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Name (Synonyms) | Correlation | |
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drug4562 | lung ultrasound (LUS) Wiki | 1.00 |
drug1573 | Formulation without Active Drug Wiki | 1.00 |
drug2916 | Placebo Wiki | 0.04 |
Name (Synonyms) | Correlation | |
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D003141 | Communicable Diseases NIH | 0.07 |
D007239 | Infection NIH | 0.05 |
Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
This is a 6-part study to evaluate the safety, tolerability, and PK of MEDI7219 in healthy subjects. Parts A, B, C & E are the single-dose parts of the study. Parts D & F are the multiple ascending dose (MAD) parts of the study. The starting dose and formulation for Parts D & F will be selected from data emerging from Parts A, B and E. Enrollment of approximately 198 subjects is anticipated.
Description: Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Measure: Number of subjects with Adverse Events as a measure of safety and tolerability of MEDI7219 Time: Baseline to last follow up visit (Parts A and C - Day 28) (Part D & F Day 63) and (Parts B and E 28 days post last dose)Description: PK parameters will be calculated from the plasma concentration versus time data for Cmax (maximum observed concentration)
Measure: Pharmacokinetics of MEDI7219: Cmax Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visitDescription: PK parameters will be calculated from the plasma concentration versus time data for Tmax (time to maximum observed concentration)
Measure: Pharmacokinetics of MEDI7219: Tmax Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visit, Parts F cohort 2 ONLY: Pre-dose and 8 hours post-doseDescription: PK parameters will be calculated from the plasma concentration versus time data for T1/2 (terminal half-life)
Measure: Pharmacokinetics of MEDI7219: t1/2 Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visitDescription: PK parameters will be calculated from the plasma concentration versus time data for AUC (0-inf) [area under the curve (AUC) extrapolated to infinity]
Measure: Pharmacokinetics of MEDI7219: AUC (0-inf) Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visitDescription: PK parameters will be calculated from the plasma concentration versus time data for AUC (0-last) [area under the curve (AUC) from time 0 to last measurable concentration]
Measure: Pharmacokinetics of MEDI7219: AUC(0-last) Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visitDescription: PK parameters will be calculated from the plasma concentration versus time data for (AUC 0-24) [area under the curve (AUC) from time 0 to 24 hours post dose]
Measure: Pharmacokinetics of MEDI7219: AUC(0-24h) Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visitDescription: PK parameters will be calculated from the plasma concentration versus time data for AUC%extrapolated [The percentage of AUC(0-inf) accounted for by extrapolation]
Measure: Pharmacokinetics of MEDI7219: AUC (%extrap) Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only)Description: PK parameters will be calculated from the plasma concentration versus time data for Lambda-z [Slope of the regression line passing through the apparent elimination phase in a concentration vs time plot]
Measure: Pharmacokinetics of MEDI7219: Lambda-z Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only)Description: PK parameters will be calculated from the plasma concentration for CL/F (apparent clearance)
Measure: Pharmacokinetics of MEDI7219: CL/F Time: Pre-dose to 144 hours post-dose (Parts A, B and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only)Description: PK parameters will be calculated from the plasma concentration for Vz/F (volume of distribution)
Measure: Pharmacokinetics of MEDI7219: Vz/F Time: Pre-dose to 144 hours post-dose (Parts A, B and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Pre-dose to Day 63/EOS visit (Parts D & F)Description: PK parameters will be calculated from the plasma concentration for Frel (relative bioavailability)
Measure: Pharmacokinetics of MEDI7219: Frel Time: Pre-dose to 144 hours post-dose (Parts B and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only)Description: PK parameters will be calculated from the plasma concentration for Vd (volume of distribution)
Measure: Pharmacokinetics of MEDI7219: Vd Time: Pre-dose to 144 hours (Part C)Description: PK parameters will be calculated from the plasma concentration for F (absolute bioavailability)
Measure: Pharmacokinetics of MEDI7219: F Time: Pre-dose to 144 hours (Part C )Description: PK parameters will be calculated from the plasma concentration versus time data for AUC (0-tau) [area under the curve (AUC) for a dosing interval]
Measure: Pharmacokinetics of MEDI7219: AUC (0-tau) Time: Pre-dose to Day 63/EOS visit (Parts D & F)Description: Presence of Anti-drug antibody to MEDI7219
Measure: Immunogenicity Time: Day -1 to Day 28/EOS Visit (Parts A and C); Day -1 to Day 63/EOS Visit (Parts D & F); Day -1 to 28 days post last dose of final period/EOS Visit (Parts B and E)Description: PK parameters will be calculated from the plasma concentration versus time data for Cmax (maximum observed concentration)
Measure: Pharmacokinetics of Formulation Component: Cmax Time: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)Description: PK parameters will be calculated from the plasma concentration versus time data for Tmax (time to maximum observed concentration)
Measure: Pharmacokinetics of Formulation Component: Tmax Time: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)Description: PK parameters will be calculated from the plasma concentration versus time data for T1/2 (terminal half-life)
Measure: Pharmacokinetics of Formulation Component: T(1/2) Time: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)Description: PK parameters will be calculated from the plasma concentration versus time data for AUC (0-inf) [area under the curve (AUC) extrapolated to infinity]
Measure: Pharmacokinetics of Formulation Component: AUC (0-inf) Time: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)Description: PK parameters will be calculated from the plasma concentration versus time data for AUC (0-last) [area under the curve (AUC) from time 0 to last measurable concentration]
Measure: Pharmacokinetics of Formulation Component: AUC (0-last) Time: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)Description: PK parameters will be calculated from the plasma concentration versus time data for (AUC 0-24) [area under the curve (AUC) from time 0 to 8 hours post dose]
Measure: Pharmacokinetics of Formulation Component: AUC (0-8h) Time: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)Description: PK parameters will be calculated from the plasma concentration from CL (apparent clearance)
Measure: Pharmacokinetics of MEDI7219: CL Time: Pre-dose to 144 hours post-dose (Part C)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