Healthy VolunteerPhase 1NCT04211558
A Study to Evaluate the Pharmacokinetics of Single Oral Doses of Ozanimod in Healthy Adult Chinese Subjects
A Phase 1 study testing Ozanimod in people with Healthy Volunteer, run by Celgene at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Ozanimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2020to 9 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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).
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- 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.
- Subject has donated greater than 400 mL of blood within 60 days prior to dosing of the IP or the subject has accepted a blood transfusion or received blood products.
- Subject has had surgery within 4 weeks prior to dosing, or plans to have surgery during the study period.
- Subject has a special diet requirement and cannot follow the CRU's or hospital's standard meal.
- Subject drink large amounts of tea, coffee and or caffeinated drinks (>8 cups/day, 1 cup = 250mL) daily.
- Subject has a history of any medical condition or medical history that, in the opinion of the Investigator, might confound the results of the study or jeopardize the safety or welfare of the subject.
- Subject has history of hypersensitivity or allergic reaction to food or other drugs including S1P receptor modulators.
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University - Beijing Anzhen Hospital
Beijing, 100029
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Ozanimod in Healthy Adult Chinese Subjects
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.
Read more
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
- Being tested
- Ozanimod
- Keywords
- Healthy Volunteer, Pharmacokinetics (PK), Ozanimod, Adult Chinese Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
Ozanimod
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ozanimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic - Cmax (Ozanimod, CC112273 and CC1084037)
Maximum observed plasma concentration within the dosing interval
Measured: 14 days
Pharmacokinetic - Tmax (Ozanimod, CC112273 and CC1084037)
Time to Cmax
Measured: 14 days
Pharmacokinetic - AUC∞ (Ozanimod)
Area under the concentration-time curve from time 0 to infinity
Measured: 14 days
Pharmacokinetic - CL/F (Ozanimod)
Apparent oral clearance
Measured: 14 days
Pharmacokinetic - Vz/F (Ozanimod)
Apparent volume of distribution during terminal phase after oral administration
Measured: 14 days
Pharmacokinetic - t1/2 (Ozanimod, CC112273 and CC1084037)
Terminal elimination half-life
Measured: 14 days
Pharmacokinetic - AUClast (CC112273 and CC1084037)
Area under the concentration-time curve from time 0 to time of last quantifiable concentration
Measured: 14 days
Pharmacokinetic - AUC0-14d (CC112273 and CC1084037)
Area under the concentration-time curve from time 0 to 14 days postdose
Measured: 14 days
Secondary outcomes (1)
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.
Measured: From consent until 30 days after the last dose of IP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start12 Aug 2020
- Primary completion26 Sep 2020
- Study completion9 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peijin Zhang, M.D, PhD, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211558
- Sponsor's protocol ID
- RPC-1063-CP-002
- Other IDs
- U1111-1244-6464
- Status last verified
- Mar 2021
- First submitted
- 24 Dec 2019
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Ozanimod in Healthy Adult Chinese Subjects
- ClinicalTrials.gov ID
- NCT04211558
- Acronym / sponsor ID
- RPC-1063-CP-002
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, Pharmacokinetics (PK), Ozanimod, Adult Chinese Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 26 Sep 2020 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozanimod 0.46mg | Experimental | Drug: OzanimodOzanimod 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. |
| Ozanimod 0.92mg | Experimental | Drug: OzanimodOzanimod 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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:
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzanimodOzanimod | Drug | Ozanimod 0.46mg, Ozanimod 0.92mg |
Primary outcome
Pharmacokinetic - Cmax (Ozanimod, CC112273 and CC1084037)
Time frame: 14 days
Maximum observed plasma concentration within the dosing interval
Pharmacokinetic - Tmax (Ozanimod, CC112273 and CC1084037)
Time frame: 14 days
Time to Cmax
Pharmacokinetic - AUC∞ (Ozanimod)
Time frame: 14 days
Area under the concentration-time curve from time 0 to infinity
Pharmacokinetic - CL/F (Ozanimod)
Time frame: 14 days
Apparent oral clearance
Pharmacokinetic - Vz/F (Ozanimod)
Time frame: 14 days
Apparent volume of distribution during terminal phase after oral administration
Pharmacokinetic - t1/2 (Ozanimod, CC112273 and CC1084037)
Time frame: 14 days
Terminal elimination half-life
Pharmacokinetic - AUClast (CC112273 and CC1084037)
Time frame: 14 days
Area under the concentration-time curve from time 0 to time of last quantifiable concentration
Pharmacokinetic - AUC0-14d (CC112273 and CC1084037)
Time frame: 14 days
Area under the concentration-time curve from time 0 to 14 days postdose
1 secondary outcome
Adverse Events (AEs)
Time frame: From consent until 30 days after the last dose of IP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peijin Zhang, M.D, PhD study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ozanimod in people with Healthy Volunteer, run by Celgene at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic - Cmax (Ozanimod, CC112273 and CC1084037) (time frame: 14 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.