Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1060469 in Healthy Asian Male Volunteers

Inclusion criteria

• Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
• Chinese ethnicity, Japanese ethnicity according to the following criteria:

Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in china Japanese; born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan

• Age within the range of 18 to 45 years
• Body mass index within the range of 18.5 and 25 kg/m2
• 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, pulse rate or ECG(electrocardiogram)) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 beat per minute or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement.
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Serum creatinine laboratory value outside the normal range
• Glomerular Filtration Rate according to CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Formula < 60 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)
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
• Diseases of the central nervous system (such as epilepsy), central neurological disorders or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Relevant chronic or acute infections
• History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
• Intake of drugs with a long half-life (greater than 24 hours) within 30 days or less than 10 half-lives of the respective drug prior to study drug administration
• Intake of any NSAIDs(Nonsteroidal anti-inflammatory drugs), COX2(Cyclooxygenase-2) inhibitors, aspirin, ACE(Angiotensin Converting Enzyme) inhibitors, H2-blockers or OTC(Over the Counter Drug)- or nutripharmaceuticals between screening examination and drug administration
• Use of drugs that might reasonably influence the results of the trial (including renal function measurements) or that might prolong the QT/QTc interval within 14 days prior to study drug administration
• Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on specified trial days
• Alcohol abuse (consumption of more than 30 g/day)
• Drug abuse or positive drug screen
• Blood donation (more than 100 mL within 30 days prior to administration of trial medication or intended during the trial)
• Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
• Inability to comply with dietary regimen of trial site
• A marked baseline prolongation of QT/QTc interval (such as repeated demonstration of a QTc interval greater than 450 ms) or any other relevant ECG finding
• A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
• Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study