<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/NCT02253849</url>
  </required_header>
  <id_info>
    <org_study_id>1182.80</org_study_id>
    <nct_id>NCT02253849</nct_id>
  </id_info>
  <brief_title>Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers</brief_title>
  <official_title>A Single Centre, Open-label Study With Healthy Adult Volunteers to Determine the Effects of Single-dose and Steady-state TPV/r 500/200 mg on the Steady-state Pharmacokinetics of Carbamazepine (200 mg Twice Daily)</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 steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg&#xD;
      twice daily, depending on tolerability, and administered alone and in combination with&#xD;
      tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg&#xD;
      twice-daily)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2005</start_date>
  <primary_completion_date type="Actual">June 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>Area under the concentration-time curve of Carbamazepine in plasma over the time interval t0h to t12h (AUC0-12h)</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of Carbamazepine in plasma (Cmax)</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Drug concentration of Carbamazepine in plasma at 12 hours after drug administration (Cp12h)</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-12h</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>up to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cp12h</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance (CL/F)</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to the maximum concentration (Tmax)</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal elimination half-life)</measure>
    <time_frame>up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 35 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically relevant changes in laboratory parameters</measure>
    <time_frame>up to 35 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>CBZ - TPB/r+CBZ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Days 1-14: carbamazepine (CBZ) twice daily&#xD;
Days 15-22: CBZ twice daily plus TPV/r twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbamazepine</intervention_name>
    <arm_group_label>CBZ - TPB/r+CBZ</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tipranavir</intervention_name>
    <arm_group_label>CBZ - TPB/r+CBZ</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritonavir</intervention_name>
    <arm_group_label>CBZ - TPB/r+CBZ</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and non-pregnant, non-lactating female subjects as determined by results&#xD;
             of screening&#xD;
&#xD;
          -  Signed written informed consent in accordance with Good Clinical Practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  The ability to understand and sign a written informed consent form, prior to&#xD;
             participation in any screening procedures and must be willing to comply with all study&#xD;
             requirements&#xD;
&#xD;
          -  Age &gt;19 and &lt;59 years&#xD;
&#xD;
          -  Weight ≥ 60 kg&#xD;
&#xD;
          -  BMI &gt;18.5 and &lt;35 kg/m2&#xD;
&#xD;
          -  Ability to maintain adequate contraception if applicable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate, and&#xD;
             electrocardiogram) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  AV block including 1°&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic,&#xD;
             haematological, oncological or hormonal disorders&#xD;
&#xD;
          -  Surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  Relevant 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;
          -  Known hypersensitivity to TPV, Ritonavir (RTV), carbamazepine or antiretroviral drugs&#xD;
             (marketed or experimental use as part of clinical research studies)&#xD;
&#xD;
          -  Known elevated liver enzymes in past trials with any compound&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt;24 hours) (&lt;1 month prior to administration or&#xD;
             during the trial)&#xD;
&#xD;
          -  Prescription or over the counter medications (including vitamins, minerals, herbal&#xD;
             supplements and antacids), dietary supplements 14 days prior to study drug&#xD;
             administration or expected during the trial)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (&lt;2 months prior to&#xD;
             administration or expected during trial)&#xD;
&#xD;
          -  Smoker with a consumption of &gt;10 cigarettes or &gt;3 cigars or &gt;3 pipes/day and those who&#xD;
             cannot keep tobacco intake constant&#xD;
&#xD;
          -  Alcohol abuse (&gt;60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation or loss &gt;400 mL, &lt;1 month prior to administration or expected during&#xD;
             the trial&#xD;
&#xD;
          -  Clinically relevant laboratory abnormalities&#xD;
&#xD;
          -  Inability to comply with dietary regimen of study centre&#xD;
&#xD;
        For female subjects:&#xD;
&#xD;
          -  Pregnancy or planning to become pregnant within 60 days of study completion&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  Have not been using a barrier method of contraception for at least 3 months prior to&#xD;
             participation in the study&#xD;
&#xD;
          -  Are not willing or are unable to use a reliable method of barrier contraception (such&#xD;
             as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during&#xD;
             and up to 2 months after completion/termination of the trial&#xD;
&#xD;
          -  Chronic use of oral contraception or hormone replacement containing ethinyl estradiol&#xD;
&#xD;
          -  Breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>58 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>Carbamazepine</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/NCT02253849
org study id: 1182.80
nct id: NCT02253849
lead sponsor: 
Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg
      twice daily, depending on tolerability, and administered alone and in combination with
      tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg
      twice-daily)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve of Carbamazepine in plasma over the time interval t0h to t12h (AUC0-12h)
time frame: up to 12 hours after drug administration
measure: Maximum measured concentration of Carbamazepine in plasma (Cmax)
time frame: up to 12 hours after drug administration
measure: Drug concentration of Carbamazepine in plasma at 12 hours after drug administration (Cp12h)
time frame: up to 12 hours after drug administration
measure: AUC0-12h
time frame: up to 12 hours after drug administration
measure: Cmax
time frame: up to 12 hours
measure: Cp12h
time frame: up to 12 hours after drug administration
measure: Clearance (CL/F)
time frame: up to 12 hours after drug administration
measure: Volume of distribution
time frame: up to 12 hours after drug administration
measure: Time from dosing to the maximum concentration (Tmax)
time frame: up to 12 hours after drug administration
measure: t1/2 (terminal elimination half-life)
time frame: up to 12 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 35 days
measure: Number of subjects with clinically relevant changes in laboratory parameters
time frame: up to 35 days
arm group label: CBZ - TPB/r+CBZ
arm group type: Experimental
description: Days 1-14: carbamazepine (CBZ) twice daily
Days 15-22: CBZ twice daily plus TPV/r twice daily
intervention type: Drug
intervention name: Carbamazepine
arm group label: CBZ - TPB/r+CBZ
intervention type: Drug
intervention name: Tipranavir
arm group label: CBZ - TPB/r+CBZ
intervention type: Drug
intervention name: Ritonavir
arm group label: CBZ - TPB/r+CBZ
criteria: 
gender: All
minimum age: 20 Years
maximum age: 58 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: Carbamazepine