Clinical Pharmacology Unit
Merksem, 2170, Belgium
NCT Number: NCT05552196
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Merksem, 2170, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ponesimod tablet will be administered orally.
Other names: JNJ-67896153, ACT-128800, Ponvory
Carbamazepine tablet will be administered orally.
Other names: Tegretol
Time frame: Pre dose up to 120 hours post dose on Day 15
Cmax is the maximum observed plasma concentration of Ponesimod.
Time frame: 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.
Time frame: Pre dose up to 120 hours post dose on Day 22
Cmax is the maximum observed plasma concentration of Ponesimod.
Time frame: 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.
Time frame: 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.
Time frame: Treatment A: Day 1 (Baseline) and Day 16; Treatment B: Day 1 (Baseline) and Day 23
Total lymphocyte count will be reported.
Time frame: Treatment A: Baseline and Day 16, Treatment B: Baseline and Day 23
Percentage change in lymphocytes from baseline will be reported.
Janssen Pharmaceutica N.V., Belgium
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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