Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07453784
PHASE1

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

Sponsor: Abivax S.A.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2026-03-03

Completion Date

2026-10

Last Updated

2026-04-06

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Obefazimod 50 mg Capsule

Adult formulation

DRUG

Obefazimod Minitablet 50 mg

Pediatric formulation

Locations (1)

Quotient Sciences

Nottingham, United Kingdom