Status:
COMPLETED
Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 1464 (Tablet) in Hyperlipemic Healthy Male Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary pharmacokinetics
Eligibility Criteria
Inclusion
- Healthy male Caucasian subjects as determined by results of screening
- Written informed consent in accordance with GCP and local legislation given
- Age \>= 18 and \<= 65 years
- Broca \>= - 20% and \<= + 30%
- LDL-cholesterol level \>= 3.3 mmol/L at pre-screening and at the two screening visits
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 (including thyroid) disorder
- Surgery of the gastro-intestinal tract (except appendectomy)
- Disease of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History or orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged 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 result of the trial (\<= 10 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (\<= 2 month prior to administration or during the trial)
- Smoker (\> 10 cigarettes or \> 3 cigars or \>3 pipes/day)
- Inability to refrain from smoking during the period of the study
- Alcohol abuse (\>60/g/day)
- Drug abuse
- Blood donation (\>400ml \<=1 month prior to administration)
- Excessive physical activities (\<=5 days prior to administration)
- Any laboratory value outside the normal range of clinical relevance
- LDL - cholesterol screening measurements day -1 and day -7 the different between these two values exceed 12% of the higher dose
- subjects who are vegetarian
- Eye-lens
- Cataract extraction in one or both eyes deemed likely within 2 years ("senile", non-idiopathic will not automatically exclude patients from participation)
- Lens Opacities Classification System (LOCS) III grade \>3.0 (for nuclear opalescence or cortical grad) \>0.5 (for posterior sub capsular grad)
- Log MAR Bailey-Lovie visual acuity \>0.5
- Corneal or conjunctival problems which would preclude lens photography
- Shallow anterior chamber with risk of angle-closure glaucoma
- Pupil will not dilate to at least 6 mm
- Visually significant fundus pathology in clinician's judgment
- Amblyopia, optic nerve disease, iritis, history of eye surgery, argon or YAG laser, major eye trauma, extended use (daily for \>3 month) of ocular or systemic corticosteroid treatment , use of anticoagulants, or glaucoma therapy, or participation in another clinical trial investigation an anti-cataract or cataractogenic formulation within the last year
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02229773
Start Date
January 1 2000
Last Update
September 1 2014
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