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

Exclusion Criteria19

• 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