<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/NCT02253953</url>
  </required_header>
  <id_info>
    <org_study_id>1188.4</org_study_id>
    <nct_id>NCT02253953</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Single Doses of BILR 355 BS Given With Ritonavir in Healthy Male Volunteers</brief_title>
  <official_title>An Open Study to Investigate the Effect of Two Times Oral 100 mg Ritonavir Capsules on Pharmacokinetics of Single Doses of BILR 355 BS (Dose Steps: 5 and 12.5 mg) Dissolved in 5 mL PEG 400 After Oral Administration in Healthy Male Volunteers, and a Double Blind, Placebo Controlled Study for Doses From 25 mg to 100 mg BILR 355 BS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Assessment of the effect of two times oral 100 mg ritonavir capsules on pharmacokinetics of a&#xD;
      single dose of BILR 355 BS dissolved in PEG 400&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2002</start_date>
  <primary_completion_date type="Actual">December 2003</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>Maximum observed concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to reach Cmax (tmax)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve (AUC)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal half-life of the analyte in plasma (t1/2)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total clearance of the analyte in plasma (CL/F)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total mean residence time (MRTtot)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution (Vz/F)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal clearance (CLR)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary excretion (Ae)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 26 days</time_frame>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>D1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>D2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>D4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>D5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>D6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>D7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>D8</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>D10</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>
    <description>for D3 - D10</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 BS, D1</intervention_name>
    <arm_group_label>D1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 BS, D2</intervention_name>
    <arm_group_label>D2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 BS, D3</intervention_name>
    <arm_group_label>D3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 BS, D4</intervention_name>
    <arm_group_label>D4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 BS, D5</intervention_name>
    <arm_group_label>D5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 BS, D6</intervention_name>
    <arm_group_label>D6</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 BS, D7</intervention_name>
    <arm_group_label>D7</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 BS, D8</intervention_name>
    <arm_group_label>D8</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 BS, D10</intervention_name>
    <arm_group_label>D10</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>Other</intervention_type>
    <intervention_name>high-fat breakfast</intervention_name>
    <arm_group_label>D10</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritonavir</intervention_name>
    <arm_group_label>D1</arm_group_label>
    <arm_group_label>D10</arm_group_label>
    <arm_group_label>D2</arm_group_label>
    <arm_group_label>D3</arm_group_label>
    <arm_group_label>D4</arm_group_label>
    <arm_group_label>D5</arm_group_label>
    <arm_group_label>D6</arm_group_label>
    <arm_group_label>D7</arm_group_label>
    <arm_group_label>D8</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants in the study should be healthy males&#xD;
&#xD;
          -  Age range from 21 to 50 years&#xD;
&#xD;
          -  Body mass index (BMI) be within 18.5 to 29.9 kg/m2&#xD;
&#xD;
          -  In accordance with Good Clinical Practice and the local legislation all volunteers&#xD;
             will have given their written informed consent prior to admission to the study&#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 disorders&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of 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 by the investigator&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within at least one month or less&#xD;
             than ten half-lives of the respective drug before enrolment in the study or during the&#xD;
             study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial up to 7 days prior to&#xD;
             enrolment in the study or during the study&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (≤ two months prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars of &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (≥ 100 mL within four weeks prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the clinically accepted reference range&#xD;
&#xD;
          -  Excessive physical activities within the last week before the trial or during the&#xD;
             trial&#xD;
&#xD;
        Following exclusion criteria are of special interest for this study:&#xD;
&#xD;
          -  Erythema, exanthema and comparable skin alterations&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 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/NCT02253953
org study id: 1188.4
nct id: NCT02253953
lead sponsor: 
Assessment of the effect of two times oral 100 mg ritonavir capsules on pharmacokinetics of a
      single dose of BILR 355 BS dissolved in PEG 400
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Maximum observed concentration of the analyte in plasma (Cmax)
time frame: up to 120 hours after drug administration
measure: Time to reach Cmax (tmax)
time frame: up to 120 hours after drug administration
measure: Area under the concentration-time curve (AUC)
time frame: up to 120 hours after drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
time frame: up to 120 hours after drug administration
measure: Total clearance of the analyte in plasma (CL/F)
time frame: up to 120 hours after drug administration
measure: Total mean residence time (MRTtot)
time frame: up to 120 hours after drug administration
measure: Apparent volume of distribution (Vz/F)
time frame: up to 120 hours after drug administration
measure: Renal clearance (CLR)
time frame: up to 72 hours after drug administration
measure: Urinary excretion (Ae)
time frame: up to 72 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 26 days
arm group label: D1
arm group type: Experimental
arm group label: D2
arm group type: Experimental
arm group label: D3
arm group type: Experimental
arm group label: D4
arm group type: Experimental
arm group label: D5
arm group type: Experimental
arm group label: D6
arm group type: Experimental
arm group label: D7
arm group type: Experimental
arm group label: D8
arm group type: Experimental
arm group label: D10
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
description: for D3 - D10
intervention type: Drug
intervention name: BILR 355 BS, D1
arm group label: D1
intervention type: Drug
intervention name: BILR 355 BS, D2
arm group label: D2
intervention type: Drug
intervention name: BILR 355 BS, D3
arm group label: D3
intervention type: Drug
intervention name: BILR 355 BS, D4
arm group label: D4
intervention type: Drug
intervention name: BILR 355 BS, D5
arm group label: D5
intervention type: Drug
intervention name: BILR 355 BS, D6
arm group label: D6
intervention type: Drug
intervention name: BILR 355 BS, D7
arm group label: D7
intervention type: Drug
intervention name: BILR 355 BS, D8
arm group label: D8
intervention type: Drug
intervention name: BILR 355 BS, D10
arm group label: D10
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Other
intervention name: high-fat breakfast
arm group label: D10
intervention type: Drug
intervention name: Ritonavir
arm group label: D1
arm group label: D10
arm group label: D2
arm group label: D3
arm group label: D4
arm group label: D5
arm group label: D6
arm group label: D7
arm group label: D8
arm group label: Placebo
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Ritonavir