<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/NCT01694706</url>
  </required_header>
  <id_info>
    <org_study_id>1220.59</org_study_id>
    <secondary_id>2012-002941-39</secondary_id>
    <nct_id>NCT01694706</nct_id>
  </id_info>
  <brief_title>Investigation of Food Effect and Gastric ph Increase on the Bioavailability of Faldapravir</brief_title>
  <official_title>Investigation of the Effect of Food and of Increased Gastric pH on the Relative Bioavailability of a Single Oral Dose of 240 mg Faldaprevir in an Open-label, Randomised, Three-way Cross-over Trial in Healthy Subjects</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 of this trial is to investigate the effect of food and of gastric pH&#xD;
      increase on the relative bioavailability of faldaprevir.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)</measure>
    <time_frame>1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration</time_frame>
    <description>Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity&#xD;
In this endpoint, the &quot;measured values&quot; show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Faldaprevir: Maximum Measured Concentration (Cmax)</measure>
    <time_frame>1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration</time_frame>
    <description>Maximum measured concentration of the faldaprevir in plasma&#xD;
In this endpoint, the &quot;measured values&quot; show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)</measure>
    <time_frame>1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration</time_frame>
    <description>Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the last quantifiable drug plasma concentration&#xD;
In this endpoint, the &quot;measured values&quot; show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Reference</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>faldaprevir medium, fasted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>faldaprevir medium, fed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>faldaprevir medium + omeprazole medium</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>faldaprevir</intervention_name>
    <description>medium dose of faldaprevir</description>
    <arm_group_label>Test 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>faldaprevir</intervention_name>
    <description>medium dose of faldaprevir</description>
    <arm_group_label>Reference</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>omeprazole</intervention_name>
    <description>medium dose of omeprazole</description>
    <arm_group_label>Test 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>faldaprevir</intervention_name>
    <description>medium dose of faldaprevir</description>
    <arm_group_label>Test 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        1. Healthy male and female subjects&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        1. Any relevant deviation from healthy condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1220.59.1 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Biberach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <results_first_submitted>July 3, 2015</results_first_submitted>
  <results_first_submitted_qc>July 3, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 30, 2015</results_first_posted>
  <last_update_submitted>July 3, 2015</last_update_submitted>
  <last_update_submitted_qc>July 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2015</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>Omeprazole</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This was a randomised open label, 3-way cross over study with three sequences. Faldaprevir administrations in each treatment period were separated by washout period of at least 14 days.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Faldaprevir/Faldaprevir+ OMP/Faldaprevir Fed</title>
          <description>Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration.&#xD;
Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.&#xD;
Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.</description>
        </group>
        <group group_id="P2">
          <title>Faldaprevir Fed/ Faldaprevir/ Faldaprevir+ OMP</title>
          <description>Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.&#xD;
Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)&#xD;
faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.</description>
        </group>
        <group group_id="P3">
          <title>Faldaprevir+ OMP/ Faldaprevir Fed/ Faldaprevir</title>
          <description>Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.&#xD;
Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.&#xD;
Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Faldaprevir</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Faldaprevir +OMP</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Faldaprevir Fed</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>other reason not defined above</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated set (TS) including all subjects who received at least 1 dose of study drug</population>
      <group_list>
        <group group_id="B1">
          <title>Entire Study Population</title>
          <description>All subjects received all tested treatments in a randomised, open label, 3-way cross over study. The treatments were:&#xD;
Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)&#xD;
Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.&#xD;
Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.&#xD;
Drug administrations were separated by a washout period of at least 14 days</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.7" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)</title>
        <description>Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity&#xD;
In this endpoint, the &quot;measured values&quot; show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.</description>
        <time_frame>1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration</time_frame>
        <population>Pharmacokinetic (PK) set: Included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Faldaprevir in Fasting</title>
            <description>Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)</description>
          </group>
          <group group_id="O2">
            <title>Faldaprevir After a High-fat Meal</title>
            <description>Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less</description>
          </group>
          <group group_id="O3">
            <title>Faldaprevir and Omeprazole</title>
            <description>Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir</description>
          </group>
        </group_list>
        <measure>
          <title>Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)</title>
          <description>Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity&#xD;
In this endpoint, the &quot;measured values&quot; show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.</description>
          <population>Pharmacokinetic (PK) set: Included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.</population>
          <units>[ng*h/mL]</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37900" spread="67.2"/>
                    <measurement group_id="O2" value="48200" spread="41.7"/>
                    <measurement group_id="O3" value="36000" spread="63.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>no formal testing, investigation of bioavailability</non_inferiority_desc>
            <p_value>0.3420</p_value>
            <method>ANOVA</method>
            <method_desc>Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting</method_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>120.35</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>23.2</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>102.09</ci_lower_limit>
            <ci_upper_limit>141.88</ci_upper_limit>
            <estimate_desc>Standard deviation is actually the geometric coefficient of variation (gCV)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>no formal testing, investigation of bioavailability</non_inferiority_desc>
            <p_value>0.0962</p_value>
            <method>ANOVA</method>
            <method_desc>Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting</method_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>94.33</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>30.8</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>76.21</ci_lower_limit>
            <ci_upper_limit>116.76</ci_upper_limit>
            <estimate_desc>Standard deviation is actually the geometric coefficient of variation (gCV)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Faldaprevir: Maximum Measured Concentration (Cmax)</title>
        <description>Maximum measured concentration of the faldaprevir in plasma&#xD;
In this endpoint, the &quot;measured values&quot; show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.</description>
        <time_frame>1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration</time_frame>
        <population>PK set</population>
        <group_list>
          <group group_id="O1">
            <title>Faldaprevir in Fasting</title>
            <description>Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)</description>
          </group>
          <group group_id="O2">
            <title>Faldaprevir After a High-fat Meal</title>
            <description>Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less</description>
          </group>
          <group group_id="O3">
            <title>Faldaprevir and Omeprazole</title>
            <description>Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir</description>
          </group>
        </group_list>
        <measure>
          <title>Faldaprevir: Maximum Measured Concentration (Cmax)</title>
          <description>Maximum measured concentration of the faldaprevir in plasma&#xD;
In this endpoint, the &quot;measured values&quot; show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.</description>
          <population>PK set</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2030" spread="140"/>
                    <measurement group_id="O2" value="2600" spread="57.5"/>
                    <measurement group_id="O3" value="1920" spread="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>no formal testing, investigation of bioavailability</non_inferiority_desc>
            <p_value>0.3993</p_value>
            <method>ANOVA</method>
            <method_desc>Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting</method_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>118.79</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>52.4</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>83.190</ci_lower_limit>
            <ci_upper_limit>169.628</ci_upper_limit>
            <estimate_desc>Standard deviation is actually the geometric coefficient of variation (gCV)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>no formal testing, investigation of bioavailability</non_inferiority_desc>
            <p_value>0.2204</p_value>
            <method>ANOVA</method>
            <method_desc>Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting</method_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>93.55</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>53.0</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>65.783</ci_lower_limit>
            <ci_upper_limit>133.030</ci_upper_limit>
            <estimate_desc>Standard deviation is actually the geometric coefficient of variation (gCV)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)</title>
        <description>Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the last quantifiable drug plasma concentration&#xD;
In this endpoint, the &quot;measured values&quot; show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.</description>
        <time_frame>1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration</time_frame>
        <population>PK set</population>
        <group_list>
          <group group_id="O1">
            <title>Faldaprevir in Fasting</title>
            <description>Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)</description>
          </group>
          <group group_id="O2">
            <title>Faldaprevir After a High-fat Meal</title>
            <description>Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less</description>
          </group>
          <group group_id="O3">
            <title>Faldaprevir and Omeprazole</title>
            <description>Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir</description>
          </group>
        </group_list>
        <measure>
          <title>Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)</title>
          <description>Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the last quantifiable drug plasma concentration&#xD;
In this endpoint, the &quot;measured values&quot; show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.</description>
          <population>PK set</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36300" spread="70.3"/>
                    <measurement group_id="O2" value="46400" spread="42.6"/>
                    <measurement group_id="O3" value="34400" spread="65.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>no formal testing, investigation of bioavailability</non_inferiority_desc>
            <p_value>0.3765</p_value>
            <method>ANOVA</method>
            <method_desc>Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting</method_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>121.28</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>24.0</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>102.32</ci_lower_limit>
            <ci_upper_limit>143.74</ci_upper_limit>
            <estimate_desc>Standard deviation is actually the geometric coefficient of variation (gCV)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>no formal testing, investigation of bioavailability</non_inferiority_desc>
            <p_value>0.0946</p_value>
            <method>ANOVA</method>
            <method_desc>Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting</method_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>94.72</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>31.4</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>76.25</ci_lower_limit>
            <ci_upper_limit>117.67</ci_upper_limit>
            <estimate_desc>Standard deviation is actually the geometric coefficient of variation (gCV)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first drug administration until the end of trial visit, up until 20 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Faldaprevir in Fasting</title>
          <description>Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)</description>
        </group>
        <group group_id="E2">
          <title>Faldaprevir After a High-fat Meal</title>
          <description>Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less</description>
        </group>
        <group group_id="E3">
          <title>Faldaprevir and Omeprazole</title>
          <description>Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast</description>
        </group>
        <group group_id="E4">
          <title>Omeprazole</title>
          <description>40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MEDDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01694706
org study id: 1220.59
secondary id: 2012-002941-39
nct id: NCT01694706
lead sponsor: 
The primary objective of this trial is to investigate the effect of food and of gastric pH
      increase on the relative bioavailability of faldaprevir.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration
description: Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
measure: Faldaprevir: Maximum Measured Concentration (Cmax)
time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration
description: Maximum measured concentration of the faldaprevir in plasma
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
measure: Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration
description: Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the last quantifiable drug plasma concentration
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
arm group label: Reference
arm group type: Experimental
description: faldaprevir medium, fasted
arm group label: Test 1
arm group type: Active Comparator
description: faldaprevir medium, fed
arm group label: Test 2
arm group type: Active Comparator
description: faldaprevir medium + omeprazole medium
intervention type: Drug
intervention name: faldaprevir
description: medium dose of faldaprevir
arm group label: Test 1
intervention type: Drug
intervention name: faldaprevir
description: medium dose of faldaprevir
arm group label: Reference
intervention type: Drug
intervention name: omeprazole
description: medium dose of omeprazole
arm group label: Test 2
intervention type: Drug
intervention name: faldaprevir
description: medium dose of faldaprevir
arm group label: Test 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Germany
url: http://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Omeprazole
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 