A Study of Ponesimod in Healthy Adult Participants

NCT05552196 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1092542022-000502-9767896153MSC1001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Healthy

Outcome Measures

Primary Outcomes (4)

• Treatment A: Cmax is the maximum Observed Plasma Concentration (Cmax) of Ponesimod

  Cmax is the maximum observed plasma concentration of Ponesimod.

  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.

  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.

  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.

  Pre dose up to 120 hours post dose on Day 22

Secondary Outcomes (3)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs)

  Up to Day 27

• Total Lymphocyte Count

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

• Percentage Change in Lymphocytes From Baseline

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

Study Arms (2)

Treatment A: Ponesimod

EXPERIMENTAL

Participants will receive up-titrated Ponesimod orally once daily from Day 1 to Day 15.

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.

Drug: Ponesimod; Drug: Carbamazepine

Interventions

Ponesimod DRUG

Ponesimod tablet will be administered orally.

Also known as: JNJ-67896153, ACT-128800, Ponvory

Treatment A: Ponesimod; Treatment B: Ponesimod + Carbamazepine

Carbamazepine DRUG

Carbamazepine tablet will be administered orally.

Also known as: Tegretol

Treatment B: Ponesimod + Carbamazepine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

ponesimod; Carbamazepine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Pharmaceutica N.V., Belgium Clinical Trial

  Janssen Pharmaceutica N.V., Belgium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: October 18, 2022
• Primary Completion: March 5, 2023
• Study Completion: March 29, 2023
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)