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Clinical Trials, and HPO
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There is one clinical trial.
This is a Phase 1, double-blind, randomized, placebo-controlled, first time in human (FTIH) study to assess the safety, tolerability and PK of a single dose of GSK3494245. The study will consist of 3 cohorts, conducted in a sequential manner. Cohorts 1 and 2 will consist of a single ascending dose (SAD), crossover design where each participant will receive a maximum of 3 ascending oral doses of GSK3494245 and 1 placebo dose under fasted conditions. At each dose level, GSK3494245 and placebo will be administered in a 3:1 ratio, within each period, according to the randomization schedule in a blinded manner. Cohort 3 will comprise of a 2-way crossover which includes 1 dosing regimen under fasted then fed conditions and 1 regimen under fed then fasted conditions in a 1:1 ratio. The fed conditions will investigate the effect of safety, tolerability and PK of a single dose of GSK3494245 following food administration.
Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose: results in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Measure: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Time: Up to 14 days post last dose in each treatment periodDescription: Treatment emergent AE and SAE are any untoward medical occurrences in a clinical study participant, having causal relation with the use of a study intervention.
Measure: Number of participants with treatment emergent AEs and SAEs Time: Up to 14 days post last dose in each treatment periodDescription: Blood samples will be collected for the assessment of hematology parameters.
Measure: Number of participants with clinically significant abnormal findings in hematology parameters Time: Up to 14 days post last dose in each treatment periodDescription: Blood samples will be collected for the assessment of chemistry parameters
Measure: Number of participants with clinically significant abnormal findings in clinical chemistry parameters Time: Up to 14 days post last dose in each treatment periodDescription: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Number of participants with urinalysis findings Time: Up to 14 days post last dose in each treatment periodDescription: Number of participants with abnormal vital signs will be assessed.
Measure: Number of participants with clinically significant abnormal findings in vital signs Time: Up to 14 days post last dose in each treatment periodDescription: Triplicate 12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS interval, QT interval, Corrected QT (QTc) interval.
Measure: Number of participants with clinically significant abnormal findings in Electrocardiogram (ECG) Parameters Time: Up to 14 days post last dose in each treatment periodDescription: Telemetry is the continuous monitoring of a participants heart rate and rhythm from a remote location. Continuous cardiac telemetry will start in a supine position after at least 5 minutes rest.
Measure: Number of participants with abnormal cardiac telemetry findings Time: Up to 24 hours post dose on Day 1Description: Blood samples will be collected at the indicated time points to evaluate AUC (0-t) of GSK3494245 under fasting condition.
Measure: Area under the plasma drug concentration (AUC) versus time curve (AUC[0-t]) of GSK3494245 following single dose administration under fasting condition Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 minutes [min], 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate AUC (0-t) of GSK3494245 under fed condition.
Measure: AUC (0-t) of GSK3494245 following single dose administration under fed condition Time: Cohort 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate AUC (0-inf) of GSK3494245 under fasting condition.
Measure: AUC-time curve from time zero to extrapolated to infinity (AUC[0-inf]) of GSK3494245 following single dose administration under fasting condition Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate AUC(0-inf) of GSK3494245 under fed condition.
Measure: AUC (0-inf) of GSK3494245 following single dose administration under fed condition Time: Cohort 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate Cmax of GSK3494245 under fasting condition.
Measure: Maximum observed plasma drug concentration (Cmax) of GSK3494245 following single dose administration under fasting condition Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate Cmax of GSK3494245 under fed condition.
Measure: Cmax of GSK3494245 following single dose administration under fed condition Time: Cohort 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate Tmax of GSK3494245 under fasting condition.
Measure: Time to maximum observed plasma drug concentration (Tmax) of GSK3494245 following single dose administration under fasting condition Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate Tmax of GSK3494245 under fed condition.
Measure: Tmax of GSK3494245 following single dose administration under fed condition Time: Cohort 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate t1/2 of GSK3494245.
Measure: Apparent terminal half-life (t1/2) of GSK3494245 following single dose administration under fasting condition Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate t1/2 of GSK3494245.
Measure: t1/2 of GSK3494245 following single dose administration under fed condition Time: Cohort 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Urine samples will be collected at the indicated time points to evaluate Ae0-24h of GSK3494245.
Measure: Amount of GSK3494245 excreted in urine over 24 hours (Ae0-24h) following single dose administration Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Urine samples will be collected at the indicated time points to evaluate fe% of GSK3494245
Measure: Fraction of dose excreted in urine over 24 hours (fe%) of GSK3494245 following single dose administration Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Urine samples will be collected at the indicated time points to evaluate CLr of GSK3494245.
Measure: Renal Clearance (CLr) of GSK3494245 following single dose administration Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate AUC(0-inf) of GSK3494245.
Measure: Dose-proportionality assessment using AUC(0-inf) following single dose of GSK3494245 Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Description: Blood samples will be collected at the indicated time points to evaluate Cmax of GSK3494245.
Measure: Dose-proportionality assessment using Cmax following single dose of GSK3494245 Time: Cohort 1, 2 and 3: Day 1 (Pre-dose, 10 min, 30 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hour post dose in each treatment period)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports