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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Adult formulation
Pediatric formulation
Quotient Sciences
Nottingham, United Kingdom
RECRUITINGMaximum Plasma Concentration (Cmax)
Cmax of obefazimod in the Minitablet and Capsule regimens
Time frame: Up to 336 hours post-dose (Day 15) at each period
Area under the plasma concentration versus time curve from time zero up to the last measurable concentration (AUC (0-last)
AUC (0-last) of obefazimod in the Minitablet and Capsule regimens
Time frame: Up to 336 hours post-dose (Day 15) at each period
Area under the plasma concentration versus time curve up from time zero to infinity [AUC(0-inf)]
AUC(0-inf) of obefazimod in the Minitablet and Capsule regimens
Time frame: Up to 336 hours post-dose (Day 15) at each period
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