Drug-drug Interaction Study of Ozanimod With Pseudoephedrine to Evaluate the Effect on Blood Pressure and Heart Rate

Exclusion Criteria

• •1. Subject has clinically significant electrocardiogram (ECG) and cardiovascular symptoms at Screening.
• •2. 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 study drugs or would limit the subject's ability to participate in and complete this clinical study.
• •3. Subject has a history of clinically significant or unstable vascular disease, or a history of syncope associated with hypotension within the last 2 years or a history of orthostatic hypotension (or SBP decrease of ≥ 20 mmHg 2 minutes after standing compared with supine SBP).
• •4. Subject with a seated pulse rate outside 55 to 90 beats per minute (bpm) at Screening or Day -2.
• •5. Subject with a resting Fridericia-corrected interval between Q and T wave in the heart's electrical cycle (QTcF) \> 450 msec (males) or \> 470 msec (females) or interval from the beginning of the P wave to the beginning of the QRS complex (PR) \> 200 msec at Screening.
• •6. Subject has a history of alcoholism, drug abuse, or addiction within 24 months prior to Screening.
• •7. Subject has a positive serum test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at Screening.
• •8. Subject has used any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, vape, electronic cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 3 months prior to the first dose of IP.
• •9. Subject has consumed any marijuana products within 3 months prior to the first dose of IP.
• •10. Subject has a positive urine drug test including cotinine at Screening or Day -2.
• •11. Subject has a positive alcohol urine or breath test at Screening or Day -2.
• •12. 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.
• •13. Subject has used any systemic over-the-counter medication (excluding acetaminophen up to 1 g/day), dietary or herbal supplement (excluding vitamins/multi-vitamins) within 7 days prior to the first dose of IP. St. John's wort must be discontinued at least 28 days prior to the first dose of IP.
• •14. 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.
• •15. Subject has used any known MAO inhibitors within 90 days prior to the first dose of IP. 16. Subject has a history of allergic reaction to pseudoephedrine or ozanimod.
• •17\. Subject has ingested alcohol within 7 days prior to the first dose of IP. 18. Subject plans or will participate in strenuous physical activities during the 24-hour period prior to the first dose of IP.
• •19\. Subject has poor peripheral venous access. 20. Subject has donated greater than 400 mL of blood within 60 days prior to the first dose of IP.
• •21\. Subject has a history of any 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.