Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects

Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects

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