Overview

A Study of Macitentan, in Healthy Japanese Male Participants

Status:
Completed
Trial end date:
2020-12-14
Target enrollment:
Participant gender:
Summary
The main purpose of this study is to evaluate the safety and tolerability after multiple-dose administrations of macitentan with titration regimen starting from Dose 1 once daily (qd) up to Dose 2 qd in Japanese healthy adult male participants (Part 1) and to evaluate the effect of food on pharmacokinetics of macitentan and its active metabolite (ACT-132577) in Japanese healthy adult male participants with macitentan Dose 3 tablet (Part 2).
Phase:
Phase 1
Details
Lead Sponsor:
Janssen Pharmaceutical K.K.
Treatments:
Macitentan