Testing a new skin patch for delivering Ozanimod in healthy individuals

A Pharmacokinetic, Safety and Tolerability Formulation Screening Comparing Corplex Ozanimod TDS to Oral Ozanimod Capsules in Healthy Adults Subjects

This study is testing a new skin patch to see if it delivers the medication Ozanimod as well as taking it in a pill form in healthy people.

Quick facts

• Study type: Observational
• Enrollment: 24 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Corium Innovations, Inc. (Industry-sponsored)
• Drugs / interventions: geftinib
• Locations: 1 site (Ampang, Selangor)
• Trial ID: NCT06528665 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate how well Ozanimod can be delivered through a transdermal delivery system (patch) compared to oral capsules. Healthy participants will receive either a single capsule of Zeposia or wear a patch for seven days, during which blood samples will be collected to assess drug absorption and safety. The study will focus on the pharmacokinetic profiles of Ozanimod and its metabolites, comparing the effectiveness and tolerability of the two delivery methods. The trial will involve around 24 healthy subjects and will be conducted in a single center.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 55 with a BMI between 18-30 kg/m2.

Not a fit: Patients who are pregnant, breastfeeding, or have significant cardiovascular issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved drug delivery methods for patients with multiple sclerosis and ulcerative colitis.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving drug delivery methods, though this specific method remains largely untested.

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.

Where this trial is running

Ampang, Selangor

• Hospital Ampang — Ampang, Selangor, Malaysia (Recruiting)

Study contacts

• Principal investigator: Damenthi Nair, MD — Hospital Ampang, 68000 Ampang, Malaysia
• Study coordinator: David Xu, Director of Clinical Department, MD, PhD

Conditions Multiple Sclerosis; Ulcerative Colitis; Ozanimod; Transdermal Delivery system; Pharmacokinetics