HealthyPhase 1NCT05552196
A Study of Ponesimod in Healthy Adult Participants
A Phase 1 study testing Ponesimod and Carbamazepine in people with Healthy, run by Janssen Pharmaceutica N.V., Belgium at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the effect of steady-state carbamazepine (CBZ; a strong pregnane X receptor [PXR] agonist) on the pharmacokinetics (PK) of ponesimod following a gradual up-titration regimen in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ponesimod and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Oct 2022to 29 Mar 2023
- 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
- Body mass index between (BMI) 18-30 kilograms per meter square (kg/m^2)
- Willing and able to adhere to the prohibitions and restrictions.
- Female participants with negative pregnancy test.
- Women of childbearing potential (WOCBP) must use 2 methods of contraception.
- Healthy on the basis of physical examination (including neurological examination and skin examination), Columbia suicide severity rating scale questionnaire (C-SSRS) questionnaire, ophthalmological examination, medical history, vital signs, and 12-lead electrocardiogram (ECG).
- Positive varicella zoster virus (VZV).
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 60 milliliter per minute [mL/min]), thyroid disease, neurologic or psychiatric disease, confirmed or suspected macular edema, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
- Contraindications to the use of Carbamazepine (CBZ) as per local prescribing information
- Any immunosuppressive treatment within 6 weeks before first study drug administration.
- Lymphopenia (less than 1,000 cells per microliter).
- Received an investigational drug or used an invasive investigational medical device within 30 days before the first study drug intake or received a biological product within 3 months or 5 half-lives (whichever is longer) before the first study drug intake, or is currently enrolled in an investigational study.
- Lack of good/reasonable venous access.
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Parallel-group Study to Assess the Effect of Steady-state Carbamazepine on the Pharmacokinetics of Ponesimod in Healthy Adult Participants
The purpose of this study is to evaluate the effect of steady-state carbamazepine (CBZ; a strong pregnane X receptor [PXR] agonist) on the pharmacokinetics (PK) of ponesimod following a gradual up-titration regimen in healthy adult participants.
- Conditions
- Healthy
- Being tested
- Ponesimod, Carbamazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PonesimodDrug
Also called JNJ-67896153, ACT-128800, Ponvory
Ponesimod tablet will be administered orally.
CarbamazepineDrug
Also called Tegretol
Carbamazepine tablet will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Ponesimod | Experimental | Participants will receive up-titrated Ponesimod orally once daily from Day 1 to Day 15. Receives: Drug: Ponesimod |
| Treatment B: Ponesimod + Carbamazepine | Experimental | Participants will receive up-titrated Carbamazepine from Day 1 to Day 7 and from Day 23 to Day 26. Participants will also receive up-titrated Ponesimod and Carbamazepine from Day 8 to Day 22. Receives: Drug: Ponesimod; Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment A: Cmax is the maximum Observed Plasma Concentration (Cmax) of Ponesimod
Cmax is the maximum observed plasma concentration of Ponesimod.
Measured: Pre dose up to 120 hours post dose on Day 15
Treatment A: Area Under The Plasma Concentration-time Curve of Ponesimod From Time 0 to 24 Hours Post Dose (AUC [0-24h])
AUC (0-24h) is the plasma concentration-time curve of Ponesimod from time 0 to 24 hours post dose, calculated by linear-linear trapezoidal summation.
Measured: Pre dose up to 120 hours post dose on Day 15
Treatment B: Cmax is the maximum Observed Plasma Concentration (Cmax) of Ponesimod
Cmax is the maximum observed plasma concentration of Ponesimod.
Measured: Pre dose up to 120 hours post dose on Day 22
Treatment B: Area Under The Plasma Concentration-time Curve of Ponesimod From Time 0 to 24 Hours Post Dose (AUC [0-24h])
AUC (0-24h) is the plasma concentration-time curve of Ponesimod from time 0 to 24 hours post dose, calculated by linear-linear trapezoidal summation.
Measured: Pre dose up to 120 hours post dose on Day 22
Secondary outcomes (3)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Measured: Up to Day 27
Total Lymphocyte Count
Total lymphocyte count will be reported.
Measured: Treatment A: Day 1 (Baseline) and Day 16; Treatment B: Day 1 (Baseline) and Day 23
Percentage Change in Lymphocytes From Baseline
Percentage change in lymphocytes from baseline will be reported.
Measured: Treatment A: Baseline and Day 16, Treatment B: Baseline and Day 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start18 Oct 2022
- Primary completion5 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica N.V., Belgium Clinical Trial, Study director, Janssen Pharmaceutica N.V., Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552196
- Sponsor's protocol ID
- CR109254
- Other IDs
- 2022-000502-97, 67896153MSC1001
- Status last verified
- Apr 2025
- First submitted
- 21 Sep 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Parallel-group Study to Assess the Effect of Steady-state Carbamazepine on the Pharmacokinetics of Ponesimod in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05552196
- Acronym / sponsor ID
- CR109254
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 23 Sep 2022 (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 purpose of this study is to evaluate the effect of steady-state carbamazepine (CBZ; a strong pregnane X receptor [PXR] agonist) on the pharmacokinetics (PK) of ponesimod following a gradual up-titration regimen in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Ponesimod | Experimental | Drug: PonesimodParticipants will receive up-titrated Ponesimod orally once daily from Day 1 to Day 15. |
| Treatment B: Ponesimod + Carbamazepine | Experimental | Drug: Ponesimod, Drug: CarbamazepineParticipants will receive up-titrated Carbamazepine from Day 1 to Day 7 and from Day 23 to Day 26. Participants will also receive up-titrated Ponesimod and Carbamazepine from Day 8 to Day 22. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body mass index between (BMI) 18-30 kilograms per meter square (kg/m^2)
- Willing and able to adhere to the prohibitions and restrictions.
- Female participants with negative pregnancy test.
- Women of childbearing potential (WOCBP) must use 2 methods of contraception.
- Healthy on the basis of physical examination (including neurological examination and skin examination), Columbia suicide severity rating scale questionnaire (C-SSRS) questionnaire, ophthalmological examination, medical history, vital signs, and 12-lead electrocardiogram (ECG).
Key exclusion criteria (7 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 60 milliliter per minute [mL/min]), thyroid disease, neurologic or psychiatric disease, confirmed or suspected macular edema, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
- Contraindications to the use of Carbamazepine (CBZ) as per local prescribing information
- Any immunosuppressive treatment within 6 weeks before first study drug administration.
- Lymphopenia (less than 1,000 cells per microliter).
- Received an investigational drug or used an invasive investigational medical device within 30 days before the first study drug intake or received a biological product within 3 months or 5 half-lives (whichever is longer) before the first study drug intake, or is currently enrolled in an investigational study.
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 |
|---|---|---|
| PonesimodAlso: JNJ-67896153, ACT-128800, PonvoryPonesimod tablet will be administered orally. | Drug | Treatment A: Ponesimod, Treatment B: Ponesimod + Carbamazepine |
| CarbamazepineAlso: TegretolCarbamazepine tablet will be administered orally. | Drug | Treatment B: Ponesimod + Carbamazepine |
Primary outcome
Treatment A: Cmax is the maximum Observed Plasma Concentration (Cmax) of Ponesimod
Time frame: Pre dose up to 120 hours post dose on Day 15
Cmax is the maximum observed plasma concentration of Ponesimod.
Treatment A: Area Under The Plasma Concentration-time Curve of Ponesimod From Time 0 to 24 Hours Post Dose (AUC [0-24h])
Time frame: Pre dose up to 120 hours post dose on Day 15
AUC (0-24h) is the plasma concentration-time curve of Ponesimod from time 0 to 24 hours post dose, calculated by linear-linear trapezoidal summation.
Treatment B: Cmax is the maximum Observed Plasma Concentration (Cmax) of Ponesimod
Time frame: Pre dose up to 120 hours post dose on Day 22
Cmax is the maximum observed plasma concentration of Ponesimod.
Treatment B: Area Under The Plasma Concentration-time Curve of Ponesimod From Time 0 to 24 Hours Post Dose (AUC [0-24h])
Time frame: Pre dose up to 120 hours post dose on Day 22
AUC (0-24h) is the plasma concentration-time curve of Ponesimod from time 0 to 24 hours post dose, calculated by linear-linear trapezoidal summation.
3 secondary outcomes
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 27
Total Lymphocyte Count
Time frame: Treatment A: Day 1 (Baseline) and Day 16; Treatment B: Day 1 (Baseline) and Day 23
Percentage Change in Lymphocytes From Baseline
Time frame: Treatment A: Baseline and Day 16, Treatment B: Baseline and Day 23
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 27 Apr 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen Pharmaceutica N.V., Belgium Clinical Trial study director
Janssen Pharmaceutica N.V., Belgium
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 Ponesimod and Carbamazepine in people with Healthy, run by Janssen Pharmaceutica N.V., Belgium at 1 site in Belgium.
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 6 inclusion and 7 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 27 Apr 2025. 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 Belgium. 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?
Treatment A: Cmax is the maximum Observed Plasma Concentration (Cmax) of Ponesimod (time frame: Pre dose up to 120 hours post dose on Day 15). The study lists 4 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 27 Apr 2025.