<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/NCT03019549</url>
  </required_header>
  <id_info>
    <org_study_id>15994</org_study_id>
    <secondary_id>I8D-MC-AZEB</secondary_id>
    <nct_id>NCT03019549</nct_id>
  </id_info>
  <brief_title>A Study of Lanabecestat (LY3314814) in Healthy Participants When Taken With Rosuvastatin</brief_title>
  <official_title>Effect of LY3314814 on the Pharmacokinetics of Rosuvastatin in Caucasian Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of lanabecestat on rosuvastatin. The&#xD;
      amount of rosuvastatin in the blood will be compared, when taken alone, and then when taken&#xD;
      with lanabecestat. The amount of lanabecestat that gets into the bloodstream will be&#xD;
      measured. Information about any side effects that may occur will also be collected.&#xD;
&#xD;
      Participants will be on study for 21 days with a follow-up at least 7 days afterwards.&#xD;
&#xD;
      Screening will be undertaken within 45 days prior to enrollment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2017</start_date>
  <completion_date type="Actual">May 22, 2017</completion_date>
  <primary_completion_date type="Actual">May 22, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin</measure>
    <time_frame>1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose</time_frame>
    <description>Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)</measure>
    <time_frame>Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose</time_frame>
    <description>Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat</measure>
    <time_frame>.Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose</time_frame>
    <description>Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1: 20 mg rosuvastatin administered once orally (PO)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lanabecestat + Rosuvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 2: 50 mg Lanabecestat (LY3314814) administered orally (PO) Day 1 to Day 12 Rosuvastatin: 20 mg co-administered PO on Day 8</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lanabecestat</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Lanabecestat + Rosuvastatin</arm_group_label>
    <other_name>LY3314814</other_name>
    <other_name>AZD3293</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Lanabecestat + Rosuvastatin</arm_group_label>
    <arm_group_label>Rosuvastatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women not of childbearing potential may participate and include those who are:&#xD;
&#xD;
               -  Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or&#xD;
                  tubal ligation), congenital anomaly such as mullerian agenesis; or&#xD;
&#xD;
               -  Postmenopausal - defined as women over 50 years of age with an intact uterus who&#xD;
                  have not taken hormones or oral contraceptives within 1 year, who have had either&#xD;
                  Spontaneous cessation of menses for at least 12 consecutive months, or 6 to 12&#xD;
                  months of spontaneous amenorrhea with follicle-stimulating hormone level greater&#xD;
                  than (&gt;)40 milli-international units per millilitre (mIU/mL) consistent with&#xD;
                  menopause&#xD;
&#xD;
          -  Caucasian and may be of Hispanic ethnicity&#xD;
&#xD;
          -  Body mass index (BMI) of 19 to 32 kilogram per meter square (kg/m²), inclusive, at the&#xD;
             time of screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Have a clinically significant abnormal blood pressure or heart rate (supine) as&#xD;
        determined by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Inc</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=15994&amp;amp;attachmentIdentifier=87713afe-ea99-4c11-b4da-b46306330ffb&amp;amp;fileName=CSP_NCT03019549.pdf&amp;amp;versionIdentifier=</url>
    <description>CSP</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=15994&amp;amp;attachmentIdentifier=b280b981-c986-4621-b8bd-ce2ab29f17e8&amp;amp;fileName=SAP_NCT03019549.pdf&amp;amp;versionIdentifier=</url>
    <description>SAP</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <results_first_submitted>December 13, 2018</results_first_submitted>
  <results_first_submitted_qc>April 12, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 16, 2019</results_first_posted>
  <last_update_submitted>October 18, 2019</last_update_submitted>
  <last_update_submitted_qc>October 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</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>Rosuvastatin Calcium</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03019549/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03019549/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>11 participants completed Period 1 but did not enter Period 2 because they did not meet the genotype criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Overall Study</title>
          <description>All participants received: Period 1, Day 1: single, PO dose 20 mg rosuvastatin with a seven day wash-out. Period 2: Day 1-7 single, PO dose 50 mg lanabecestat (LY3314814) with a single 20 mg rosuvastatin dose coadminstered on Day 8</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>DId not meet genotype criteria</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Overall Study</title>
          <description>All participants who received at least 1 dose of study drug.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
          </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="45.2" spread="13.1"/>
                  </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="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Genotype rsl045642 (ABCB1)</title>
          <description>Results from genotype rsl045642 was used to explore polymorphisms in genes coding for certain transporters on the magnitude of the interaction between rosuvastatin and LY3314814.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Genotype A/A</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genotype A/G</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genotype G/G</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not performed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin</title>
        <description>Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin</description>
        <time_frame>1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose</time_frame>
        <population>All participants who received at least 1 dose of study drug, had evaluable PK parameters. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality.</population>
        <group_list>
          <group group_id="O1">
            <title>Rosuvastatin</title>
            <description>20 mg rosuvastatin administered PO</description>
          </group>
          <group group_id="O2">
            <title>Rosuvastatin + Lanabecestat (LY3314814)</title>
            <description>20 mg rosuvastatin and 50 mg lanabescestat (LY3314814) administered in combination.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin</title>
          <description>Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin</description>
          <population>All participants who received at least 1 dose of study drug, had evaluable PK parameters. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality.</population>
          <units>hours times nanogram per milliliter</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="31"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" spread="47"/>
                    <measurement group_id="O2" value="78" spread="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)</title>
        <description>Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)</description>
        <time_frame>Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose</time_frame>
        <population>All participants who received at least 1 dose of study drug, had evaluable PK parameters. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanabecestat (LY3314814)</title>
            <description>50 mg lanabecestat (LY3314814) PO once daily (QD)</description>
          </group>
          <group group_id="O2">
            <title>Rosuvastatin + Lanabecestat (LY3314814)</title>
            <description>20 mg rosuvastatin and 50 mg lanabescestat (LY3314814) administered in combination PO</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)</title>
          <description>Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)</description>
          <population>All participants who received at least 1 dose of study drug, had evaluable PK parameters. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality.</population>
          <units>hours times nanograms per milliliter</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="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3650" spread="25"/>
                    <measurement group_id="O2" value="3790" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat</title>
        <description>Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat</description>
        <time_frame>.Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose</time_frame>
        <population>All participants who received at least 1 dose of study drug and had evaluable PK data. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanabecestat (LY3314814)</title>
            <description>50 mg lanabecestat (LY3314814) PO once daily (QD)</description>
          </group>
          <group group_id="O2">
            <title>Rosuvastatin + Lanabecestat (LY3314814)</title>
            <description>20 mg rosuvastatin and 50 mg lanabescestat (LY3314814) administered in combination PO</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat</title>
          <description>Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat</description>
          <population>All participants who received at least 1 dose of study drug and had evaluable PK data. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality.</population>
          <units>nanograms per milliliter</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="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="369" spread="27"/>
                    <measurement group_id="O2" value="399" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 5 months</time_frame>
      <desc>All participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>20 mg Rosuvastatin</title>
          <description>Period 1: rosuvastatin: 20 mg PO on Day 1</description>
        </group>
        <group group_id="E2">
          <title>50 mg Lanabecestat (LY3314814)</title>
          <description>Period 2: Day 1-7,50 mg lanabecestat (LY3314814) PO once daily (QD)</description>
        </group>
        <group group_id="E3">
          <title>Lanabecestat (LY3314814) + 20 mg Rosuvastatin</title>
          <description>Period 2: Lanabecestat (LY3314814) 50 mg PO Days 1-12 with a single dose of 20 mg rosuvastatin PO on Day 8</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</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="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Surgical skin tear</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>11 participants completed Period 1 and then discontinued due to genotyping criteria.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Compnay</organization>
      <phone>800-545-5979</phone>
      <email>Clinicaltrials.gov@lilly.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/NCT03019549
org study id: 15994
secondary id: I8D-MC-AZEB
nct id: NCT03019549
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the effect of lanabecestat on rosuvastatin. The
      amount of rosuvastatin in the blood will be compared, when taken alone, and then when taken
      with lanabecestat. The amount of lanabecestat that gets into the bloodstream will be
      measured. Information about any side effects that may occur will also be collected.

      Participants will be on study for 21 days with a follow-up at least 7 days afterwards.

      Screening will be undertaken within 45 days prior to enrollment.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin
time frame: 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
description: Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin
measure: Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)
time frame: Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose
description: Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat
time frame: .Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose
description: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat
arm group label: Rosuvastatin
arm group type: Experimental
description: Period 1: 20 mg rosuvastatin administered once orally (PO)
arm group label: Lanabecestat + Rosuvastatin
arm group type: Experimental
description: Period 2: 50 mg Lanabecestat (LY3314814) administered orally (PO) Day 1 to Day 12 Rosuvastatin: 20 mg co-administered PO on Day 8
intervention type: Drug
intervention name: Lanabecestat
description: Administered orally
arm group label: Lanabecestat + Rosuvastatin
other name: LY3314814
other name: AZD3293
intervention type: Drug
intervention name: Rosuvastatin
description: Administered orally
arm group label: Lanabecestat + Rosuvastatin
arm group label: Rosuvastatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: United States
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=15994&amp;attachmentIdentifier=87713afe-ea99-4c11-b4da-b46306330ffb&amp;fileName=CSP_NCT03019549.pdf&amp;versionIdentifier=
description: CSP
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=15994&amp;attachmentIdentifier=b280b981-c986-4621-b8bd-ce2ab29f17e8&amp;fileName=SAP_NCT03019549.pdf&amp;versionIdentifier=
description: SAP
responsible party type: Sponsor
mesh term: Rosuvastatin Calcium
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: 11 participants completed Period 1 and then discontinued due to genotyping criteria.
point of contact: 