Trials / Completed
CompletedNCT05552196
A Study of Ponesimod in Healthy Adult Participants
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Janssen Pharmaceutica N.V., Belgium · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ponesimod | Ponesimod tablet will be administered orally. |
| DRUG | Carbamazepine | Carbamazepine tablet will be administered orally. |
Timeline
- Start date
- 2022-10-18
- Primary completion
- 2023-03-05
- Completion
- 2023-03-29
- First posted
- 2022-09-23
- Last updated
- 2025-04-27
Locations
1 site across 1 country: Belgium
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05552196. Inclusion in this directory is not an endorsement.