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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

Tracking Information
First Submitted Date  ICMJE August 28, 2014
First Posted Date  ICMJE September 1, 2014
Last Update Posted Date September 1, 2014
Study Start Date  ICMJE January 2000
Actual Primary Completion Date May 2000   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
  • Percentage change of LDL plasma cholesterol [ Time Frame: baseline, 2 weeks ]
  • Percentage change of total plasma cholesterol [ Time Frame: baseline, 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
  • Percentage change in lipid profile [ Time Frame: baseline, 1 week ]
  • Number of patients with adverse events [ Time Frame: Up to day 42 ]
  • Number of patients with clinical significant findings in eye lens opacification [ Time Frame: Up to day 42 ]
  • Number of patients with clinical significant findings in laboratory parameters [ Time Frame: Up to day 28 ]
  • Number of patients with clinical significant findings in electrocardiogram (ECG) [ Time Frame: Up to day 28 ]
  • Number of patients with clinical significant findings in physical examination [ Time Frame: Up to day 28 ]
  • Number of patients with clinical significant findings in vital signs [ Time Frame: Up to day 15 ]
  • Investigator assessed tolerability on a 4 point scale [ Time Frame: day 42 ]
  • Amount of drug excreted in urine [ Time Frame: Up to day 15 ]
  • Drug plasma concentration [ Time Frame: Up to day 28 ]
  • Monoepoxysqualene (MES) plasma concentration [ Time Frame: Up to day 28 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 1464 (Tablet) in Hyperlipemic Healthy Male Subjects
Official Title  ICMJE 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])
Brief Summary Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary pharmacokinetics
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BIBB 1464 MS low dose
  • Drug: Placebo
  • Drug: Pravastatin
  • Drug: BIBB 1464 MS medium dose
  • Drug: BIBB 1464 MS high dose
Study Arms  ICMJE
  • Experimental: BIBB 1464 MS low dose
    Intervention: Drug: BIBB 1464 MS low dose
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Pravastatin
    Intervention: Drug: Pravastatin
  • Experimental: BIBB 1464 MS medium dose
    Intervention: Drug: BIBB 1464 MS medium dose
  • Experimental: BIBB 1464 MS high dose
    Intervention: Drug: BIBB 1464 MS high dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2014)
100
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2000   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02229773
Other Study ID Numbers  ICMJE 1178.2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP