<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/NCT02253940</url>
  </required_header>
  <id_info>
    <org_study_id>1188.33</org_study_id>
    <nct_id>NCT02253940</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Safety of BILR 355 in Healthy Male Volunteers</brief_title>
  <official_title>An Open-label, Randomized, Crossover Relative BA Study of Pharmacokinetics and Safety of New SDS-containing Tablet and Capsule Formulations of BILR 355 Compared to the Current Formulation (50 mg Tablet), After Single Dose Oral Administration of BILR 355 Plus Low Dose Ritonavir 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>
      Study to determine the single dose, relative BA of new SDS-containing formulations of BILR&#xD;
      355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet&#xD;
      formulation (50 mg tablet)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2006</start_date>
  <primary_completion_date type="Actual">December 2006</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-inf (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of analyte in plasma)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of the analyte in the plasma after extravascular administration)</measure>
    <time_frame>up to 96 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 12 days following last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 48 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Dose Group 1 - low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment sequences ABC / CAB / BCA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Group 2 - high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment sequences DE / ED</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 - Treatment A (current tablet formulation)</intervention_name>
    <arm_group_label>Dose Group 1 - low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 - Treatment B (new tablet formulation)</intervention_name>
    <arm_group_label>Dose Group 1 - low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 - Treatment C (new capsule formulation)</intervention_name>
    <arm_group_label>Dose Group 1 - low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 - Treatment D (current tablet formulation)</intervention_name>
    <arm_group_label>Dose Group 2 - high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 - Treatment E (new capsule formulation)</intervention_name>
    <arm_group_label>Dose Group 2 - high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritonavir</intervention_name>
    <arm_group_label>Dose Group 1 - low dose</arm_group_label>
    <arm_group_label>Dose Group 2 - high dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy HIV negative adult male volunteers&#xD;
&#xD;
          2. Age ≥18 and ≤60 years&#xD;
&#xD;
          3. BMI ≥18.5 and BMI ≤29.9 kg/m2&#xD;
&#xD;
          4. Ability to give signed and dated written informed consent prior to admission to the&#xD;
             study in accordance with Good Clinical Practice (GCP) and the local regulations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          2. Surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          4. History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          5. Chronic or relevant acute infections&#xD;
&#xD;
          6. History of allergy/hypersensitivity (including drug allergy) which was deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          7. Intake of drugs with a long half-life (&gt;24 hours) within at least one month prior to&#xD;
             study drug administration and during the trial&#xD;
&#xD;
          8. Use of drugs within 10 days prior to administration or during the trial which might&#xD;
             reasonably influence the results of the trial&#xD;
&#xD;
          9. Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
         10. Current smoker&#xD;
&#xD;
         11. Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
         12. Drug abuse (positive urine test for illicit prescription or non-prescription drugs or&#xD;
             drugs of abuse)&#xD;
&#xD;
         13. Blood donation (more than 100 mL within four weeks prior to study drug administration&#xD;
             or during the trial)&#xD;
&#xD;
         14. Excessive physical activities (within one week prior to study drug administration or&#xD;
             during the trial)&#xD;
&#xD;
         15. Any laboratory value outside the reference range that was of clinical relevance at&#xD;
             screening, according to the judgment of the investigator&#xD;
&#xD;
         16. Inability to comply with dietary regimen required by the protocol&#xD;
&#xD;
         17. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B&#xD;
             surface antigen, or hepatitis C antibody positive)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 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>September 2014</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 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>Ritonavir</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/NCT02253940
org study id: 1188.33
nct id: NCT02253940
lead sponsor: 
Study to determine the single dose, relative BA of new SDS-containing formulations of BILR
      355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet
      formulation (50 mg tablet)
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-inf (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 96 hours after drug administration
measure: Cmax (maximum measured concentration of analyte in plasma)
time frame: up to 96 hours after drug administration
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: up to 96 hours after drug administration
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 96 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 96 hours after drug administration
measure: CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
time frame: up to 96 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 12 days following last drug administration
measure: Number of subjects with abnormal changes in laboratory parameters
time frame: up to 48 hours after drug administration
arm group label: Dose Group 1 - low dose
arm group type: Experimental
description: Treatment sequences ABC / CAB / BCA
arm group label: Dose Group 2 - high dose
arm group type: Experimental
description: Treatment sequences DE / ED
intervention type: Drug
intervention name: BILR 355 - Treatment A (current tablet formulation)
arm group label: Dose Group 1 - low dose
intervention type: Drug
intervention name: BILR 355 - Treatment B (new tablet formulation)
arm group label: Dose Group 1 - low dose
intervention type: Drug
intervention name: BILR 355 - Treatment C (new capsule formulation)
arm group label: Dose Group 1 - low dose
intervention type: Drug
intervention name: BILR 355 - Treatment D (current tablet formulation)
arm group label: Dose Group 2 - high dose
intervention type: Drug
intervention name: BILR 355 - Treatment E (new capsule formulation)
arm group label: Dose Group 2 - high dose
intervention type: Drug
intervention name: Ritonavir
arm group label: Dose Group 1 - low dose
arm group label: Dose Group 2 - high dose
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Ritonavir