NCT04211272

A 2-part Study to Investigate the Effect of Macitentan in Healthy Male Participants

A Single-center, Open-label, Single-sequence, 2-part Study to Investigate the Effect of 75 mg Macitentan Once Daily at Steady State on the Pharmacokinetics of Riociguat, Sildenafil, Rosuvastatin and Tadalafil in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Actelion · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of macitentan at steady state on the pharmacokinetic (PK) of a single dose of riociguat and sildenafil (Part A); and rosuvastatin (Part B) when co-administered to healthy male participants under fasted conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Macitentan	Macitentan will be administrated as film-coated tablet in Part A and Part B.
DRUG	Sildenafil	Sildenafil will be administrated as film-coated tablet in Part A.
DRUG	Riociguat	Riociguat will be administrated as film-coated tablet in Part A.
DRUG	Rosuvastatin	Rosuvastatin will be administrated as film-coated tablet in Part B.

Timeline

• Start date: 2020-01-14
• Primary completion: 2021-04-19
• Completion: 2021-04-19
• First posted: 2019-12-26
• Last updated: 2025-03-30

Locations

1 site across 1 country: Belgium