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MEDI7219Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)


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

Correlated MeSH Terms (5)


Name (Synonyms) Correlation
D011565 Psoriasis NIH 1.00
D003141 Communicable Diseases NIH 0.09
D007239 Infection NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0003765 Psoriasiform dermatitis HPO 1.00

There is one clinical trial.

Clinical Trials


1 A Phase 1 Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI7219 in Healthy Subjects, Including Assessment of the Impact of Changes to the Oral Formulation and Determination of Intravenous Pharmacokinetics

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.

NCT03362593 Healthy Volunteers Drug: MEDI7219 Drug: Placebo Drug: Formulation without Active Drug

Primary Outcomes

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)

Secondary Outcomes

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 visit

Description: 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-dose

Description: 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 visit

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 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 visit

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 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 visit

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 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 visit

Description: 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)


No related HPO nodes (Using clinical trials)