 1) | 3.40 Micromoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen | Days 8 to 10 | 3.40 Micromoles per liter | Standard Deviation 0 |
Secondary
Part 1: Absorption Lag Time (Tlag) Following Administration of GSK3640254 on Day 1
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Absorption Lag Time (Tlag) Following Administration of GSK3640254 on Day 1 | 0.500 Hours |
| Part 1: GSK3640254 200 mg | Part 1: Absorption Lag Time (Tlag) Following Administration of GSK3640254 on Day 1 | 0.000 Hours |
Secondary
Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The accumulation ratios (Ro) were calculated as Ro\_AUC equal to (=) AUC(0-tau) Days 8 to 10 divided by (/) AUC(0-24) Day 1; Ro\_Cmax=Cmax Days 8 to 10/Cmax Day 1; and Ro\_Ctau=Ctau Days 8 to 10/C24 Day 1.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_AUC(0-tau), n=5,6 | 1.5352 Ratio | Geometric Coefficient of Variation 24.5 |
| Part 1: GSK3640254 10 mg | Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_Cmax, n=6,6 | 0.9287 Ratio | Geometric Coefficient of Variation 171.7 |
| Part 1: GSK3640254 10 mg | Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_Ctau, n=6,6 | 1.4790 Ratio | Geometric Coefficient of Variation 22.2 |
| Part 1: GSK3640254 200 mg | Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_AUC(0-tau), n=5,6 | 2.2542 Ratio | Geometric Coefficient of Variation 72.1 |
| Part 1: GSK3640254 200 mg | Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_Cmax, n=6,6 | 1.9785 Ratio | Geometric Coefficient of Variation 69.4 |
| Part 1: GSK3640254 200 mg | Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_Ctau, n=6,6 | 1.9796 Ratio | Geometric Coefficient of Variation 61.2 |
Secondary
Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 AUC(0-tau)
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Statistical analysis for relationship between PK parameters (AUC) and PD measures (Change from Baseline in plasma HIV-1 RNA) were explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: maximum response (Emax), PK parameter value that attains 50 percent (%) of the maximal effect (EC50) and residual variability (s2e). PK/PD Population consisted of participants who met criteria for Per-Protocol and Pharmacokinetic Population analysis sets and who underwent PD sampling during the study.
Time frame: Baseline (Day 1) and Day 8
Population: PK/PD Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 AUC(0-tau) | 12071.4 Copies per milliliter | Standard Deviation 42117.29 |
| Part 1: GSK3640254 200 mg | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 AUC(0-tau) | -113331.4 Copies per milliliter | Standard Deviation 89475 |
| Part 1: Placebo | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 AUC(0-tau) | -48655.0 Copies per milliliter | Standard Deviation 26269.41 |
| Part 2: Placebo | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 AUC(0-tau) | -37904.3 Copies per milliliter | Standard Deviation 38814.54 |
| Part 2: GSK3640254 140 mg | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 AUC(0-tau) | -64861.5 Copies per milliliter | Standard Deviation 83728.15 |
95% CI: [-2.484, -1.389]
95% CI: [0.585, 13.602]
95% CI: [0.062, 0.212]
Secondary
Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Cmax
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Statistical analysis for relationship between PK parameters (Cmax) and PD measures (Change from Baseline in plasma HIV-1 RNA) were explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: Emax, EC50 and s2e.
Time frame: Baseline (Day 1) and Day 8
Population: PK/PD Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Cmax | 12071.4 Copies per milliliter | Standard Deviation 42117.29 |
| Part 1: GSK3640254 200 mg | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Cmax | -113331.4 Copies per milliliter | Standard Deviation 89475 |
| Part 1: Placebo | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Cmax | -48655.0 Copies per milliliter | Standard Deviation 26269.41 |
| Part 2: Placebo | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Cmax | -37904.3 Copies per milliliter | Standard Deviation 38814.54 |
| Part 2: GSK3640254 140 mg | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Cmax | -64861.5 Copies per milliliter | Standard Deviation 83728.15 |
95% CI: [0.063, 0.216]
95% CI: [-2.479, -1.379]
95% CI: [0.03, 0.861]
Secondary
Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Ctau
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Statistical analysis for relationship between PK parameters (Ctau) and PD measures (Change from Baseline in plasma HIV-1 RNA) were explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: Emax, EC50 and s2e.
Time frame: Baseline (Day 1) and Day 8
Population: PK/PD Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Ctau | 12071.4 Copies per milliliter | Standard Deviation 42117.29 |
| Part 1: GSK3640254 200 mg | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Ctau | -113331.4 Copies per milliliter | Standard Deviation 89475 |
| Part 1: Placebo | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Ctau | -48655.0 Copies per milliliter | Standard Deviation 26269.41 |
| Part 2: Placebo | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Ctau | -37904.3 Copies per milliliter | Standard Deviation 38814.54 |
| Part 2: GSK3640254 140 mg | Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Ctau | -64861.5 Copies per milliliter | Standard Deviation 83728.15 |
95% CI: [0.065, 0.222]
95% CI: [-2.498, -1.354]
95% CI: [0.007, 0.386]
Secondary
Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on AUC(0-24)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on AUC(0-24) | 1.018 Slope of log dose |
Secondary
Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on C24
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on C24 | 1.061 Slope of log dose |
Secondary
Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on Cmax
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on Cmax | 0.964 Slope of log dose |
Secondary
Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on AUC(0-tau)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.
Time frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on AUC(0-tau) | 1.179 Slope of log dose |
Secondary
Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Cmax
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.
Time frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Cmax | 1.204 Slope of log dose |
Secondary
Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Ctau
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.
Time frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Ctau | 1.137 Slope of log dose |
Secondary
Part 1: Apparent Oral Clearance (CL/F) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Apparent Oral Clearance (CL/F) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | 11010.5393 Milliliter per hour | Geometric Coefficient of Variation 44.7 |
| Part 1: GSK3640254 200 mg | Part 1: Apparent Oral Clearance (CL/F) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | 7159.1443 Milliliter per hour | Geometric Coefficient of Variation 18.4 |
Secondary
Part 1: Apparent Terminal Phase Half-life (t1/2) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Apparent Terminal Phase Half-life (t1/2) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | NA Hours |
| Part 1: GSK3640254 200 mg | Part 1: Apparent Terminal Phase Half-life (t1/2) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | NA Hours |
Secondary
Part 1: Area Under the Plasma Concentration Time Curve From Zero to 24 (AUC[0-24]) Following Administration of GSK3640254 on Day 1
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Pharmacokinetic (PK) Population consisted of all participants who received GSK3640254 and underwent plasma PK sampling during the study.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Area Under the Plasma Concentration Time Curve From Zero to 24 (AUC[0-24]) Following Administration of GSK3640254 on Day 1 | 0.6946 Hours*microgram per milliliter | Geometric Coefficient of Variation 13.5 |
| Part 1: GSK3640254 200 mg | Part 1: Area Under the Plasma Concentration Time Curve From Zero to 24 (AUC[0-24]) Following Administration of GSK3640254 on Day 1 | 12.3929 Hours*microgram per milliliter | Geometric Coefficient of Variation 91.3 |
Secondary
Part 1: Area Under the Plasma Drug Concentration-time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Area Under the Plasma Drug Concentration-time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | 0.9082 Hours*microgram per milliliter | Geometric Coefficient of Variation 44.7 |
| Part 1: GSK3640254 200 mg | Part 1: Area Under the Plasma Drug Concentration-time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | 27.9363 Hours*microgram per milliliter | Geometric Coefficient of Variation 18.4 |
Secondary
Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST)
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) | ALP | 10.5 International units per liter | Standard Deviation 23.36 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) | ALT | 2.7 International units per liter | Standard Deviation 7.79 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) | AST | -0.5 International units per liter | Standard Deviation 3.94 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) | ALP | -3.5 International units per liter | Standard Deviation 4.64 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) | ALT | -1.7 International units per liter | Standard Deviation 4.46 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) | AST | -2.0 International units per liter | Standard Deviation 8.6 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) | ALT | 9.5 International units per liter | Standard Deviation 6.36 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) | AST | 4.5 International units per liter | Standard Deviation 2.12 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) | ALP | -4.0 International units per liter | Standard Deviation 1.41 |
Secondary
Part 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 6 (Day 11)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed. Amylase and lipase results were collected for two participants in GSK3640254 10 mg arm during Part 1 of the study. No data were collected for Placebo and GSK3640254 200 mg arms at Visit 6 (Day 11) due to delays in approval of Protocol Amendment 02 into which testing for amylase and lipase was added.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase | 0.0 Units per liter | Standard Deviation 11.31 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase | -2.0 Units per liter | Standard Deviation 2.83 |
Secondary
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Creatinine | 1.77 Micromoles per liter | Standard Deviation 5.565 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Bilirubin | -0.3 Micromoles per liter | Standard Deviation 3.2 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Creatinine | -1.33 Micromoles per liter | Standard Deviation 4.291 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Bilirubin | -2.0 Micromoles per liter | Standard Deviation 2.53 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Creatinine | 0.00 Micromoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Bilirubin | 3.0 Micromoles per liter | Standard Deviation 9.9 |
Secondary
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Glucose, n=6,6,2 | -0.20 Millimoles per liter | Standard Deviation 0.253 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Calcium, n=6,6,2 | -0.007 Millimoles per liter | Standard Deviation 0.1343 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Chloride, n=6,6,2 | 0.0 Millimoles per liter | Standard Deviation 2.1 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Phosphate, n=6,6,2 | 0.042 Millimoles per liter | Standard Deviation 0.1594 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Potassium, n=6,6,2 | 0.02 Millimoles per liter | Standard Deviation 0.24 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Magnesium, n=6,6,2 | 0.000 Millimoles per liter | Standard Deviation 0.0551 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Sodium, n=6,6,2 | 0.2 Millimoles per liter | Standard Deviation 2.4 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Urea, n=6,6,2 | -0.08 Millimoles per liter | Standard Deviation 1.021 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Chloride, n=6,6,2 | 0.8 Millimoles per liter | Standard Deviation 3.06 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Sodium, n=6,6,2 | -0.8 Millimoles per liter | Standard Deviation 1.6 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Phosphate, n=6,6,2 | 0.058 Millimoles per liter | Standard Deviation 0.1772 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Potassium, n=6,6,2 | -0.03 Millimoles per liter | Standard Deviation 0.242 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Magnesium, n=6,6,2 | -0.007 Millimoles per liter | Standard Deviation 0.0561 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Glucose, n=6,6,2 | 0.28 Millimoles per liter | Standard Deviation 0.595 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Calcium, n=6,6,2 | -0.027 Millimoles per liter | Standard Deviation 0.0468 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Urea, n=6,6,2 | -0.08 Millimoles per liter | Standard Deviation 0.801 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Chloride, n=6,6,2 | -0.5 Millimoles per liter | Standard Deviation 3.54 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Calcium, n=6,6,2 | 0.020 Millimoles per liter | Standard Deviation 0.0283 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Glucose, n=6,6,2 | 0.00 Millimoles per liter | Standard Deviation 0.424 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Phosphate, n=6,6,2 | -0.075 Millimoles per liter | Standard Deviation 0.1061 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Sodium, n=6,6,2 | -1.0 Millimoles per liter | Standard Deviation 1.41 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Magnesium, n=6,6,2 | -0.020 Millimoles per liter | Standard Deviation 0.0283 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Potassium, n=6,6,2 | -0.10 Millimoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol | Urea, n=6,6,2 | 1.00 Millimoles per liter | Standard Deviation 0 |
Secondary
Part 1: Change From Baseline in Chemistry Parameters: Protein
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Chemistry Parameters: Protein | -1.3 Grams per liter | Standard Deviation 4.93 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Chemistry Parameters: Protein | -1.0 Grams per liter | Standard Deviation 2.97 |
| Part 1: Placebo | Part 1: Change From Baseline in Chemistry Parameters: Protein | 1.0 Grams per liter | Standard Deviation 2.83 |
Secondary
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF)
Twelve lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcB Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1), Visit 5 (Days 8 to 10: Pre-dose, 2, 4 and 6 hours)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB Interval- Days 8 to 10: 4 hours | 0.77 Milliseconds | Standard Deviation 15.517 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS Duration- Days 8 to 10: 6 hours | -3.6 Milliseconds | Standard Deviation 5.56 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | PR Interval- Days 8 to 10: Pre-dose | -0.4 Milliseconds | Standard Deviation 5.32 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB Interval- Days 8 to 10: 2 hours | -10.45 Milliseconds | Standard Deviation 22.433 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QT Interval- Days 8 to 10: Pre-dose | 0.7 Milliseconds | Standard Deviation 8.15 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | PR Interval- Days 8 to 10: 6 hours | 1.4 Milliseconds | Standard Deviation 13.22 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB Interval- Days 8 to 10: Pre-dose | 1.65 Milliseconds | Standard Deviation 15.813 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QT Interval- Days 8 to 10: 2 hours | -2.4 Milliseconds | Standard Deviation 17.61 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF Interval- Days 8 to 10: 6 hours | 4.0 Milliseconds | Standard Deviation 12.82 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QT Interval- Days 8 to 10: 6 hours | 5.7 Milliseconds | Standard Deviation 16.48 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QT Interval- Days 8 to 10: 4 hours | 8.7 Milliseconds | Standard Deviation 18.43 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF Interval- Days 8 to 10: 2 hours | -7.5 Milliseconds | Standard Deviation 19.44 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS Duration- Days 8 to 10: Pre-dose | -3.1 Milliseconds | Standard Deviation 6.65 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF Interval- Days 8 to 10: 4 hours | 3.7 Milliseconds | Standard Deviation 15.18 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF Interval- Days 8 to 10: Pre-dose | 1.2 Milliseconds | Standard Deviation 10.75 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS Duration- Days 8 to 10: 2 hours | -2.1 Milliseconds | Standard Deviation 6.6 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | PR Interval- Days 8 to 10: 4 hours | -0.1 Milliseconds | Standard Deviation 10 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB Interval- Days 8 to 10: 6 hours | 2.65 Milliseconds | Standard Deviation 13.391 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS Duration- Days 8 to 10: 4 hours | -3.3 Milliseconds | Standard Deviation 3.5 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | PR Interval- Days 8 to 10: 2 hours | 1.4 Milliseconds | Standard Deviation 5.47 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF Interval- Days 8 to 10: 2 hours | -1.3 Milliseconds | Standard Deviation 14.06 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | PR Interval- Days 8 to 10: Pre-dose | -7.6 Milliseconds | Standard Deviation 5.69 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | PR Interval- Days 8 to 10: 2 hours | -6.3 Milliseconds | Standard Deviation 9.71 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | PR Interval- Days 8 to 10: 4 hours | 0.2 Milliseconds | Standard Deviation 9.81 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | PR Interval- Days 8 to 10: 6 hours | -5.9 Milliseconds | Standard Deviation 3.93 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS Duration- Days 8 to 10: Pre-dose | -3.4 Milliseconds | Standard Deviation 9.9 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS Duration- Days 8 to 10: 2 hours | 0.4 Milliseconds | Standard Deviation 6.27 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS Duration- Days 8 to 10: 4 hours | -1.7 Milliseconds | Standard Deviation 6.75 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS Duration- Days 8 to 10: 6 hours | -2.9 Milliseconds | Standard Deviation 4.55 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QT Interval- Days 8 to 10: Pre-dose | -2.7 Milliseconds | Standard Deviation 19.6 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QT Interval- Days 8 to 10: 2 hours | 4.4 Milliseconds | Standard Deviation 20.33 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QT Interval- Days 8 to 10: 4 hours | 8.9 Milliseconds | Standard Deviation 13.72 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QT Interval- Days 8 to 10: 6 hours | 5.8 Milliseconds | Standard Deviation 14.19 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB Interval- Days 8 to 10: Pre-dose | 3.60 Milliseconds | Standard Deviation 18.218 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB Interval- Days 8 to 10: 2 hours | -4.60 Milliseconds | Standard Deviation 14.266 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB Interval- Days 8 to 10: 4 hours | -10.37 Milliseconds | Standard Deviation 20.176 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB Interval- Days 8 to 10: 6 hours | -9.15 Milliseconds | Standard Deviation 15.513 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF Interval- Days 8 to 10: Pre-dose | 1.2 Milliseconds | Standard Deviation 9.56 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF Interval- Days 8 to 10: 4 hours | -3.7 Milliseconds | Standard Deviation 10.84 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF Interval- Days 8 to 10: 6 hours | -3.8 Milliseconds | Standard Deviation 13.06 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | PR Interval- Days 8 to 10: 2 hours | -11.5 Milliseconds | Standard Deviation 0.71 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB Interval- Days 8 to 10: 2 hours | -27.38 Milliseconds | Standard Deviation 32.315 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS Duration- Days 8 to 10: 4 hours | -1.3 Milliseconds | Standard Deviation 3.77 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF Interval- Days 8 to 10: 6 hours | -12.2 Milliseconds | Standard Deviation 14.85 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB Interval- Days 8 to 10: 4 hours | -30.23 Milliseconds | Standard Deviation 51.76 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS Duration- Days 8 to 10: 2 hours | 0.2 Milliseconds | Standard Deviation 4.01 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF Interval- Days 8 to 10: 4 hours | -28.7 Milliseconds | Standard Deviation 41.01 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB Interval- Days 8 to 10: 6 hours | -4.88 Milliseconds | Standard Deviation 11.102 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS Duration- Days 8 to 10: Pre-dose | -5.3 Milliseconds | Standard Deviation 3.3 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | PR Interval- Days 8 to 10: Pre-dose | -2.5 Milliseconds | Standard Deviation 2.12 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF Interval- Days 8 to 10: Pre-dose | -7.7 Milliseconds | Standard Deviation 11.31 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | PR Interval- Days 8 to 10: 6 hours | -25.0 Milliseconds | Standard Deviation 4.24 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QT Interval- Days 8 to 10: 4 hours | -25.2 Milliseconds | Standard Deviation 19.09 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QT Interval- Days 8 to 10: 2 hours | -28.7 Milliseconds | Standard Deviation 4.24 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | PR Interval- Days 8 to 10: 4 hours | -3.5 Milliseconds | Standard Deviation 0.71 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QT Interval- Days 8 to 10: 6 hours | -24.2 Milliseconds | Standard Deviation 21.92 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QT Interval- Days 8 to 10: Pre-dose | -19.7 Milliseconds | Standard Deviation 21.21 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF Interval- Days 8 to 10: 2 hours | -27.7 Milliseconds | Standard Deviation 22.63 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB Interval- Days 8 to 10: Pre-dose | -1.38 Milliseconds | Standard Deviation 6.435 |
| Part 1: Placebo | Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS Duration- Days 8 to 10: 6 hours | -2.3 Milliseconds | Standard Deviation 13.2 |
Secondary
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | -0.10 10^12 cells per liter | Standard Deviation 0.19 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | -0.07 10^12 cells per liter | Standard Deviation 0.197 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | 0.00 10^12 cells per liter | Standard Deviation 0.141 |
Secondary
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.08 Picograms | Standard Deviation 0.286 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | 0.03 Picograms | Standard Deviation 0.266 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.15 Picograms | Standard Deviation 0.071 |
Secondary
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 0.0 Femtoliter | Standard Deviation 0.89 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | -0.3 Femtoliter | Standard Deviation 1.03 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 0.0 Femtoliter | Standard Deviation 0 |
Secondary
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | -0.0117 Proportion of red blood cells in blood | Standard Deviation 0.01684 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | -0.0073 Proportion of red blood cells in blood | Standard Deviation 0.01919 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | -0.0010 Proportion of red blood cells in blood | Standard Deviation 0.01838 |
Secondary
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | -4.2 Grams per liter | Standard Deviation 4.96 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | -1.8 Grams per liter | Standard Deviation 5.98 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | -1.0 Grams per liter | Standard Deviation 5.66 |
Secondary
Part 1: Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocyte
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: reticulocytes/erythrocyte (erythro). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocyte | 0.0042 Percentage of reticulocytes in erythro | Standard Deviation 0.00449 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocyte | 0.0012 Percentage of reticulocytes in erythro | Standard Deviation 0.00172 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocyte | 0.0020 Percentage of reticulocytes in erythro | Standard Deviation 0 |
Secondary
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count
Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Eosinophils | -0.023 10^9 cells per liter | Standard Deviation 0.1296 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Neutrophils | -0.045 10^9 cells per liter | Standard Deviation 0.4624 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Monocytes | 0.100 10^9 cells per liter | Standard Deviation 0.1124 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Basophils | 0.005 10^9 cells per liter | Standard Deviation 0.0266 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Platelet count | 25.0 10^9 cells per liter | Standard Deviation 46.35 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Leukocytes | 0.02 10^9 cells per liter | Standard Deviation 0.679 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Lymphocytes | -0.027 10^9 cells per liter | Standard Deviation 0.5267 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Monocytes | -0.000 10^9 cells per liter | Standard Deviation 0.098 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Basophils | -0.017 10^9 cells per liter | Standard Deviation 0.0234 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Eosinophils | 0.058 10^9 cells per liter | Standard Deviation 0.1134 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Lymphocytes | 0.458 10^9 cells per liter | Standard Deviation 0.4412 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Neutrophils | -0.525 10^9 cells per liter | Standard Deviation 0.8169 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Leukocytes | -0.02 10^9 cells per liter | Standard Deviation 1.057 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Platelet count | 11.8 10^9 cells per liter | Standard Deviation 12.04 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Neutrophils | 0.345 10^9 cells per liter | Standard Deviation 0.1485 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Eosinophils | -0.025 10^9 cells per liter | Standard Deviation 0.0212 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Platelet count | 13.0 10^9 cells per liter | Standard Deviation 2.83 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Leukocytes | 0.45 10^9 cells per liter | Standard Deviation 0.212 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Monocytes | 0.055 10^9 cells per liter | Standard Deviation 0.0212 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Lymphocytes | 0.070 10^9 cells per liter | Standard Deviation 0.0566 |
| Part 1: Placebo | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Basophils | 0.015 10^9 cells per liter | Standard Deviation 0.0212 |
Secondary
Part 1: Change From Baseline in Pulse Rate
Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Pulse Rate | -5.2 Beats per minute | Standard Deviation 4.36 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Pulse Rate | 5.5 Beats per minute | Standard Deviation 10.99 |
| Part 1: Placebo | Part 1: Change From Baseline in Pulse Rate | 6.0 Beats per minute | Standard Deviation 2.83 |
Secondary
Part 1: Change From Baseline in Respiratory Rate
Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Respiratory Rate | -1.0 Breaths per minute | Standard Deviation 1.79 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Respiratory Rate | 0.2 Breaths per minute | Standard Deviation 2.32 |
| Part 1: Placebo | Part 1: Change From Baseline in Respiratory Rate | -1.0 Breaths per minute | Standard Deviation 1.41 |
Secondary
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | -2.5 Millimeters of mercury | Standard Deviation 8.41 |
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | -0.3 Millimeters of mercury | Standard Deviation 14.5 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | 0.5 Millimeters of mercury | Standard Deviation 9.65 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0.8 Millimeters of mercury | Standard Deviation 4.67 |
| Part 1: Placebo | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | -1.5 Millimeters of mercury | Standard Deviation 3.54 |
| Part 1: Placebo | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0.5 Millimeters of mercury | Standard Deviation 0.71 |
Secondary
Part 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH)
Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) | 0.17 pH | Standard Deviation 1.033 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) | -0.33 pH | Standard Deviation 0.683 |
| Part 1: Placebo | Part 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) | -0.50 pH | Standard Deviation 0 |
Secondary
Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | 0.0002 Ratio | Standard Deviation 0.00615 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | 0.0008 Ratio | Standard Deviation 0.00232 |
| Part 1: Placebo | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | 0.0000 Ratio | Standard Deviation 0.00283 |
Secondary
Part 1: Change From Baseline in Urinalysis Parameter: Urobilinogen
Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Days 8 to 10)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Change From Baseline in Urinalysis Parameter: Urobilinogen | 4.50 Micromoles per liter | Standard Deviation 6.971 |
| Part 1: GSK3640254 200 mg | Part 1: Change From Baseline in Urinalysis Parameter: Urobilinogen | 0.00 Micromoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Part 1: Change From Baseline in Urinalysis Parameter: Urobilinogen | 0.00 Micromoles per liter | Standard Deviation 0 |
Secondary
Part 1: Cmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Cmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | 0.0549 Microgram per milliliter | Geometric Coefficient of Variation 41.3 |
| Part 1: GSK3640254 200 mg | Part 1: Cmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | 1.8559 Microgram per milliliter | Geometric Coefficient of Variation 19.5 |
Secondary
Part 1: Concentration at 24 Hours Post-dose (C24) Following Administration of GSK3640254 on Day 1
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Concentration at 24 Hours Post-dose (C24) Following Administration of GSK3640254 on Day 1 | 0.0180 Microgram per milliliter | Geometric Coefficient of Variation 27.5 |
| Part 1: GSK3640254 200 mg | Part 1: Concentration at 24 Hours Post-dose (C24) Following Administration of GSK3640254 on Day 1 | 0.3553 Microgram per milliliter | Geometric Coefficient of Variation 92.7 |
Secondary
Part 1: Concentration at End of Dosing Interval (Ctau) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Concentration at End of Dosing Interval (Ctau) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | 0.0267 Microgram per milliliter | Geometric Coefficient of Variation 47 |
| Part 1: GSK3640254 200 mg | Part 1: Concentration at End of Dosing Interval (Ctau) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | 0.7033 Microgram per milliliter | Geometric Coefficient of Variation 29.6 |
Secondary
Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK3640254 on Day 1
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK3640254 on Day 1 | 0.0591 Microgram per milliliter | Geometric Coefficient of Variation 177.4 |
| Part 1: GSK3640254 200 mg | Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK3640254 on Day 1 | 0.9381 Microgram per milliliter | Geometric Coefficient of Variation 82.3 |
Secondary
Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per Medical or scientific judgment. Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Time frame: Up to Day 24
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Non-SAEs | 3 Participants |
| Part 1: GSK3640254 10 mg | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Non-SAEs | 5 Participants |
| Part 1: GSK3640254 200 mg | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Non-SAEs | 0 Participants |
| Part 1: Placebo | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Secondary
Part 1: Pre-dose Concentration (C0) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Blood sample was collected at indicated time point for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 8 to 10: Pre-dose
Population: PK Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Pre-dose Concentration (C0) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | 0.0268 Microgram per milliliter | Geometric Coefficient of Variation 41.6 |
| Part 1: GSK3640254 200 mg | Part 1: Pre-dose Concentration (C0) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | 0.6928 Microgram per milliliter | Geometric Coefficient of Variation 33.6 |
Secondary
Part 1: Time to Maximum Observed Concentration (Tmax) Following Administration of GSK3640254 on Day 1
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Time to Maximum Observed Concentration (Tmax) Following Administration of GSK3640254 on Day 1 | 2.9250 Hours |
| Part 1: GSK3640254 200 mg | Part 1: Time to Maximum Observed Concentration (Tmax) Following Administration of GSK3640254 on Day 1 | 5.5250 Hours |
Secondary
Part 1: Tmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 1: Tmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | 4.0167 Hours |
| Part 1: GSK3640254 200 mg | Part 1: Tmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10 | 5.4833 Hours |
Secondary
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST
Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALT, n=6,6,6,2 | 18.3 International units per liter | Standard Deviation 14.07 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Day 7: ALT, n=6,6,6,1 | 14.5 International units per liter | Standard Deviation 7.66 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALP, n=6,6,6,2 | 63.3 International units per liter | Standard Deviation 15.08 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Day 7: ALP, n=6,6,6,1 | 60.2 International units per liter | Standard Deviation 16.53 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): AST, n=6,6,6,2 | 26.8 International units per liter | Standard Deviation 15.39 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Day 7: AST, n=6,6,6,1 | 21.7 International units per liter | Standard Deviation 6.74 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Day 7: AST, n=6,6,6,1 | 18.8 International units per liter | Standard Deviation 3.31 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Day 7: ALP, n=6,6,6,1 | 63.0 International units per liter | Standard Deviation 5.25 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALT, n=6,6,6,2 | 17.8 International units per liter | Standard Deviation 7.63 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALP, n=6,6,6,2 | 63.7 International units per liter | Standard Deviation 4.68 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Day 7: ALT, n=6,6,6,1 | 16.7 International units per liter | Standard Deviation 5.24 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): AST, n=6,6,6,2 | 18.5 International units per liter | Standard Deviation 6.6 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Day 7: ALT, n=6,6,6,1 | 27.0 International units per liter | Standard Deviation 18 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALP, n=6,6,6,2 | 60.8 International units per liter | Standard Deviation 9 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Day 7: ALP, n=6,6,6,1 | 59.0 International units per liter | Standard Deviation 5.18 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Day 7: AST, n=6,6,6,1 | 22.0 International units per liter | Standard Deviation 3.74 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): AST, n=6,6,6,2 | 26.7 International units per liter | Standard Deviation 8.14 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALT, n=6,6,6,2 | 33.2 International units per liter | Standard Deviation 23.07 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): AST, n=6,6,6,2 | 50.0 International units per liter | Standard Deviation 39.6 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Day 7: AST, n=6,6,6,1 | 26.0 International units per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Day 7: ALT, n=6,6,6,1 | 29.0 International units per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Day 7: ALP, n=6,6,6,1 | 55.0 International units per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALT, n=6,6,6,2 | 34.5 International units per liter | Standard Deviation 6.36 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST | Baseline (Day 1): ALP, n=6,6,6,2 | 43.0 International units per liter | Standard Deviation 18.38 |
Secondary
Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase
Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Baseline (Day 1): Amylase, n=6,6,6,2 | 47.2 Units per liter | Standard Deviation 18.15 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 7: Amylase, n=6,6,6,1 | 44.8 Units per liter | Standard Deviation 17.81 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Baseline (Day 1): Lipase, n=6,6,6,2 | 26.5 Units per liter | Standard Deviation 14.08 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 7: Lipase, n=6,6,6,1 | 25.5 Units per liter | Standard Deviation 11.64 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 7: Amylase, n=6,6,6,1 | 51.8 Units per liter | Standard Deviation 22.71 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Baseline (Day 1): Lipase, n=6,6,6,2 | 29.7 Units per liter | Standard Deviation 10.95 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 7: Lipase, n=6,6,6,1 | 27.5 Units per liter | Standard Deviation 13.4 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Baseline (Day 1): Amylase, n=6,6,6,2 | 51.0 Units per liter | Standard Deviation 21.65 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Baseline (Day 1): Lipase, n=6,6,6,2 | 43.2 Units per liter | Standard Deviation 32.32 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 7: Amylase, n=6,6,6,1 | 61.8 Units per liter | Standard Deviation 25.86 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 7: Lipase, n=6,6,6,1 | 47.7 Units per liter | Standard Deviation 34.7 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Baseline (Day 1): Amylase, n=6,6,6,2 | 55.2 Units per liter | Standard Deviation 18.61 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 7: Lipase, n=6,6,6,1 | 44.0 Units per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Day 7: Amylase, n=6,6,6,1 | 64.0 Units per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Baseline (Day 1): Amylase, n=6,6,6,2 | 56.0 Units per liter | Standard Deviation 25.46 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Baseline (Day 1): Lipase, n=6,6,6,2 | 26.0 Units per liter | Standard Deviation 14.14 |
Secondary
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin
Blood samples were collected to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Creatinine, n=6,6,6,2 | 71.30 Micromoles per liter | Standard Deviation 12.207 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Day 7: Creatinine, n=6,6,6,1 | 72.65 Micromoles per liter | Standard Deviation 14.109 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Bilirubin, n=6,6,6,2 | 10.0 Micromoles per liter | Standard Deviation 5.66 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Day 7: Bilirubin, n=6,6,6,1 | 9.7 Micromoles per liter | Standard Deviation 4.97 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Day 7: Creatinine, n=6,6,6,1 | 70.28 Micromoles per liter | Standard Deviation 8.269 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Bilirubin, n=6,6,6,2 | 9.3 Micromoles per liter | Standard Deviation 1.03 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Day 7: Bilirubin, n=6,6,6,1 | 10.7 Micromoles per liter | Standard Deviation 5.47 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Creatinine, n=6,6,6,2 | 73.67 Micromoles per liter | Standard Deviation 7.12 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Bilirubin, n=6,6,6,2 | 7.7 Micromoles per liter | Standard Deviation 3.44 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Day 7: Creatinine, n=6,6,6,1 | 73.35 Micromoles per liter | Standard Deviation 8.195 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Day 7: Bilirubin, n=6,6,6,1 | 8.0 Micromoles per liter | Standard Deviation 2.83 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Creatinine, n=6,6,6,2 | 73.52 Micromoles per liter | Standard Deviation 12.761 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Day 7: Bilirubin, n=6,6,6,1 | 6.0 Micromoles per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Day 7: Creatinine, n=6,6,6,1 | 76.00 Micromoles per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Creatinine, n=6,6,6,2 | 86.65 Micromoles per liter | Standard Deviation 13.789 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin | Baseline (Day 1): Bilirubin, n=6,6,6,2 | 11.0 Micromoles per liter | Standard Deviation 7.07 |
Secondary
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol
Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Sodium, n=6,6,6,1 | 136.8 Millimoles per liter | Standard Deviation 3.54 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Potassium, n=6,6,6,1 | 3.87 Millimoles per liter | Standard Deviation 0.273 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Triglycerides, n=6,6,6,2 | 1.183 Millimoles per liter | Standard Deviation 0.1924 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Sodium, n=6,6,6,2 | 137.7 Millimoles per liter | Standard Deviation 1.63 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Magnesium, n=6,6,6,2 | 0.790 Millimoles per liter | Standard Deviation 0.0395 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Glucose, n=6,6,6,2 | 4.68 Millimoles per liter | Standard Deviation 0.306 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Magnesium, n=6,6,6,1 | 0.797 Millimoles per liter | Standard Deviation 0.0731 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Glucose, n=6,6,6,1 | 4.63 Millimoles per liter | Standard Deviation 0.408 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): HDL cholesterol, n=6,6,6,2 | 1.242 Millimoles per liter | Standard Deviation 0.3277 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Calcium, n=6,6,6,2 | 2.330 Millimoles per liter | Standard Deviation 0.0629 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Calcium, n=6,6,6,1 | 2.273 Millimoles per liter | Standard Deviation 0.0628 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Urea, n=6,6,6,1 | 4.08 Millimoles per liter | Standard Deviation 0.97 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Chloride, n=6,6,6,2 | 103.0 Millimoles per liter | Standard Deviation 1.67 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): LDL cholesterol, n=6,6,6,2 | 2.448 Millimoles per liter | Standard Deviation 0.6649 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Chloride, n=6,6,6,1 | 102.3 Millimoles per liter | Standard Deviation 1.51 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Cholesterol, n=6,6,6,2 | 4.233 Millimoles per liter | Standard Deviation 0.6758 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Urea, n=6,6,6,2 | 4.50 Millimoles per liter | Standard Deviation 1.517 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Phosphate, n=6,6,6,2 | 1.317 Millimoles per liter | Standard Deviation 0.1693 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Phosphate, n=6,6,6,1 | 1.200 Millimoles per liter | Standard Deviation 0.1265 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Potassium, n=6,6,6,2 | 4.07 Millimoles per liter | Standard Deviation 0.476 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Sodium, n=6,6,6,1 | 138.2 Millimoles per liter | Standard Deviation 1.94 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Potassium, n=6,6,6,2 | 3.98 Millimoles per liter | Standard Deviation 0.325 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): HDL cholesterol, n=6,6,6,2 | 1.133 Millimoles per liter | Standard Deviation 0.3312 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Sodium, n=6,6,6,2 | 138.5 Millimoles per liter | Standard Deviation 2.43 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Calcium, n=6,6,6,1 | 2.293 Millimoles per liter | Standard Deviation 0.0766 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Potassium, n=6,6,6,1 | 4.03 Millimoles per liter | Standard Deviation 0.242 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Glucose, n=6,6,6,2 | 4.72 Millimoles per liter | Standard Deviation 0.928 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): LDL cholesterol, n=6,6,6,2 | 2.578 Millimoles per liter | Standard Deviation 0.8267 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Phosphate, n=6,6,6,1 | 1.175 Millimoles per liter | Standard Deviation 0.1969 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Magnesium, n=6,6,6,2 | 0.830 Millimoles per liter | Standard Deviation 0.0518 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Chloride, n=6,6,6,2 | 102.2 Millimoles per liter | Standard Deviation 2.64 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Magnesium, n=6,6,6,1 | 0.837 Millimoles per liter | Standard Deviation 0.0427 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Phosphate, n=6,6,6,2 | 1.108 Millimoles per liter | Standard Deviation 0.1281 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Triglycerides, n=6,6,6,2 | 1.447 Millimoles per liter | Standard Deviation 0.6008 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Urea, n=6,6,6,2 | 4.25 Millimoles per liter | Standard Deviation 1.508 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Cholesterol, n=6,6,6,2 | 4.375 Millimoles per liter | Standard Deviation 1.1626 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Chloride, n=6,6,6,1 | 102.0 Millimoles per liter | Standard Deviation 1.79 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Calcium, n=6,6,6,2 | 2.320 Millimoles per liter | Standard Deviation 0.098 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Glucose, n=6,6,6,1 | 4.90 Millimoles per liter | Standard Deviation 0.19 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Urea, n=6,6,6,1 | 4.00 Millimoles per liter | Standard Deviation 0.632 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Magnesium, n=6,6,6,2 | 0.803 Millimoles per liter | Standard Deviation 0.032 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Glucose, n=6,6,6,2 | 4.80 Millimoles per liter | Standard Deviation 0.456 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Glucose, n=6,6,6,1 | 4.77 Millimoles per liter | Standard Deviation 0.32 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Cholesterol, n=6,6,6,2 | 4.150 Millimoles per liter | Standard Deviation 0.8573 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Triglycerides, n=6,6,6,2 | 1.120 Millimoles per liter | Standard Deviation 0.4879 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Calcium, n=6,6,6,2 | 2.290 Millimoles per liter | Standard Deviation 0.0701 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Calcium, n=6,6,6,1 | 2.320 Millimoles per liter | Standard Deviation 0.078 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Chloride, n=6,6,6,2 | 103.7 Millimoles per liter | Standard Deviation 2.34 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Chloride, n=6,6,6,1 | 103.0 Millimoles per liter | Standard Deviation 1.1 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Phosphate, n=6,6,6,2 | 1.083 Millimoles per liter | Standard Deviation 0.1211 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Phosphate, n=6,6,6,1 | 1.167 Millimoles per liter | Standard Deviation 0.1329 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Potassium, n=6,6,6,2 | 3.95 Millimoles per liter | Standard Deviation 0.164 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Potassium, n=6,6,6,1 | 4.15 Millimoles per liter | Standard Deviation 0.122 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Magnesium, n=6,6,6,1 | 0.830 Millimoles per liter | Standard Deviation 0.0654 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Sodium, n=6,6,6,2 | 137.8 Millimoles per liter | Standard Deviation 3.06 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Sodium, n=6,6,6,1 | 137.7 Millimoles per liter | Standard Deviation 1.97 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Urea, n=6,6,6,2 | 5.92 Millimoles per liter | Standard Deviation 1.068 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Urea, n=6,6,6,1 | 5.58 Millimoles per liter | Standard Deviation 0.492 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): HDL cholesterol, n=6,6,6,2 | 1.200 Millimoles per liter | Standard Deviation 0.3194 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): LDL cholesterol, n=6,6,6,2 | 2.437 Millimoles per liter | Standard Deviation 0.6955 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Phosphate, n=6,6,6,1 | 0.750 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Phosphate, n=6,6,6,2 | 0.950 Millimoles per liter | Standard Deviation 0.2828 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): HDL cholesterol, n=6,6,6,2 | 1.250 Millimoles per liter | Standard Deviation 0.0707 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Sodium, n=6,6,6,1 | 138.0 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Chloride, n=6,6,6,1 | 104.0 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Chloride, n=6,6,6,2 | 105.5 Millimoles per liter | Standard Deviation 0.71 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Glucose, n=6,6,6,1 | 4.80 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Urea, n=6,6,6,2 | 6.25 Millimoles per liter | Standard Deviation 2.475 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Calcium, n=6,6,6,1 | 2.220 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Calcium, n=6,6,6,2 | 2.280 Millimoles per liter | Standard Deviation 0.0849 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Glucose, n=6,6,6,2 | 4.90 Millimoles per liter | Standard Deviation 0.849 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Urea, n=6,6,6,1 | 4.00 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Triglycerides, n=6,6,6,2 | 0.540 Millimoles per liter | Standard Deviation 0.198 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Magnesium, n=6,6,6,2 | 0.810 Millimoles per liter | Standard Deviation 0.0707 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Cholesterol, n=6,6,6,2 | 3.400 Millimoles per liter | Standard Deviation 0.3536 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Magnesium, n=6,6,6,1 | 0.760 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Day 7: Potassium, n=6,6,6,1 | 3.70 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Potassium, n=6,6,6,2 | 4.10 Millimoles per liter | Standard Deviation 0.424 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): LDL cholesterol, n=6,6,6,2 | 1.905 Millimoles per liter | Standard Deviation 0.3748 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Baseline (Day 1): Sodium, n=6,6,6,2 | 140.5 Millimoles per liter | Standard Deviation 2.12 |
Secondary
Part 2: Absolute Values for Chemistry Parameters: Protein
Blood samples were collected to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Protein | Baseline (Day 1): n=6,6,6,2 | 78.8 Grams per liter | Standard Deviation 12.78 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Chemistry Parameters: Protein | Day 7: n=6,6,6,1 | 76.7 Grams per liter | Standard Deviation 12.01 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Protein | Day 7: n=6,6,6,1 | 72.5 Grams per liter | Standard Deviation 5.13 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Chemistry Parameters: Protein | Baseline (Day 1): n=6,6,6,2 | 73.3 Grams per liter | Standard Deviation 5.5 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Protein | Baseline (Day 1): n=6,6,6,2 | 76.7 Grams per liter | Standard Deviation 10.03 |
| Part 1: Placebo | Part 2: Absolute Values for Chemistry Parameters: Protein | Day 7: n=6,6,6,1 | 78.2 Grams per liter | Standard Deviation 8.93 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Protein | Baseline (Day 1): n=6,6,6,2 | 73.5 Grams per liter | Standard Deviation 0.71 |
| Part 2: Placebo | Part 2: Absolute Values for Chemistry Parameters: Protein | Day 7: n=6,6,6,1 | 72.0 Grams per liter | — |
Secondary
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval and QTcB interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1), Visit 5 (Day 7: Pre-dose, 2, 4 and 6 hours)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Baseline (Day 1) | 156.8 Milliseconds | Standard Deviation 33.02 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: 6 hours | 387.8 Milliseconds | Standard Deviation 11.29 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: 2 hours | 405.78 Milliseconds | Standard Deviation 10.923 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: 2 hours | 95.0 Milliseconds | Standard Deviation 9.78 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: Pre-dose | 398.72 Milliseconds | Standard Deviation 26.663 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: 2 hours | 162.8 Milliseconds | Standard Deviation 28.34 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: Pre-dose | 391.5 Milliseconds | Standard Deviation 24.01 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: 4 hours | 94.3 Milliseconds | Standard Deviation 8.89 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: 6 hours | 365.2 Milliseconds | Standard Deviation 34.53 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: 6 hours | 160.7 Milliseconds | Standard Deviation 24.81 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: 4 hours | 373.8 Milliseconds | Standard Deviation 24.25 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: 6 hours | 93.2 Milliseconds | Standard Deviation 10.61 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: 4 hours | 388.0 Milliseconds | Standard Deviation 18.21 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: Pre-dose | 166.5 Milliseconds | Standard Deviation 25.62 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Baseline (Day 1) | 397.4 Milliseconds | Standard Deviation 24.6 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Baseline (Day 1) | 386.6 Milliseconds | Standard Deviation 28.86 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Baseline (Day 1) | 92.6 Milliseconds | Standard Deviation 10.22 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Baseline (Day 1) | 402.88 Milliseconds | Standard Deviation 26.814 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: 4 hours | 395.92 Milliseconds | Standard Deviation 22.851 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: Pre-dose | 379.2 Milliseconds | Standard Deviation 33.3 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: 2 hours | 390.2 Milliseconds | Standard Deviation 12.16 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: 4 hours | 162.0 Milliseconds | Standard Deviation 24.85 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: 6 hours | 399.62 Milliseconds | Standard Deviation 19.074 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: 2 hours | 362.2 Milliseconds | Standard Deviation 31.24 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: Pre-dose | 96.5 Milliseconds | Standard Deviation 8.14 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: 2 hours | 351.5 Milliseconds | Standard Deviation 25.05 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: 4 hours | 397.68 Milliseconds | Standard Deviation 20.635 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: 4 hours | 360.2 Milliseconds | Standard Deviation 23.07 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: 6 hours | 361.8 Milliseconds | Standard Deviation 25.88 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: 2 hours | 398.33 Milliseconds | Standard Deviation 33.672 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Baseline (Day 1) | 398.24 Milliseconds | Standard Deviation 25.587 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: Pre-dose | 398.58 Milliseconds | Standard Deviation 21.075 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: 6 hours | 160.7 Milliseconds | Standard Deviation 27.25 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: Pre-dose | 161.8 Milliseconds | Standard Deviation 31.06 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: 2 hours | 382.2 Milliseconds | Standard Deviation 30.2 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Baseline (Day 1) | 95.1 Milliseconds | Standard Deviation 21.97 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Baseline (Day 1) | 162.9 Milliseconds | Standard Deviation 29.73 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: Pre-dose | 98.3 Milliseconds | Standard Deviation 28.86 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: Pre-dose | 383.0 Milliseconds | Standard Deviation 24.9 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: 2 hours | 95.8 Milliseconds | Standard Deviation 19.29 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: 4 hours | 95.2 Milliseconds | Standard Deviation 18.94 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: 2 hours | 160.5 Milliseconds | Standard Deviation 28.73 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Baseline (Day 1) | 383.5 Milliseconds | Standard Deviation 23.72 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: 6 hours | 95.0 Milliseconds | Standard Deviation 21.29 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: 6 hours | 388.0 Milliseconds | Standard Deviation 21.76 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Baseline (Day 1) | 355.9 Milliseconds | Standard Deviation 25.37 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: 4 hours | 384.7 Milliseconds | Standard Deviation 20.42 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: 6 hours | 402.42 Milliseconds | Standard Deviation 22.916 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: Pre-dose | 354.3 Milliseconds | Standard Deviation 31.94 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: 4 hours | 164.0 Milliseconds | Standard Deviation 31.51 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Baseline (Day 1) | 411.18 Milliseconds | Standard Deviation 15.858 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Baseline (Day 1) | 162.8 Milliseconds | Standard Deviation 20.83 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: Pre-dose | 155.5 Milliseconds | Standard Deviation 26.1 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: 2 hours | 159.7 Milliseconds | Standard Deviation 26.04 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: 4 hours | 154.5 Milliseconds | Standard Deviation 20.51 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: 6 hours | 160.7 Milliseconds | Standard Deviation 25.9 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Baseline (Day 1) | 88.9 Milliseconds | Standard Deviation 7.4 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: Pre-dose | 88.5 Milliseconds | Standard Deviation 3.99 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: 2 hours | 88.8 Milliseconds | Standard Deviation 4.49 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: 4 hours | 85.8 Milliseconds | Standard Deviation 4.88 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: 6 hours | 88.2 Milliseconds | Standard Deviation 8.11 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Baseline (Day 1) | 362.5 Milliseconds | Standard Deviation 19.45 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: Pre-dose | 367.5 Milliseconds | Standard Deviation 26.93 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: 2 hours | 364.3 Milliseconds | Standard Deviation 17.32 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: 4 hours | 360.8 Milliseconds | Standard Deviation 18.64 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: 6 hours | 363.2 Milliseconds | Standard Deviation 19.5 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: Pre-dose | 414.63 Milliseconds | Standard Deviation 17.816 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: 2 hours | 406.30 Milliseconds | Standard Deviation 27.565 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: 4 hours | 412.48 Milliseconds | Standard Deviation 27.377 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: 6 hours | 409.50 Milliseconds | Standard Deviation 19.009 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Baseline (Day 1) | 394.1 Milliseconds | Standard Deviation 12.71 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: Pre-dose | 398.2 Milliseconds | Standard Deviation 18.58 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: 2 hours | 391.8 Milliseconds | Standard Deviation 22.44 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: 4 hours | 394.7 Milliseconds | Standard Deviation 18.91 |
| Part 1: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: 6 hours | 393.3 Milliseconds | Standard Deviation 17.2 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: 4 hours | 382.90 Milliseconds | Standard Deviation 17.961 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: Pre-dose | 382.0 Milliseconds | Standard Deviation 1.41 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Baseline (Day 1) | 378.8 Milliseconds | Standard Deviation 1.18 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: 6 hours | 391.5 Milliseconds | Standard Deviation 4.95 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: 6 hours | 396.90 Milliseconds | Standard Deviation 3.253 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: 6 hours | 88.5 Milliseconds | Standard Deviation 17.68 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: 4 hours | 89.5 Milliseconds | Standard Deviation 7.78 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: 4 hours | 385.0 Milliseconds | Standard Deviation 18.38 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Baseline (Day 1) | 397.3 Milliseconds | Standard Deviation 13.67 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: 2 hours | 90.0 Milliseconds | Standard Deviation 12.73 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Day 7: Pre-dose | 88.0 Milliseconds | Standard Deviation 4.24 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: Pre-dose | 137.0 Milliseconds | Standard Deviation 5.66 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: Pre-dose | 394.0 Milliseconds | Standard Deviation 12.73 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QRS Duration- Baseline (Day 1) | 85.7 Milliseconds | Standard Deviation 11.31 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: 6 hours | 136.5 Milliseconds | Standard Deviation 3.54 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Baseline (Day 1) | 144.3 Milliseconds | Standard Deviation 6.13 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcF Interval- Day 7: 2 hours | 385.0 Milliseconds | Standard Deviation 14.14 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: Pre-dose | 399.65 Milliseconds | Standard Deviation 18.173 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Baseline (Day 1) | 406.73 Milliseconds | Standard Deviation 20.742 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: 6 hours | 381.5 Milliseconds | Standard Deviation 6.36 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: 4 hours | 149.0 Milliseconds | Standard Deviation 11.31 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QTcB Interval- Day 7: 2 hours | 388.50 Milliseconds | Standard Deviation 17.819 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: 4 hours | 390.0 Milliseconds | Standard Deviation 18.38 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | QT Interval- Day 7: 2 hours | 378.5 Milliseconds | Standard Deviation 4.95 |
| Part 2: Placebo | Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals | PR Interval- Day 7: 2 hours | 150.5 Milliseconds | Standard Deviation 3.54 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day 1): n=6,6,5,2 | 4.53 10^12 cells per liter | Standard Deviation 0.476 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 7: n=5,6,6,2 | 4.26 10^12 cells per liter | Standard Deviation 0.503 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 7: n=5,6,6,2 | 5.00 10^12 cells per liter | Standard Deviation 0.518 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day 1): n=6,6,5,2 | 5.17 10^12 cells per liter | Standard Deviation 0.45 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day 1): n=6,6,5,2 | 4.74 10^12 cells per liter | Standard Deviation 0.23 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 7: n=5,6,6,2 | 4.52 10^12 cells per liter | Standard Deviation 0.431 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Baseline (Day 1): n=6,6,5,2 | 4.80 10^12 cells per liter | Standard Deviation 0 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | Day 7: n=5,6,6,2 | 4.50 10^12 cells per liter | Standard Deviation 0 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7: n=5,6,6,2 | 30.22 Picograms | Standard Deviation 2.017 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1): n=6,6,5,2 | 30.07 Picograms | Standard Deviation 1.87 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1): n=6,6,5,2 | 29.15 Picograms | Standard Deviation 3.531 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7: n=5,6,6,2 | 29.10 Picograms | Standard Deviation 3.553 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1): n=6,6,5,2 | 29.80 Picograms | Standard Deviation 0.925 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7: n=5,6,6,2 | 29.97 Picograms | Standard Deviation 0.898 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 7: n=5,6,6,2 | 30.90 Picograms | Standard Deviation 1.838 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1): n=6,6,5,2 | 30.95 Picograms | Standard Deviation 1.485 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1): n=6,6,5,2 | 88.8 Femtoliter | Standard Deviation 3.76 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7: n=5,6,6,2 | 89.6 Femtoliter | Standard Deviation 3.44 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7: n=5,6,6,2 | 88.0 Femtoliter | Standard Deviation 8.53 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1): n=6,6,5,2 | 87.8 Femtoliter | Standard Deviation 8.59 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1): n=6,6,5,2 | 89.2 Femtoliter | Standard Deviation 1.64 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7: n=5,6,6,2 | 90.0 Femtoliter | Standard Deviation 2.97 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1): n=6,6,5,2 | 91.0 Femtoliter | Standard Deviation 4.24 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 7: n=5,6,6,2 | 89.0 Femtoliter | Standard Deviation 7.07 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day 1): n=6,6,5,2 | 0.4037 Proportion of red blood cells in blood | Standard Deviation 0.04646 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 7: n=5,6,6,2 | 0.3826 Proportion of red blood cells in blood | Standard Deviation 0.05125 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 7: n=5,6,6,2 | 0.4382 Proportion of red blood cells in blood | Standard Deviation 0.01579 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day 1): n=6,6,5,2 | 0.4505 Proportion of red blood cells in blood | Standard Deviation 0.02992 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day 1): n=6,6,5,2 | 0.4222 Proportion of red blood cells in blood | Standard Deviation 0.01879 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 7: n=5,6,6,2 | 0.4062 Proportion of red blood cells in blood | Standard Deviation 0.03107 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Baseline (Day 1): n=6,6,5,2 | 0.4330 Proportion of red blood cells in blood | Standard Deviation 0.01838 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Hematocrit | Day 7: n=5,6,6,2 | 0.4015 Proportion of red blood cells in blood | Standard Deviation 0.03323 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day 1): n=6,6,5,2 | 136.3 Grams per liter | Standard Deviation 16.34 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 7: n=5,6,6,2 | 129.4 Grams per liter | Standard Deviation 19.55 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 7: n=5,6,6,2 | 144.5 Grams per liter | Standard Deviation 7.87 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day 1): n=6,6,5,2 | 149.2 Grams per liter | Standard Deviation 13.44 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day 1): n=6,6,5,2 | 141.2 Grams per liter | Standard Deviation 7.98 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 7: n=5,6,6,2 | 135.8 Grams per liter | Standard Deviation 11.02 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Baseline (Day 1): n=6,6,5,2 | 147.0 Grams per liter | Standard Deviation 7.07 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | Day 7: n=5,6,6,2 | 139.0 Grams per liter | Standard Deviation 8.49 |
Secondary
Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro
Blood samples were collected to analyze the hematology parameter: reticulocytes/erythro. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Baseline (Day 1): n=6,6,5,2 | 0.0102 Percentage of reticulocytes in erythro | Standard Deviation 0.00223 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Day 7: n=5,6,6,2 | 0.0124 Percentage of reticulocytes in erythro | Standard Deviation 0.00297 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Day 7: n=5,6,6,2 | 0.0098 Percentage of reticulocytes in erythro | Standard Deviation 0.0016 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Baseline (Day 1): n=6,6,5,2 | 0.0082 Percentage of reticulocytes in erythro | Standard Deviation 0.00147 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Baseline (Day 1): n=6,6,5,2 | 0.0108 Percentage of reticulocytes in erythro | Standard Deviation 0.00492 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Day 7: n=5,6,6,2 | 0.0107 Percentage of reticulocytes in erythro | Standard Deviation 0.00344 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Baseline (Day 1): n=6,6,5,2 | 0.0070 Percentage of reticulocytes in erythro | Standard Deviation 0.00141 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro | Day 7: n=5,6,6,2 | 0.0090 Percentage of reticulocytes in erythro | Standard Deviation 0.00141 |
Secondary
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Neutrophils, n=6,6,5,2 | 2.512 10^9 cells per liter | Standard Deviation 1.2631 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Monocytes, n=5,6,5,2 | 0.530 10^9 cells per liter | Standard Deviation 0.221 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Lymphocytes, n=6,6,5,2 | 1.990 10^9 cells per liter | Standard Deviation 0.3013 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Platelet count, n=4,6,6,2 | 292.0 10^9 cells per liter | Standard Deviation 77.06 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Monocytes, n=6,6,5,2 | 0.560 10^9 cells per liter | Standard Deviation 0.2082 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Lymphocytes, n=5,6,5,2 | 1.960 10^9 cells per liter | Standard Deviation 0.345 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Leukocytes, n=5,6,6,2 | 5.66 10^9 cells per liter | Standard Deviation 1.527 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Basophils, n=6,6,5,2 | 0.042 10^9 cells per liter | Standard Deviation 0.0232 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Eosinophils, n=6,6,5,2 | 0.402 10^9 cells per liter | Standard Deviation 0.3307 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Platelet count, n=5,6,5,2 | 276.6 10^9 cells per liter | Standard Deviation 54.29 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Leukocytes, n=6,6,5,2 | 5.50 10^9 cells per liter | Standard Deviation 1.633 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Neutrophils, n=5,6,5,2 | 2.826 10^9 cells per liter | Standard Deviation 1.1821 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Eosinophils, n=5,6,5,2 | 0.316 10^9 cells per liter | Standard Deviation 0.178 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Basophils, n=5,6,5,2 | 0.050 10^9 cells per liter | Standard Deviation 0.0274 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Leukocytes, n=6,6,5,2 | 5.28 10^9 cells per liter | Standard Deviation 1.947 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Basophils, n=6,6,5,2 | 0.042 10^9 cells per liter | Standard Deviation 0.0117 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Basophils, n=5,6,5,2 | 0.062 10^9 cells per liter | Standard Deviation 0.0223 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Eosinophils, n=6,6,5,2 | 0.290 10^9 cells per liter | Standard Deviation 0.2628 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Eosinophils, n=5,6,5,2 | 0.243 10^9 cells per liter | Standard Deviation 0.1546 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Lymphocytes, n=6,6,5,2 | 2.047 10^9 cells per liter | Standard Deviation 0.6167 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Lymphocytes, n=5,6,5,2 | 1.985 10^9 cells per liter | Standard Deviation 0.2983 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Monocytes, n=6,6,5,2 | 0.477 10^9 cells per liter | Standard Deviation 0.1442 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Monocytes, n=5,6,5,2 | 0.498 10^9 cells per liter | Standard Deviation 0.2647 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Neutrophils, n=6,6,5,2 | 2.442 10^9 cells per liter | Standard Deviation 1.1951 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Neutrophils, n=5,6,5,2 | 4.120 10^9 cells per liter | Standard Deviation 2.9025 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Leukocytes, n=5,6,6,2 | 6.90 10^9 cells per liter | Standard Deviation 3.31 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Platelet count, n=5,6,5,2 | 236.7 10^9 cells per liter | Standard Deviation 41.87 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Platelet count, n=4,6,6,2 | 254.2 10^9 cells per liter | Standard Deviation 37.39 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Leukocytes, n=6,6,5,2 | 6.20 10^9 cells per liter | Standard Deviation 0.938 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Platelet count, n=5,6,5,2 | 232.2 10^9 cells per liter | Standard Deviation 40.12 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Basophils, n=5,6,5,2 | 0.054 10^9 cells per liter | Standard Deviation 0.0251 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Eosinophils, n=5,6,5,2 | 0.210 10^9 cells per liter | Standard Deviation 0.1239 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Leukocytes, n=5,6,6,2 | 6.55 10^9 cells per liter | Standard Deviation 0.973 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Basophils, n=6,6,5,2 | 0.030 10^9 cells per liter | Standard Deviation 0.02 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Neutrophils, n=5,6,5,2 | 3.344 10^9 cells per liter | Standard Deviation 0.6322 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Monocytes, n=5,6,5,2 | 0.414 10^9 cells per liter | Standard Deviation 0.1467 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Lymphocytes, n=5,6,5,2 | 2.694 10^9 cells per liter | Standard Deviation 0.706 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Eosinophils, n=6,6,5,2 | 0.320 10^9 cells per liter | Standard Deviation 0.2542 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Lymphocytes, n=6,6,5,2 | 2.236 10^9 cells per liter | Standard Deviation 0.301 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Platelet count, n=4,6,6,2 | 249.0 10^9 cells per liter | Standard Deviation 38.72 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Monocytes, n=6,6,5,2 | 0.534 10^9 cells per liter | Standard Deviation 0.1459 |
| Part 1: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Neutrophils, n=6,6,5,2 | 3.060 10^9 cells per liter | Standard Deviation 0.5711 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Monocytes, n=6,6,5,2 | 0.435 10^9 cells per liter | Standard Deviation 0.1061 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Monocytes, n=5,6,5,2 | 0.305 10^9 cells per liter | Standard Deviation 0.0071 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Platelet count, n=5,6,5,2 | 197.0 10^9 cells per liter | Standard Deviation 59.4 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Neutrophils, n=6,6,5,2 | 2.280 10^9 cells per liter | Standard Deviation 1.0465 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Eosinophils, n=6,6,5,2 | 0.055 10^9 cells per liter | Standard Deviation 0.0354 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Neutrophils, n=5,6,5,2 | 2.065 10^9 cells per liter | Standard Deviation 1.3647 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Basophils, n=5,6,5,2 | 0.035 10^9 cells per liter | Standard Deviation 0.0071 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Leukocytes, n=6,6,5,2 | 4.65 10^9 cells per liter | Standard Deviation 1.485 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Platelet count, n=4,6,6,2 | 201.5 10^9 cells per liter | Standard Deviation 60.1 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Leukocytes, n=5,6,6,2 | 4.20 10^9 cells per liter | Standard Deviation 1.414 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Lymphocytes, n=6,6,5,2 | 1.865 10^9 cells per liter | Standard Deviation 0.3606 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Baseline (Day 1): Basophils, n=6,6,5,2 | 0.040 10^9 cells per liter | Standard Deviation 0.0283 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Lymphocytes, n=5,6,5,2 | 1.755 10^9 cells per liter | Standard Deviation 0.0919 |
| Part 2: Placebo | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Day 7: Eosinophils, n=5,6,5,2 | 0.075 10^9 cells per liter | Standard Deviation 0.0354 |
Secondary
Part 2: Absolute Values for Pulse Rate
Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Pulse Rate | Baseline (Day 1) | 68.3 Beats per minute | Standard Deviation 9.91 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Pulse Rate | Day 7 | 72.5 Beats per minute | Standard Deviation 16.34 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Pulse Rate | Day 7 | 76.5 Beats per minute | Standard Deviation 7.87 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Pulse Rate | Baseline (Day 1) | 74.5 Beats per minute | Standard Deviation 8.36 |
| Part 1: Placebo | Part 2: Absolute Values for Pulse Rate | Baseline (Day 1) | 77.0 Beats per minute | Standard Deviation 10.16 |
| Part 1: Placebo | Part 2: Absolute Values for Pulse Rate | Day 7 | 79.8 Beats per minute | Standard Deviation 12.45 |
| Part 2: Placebo | Part 2: Absolute Values for Pulse Rate | Baseline (Day 1) | 64.5 Beats per minute | Standard Deviation 13.44 |
| Part 2: Placebo | Part 2: Absolute Values for Pulse Rate | Day 7 | 75.0 Beats per minute | Standard Deviation 5.66 |
Secondary
Part 2: Absolute Values for Respiratory Rate
Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Respiratory Rate | Baseline (Day 1) | 17.3 Breaths per minute | Standard Deviation 2.66 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Respiratory Rate | Day 7 | 17.2 Breaths per minute | Standard Deviation 2.56 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Respiratory Rate | Day 7 | 17.3 Breaths per minute | Standard Deviation 2.07 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Respiratory Rate | Baseline (Day 1) | 17.2 Breaths per minute | Standard Deviation 1.17 |
| Part 1: Placebo | Part 2: Absolute Values for Respiratory Rate | Baseline (Day 1) | 17.2 Breaths per minute | Standard Deviation 2.4 |
| Part 1: Placebo | Part 2: Absolute Values for Respiratory Rate | Day 7 | 16.2 Breaths per minute | Standard Deviation 2.23 |
| Part 2: Placebo | Part 2: Absolute Values for Respiratory Rate | Baseline (Day 1) | 16.0 Breaths per minute | Standard Deviation 0 |
| Part 2: Placebo | Part 2: Absolute Values for Respiratory Rate | Day 7 | 16.5 Breaths per minute | Standard Deviation 2.12 |
Secondary
Part 2: Absolute Values for SBP and DBP
SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for SBP and DBP | Baseline (Day 1): SBP | 117.0 Millimeters of mercury | Standard Deviation 7.95 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for SBP and DBP | Day 7: SBP | 118.0 Millimeters of mercury | Standard Deviation 12.07 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for SBP and DBP | Baseline (Day 1): DBP | 71.5 Millimeters of mercury | Standard Deviation 4.51 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for SBP and DBP | Day 7: DBP | 69.7 Millimeters of mercury | Standard Deviation 4.5 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for SBP and DBP | Day 7: SBP | 114.3 Millimeters of mercury | Standard Deviation 8.36 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for SBP and DBP | Baseline (Day 1): DBP | 74.0 Millimeters of mercury | Standard Deviation 4.69 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for SBP and DBP | Day 7: DBP | 73.0 Millimeters of mercury | Standard Deviation 5.06 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for SBP and DBP | Baseline (Day 1): SBP | 116.5 Millimeters of mercury | Standard Deviation 11.04 |
| Part 1: Placebo | Part 2: Absolute Values for SBP and DBP | Baseline (Day 1): DBP | 71.8 Millimeters of mercury | Standard Deviation 12.89 |
| Part 1: Placebo | Part 2: Absolute Values for SBP and DBP | Day 7: SBP | 119.5 Millimeters of mercury | Standard Deviation 8.87 |
| Part 1: Placebo | Part 2: Absolute Values for SBP and DBP | Day 7: DBP | 74.2 Millimeters of mercury | Standard Deviation 5.27 |
| Part 1: Placebo | Part 2: Absolute Values for SBP and DBP | Baseline (Day 1): SBP | 112.2 Millimeters of mercury | Standard Deviation 9.93 |
| Part 2: Placebo | Part 2: Absolute Values for SBP and DBP | Day 7: DBP | 70.5 Millimeters of mercury | Standard Deviation 4.95 |
| Part 2: Placebo | Part 2: Absolute Values for SBP and DBP | Day 7: SBP | 106.5 Millimeters of mercury | Standard Deviation 4.95 |
| Part 2: Placebo | Part 2: Absolute Values for SBP and DBP | Baseline (Day 1): SBP | 105.5 Millimeters of mercury | Standard Deviation 2.12 |
| Part 2: Placebo | Part 2: Absolute Values for SBP and DBP | Baseline (Day 1): DBP | 71.0 Millimeters of mercury | Standard Deviation 12.73 |
Secondary
Part 2: Absolute Values for Urinalysis Parameter: pH
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Baseline (Day 1) | 5.33 pH | Standard Deviation 0.258 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 7 | 5.50 pH | Standard Deviation 0.775 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 7 | 5.67 pH | Standard Deviation 0.258 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Urinalysis Parameter: pH | Baseline (Day 1) | 5.83 pH | Standard Deviation 0.753 |
| Part 1: Placebo | Part 2: Absolute Values for Urinalysis Parameter: pH | Baseline (Day 1) | 5.25 pH | Standard Deviation 0.418 |
| Part 1: Placebo | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 7 | 5.33 pH | Standard Deviation 0.258 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: pH | Baseline (Day 1) | 5.50 pH | Standard Deviation 0 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: pH | Day 7 | 5.75 pH | Standard Deviation 0.354 |
Secondary
Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day 1) | 1.0223 Ratio | Standard Deviation 0.00866 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 7 | 1.0233 Ratio | Standard Deviation 0.00686 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 7 | 1.0250 Ratio | Standard Deviation 0.00522 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day 1) | 1.0272 Ratio | Standard Deviation 0.0036 |
| Part 1: Placebo | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day 1) | 1.0255 Ratio | Standard Deviation 0.00918 |
| Part 1: Placebo | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 7 | 1.0273 Ratio | Standard Deviation 0.00327 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Baseline (Day 1) | 1.0375 Ratio | Standard Deviation 0.00495 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity | Day 7 | 1.0265 Ratio | Standard Deviation 0.00919 |
Secondary
Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen
Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen | Baseline (Day 1) | 3.40 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 10 mg | Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen | Day 7 | 3.40 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen | Day 7 | 7.90 Micromoles per liter | Standard Deviation 6.971 |
| Part 1: GSK3640254 200 mg | Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen | Baseline (Day 1) | 3.40 Micromoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen | Baseline (Day 1) | 3.40 Micromoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen | Day 7 | 3.40 Micromoles per liter | Standard Deviation 0 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen | Baseline (Day 1) | 3.40 Micromoles per liter | Standard Deviation 0 |
| Part 2: Placebo | Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen | Day 7 | 3.40 Micromoles per liter | Standard Deviation 0 |
Secondary
Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The accumulation ratios (Ro) were calculated as Ro\_AUC=AUC(0-tau) Day 7/AUC(0-24) Day 1; Ro\_Cmax=Cmax Day 7/Cmax Day 1; and Ro\_Ctau=Ctau Day 7/C24 Day 1.
Time frame: Days 1 and 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_Cmax | 2.0258 Ratio | Geometric Coefficient of Variation 24.4 |
| Part 1: GSK3640254 10 mg | Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_AUC(0-tau) | 2.2943 Ratio | Geometric Coefficient of Variation 11.2 |
| Part 1: GSK3640254 10 mg | Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_Ctau | 2.2985 Ratio | Geometric Coefficient of Variation 6.4 |
| Part 1: GSK3640254 200 mg | Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_Cmax | 1.7258 Ratio | Geometric Coefficient of Variation 17.6 |
| Part 1: GSK3640254 200 mg | Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_AUC(0-tau) | 1.9314 Ratio | Geometric Coefficient of Variation 18.6 |
| Part 1: GSK3640254 200 mg | Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_Ctau | 1.9389 Ratio | Geometric Coefficient of Variation 20.8 |
| Part 1: Placebo | Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_AUC(0-tau) | 2.0875 Ratio | Geometric Coefficient of Variation 29.2 |
| Part 1: Placebo | Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_Ctau | 1.8967 Ratio | Geometric Coefficient of Variation 16 |
| Part 1: Placebo | Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 | Ro_Cmax | 2.0236 Ratio | Geometric Coefficient of Variation 37.5 |
Secondary
Part 2: AUC(0-24) Following Administration of GSK3640254 on Day 1
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: AUC(0-24) Following Administration of GSK3640254 on Day 1 | 3.2527 Hours*microgram per milliliter | Geometric Coefficient of Variation 31.7 |
| Part 1: GSK3640254 200 mg | Part 2: AUC(0-24) Following Administration of GSK3640254 on Day 1 | 6.1228 Hours*microgram per milliliter | Geometric Coefficient of Variation 38.8 |
| Part 1: Placebo | Part 2: AUC(0-24) Following Administration of GSK3640254 on Day 1 | 14.0335 Hours*microgram per milliliter | Geometric Coefficient of Variation 36.6 |
Secondary
Part 2: AUC(0-tau) Following Repeat Dose Administration of GSK3640254 on Day 7
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: AUC(0-tau) Following Repeat Dose Administration of GSK3640254 on Day 7 | 7.4626 Hours*microgram per milliliter | Geometric Coefficient of Variation 26.8 |
| Part 1: GSK3640254 200 mg | Part 2: AUC(0-tau) Following Repeat Dose Administration of GSK3640254 on Day 7 | 11.8256 Hours*microgram per milliliter | Geometric Coefficient of Variation 26.7 |
| Part 1: Placebo | Part 2: AUC(0-tau) Following Repeat Dose Administration of GSK3640254 on Day 7 | 29.2952 Hours*microgram per milliliter | Geometric Coefficient of Variation 27.9 |
Secondary
Part 2: C0 Following Repeat Dose Administration of GSK3640254 on Day 7
Blood sample was collected at indicated time point for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: C0 Following Repeat Dose Administration of GSK3640254 on Day 7 | 0.2155 Microgram per milliliter | Geometric Coefficient of Variation 24.2 |
| Part 1: GSK3640254 200 mg | Part 2: C0 Following Repeat Dose Administration of GSK3640254 on Day 7 | 0.3575 Microgram per milliliter | Geometric Coefficient of Variation 38 |
| Part 1: Placebo | Part 2: C0 Following Repeat Dose Administration of GSK3640254 on Day 7 | 0.7520 Microgram per milliliter | Geometric Coefficient of Variation 38.8 |
Secondary
Part 2: C24 Following Administration of GSK3640254 on Day 1
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: C24 Following Administration of GSK3640254 on Day 1 | 0.0951 Microgram per milliliter | Geometric Coefficient of Variation 33.7 |
| Part 1: GSK3640254 200 mg | Part 2: C24 Following Administration of GSK3640254 on Day 1 | 0.1856 Microgram per milliliter | Geometric Coefficient of Variation 36.2 |
| Part 1: Placebo | Part 2: C24 Following Administration of GSK3640254 on Day 1 | 0.4207 Microgram per milliliter | Geometric Coefficient of Variation 33.8 |
Secondary
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST
Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | ALT | -3.8 International units per liter | Standard Deviation 6.62 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | AST | -5.2 International units per liter | Standard Deviation 9.37 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | ALP | -3.2 International units per liter | Standard Deviation 3.19 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | ALT | -1.2 International units per liter | Standard Deviation 3.76 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | AST | 0.3 International units per liter | Standard Deviation 5.79 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | ALP | -0.7 International units per liter | Standard Deviation 5.35 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | ALP | -1.8 International units per liter | Standard Deviation 8.61 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | ALT | -6.2 International units per liter | Standard Deviation 8.33 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | AST | -4.7 International units per liter | Standard Deviation 7.37 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | ALT | -1.0 International units per liter | — |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | AST | 4.0 International units per liter | — |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST | ALP | -1.0 International units per liter | — |
Secondary
Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase | -2.3 Units per liter | Standard Deviation 8.62 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase | -1.0 Units per liter | Standard Deviation 8.27 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase | -2.2 Units per liter | Standard Deviation 6.37 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase | 0.8 Units per liter | Standard Deviation 9.87 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase | 6.7 Units per liter | Standard Deviation 7.84 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase | 4.5 Units per liter | Standard Deviation 8.29 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Amylase | -10.0 Units per liter | — |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Lipase | 8.0 Units per liter | — |
Secondary
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin
Blood samples were collected to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Creatinine | 1.35 Micromoles per liter | Standard Deviation 3.23 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Bilirubin | -0.3 Micromoles per liter | Standard Deviation 2.34 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Bilirubin | 1.3 Micromoles per liter | Standard Deviation 6.02 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Creatinine | -3.38 Micromoles per liter | Standard Deviation 2.23 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Creatinine | -0.17 Micromoles per liter | Standard Deviation 8.362 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Bilirubin | 0.3 Micromoles per liter | Standard Deviation 1.51 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Creatinine | -0.90 Micromoles per liter | — |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin | Bilirubin | 0.0 Micromoles per liter | — |
Secondary
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol
Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Glucose, n=6,6,6,1 | -0.05 Millimoles per liter | Standard Deviation 0.327 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Calcium, n=6,6,6,1 | -0.057 Millimoles per liter | Standard Deviation 0.0638 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Chloride, n=6,6,6,1 | -0.7 Millimoles per liter | Standard Deviation 2.25 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Phosphate, n=6,6,6,1 | -0.117 Millimoles per liter | Standard Deviation 0.216 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Potassium, n=6,6,6,1 | -0.20 Millimoles per liter | Standard Deviation 0.261 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Magnesium, n=6,6,6,1 | 0.007 Millimoles per liter | Standard Deviation 0.0484 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Sodium, n=6,6,6,1 | -0.8 Millimoles per liter | Standard Deviation 2.23 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Urea, n=6,6,6,1 | -0.42 Millimoles per liter | Standard Deviation 0.861 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Magnesium, n=6,6,6,1 | 0.007 Millimoles per liter | Standard Deviation 0.0413 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Potassium, n=6,6,6,1 | 0.05 Millimoles per liter | Standard Deviation 0.383 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Calcium, n=6,6,6,1 | -0.027 Millimoles per liter | Standard Deviation 0.0628 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Urea, n=6,6,6,1 | -0.25 Millimoles per liter | Standard Deviation 1.037 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Sodium, n=6,6,6,1 | -0.3 Millimoles per liter | Standard Deviation 1.37 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Phosphate, n=6,6,6,1 | 0.067 Millimoles per liter | Standard Deviation 0.1211 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Chloride, n=6,6,6,1 | -0.2 Millimoles per liter | Standard Deviation 1.47 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Glucose, n=6,6,6,1 | 0.18 Millimoles per liter | Standard Deviation 1.085 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Sodium, n=6,6,6,1 | -0.2 Millimoles per liter | Standard Deviation 1.72 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Chloride, n=6,6,6,1 | -0.7 Millimoles per liter | Standard Deviation 2.34 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Phosphate, n=6,6,6,1 | 0.083 Millimoles per liter | Standard Deviation 0.1329 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Potassium, n=6,6,6,1 | 0.20 Millimoles per liter | Standard Deviation 0.21 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Magnesium, n=6,6,6,1 | 0.027 Millimoles per liter | Standard Deviation 0.0501 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Urea, n=6,6,6,1 | -0.33 Millimoles per liter | Standard Deviation 0.931 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Glucose, n=6,6,6,1 | -0.03 Millimoles per liter | Standard Deviation 0.446 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Calcium, n=6,6,6,1 | 0.030 Millimoles per liter | Standard Deviation 0.1002 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Chloride, n=6,6,6,1 | -2.0 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Phosphate, n=6,6,6,1 | 0.000 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Calcium, n=6,6,6,1 | 0.000 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Glucose, n=6,6,6,1 | 0.50 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Potassium, n=6,6,6,1 | -0.10 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Urea, n=6,6,6,1 | -0.50 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Sodium, n=6,6,6,1 | -4.0 Millimoles per liter | — |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol | Magnesium, n=6,6,6,1 | 0.000 Millimoles per liter | — |
Secondary
Part 2: Change From Baseline in Chemistry Parameters: Protein
Blood samples were collected to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Chemistry Parameters: Protein | -2.2 Grams per liter | Standard Deviation 3.25 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Chemistry Parameters: Protein | -0.8 Grams per liter | Standard Deviation 4.07 |
| Part 1: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Protein | 1.5 Grams per liter | Standard Deviation 4.64 |
| Part 2: Placebo | Part 2: Change From Baseline in Chemistry Parameters: Protein | -2.0 Grams per liter | — |
Secondary
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF
Twelve lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcB Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1), Visit 5 (Day 7: Pre-dose, 2, 4 and 6 hours)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: 6 hours | -3.26 Milliseconds | Standard Deviation 16.691 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: 6 hours | -21.4 Milliseconds | Standard Deviation 36.18 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: Pre-dose | 9.7 Milliseconds | Standard Deviation 13.92 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: 4 hours | -6.96 Milliseconds | Standard Deviation 23.15 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: Pre-dose | -4.16 Milliseconds | Standard Deviation 14.78 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: 2 hours | 2.90 Milliseconds | Standard Deviation 19.936 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: 6 hours | 3.9 Milliseconds | Standard Deviation 16.8 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: 4 hours | -9.4 Milliseconds | Standard Deviation 21.24 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: Pre-dose | 3.9 Milliseconds | Standard Deviation 5.11 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: 2 hours | 2.4 Milliseconds | Standard Deviation 4.18 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: 2 hours | 6.1 Milliseconds | Standard Deviation 14.2 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: 2 hours | -7.2 Milliseconds | Standard Deviation 22.91 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: 4 hours | 1.7 Milliseconds | Standard Deviation 4.06 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: 6 hours | 0.5 Milliseconds | Standard Deviation 11.78 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: Pre-dose | -5.9 Milliseconds | Standard Deviation 18.89 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: Pre-dose | -7.4 Milliseconds | Standard Deviation 33.78 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: 6 hours | -9.5 Milliseconds | Standard Deviation 19.08 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: 2 hours | -24.4 Milliseconds | Standard Deviation 33.17 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: 4 hours | 5.2 Milliseconds | Standard Deviation 22.87 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: 4 hours | -12.8 Milliseconds | Standard Deviation 25.96 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: 6 hours | -0.1 Milliseconds | Standard Deviation 3.04 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: 4 hours | 4.2 Milliseconds | Standard Deviation 12.84 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: 4 hours | 1.1 Milliseconds | Standard Deviation 8.56 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: 4 hours | -0.56 Milliseconds | Standard Deviation 13.559 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: 2 hours | 0.7 Milliseconds | Standard Deviation 4.89 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: 6 hours | 5.9 Milliseconds | Standard Deviation 12.19 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: Pre-dose | -1.1 Milliseconds | Standard Deviation 6.89 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: 2 hours | -4.4 Milliseconds | Standard Deviation 8.9 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: 6 hours | 4.17 Milliseconds | Standard Deviation 12.302 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: Pre-dose | 0.34 Milliseconds | Standard Deviation 11.468 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: 4 hours | 1.2 Milliseconds | Standard Deviation 8.15 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: 2 hours | 0.09 Milliseconds | Standard Deviation 14.494 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: 4 hours | 0.1 Milliseconds | Standard Deviation 4.41 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: 2 hours | -2.4 Milliseconds | Standard Deviation 7.9 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: 6 hours | -2.3 Milliseconds | Standard Deviation 6.24 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: 6 hours | 4.5 Milliseconds | Standard Deviation 5.69 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: Pre-dose | -0.5 Milliseconds | Standard Deviation 4.12 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: Pre-dose | -1.6 Milliseconds | Standard Deviation 13.03 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: Pre-dose | 3.2 Milliseconds | Standard Deviation 7.81 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: 2 hours | -1.3 Milliseconds | Standard Deviation 8.73 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: Pre-dose | 3.45 Milliseconds | Standard Deviation 6.785 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: Pre-dose | -7.3 Milliseconds | Standard Deviation 9.2 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: 2 hours | -3.1 Milliseconds | Standard Deviation 8.61 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: 4 hours | -8.3 Milliseconds | Standard Deviation 6.81 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: 6 hours | -2.1 Milliseconds | Standard Deviation 5.82 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: 2 hours | -0.1 Milliseconds | Standard Deviation 8.45 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: 4 hours | -3.1 Milliseconds | Standard Deviation 6.25 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: 6 hours | -0.8 Milliseconds | Standard Deviation 3.7 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: Pre-dose | 5.0 Milliseconds | Standard Deviation 20.49 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: 2 hours | 1.8 Milliseconds | Standard Deviation 12.6 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: 4 hours | -1.7 Milliseconds | Standard Deviation 13.65 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: 6 hours | 0.7 Milliseconds | Standard Deviation 12.92 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: Pre-dose | -0.4 Milliseconds | Standard Deviation 6.87 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: 2 hours | -4.88 Milliseconds | Standard Deviation 17.444 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: 4 hours | 1.30 Milliseconds | Standard Deviation 14.341 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: 6 hours | -1.68 Milliseconds | Standard Deviation 10.181 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: Pre-dose | 4.1 Milliseconds | Standard Deviation 9.23 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: 2 hours | -2.3 Milliseconds | Standard Deviation 12.87 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: 4 hours | 0.6 Milliseconds | Standard Deviation 9 |
| Part 1: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: 6 hours | -0.8 Milliseconds | Standard Deviation 7.79 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: 2 hours | -0.3 Milliseconds | Standard Deviation 6.13 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: Pre-dose | 3.2 Milliseconds | Standard Deviation 2.59 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: 4 hours | -12.3 Milliseconds | Standard Deviation 4.71 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: 6 hours | -9.83 Milliseconds | Standard Deviation 17.489 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: 6 hours | 2.8 Milliseconds | Standard Deviation 6.36 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: 4 hours | 3.8 Milliseconds | Standard Deviation 3.54 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: 2 hours | 6.2 Milliseconds | Standard Deviation 2.59 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: Pre-dose | -3.3 Milliseconds | Standard Deviation 0.94 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: 2 hours | 4.3 Milliseconds | Standard Deviation 1.41 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QRS Duration- Day 7: Pre-dose | 2.3 Milliseconds | Standard Deviation 7.07 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: Pre-dose | -7.3 Milliseconds | Standard Deviation 0.47 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: 2 hours | -12.3 Milliseconds | Standard Deviation 0.47 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: 6 hours | -7.8 Milliseconds | Standard Deviation 9.66 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: Pre-dose | -7.08 Milliseconds | Standard Deviation 2.569 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | PR Interval- Day 7: 4 hours | 4.7 Milliseconds | Standard Deviation 5.19 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: 2 hours | -18.23 Milliseconds | Standard Deviation 2.923 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: 6 hours | 2.7 Milliseconds | Standard Deviation 7.54 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QT Interval- Day 7: 4 hours | 11.2 Milliseconds | Standard Deviation 19.56 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcF Interval- Day 7: 6 hours | -5.8 Milliseconds | Standard Deviation 8.72 |
| Part 2: Placebo | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | QTcB Interval- Day 7: 4 hours | -23.83 Milliseconds | Standard Deviation 2.781 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | -0.24 10^12 cells per liter | Standard Deviation 0.207 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | -0.17 10^12 cells per liter | Standard Deviation 0.216 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | -0.08 10^12 cells per liter | Standard Deviation 0.223 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | -0.30 10^12 cells per liter | Standard Deviation 0 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.28 Picograms | Standard Deviation 0.85 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.05 Picograms | Standard Deviation 0.187 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.02 Picograms | Standard Deviation 0.337 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.05 Picograms | Standard Deviation 0.354 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | -0.2 Femtoliter | Standard Deviation 0.45 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 0.2 Femtoliter | Standard Deviation 0.98 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 0.2 Femtoliter | Standard Deviation 0.98 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | -2.0 Femtoliter | Standard Deviation 2.83 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | -0.0230 Proportion of red blood cells in blood | Standard Deviation 0.01762 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | -0.0123 Proportion of red blood cells in blood | Standard Deviation 0.02096 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | -0.0058 Proportion of red blood cells in blood | Standard Deviation 0.02094 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | -0.0315 Proportion of red blood cells in blood | Standard Deviation 0.01485 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | -8.0 Grams per liter | Standard Deviation 5.1 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | -4.7 Grams per liter | Standard Deviation 6.59 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | -1.7 Grams per liter | Standard Deviation 7.31 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | -8.0 Grams per liter | Standard Deviation 1.41 |
Secondary
Part 2: Change From Baseline in Hematology Parameter: Reticulocytes/Erythro
Blood samples were collected to analyze the hematology parameter: reticulocytes/erythro. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameter: Reticulocytes/Erythro | 0.0030 Percentage of reticulocytes in erythro | Standard Deviation 0.00235 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameter: Reticulocytes/Erythro | 0.0017 Percentage of reticulocytes in erythro | Standard Deviation 0.00258 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameter: Reticulocytes/Erythro | 0.0007 Percentage of reticulocytes in erythro | Standard Deviation 0.0035 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameter: Reticulocytes/Erythro | 0.0020 Percentage of reticulocytes in erythro | Standard Deviation 0.00283 |
Secondary
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Basophils, n=5,6,5,2 | 0.010 10^9 cells per liter | Standard Deviation 0.0141 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Leukocytes, n=5,6,6,2 | 0.34 10^9 cells per liter | Standard Deviation 0.385 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Neutrophils, n=5,6,5,2 | 0.424 10^9 cells per liter | Standard Deviation 0.6401 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Eosinophils, n=5,6,5,2 | -0.066 10^9 cells per liter | Standard Deviation 0.2145 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Platelet count, n=4,6,6,2 | 1.5 10^9 cells per liter | Standard Deviation 45.82 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Lymphocytes, n=5,6,5,2 | 0.006 10^9 cells per liter | Standard Deviation 0.4458 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Monocytes, n=5,6,5,2 | -0.020 10^9 cells per liter | Standard Deviation 0.0869 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Leukocytes, n=5,6,6,2 | 1.62 10^9 cells per liter | Standard Deviation 2.244 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Monocytes, n=5,6,5,2 | 0.022 10^9 cells per liter | Standard Deviation 0.1705 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Lymphocytes, n=5,6,5,2 | -0.062 10^9 cells per liter | Standard Deviation 0.4731 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Neutrophils, n=5,6,5,2 | 1.678 10^9 cells per liter | Standard Deviation 2.1754 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Platelet count, n=4,6,6,2 | 17.5 10^9 cells per liter | Standard Deviation 30.26 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Eosinophils, n=5,6,5,2 | -0.047 10^9 cells per liter | Standard Deviation 0.1775 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Basophils, n=5,6,5,2 | 0.020 10^9 cells per liter | Standard Deviation 0.0237 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Monocytes, n=5,6,5,2 | -0.084 10^9 cells per liter | Standard Deviation 0.1436 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Basophils, n=5,6,5,2 | 0.022 10^9 cells per liter | Standard Deviation 0.0084 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Eosinophils, n=5,6,5,2 | 0.034 10^9 cells per liter | Standard Deviation 0.0404 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Lymphocytes, n=5,6,5,2 | 0.536 10^9 cells per liter | Standard Deviation 0.4766 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Neutrophils, n=5,6,5,2 | 0.432 10^9 cells per liter | Standard Deviation 0.7007 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Leukocytes, n=5,6,6,2 | 0.52 10^9 cells per liter | Standard Deviation 1.211 |
| Part 1: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Platelet count, n=4,6,6,2 | 16.0 10^9 cells per liter | Standard Deviation 21.57 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Lymphocytes, n=5,6,5,2 | -0.110 10^9 cells per liter | Standard Deviation 0.2687 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Platelet count, n=4,6,6,2 | 4.5 10^9 cells per liter | Standard Deviation 0.71 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Leukocytes, n=5,6,6,2 | -0.45 10^9 cells per liter | Standard Deviation 0.071 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Eosinophils, n=5,6,5,2 | 0.020 10^9 cells per liter | Standard Deviation 0 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Basophils, n=5,6,5,2 | -0.005 10^9 cells per liter | Standard Deviation 0.0354 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Neutrophils, n=5,6,5,2 | -0.215 10^9 cells per liter | Standard Deviation 0.3182 |
| Part 2: Placebo | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count | Monocytes, n=5,6,5,2 | -0.130 10^9 cells per liter | Standard Deviation 0.1131 |
Secondary
Part 2: Change From Baseline in Pulse Rate
Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Pulse Rate | 4.2 Beats per minute | Standard Deviation 17.36 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Pulse Rate | 2.0 Beats per minute | Standard Deviation 11.14 |
| Part 1: Placebo | Part 2: Change From Baseline in Pulse Rate | 2.8 Beats per minute | Standard Deviation 6.4 |
| Part 2: Placebo | Part 2: Change From Baseline in Pulse Rate | 10.5 Beats per minute | Standard Deviation 7.78 |
Secondary
Part 2: Change From Baseline in Respiratory Rate
Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Respiratory Rate | -0.2 Breaths per minute | Standard Deviation 1.83 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Respiratory Rate | 0.2 Breaths per minute | Standard Deviation 1.47 |
| Part 1: Placebo | Part 2: Change From Baseline in Respiratory Rate | -1.0 Breaths per minute | Standard Deviation 4.47 |
| Part 2: Placebo | Part 2: Change From Baseline in Respiratory Rate | 0.5 Breaths per minute | Standard Deviation 2.12 |
Secondary
Part 2: Change From Baseline in SBP and DBP
SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in SBP and DBP | SBP | 1.0 Millimeters of mercury | Standard Deviation 8.27 |
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in SBP and DBP | DBP | -1.8 Millimeters of mercury | Standard Deviation 2.4 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in SBP and DBP | DBP | -1.0 Millimeters of mercury | Standard Deviation 6.36 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in SBP and DBP | SBP | -2.2 Millimeters of mercury | Standard Deviation 4.45 |
| Part 1: Placebo | Part 2: Change From Baseline in SBP and DBP | SBP | 7.3 Millimeters of mercury | Standard Deviation 11.55 |
| Part 1: Placebo | Part 2: Change From Baseline in SBP and DBP | DBP | 2.3 Millimeters of mercury | Standard Deviation 15.72 |
| Part 2: Placebo | Part 2: Change From Baseline in SBP and DBP | SBP | 1.0 Millimeters of mercury | Standard Deviation 2.83 |
| Part 2: Placebo | Part 2: Change From Baseline in SBP and DBP | DBP | -0.5 Millimeters of mercury | Standard Deviation 7.78 |
Secondary
Part 2: Change From Baseline in Urinalysis Parameter: pH
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Urinalysis Parameter: pH | 0.17 pH | Standard Deviation 0.683 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Urinalysis Parameter: pH | -0.17 pH | Standard Deviation 0.683 |
| Part 1: Placebo | Part 2: Change From Baseline in Urinalysis Parameter: pH | 0.08 pH | Standard Deviation 0.492 |
| Part 2: Placebo | Part 2: Change From Baseline in Urinalysis Parameter: pH | 0.25 pH | Standard Deviation 0.354 |
Secondary
Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | 0.0010 Ratio | Standard Deviation 0.00746 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | -0.0022 Ratio | Standard Deviation 0.00794 |
| Part 1: Placebo | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | 0.0018 Ratio | Standard Deviation 0.00744 |
| Part 2: Placebo | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | -0.0110 Ratio | Standard Deviation 0.00424 |
Secondary
Part 2: Change From Baseline in Urinalysis Parameter: Urobilinogen
Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1) and Visit 5 (Day 7)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Change From Baseline in Urinalysis Parameter: Urobilinogen | 0.00 Micromoles per liter | Standard Deviation 0 |
| Part 1: GSK3640254 200 mg | Part 2: Change From Baseline in Urinalysis Parameter: Urobilinogen | 4.50 Micromoles per liter | Standard Deviation 6.971 |
| Part 1: Placebo | Part 2: Change From Baseline in Urinalysis Parameter: Urobilinogen | 0.00 Micromoles per liter | Standard Deviation 0 |
| Part 2: Placebo | Part 2: Change From Baseline in Urinalysis Parameter: Urobilinogen | 0.00 Micromoles per liter | Standard Deviation 0 |
Secondary
Part 2: CL/F Following Repeat Dose Administration of GSK3640254 on Day 7
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: CL/F Following Repeat Dose Administration of GSK3640254 on Day 7 | 5360.0526 Milliliter per hour | Geometric Coefficient of Variation 26.8 |
| Part 1: GSK3640254 200 mg | Part 2: CL/F Following Repeat Dose Administration of GSK3640254 on Day 7 | 6764.9862 Milliliter per hour | Geometric Coefficient of Variation 26.7 |
| Part 1: Placebo | Part 2: CL/F Following Repeat Dose Administration of GSK3640254 on Day 7 | 4778.9430 Milliliter per hour | Geometric Coefficient of Variation 27.9 |
Secondary
Part 2: Cmax Following Administration of GSK3640254 on Day 1
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Cmax Following Administration of GSK3640254 on Day 1 | 0.2316 Microgram per milliliter | Geometric Coefficient of Variation 30.5 |
| Part 1: GSK3640254 200 mg | Part 2: Cmax Following Administration of GSK3640254 on Day 1 | 0.4329 Microgram per milliliter | Geometric Coefficient of Variation 33.6 |
| Part 1: Placebo | Part 2: Cmax Following Administration of GSK3640254 on Day 1 | 0.9178 Microgram per milliliter | Geometric Coefficient of Variation 41.5 |
Secondary
Part 2: Cmax Following Repeat Dose Administration of GSK3640254 on Day 7
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Cmax Following Repeat Dose Administration of GSK3640254 on Day 7 | 0.4692 Microgram per milliliter | Geometric Coefficient of Variation 20.6 |
| Part 1: GSK3640254 200 mg | Part 2: Cmax Following Repeat Dose Administration of GSK3640254 on Day 7 | 0.7470 Microgram per milliliter | Geometric Coefficient of Variation 23.7 |
| Part 1: Placebo | Part 2: Cmax Following Repeat Dose Administration of GSK3640254 on Day 7 | 1.8574 Microgram per milliliter | Geometric Coefficient of Variation 26 |
Secondary
Part 2: Ctau Following Repeat Dose Administration of GSK3640254 on Day 7
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Ctau Following Repeat Dose Administration of GSK3640254 on Day 7 | 0.2187 Microgram per milliliter | Geometric Coefficient of Variation 30.1 |
| Part 1: GSK3640254 200 mg | Part 2: Ctau Following Repeat Dose Administration of GSK3640254 on Day 7 | 0.3599 Microgram per milliliter | Geometric Coefficient of Variation 31.1 |
| Part 1: Placebo | Part 2: Ctau Following Repeat Dose Administration of GSK3640254 on Day 7 | 0.7979 Microgram per milliliter | Geometric Coefficient of Variation 34.1 |
Secondary
Part 2: Number of Participants With Non-SAEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per Medical or scientific judgment.
Time frame: Up to Day 12
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Non-SAEs and SAEs | Non-SAEs | 5 Participants |
| Part 1: GSK3640254 10 mg | Part 2: Number of Participants With Non-SAEs and SAEs | SAEs | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 2: Number of Participants With Non-SAEs and SAEs | SAEs | 0 Participants |
| Part 1: GSK3640254 200 mg | Part 2: Number of Participants With Non-SAEs and SAEs | Non-SAEs | 4 Participants |
| Part 1: Placebo | Part 2: Number of Participants With Non-SAEs and SAEs | Non-SAEs | 4 Participants |
| Part 1: Placebo | Part 2: Number of Participants With Non-SAEs and SAEs | SAEs | 1 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Non-SAEs and SAEs | Non-SAEs | 0 Participants |
| Part 2: Placebo | Part 2: Number of Participants With Non-SAEs and SAEs | SAEs | 0 Participants |
Secondary
Part 2: t1/2 Following Repeat Dose Administration of GSK3640254 on Day 7
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: t1/2 Following Repeat Dose Administration of GSK3640254 on Day 7 | NA Hours |
| Part 1: GSK3640254 200 mg | Part 2: t1/2 Following Repeat Dose Administration of GSK3640254 on Day 7 | NA Hours |
| Part 1: Placebo | Part 2: t1/2 Following Repeat Dose Administration of GSK3640254 on Day 7 | NA Hours |
Secondary
Part 2: Tlag Following Administration of GSK3640254 on Day 1
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Tlag Following Administration of GSK3640254 on Day 1 | 0.483 Hours |
| Part 1: GSK3640254 200 mg | Part 2: Tlag Following Administration of GSK3640254 on Day 1 | 0.000 Hours |
| Part 1: Placebo | Part 2: Tlag Following Administration of GSK3640254 on Day 1 | 0.000 Hours |
Secondary
Part 2: Tmax Following Administration of GSK3640254 on Day 1
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Tmax Following Administration of GSK3640254 on Day 1 | 4.4167 Hours |
| Part 1: GSK3640254 200 mg | Part 2: Tmax Following Administration of GSK3640254 on Day 1 | 4.0750 Hours |
| Part 1: Placebo | Part 2: Tmax Following Administration of GSK3640254 on Day 1 | 5.5083 Hours |
Secondary
Part 2: Tmax Following Repeat Dose Administration of GSK3640254 on Day 7
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3640254 10 mg | Part 2: Tmax Following Repeat Dose Administration of GSK3640254 on Day 7 | 4.0583 Hours |
| Part 1: GSK3640254 200 mg | Part 2: Tmax Following Repeat Dose Administration of GSK3640254 on Day 7 | 4.5750 Hours |
| Part 1: Placebo | Part 2: Tmax Following Repeat Dose Administration of GSK3640254 on Day 7 | 4.0750 Hours |