Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ponesimod dose range · 1 trial · 1 indication
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...
Ponesimod dose range is an investigational small molecule being studied in healthy adult participants. It is being evaluated in a clinical trial to assess its effects when given alongside propranolol at steady state. The drug is in Phase 1 clinical development and is not yet approved for any medical use.
Ponesimod dose range is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development for use in healthy participants.
Ponesimod dose range is in Phase 1 clinical development. It is an investigational drug being studied in healthy adult participants. The drug has not been approved by regulatory authorities and remains in clinical trials to evaluate its safety and effects.
Ponesimod dose range has one completed clinical trial, identified as NCT03882255. This Phase 1 study, titled "A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady State," enrolled 52 participants in Belgium. The trial was randomized, double-blind, and controlled.
Ponesimod dose range is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied in healthy adult participants to evaluate its effects, but it has not received regulatory approval for any medical use.