A Study of Ponesimod in Healthy Adult Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Carbamazepine; Drug: Ponesimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT05552196

2022-000502-97 (EudraCT Number)

67896153MSC1001 (Other Identifier)

CR109254

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Treatment A: Ponesimod

Experimental group

Description:

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

Treatment:

Drug: Ponesimod

Treatment B: Ponesimod + Carbamazepine

Experimental group

Description:

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.

Treatment:

Drug: Ponesimod

Drug: Carbamazepine