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

Study Overview
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Brief Summary
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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)

Official Title
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A Study to Investigate the Effects of Multiple Doses of BI 425809 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Midazolam, Warfarin and Omeprazole) and a P Glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Midazolam
* Drug: Warfarin
* Drug: Omeprazole
* Drug: Midazolam
* Drug: Digoxin
* Drug: BI 425809


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single dose cocktail (Midazolam, Warfarin, Omeprazole)<br> | Drug: Midazolam<br> <br> Drug: Warfarin<br> <br> Drug: Omeprazole<br> <br> |
| Experimental: single dose Midazolam<br> | Drug: Midazolam<br> <br> |
| Experimental: single dose Digoxin<br> | Drug: Digoxin<br> <br> |
| Experimental: multiple dose BI 425809<br> | Drug: BI 425809<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) |  | 0-119 hours | 
| Cmax (maximum measured concentration of the analyte in plasma) |  | 0-119 hours |