<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/NCT02257021</url>
  </required_header>
  <id_info>
    <org_study_id>1188.7</org_study_id>
    <nct_id>NCT02257021</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir in Healthy Male Volunteers</brief_title>
  <official_title>Study of Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir</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 effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of&#xD;
      tipranavir/r on BILR 355 BS pharmacokinetics&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2005</start_date>
  <primary_completion_date type="Actual">May 2005</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration-time curve of tipranavir and BILR 355 BS in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss)</measure>
    <time_frame>up to 18 days after start of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of tipranavir and BILR 355 BS in plasma at steady state over a dosing interval τ (Cmax,ss)</measure>
    <time_frame>up to 18 days after start of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of BILR 355 BS, tipranavir and ritonavir in plasma following extravascular administration at steady state (CL/F,ss)</measure>
    <time_frame>up to 18 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to the maximum concentration of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (tmax,ss)</measure>
    <time_frame>up to 18 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (t1/2,ss)</measure>
    <time_frame>up to 18 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution of BILR 355 BS, tipranavir and ritonavir during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss)</measure>
    <time_frame>up to 18 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of ritonavir in plasma over one dosing interval (12 hours), (AUC0-12h)</measure>
    <time_frame>up to 18 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum measured concentration of ritonavir in plasma at steady state over a dosing interval τ (Cmax,ss)</measure>
    <time_frame>up to 18 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measured concentration of BILR 355 BS, tipranavir and ritonavir in plasma 12 hours post last dose at steady state (Cp12h,ss)</measure>
    <time_frame>up to 18 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically relevant changes in laboratory parameters</measure>
    <time_frame>up to 28 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically relevant changes in vital signs (blood pressure, pulse rate)</measure>
    <time_frame>up to 28 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically relevant changes in 12-lead ECG</measure>
    <time_frame>up to 14 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Up to 7 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Tipranavir and high dose of ritonavir plus BILR 355 BS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BILR 355 BS with low dose of ritonavir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 BS</intervention_name>
    <arm_group_label>BILR 355 BS with low dose of ritonavir</arm_group_label>
    <arm_group_label>Tipranavir and high dose of ritonavir plus BILR 355 BS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tipranavir</intervention_name>
    <arm_group_label>Tipranavir and high dose of ritonavir plus BILR 355 BS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose of ritonavir</intervention_name>
    <arm_group_label>BILR 355 BS with low dose of ritonavir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose of ritonavir</intervention_name>
    <arm_group_label>Tipranavir and high dose of ritonavir plus BILR 355 BS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥19 and &lt;60 years&#xD;
&#xD;
          -  BMI ≥18.5 and BMI ≤29.9 kg/m2&#xD;
&#xD;
          -  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;
          -  Current (symptomatic within the last 30 days) and medically relevant gastrointestinal,&#xD;
             hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal&#xD;
             disorders&#xD;
&#xD;
          -  Surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  Currently active (symptomatic within the last 30 days) diseases of the central nervous&#xD;
             system (such as epilepsy) or psychiatric disorders or neurological disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts&#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 of study drug or during the trial (review with clinical monitor if&#xD;
             questionable)&#xD;
&#xD;
          -  Use of drugs within 10 days prior to administration or during the trial, which might&#xD;
             reasonably influence the results of the trial based on the knowledge at the time of&#xD;
             protocol preparation (review with clinical monitor if questionable)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within one month prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Current smoker or smoked within the past 30 days&#xD;
&#xD;
          -  Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit&#xD;
             prescription or non-prescription drugs or drugs of abuse)&#xD;
&#xD;
          -  Recent blood donation (more than 100 mL within 56 days prior to administration or&#xD;
             during the trial)&#xD;
&#xD;
          -  Excessive physical activities (within 1 week prior to study drug administration or&#xD;
             during the trial)&#xD;
&#xD;
          -  Any laboratory value outside the normal reference range that is of clinical relevance&#xD;
             at screening, according to the judgment of the investigator&#xD;
&#xD;
          -  Inability to comply with dietary regimen required by the protocol&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B&#xD;
             surface antigen, or hepatitis C antibody positive)&#xD;
&#xD;
          -  HIV-1 infected as defined by a positive HIV ELISA test&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>59 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 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 2, 2014</last_update_submitted>
  <last_update_submitted_qc>October 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 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>
    <mesh_term>Tipranavir</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/NCT02257021
org study id: 1188.7
nct id: NCT02257021
lead sponsor: 
To determine the effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of
      tipranavir/r on BILR 355 BS pharmacokinetics
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve of tipranavir and BILR 355 BS in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss)
time frame: up to 18 days after start of treatment
measure: Maximum measured concentration of tipranavir and BILR 355 BS in plasma at steady state over a dosing interval τ (Cmax,ss)
time frame: up to 18 days after start of treatment
measure: Apparent clearance of BILR 355 BS, tipranavir and ritonavir in plasma following extravascular administration at steady state (CL/F,ss)
time frame: up to 18 days after start of treatment
measure: Time from dosing to the maximum concentration of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (tmax,ss)
time frame: up to 18 days after start of treatment
measure: Terminal half-life of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (t1/2,ss)
time frame: up to 18 days after start of treatment
measure: Apparent volume of distribution of BILR 355 BS, tipranavir and ritonavir during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss)
time frame: up to 18 days after start of treatment
measure: Area under the concentration-time curve of ritonavir in plasma over one dosing interval (12 hours), (AUC0-12h)
time frame: up to 18 days after start of treatment
measure: Maximum measured concentration of ritonavir in plasma at steady state over a dosing interval τ (Cmax,ss)
time frame: up to 18 days after start of treatment
measure: Measured concentration of BILR 355 BS, tipranavir and ritonavir in plasma 12 hours post last dose at steady state (Cp12h,ss)
time frame: up to 18 days after start of treatment
measure: Number of participants with clinically relevant changes in laboratory parameters
time frame: up to 28 days after start of treatment
measure: Number of participants with clinically relevant changes in vital signs (blood pressure, pulse rate)
time frame: up to 28 days after start of treatment
measure: Number of participants with clinically relevant changes in 12-lead ECG
time frame: up to 14 days after start of treatment
measure: Number of participants with adverse events
time frame: Up to 7 weeks
arm group label: Tipranavir and high dose of ritonavir plus BILR 355 BS
arm group type: Experimental
arm group label: BILR 355 BS with low dose of ritonavir
arm group type: Experimental
intervention type: Drug
intervention name: BILR 355 BS
arm group label: BILR 355 BS with low dose of ritonavir
arm group label: Tipranavir and high dose of ritonavir plus BILR 355 BS
intervention type: Drug
intervention name: Tipranavir
arm group label: Tipranavir and high dose of ritonavir plus BILR 355 BS
intervention type: Drug
intervention name: Low dose of ritonavir
arm group label: BILR 355 BS with low dose of ritonavir
intervention type: Drug
intervention name: High dose of ritonavir
arm group label: Tipranavir and high dose of ritonavir plus BILR 355 BS
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Ritonavir
mesh term: Tipranavir