Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male subjects as well as to investigate pharmacokinetics, safety and tolerability

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), pulse rate (PR)), 12-lead ECG, and clinical laboratory tests
• Age of 18 to 50 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 GCP and local legislation

Exclusion criteria:

• Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Repeated measurement of pulse rate < 50 bpm and > 90 bpm at screening
• Serum creatinine laboratory value outside the normal range
• estimated glomerular filtration rate (eGFR) according to CKD-EPI-Creatinine Formula < 90 ml/ min
• Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
• Any evidence of a concomitant disease judged as clinically relevant by the investigator Repeated measurement of pulse rate < 50 bpm and > 90 bpm at screening
• Serum creatinine laboratory value outside the normal range
• estimated glomerular filtration rate (eGFR) according to CKD-EPI-Creatinine Formula < 90 ml/ min
• Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
• Any evidence of a concomitant disease judged as clinically relevant by the investigator