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Sections: Correlations,
Clinical Trials, and HPO
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| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, first time in human (FTIH) study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and pharmacokinetics (PK) of GSK3882347 in healthy adult men and Woman of Non Childbearing Potential (WONCBP). Part 1 will be the single ascending dose (SAD) phase and Part 2 will be the multiple ascending dose (MAD) phase. Each participant in the SAD cohort will receive a single dose of GSK3882347 or placebo (PBO) in 3:1 ratio and in Part 2 (MAD), participants will be randomized in a 4:1 ratio to receive active treatment and placebo. Part 1 will consist of two cohorts with a maximum of four-period for each cohort, the food effect evaluation will be conducted in last period (Period 4) in only one of the cohorts based on the observed human pharmacokinetics (PK). Part 2 will consist of maximum of four cohorts for each of the MAD dose or placebo.
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.
Measure: Part 1: Number of participants with Adverse events (AEs) Time: Up to Week 15Description: 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.
Measure: Part 2: Number of participants with AEs Time: Up to Week 4Description: Treatment related AE is any untoward medical occurrence in a clinical study participant, having causal relation with the use of a study intervention.
Measure: Part 1: Number of participants with treatment related AEs Time: Up to Week 15Description: Treatment related AE is any untoward medical occurrence in a clinical study participant, having causal relation with the use of a study intervention.
Measure: Part 2: Number of participants with treatment related AEs Time: Up to Week 4Description: Number of participants with clinically significant abnormal findings in hematology parameters will be assessed.
Measure: Part 1: Number of participants with clinically significant abnormal findings in hematology parameters Time: Up to Week 15Description: Number of participants with clinically significant abnormal findings in hematology parameters will be assessed.
Measure: Part 2: Number of participants with clinically significant abnormal findings in hematology parameters Time: Up to Week 4Description: Number of participants with clinically significant abnormal findings in clinical chemistry parameters will be assessed.
Measure: Part 1: Number of participants with clinically significant abnormal findings in clinical chemistry parameters Time: Up to Week 15Description: Number of participants with clinically significant abnormal findings in clinical chemistry parameters will be assessed.
Measure: Part 2: Number of participants with clinically significant abnormal findings in clinical chemistry parameters Time: Up to Week 4Description: Number of participants with abnormal urinalysis parameters will be assessed.
Measure: Part 1: Number of participants with abnormal urinalysis results Time: Up to Week 15Description: Number of participants with abnormal urinalysis parameters will be assessed.
Measure: Part 2: Number of participants with abnormal urinalysis results Time: Up to Week 4Description: Number of participants with clinically significant abnormal vital signs will be assessed.
Measure: Part 1: Number of participants with clinically significant abnormal vital signs Time: Up to Week 15Description: Number of participants with clinically significant abnormal vital signs will be assessed.
Measure: Part 2: Number of participants with clinically significant abnormal vital signs Time: Up to Week 4Description: Number of participants with abnormal ECG parameters will be assessed.
Measure: Part 1: Number of participants with clinically significant abnormal Electrocardiogram (ECG) findings Time: Up to Week 15Description: Number of participants with abnormal ECG parameters will be assessed.
Measure: Part 2: Number of participants with clinically significant abnormal ECG findings Time: Up to Week 4Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: Area under the concentration-time curve from time zero to 24 hours after dosing (AUC [0-24]) of GSK3882347 single dose Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hour post dose in each treatment period]Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of GSK3882347 single dose Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: AUC extrapolated from time zero to infinity (AUC[0-inf]) of GSK3882347 single dose Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: Maximum plasma concentration (Cmax) of GSK3882347 single dose (nanograms per milliliter) Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: Plasma concentrations at 24 hours after dosing (C24h) of GSK3882347 single dose Time: Day 1: 24 hour post dose in each treatment periodDescription: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: Time to Cmax (Tmax) of GSK3882347 single dose Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: Lag time for absorption (tlag) of GSK3882347 single dose Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: Terminal elimination half-life (T1/2) of GSK3882347 single dose Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 2: AUC over the dosing interval tau (AUC[0-tau]) of GSK3882347 repeat dose Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hour post dose]Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 2: Cmax of GSK3882347 repeat dose Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hour post dose]Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 2: Tmax of GSK3882347 repeat dose Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hour post dose]Description: Plasma samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 2: Plasma concentrations over the dosing interval (Ctau) of GSK3882347 repeat dose Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hour post dose]Description: Urine samples will be collected at indicated time points for the assessment of urinary concentration.
Measure: Part 1: Urine concentration at 22-24 hours collection time point Time: Day 1 [22-24 hours post dose in each treatment period]Description: Urine samples will be collected at indicated time points for the assessment of urinary concentration.
Measure: Part 2: Urine concentration at 22-24 hours collection time point Time: Days 1 and 7 [22-24 hours post dose]Description: Urine samples will be collected at indicated time intervals for the assessment of amount excreted in urine of unchanged GSK3882347.
Measure: Part 1: Amount excreted in urine (Ae) of unchanged GSK3882347 Time: Day 1 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48- 60, 60-72, 72-84, and 84-96 hour post dose in each treatment period]Description: Urine samples will be collected at indicated time intervals for the assessment of amount excreted in urine of unchanged GSK3882347.
Measure: Part 2: Amount excreted in urine (Ae) of unchanged GSK3882347 Time: Days 1 and 7 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hour post dose]Description: Urine samples will be collected at indicated time points for the assessment of fraction of the dose excreted in urine GSK3882347.
Measure: Part 1 Fraction of the dose excreted in urine (fe) following single dose GSK3882347 Time: Day 1 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48- 60, 60-72, 72-84, and 84-96 hours post dose in each treatment period]Description: Urine samples will be collected at indicated time points for the assessment of fraction of the dose excreted in urine GSK3882347.
Measure: Part 2: Fraction of the dose excreted in urine (fe) following single dose GSK3882347 Time: Days 1 and 7 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 post dose in each of the 4 cohorts]Description: Urine samples will be collected at indicated time points for the assessment renal clearance of GSK3882347.
Measure: Part 1: Renal clearance (CLr) following single dose GSK3882347 Time: Day 1 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48- 60, 60-72, 72-84, and 84-96 hours post dose]Description: Urine samples will be collected at indicated time points for the assessment renal clearance of GSK3882347.
Measure: Part 2: Renal clearance (CLr) following single dose GSK3882347 Time: Days 1 and 7 [0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 post dose]Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: AUC from time zero to 12 hours after dosing (AUC[0-12]) following single dose of GSK3882347 Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hour post dose in each treatment period]Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: Plasma concentrations at 12 hours (C12) following single dose of GSK3882347 Time: Day 1 [12 hour post dose in each treatment period]Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: Apparent oral clearance (CL/F) following single dose of GSK3882347 Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: Apparent volume of distribution after non-intravenous administration (Vd/F) following single dose of GSK3882347 Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 1: Mean residence time (MRT) following single dose of GSK3882347 Time: Day 1 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72, and 96 hour post dose in each treatment period]Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 2: AUC[0-12] following repeat dose of GSK3882347 Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, and 12, hour post dose]Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 2: C12 following repeat dose of GSK3882347 Time: Days 1 and Day 7 [12 hour post dose]Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347.
Measure: Part 2: Observed accumulation ratio (Ro) using AUC(0-tau) following repeat dose of GSK3882347 Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24, hour post dose]Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3882347. The time invariance will be estimated by calculating the ratio of AUC(0-tau) on Day 7 to AUC(0-inf) on Day 1.
Measure: Part 2: Time invariance of GSK3882347 using AUC(0-tau) (repeat dose) and AUC(0-inf) (single dose) Time: Days 1 and 7 [Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, and 24, hour post dose]Description: Blood samples will be collected at indicated time points to confirm achievement of steady-state of GSK3882347 after repeated dosings.
Measure: Part 2: Plasma concentrations over the dosing interval (Ctau) of GSK3882347 after repeat doses Time: Pre-dose on Days 3 through 7Alphabetical 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