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

NCT04211558 | Completed Phase 1

• 2 other identifiers: RPC-1063-CP-002U1111-1244-6464
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; Pharmacokinetics (PK); Ozanimod; Adult Chinese Subjects

Outcome Measures

Primary Outcomes (8)

• Pharmacokinetic - Cmax (Ozanimod, CC112273 and CC1084037)

  Maximum observed plasma concentration within the dosing interval

  14 days

• Pharmacokinetic - Tmax (Ozanimod, CC112273 and CC1084037)

  Time to Cmax

  14 days

• Pharmacokinetic - AUC∞ (Ozanimod)

  Area under the concentration-time curve from time 0 to infinity

  14 days

• Pharmacokinetic - CL/F (Ozanimod)

  Apparent oral clearance

  14 days

• Pharmacokinetic - Vz/F (Ozanimod)

  Apparent volume of distribution during terminal phase after oral administration

  14 days

• Pharmacokinetic - t1/2 (Ozanimod, CC112273 and CC1084037)

  Terminal elimination half-life

  14 days

• Pharmacokinetic - AUClast (CC112273 and CC1084037)

  Area under the concentration-time curve from time 0 to time of last quantifiable concentration

  14 days

• Pharmacokinetic - AUC0-14d (CC112273 and CC1084037)

  Area under the concentration-time curve from time 0 to 14 days postdose

  14 days

Secondary Outcomes (1)

• Adverse Events (AEs)

  From consent until 30 days after the last dose of IP

Study Arms (2)

Ozanimod 0.46mg

EXPERIMENTAL

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.

Drug: Ozanimod

Ozanimod 0.92mg

EXPERIMENTAL

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.

Drug: Ozanimod

Interventions

Ozanimod DRUG

Ozanimod

Ozanimod 0.46mg; Ozanimod 0.92mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception.
• Subject has a total body weight of at least 50 kg (110 lbs); body mass index (BMI) within the range of 19.0 to 24.0 kg/m2
• Subject is in good health, as determined by no clinically significant findings from medical or surgical history, 12-lead ECG, physical examination, clinical laboratory tests, and vital signs.
• Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Subject is willing and able to adhere to the study visit schedule and other protocol

You may not qualify if:

• 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 -1.
• Subject with a seated pulse rate outside 55 to 90 bpm at Screening or Day -1.
• 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 -1.
• Subject has a positive alcohol urine or breath test at Screening or Day -1.
• 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.
• Subject has used any systemic over-the-counter medication (excluding acetaminophen up to 1 g/day), dietary or herbal supplement including traditional Chinese medicine (excluding vitamins/multivitamins) within 14 days prior to the first dose of IP. St. John's wort, naringenin, curcumin/turmeric, passion flower, and quercetin must be discontinued at least 28 days prior to dosing of the IP.
• Subject has used any systemic prescription medication (excluding hormonal contraceptives) within 28 days or 5 times the elimination half-life, whichever is longer, prior to dosing of the IP.
• Subject has ingested alcohol within 7 days prior to dosing of the IP.
• Subject fails or is unwilling to abstain from strenuous physical activities for at least 24 hours prior to dosing of the IP.
• Subject has poor peripheral venous access.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Capital Medical University - Beijing Anzhen Hospital

Beijing, 100029, China

Location

MeSH Terms

Interventions

ozanimod

Study Officials

• Peijin Zhang, M.D, PhD

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: December 26, 2019
• Study Start: August 12, 2020
• Primary Completion: September 26, 2020
• Study Completion: October 9, 2020
• Last Updated: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

CN (1)