HV Study to Evaluate the PK, Safety & Tolerability of MEDI7219 117903
Research type
Research Study
Full title
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
IRAS ID
234714
Contact name
Meena Jain
Contact email
Sponsor organisation
MedImmune Limited, a wholly owned subsidary of AstraZeneca
Eudract number
2017-003554-16
Duration of Study in the UK
0 years, 7 months, 17 days
Research summary
The Sponsor is developing the study drug, MEDI7219, for the potential treatment of type 2 diabetes. The study drug will be a tablet taken by mouth, the currently available medication is taken as a daily or weekly injection. Injections can be uncomfortable and inconvenient, so MEDI7219 is being developed to help with convenience of taking the medicine and to help people stick to their treatment.
The study is a first in human, single and multiple ascending dose study designed to identify the safety, tolerability and pharmacokinetics (how the drug moves through the body) of MEDI7219, following being given by mouth (Part A, B and D) and into the vein (Part C). The study will also look at the impact of changes to the tablet taken by mouth.
The study will consist of 4 parts involving approximately 106 healthy male and female subjects (and up to 80 additional subjects). In Part A, 6 cohorts of 10 subjects each (with an optional 2 cohorts) will be randomized to receive MEDI7219 or one of two placebos. Each cohort will receive a different formulation of the study drug.
In part B a single cohort of 16 subjects (with an optional second cohort) will receive a different formulation of MEDI1729 per period in up to 5 periods. These formulations will be decided by a review of the data from part A.
In Part C, 12 subjects will receive a single intravenous dose (injection into the vein) of MEDI7219. The dose will be decided based on data from Part A.
In Part D, one cohort of 18 subjects (with an optional second cohort) will be randomized to receive MEDI7219 or placebo. Subjects will start on a dose decided based on data from previous parts and will receive ascending doses for 20 days.
REC name
HSC REC B
REC reference
17/NI/0215
Date of REC Opinion
14 Nov 2017
REC opinion
Favourable Opinion