<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/NCT02253914</url>
  </required_header>
  <id_info>
    <org_study_id>1188.2</org_study_id>
    <nct_id>NCT02253914</nct_id>
  </id_info>
  <brief_title>Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of BILR 355 BS Plus Low Dose Ritonavir in HIV-uninfected Male Volunteers</brief_title>
  <official_title>An Investigator Blinded, Randomized, Placebo-controlled Multiple Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of BILR 355 BS Plus Low Dose Ritonavir in HIV-uninfected Male 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 determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose&#xD;
      ritonavir in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2004</start_date>
  <primary_completion_date type="Actual">December 2004</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUCτ (area under the concentration time curve of BILR 355 in plasma over one dosing interval at steady state)</measure>
    <time_frame>up to day 11</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum concentration of BILR 355 in plasma)</measure>
    <time_frame>up to day 11</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time for BILR 355 BS to achieve steady state</measure>
    <time_frame>up to day 11</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmin,ss (trough concentration of BILR 355 BS in plasma at steady state)</measure>
    <time_frame>up to day 11</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of dose limiting toxicity</measure>
    <time_frame>up to day 21</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of BILR 355 in plasma)</measure>
    <time_frame>up to day 11</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCτ (area under the concentration time curve of metabolite 402 in plasma over one dosing interval at steady state)</measure>
    <time_frame>up to day 11</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum concentration of metabolite 402 in plasma)</measure>
    <time_frame>up to day 11</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ae (amount of BILR 355 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)</measure>
    <time_frame>up to day 11</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolite BILR 402 Ae (amount of BILR 402 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)</measure>
    <time_frame>up to day 11</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 42 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BILR 355 BS, solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>escalating doses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BILR 355 BS, tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>escalating doses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 BS, solution</intervention_name>
    <arm_group_label>BILR 355 BS, solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BILR 355 BS, tablet</intervention_name>
    <arm_group_label>BILR 355 BS, tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritonavir</intervention_name>
    <arm_group_label>BILR 355 BS, solution</arm_group_label>
    <arm_group_label>BILR 355 BS, tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males who meet the following criteria:&#xD;
&#xD;
             Based upon a complete medical history, including the physical examination, vital signs&#xD;
             (BP, PR), 12-lead ECG, clinical laboratory tests&#xD;
&#xD;
               -  No finding deviating from normal (except as noted below) and of clinical&#xD;
                  relevance&#xD;
&#xD;
               -  No evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          2. Age ≥18 years and &lt;60&#xD;
&#xD;
          3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)&#xD;
&#xD;
          4. Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current and medically relevant gastrointestinal, hepatic, renal, respiratory,&#xD;
             cardiovascular, metabolic, 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 one month prior to&#xD;
             administration of study drug or 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 based on the knowledge at the time of&#xD;
             protocol preparation&#xD;
&#xD;
          9. Participation in another trial with an investigational drug within one month prior to&#xD;
             administration or during the trial&#xD;
&#xD;
         10. Smoker&#xD;
&#xD;
         11. Inability to refrain from smoking on trial days&#xD;
&#xD;
         12. Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
         13. Drug abuse&#xD;
&#xD;
         14. Recent blood donation (more than 100 mL within 4 weeks prior to administration or&#xD;
             during the trial)&#xD;
&#xD;
         15. Excessive physical activities (within 1 week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
         16. Any laboratory value outside the normal reference range that is of clinical relevance&#xD;
&#xD;
         17. Inability to comply with dietary regimen of study centre&#xD;
&#xD;
         18. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B&#xD;
             surface antigen, hepatitis B core antibody, or hepatitis C antibody positive)&#xD;
&#xD;
         19. HIV-1 infected as defined by a positive HIV ELISA test&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 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/NCT02253914
org study id: 1188.2
nct id: NCT02253914
lead sponsor: 
Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose
      ritonavir in healthy male volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: AUCτ (area under the concentration time curve of BILR 355 in plasma over one dosing interval at steady state)
time frame: up to day 11
measure: Cmax (maximum concentration of BILR 355 in plasma)
time frame: up to day 11
measure: Time for BILR 355 BS to achieve steady state
time frame: up to day 11
measure: Cmin,ss (trough concentration of BILR 355 BS in plasma at steady state)
time frame: up to day 11
measure: Incidence of dose limiting toxicity
time frame: up to day 21
measure: tmax (time from dosing to the maximum concentration of BILR 355 in plasma)
time frame: up to day 11
measure: AUCτ (area under the concentration time curve of metabolite 402 in plasma over one dosing interval at steady state)
time frame: up to day 11
measure: Cmax (maximum concentration of metabolite 402 in plasma)
time frame: up to day 11
measure: Ae (amount of BILR 355 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)
time frame: up to day 11
measure: Metabolite BILR 402 Ae (amount of BILR 402 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)
time frame: up to day 11
measure: Number of subjects with adverse events
time frame: up to 42 days
arm group label: BILR 355 BS, solution
arm group type: Experimental
description: escalating doses
arm group label: BILR 355 BS, tablet
arm group type: Experimental
description: escalating doses
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BILR 355 BS, solution
arm group label: BILR 355 BS, solution
intervention type: Drug
intervention name: BILR 355 BS, tablet
arm group label: BILR 355 BS, tablet
intervention type: Drug
intervention name: Ritonavir
arm group label: BILR 355 BS, solution
arm group label: BILR 355 BS, tablet
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Ritonavir