A Study to Evaluate the Pharmacokinetics of Single Oral Doses of Ozanimod in Healthy Adult Chinese Subjects
Status:
Completed
Trial end date:
2020-10-09
Target enrollment:
Participant gender:
Summary
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.