Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03882255 | A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady State | PHASE1 | COMPLETED | 52 | — | — | Mar 20, 2019 | Aug 26, 2019 | Apr 27, 2025 | 1 | Belgium |
Emax HR is defined as the maximum decrease from baseline in mean hourly HR.
Emax HR is defined as the maximum decrease from baseline in mean hourly HR.
HR nadir will be defined as the minimum of the mean hourly HR for each day and will be summarized by descriptive statistics.
HR nadir will be defined as the minimum of the mean hourly HR for each day and will be summarized by descriptive statistics.
| Arm | Type | Description |
|---|---|---|
| Treatment Period 1: Ponesimod (2 mg) | EXPERIMENTAL | Participants will receive a single dose ponesimod 2 milligram (mg) oral tablet under fed conditions on Day 1. Participants not fulfilling discontinuation criteria can continue to Treatment Period 2 after a washout period of at least 7 days and a maximum of 14 days. |
| Treatment Period 2:Ponesimod, Propranolol, Placebo Propranolol | EXPERIMENTAL | Participants who do not fulfill any of discontinuation criteria will be randomized to 1 of 2 Treatments (Treatment A or B) on Day 1. Treatment A: up-titration regimen of ponesimod (2mg-20mg) once daily from Day 5 to Day 19 plus placebo propranolol once daily from Day 1 to Day 19; Treatment B: up-titration regimen of ponesimod (2mg-20mg) once daily from Day 5 to Day 19 plus 80 mg propranolol once daily from Day 1 to Day 19. |
| Name | Type | Description |
|---|---|---|
| Ponesimod dose range (2 - 20 mg) | DRUG | Participants will receive ponesimod oral tablet at a dose of 2 mg in Treatment period 1 and as an up-titrating regimen (dose range: 2mg-20mg) in Treatments period 2. |
| Placebo Propranolol | DRUG | Participants will be administered placebo propranolol oral capsule from Day 1 to Day 19 in Treatment A of Treatment period 2. |
| Propranolol 80 mg | DRUG | Participants will receive propranolol 80 mg long acting oral capsule from Day 1 to Day 19 in Treatment B of Treatment period 2. |
Inclusion Criteria: * Systolic blood pressure (SBP) 90 to 140 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) 50 to 90 mmHg measured on the right arm in supine position after at least 5 minutes rest in the supine position at screening, on Day 1 of the Treatment Period 1, and on Day...