Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 515 BS or Pravastatin in Hyperlipemic Healthy Male Subjects

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Pravastatin

Drug: Placebo

Drug: BIBB 515 BS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02266485

525.3

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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