Status:
COMPLETED
Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 515 BS or Pravastatin in Hyperlipemic Healthy Male Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
Investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, MES as marker), effect on routine lipid profile parameters, safety and preliminary pharmacokinetics
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02266485
Start Date
July 1 1998
Last Update
October 17 2014
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