Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 425809 in Healthy Male Subjects (Partially Randomised, Single-blind, Placebo-controlled) and Investigation of Relative Bioavailability and Food Effect of BI 425809 (Open-label, Randomised, Three-way Crossover)

To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed

Inclusion criteria:

• Healthy male subjects
• Age 18 to 45 years (incl.)
• Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
• Subject must be able to understand and comply with study requirements

Exclusion criteria:

• Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator
• Repeated measurement of systolic blood pressure <90 or >140 mmHg, or diastolic blood pressure <50 or >90 mmHg, or pulse rate <50 or >90
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged 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 study drug(s)
• Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders