Healthy VolunteerPhase 1NCT03624959

Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A

A Phase 1 study testing Ozanimod, Gemfibrozil and Itraconazole in people with Healthy Volunteer, run by Celgene at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effect of the following index inhibitors or inducers of CYP2C8 and/or CYP3A on the single-dose pharmacokinetics (PK) of ozanimod and its major active metabolite, CC112273, in healthy adult subjects: gemfibrozil (strong inhibitor of CYP2C8), rifampin (moderate inducer of… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: Ozanimod, Gemfibrozil and Itraconazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 20 Jun 2018to 10 Aug 2018
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

Subject is a man or non-pregnant, non-lactating woman, ages 18 to 55 years, inclusive, at the time of signing of 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 (women of child-bearing potential [WOCBP] 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.
Females of child-bearing potential:

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Must agree to practice a highly effective method of contraception throughout the study until completion of the 75-day Safety Follow-up. 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
Male subjects:
Must agree to use a latex condom with spermicide during sexual contact with WOCBP while participating in the study and until completion of the 75-day Safety Follow-up.
All subjects:
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.
Male subjects must agree to refrain from donating sperm throughout the study and until completion of the 75-day Safety Follow-up.
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 be able to comprehend and provide written informed consent, and must be able to comply with the requirements of the study, including the study visit schedule and other protocol requirements.

Who cannot join

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 Investigational product (IP) 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 the first dose of IP.

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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. St. John's wort, naringenin, curcurmin/turmeric, passion flower, and quercetin must be discontinued at least 28 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 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 S1P receptor modulators (both Parts 1 and 2), gemfibrozil (Part 1 only), itraconazole or other azole antifungals (Part 2 only), or rifampin (Part 2 only).
Subject has a history of gall bladder disease (Part 2 only).

Trial locations and contacts

1 site in 1 country.

United States1 site

PPD Phase 1 Clinic
Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effect of the Modulators of the Cytochrome P450 (CYP) 2C8 and/or 3A on the Single-Dose Pharmacokinetics of Ozanimod and CC112273 in Healthy Adult Subjects

Study Design

This is a Phase 1, randomized, parallel-group, open-label study with two parts, 1 and 2. Forty subjects will be enrolled in Part 1 and will be randomized into 1 of the 2 treatment groups, with 20 subjects in each treatment group. Sixty subjects will be enrolled in Part 2 and will be randomized into 1 of the 3 treatment groups, with 20 subjects in each treatment group. . Study parts and treatment groups are as follow:

Part 1:

Treatment Group A (reference): A single dose of ozanimod.
Treatment Group B (test): Gemfibrozil 600 mg twice daily (BID) on Days 1 through 17. On Day 4, a single dose of ozanimod will be coadministered with the morning dose of gemfibrozil.

Part 2:

Treatment Group C (reference): A single dose of ozanimod.
Treatment Group D (test): Itraconazole 200 mg once daily (QD) on Days 1 through 17. On Day 4, a single dose of ozanimod will be coadministered with itraconazole.
Treatment Group E (test): Rifampin 600 mg QD on Days 1 through 21. On Day 8, a single dose of ozanimod will be coadministered with rifampin.

Study Population Subjects will be healthy men and non-pregnant, non-lactating women, ages 18 to 55 years, inclusive, with 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.

Length of Study The study duration ranges from 43 days to 50 days.

Conditions: Healthy Volunteer
Being tested: Ozanimod, Gemfibrozil, Itraconazole, Rifampin
Keywords: Healthy Volunteer, Cytochrome P450 (CYP), ozanimod

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OzanimodDrug
ozanimod
GemfibrozilDrug
Gemfibrozil
ItraconazoleDrug
Itraconazole
RifampinDrug
Rifampin

Study groups in NCT03624959
Study group	Role	What they receive
Treatment Group A - Ozanimod 0.46mg	Experimental	A single dose of ozanimod 0.46 mg on Day 1 Receives: Drug: Ozanimod
Treatment Group B - Ozanimod plus Gemfibrozil	Experimental	Gemfibrozil 600 mg twice daily (BID) on Days 1 through 17. On Day 4, a single dose of ozanimod 0.46 mg will be coadministered with the morning dose of gemfibrozil. Receives: Drug: Ozanimod; Drug: Gemfibrozil
Treatment Group C - Ozanimod 0.92mg	Experimental	A single dose of ozanimod 0.92 mg on Day 1. Receives: Drug: Ozanimod
Treatment Group D - Ozanimod plus Itraconazole	Experimental	Itraconazole 200 mg once daily (QD) on Days 1 through 17. On Day 4, a single dose of ozanimod 0.92 mg will be co-administered with itraconazole. Receives: Drug: Ozanimod; Drug: Itraconazole
Treatment Group E - Ozanimod plus Rifampin	Experimental	Rifampin 600 mg QD on Days 1 through 21. On Day 8, a single dose of ozanimod 0.92 mg will be coadministered with rifampin Receives: Drug: Ozanimod; Drug: Rifampin

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics- Cmax
Maximum observed plasma concentration
Measured: Up to 14 days after ozanimod dosing
Pharmacokinetics- AUC∞
Area under the concentration-time curve from time 0 to infinity
Measured: Up to 14 days after ozanimod dosing
Pharmacokinetics- AUC0-14d
Area under the concentration-time curve from time 0 to 14 days post dose
Measured: Up to 14 days after ozanimod dosing

Secondary outcomes (6)

Adverse Events (AEs)
The incidence, severity, and relationship of TEAEs
Measured: From enrollment until at least 75 days after ozanimod dosing
Pharmacokinetics- Tmax
Time to Cmax
Measured: Up to 14 days after ozanimod dosing
Pharmacokinetics- CL/F
Apparent oral clearance
Measured: Up to 14 days after ozanimod dosing
Pharmacokinetics- Vz/F
Apparent volume of distribution during terminal phase after oral administration
Measured: Up to 14 days after ozanimod dosing
Pharmacokinetics- λz
Terminal elimination rate constant
Measured: Up to 14 days after ozanimod dosing
Pharmacokinetics- t1/2
Terminal elimination half-life
Measured: Up to 14 days after ozanimod dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 201810 Aug 2018

First posted10 Aug 2018
Study start20 Jun 2018
Primary completion10 Aug 2018
Study completion10 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03624959
Sponsor's protocol ID: RPC01-1912
Other IDs: U1111-1215-6965
Status last verified: May 2019
First submitted: 6 Jul 2018
Last updated: 30 May 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Tran JQ, Zhang P, Ghosh A, Liu L, Syto M, Wang X, Palmisano M. Single-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites Alone and in Combination with Gemfibrozil, Itraconazole, or Rifampin in Healthy Subjects: A Randomized, Parallel-Group, Open-Label Study. Adv Ther. 2020 Oct;37(10):4381-4395. doi: 10.1007/s12325-020-01473-0. Epub 2020 Aug 28.
PubMed 32857315

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 May 2019. 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 the Modulators of the Cytochrome P450 (CYP) 2C8 and/or 3A on the Single-Dose Pharmacokinetics of Ozanimod and CC112273 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT03624959
Acronym / sponsor ID: RPC01-1912
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer, Cytochrome P450 (CYP), ozanimod
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: CelgeneIndustry (pharma, biotech, devices)
Study start: 20 Jun 2018 (actual)
Primary completion: 10 Aug 2018 (actual)
Study completion: 10 Aug 2018 (actual)
First posted: 10 Aug 2018 (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.

Study Design

Part 1:

Treatment Group A (reference): A single dose of ozanimod.
Treatment Group B (test): Gemfibrozil 600 mg twice daily (BID) on Days 1 through 17. On Day 4, a single dose of ozanimod will be coadministered with the morning dose of gemfibrozil.

Part 2:

Treatment Group C (reference): A single dose of ozanimod.
Treatment Group D (test): Itraconazole 200 mg once daily (QD) on Days 1 through 17. On Day 4, a single dose of ozanimod will be coadministered with itraconazole.
Treatment Group E (test): Rifampin 600 mg QD on Days 1 through 21. On Day 8, a single dose of ozanimod will be coadministered with rifampin.

Length of Study The study duration ranges from 43 days to 50 days.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Treatment Group A - Ozanimod 0.46mg	Experimental	Drug: OzanimodA single dose of ozanimod 0.46 mg on Day 1
Treatment Group B - Ozanimod plus Gemfibrozil	Experimental	Drug: Ozanimod, Drug: GemfibrozilGemfibrozil 600 mg twice daily (BID) on Days 1 through 17. On Day 4, a single dose of ozanimod 0.46 mg will be coadministered with the morning dose of gemfibrozil.
Treatment Group C - Ozanimod 0.92mg	Experimental	Drug: OzanimodA single dose of ozanimod 0.92 mg on Day 1.
Treatment Group D - Ozanimod plus Itraconazole	Experimental	Drug: Ozanimod, Drug: ItraconazoleItraconazole 200 mg once daily (QD) on Days 1 through 17. On Day 4, a single dose of ozanimod 0.92 mg will be co-administered with itraconazole.
Treatment Group E - Ozanimod plus Rifampin	Experimental	Drug: Ozanimod, Drug: RifampinRifampin 600 mg QD on Days 1 through 21. On Day 8, a single dose of ozanimod 0.92 mg will be coadministered with rifampin

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (22 listed)

Subject is a man or non-pregnant, non-lactating woman, ages 18 to 55 years, inclusive, at the time of signing of the informed consent form (ICF).
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 completion of the 75-day Safety Follow-up. 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.
Must agree to use a latex condom with spermicide during sexual contact with WOCBP while participating in the study and until completion of the 75-day Safety Follow-up.

Key exclusion criteria (18 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 Investigational product (IP) 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	Treatment Group A - Ozanimod 0.46mg, Treatment Group B - Ozanimod plus Gemfibrozil, Treatment Group C - Ozanimod 0.92mg, Treatment Group D - Ozanimod plus Itraconazole, Treatment Group E - Ozanimod plus Rifampin
GemfibrozilGemfibrozil	Drug	Treatment Group B - Ozanimod plus Gemfibrozil
ItraconazoleItraconazole	Drug	Treatment Group D - Ozanimod plus Itraconazole
RifampinRifampin	Drug	Treatment Group E - Ozanimod plus Rifampin

Primary outcome

Pharmacokinetics- Cmax
Time frame: Up to 14 days after ozanimod dosing
Maximum observed plasma concentration
Pharmacokinetics- AUC∞
Time frame: Up to 14 days after ozanimod dosing
Area under the concentration-time curve from time 0 to infinity
Pharmacokinetics- AUC0-14d
Time frame: Up to 14 days after ozanimod dosing
Area under the concentration-time curve from time 0 to 14 days post dose

6 secondary outcomes

Adverse Events (AEs)
Time frame: From enrollment until at least 75 days after ozanimod dosing
Pharmacokinetics- Tmax
Time frame: Up to 14 days after ozanimod dosing
Pharmacokinetics- CL/F
Time frame: Up to 14 days after ozanimod dosing
Pharmacokinetics- Vz/F
Time frame: Up to 14 days after ozanimod dosing
Pharmacokinetics- λz
Time frame: Up to 14 days after ozanimod dosing
Pharmacokinetics- t1/2
Time frame: Up to 14 days after ozanimod dosing

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 30 May 2019.
Derived from this study: PubMed 32857315Tran JQ, Zhang P, Ghosh A, Liu L, Syto M, Wang X, Palmisano M. Single-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites Alone and in Combination with Gemfibrozil, Itraconazole, or Rifampin in Healthy Subjects: A Randomized, Parallel-Group, Open-Label Study. Adv Ther. 2020 Oct;37(10):4381-4395. doi: 10.1007/s12325-020-01473-0. Epub 2020 Aug 28.

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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 Corporation

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, Gemfibrozil and Itraconazole in people with Healthy Volunteer, 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 22 inclusion and 18 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 30 May 2019. 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?

Pharmacokinetics- Cmax (time frame: Up to 14 days after ozanimod dosing). 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?

On the ClinicalTrials.gov record for NCT03624959, which also lists 1 linked publication.

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 30 May 2019.