Clinical Trial

Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation

Recruiting Phase 1
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-07
Trial Details
NCT Number NCT07453784
Lead Sponsor Abivax S.A.
Collaborators: Quotient Sciences
Conditions Healthy
Enrollment 44 participants
Start Date 2026-03-03
Primary Completion 2026-09 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-04-06