Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 1464 (Tablet) in Hyperlipemic Healthy Male Subjects

NCT ID: NCT02229773

Last Updated: 2014-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31

Brief Summary

Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary pharmacokinetics

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIBB 1464 MS low dose

Group Type: EXPERIMENTAL

BIBB 1464 MS low dose

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pravastatin

Group Type: ACTIVE_COMPARATOR

Pravastatin

Intervention Type: DRUG

BIBB 1464 MS medium dose

Group Type: EXPERIMENTAL

BIBB 1464 MS medium dose

Intervention Type: DRUG

BIBB 1464 MS high dose

Group Type: EXPERIMENTAL

BIBB 1464 MS high dose

Intervention Type: DRUG

Interventions

BIBB 1464 MS low dose

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Pravastatin

Intervention Type: DRUG

BIBB 1464 MS medium dose

Intervention Type: DRUG

BIBB 1464 MS high dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 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 (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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1178.2

Identifier Type: -

Identifier Source: org_study_id