A Pharmacokinetic, Safety and Tolerability Formulation Screening Comparing Corplex Ozanimod TDS to Oral Ozanimod Capsules in Healthy Adults Subjects
A Pharmacokinetic, Safety and Tolerability Formulation Screening Comparing Corplex Ozanimod TDS to Oral Ozanimod Capsules in Healthy Adults Subjects
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.
This is a single-dose, single-center, open-label, randomized, parallel relative bioavailability study (4 treatments and 1 period) of 3 test products of a Transdermal Delivery System of Ozanimod (Corplex Ozanimod TDS) with the Reference Listed Drug (Zeposia Capsule 0.92 mg), recruiting around 24 healthy (male: female = 1:1) subjects under fasting conditions.
The following goals will be procured through this study:
Inclusion Criteria:
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.
Family history of sudden cardiac death.
Clinically significant physical examination finding.
Clinically significant laboratory abnormalities.
Haemoglobin < 12.0 g/dL for male and < 11.0 g/dL for female at screening.
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.
Hepatitis B, Hepatitis C or HIV positive.
Urine DOA test positive.
Breath alcohol test positive.
Any use of tobacco product(s) 30 days prior to study recruitment.
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).
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.
Clinically significant illness or injury or hospitalisation for any reason within 28 days before consent-taking.
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.
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:
Any upper arm conditions that will disallow study drug administration or difficulty to swallow the study drug.
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.
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.
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:
Ampang, Selangor 68000, Malaysia