Trials / Completed
CompletedNCT05723874
A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood
The Effect of Multiple Oral Doses of Bosentan on the Steady State Kinetics of BI 425809 After Oral Administration to Healthy Male Subjects (an Open-label, Two-period Fixed Sequence Trial)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- Male
- Age
- 30 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2023-03-06
- Primary completion
- 2023-05-26
- Completion
- 2023-05-26
- First posted
- 2023-02-13
- Last updated
- 2026-03-30
- Results posted
- 2026-03-30
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05723874. Inclusion in this directory is not an endorsement.