<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/NCT02260076</url>
  </required_header>
  <id_info>
    <org_study_id>352.2030</org_study_id>
    <nct_id>NCT02260076</nct_id>
  </id_info>
  <brief_title>Safety of Total Daily Doses of Polyethylene Glycol (PEG) 400 Administered Orally to Healthy Male Human Subjects</brief_title>
  <official_title>Safety of Total Daily Doses of 5, 10, 15 and 20 mL PEG 400 Administered Orally to Healthy Male Human Subjects Once (QD) or Twice (BID) for 14 Days. A Single Center, Multiple Rising Dose Study, Placebo Controlled, Double-blinded at Each Dose Level</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2001</start_date>
  <primary_completion_date type="Actual">March 2002</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>Number of subjects with clinically relevant findings in vital signs</measure>
    <time_frame>up to 7 days after last drug administration</time_frame>
    <description>blood pressure, pulse rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant findings in laboratory tests</measure>
    <time_frame>up to 7 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant findings in 12-lead ECG</measure>
    <time_frame>up to 7 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant findings in physical examination</measure>
    <time_frame>up to 7 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 7 days after last drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of global tolerability by the investigator on a 4-point rating scale</measure>
    <time_frame>up to 7 days after last drug administration</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>PEG 400</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>multiple rising doses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEG 400</intervention_name>
    <arm_group_label>PEG 400</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects as determined by results of screening&#xD;
&#xD;
          -  Signed written informed consent in accordance with good clinical practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 55 years&#xD;
&#xD;
          -  Broca ≥ - 20 % and ≤ + 20 %&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and&#xD;
             electrocardiogram [ECG]) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  History of current gastrointestinal, hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic, immunologic, hormonal disorders, including a clinical history of viral&#xD;
             hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells and blackouts&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#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 by the investigator&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within one month prior to&#xD;
             administration&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial within 10 days prior&#xD;
             to administration or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within one month prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or three cigars or three pipes/day) or inability to refrain&#xD;
             from smoking 10 hours before the morning dose and one hour before afternoon/evening&#xD;
             dose and one hour after any dose&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation within one month prior to administration or during the trial&#xD;
&#xD;
          -  Excessive physical activities within five days prior to administration or during the&#xD;
             trial&#xD;
&#xD;
          -  Any laboratory value outside the clinically accepted reference range and of clinical&#xD;
             relevance&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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>October 2014</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 8, 2014</last_update_submitted>
  <last_update_submitted_qc>October 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02260076
org study id: 352.2030
nct id: NCT02260076
lead sponsor: 
To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of subjects with clinically relevant findings in vital signs
time frame: up to 7 days after last drug administration
description: blood pressure, pulse rate
measure: Number of subjects with clinically relevant findings in laboratory tests
time frame: up to 7 days after last drug administration
measure: Number of subjects with clinically relevant findings in 12-lead ECG
time frame: up to 7 days after last drug administration
measure: Number of subjects with clinically relevant findings in physical examination
time frame: up to 7 days after last drug administration
measure: Number of subjects with adverse events
time frame: up to 7 days after last drug administration
measure: Assessment of global tolerability by the investigator on a 4-point rating scale
time frame: up to 7 days after last drug administration
arm group label: PEG 400
arm group type: Experimental
description: multiple rising doses
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: PEG 400
arm group label: PEG 400
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor