Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAbivax S.A.
About this trial
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.
Eligibility criteria
Qualifiers
Aged 18 to 55 years inclusive at the time of signing informed consent
Must agree to adhere to the contraception requirements.
Healthy male or non-pregnant, non-lactating female participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG and laboratory safety tests without any clinically significant abnormalities
Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
Disqualifiers
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.
History of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator
Participants with a history of cholecystectomy or gall stones
Participants with chronic or recurrent infection
Trial design
Treatments tested in this trial
- Obefazimod 50 mg Capsule
- Obefazimod Minitablet 50 mg
Treatment groups
44 Participants
are divided into 2 treatment groupsSponsors and collaborators
Abivax S.A.
Lead sponsor
Quotient Sciences
Collaborator
Source ClinicalTrials.gov