NCT04211558

A Study to Evaluate the Pharmacokinetics of Single Oral Doses of Ozanimod in Healthy Adult Chinese Subjects

A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Ozanimod in Healthy Adult Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Ozanimod	Ozanimod

Timeline

• Start date: 2020-08-12
• Primary completion: 2020-09-26
• Completion: 2020-10-09
• First posted: 2019-12-26
• Last updated: 2021-03-25

Locations

1 site across 1 country: China