Phase 1
N=14
A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05723874 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Area Under the Concentration-time Curve of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) — 4063.86; 1957.60 hours * nanomole/liter (h*nmol/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 425809 (Drug); Bosentan (Drug)
- Age
- Adult · 30+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) |
4063.86; 1957.60 | — |
| PRIMARY Maximum Measured Concentration of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) |
246.30; 155.04 | — |
| SECONDARY Minimum Concentration of BI 425809 in Plasma at Steady State Within a Uniform Dosing Interval τ (Cmin,ss) |
119.47; 43.64 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Age of 30 to 55 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Exclusion Criteria
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 millimetre of mercury (mmHg), or pulse rate outside the range of 45 to 90 beats per minute (bpm)
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT05723874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.