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Completed

NCT Number: NCT05552196

A Study 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Ponesimod

Drug

Ponesimod tablet will be administered orally.

Other names: JNJ-67896153, ACT-128800, Ponvory

carbamazepine

Drug

Carbamazepine tablet will be administered orally.

Other names: Tegretol

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to Day 27

    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.

  2. Total Lymphocyte Count

    Time frame: Treatment A: Day 1 (Baseline) and Day 16; Treatment B: Day 1 (Baseline) and Day 23

    Total lymphocyte count will be reported.

  3. Percentage Change in Lymphocytes From Baseline

    Time frame: Treatment A: Baseline and Day 16, Treatment B: Baseline and Day 23

    Percentage change in lymphocytes from baseline will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutica N.V., Belgium

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2022
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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