Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000502-97 | EudraCT Number | ||
| 67896153MSC1001 | Other Identifier | Janssen Pharmaceutica N.V., Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Ponesimod | Experimental | Participants will receive up-titrated Ponesimod orally once daily from Day 1 to Day 15. |
|
| Treatment B: Ponesimod + Carbamazepine | Experimental | Participants will receive up-titrated Carbamazepine from Day 1 to Day 7 and from Day 23 to Day 26. Participants will also receive up-titrated Ponesimod and Carbamazepine from Day 8 to Day 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ponesimod | Drug | Ponesimod tablet will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica N.V., Belgium Clinical Trial | Janssen Pharmaceutica N.V., Belgium | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C550169 | ponesimod |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Carbamazepine | Drug | Carbamazepine tablet will be administered orally. |
|
|
| Up to Day 27 |
| 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 |
| 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 |