Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809

Non-randomised, Open Label, Sequential-group Study to Assess the Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809 in Healthy Male Volunteers

To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid.

Inclusion criteria:

• Healthy male according to the investigator's 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

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 and considered as clinical relevant by investigator
• 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
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
• 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 may apply