Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation
brief summary
The sponsor is developing a pediatric minitablet formulation as part of the overall pharmaceutical development strategy. In vitro dissolution and physiological-based bio-pharmaceutics modelling and simulation have been used to guide the development of the mini-tablet formulation to match the PK exposure of the adult capsule formulation. The study aims to investigate the relative bioavailability of the 50mg minitablet compared to the adult obefazimod 50 mg capsule in adult healthy volunteers.
detailed description
This is a single center, open-label, two-part study in healthy male and female participants.
Part 1 of this study aims to investigate the PK properties of single dose of obefazimod 50 mg minitablet formulation and to identify a dose that provides systemic exposures (Cmax and AUC) comparable to that of the adult clinical obefazimod 50 mg capsule formulation.
In part 2, the minitablet formulation will be administered with a soft food vehicle (applesauce, yogurt or chocolate pudding or water) to investigate the relative bioavailability of the 50mg minitablet mixed with water or soft foods compared to the adult obefazimod 50 mg capsule administered with no vehicle.
official title
Two-Part, Open-Label Study to Evaluate Single Dose Pharmacokinetics of an Obefazimod Minitablet Formulation, Estimate the Relative Bioavailability of the Minitablet Formulation and to Evaluate Minitablet Palatability in Healthy Participants