Investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, MES as marker), effect on routine lipid profile parameters, safety and preliminary pharmacokinetics

Inclusion Criteria:

• Healthy male caucasian subjects as determined by results of screening
• Written informed consent in accordance with good clinical practice (GCP) and local legislation given
• Age ≥ 18 and ≤ 65 years
• Broca ≥ - 20 % and ≤ + 30 %
• Cholesterol level ≥ 5.4 mmol/l

Exclusion Criteria:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (> 24 hours) (≤ 1 month prior to administration or during the trial)
• Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation > 100 ml (≤ 4 weeks prior to administration or during the trial)
• Excessive physical activities (≤ 10 days prior to administration or during the trial)
• Any laboratory value outside the reference range of clinical relevance
• Abnormal findings at eye lens examination