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

Celgene1 site in 1 country24 target enrollmentAugust 12, 2020

ConditionsHealthy Volunteer

InterventionsOzanimod

DrugsOzanimod

Overview

Phase: Phase 1
Intervention: Ozanimod
Conditions: Healthy Volunteer
Sponsor: Celgene
Enrollment: 24
Locations: 1
Primary Endpoint: Pharmacokinetic - Cmax (Ozanimod, CC112273 and CC1084037)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 12, 2020

End Date

October 9, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Celgene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must satisfy the following criteria to be enrolled in the study:
•Subject is a male or female, ages 18 to 45 years
•Subject is of Chinese origin; individual currently residing in mainland China who was born in China and has both parents of Chinese descent
•Female subjects must meet at least 1 of the following criteria:
•Negative serum pregnancy test at Screening and Day -1
•Postmenopausal
•Received surgical sterilization at least 6 months before Screening with medical records.
•Females of child-bearing potential:
•Must agree to practice a highly effective method of contraception throughout the study until 90 days postdose. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
•All subjects:

Exclusion Criteria

•The presence of any of the following will exclude a subject from enrollment:
•Subject with a seated blood pressure outside 90 to 140 mmHg systolic or 50 to 90 mmHg diastolic at Screening or Day -
•Subject with a seated pulse rate outside 55 to 90 bpm at Screening or Day -
•Subject has a presence or history of any abnormality or illness that, in the opinion of the Investigator, may affect absorption, distribution, metabolism, or elimination of the IP(s) or would limit the subject's ability to participate in and complete this clinical study.
•Subject has a history of alcoholism, drug abuse, or addiction within 24 months prior to Screening.
•Subject has a positive serum test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
•Subject has used any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, electronic cigarettes, vape, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) or marijuana (cigarette, joint, vape, edibles, etc) within 3 months prior to dosing of the IP.
•Subject has a positive urine drug test including cotinine at Screening or Day -
•Subject has a positive alcohol urine or breath test at Screening or Day -
•Subject has received any investigational drug within 30 days or 5 times the elimination half-life (if known), whichever is longer, prior to dosing of the IP.

Arms & Interventions

Ozanimod 0.46mg

Ozanimod single doses of 0.46 mg (1 x 0.46 mg capsule) will be administered on Day 1. Ozanimod will be administered following an overnight fast of at least 10 hours before dosing and with approximately 240 mL of nonrefrigerated, noncarbonated water (additional water may be allowed if required for the subject to complete dosing). Subjects will remain fasted for 4 hours after ozanimod dosing.

Intervention: Ozanimod

Ozanimod 0.92mg

Ozanimod single doses of 0.92 mg (1 x 0.92-mg capsule) will be administered on Day 1. Ozanimod will be administered following an overnight fast of at least 10 hours before dosing and with approximately 240 mL of nonrefrigerated, noncarbonated water (additional water may be allowed if required for the subject to complete dosing). Subjects will remain fasted for 4 hours after ozanimod dosing.

Intervention: Ozanimod