<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/NCT02253927</url>
  </required_header>
  <id_info>
    <org_study_id>1188.32</org_study_id>
    <nct_id>NCT02253927</nct_id>
  </id_info>
  <brief_title>Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers</brief_title>
  <official_title>Phase I Sequential Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose (225 Mg-450 mg) Oral Administration of BILR 355 (SDS) Plus Low-dose Ritonavir 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>
      The primary objective was to explore the relative bioavailability of increasing doses of BILR&#xD;
      355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with&#xD;
      ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses.&#xD;
&#xD;
      A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355&#xD;
      (SDS)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2006</start_date>
  <primary_completion_date type="Actual">August 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>AUC0-inf (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (Maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F (Apparent clearance of the analyte in plasma following extravascular administration)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax (Time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>t½ (Terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 120 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 10 days after last dose administration</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BILR 355 (dose escalation) + Ritonavir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>escalating dose groups, for food effect evaluation lowest dose group (D1) with high fat meal breakfast after wash-out period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 - D1</intervention_name>
    <arm_group_label>BILR 355 (dose escalation) + Ritonavir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 - D2</intervention_name>
    <arm_group_label>BILR 355 (dose escalation) + Ritonavir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 - D3</intervention_name>
    <arm_group_label>BILR 355 (dose escalation) + Ritonavir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 - D4</intervention_name>
    <arm_group_label>BILR 355 (dose escalation) + Ritonavir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritonavir</intervention_name>
    <arm_group_label>BILR 355 (dose escalation) + Ritonavir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high fat breakfast</intervention_name>
    <arm_group_label>BILR 355 (dose escalation) + Ritonavir</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females who met the inclusion/exclusion criteria, females who are not&#xD;
             pregnant nor nursing, and who agreed to use a double-barrier method of birth control&#xD;
             (condoms or diaphragm plus spermicide) throughout the trial (alone or in addition to&#xD;
             other methods of birth control such as oral contraceptives)&#xD;
&#xD;
          2. Healthy HIV negative adult volunteers&#xD;
&#xD;
          3. Age ≥18 and ≤60 years&#xD;
&#xD;
          4. BMI ≥18.5 and BMI ≤29.9 kg/m2&#xD;
&#xD;
          5. Ability to give signed and dated written informed consent prior to admission to the&#xD;
             study in accordance with Good Clinical Practice (GCP) and the local regulations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          2. Surgery of gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          4. History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          5. Chronic or relevant acute infections&#xD;
&#xD;
          6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             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 prior to&#xD;
             study drug administration and during the trial&#xD;
&#xD;
          8. Use of drugs within 10 days prior to administration or during the trial which might&#xD;
             reasonably influence the results of 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. Current smoker&#xD;
&#xD;
         11. Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
         12. Drug abuse (positive urine test for illicit prescription or non-prescription drugs or&#xD;
             drugs of abuse)&#xD;
&#xD;
         13. Blood donation (more than 100 mL within four weeks prior to study drug administration&#xD;
             or during the trial)&#xD;
&#xD;
         14. Excessive physical activities (within one week prior to study drug administration or&#xD;
             during the trial)&#xD;
&#xD;
         15. Any laboratory value outside the reference range that is of clinical relevance at&#xD;
             screening, according to the judgment of the investigator&#xD;
&#xD;
         16. Inability to comply with dietary regimen required by the protocol&#xD;
&#xD;
         17. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B&#xD;
             surface antigen, or hepatitis C antibody positive)&#xD;
&#xD;
         18. Pregnant or lactating females&#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 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>
  </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/NCT02253927
org study id: 1188.32
nct id: NCT02253927
lead sponsor: 
The primary objective was to explore the relative bioavailability of increasing doses of BILR
      355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with
      ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses.

      A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355
      (SDS)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-inf (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 120 hours after drug administration
measure: Cmax (Maximum measured concentration of the analyte in plasma)
time frame: up to 120 hours after drug administration
measure: AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
time frame: up to 120 hours after drug administration
measure: CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
time frame: up to 120 hours after drug administration
measure: Tmax (Time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 120 hours after drug administration
measure: t½ (Terminal half-life of the analyte in plasma)
time frame: up to 120 hours after drug administration
measure: Number of patients with adverse events
time frame: up to 10 days after last dose administration
arm group label: BILR 355 (dose escalation) + Ritonavir
arm group type: Experimental
description: escalating dose groups, for food effect evaluation lowest dose group (D1) with high fat meal breakfast after wash-out period
intervention type: Drug
intervention name: BILR 355 - D1
arm group label: BILR 355 (dose escalation) + Ritonavir
intervention type: Drug
intervention name: BILR 355 - D2
arm group label: BILR 355 (dose escalation) + Ritonavir
intervention type: Drug
intervention name: BILR 355 - D3
arm group label: BILR 355 (dose escalation) + Ritonavir
intervention type: Drug
intervention name: BILR 355 - D4
arm group label: BILR 355 (dose escalation) + Ritonavir
intervention type: Drug
intervention name: Ritonavir
arm group label: BILR 355 (dose escalation) + Ritonavir
intervention type: Other
intervention name: high fat breakfast
arm group label: BILR 355 (dose escalation) + Ritonavir
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
mesh term: Ritonavir