Healthy VolunteersPhase 1NCT04149678
Drug Interaction Study of the Effect on Cyclosporine on Ozanimod and Major Active Metabolites
A Phase 1 study testing Ozanimod and Cyclosporine in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
This is a Phase 1, randomized, parallel-group, open-label study. Forty subjects will be enrolled and will be randomized into 1 of the 2 treatment groups, with 20 subjects in each treatment group(sex will be used as a stratifying factor) as follows: Treatment Group A (reference): A single oral dose of ozanimod 0.46 mg… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Ozanimod and Cyclosporine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2019to 26 Dec 2019
- 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 55 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 man or non-pregnant, non-lactating woman, ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
- Female subjects must meet at least 1 of the following criteria:
- Negative serum pregnancy test at Screening and Day -1 (females of child-bearing potential [FCBP] only).
- Postmenopausal (defined as 2 years after the last period and follicle-stimulating hormone [FSH] > 40 IU/L).
- Received surgical sterilization (eg, bilateral tubal ligation, bilateral oophorectomy, hysterectomy) at least 6 months before Screening with medical records.
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- Female subjects of child-bearing potential must agree to practice a highly effective method of contraception throughout the study until completion of the follow-up phone call. 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. Acceptable methods of birth control in this study are the following:
- Combined hormonal (oestrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, implantable
- Placement of an intrauterine device or intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
- Subject has a body weight of at least 110 pounds (50 kg); body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive (Screening and Day -1).
- 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 requirements.
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 beats per minute (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 (or would limit the subject's ability to participate in and complete this clinical study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject has a history of alcoholism, drug abuse, or addiction within 24 months prior to Screening.
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- 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 the first dose of 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 the first dose of IP.
- Subject has used any systemic over-the-counter medication (excluding acetaminophen up to 1 g/day), dietary or herbal supplement (excluding vitamins/multivitamins) within 7 days prior to the first dose of IP. Herbal supplements including St. John's wort must be discontinued at least 28 days prior to the first dose of IP.
- Subject has consumed pomelo-variety citrus fruits or juice (including pomelo, grapefruit, Seville oranges) within 7 days prior to the first dose of 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 the first dose of IP.
- Subject has ingested alcohol within 7 days prior to the first dose of IP.
- Subject fails or is unwilling to abstain from strenuous physical activities for at least 24 hours prior to the first dose of IP.
- Subject has poor peripheral venous access.
- Subject has donated greater than 400 mL of blood within 60 days prior to Day 1.
- Subject has history of hypersensitivity or allergic reaction to sphingosine 1-phosphate (S1P) receptor modulators or cyclosporine.
- Subject with 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Parallel-group, Open-label Study to Evaluate the Effect of Cyclosporine on the Single-dose Pharmacokinetics of Ozanimod and Major Active Metabolites in Healthy Adult Subjects
This is a Phase 1, randomized, parallel-group, open-label study. Forty subjects will be enrolled and will be randomized into 1 of the 2 treatment groups, with 20 subjects in each treatment group(sex will be used as a stratifying factor) as follows:
- Treatment Group A (reference): A single oral dose of ozanimod 0.46 mg
- Treatment Group B (test): A single oral dose of ozanimod 0.46 mg plus a single oral dose of cyclosporine 600 mg
- Conditions
- Healthy Volunteers
- Being tested
- Ozanimod, Cyclosporine
- Keywords
- Healthy Subjects, Ozanimod, Cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
Ozanimod
CyclosporineDrug
Cyclosporine
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A - Ozanimod | Experimental | Subjects will receive a single oral dose of ozanimod 0.46 mg Receives: Drug: Ozanimod |
| Treatment Group B - Ozanimod plus Cyclosporine | Experimental | Subjects will receive a single oral dose of ozanimod 0.46 mg plus a single oral dose of cyclosporine 600 mg Receives: Drug: Ozanimod; Drug: Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic - Cmax
Maximum observed plasma concentration
Measured: Up to approximately 15 days
Pharmacokinetic - AUC∞
Area under the concentration-time curve from time 0 to infinity
Measured: Up to approximately 15 days
Pharmacokinetic - AUClast
Area under the concentration-time curve from time 0 to time of last quantifiable concentration
Measured: Up to approximately 15 days
Secondary outcomes (5)
Adverse Events (AEs)
Number of participants with adverse event
Measured: From enrollment until 60 days after ozanimod dosing
Pharmacokinetic - Tmax
Time to Cmax
Measured: Up to approximately 15 days
Pharmacokinetic - CL/F
Apparent oral clearance
Measured: Up to approximately 15 days
Pharmacokinetic - Vz/F
Apparent volume of distribution during terminal phase after oral administration
Measured: Up to approximately 15 days
Pharmacokinetic - t1/2
Terminal elimination half-life
Measured: Up to approximately 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start4 Oct 2019
- Primary completion13 Nov 2019
- Study completion26 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Tran, Pharm.D, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149678
- Sponsor's protocol ID
- RPC-1063-CP-001
- Other IDs
- U1111-1239-1156
- Status last verified
- Aug 2020
- First submitted
- 31 Oct 2019
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Parallel-group, Open-label Study to Evaluate the Effect of Cyclosporine on the Single-dose Pharmacokinetics of Ozanimod and Major Active Metabolites in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04149678
- Acronym / sponsor ID
- RPC-1063-CP-001
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Subjects, Ozanimod, Cyclosporine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 4 Nov 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, randomized, parallel-group, open-label study. Forty subjects will be enrolled and will be randomized into 1 of the 2 treatment groups, with 20 subjects in each treatment group(sex will be used as a stratifying factor) as follows:
- Treatment Group A (reference): A single oral dose of ozanimod 0.46 mg
- Treatment Group B (test): A single oral dose of ozanimod 0.46 mg plus a single oral dose of cyclosporine 600 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A - Ozanimod | Experimental | Drug: OzanimodSubjects will receive a single oral dose of ozanimod 0.46 mg |
| Treatment Group B - Ozanimod plus Cyclosporine | Experimental | Drug: Ozanimod, Drug: CyclosporineSubjects will receive a single oral dose of ozanimod 0.46 mg plus a single oral dose of cyclosporine 600 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Subject is a man or non-pregnant, non-lactating woman, ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
- Female subjects must meet at least 1 of the following criteria:
- Female subjects of child-bearing potential must agree to practice a highly effective method of contraception throughout the study until completion of the follow-up phone call. 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. Acceptable methods of birth control in this study are the following:
- Subject has a body weight of at least 110 pounds (50 kg); body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive (Screening and Day -1).
- 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.
Key exclusion criteria (20 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 beats per minute (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 (or would limit the subject's ability to participate in and complete this clinical study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject has a history of alcoholism, drug abuse, or addiction within 24 months prior to Screening.
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 | Treatment Group A - Ozanimod, Treatment Group B - Ozanimod plus Cyclosporine |
| CyclosporineCyclosporine | Drug | Treatment Group B - Ozanimod plus Cyclosporine |
Primary outcome
Pharmacokinetic - Cmax
Time frame: Up to approximately 15 days
Maximum observed plasma concentration
Pharmacokinetic - AUC∞
Time frame: Up to approximately 15 days
Area under the concentration-time curve from time 0 to infinity
Pharmacokinetic - AUClast
Time frame: Up to approximately 15 days
Area under the concentration-time curve from time 0 to time of last quantifiable concentration
5 secondary outcomes
Adverse Events (AEs)
Time frame: From enrollment until 60 days after ozanimod dosing
Pharmacokinetic - Tmax
Time frame: Up to approximately 15 days
Pharmacokinetic - CL/F
Time frame: Up to approximately 15 days
Pharmacokinetic - Vz/F
Time frame: Up to approximately 15 days
Pharmacokinetic - t1/2
Time frame: Up to approximately 15 days
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 24 Aug 2020.
- 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.
Jonathan Tran, Pharm.D study director
Celgene
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 and Cyclosporine in people with Healthy Volunteers, run by Celgene at 1 site in United States.
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 17 inclusion and 20 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 24 Aug 2020. 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 United States. 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 (time frame: Up to approximately 15 days). The study lists 3 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 24 Aug 2020.