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

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ClinicalTrials.gov Identifier: NCT02229773
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BIBB 1464 MS low dose Drug: Placebo Drug: Pravastatin Drug: BIBB 1464 MS medium dose Drug: BIBB 1464 MS high dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability After Multiple Oral Doses of 0.25 mg, 0.5 mg and 1 mg o.d. BIBB 1464 (Tablet) or Pravastatin 20 mg Over 2 Weeks in Hyperlipemic Healthy Male Subjects (Parallel Group Comparison, Randomized, Placebo Controlled, Partly Double Blind [Pravastatin Open])
Study Start Date : January 2000
Actual Primary Completion Date : May 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Pravastatin

Arm Intervention/treatment
Experimental: BIBB 1464 MS low dose Drug: BIBB 1464 MS low dose
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Pravastatin Drug: Pravastatin
Experimental: BIBB 1464 MS medium dose Drug: BIBB 1464 MS medium dose
Experimental: BIBB 1464 MS high dose Drug: BIBB 1464 MS high dose



Primary Outcome Measures :
  1. Percentage change of LDL plasma cholesterol [ Time Frame: baseline, 2 weeks ]
  2. Percentage change of total plasma cholesterol [ Time Frame: baseline, 2 weeks ]

Secondary Outcome Measures :
  1. Percentage change in lipid profile [ Time Frame: baseline, 1 week ]
  2. Number of patients with adverse events [ Time Frame: Up to day 42 ]
  3. Number of patients with clinical significant findings in eye lens opacification [ Time Frame: Up to day 42 ]
  4. Number of patients with clinical significant findings in laboratory parameters [ Time Frame: Up to day 28 ]
  5. Number of patients with clinical significant findings in electrocardiogram (ECG) [ Time Frame: Up to day 28 ]
  6. Number of patients with clinical significant findings in physical examination [ Time Frame: Up to day 28 ]
  7. Number of patients with clinical significant findings in vital signs [ Time Frame: Up to day 15 ]
  8. Investigator assessed tolerability on a 4 point scale [ Time Frame: day 42 ]
  9. Amount of drug excreted in urine [ Time Frame: Up to day 15 ]
  10. Drug plasma concentration [ Time Frame: Up to day 28 ]
  11. Monoepoxysqualene (MES) plasma concentration [ Time Frame: Up to day 28 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02229773     History of Changes
Other Study ID Numbers: 1178.2
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors