A Study of Ponesimod in Healthy Adult Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05552196
• Other study ID #: CR109254
• Secondary ID: 2022-000502-9767
• Status: Completed
• Phase: Phase 1
• Start date: October 18, 2022
• Est. completion date: March 29, 2023

Study information

• Verified date: March 2024
• Source: Janssen Pharmaceutica N.V., Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 29, 2023
• Est. primary completion date: March 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Ponesimod
Ponesimod tablet will be administered orally.
• Carbamazepine
Carbamazepine tablet will be administered orally.

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit	Merksem

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica N.V., Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	Up to Day 27
Secondary	Total Lymphocyte Count	Total lymphocyte count will be reported.	Treatment A: Day 1 (Baseline) and Day 16; Treatment B: Day 1 (Baseline) and Day 23
Secondary	Percentage Change in Lymphocytes From Baseline	Percentage change in lymphocytes from baseline will be reported.	Treatment A: Baseline and Day 16, Treatment B: Baseline and Day 23