<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/NCT02191189</url>
  </required_header>
  <id_info>
    <org_study_id>1100.1484</org_study_id>
    <nct_id>NCT02191189</nct_id>
  </id_info>
  <brief_title>Pharmacoscintigraphic Investigation Into the Absorption of Nevirapine When Released Into Different Parts of the Gastro-intestinal Tract in Healthy Males</brief_title>
  <official_title>A Single-dose, 2-part, Open-label, Randomised, Pharmacoscintigraphic Investigation Into the Absorption of Nevirapine When Released Into Different Parts of the Gastro-intestinal Tract</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 determine the absorption of Nevirapine from different regions of the Gastro&#xD;
      Intestinal tract.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2005</start_date>
  <primary_completion_date type="Actual">January 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration-time curve of nevirapine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum measured concentration of nevirapine in plasma (Cmax)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to the maximum concentration of nevirapine in plasma (tmax)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of nevirapine in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination rate constant of nevirapine concentration in plasma (λz)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of nevirapine in plasma (t1/2)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of nevirapine in the body after oral administration (MRTpo)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of nevirapine in the plasma after extravascular administration (CL/F)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution during the terminal elimination phase following an extravascular dose (Vz/F)</measure>
    <time_frame>up to 72 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 78 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator</measure>
    <time_frame>Days 1-4 of each treatment period and at the end-of-study visit</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment A, p.o.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 mg Nevirapine administered orally in 100 mL water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B, ascending colon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 mg Nevirapine administered to the ascending colon via Enterion™ capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C, jejunum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 mg Nevirapine administered to the jejunum via Enterion™ capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment D, ileum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 mg Nevirapine administered to the ileum via Enterion™ capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment E, descending colon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 mg Nevirapine administered to the descending colon via Enterion™ capsule</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine suspension, into Enterion™ capsule</intervention_name>
    <arm_group_label>Treatment B, ascending colon</arm_group_label>
    <arm_group_label>Treatment C, jejunum</arm_group_label>
    <arm_group_label>Treatment D, ileum</arm_group_label>
    <arm_group_label>Treatment E, descending colon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine suspension</intervention_name>
    <arm_group_label>Treatment A, p.o.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males according to the following criteria: complete medical history, including&#xD;
             the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead&#xD;
             electrocardiogram (ECG), clinical laboratory tests&#xD;
&#xD;
          -  Aged 18-65 years&#xD;
&#xD;
          -  Body Mass Index of between 18 and 35 kg/m2&#xD;
&#xD;
          -  Subjects must be able to demonstrate ability to swallow an empty size 000 gelatin&#xD;
             capsule&#xD;
&#xD;
          -  Must be willing and able to participate in the whole study&#xD;
&#xD;
          -  Must be able to provide signed and dated written informed consent prior to admission&#xD;
             to the study in accordance with Good Clinical Practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in a clinical research study involving investigational drugs or dosage&#xD;
             forms within the previous 3 months&#xD;
&#xD;
          -  Those who are unable/unwilling to consume all the components of a standard meal or&#xD;
             gelatine&#xD;
&#xD;
          -  Subjects who have ever self referred or who have been referred to a physician or&#xD;
             counsellor for abuse or misuse of alcohol, non-medical, medicinal drugs or other&#xD;
             substance abuse e.g. solvents&#xD;
&#xD;
          -  Any current or previous use of Class A drugs such as opiates, cocaine, ecstasy,&#xD;
             lysergic acid diethylamide (LSD), and amphetamines (Class B unless prepared for&#xD;
             injection, in which case amphetamines are Class A)&#xD;
&#xD;
          -  Volunteers that admit to occasional past use of cannabis will not be excluded as long&#xD;
             as they have a negative drugs of abuse test and have been abstinent for at least 12&#xD;
             months&#xD;
&#xD;
          -  Positive drugs of abuse test result&#xD;
&#xD;
          -  Regular alcohol consumption in males &gt;= 21 units per week. (1 Unit = ½ pint beer, a 25&#xD;
             mL shot of 40% spirit or a 125 mL glass of wine)&#xD;
&#xD;
          -  Smoking of more than 10 cigarettes per day or equivalent (e.g. pipe, cigar, chewing&#xD;
             tobacco)&#xD;
&#xD;
          -  A breath carbon monoxide reading of greater than 20 ppm&#xD;
&#xD;
          -  Inability to refrain from smoking for the duration of each study period&#xD;
&#xD;
          -  Radiation exposure from clinical trials, including that from the present study and&#xD;
             from diagnostic X-rays but excluding background radiation, exceeding 5 Millisieverts&#xD;
             (mSv) in the last twelve months or 10 mSv in the last five years. No occupationally&#xD;
             exposed worker, as defined in the Ionising Radiation Regulations 1999, shall&#xD;
             participate in the study&#xD;
&#xD;
          -  Clinically significant abnormal biochemistry, haematology or urinalysis, as judged by&#xD;
             the Investigator&#xD;
&#xD;
          -  Liver function laboratory test (LFT) results outside the upper normal range. Subjects&#xD;
             with LFTs &gt; grade 1 will not be included&#xD;
&#xD;
          -  History of gastrointestinal surgery, with the exception of appendicectomy unless it&#xD;
             was performed within the previous 12 months&#xD;
&#xD;
          -  History of clinically significant cardiovascular, renal, hepatic, respiratory and&#xD;
             particularly gastrointestinal disease, especially peptic ulceration, gastrointestinal&#xD;
             bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome&#xD;
&#xD;
          -  History of chronic or acute infections&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) and psychiatric or&#xD;
             neurological disorders&#xD;
&#xD;
          -  Acute diarrhoea or constipation in the 7 days before the predicted first study day. If&#xD;
             screening occurs &gt;14 days before first study day, this criterion to be determined on&#xD;
             first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a&#xD;
             stool frequency of greater than three times per day. Constipation will be defined as a&#xD;
             failure to open the bowels more frequently than every other day&#xD;
&#xD;
          -  Donation of blood within the previous three months&#xD;
&#xD;
          -  Presence of non-removable metal objects such as metal plates, screws etc, in the&#xD;
             abdominal region of the body&#xD;
&#xD;
          -  Subjects will be excluded from the study if they are considered by the investigator to&#xD;
             be at risk of transmitting through blood and other body fluids the agents responsible&#xD;
             for AIDS (Acquired Immunodeficiency Syndrome) or other sexually transmitted disease or&#xD;
             hepatitis. This will be achieved by the use of a card (similar to that used by the&#xD;
             National Blood Transfusion Service), which asks a potential subject if they have&#xD;
             reason to believe that they may fall into any category included on the card. If the&#xD;
             verbal answer is in the affirmative then they will be excluded from the study.&#xD;
&#xD;
          -  Positive hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV test results&#xD;
&#xD;
          -  Subjects receiving prohibited medication. Subjects must not stop taking a prescribed&#xD;
             medication for the purpose of entering the study.&#xD;
&#xD;
          -  Failure to satisfy the Principal Medical Investigator of fitness to participate for&#xD;
             any other reason&#xD;
&#xD;
        As a precaution, male subjects will be instructed to use appropriate barrier method&#xD;
        contraception (e.g. condoms and spermicide) during the time interval between taking the&#xD;
        first dose and three months following the last dose. Subjects will be advised to inform&#xD;
        Pharmaceutical Profiles if their partner becomes pregnant within three months of them&#xD;
        receiving the last dose of the study drug. Pharmaceutical Profiles will monitor the&#xD;
        pregnancy to conclusion.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1484_U07-1066-01.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 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>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/NCT02191189
org study id: 1100.1484
nct id: NCT02191189
lead sponsor: 
Study to determine the absorption of Nevirapine from different regions of the Gastro
      Intestinal tract.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve of nevirapine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
time frame: up to 72 hours after drug administration
measure: Maximum measured concentration of nevirapine in plasma (Cmax)
time frame: up to 72 hours after drug administration
measure: Time from dosing to the maximum concentration of nevirapine in plasma (tmax)
time frame: up to 72 hours after drug administration
measure: Area under the concentration-time curve of nevirapine in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
time frame: up to 72 hours after drug administration
measure: Terminal elimination rate constant of nevirapine concentration in plasma (λz)
time frame: up to 72 hours after drug administration
measure: Terminal half-life of nevirapine in plasma (t1/2)
time frame: up to 72 hours after drug administration
measure: Mean residence time of nevirapine in the body after oral administration (MRTpo)
time frame: up to 72 hours after drug administration
measure: Apparent clearance of nevirapine in the plasma after extravascular administration (CL/F)
time frame: up to 72 hours after drug administration
measure: Apparent volume of distribution during the terminal elimination phase following an extravascular dose (Vz/F)
time frame: up to 72 hours after drug administration
measure: Number of patients with adverse events
time frame: up to 78 days
measure: Assessment of tolerability by investigator
time frame: Days 1-4 of each treatment period and at the end-of-study visit
arm group label: Treatment A, p.o.
arm group type: Active Comparator
description: 50 mg Nevirapine administered orally in 100 mL water
arm group label: Treatment B, ascending colon
arm group type: Experimental
description: 50 mg Nevirapine administered to the ascending colon via Enterion™ capsule
arm group label: Treatment C, jejunum
arm group type: Experimental
description: 50 mg Nevirapine administered to the jejunum via Enterion™ capsule
arm group label: Treatment D, ileum
arm group type: Experimental
description: 50 mg Nevirapine administered to the ileum via Enterion™ capsule
arm group label: Treatment E, descending colon
arm group type: Experimental
description: 50 mg Nevirapine administered to the descending colon via Enterion™ capsule
intervention type: Drug
intervention name: Nevirapine suspension, into Enterion™ capsule
arm group label: Treatment B, ascending colon
arm group label: Treatment C, jejunum
arm group label: Treatment D, ileum
arm group label: Treatment E, descending colon
intervention type: Drug
intervention name: Nevirapine suspension
arm group label: Treatment A, p.o.
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1484_U07-1066-01.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Nevirapine