<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/NCT02248883</url>
  </required_header>
  <id_info>
    <org_study_id>1182.60</org_study_id>
    <nct_id>NCT02248883</nct_id>
  </id_info>
  <brief_title>Electrophysiological Effects of Tipranavir Co-administered With Ritonavir on the QT Interval in Healthy Female and Male Subjects</brief_title>
  <official_title>Assessment of Electrophysiological Effects of Tipranavir Co-administered With Ritonavir Given b.i.d. for 2.5 Days on the QT Interval in Healthy Female and Male Subjects. A Double-blind, Randomised, Placebo Controlled, Two-way Crossover Study With a Positive Control (Moxifloxacin) and Parallel Dose Groups</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 demonstrate that tipranavir (TPV) co-administered with ritonavir (RTV) does not affect the&#xD;
      QT interval more than placebo co-administered with ritonavir&#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>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in individually heart rate corrected QT interval length (QTcI)</measure>
    <time_frame>baseline and 2 to 4 hours after drug administration on day3</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in (QTcI)</measure>
    <time_frame>baseline and 2 to 4 hours after drug administration on day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in (QTcI)</measure>
    <time_frame>baseline and 1 to 12 hours after drug administration on day1 and 3</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>low TPV/RTV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>high TPV/RTV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo/RTV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TPV low</intervention_name>
    <arm_group_label>low TPV/RTV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo/RTV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin</intervention_name>
    <arm_group_label>Placebo/RTV</arm_group_label>
    <arm_group_label>high TPV/RTV</arm_group_label>
    <arm_group_label>low TPV/RTV</arm_group_label>
    <other_name>Avelox®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TPV high</intervention_name>
    <arm_group_label>high TPV/RTV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RTV</intervention_name>
    <arm_group_label>Placebo/RTV</arm_group_label>
    <arm_group_label>high TPV/RTV</arm_group_label>
    <arm_group_label>low TPV/RTV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy female and male volunteers as determined by the results of screening according&#xD;
             to the following criteria: Based upon a complete medical history, including the&#xD;
             physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests&#xD;
&#xD;
          2. Age ≥ 18 and Age ≤ 55 years&#xD;
&#xD;
          3. BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)&#xD;
&#xD;
          4. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with GCP and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          2. Gastrointestinal tract surgery (except appendectomy)&#xD;
&#xD;
          3. Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric&#xD;
             disorders or neurological disorders&#xD;
&#xD;
          4. History of relevant orthostatic hypotension, fainting spells or blackouts.&#xD;
&#xD;
          5. Relevant acute, chronic or active chronic infections (e.g. hepatitis, HIV).&#xD;
&#xD;
          6. History of allergy/hypersensitivity (including drug allergies) that are deemed&#xD;
             relevant 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 or less&#xD;
             than 10 half-lives of the respective drug prior to administration or during the trial&#xD;
&#xD;
          8. Use of drugs which might reasonably influence the results of the trial based on the&#xD;
             knowledge at the time of protocol preparation within 10 days prior to administration&#xD;
             or during 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. Smoker (more than 10 cigarettes/day or 3 cigars/day or 3 pipes/day)&#xD;
&#xD;
         11. Inability to refrain from smoking on trial days&#xD;
&#xD;
         12. Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
         13. Drug abuse&#xD;
&#xD;
         14. Veins unsuited for i.v. puncture on either arm (e.g. veins which are difficult to&#xD;
             locate, access or puncture, veins with a tendency to rupture during or after puncture)&#xD;
&#xD;
         15. Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
         16. History of any bleeding disorder or acute blood coagulation defect&#xD;
&#xD;
         17. Hypersensitivity to ritonavir, moxifloxacin and/or related drugs of these classes&#xD;
&#xD;
         18. History of Glucose-6-phosphate-deficiency&#xD;
&#xD;
         19. Excessive physical activities (within one week prior to trial or during the trial)&#xD;
&#xD;
         20. Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
         21. A history of additional risk factors for torsade de pointes (TdP) (e.g., heart&#xD;
             failure, hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
         22. Heart rate at screening of &gt; 80 bpm or &lt; 45 bpm&#xD;
&#xD;
         23. Any screening ECG value outside of the reference range of clinical relevance&#xD;
             including, but not limited to PR interval &gt; 240 ms, QRS interval &gt; 120 ms, QTcB or&#xD;
             QTcF &gt; 450 ms, or QT (uncorrected) &gt; 470 ms&#xD;
&#xD;
         24. Inability to comply with the dietary regimen of the study centre&#xD;
&#xD;
             For female subjects:&#xD;
&#xD;
         25. Pregnancy&#xD;
&#xD;
         26. Positive pregnancy test&#xD;
&#xD;
         27. No adequate contraception (adequate contraception e.g. sterilisation, intrauterine&#xD;
             pessary (IUP) or oral contraception not containing ethinyl estradiol)&#xD;
&#xD;
         28. Oral contraception containing ethinyl estradiol without the use of an additional&#xD;
             barrier method&#xD;
&#xD;
         29. Hormone replacement containing ethinyl estradiol&#xD;
&#xD;
         30. Inability to maintain this adequate contraception during the whole study period&#xD;
&#xD;
         31. Lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</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 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 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>Moxifloxacin</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/NCT02248883
org study id: 1182.60
nct id: NCT02248883
lead sponsor: 
To demonstrate that tipranavir (TPV) co-administered with ritonavir (RTV) does not affect the
      QT interval more than placebo co-administered with ritonavir
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: Change from baseline in individually heart rate corrected QT interval length (QTcI)
time frame: baseline and 2 to 4 hours after drug administration on day3
measure: Change from baseline in (QTcI)
time frame: baseline and 2 to 4 hours after drug administration on day 1
measure: Change from baseline in (QTcI)
time frame: baseline and 1 to 12 hours after drug administration on day1 and 3
arm group label: low TPV/RTV
arm group type: Experimental
arm group label: high TPV/RTV
arm group type: Experimental
arm group label: Placebo/RTV
arm group type: Experimental
intervention type: Drug
intervention name: TPV low
arm group label: low TPV/RTV
intervention type: Drug
intervention name: Placebo
arm group label: Placebo/RTV
intervention type: Drug
intervention name: Moxifloxacin
arm group label: Placebo/RTV
arm group label: high TPV/RTV
arm group label: low TPV/RTV
other name: Avelox®
intervention type: Drug
intervention name: TPV high
arm group label: high TPV/RTV
intervention type: Drug
intervention name: RTV
arm group label: Placebo/RTV
arm group label: high TPV/RTV
arm group label: low TPV/RTV
criteria: 
gender: All
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: Moxifloxacin