This is a Phase 1, open-label, single-dose study. Approximately 24 Chinese healthy adult subjects will be enrolled to receive a single oral dose of ozanimod 0.46 mg or 0.92 mg (12 subjects per dose cohort). Subjects will be screened for participation within 28 days prior to dosing. Eligible subjects will be admitted to the clinical research unit (CRU) or hospital one day before dosing (Day -1) and will be domiciled until Day 15 (approximately 336 hours after ozanimod dosing). Serial PK blood samples for the measurement of plasma concentrations of ozanimod and active metabolites will be collected predose and up to 336 hours after ozanimod dosing. Physical examinations,12-lead electrocardiograms (ECGs) and ambulatory ECGs, vital sign measurements,pulmonary function tests (PFTs), and clinical laboratory tests will be performed and adverse events and concomitant medications will be monitored throughout the study to assess safety. Subjects will be contacted by telephone approximately 30 ± 5 days after dosing for a follow-up safety assessment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Ozanimod
Capital Medical University - Beijing Anzhen Hospital
Beijing, China
Pharmacokinetic - Cmax (Ozanimod, CC112273 and CC1084037)
Maximum observed plasma concentration within the dosing interval
Time frame: 14 days
Pharmacokinetic - Tmax (Ozanimod, CC112273 and CC1084037)
Time to Cmax
Time frame: 14 days
Pharmacokinetic - AUC∞ (Ozanimod)
Area under the concentration-time curve from time 0 to infinity
Time frame: 14 days
Pharmacokinetic - CL/F (Ozanimod)
Apparent oral clearance
Time frame: 14 days
Pharmacokinetic - Vz/F (Ozanimod)
Apparent volume of distribution during terminal phase after oral administration
Time frame: 14 days
Pharmacokinetic - t1/2 (Ozanimod, CC112273 and CC1084037)
Terminal elimination half-life
Time frame: 14 days
Pharmacokinetic - AUClast (CC112273 and CC1084037)
Area under the concentration-time curve from time 0 to time of last quantifiable concentration
Time frame: 14 days
Pharmacokinetic - AUC0-14d (CC112273 and CC1084037)
Area under the concentration-time curve from time 0 to 14 days postdose
Time frame: 14 days
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.
Time frame: From consent until 30 days after the last dose of IP
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