<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/NCT02251873</url>
  </required_header>
  <id_info>
    <org_study_id>1182.42</org_study_id>
    <nct_id>NCT02251873</nct_id>
  </id_info>
  <brief_title>Evaluation of the Pharmacokinetic Interaction of Steady State Tipranavir and Ritonavir or Tipranavir and Ritonavir With Single Dose Didanosine in Healthy Volunteers</brief_title>
  <official_title>An Open Label, Randomised, Parallel Group Study of the Drug-drug Pharmacokinetic Interaction of Steady State Tipranavir (SEDDS SEC) 500 mg and Ritonavir (Soft Gelatin Capsules) 100 mg or Tipranavir 750 mg and Ritonavir 200 mg, Both Bid for 13.5 Days With Single Dose Didanosine 400 mg (Delayed Release Capsule EC Beadlets) in Healthy 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 characterise the effects of concurrent tipranavir (TPV) and ritonavir (RTV)&#xD;
      administration on the single dose pharmacokinetics of didanosine (ddI), to characterise the&#xD;
      effects of single-dose ddI on the pharmacokinetics of TPV and RTV and to assess the&#xD;
      short-term safety of this combination&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2001</start_date>
  <primary_completion_date type="Actual">March 2002</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>(AUC 0-12) Area under the plasma concentration time curve from 0-12 hours</measure>
    <time_frame>up to 12 hours after dose administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (Maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 12 hours after dose administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>(C6h) drug concentration in plasma at 6 hours after drug administration</measure>
    <time_frame>up to 6 hours after dose administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>(C12h) drug concentration in plasma at 12 hours after drug administration</measure>
    <time_frame>up to 12 hours after dose administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cnh (plasma concentration n hours after drug administration)</measure>
    <time_frame>up to 12 hours after dose administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss (maximum plasma concentration at steady state)</measure>
    <time_frame>up to 12 hours after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT (mean residence time)</measure>
    <time_frame>up to 12 hours after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax (time to the maximum plasma concentration)</measure>
    <time_frame>up to 12 hours after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent oral clearance)</measure>
    <time_frame>up to 12 hours after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution)</measure>
    <time_frame>up to 12 hours after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (Terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 12 hours after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 40 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 40 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>TPV + RTV (low dose)+ ddI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>TPV+ RTV (high dose)+ ddI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TPV + RTV (low dose)</intervention_name>
    <arm_group_label>TPV + RTV (low dose)+ ddI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TPV + RTV (high dose)</intervention_name>
    <arm_group_label>TPV+ RTV (high dose)+ ddI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ddl</intervention_name>
    <arm_group_label>TPV + RTV (low dose)+ ddI</arm_group_label>
    <arm_group_label>TPV+ RTV (high dose)+ ddI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female subjects as determined by results of screening&#xD;
&#xD;
          -  Female subjects were not lactating and not of child bearing potential as defined by&#xD;
             surgically sterile or post menopausal (no periods for at least 12 months and elevated&#xD;
             follicle stimulating hormone (FSH) with low estradiol and no estrogen&#xD;
             supplementation). Females were to use barrier contraception (e.g. condoms) for at&#xD;
             least one month prior to administration of study medication, during the study and at&#xD;
             least one month after release from the study. Women were to have negative pregnancy&#xD;
             tests&#xD;
&#xD;
          -  Signed written informed consent in accordance with Good Clinical Practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age &gt;=18 and &lt;=60 years&#xD;
&#xD;
          -  Body mass index (BMI) &gt;=18.5 and &lt;=29.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic, immunologic, hormonal disorders, including a clinical history of viral&#xD;
             hepatitis, or serological evidence of active Hepatitis B, Hepatitis C, or HIV&#xD;
             infection&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells and blackouts&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which was deemed relevant&#xD;
             to the trial as judged by the investigator including study drugs&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) or enzyme altering drug within 1&#xD;
             month prior to administration of study drugs&#xD;
&#xD;
          -  Use of any drugs that might have influenced the results of the trial within 10 days&#xD;
             prior to administration or during the trial (in addition to specific medication&#xD;
             prohibitions mentioned in exclusion criteria above)&#xD;
&#xD;
          -  Use of grapefruit or grapefruit juice, alcohol, green tea, methylxanthine-containing&#xD;
             products or tobacco within one week of study drug administration&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within 2 months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from&#xD;
             smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood or plasma donation within 1 month prior to administration or during the trial&#xD;
&#xD;
          -  Excessive physical activities within 5 days prior to administration or during the&#xD;
             trial&#xD;
&#xD;
          -  Following specific laboratory findings: activated partial thromboplastin time (aPTT),&#xD;
             prothrombin time international normalised ratio (INR), aspartate transaminase (AST),&#xD;
             alanine transaminase (ALT), gamma-glutamyl-transferase (GGT), amylase, lipase, or&#xD;
             triglyceride above the normal range&#xD;
&#xD;
          -  Any other laboratory value outside the clinically accepted reference range and of&#xD;
             clinical relevance&#xD;
&#xD;
          -  History of any familial bleeding disorder&#xD;
&#xD;
          -  Inability to swallow multiple large capsules&#xD;
&#xD;
          -  Inability to comply with dietary regimen of study centre&#xD;
&#xD;
          -  Inability to comply with investigator's instructions&#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 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02251873
org study id: 1182.42
nct id: NCT02251873
lead sponsor: 
Study to characterise the effects of concurrent tipranavir (TPV) and ritonavir (RTV)
      administration on the single dose pharmacokinetics of didanosine (ddI), to characterise the
      effects of single-dose ddI on the pharmacokinetics of TPV and RTV and to assess the
      short-term safety of this combination
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: (AUC 0-12) Area under the plasma concentration time curve from 0-12 hours
time frame: up to 12 hours after dose administration
measure: Cmax (Maximum measured concentration of the analyte in plasma)
time frame: up to 12 hours after dose administration
measure: (C6h) drug concentration in plasma at 6 hours after drug administration
time frame: up to 6 hours after dose administration
measure: (C12h) drug concentration in plasma at 12 hours after drug administration
time frame: up to 12 hours after dose administration
measure: Cnh (plasma concentration n hours after drug administration)
time frame: up to 12 hours after dose administration
measure: Cmax,ss (maximum plasma concentration at steady state)
time frame: up to 12 hours after dose administration
measure: MRT (mean residence time)
time frame: up to 12 hours after dose administration
measure: Tmax (time to the maximum plasma concentration)
time frame: up to 12 hours after dose administration
measure: CL/F (apparent oral clearance)
time frame: up to 12 hours after dose administration
measure: Vz/F (apparent volume of distribution)
time frame: up to 12 hours after dose administration
measure: t½ (Terminal half-life of the analyte in plasma)
time frame: up to 12 hours after dose administration
measure: Number of subjects with adverse events
time frame: up to 40 days
measure: Number of subjects with abnormal changes in laboratory parameters
time frame: up to 40 days
arm group label: TPV + RTV (low dose)+ ddI
arm group type: Experimental
arm group label: TPV+ RTV (high dose)+ ddI
arm group type: Experimental
intervention type: Drug
intervention name: TPV + RTV (low dose)
arm group label: TPV + RTV (low dose)+ ddI
intervention type: Drug
intervention name: TPV + RTV (high dose)
arm group label: TPV+ RTV (high dose)+ ddI
intervention type: Drug
intervention name: ddl
arm group label: TPV + RTV (low dose)+ ddI
arm group label: TPV+ RTV (high dose)+ ddI
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