<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/NCT02222233</url>
  </required_header>
  <id_info>
    <org_study_id>1268.60</org_study_id>
    <nct_id>NCT02222233</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability of BI 671800 HEA in Healthy Male Volunteers</brief_title>
  <official_title>Relative Bioavailability of Single Doses of 200 mg BI 671800 HEA Administered Orally as a Delayed Release (Enteric Coated) Tablet; or Via the EnterionTM Capsule as Solution to the Jejunum, Ascending Colon or Descending Colon; or Via the EnterionTM Capsule as Particulate to the Ascending Colon. An Open-label, Five Periods, Fixed Sequence Phase I Study in Healthy Male Volunteers</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 determine the relative bioavailability of single doses of 200 mg BI 671800 HEA (choline)&#xD;
      administered as a delayed release (enteric coated) tablet; or via the EnterionTM capsule as&#xD;
      solution to the jejunum, ascending or descending colon, or as particulate to the ascending&#xD;
      colon&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <primary_completion_date type="Actual">March 2010</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-∞ (area under the concentration-time curve of BI 671800 in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>Up to 24 hours after last drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of BI 671800 in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of BI 671800 in plasma)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (the maximum concentration of BI 671800 in plasma)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (terminal half-life of BI 671800 in plasma)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of BI 671800 in the body after oral administration)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of BI 671800 in the plasma after extravascular administration)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tlag (time to first quantifiable plasma concentration)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in physical examination</measure>
    <time_frame>Up to 10 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in vital signs</measure>
    <time_frame>Up to 10 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in 12-lead electrocardiogram (ECG)</measure>
    <time_frame>Up to 10 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in clinical laboratory tests</measure>
    <time_frame>Up to 10 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 10 days after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 671800 HEA delayed release (enteric coated) tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 671800 HEA solution released in jejunum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 671800 HEA solution in the Enterion® capsule released in the jejunum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 671800 HEA solution released in ascending colon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 671800 HEA solution in the Enterion® capsule released in the ascending colon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 671800 HEA solution released in descending colon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 671800 HEA solution in the Enterion® capsule released in the descending colon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 671800 HEA particulate released in ascending colon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 671800 HEA as particulate in the Enterion® capsule released in the ascending colon</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 671800 HEA delayed release (enteric coated) tablet</intervention_name>
    <arm_group_label>BI 671800 HEA delayed release (enteric coated) tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 671800 HEA solution</intervention_name>
    <arm_group_label>BI 671800 HEA solution released in ascending colon</arm_group_label>
    <arm_group_label>BI 671800 HEA solution released in descending colon</arm_group_label>
    <arm_group_label>BI 671800 HEA solution released in jejunum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 671800 HEA particulate</intervention_name>
    <arm_group_label>BI 671800 HEA particulate released in ascending colon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males subjects&#xD;
&#xD;
          2. Aged 21-65 years&#xD;
&#xD;
          3. Body Mass Index (BMI) of 18.5-29.9 kg/m2 inclusive&#xD;
&#xD;
          4. Subjects must demonstrate their ability to swallow an empty size 000 capsule&#xD;
&#xD;
          5. Must be willing and able to participate in the whole study and must provide written&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in a clinical research study involving investigational drugs or dosage&#xD;
             forms within the previous 3 months&#xD;
&#xD;
          2. Subjects who have previously been enrolled in this study&#xD;
&#xD;
          3. Subjects who have ever sought advice from or been referred to a general practitioner&#xD;
             or counsellor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or&#xD;
             other substance abuse e.g. solvents&#xD;
&#xD;
          4. Subjects who admit to any current or previous use of Class A drugs such as opiates,&#xD;
             cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines&#xD;
             (Subjects who admit to occasional past use of cannabis will not be excluded as long as&#xD;
             they have a negative drugs of abuse test and have been abstinent for at least 12&#xD;
             months)&#xD;
&#xD;
          5. Positive drugs of abuse test result&#xD;
&#xD;
          6. Regular alcohol consumption &gt;21 units per week (1 Unit = ½ pint beer, a 25 mL shot of&#xD;
             40% spirit or a 125 mL glass of wine)&#xD;
&#xD;
          7. Current smokers and those who have smoked within the last 6 months. A breath carbon&#xD;
             monoxide reading of greater than 10 ppm at screening&#xD;
&#xD;
          8. Radiation exposure from clinical trials, including that from the present study,&#xD;
             excluding background radiation but including diagnostic X-rays and other medical&#xD;
             exposures, exceeding 5 millisievert (mSv) in the last twelve months or 10 mSv in the&#xD;
             last five years. No occupationally exposed worker, as defined in the Ionising&#xD;
             Radiation Regulations 1999, shall participate in the study.&#xD;
&#xD;
          9. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by&#xD;
             the Investigator, repeated alanine aminotransferase (ALT), aspartame aminotransferase&#xD;
             (AST), gamma-glutamyltransferase (GGT), alkaline phosphatase (ALP) or Total bilirubin&#xD;
             above upper limit normal (ULN)&#xD;
&#xD;
         10. History of gastrointestinal surgery (with the exception of appendectomy unless it was&#xD;
             performed within the previous 12 months)&#xD;
&#xD;
         11. History of clinically significant disease such as cardiovascular, renal, hepatic,&#xD;
             respiratory, central nervous system (CNS), metabolic and particularly gastrointestinal&#xD;
             disease, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis,&#xD;
             Crohn's Disease or Irritable Bowel Syndrome&#xD;
&#xD;
         12. History of adverse reaction or allergy to study drug or its excipients, e.g. lactose&#xD;
             or rescue medication (if specified by the Sponsor). If subject suffers from hayfever&#xD;
             they must not have or be expecting to have symptoms during the study period&#xD;
&#xD;
         13. Acute diarrhoea or constipation in the 7 days before the predicted first study day. If&#xD;
             screening occurs &gt;7 days before the first study day, this criterion will be determined&#xD;
             on first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a&#xD;
             stool frequency of greater than three times per day. Constipation will be defined as a&#xD;
             failure to open the bowels more frequently than every other day&#xD;
&#xD;
         14. Donation of blood or significant blood loss within the previous three months&#xD;
&#xD;
         15. Presence of non-removable metal objects such as metal plates, screws, etc, in the&#xD;
             abdominal region of the body (with the exception of sterilisation clips)&#xD;
&#xD;
         16. Subjects will be excluded from the study if they are considered by the Investigator to&#xD;
             be at risk of transmitting, through blood or other body fluids, the agents responsible&#xD;
             for acquired immunodeficiency syndrome (AIDS) or other sexually transmitted disease or&#xD;
             hepatitis&#xD;
&#xD;
         17. Positive hepatitis B (HBV), hepatitis C (HCV) or HIV results&#xD;
&#xD;
         18. Subjects receiving prohibited medication as described in Section 4.2&#xD;
&#xD;
         19. Unwilling to avoid excessive sunlight exposure&#xD;
&#xD;
         20. Failure to satisfy the Investigator of fitness to participate for any other reason&#xD;
&#xD;
         21. Use of drugs which might reasonably influence the results of the trial or that prolong&#xD;
             the QT/QTc interval within 10 days prior to administration or during the trial, and&#xD;
             CYP2C8 substrates such as amiodarone, amodiaquine, paclitaxel, rosiglitazone,&#xD;
             pioglitazone and repaglinide or CYP2C9 such as warfarin, tolbutamide, phenytoin,&#xD;
             losartan, acenocoumarol within 1 month or six half lives (whichever is greater)&#xD;
&#xD;
         22. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a&#xD;
             QTc interval &gt;450 ms)&#xD;
&#xD;
         23. A history of additional risk factors for torsade de pointes (e.g., heart failure,&#xD;
             hypokalaemia, family history of Long QT Syndrome)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 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 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 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/NCT02222233
org study id: 1268.60
nct id: NCT02222233
lead sponsor: 
To determine the relative bioavailability of single doses of 200 mg BI 671800 HEA (choline)
      administered as a delayed release (enteric coated) tablet; or via the EnterionTM capsule as
      solution to the jejunum, ascending or descending colon, or as particulate to the ascending
      colon
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-∞ (area under the concentration-time curve of BI 671800 in plasma over the time interval from 0 extrapolated to infinity)
time frame: Up to 24 hours after last drug administration
measure: AUC0-tz (area under the concentration-time curve of BI 671800 in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: Up to 24 hours after drug administration
measure: tmax (time from dosing to the maximum concentration of BI 671800 in plasma)
time frame: Up to 24 hours after drug administration
measure: Cmax (the maximum concentration of BI 671800 in plasma)
time frame: Up to 24 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: Up to 24 hours after drug administration
measure: t½ (terminal half-life of BI 671800 in plasma)
time frame: Up to 24 hours after drug administration
measure: MRTpo (mean residence time of BI 671800 in the body after oral administration)
time frame: Up to 24 hours after drug administration
measure: CL/F (apparent clearance of BI 671800 in the plasma after extravascular administration)
time frame: Up to 24 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: Up to 24 hours after drug administration
measure: tlag (time to first quantifiable plasma concentration)
time frame: Up to 24 hours after drug administration
measure: Number of patients with clinical significant findings in physical examination
time frame: Up to 10 days after last drug administration
measure: Number of patients with clinical significant findings in vital signs
time frame: Up to 10 days after last drug administration
measure: Number of patients with clinical significant findings in 12-lead electrocardiogram (ECG)
time frame: Up to 10 days after last drug administration
measure: Number of patients with clinical significant findings in clinical laboratory tests
time frame: Up to 10 days after last drug administration
measure: Number of patients with adverse events
time frame: Up to 10 days after last drug administration
arm group label: BI 671800 HEA delayed release (enteric coated) tablet
arm group type: Experimental
arm group label: BI 671800 HEA solution released in jejunum
arm group type: Experimental
description: BI 671800 HEA solution in the Enterion® capsule released in the jejunum
arm group label: BI 671800 HEA solution released in ascending colon
arm group type: Experimental
description: BI 671800 HEA solution in the Enterion® capsule released in the ascending colon
arm group label: BI 671800 HEA solution released in descending colon
arm group type: Experimental
description: BI 671800 HEA solution in the Enterion® capsule released in the descending colon
arm group label: BI 671800 HEA particulate released in ascending colon
arm group type: Experimental
description: BI 671800 HEA as particulate in the Enterion® capsule released in the ascending colon
intervention type: Drug
intervention name: BI 671800 HEA delayed release (enteric coated) tablet
arm group label: BI 671800 HEA delayed release (enteric coated) tablet
intervention type: Drug
intervention name: BI 671800 HEA solution
arm group label: BI 671800 HEA solution released in ascending colon
arm group label: BI 671800 HEA solution released in descending colon
arm group label: BI 671800 HEA solution released in jejunum
intervention type: Drug
intervention name: BI 671800 HEA particulate
arm group label: BI 671800 HEA particulate released in ascending colon
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor