Name (Synonyms) | Correlation | |
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drug965 | Formulation without Active Drug Wiki | 1.00 |
drug1575 | Nasopharyngeal swab Wiki | 0.58 |
drug1822 | Placebo Wiki | 0.06 |
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)