Healthy VolunteersPhase 1NCT04528290

A Study to Evaluate the Relative Bioavailability of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects

A Phase 1 study testing Ozanimod in people with Healthy Volunteers, 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.

Trial summary

This is a Phase 1, open-label, randomized, parallel-group, single-dose study. Approximately 56 participants will be enrolled and randomized into 1 of the 2 treatment groups, with 28 participants in each treatment group as follows: Treatment Group A (reference): Current ozanimod capsule formulation Treatment Group B… 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteUnited States
Study dates: 7 Oct 2020to 1 Jun 2021
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 male or female, ≥ 18 and ≤ 55 years
Female subjects must meet at least 1 of the following criteria:
Negative serum pregnancy test at Screening and Day -1
Postmenopausal
Received surgical sterilization

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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 (estrogen 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
Complete sexual abstinence
All subjects:
Periodic abstinence, withdrawal, 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
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 IPs 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, naringenin, curcurmin/turmeric, passion flower, and quercetin 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 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.
Subject has history of hypersensitivity or allergic reaction to S1P receptor modulators.

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, Single-dose, Relative Bioavailability Study of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects

Treatment Group A (reference): Current ozanimod capsule formulation
Treatment Group B (test): Ozanimod granule formulation participants will be screened within 28 days prior to dosing.

Eligible participants will be admitted to the clinical research unit one day before dosing (Day -1) and will be domiciled until Day 15. On Day 1, a single oral dose of 0.92 mg of ozanimod will be administered using either the current capsule formulation (Group A) or the granule formulation (Group B).

Participants will be contacted by telephone 30 ± 5 days after dosing for a follow up safety assessment.

Conditions: Healthy Volunteers
Being tested: Ozanimod
Keywords: Ozanimod, RPC-1063, Pediatric Granule Formulation, Healthy Volunteer, Pharmacokinetics (PK)

What participants receive

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

OzanimodDrug
Also called RPC1063
Ozanimod capsule formulation of 0.92mg
OzanimodDrug
Ozanimod, granule formulation of 0.92mg

Study groups in NCT04528290
Study group	Role	What they receive
Group A (reference): Current ozanimod capsule formulation	Experimental	Single oral dose of ozanimod 0.92 mg Receives: Drug: Ozanimod
Group B (test): Ozanimod granule formulation	Experimental	Single oral dose of ozanimod 0.92 mg using Sprinkle capsule. Ozanimod Sprinkle Capsule will be opened, and the entire contents sprinkled onto a teaspoon (5 mL) of applesauce. Receives: Drug: Ozanimod

What is being measured

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

Pharmacokinetic- Cmax (Ozanimod, CC112273, CC1084037)
Maximum observed plasma concentration
Measured: Up to 14 days
Pharmacokinetic- AUC∞(Ozanimod)
Area under the concentration-time curve from time 0 to infinity
Measured: Up to 14 days
Pharmacokinetic- AUClast (CC112273 and CC1084037)
Area under the concentration-time curve from time 0 to last quantifiable concentration
Measured: Up to 14 days

Secondary outcomes (6)

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 preexisting condition) should be considered an AE.
Measured: From enrollment until at least 30 days after last dose of IP
Pharmacokinetic- AUClast (Ozanimod)
Area under the concentration-time curve from time 0 to last quantifiable concentration
Measured: Up to 14 days
Pharmacokinetic- Tmax (Ozanimod, CC112273, and CC1084037)
Time to Cmax
Measured: Up to 14 days
Pharmacokinetic- CL/F (Ozanimod)
Apparent oral clearance
Measured: Up to 14 days
Pharmacokinetic- Vz/F (Ozanimod)
Apparent volume of distribution during terminal phase after oral administration
Measured: Up to 14 days
Pharmacokinetic- t1/2 (Ozanimod, CC112273, and CC1084037)
Terminal elimination half-life
Measured: Up to 14 days

Timeline

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

7 Oct 20201 Jun 2021

First posted27 Aug 2020
Study start7 Oct 2020
Primary completion19 May 2021
Study completion1 Jun 2021

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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04528290
Sponsor's protocol ID: RPC-1063-CP-003
Other IDs: U1111-1256-5078
Status last verified: Sep 2021
First submitted: 24 Aug 2020
Last updated: 20 Sep 2021
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/

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?

See locations

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Parallel-group, Open-label, Single-dose, Relative Bioavailability Study of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT04528290
Acronym / sponsor ID: RPC-1063-CP-003
Conditions: Healthy Volunteers
Keywords: Ozanimod, RPC-1063, Pediatric Granule Formulation, Healthy Volunteer, Pharmacokinetics (PK)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: CelgeneIndustry (pharma, biotech, devices)
Study start: 7 Oct 2020 (actual)
Primary completion: 19 May 2021 (actual)
Study completion: 1 Jun 2021 (actual)
First posted: 27 Aug 2020 (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.

Treatment Group A (reference): Current ozanimod capsule formulation
Treatment Group B (test): Ozanimod granule formulation participants will be screened within 28 days prior to dosing.

Participants will be contacted by telephone 30 ± 5 days after dosing for a follow up safety assessment.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A (reference): Current ozanimod capsule formulation	Experimental	Drug: OzanimodSingle oral dose of ozanimod 0.92 mg
Group B (test): Ozanimod granule formulation	Experimental	Drug: OzanimodSingle oral dose of ozanimod 0.92 mg using Sprinkle capsule. Ozanimod Sprinkle Capsule will be opened, and the entire contents sprinkled onto a teaspoon (5 mL) of applesauce.

Who may qualify

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

Key inclusion criteria (22 listed)

Subject is a male or female, ≥ 18 and ≤ 55 years
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.

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 IPs 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
OzanimodAlso: RPC1063Ozanimod capsule formulation of 0.92mg	Drug	Group A (reference): Current ozanimod capsule formulation
OzanimodOzanimod, granule formulation of 0.92mg	Drug	Group B (test): Ozanimod granule formulation

Primary outcome

Pharmacokinetic- Cmax (Ozanimod, CC112273, CC1084037)
Time frame: Up to 14 days
Maximum observed plasma concentration
Pharmacokinetic- AUC∞(Ozanimod)
Time frame: Up to 14 days
Area under the concentration-time curve from time 0 to infinity
Pharmacokinetic- AUClast (CC112273 and CC1084037)
Time frame: Up to 14 days
Area under the concentration-time curve from time 0 to last quantifiable concentration

6 secondary outcomes

Adverse Events (AEs)
Time frame: From enrollment until at least 30 days after last dose of IP
Pharmacokinetic- AUClast (Ozanimod)
Time frame: Up to 14 days
Pharmacokinetic- Tmax (Ozanimod, CC112273, and CC1084037)
Time frame: Up to 14 days
Pharmacokinetic- CL/F (Ozanimod)
Time frame: Up to 14 days
Pharmacokinetic- Vz/F (Ozanimod)
Time frame: Up to 14 days
Pharmacokinetic- t1/2 (Ozanimod, CC112273, and CC1084037)
Time frame: Up to 14 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 20 Sep 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.

Bristol-Myers Squibb 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 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 22 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 20 Sep 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 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 (Ozanimod, CC112273, CC1084037) (time frame: Up to 14 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?

On the ClinicalTrials.gov record for NCT04528290.

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 20 Sep 2021.