PK study of modified ALXN2050 formulations compared to a reference formulation (QSC205131)
A Two-Part Phase 1 Study to Evaluate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants
Alexion Pharmaceuticals, Inc.
The Sponsor is developing new formulations (recipes) of the test medicine, ALXN2050, for the potential treatment of diseases related to excessive immune system activation. Examples include paroxysmal nocturnal hemoglobinuria, a disease which is characterised by destruction of red blood cells and impaired bone marrow function, and generalized myasthenia gravis, a disease that causes weakness in the skeletal muscles.\n\nThis two-part healthy volunteer study aims to identify the pharmacokinetics (what the body does to the drug) of the test medicine when given as different recipes and how these recipes are taken up by the body compared to a reference product. \n\nThis study will take place at one non-NHS site, enrolling up to 45 male and female volunteers aged 18-55. Different volunteers will be enrolled in Part 1 and Part 2.\n\nIn Part 1, up to 30 volunteers will be split into 2 cohorts. Each cohort will receive up to 6 oral doses of the test medicine as different recipes on 6 separate occasions. The recipes will be at different dose levels and given in the fasted or fed state. There will be a minimum 7-day break between each dose. Volunteers will be discharged on Day 5 at the end of each study period.\n\nPart 2 is optional. Up to 15 volunteers will receive single oral doses of a test medicine recipe (selected based on Part 1 results) for six consecutive days, in the fasted or fed state. Volunteers will be discharged on Day 10.\n\nAll volunteers will return for a follow-up visit 7-9 days post final dose.\n\nVolunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. \n\nVolunteers are expected to be involved in this study for approximately 15 weeks from screening to the follow-up visit in Part 1, and approximately 6 weeks in Part 2.
London - Surrey Borders Research Ethics Committee
Date of REC Opinion
15 Mar 2023
Further Information Favourable Opinion