Multiple SclerosisNCT06528665
Determine PK Profiles of Ozanimod and Its' Major Metabolites in Healthy Subjects
An observational study of Multiple Sclerosis and Ulcerative Colitis, run by Corium Innovations, Inc. at 1 site in Malaysia.
Trial summary
The goal of this clinical trial is to learn how Ozanimod drug can be administered to the healthy subjects via transdermal delivery system (TDS, patch) to achieve better drug absorption and delivery than via oral capsules (Zeposia). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Ulcerative Colitis
- What is being tested?
- ZEPOSIA® indicated for the treatment of: Relapsing forms of multiple sclerosis, and active ulcerative colitis in adults
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 Feb 2025to 16 Apr 2025
- How long will I take part?
- 15 Days
- Phase
- Observational
- 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
Study population: Local subjects participate in the Hospital Ampang, Malaysia
Who may be able to join
- Subject age between 18 to 55 years old.
- Subject body weight ≤ 120 kg, with a BMI within 18-30 kg/m2.
- Subject is able to complete the clinical study including the follow-up.
- Subject is capable of providing written informed consent.
Who cannot join
- Breastfeeding female.
- Pregnancy test positive female.
- At rest systolic blood pressure outside 90-140 mmHg or diastolic blood pressure outside 50-90 mmHg.
- At rest sinus bradycardia defined as symptomatic heart rate \< 50 bpm, or asymptomatic heart rate \< 45 bpm; and sinus tachycardia defined as heart rate \> 100 bpm.
- Clinically significant ECG abnormalities or Participant with history or presence of second-degree atrioventricular (AV) block Type II or third-degree AV block or sick sinus syndrome unless the patient has a functioning pacemaker.
- QTc \> 450 ms for male and \> 460 ms for female.
Show all 36Show fewer
- A history of allergies, or any significant adverse reactions, to any medications, unless the clinician considers that they are not clinically significant.
- Clinically significant medical history of eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, genitourinary, neurological, haematopoietic, lymphatic, endocrine, metabolic, dermatological, musculoskeletal, psychological, family history or surgical history.
- Family history of sudden cardiac death.
- Clinically significant physical examination finding.
- Clinically significant laboratory abnormalities.
- Haemoglobin \< 12.0 g/dL for male and \< 11.0 g/dL for female at screening.
- Total bilirubin \> 1.25 x upper limit of normal (unless it is an isolated elevation where the direct bilirubin is ≤ 35% of total), ALT/AST \> 1.5 x upper limit of normal, or CK \> 2 x upper limit of normal.
- Hepatitis B, Hepatitis C or HIV positive.
- Urine DOA test positive.
- Breath alcohol test positive.
- Any use of tobacco product(s) 30 days prior to study recruitment.
- A history of drug or substance abuse, including alcohol (≥ 14 units per week) within 6 months before consent taking (1 unit of alcohol equals approximately ½ pint [285 mL] of beer, 1 glass [125 mL] of wine, or 1 shot [25 mL] of spirit).
- Unable to refrain from taking any medications (including herbal remedies) within 7 days before dosing, with the exception of birth control medications and other medications deemed acceptable by the Investigator.
- Clinically significant illness or injury or hospitalisation for any reason within 28 days before consent-taking.
- Unable to refrain or has participation in other clinical study involving a marketed or investigational drug within 28 days or 10 half-lives of the drug before dosing, whichever is longer.
- Unable to refrain or has donation of \> 500 mL of plasma within 14 days before dosing; or donation or loss of whole blood (excluding the amount of blood collected during screening) before dosing as follows:
- 50-300 mL within 28 days,
- 301-500 mL within 42 days, or
- \> 500 mL within 84 days.
- Any upper arm conditions that will disallow study drug administration or difficulty to swallow the study drug.
- Any other medical condition or reason that, in the opinion of the Investigator or Research Physician, makes the subject unsuitable to participate in the clinical study.
- Unable to refrain from taking any of the following systemic medications:
- Strong inhibitors of CYP3A, and all inhibitors of CYP2C8 or BCRP, (i.e., cyclosporine eltrombopag, geftinib) within 7 days or 5 half-lives, whichever is longer, prior to dosing or Strong inducers of CYP3A, and all inducers of CYP2C8 within 14 days or 5 half-lives, whichever is longer, prior to dosing, or Any known MAO inhibitors within 30 days or 5 half-lives, whichever is longer, prior to Day 1.
- Examples of MAO inhibitors include but are not limited to phenelzine, selegiline, isocarboxazid, rasagiline, tranylcypromine, pargyline, procarbazine, and furazolidone.
- Female of childbearing potential unable to refrain from having unprotected sexual intercourse with any non-sterile male partner within 14 days before dosing; acceptable methods of contraception include:
- double barrier (1 by each partner), and at least 1 of these barriers (condom, cervical cap, diaphragm or sponge) must contain spermicide,
- hormonal (oral, injectable, transdermal, intravaginal or implantable),
- intrauterine contraceptive system,
- surgical (vasectomy or tubal ligation), or
- sexual abstinence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic, Safety and Tolerability Formulation Screening Comparing Corplex Ozanimod TDS to Oral Ozanimod Capsules in Healthy Adults Subjects
The goal of this clinical trial is to learn how Ozanimod drug can be administered to the healthy subjects via transdermal delivery system (TDS, patch) to achieve better drug absorption and delivery than via oral capsules (Zeposia). Researchers will compare two administered routes of Ozanimod TDS and oral Zeposia in drug pharmacokinetics, tolerability and safety. Participants will either take one capsule only or wear a patch on his/her arm for 7 days, and blood samples will be collected to measure drug concentrations and local skin reactions will be also observed.
Read the detailed description
This is a single-dose, single-center, open-label, randomized, parallel relative bioavailability study (4 treatments and 1 period) of 3 test products of a Transdermal Delivery System of Ozanimod (Corplex Ozanimod TDS) with the Reference Listed Drug (Zeposia Capsule 0.92 mg), recruiting around 24 healthy (male: female = 1:1) subjects under fasting conditions.
The following goals will be procured through this study:
- To determine the pharmacokinetic profiles of Ozanimod and its' major metabolites (CC112273 and CC1084037) from the Corplex Ozanimod TDS (OZ-TDS 1, OZ-TDS 2 and OZ-TDS 3 manufactured by Corium Innovations, Inc.) (Test Product 1, Test Product 2 and Test Product 3) and the comparator (Zeposia Capsule 0.92 mg manufactured by Bristol Myers Squibb) (Reference Product) in healthy subjects;
- To compare the relative bioavailability between the Corplex Ozanimod TDS and the oral capsules in healthy subjects;
- To compare three formulations of the Corplex Ozanimod TDS in healthy subjects;
- To determine the safety and tolerability of the Corplex Ozanimod TDS vs the oral capsules in healthy subjects.
- Conditions
- Multiple Sclerosis, Ulcerative Colitis
- Being tested
- ZEPOSIA® indicated for the treatment of: Relapsing forms of multiple sclerosis, and active ulcerative colitis in adults
- Keywords
- Ozanimod; Transdermal Delivery system; Pharmacokinetics
- Medical subject headings
- Multiple Sclerosis, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEPOSIA® indicated for the treatment of: Relapsing forms of multiple sclerosis, and active ulcerative colitis in adultsDrug
ZEPOSIA®
- Titration is required for treatment initiation.
- The recommended maintenance dosage is 0.92 mg orally once daily.
- If a dose is missed within the first 2 weeks of treatment, reinitiate with the titration regimen. If a dose is missed after the first 2 weeks of treatment, continue treatment as planned.
| Study group | Role | What they receive |
|---|---|---|
| 4 groups subjects will be recruited. Each group will be composed of 6 subjects, sex ratio 1:1 | Group1, 2,3 will be administered with 3 different patches (TDS) once for a week, respectively; Group 4 will be oral administered with one capsule (0.92 mg) only. Receives: Drug: ZEPOSIA® indicated for the treatment of: Relapsing forms of multiple sclerosis, and active ulcerative colitis in adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Pharmacokinetic- AUC 0-t (Ozanimod, CC112273, CC1084037)
area under the concentration-time curve from time-zero to the time of the last quantifiable concentration
Measured: 15 days
Plasma Pharmacokinetic- AUC 0-∞ (Ozanimod, CC112273, CC1084037)
area under the concentration-time curve from time-zero to infinity
Measured: 15 days
Plasma Pharmacokinetic- Cmax (Ozanimod, CC112273, CC1084037)
Peak concentration within the dosing interval
Measured: 15 days
Plasma Pharmacokinetic- Tmax (Ozanimod, CC112273, CC1084037)
Time to peak concentration (Cmax)
Measured: 15 days
Plasma Pharmacokinetic- T 1/2 (Ozanimod, CC112273, CC1084037)
Terminal elimination half-life
Measured: 15 days
Plasma Pharmacokinetic- MTR(Ozanimod, CC112273, CC1084037)
Mean residence time
Measured: 15 days
Plasma Pharmacokinetic-Lambda z(λz) (Ozanimod, CC112273, CC1084037)
Terminal elimination rate constant
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start10 Feb 2025
- Primary completion16 Mar 2025
- Study completion16 Apr 2025
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 Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Corium Innovations, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Damenthi Nair, MD, Principal investigator, Hospital Ampang, 68000 Ampang, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528665
- Sponsor's protocol ID
- OZ101A
- Status last verified
- Feb 2026
- First submitted
- 25 Jul 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic, Safety and Tolerability Formulation Screening Comparing Corplex Ozanimod TDS to Oral Ozanimod Capsules in Healthy Adults Subjects
- ClinicalTrials.gov ID
- NCT06528665
- Acronym / sponsor ID
- OZ101A
- Conditions
- Multiple Sclerosis, Ulcerative Colitis
- Keywords
- Ozanimod; Transdermal Delivery system; Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Corium Innovations, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 30 Jul 2024 (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.
The goal of this clinical trial is to learn how Ozanimod drug can be administered to the healthy subjects via transdermal delivery system (TDS, patch) to achieve better drug absorption and delivery than via oral capsules (Zeposia). Researchers will compare two administered routes of Ozanimod TDS and oral Zeposia in drug pharmacokinetics, tolerability and safety. Participants will either take one capsule only or wear a patch on his/her arm for 7 days, and blood samples will be collected to measure drug concentrations and local skin reactions will be also observed.
Detailed description
This is a single-dose, single-center, open-label, randomized, parallel relative bioavailability study (4 treatments and 1 period) of 3 test products of a Transdermal Delivery System of Ozanimod (Corplex Ozanimod TDS) with the Reference Listed Drug (Zeposia Capsule 0.92 mg), recruiting around 24 healthy (male: female = 1:1) subjects under fasting conditions.
The following goals will be procured through this study:
- To determine the pharmacokinetic profiles of Ozanimod and its' major metabolites (CC112273 and CC1084037) from the Corplex Ozanimod TDS (OZ-TDS 1, OZ-TDS 2 and OZ-TDS 3 manufactured by Corium Innovations, Inc.) (Test Product 1, Test Product 2 and Test Product 3) and the comparator (Zeposia Capsule 0.92 mg manufactured by Bristol Myers Squibb) (Reference Product) in healthy subjects;
- To compare the relative bioavailability between the Corplex Ozanimod TDS and the oral capsules in healthy subjects;
- To compare three formulations of the Corplex Ozanimod TDS in healthy subjects;
- To determine the safety and tolerability of the Corplex Ozanimod TDS vs the oral capsules in healthy subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4 groups subjects will be recruited. Each group will be composed of 6 subjects, sex ratio 1:1 | – | Drug: ZEPOSIA® indicated for the treatment of: Relapsing forms of multiple sclerosis, and active ulcerative colitis in adultsGroup1, 2,3 will be administered with 3 different patches (TDS) once for a week, respectively; Group 4 will be oral administered with one capsule (0.92 mg) only. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Local subjects participate in the Hospital Ampang, Malaysia
Key inclusion criteria (4 listed)
- Subject age between 18 to 55 years old.
- Subject body weight ≤ 120 kg, with a BMI within 18-30 kg/m2.
- Subject is able to complete the clinical study including the follow-up.
- Subject is capable of providing written informed consent.
Key exclusion criteria (36 listed)
- Breastfeeding female.
- Pregnancy test positive female.
- At rest systolic blood pressure outside 90-140 mmHg or diastolic blood pressure outside 50-90 mmHg.
- At rest sinus bradycardia defined as symptomatic heart rate \< 50 bpm, or asymptomatic heart rate \< 45 bpm; and sinus tachycardia defined as heart rate \> 100 bpm.
- Clinically significant ECG abnormalities or Participant with history or presence of second-degree atrioventricular (AV) block Type II or third-degree AV block or sick sinus syndrome unless the patient has a functioning pacemaker.
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 |
|---|---|---|
| ZEPOSIA® indicated for the treatment of: Relapsing forms of multiple sclerosis, and active ulcerative colitis in adultsZEPOSIA® * Titration is required for treatment initiation. * The recommended maintenance dosage is 0.92 mg orally once daily. * If a dose is missed within the first 2 weeks of treatment, reinitiate with the titration regimen. If a dose is missed after the first 2 weeks of treatment, continue treatment as planned. | Drug | 4 groups subjects will be recruited. Each group will be composed of 6 subjects, sex ratio 1:1 |
Primary outcome
Plasma Pharmacokinetic- AUC 0-t (Ozanimod, CC112273, CC1084037)
Time frame: 15 days
area under the concentration-time curve from time-zero to the time of the last quantifiable concentration
Plasma Pharmacokinetic- AUC 0-∞ (Ozanimod, CC112273, CC1084037)
Time frame: 15 days
area under the concentration-time curve from time-zero to infinity
Plasma Pharmacokinetic- Cmax (Ozanimod, CC112273, CC1084037)
Time frame: 15 days
Peak concentration within the dosing interval
Plasma Pharmacokinetic- Tmax (Ozanimod, CC112273, CC1084037)
Time frame: 15 days
Time to peak concentration (Cmax)
Plasma Pharmacokinetic- T 1/2 (Ozanimod, CC112273, CC1084037)
Time frame: 15 days
Terminal elimination half-life
Plasma Pharmacokinetic- MTR(Ozanimod, CC112273, CC1084037)
Time frame: 15 days
Mean residence time
Plasma Pharmacokinetic-Lambda z(λz) (Ozanimod, CC112273, CC1084037)
Time frame: 15 days
Terminal elimination rate constant
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 Feb 2026.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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.
Damenthi Nair, MD principal investigator
Hospital Ampang, 68000 Ampang, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Ulcerative Colitis, run by Corium Innovations, Inc. at 1 site in Malaysia.
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 4 inclusion and 36 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 Feb 2026. 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 Malaysia. 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.
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?
Plasma Pharmacokinetic- AUC 0-t (Ozanimod, CC112273, CC1084037) (time frame: 15 days). The study lists 7 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 NCT06528665, 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 25 Feb 2026.