<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/NCT02253875</url>
  </required_header>
  <id_info>
    <org_study_id>1182.84</org_study_id>
    <nct_id>NCT02253875</nct_id>
  </id_info>
  <brief_title>Study to Determine the Effects of Multiple-dose Omeprazole on the Single-dose Pharmacokinetics of Tipranavir (TPV) Coadministered With Ritonavir (RTV) in Healthy Adult Volunteers</brief_title>
  <official_title>A Single-centre, Open-label Study in Healthy Adult Volunteers to Determine the Effects of Multiple-dose Omeprazole (ANTRA® 40 mg qd) on the Single-dose Pharmacokinetics of Tipranavir 500 mg Coadministered With Ritonavir 200 mg</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 effects of multiple-dose omeprazole on the single-dose&#xD;
      pharmacokinetics of tipranavir and ritonavir&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2005</start_date>
  <primary_completion_date type="Actual">February 2006</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax (Maximum plasma concentration of Tipranavir in plasma)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-72h (Area Under Plasma Concentration-time curve of Tipranavir from 0-72 hr)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (Maximum plasma concentration of Ritonavir in plasma)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-72h (Area Under Plasma Concentration-time curve of Ritonavir from 0-72 hr)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞ (Area Under Plasma Concentration-time curve from 0 to infinity)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT (Mean residence time)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (apparent terminal halflife)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax (Time to maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (Oral clearance)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (Apparent volume of distribution during the terminal elimination phase divided by the bioavailability factor)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 24 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>TPV + RTV + Omeprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tipranavir (TPV)</intervention_name>
    <arm_group_label>TPV + RTV + Omeprazole</arm_group_label>
    <other_name>(Aptivus ®)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritonavir</intervention_name>
    <arm_group_label>TPV + RTV + Omeprazole</arm_group_label>
    <other_name>(Norvir-SEC®)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omeprazole</intervention_name>
    <arm_group_label>TPV + RTV + Omeprazole</arm_group_label>
    <other_name>(Antra®)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female healthy volunteers between 18 and 60 years of age inclusive&#xD;
&#xD;
          2. Clinically normal medical history&#xD;
&#xD;
          3. Clinically normal findings on physical examination&#xD;
&#xD;
          4. Clinically normal laboratory values&#xD;
&#xD;
          5. Body Mass Index (BMI) between 18.5 and 30 kg/m2 inclusive&#xD;
&#xD;
          6. Ability to swallow large capsules without difficulty&#xD;
&#xD;
          7. Capable of comprehending and communicating effectively with the investigator and site&#xD;
             staff&#xD;
&#xD;
          8. Signed and dated written informed consent form, in accordance with Ethics Committee&#xD;
             and regulatory guidelines prior to trial participation&#xD;
&#xD;
          9. Willingness to abstain from ingesting substances which may alter plasma drug levels by&#xD;
             interactions with the cytochrome P450 system during the 14 days of the study&#xD;
&#xD;
         10. Willingness to abstain from alcohol for 48 hours prior to Visit 2 and for the duration&#xD;
             of the study&#xD;
&#xD;
         11. Willingness to abstain from ingesting grapefruit and grapefruit juice for 7 days&#xD;
             before Visit 2 and for the duration of the study&#xD;
&#xD;
         12. Negative pregnancy test (β-hCG)&#xD;
&#xD;
         13. Negative HIV serology&#xD;
&#xD;
         14. Negative hepatitis serology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any clinically significant disease (a significant disease is defined as a disease,&#xD;
             which in the opinion of the investigator may either put the subject at risk because of&#xD;
             participation in the study, or a disease which may influence the results of the study&#xD;
             or the subject's ability to participate in the study)&#xD;
&#xD;
          2. Clinically significant abnormal baseline hematology, blood chemistry or urinalysis&#xD;
             findings normal at Visit 2&#xD;
&#xD;
          3. Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), cholesterol,&#xD;
             triglyceride or glucose greater than the upper limit of normal at Visit 2&#xD;
&#xD;
          4. Treatment with any investigational drug within 90 days prior to the first dose of&#xD;
             study medication&#xD;
&#xD;
          5. Inability to adhere to the requirements of the protocol as assessed by the&#xD;
             investigator&#xD;
&#xD;
          6. Prior TPV use&#xD;
&#xD;
          7. Subjects who are taking or have taken medications metabolized through the Cytochrome&#xD;
             P-450 (CYP450) enzyme system within 30 days prior to Visit 2&#xD;
&#xD;
          8. Subject with a seated systolic blood pressure either &lt;100 mmHg or &gt;150 mmHg; resting&#xD;
             heart rate either &lt;50 beats/min or &gt;100 beats/min&#xD;
&#xD;
          9. Subject with a history of any illness or allergy that in the investigator opinion&#xD;
             might confound the results of the study, or pose additional risk to the subject with&#xD;
             the administering of TPV/r or omeprazole&#xD;
&#xD;
         10. Subject who have had an acute illness within 14 days prior to Visit 2&#xD;
&#xD;
         11. Subject who are currently taking or have taken over-the-counter medications in the 14&#xD;
             days prior to Visit 2, or subjects who are currently taking any prescription&#xD;
             medication&#xD;
&#xD;
         12. Known hypersensitivity to TPV, RTV, omeprazole or antiretroviral drugs (marketed or&#xD;
             experimental use as part of clinical research studies)&#xD;
&#xD;
         13. Female subjects who are of reproductive potential and who are:&#xD;
&#xD;
               -  Pregnant or breast-feeding&#xD;
&#xD;
               -  Have a positive serum β-hCG (pregnancy test) at screening visit (Visit 1)&#xD;
&#xD;
               -  Have not been using a barrier contraceptive method for at least 60 days prior to&#xD;
                  Study Day 1&#xD;
&#xD;
               -  Are not willing to use a reliable method of double-barrier contraception during&#xD;
                  the trial and for 30 days after completion or termination of the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</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>
    <mesh_term>Tipranavir</mesh_term>
    <mesh_term>Omeprazole</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/NCT02253875
org study id: 1182.84
nct id: NCT02253875
lead sponsor: 
Study to determine the effects of multiple-dose omeprazole on the single-dose
      pharmacokinetics of tipranavir and ritonavir
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax (Maximum plasma concentration of Tipranavir in plasma)
time frame: up to 72 hours after drug administration
measure: AUC0-72h (Area Under Plasma Concentration-time curve of Tipranavir from 0-72 hr)
time frame: up to 72 hours after drug administration
measure: Cmax (Maximum plasma concentration of Ritonavir in plasma)
time frame: up to 72 hours after drug administration
measure: AUC0-72h (Area Under Plasma Concentration-time curve of Ritonavir from 0-72 hr)
time frame: up to 72 hours after drug administration
measure: AUC0-∞ (Area Under Plasma Concentration-time curve from 0 to infinity)
time frame: up to 72 hours after drug administration
measure: MRT (Mean residence time)
time frame: up to 72 hours after drug administration
measure: t1/2 (apparent terminal halflife)
time frame: up to 72 hours after drug administration
measure: Tmax (Time to maximum concentration of the analyte in plasma)
time frame: up to 72 hours after drug administration
measure: CL/F (Oral clearance)
time frame: up to 72 hours after drug administration
measure: Vz/F (Apparent volume of distribution during the terminal elimination phase divided by the bioavailability factor)
time frame: up to 72 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 24 days
arm group label: TPV + RTV + Omeprazole
arm group type: Experimental
intervention type: Drug
intervention name: Tipranavir (TPV)
arm group label: TPV + RTV + Omeprazole
other name: (Aptivus ®)
intervention type: Drug
intervention name: Ritonavir
arm group label: TPV + RTV + Omeprazole
other name: (Norvir-SEC®)
intervention type: Drug
intervention name: Omeprazole
arm group label: TPV + RTV + Omeprazole
other name: (Antra®)
criteria: 
gender: All
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
mesh term: Tipranavir
mesh term: Omeprazole