<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/NCT02253862</url>
  </required_header>
  <id_info>
    <org_study_id>1182.83</org_study_id>
    <nct_id>NCT02253862</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic of Tadalafil Co-administered With Tipranavir/Ritonavir to Healthy Male Volunteers</brief_title>
  <official_title>Assessment of Single-dose Oral Tadalafil Pharmacokinetic Characteristics When Simultaneously Co-administered With Single-dose and Steady-state Tipranavir/Ritonavir 500 mg/200 mg to 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 assess the effects of single-dose and steady-state tipranavir/ritonavir 500 mg/200&#xD;
      mg on the single-dose pharmacokinetics of tadalafil 10 mg&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2005</start_date>
  <primary_completion_date type="Actual">March 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>Maximum Plasma Concentration (Cmax) for Tadalafil</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration (Cp12h) for Tadalafil</measure>
    <time_frame>12 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under Plasma Concentration-time Curve (AUC0-72h) for Tadalafil</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞ for Tadalafil</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax for Tipranavir and Ritonavir</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cp12 for Tipranavir and Ritonavir</measure>
    <time_frame>12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-12hTipranavir and Ritonavir</measure>
    <time_frame>12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Maximum Concentration</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination half-life (t1/2)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body clearance (Cl/F)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution,</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 42 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Sequential treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tadalafil</intervention_name>
    <description>administered days 1, 8 and 16</description>
    <arm_group_label>Sequential treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tipranavir</intervention_name>
    <description>administered days 8-18</description>
    <arm_group_label>Sequential treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritonavir</intervention_name>
    <description>administered days 8-18</description>
    <arm_group_label>Sequential treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent&#xD;
&#xD;
          2. Healthy male subjects aged between 18 years and 55 years inclusive&#xD;
&#xD;
          3. Weighing at least 40 kg&#xD;
&#xD;
          4. Volunteers must be hospitalized on day of pharmacokinetic assessments for each regimen&#xD;
&#xD;
          5. Volunteers must be willing to complete all study-related activities&#xD;
&#xD;
          6. Each volunteer must have a valid social security regimen&#xD;
&#xD;
          7. Each volunteer must have acceptable medical history, physical examination and&#xD;
             laboratory test&#xD;
&#xD;
          8. Volunteers with negative HIV serology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History or presence of allergy to the study drugs or their components or drugs of&#xD;
             their class, or a history of drug or other allergy that, in the opinion of the&#xD;
             physician responsible, contraindicates their participation. (If heparin is used during&#xD;
             pharmacokinetic (PK) sampling, subjects with a history of sensibility to heparin or&#xD;
             heparin-induced thrombocytopenia should not be enrolled)&#xD;
&#xD;
          2. Any finding of the medical examination (including blood pressure, pulse rate, and&#xD;
             electrocardiogram) deviating from normal and of clinical relevance&#xD;
&#xD;
          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic,&#xD;
             haematological, oncological or hormonal disorders&#xD;
&#xD;
          4. Known elevated liver enzymes in past clinical trials with any compound (experimental&#xD;
             or marketed)&#xD;
&#xD;
          5. Clinically relevant laboratory abnormalities and all abnormal laboratory values &gt;Grade&#xD;
             1, based on the Division of AIDS Grading Scale&#xD;
&#xD;
          6. Subjects with a history of any illness or allergy that, in the opinion of the&#xD;
             investigator, might confound the results of the study or pose additional risk in&#xD;
             administering tipranavir, ritonavir or tadalafil to the subject&#xD;
&#xD;
          7. Volunteers who are using any form of organic nitrate, either regularly and/or&#xD;
             intermittently (contraindication to use tadalafil)&#xD;
&#xD;
          8. Hypersensitivity to tadalafil, tipranavir, ritonavir or their excipients&#xD;
&#xD;
          9. Concurrent treatment with other experimental compounds&#xD;
&#xD;
         10. Inadequate venous access&#xD;
&#xD;
         11. Contraindications to tadalafil: Volunteers with mild or moderate hepatic impairment,&#xD;
             Renal insufficiency or Cardiovascular disease (patients with a myocardial infarction&#xD;
             within the last 90 days, unstable angina or angina occurring during sexual&#xD;
             intercourse, patients with New York Heart Association Class 2 or greater heart failure&#xD;
             in the last 6 months, patients with uncontrolled arrhythmias, hypotension (&lt;90/50 mm&#xD;
             Hg), or uncontrolled hypertension (&gt;170/100 mm Hg), and patients with a stroke within&#xD;
             the last 6 months)&#xD;
&#xD;
         12. Clinically unacceptable result at the screening physical examination&#xD;
&#xD;
         13. Use of investigational medications within 30 days before study entry&#xD;
&#xD;
         14. Patients hospitalized in a medical or social establishment, for any other reason than&#xD;
             research&#xD;
&#xD;
         15. People deprived of judicial or administrative freedom.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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>Tadalafil</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/NCT02253862
org study id: 1182.83
nct id: NCT02253862
lead sponsor: 
Study to assess the effects of single-dose and steady-state tipranavir/ritonavir 500 mg/200
      mg on the single-dose pharmacokinetics of tadalafil 10 mg
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Plasma Concentration (Cmax) for Tadalafil
time frame: up to 72 hours after drug administration
measure: Plasma Concentration (Cp12h) for Tadalafil
time frame: 12 hours after drug administration
measure: Area Under Plasma Concentration-time Curve (AUC0-72h) for Tadalafil
time frame: up to 72 hours after drug administration
measure: AUC0-∞ for Tadalafil
time frame: up to 72 hours after drug administration
measure: Cmax for Tipranavir and Ritonavir
time frame: up to 12 hours after drug administration
measure: Cp12 for Tipranavir and Ritonavir
time frame: 12 hours after drug administration
measure: AUC0-12hTipranavir and Ritonavir
time frame: 12 hours after drug administration
measure: Time of Maximum Concentration
time frame: up to 72 hours after drug administration
measure: Elimination half-life (t1/2)
time frame: up to 72 hours after drug administration
measure: Total body clearance (Cl/F)
time frame: up to 72 hours after drug administration
measure: Volume of distribution,
time frame: up to 72 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 42 days
arm group label: Sequential treatment
arm group type: Experimental
intervention type: Drug
intervention name: Tadalafil
description: administered days 1, 8 and 16
arm group label: Sequential treatment
intervention type: Drug
intervention name: Tipranavir
description: administered days 8-18
arm group label: Sequential treatment
intervention type: Drug
intervention name: Ritonavir
description: administered days 8-18
arm group label: Sequential treatment
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 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: Tadalafil