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

Phase 1 Completed 47 enrolled Actelion

Non-randomizedSequentialOpen-labelOther

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.

Timeline

Start: 2020-01-14
Primary completion: 2021-04-19
Completion: 2021-04-19

Publications

Csonka D, Gargano C, Goyal N, De Meulder M, Yartsev V, Ruixo JJP. Effect of Once-Daily Macitentan 75 mg on the Pharmacokinetics of Sildenafil, Riociguat, or Rosuvastatin in Healthy Male Participants. J Clin Pharmacol. 2026 Apr;66(4):e70185. doi: 10.1002/jcph.70185.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Macitentan	Other / unclassified	75 mg	Oral
Subject	Riociguat	Other / unclassified	1 mg	Oral
Subject	Rosuvastatin	Small molecule	10 mg	Oral
Subject	Sildenafil	Unknown	20 mg	Oral

Indications

No indication recorded.