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

Sponsor
Boehringer Ingelheim
Study ID
NCT07649941
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
25 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Zongertinib — DRUG
    Zongertinib
  • Bosentan — DRUG
    Bosentan

Study Details

The main objective of this trial is to investigate the effect of a moderate CYP 3A inducer bosentan on the pharmacokinetics of zongertinib.

Key Dates

First listed
Jun 16, 2026
Start date
Jun 22, 2026
Status verified
Jun 2026
Primary completion
Aug 19, 2026
Completion
Aug 19, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fixed sequence arm
    First reference treatment: Zongertinib Then test treatment: Bosentan and Zongertinib

Primary Outcome Measure

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [ Time Frame: up to 8 days ]

Central Contacts

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