Healthy
Conditions
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.
Interventions
DRUGPonesimod
Ponesimod tablet will be administered orally.
DRUGCarbamazepine
Carbamazepine tablet will be administered orally.
Sponsors
Janssen Pharmaceutica N.V., Belgium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment A: Cmax is the maximum Observed Plasma Concentration (Cmax) of Ponesimod | Pre dose up to 120 hours post dose on Day 15 | Cmax is the maximum observed plasma concentration of Ponesimod. |
| Treatment A: Area Under The Plasma Concentration-time Curve of Ponesimod From Time 0 to 24 Hours Post Dose (AUC [0-24h]) | 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. |
| Treatment B: Cmax is the maximum Observed Plasma Concentration (Cmax) of Ponesimod | Pre dose up to 120 hours post dose on Day 22 | Cmax is the maximum observed plasma concentration of Ponesimod. |
| Treatment B: Area Under The Plasma Concentration-time Curve of Ponesimod From Time 0 to 24 Hours Post Dose (AUC [0-24h]) | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Lymphocyte Count | Treatment A: Day 1 (Baseline) and Day 16; Treatment B: Day 1 (Baseline) and Day 23 | Total lymphocyte count will be reported. |
| Percentage Change in Lymphocytes From Baseline | Treatment A: Baseline and Day 16, Treatment B: Baseline and Day 23 | Percentage change in lymphocytes from baseline will be reported. |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | 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. |
Countries
Belgium
Outcome results
None listed