Pharmacokinetics and palatability of a 50 mg obefazimod minitablet versus the adult capsule

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

This trial will test whether a 50 mg obefazimod minitablet gives similar blood levels to the 50 mg adult capsule and how well it can be taken with water or soft foods in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Abivax S.A. (Industry-sponsored)
• Locations: 1 site (Nottingham)
• Trial ID: NCT07453784 on ClinicalTrials.gov

What this trial studies

This single-center, open-label, two-part Phase 1 study enrolls healthy adult volunteers to compare the pharmacokinetics and palatability of a 50 mg obefazimod minitablet with the marketed 50 mg capsule. Part 1 will administer single doses to determine a minitablet dose that produces systemic exposures (Cmax and AUC) comparable to the adult capsule. Part 2 will examine the 50 mg minitablet taken with water or mixed into soft foods (applesauce, yogurt, or chocolate pudding) to evaluate relative bioavailability versus the capsule taken without a vehicle. Formulation development was guided by in vitro dissolution testing and physiologically based biopharmaceutics modeling to match adult capsule exposure.

Who should consider this trial

Good fit: Healthy men and nonpregnant, non-lactating women aged 18–55 years with BMI 18.0–32.0 kg/m2 and weight ≥50 kg who meet screening requirements and agree to contraception rules.

Not a fit: People with significant cardiovascular, renal, hepatic, gastrointestinal, neurological, or psychiatric disease, a history of gallstones or cholecystectomy, chronic/recurrent infections, or children are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the minitablet could provide a pediatric-friendly formulation that delivers the same drug exposure as the adult capsule and is easier for children to swallow or take with soft foods.

How similar studies have performed: Formulation-bridging and food-effect PK studies are common and often succeed in matching exposures for other drugs, but the obefazimod pediatric minitablet itself is a novel formulation that has not yet been proven.

Eligibility criteria

Inclusion Criteria:

* 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
* Weight ≥50 kg at screening Inclusion criteria.

Exclusion Criteria:

* 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
* Participants who have tested positive for tuberculosis
* Participants with a history of shingles within the last two months
* History of opportunistic infection while not on immunosuppressive therapy
* Part 2 only: Participant has a medical condition that may adversely affect taste or smell activity including but not limited to mouth ulcers, significant gum disease, and respiratory and/or sinus infection or cold
* Part 2 only: Participant does not agree to the consumption of, or has any known allergies to any of the food vehicles used in this study (applesauce, chocolate pudding, yogurt)
* Participants who have received any IMP (Investigational Medicinal Product) in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
* Participants who have previously been administered IMP in this study
* Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
* Participants who are taking, or have taken, any prescribed or over-the-counter drug, hormone replacement therapy (HRT) or herbal remedies (other than up to 4 g of paracetamol per day and hormonal contraception) in the 14 days or 5 elimination half-lives, whichever is longer, before first IMP administration (see Section 11.4). Exceptions may apply, as determined by the investigator
* Having any vaccination or planned vaccination within 28 days before Day 1. Participants who received live vaccine within 3 months prior to screening and/or who are planning to receive such a vaccine during the study duration.
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption in males \>21 units per week and in females \>14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
* Current smokers and those who have smoked within the last 12 months
* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
* Confirmed positive drugs of abuse test result at screening or admission

Where this trial is running

Nottingham

• Quotient Sciences — Nottingham, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Josianne Nitcheu

Conditions Healthy; Healthy participants; obefazimod; minitablet