At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
BI 425809 +1 moredrug
Likely dose
BI 425809 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating BI 425809 and Bosentan for Healthy. Completed, enrolled 14 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
First PostedFeb 2023
Enrollment StartMar 2023
Primary CompletionMay 2023
TodayJul 2026
First PostedFeb 13, 2023
Enrollment StartMar 6, 2023
Primary CompletionMay 26, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 3.4 years ago
Interventions
BI 425809drug
One daily film-coated tablet of 10 mg with 240 mL of water for 10 days (R) and for 14 days (T).
Bosentandrug
Two daily film-coated tablets of 125 mg with 240 mL of water for 14 days (T).