Actively Recruiting
Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation
Led by Abivax S.A. · Updated on 2026-04-06
44
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
A
Abivax S.A.
Lead Sponsor
Q
Quotient Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 based on medical history, physical exam, vital signs, ECG, and lab safety tests without clinically significant abnormalities
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- Weight 60 kg at screening
You will not qualify if you...
- Presence or history of clinically significant allergy requiring treatment
- History of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory or gastrointestinal disease, neurological or psychiatric disorder
- History of cholecystectomy or gall stones
- Chronic or recurrent infection
- Tested positive for tuberculosis
- History of shingles within the last two months
- History of opportunistic infection while not on immunosuppressive therapy
- Part 2 only: Medical conditions affecting taste or smell including mouth ulcers, significant gum disease, respiratory or sinus infection, or cold
- Part 2 only: Allergy or refusal to consume any of the food vehicles used (applesauce, chocolate pudding, yogurt)
- Received any investigational medicinal product in clinical research within 90 days or less than 5 elimination half-lives before Day 1
- Previously administered investigational medicinal product in this study
- Blood or plasma donation within the previous 3 months or loss of more than 400 mL of blood
- Taking prescribed or over-the-counter drugs, hormone replacement therapy, or herbal remedies (except up to 4 g paracetamol per day and hormonal contraception) within 14 days or 5 elimination half-lives before first dose
- Any vaccination or planned vaccination within 28 days before Day 1, or live vaccine within 3 months prior to screening or planned during study
- History of drug or alcohol abuse in the past 2 years
- Regular alcohol consumption exceeding 21 units per week for males or 14 units per week for females
- Current smokers or those who have smoked within the last 12 months
- Current users of e-cigarettes or nicotine replacement products or used within last 12 months
- Positive drug abuse test at screening or admission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Quotient Sciences
Nottingham, United Kingdom, NG11 6JS
Actively Recruiting
Research Team
J
Josianne Nitcheu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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