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

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: Nerandomilast; Drug: Bosentan

• Registration Number: NCT07081932
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-22
• Study First Posted: 2025-07-24
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-06
• Study Start: 2025-08-26
• Primary Completion: 2025-09-26
• Study Completion: 2025-09-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Nerandomilast alone followed by nerandomilast + bosentan	Nerandomilast	-
Nerandomilast alone followed by nerandomilast + bosentan	Bosentan	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	Up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)	Up to 4 days

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to 4 days

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany