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A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood

NCT05723874 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-03-30

Study results available
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Summary

The main objective of this trial is to investigate the relative bioavailability of BI 425809 given alone (Reference) compared to a combined administration with the moderate CYP3A4 inducer bosentan (Test) following repeated oral administration.

Conditions

  • Healthy

Interventions

DRUG

BI 425809

One daily film-coated tablet of 10 mg with 240 mL of water for 10 days (R) and for 14 days (T).

DRUG

Bosentan

Two daily film-coated tablets of 125 mg with 240 mL of water for 14 days (T).

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2023-05-26
Completion
2023-05-26

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05723874 on ClinicalTrials.gov