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

Sponsor
Boehringer Ingelheim
Study ID
NCT07100964
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • nerandomilast — DRUG
    nerandomilast
  • carbamazepine — DRUG
    carbamazepine

Study Details

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

Key Dates

Start date
Aug 11, 2025
Status verified
Oct 2025
Primary completion
Sep 20, 2025
Completion
Oct 1, 2025

Study Design

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

Arms

  • Experimental: Nerandomilast alone followed by nerandomilast + carbamazepine

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 (AUC 0-tz) [ Time Frame: Up to 30 days ]

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