CompletedNCT05552196Updated Apr 27, 2025

A Study of Ponesimod in Healthy Adult Participants

A Phase 1 interventional study of Ponesimod and Carbamazepine in Healthy, sponsored by Janssen Pharmaceutica N.V., Belgium. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-27.

Sponsored by Janssen Pharmaceutica N.V., Belgium · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Mar 2023, 3 years 7 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 28
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Healthy

In context

Lead sponsor

Janssen Pharmaceutica N.V., Belgium is the lead sponsor of 58 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 28 participants (actual)

Study arms

Experimental
Treatment A: Ponesimod
Participants will receive up-titrated Ponesimod orally once daily from Day 1 to Day 15.
Drug: Ponesimod
Experimental
Treatment B: Ponesimod + Carbamazepine
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.
Drug: Ponesimod · Drug: Carbamazepine

Interventions

DrugPonesimod
Ponesimod tablet will be administered orally.
Also known as: JNJ-67896153, ACT-128800, Ponvory
DrugCarbamazepine
Carbamazepine tablet will be administered orally.
Also known as: Tegretol

What researchers measure

Primary outcomes

Treatment A: Cmax is the maximum Observed Plasma Concentration (Cmax) of Ponesimod
Cmax is the maximum observed plasma concentration of Ponesimod.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre dose up to 120 hours post dose on Day 22

Secondary outcomes

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.
Time frame: Up to Day 27
Total Lymphocyte Count
Total lymphocyte count will be reported.
Time frame: 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.
Time frame: Treatment A: Baseline and Day 16, Treatment B: Baseline and Day 23

Study locations

1 site

Clinical Pharmacology Unit
Merksem, 2170, Belgium

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05552196
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Responsible party: Sponsor
First posted: Sep 23, 2022
Start date: Oct 18, 2022
Primary completion: Mar 5, 2023
Completion: Mar 29, 2023
Last update: Apr 27, 2025

Study contacts

Janssen Pharmaceutica N.V., Belgium Clinical Trial

study director · Janssen Pharmaceutica N.V., Belgium

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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