NCT03882255

A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady State

A Randomized, Double-blind, Parallel-group, 2-period, Placebo-controlled, Phase 1 Study to Investigate the Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of the Up-titration Regimen of Ponesimod in Healthy Adult Subjects Receiving Propranolol at Steady State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Janssen Pharmaceutica N.V., Belgium · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the effect of the up-titration regimen of ponesimod on heart rate (HR) and other electrocardiogram (ECG) parameters when administrated to healthy adult participants receiving propranolol at steady state.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ponesimod dose range (2 - 20 mg)	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.
DRUG	Placebo Propranolol	Participants will be administered placebo propranolol oral capsule from Day 1 to Day 19 in Treatment A of Treatment period 2.
DRUG	Propranolol 80 mg	Participants will receive propranolol 80 mg long acting oral capsule from Day 1 to Day 19 in Treatment B of Treatment period 2.

Timeline

• Start date: 2019-03-20
• Primary completion: 2019-08-26
• Completion: 2019-08-26
• First posted: 2019-03-20
• Last updated: 2025-04-27

Locations

1 site across 1 country: Belgium