At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Obefazimod 50 mg Capsule (drug), Obefazimod Minitablet 50 mg (drug)
- How long the study runs
- Study runs about 7 months (dates as stated)
- About the drug or intervention
- Obefazimod 50 mg Capsule — drug: Adult formulation · Obefazimod Minitablet 50 mg — drug: Pediatric formulation
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 55 Years
- Who
- All
- Number of participants
- 44
- Started
- 2026-03-03
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for healthy
- • Phase1 - 44 participants
- • The sponsor is developing a pediatric minitablet formulation as part of the overall pharmaceutical development strategy
Who can take part?
- • Ages 18 Years to 55 Years
- • Diagnosed with healthy
Where?
- • Nottingham - Quotient Sciences
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 55 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Aged 18 to 55 years inclusive at the time of signing agreement to take part
- ✓Must agree to adhere to the contraception requirements.
- ✓Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- ✓Weight ≥50 kg at screening Inclusion criteria.
Who cannot take part
- ✗Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.
- ✗History of clinically significant cardiovascular, kidney, liver, dermatological, respiratory or GI disease,...
- ✗Participants with a history of cholecystectomy or gall stones
- ✗Participants with chronic or recurrent infection
- ✗Participants who have tested positive for tuberculosis
See the full criteria
Where Is This Study? (1 UK site)
Quotient Sciences
Nottingham NG11 6JS, United Kingdom
How to Get in Touch
Josianne Nitcheu
Sponsor contactCONTACT
