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

Sponsor
Boehringer Ingelheim
Study ID
NCT07081932
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 26, 2025
Status verified
Oct 2025
Primary completion
Sep 27, 2025
Completion
Oct 8, 2025

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Nerandomilast alone followed by nerandomilast + bosentan

Primary Outcome Measure

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) [ Time Frame: Up to 4 days ]

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