NCT05392530

A Study of Two Different Test Formulations Compared to the Reference Formulation of Macitentan in Healthy Adult Participants

A Single-center, Open-label, Single-dose, Randomized, 3-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Relative Oral Bioavailability of Macitentan 75 mg as Two Different Test Formulations Compared to the Reference Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the rate and extent of absorption of a single oral dose of macitentan given as 2 test formulations compared to the reference formulation under fed conditions in healthy adult participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Macitentan	Macitentan film coated tablets will be administered orally as per assigned treatment sequence.

Timeline

• Start date: 2022-05-25
• Primary completion: 2022-08-30
• Completion: 2022-09-14
• First posted: 2022-05-26
• Last updated: 2025-03-30

Locations

1 site across 1 country: Belgium