Drug Interaction Study of the Effect on Cyclosporine on Ozanimod and Major Active Metabolites

Exclusion Criteria

• •The presence of any of the following will exclude a subject from enrollment:
• •1. Subject with a seated blood pressure outside 90 to 140 mmHg systolic or 50 to 90 mmHg diastolic at Screening or Day -1.
• •2. Subject with a seated pulse rate outside 55 to 90 beats per minute (bpm) at Screening or Day -1.
• •3. Subject has a presence or history of any abnormality or illness that, in the opinion of the investigator, may affect absorption, distribution, metabolism, or elimination of the IP (or would limit the subject's ability to participate in and complete this clinical study.
• •4. Subject has any condition that confounds the ability to interpret data from the study.
• •5. Subject has a history of alcoholism, drug abuse, or addiction within 24 months prior to Screening.
• •6. Subject has a positive serum test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
• •7. Subject has used any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, electronic cigarettes, vape, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) or marijuana (cigarette, joint, vape, edibles, etc) within 3 months prior to the first dose of IP.
• •8. Subject has a positive urine drug test including cotinine at Screening or Day -1.
• •9. Subject has a positive alcohol urine or breath test at Screening or Day -1.
• •10. Subject has received any investigational drug within 30 days or 5 times the elimination half-life (if known), whichever is longer, prior to the first dose of IP.
• •11. Subject has used any systemic over-the-counter medication (excluding acetaminophen up to 1 g/day), dietary or herbal supplement (excluding vitamins/multivitamins) within 7 days prior to the first dose of IP. Herbal supplements including St. John's wort must be discontinued at least 28 days prior to the first dose of IP.
• •12. Subject has consumed pomelo-variety citrus fruits or juice (including pomelo, grapefruit, Seville oranges) within 7 days prior to the first dose of IP.
• •13. Subject has used any systemic prescription medication (excluding hormonal contraceptives) within 28 days or 5 times the elimination half-life, whichever is longer, prior to the first dose of IP.
• •14. Subject has ingested alcohol within 7 days prior to the first dose of IP.
• •15. Subject fails or is unwilling to abstain from strenuous physical activities for at least 24 hours prior to the first dose of IP.
• •16. Subject has poor peripheral venous access.
• •17. Subject has donated greater than 400 mL of blood within 60 days prior to Day 1.
• •18. Subject has history of hypersensitivity or allergic reaction to sphingosine 1-phosphate (S1P) receptor modulators or cyclosporine.
• •19. Subject with history of any medical condition or medical history that, in the opinion of the investigator, might confound the results of the study or jeopardize the safety or welfare of the subject.