drugset
drugset / Trial / NCT04500808

A Study of Macitentan, in Healthy Japanese Male Participants

NCT04500808 ↗

Phase 1 Completed 24 enrolled Janssen Pharmaceutical K.K.
RandomizedParallel-groupTriple-blindOther

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).

Timeline

Start
2020-07-21
Primary completion
2020-12-14
Completion
2020-12-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Macitentan Other / unclassified — —

Indications

No indication recorded.