Determine PK Profiles of Ozanimod and Its' Major Metabolites in Healthy Subjects (NCT06528665) | Clinical Trial Compass
CompletedNot Applicable
Determine PK Profiles of Ozanimod and Its' Major Metabolites in Healthy Subjects
Malaysia24 participantsStarted 2025-02-10
Plain-language summary
The goal of this clinical trial is to learn how Ozanimod drug can be administered to the healthy subjects via transdermal delivery system (TDS, patch) to achieve better drug absorption and delivery than via oral capsules (Zeposia). Researchers will compare two administered routes of Ozanimod TDS and oral Zeposia in drug pharmacokinetics, tolerability and safety. Participants will either take one capsule only or wear a patch on his/her arm for 7 days, and blood samples will be collected to measure drug concentrations and local skin reactions will be also observed.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Subject age between 18 to 55 years old.
✓. Subject body weight ≤ 120 kg, with a BMI within 18-30 kg/m2.
✓. Subject is able to complete the clinical study including the follow-up.
✓. Subject is capable of providing written informed consent.
Exclusion criteria
✕. Breastfeeding female.
✕. Pregnancy test positive female.
✕. At rest systolic blood pressure outside 90-140 mmHg or diastolic blood pressure outside 50-90 mmHg.
✕. 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.
✕. 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.
✕. QTc \> 450 ms for male and \> 460 ms for female.
✕. A history of allergies, or any significant adverse reactions, to any medications, unless the clinician considers that they are not clinically significant.
✕. 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.