<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/NCT02184091</url>
  </required_header>
  <id_info>
    <org_study_id>1100.1259</org_study_id>
    <nct_id>NCT02184091</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine</brief_title>
  <official_title>An Open-Label, Single Dose Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine (VIRAMUNE®)</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 varying degrees of renal dysfunction and hepatic insufficiency&#xD;
      on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to&#xD;
      establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired&#xD;
      patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 1999</start_date>
  <primary_completion_date type="Actual">July 1999</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC (Area under the plasma concentration time curve)</measure>
    <time_frame>up to 7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (Maximum observed concentration of the analyte in plasma)</measure>
    <time_frame>up to 7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax (Time of maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2 (Terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vss/F (Volume of Distribution)</measure>
    <time_frame>up to 7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>MRT (Mean residence time of the analyte)</measure>
    <time_frame>up to 7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F (Apparent clearance of the analyte in plasma)</measure>
    <time_frame>up to 7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 21 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>Screening, Day 0, Day 7</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Renal Insufficiency</condition>
  <condition>Hepatic Insufficiency</condition>
  <arm_group>
    <arm_group_label>Nevirapine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine</intervention_name>
    <arm_group_label>Nevirapine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients of any race between the ages of 18 and 75 years with weight&#xD;
             within 30% of normal for gender, height and frame as specified by the Metropolitan&#xD;
             Life Insurance Table&#xD;
&#xD;
          -  For patients in the renal group: stable creatinine clearance based on two estimations&#xD;
             taken at least 3 days apart, corresponding to one of four groups:&#xD;
&#xD;
               -  Group 1 (mild dysfunction) = 50 ml/min &lt;= Creatinine Clearance (CLcr) &lt; 80 ml/min&#xD;
&#xD;
               -  Group 2 (moderate dysfunction) = 30 ml/min &lt;= CLcr &lt; 50 ml/min&#xD;
&#xD;
               -  Group 3 (severe dysfunction) = CLcr &lt; 30 ml/min and&#xD;
&#xD;
               -  Group 4 = end-stage renal disease (ESRD) requiring dialysis&#xD;
&#xD;
          -  For patients in the hepatic group&#xD;
&#xD;
               -  Two baseline creatinine clearances (taken at least 3 days apart) &gt; 80 ml/min&#xD;
&#xD;
               -  clinically diagnosed with hepatic insufficiency and Class A or B liver disease&#xD;
                  according to Child-Pugh's Classification; subjects must have a Child-Pugh score&#xD;
                  of 5-9 points&#xD;
&#xD;
          -  For patients in the normal group, i.e. normal with respect to hepatic and renal&#xD;
             function&#xD;
&#xD;
               -  matched with hepatic group regarding gender, age (+- 10 years), weight (+- 30&#xD;
                  pounds) and smoking history&#xD;
&#xD;
               -  Two baseline creatinine clearances (taken at least 3 days apart) &gt; 80 ml/min&#xD;
&#xD;
               -  No abnormalities on clinical or laboratory evaluations&#xD;
&#xD;
          -  Female patients of childbearing potential must be willing to use a reliable form of&#xD;
             contraception which must include a medically approved form of barrier contraception&#xD;
&#xD;
          -  Patients who are able to provide written consent and comply with study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female patients who are pregnant or breast-feeding&#xD;
&#xD;
          -  Seated systolic blood pressure either &lt; 100 mmHg or &gt; 150 mmHg and/or heart rate&#xD;
             either &lt; 50 beats/min or &gt; 90 beats/min&#xD;
&#xD;
          -  History of any illness or drug allergy that in the opinion of the investigator might&#xD;
             confound the results of the study or pose additional risk in administering nevirapine&#xD;
             to the subject&#xD;
&#xD;
          -  Patients who have had an acute illness or hospitalization other than for routine&#xD;
             dialysis within 2 weeks prior to study initiation&#xD;
&#xD;
          -  Patients who are currently taking any over-the-counter drug within 3 days prior to&#xD;
             study initiation, or who are currently taking any prescription drug that in the&#xD;
             opinion of the investigator in consultation with Boehringer Ingelheim Pharmaceuticals&#xD;
             Incorporated (BIPI) medical monitor and pharmacokineticist might interfere with the&#xD;
             absorption, distribution or metabolism on the test drug&#xD;
&#xD;
          -  Significant electrocardiogram (ECG) abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1259_U00-3125.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatic Insufficiency</mesh_term>
    <mesh_term>Liver Failure</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nevirapine</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/NCT02184091
org study id: 1100.1259
nct id: NCT02184091
lead sponsor: 
Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency
      on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to
      establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired
      patients
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC (Area under the plasma concentration time curve)
time frame: up to 7 days
measure: Cmax (Maximum observed concentration of the analyte in plasma)
time frame: up to 7 days
measure: Tmax (Time of maximum concentration of the analyte in plasma)
time frame: up to 7 days
measure: T1/2 (Terminal half-life of the analyte in plasma)
time frame: up to 7 days
measure: Vss/F (Volume of Distribution)
time frame: up to 7 days
measure: MRT (Mean residence time of the analyte)
time frame: up to 7 days
measure: CL/F (Apparent clearance of the analyte in plasma)
time frame: up to 7 days
measure: Number of patients with adverse events
time frame: up to 21 days
measure: Number of patients with abnormal changes in laboratory parameters
time frame: Screening, Day 0, Day 7
arm group label: Nevirapine
arm group type: Experimental
description: Single dose administration
intervention type: Drug
intervention name: Nevirapine
arm group label: Nevirapine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1259_U00-3125.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Hepatic Insufficiency
mesh term: Liver Failure
mesh term: Renal Insufficiency
mesh term: Nevirapine