Clinical trial NCT05552196: A Study of Ponesimod in Healthy Adult Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment A: Cmax is the maximum Observed Plasma Concentration (Cmax) of Ponesimod
timeFrame: Pre dose up to 120 hours post dose on Day 15
measure: Treatment A: Area Under The Plasma Concentration-time Curve of Ponesimod From Time 0 to 24 Hours Post Dose (AUC [0-24h])
timeFrame: Pre dose up to 120 hours post dose on Day 15
measure: Treatment B: Cmax is the maximum Observed Plasma Concentration (Cmax) of Ponesimod
timeFrame: Pre dose up to 120 hours post dose on Day 22
measure: Treatment B: Area Under The Plasma Concentration-time Curve of Ponesimod From Time 0 to 24 Hours Post Dose (AUC [0-24h])
timeFrame: Pre dose up to 120 hours post dose on Day 22
Secondary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to Day 27
measure: Total Lymphocyte Count
timeFrame: Treatment A: Day 1 (Baseline) and Day 16; Treatment B: Day 1 (Baseline) and Day 23
measure: Percentage Change in Lymphocytes From Baseline
timeFrame: Treatment A: Baseline and Day 16, Treatment B: Baseline and Day 23
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Janssen Pharmaceutica N.V., Belgium
name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
role: STUDY_DIRECTOR
References: