Determine PK Profiles of Ozanimod and Its' Major Metabolites in Healthy Subjects

Launched by CORIUM INNOVATIONS, INC. · Jul 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Ozanimod, which is used to treat conditions like Multiple Sclerosis and Ulcerative Colitis. The researchers want to find out if a new way of delivering the drug through a skin patch (called a transdermal delivery system) is more effective and safer than taking it in a pill form (known as Zeposia). Participants in the study will either wear a patch on their arm for a week or take a single capsule. Throughout the trial, blood samples will be taken to measure how much of the drug is in their system, and the researchers will also check for any skin reactions.

To be eligible for this trial, participants should be between 18 and 55 years old, weigh no more than 120 kg, and be in good health. They must also be able to understand the study and give their consent in writing. Participants can expect to be closely monitored during the study, and those with certain health issues or risks may not be able to join. This study is currently looking for volunteers, and it's a great opportunity to contribute to medical research while helping to find potential improvements in treatment methods.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject age between 18 to 55 years old.
• • 2. Subject body weight ≤ 120 kg, with a BMI within 18-30 kg/m2.
• • 3. Subject is able to complete the clinical study including the follow-up.
• • 4. Subject is capable of providing written informed consent.
• Exclusion Criteria:
• • 1. Breastfeeding female.
• • 2. Pregnancy test positive female.
• • 3. At rest systolic blood pressure outside 90-140 mmHg or diastolic blood pressure outside 50-90 mmHg.
• • 4. At rest sinus bradycardia defined as symptomatic heart rate \< 50 bpm, or asymptomatic heart rate \< 45 bpm; and sinus tachycardia defined as heart rate \> 100 bpm.
• • 5. Clinically significant ECG abnormalities or Participant with history or presence of second-degree atrioventricular (AV) block Type II or third-degree AV block or sick sinus syndrome unless the patient has a functioning pacemaker.
• • 6. QTc \> 450 ms for male and \> 460 ms for female.
• • 7. A history of allergies, or any significant adverse reactions, to any medications, unless the clinician considers that they are not clinically significant.
• • 8. Clinically significant medical history of eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, genitourinary, neurological, haematopoietic, lymphatic, endocrine, metabolic, dermatological, musculoskeletal, psychological, family history or surgical history.
• • 9. Family history of sudden cardiac death.
• • 10. Clinically significant physical examination finding.
• • 11. Clinically significant laboratory abnormalities.
• • 12. Haemoglobin \< 12.0 g/dL for male and \< 11.0 g/dL for female at screening.
• • 13. Total bilirubin \> 1.25 x upper limit of normal (unless it is an isolated elevation where the direct bilirubin is ≤ 35% of total), ALT/AST \> 1.5 x upper limit of normal, or CK \> 2 x upper limit of normal.
• • 14. Hepatitis B, Hepatitis C or HIV positive.
• • 15. Urine DOA test positive.
• • 16. Breath alcohol test positive.
• • 17. Any use of tobacco product(s) 30 days prior to study recruitment.
• • 18. A history of drug or substance abuse, including alcohol (≥ 14 units per week) within 6 months before consent taking (1 unit of alcohol equals approximately ½ pint \[285 mL\] of beer, 1 glass \[125 mL\] of wine, or 1 shot \[25 mL\] of spirit).
• • 19. Unable to refrain from taking any medications (including herbal remedies) within 7 days before dosing, with the exception of birth control medications and other medications deemed acceptable by the Investigator.
• • 20. Clinically significant illness or injury or hospitalisation for any reason within 28 days before consent-taking.
• • 21. Unable to refrain or has participation in other clinical study involving a marketed or investigational drug within 28 days or 10 half-lives of the drug before dosing, whichever is longer.
• 22. Unable to refrain or has donation of \> 500 mL of plasma within 14 days before dosing; or donation or loss of whole blood (excluding the amount of blood collected during screening) before dosing as follows:
• • 50-300 mL within 28 days,
• • 301-500 mL within 42 days, or
• • \> 500 mL within 84 days.
• • 23. Any upper arm conditions that will disallow study drug administration or difficulty to swallow the study drug.
• • 24. Any other medical condition or reason that, in the opinion of the Investigator or Research Physician, makes the subject unsuitable to participate in the clinical study.
• 25. Unable to refrain from taking any of the following systemic medications:
• • Strong inhibitors of CYP3A, and all inhibitors of CYP2C8 or BCRP, (i.e., cyclosporine eltrombopag, geftinib) within 7 days or 5 half-lives, whichever is longer, prior to dosing or Strong inducers of CYP3A, and all inducers of CYP2C8 within 14 days or 5 half-lives, whichever is longer, prior to dosing, or Any known MAO inhibitors within 30 days or 5 half-lives, whichever is longer, prior to Day 1.
• • Examples of MAO inhibitors include but are not limited to phenelzine, selegiline, isocarboxazid, rasagiline, tranylcypromine, pargyline, procarbazine, and furazolidone.
• 26. Female of childbearing potential unable to refrain from having unprotected sexual intercourse with any non-sterile male partner within 14 days before dosing; acceptable methods of contraception include:
• • double barrier (1 by each partner), and at least 1 of these barriers (condom, cervical cap, diaphragm or sponge) must contain spermicide,
• • hormonal (oral, injectable, transdermal, intravaginal or implantable),
• • intrauterine contraceptive system,
• • surgical (vasectomy or tubal ligation), or
• • sexual abstinence.