Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects

Inclusion criteria

Subjects will be healthy male volunteers who meet the criteria below:

• Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
• Persons who are 20 or older and 35 or younger
• Persons with body mass index (BMI) of 18.5 kg/m2 or more and 25.0 kg/m2 less
• Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with the GCP (Good Clinical Practice)

Exclusion criteria

• Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
• Prior history of jaundice
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of any drugs within 10 days prior to administration or during the trial
• Participation in another trial with an investigational product within four months prior to administration or during the trial
• Smoker (>10 cigarettes, >3 cigars or >3 pipes/day)
• Inability to refrain from smoking on trial days (during hospitalisation and end of trial)
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
• Excessive physical activities (within 1 week prior to administration or during the trial)
• Any laboratory value outside the reference range that is of clinical relevance
• Inability to comply with dietary regimen of the trial site
• A history of additional risk factors for torsades de pointe (e.g., heart failure, hypokalemia, and family history of long QT syndrome)
• The use of concomitant medications that prolong the QT/corrected QT interval