Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect

Launched by BOEHRINGER INGELHEIM · Oct 17, 2014

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Healthy male subjects as determined by results of screening
• • Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
• • Age ≥ 18 and ≤ 50 years
• • Broca ≥ - 20 % and ≤ + 20 %
• Exclusion Criteria:
• • Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• • History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
• • History of orthostatic hypotension, fainting spells and blackouts
• • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• • Chronic or relevant acute infections
• • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• • Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
• • Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
• • Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
• • Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days
• • Alcohol abuse (\> 60 g/day)
• • Drug abuse
• • Blood donation within 1 month prior to administration or during the trial
• • Excessive physical activities within 5 days prior to administration or during the trial
• • Any laboratory value outside the clinically accepted reference range and of clinical relevance
• • History of any familial bleeding disorder