NCT04500808

A Study of Macitentan, in Healthy Japanese Male Participants

A Double-blind, Randomized, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Macitentan and an Open-label, Randomized, Crossover, Single-dose Study to Evaluate the Effect of Food on Macitentan Pharmacokinetics, in Healthy Japanese Adult Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Macitentan Dose 1	Participants will receive Dose 1 of macitentan tablet in Part 1.
DRUG	Macitentan Dose 2	Participants will receive Dose 2 of macitentan tablet in Part 1.
DRUG	Macitentan Dose 3	Participants will receive Dose 2 of macitentan tablet in Part 1 and 2.
DRUG	Placebo	Participants will receive matching placebo from Day 1 up to Day 13.

Timeline

• Start date: 2020-07-21
• Primary completion: 2020-12-14
• Completion: 2020-12-14
• First posted: 2020-08-05
• Last updated: 2025-03-30

Locations

1 site across 1 country: Japan