Phase 1 N=13 Treatment

Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02783040 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) — 19.0; 23.5; 16.0 nanogram (ng)*hour (h)/millilitre (mL)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Midazolam (Drug); Warfarin (Drug); Omeprazole (Drug); Digoxin (Drug); BI 425809 (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Boehringer Ingelheim
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	19.0; 23.5; 16.0	—
PRIMARY Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	384; 483	—
PRIMARY Area Under the Concentration-time Curve of S-warfarin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	15200; 15100	—
PRIMARY Area Under the Concentration-time Curve of Digoxin From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)	9.51; 9.71	—
PRIMARY Maximum Concentration of Midazolam in Plasma (Cmax)	7.03; 8.54; 6.45	—
PRIMARY Maximum Concentration of Omeprazole in Plasma (Cmax)	208; 220	—
PRIMARY Maximum Concentration of S-warfarin in Plasma (Cmax)	552; 535	—
PRIMARY Maximum Concentration of Digoxin in Plasma (Cmax)	1.11; 1.10	—

Summary

To assess the influence of multiple doses of BI 425809 on single dose pharmacokinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug)

Eligibility Criteria

Inclusion criteria

Healthy male subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), puls rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (incl.)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
Ready and able to use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the subject information

Exclusion criteria

Any finding in the medical examination (including blood pressure (BP), puls rate (PR) or electrocardiogram (ECG)) is deviating from normal and judged 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 mmHg, or pulse rate outside the range of 50 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and 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 Further exclusion criteria apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02783040). 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.