NCT02841761

A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects

A Single-center, Open-label, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxy Midazolam in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577 when administered alone and in combination with midazolam.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Midalozam	Syrup for oral use
DRUG	Aprocitentan	Capsules for oral use

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2016-07-22
• Last updated: 2022-11-29

Locations

1 site across 1 country: United States