NCT07081932

A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood

The Effect of Multiple Oral Doses of Bosentan on the Single Oral Dose Pharmacokinetics of Nerandomilast in Healthy Male Subjects (an Open-label, Two-treatment, Two-period Fixed Sequence Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to investigate the effect of bosentan, a moderate Cytochrome P450 (CYP) 3A inducer on the single dose pharmacokinetics of nerandomilast.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nerandomilast	Nerandomilast
DRUG	Bosentan	Bosentan

Timeline

• Start date: 2025-08-26
• Primary completion: 2025-09-27
• Completion: 2025-10-08
• First posted: 2025-07-24
• Last updated: 2025-10-14

Locations

1 site across 1 country: Germany