<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02229773</url>
  </required_header>
  <id_info>
    <org_study_id>1178.2</org_study_id>
    <nct_id>NCT02229773</nct_id>
  </id_info>
  <brief_title>Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 1464 (Tablet) in Hyperlipemic Healthy Male Subjects</brief_title>
  <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])</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene&#xD;
      cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary&#xD;
      pharmacokinetics&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2000</start_date>
  <primary_completion_date type="Actual">May 2000</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage change of LDL plasma cholesterol</measure>
    <time_frame>baseline, 2 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage change of total plasma cholesterol</measure>
    <time_frame>baseline, 2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage change in lipid profile</measure>
    <time_frame>baseline, 1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in eye lens opacification</measure>
    <time_frame>Up to day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in laboratory parameters</measure>
    <time_frame>Up to day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in electrocardiogram (ECG)</measure>
    <time_frame>Up to day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in physical examination</measure>
    <time_frame>Up to day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in vital signs</measure>
    <time_frame>Up to day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator assessed tolerability on a 4 point scale</measure>
    <time_frame>day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of drug excreted in urine</measure>
    <time_frame>Up to day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug plasma concentration</measure>
    <time_frame>Up to day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monoepoxysqualene (MES) plasma concentration</measure>
    <time_frame>Up to day 28</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIBB 1464 MS low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pravastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBB 1464 MS medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BIBB 1464 MS high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBB 1464 MS low dose</intervention_name>
    <arm_group_label>BIBB 1464 MS low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pravastatin</intervention_name>
    <arm_group_label>Pravastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBB 1464 MS medium dose</intervention_name>
    <arm_group_label>BIBB 1464 MS medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBB 1464 MS high dose</intervention_name>
    <arm_group_label>BIBB 1464 MS high dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male Caucasian subjects as determined by results of screening&#xD;
&#xD;
          -  Written informed consent in accordance with GCP and local legislation given&#xD;
&#xD;
          -  Age &gt;= 18 and &lt;= 65 years&#xD;
&#xD;
          -  Broca &gt;= - 20% and &lt;= + 30%&#xD;
&#xD;
          -  LDL-cholesterol level &gt;= 3.3 mmol/L at pre-screening and at the two screening visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination. (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal (including thyroid) disorder&#xD;
&#xD;
          -  Surgery of the gastro-intestinal tract (except appendectomy)&#xD;
&#xD;
          -  Disease of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History or orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged the investigator&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) (&lt;= 1 month prior to administration&#xD;
             or during the trial)&#xD;
&#xD;
          -  Use of any drugs which might influence the result of the trial (&lt;= 10 days prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (&lt;= 2 month prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt;3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking during the period of the study&#xD;
&#xD;
          -  Alcohol abuse (&gt;60/g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (&gt;400ml &lt;=1 month prior to administration)&#xD;
&#xD;
          -  Excessive physical activities (&lt;=5 days prior to administration)&#xD;
&#xD;
          -  Any laboratory value outside the normal range of clinical relevance&#xD;
&#xD;
          -  LDL - cholesterol screening measurements day -1 and day -7 the different between these&#xD;
             two values exceed 12% of the higher dose&#xD;
&#xD;
          -  subjects who are vegetarian&#xD;
&#xD;
        Eye-lens&#xD;
&#xD;
          -  Cataract extraction in one or both eyes deemed likely within 2 years (&quot;senile&quot;,&#xD;
             non-idiopathic will not automatically exclude patients from participation)&#xD;
&#xD;
          -  Lens Opacities Classification System (LOCS) III grade &gt;3.0 (for nuclear opalescence or&#xD;
             cortical grad) &gt;0.5 (for posterior sub capsular grad)&#xD;
&#xD;
          -  Log MAR Bailey-Lovie visual acuity &gt;0.5&#xD;
&#xD;
          -  Corneal or conjunctival problems which would preclude lens photography&#xD;
&#xD;
          -  Shallow anterior chamber with risk of angle-closure glaucoma&#xD;
&#xD;
          -  Pupil will not dilate to at least 6 mm&#xD;
&#xD;
          -  Visually significant fundus pathology in clinician's judgment&#xD;
&#xD;
          -  Amblyopia, optic nerve disease, iritis, history of eye surgery, argon or YAG laser,&#xD;
             major eye trauma, extended use (daily for &gt;3 month) of ocular or systemic&#xD;
             corticosteroid treatment , use of anticoagulants, or glaucoma therapy, or&#xD;
             participation in another clinical trial investigation an anti-cataract or&#xD;
             cataractogenic formulation within the last year&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pravastatin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02229773
org study id: 1178.2
nct id: NCT02229773
lead sponsor: 
Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene
      cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary
      pharmacokinetics
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Percentage change of LDL plasma cholesterol
time frame: baseline, 2 weeks
measure: Percentage change of total plasma cholesterol
time frame: baseline, 2 weeks
measure: Percentage change in lipid profile
time frame: baseline, 1 week
measure: Number of patients with adverse events
time frame: Up to day 42
measure: Number of patients with clinical significant findings in eye lens opacification
time frame: Up to day 42
measure: Number of patients with clinical significant findings in laboratory parameters
time frame: Up to day 28
measure: Number of patients with clinical significant findings in electrocardiogram (ECG)
time frame: Up to day 28
measure: Number of patients with clinical significant findings in physical examination
time frame: Up to day 28
measure: Number of patients with clinical significant findings in vital signs
time frame: Up to day 15
measure: Investigator assessed tolerability on a 4 point scale
time frame: day 42
measure: Amount of drug excreted in urine
time frame: Up to day 15
measure: Drug plasma concentration
time frame: Up to day 28
measure: Monoepoxysqualene (MES) plasma concentration
time frame: Up to day 28
arm group label: BIBB 1464 MS low dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Pravastatin
arm group type: Active Comparator
arm group label: BIBB 1464 MS medium dose
arm group type: Experimental
arm group label: BIBB 1464 MS high dose
arm group type: Experimental
intervention type: Drug
intervention name: BIBB 1464 MS low dose
arm group label: BIBB 1464 MS low dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: Pravastatin
arm group label: Pravastatin
intervention type: Drug
intervention name: BIBB 1464 MS medium dose
arm group label: BIBB 1464 MS medium dose
intervention type: Drug
intervention name: BIBB 1464 MS high dose
arm group label: BIBB 1464 MS high dose
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Pravastatin