A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Nerandomilast in the Blood

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: nerandomilast; Drug: carbamazepine

• Registration Number: NCT07100964
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to investigate the effect of carbamazepine on pharmacokinetics of nerandomilast.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-28
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Study Start: 2025-08-11
• Primary Completion: 2025-09-20
• Study Completion: 2025-10-01

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 + carbamazepine	nerandomilast	-
Nerandomilast alone followed by nerandomilast + carbamazepine	carbamazepine	-

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 (AUC 0-tz)	Up to 30 days
Maximum measured concentration of the analyte in plasma (Cmax)	Up to 30 days

Secondary Outcome Measures

Name	Time	Method
Area under the Plasma Concentration Curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)	Up to 30 days

Trial Locations

Locations (1)

CRS Clinical Research Services Mannheim GmbH; 🇩🇪 Mannheim, Germany