<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/NCT02256267</url>
  </required_header>
  <id_info>
    <org_study_id>15174</org_study_id>
    <secondary_id>I3Y-MC-JPBF</secondary_id>
    <nct_id>NCT02256267</nct_id>
  </id_info>
  <brief_title>A Study of LY2835219 in Healthy Participants</brief_title>
  <official_title>Effects of CYP3A Induction by Rifampin on the Pharmacokinetics of LY2835219 and Its Metabolites in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this two-period study is to compare how much of the study drug gets into the blood&#xD;
      stream when it is given as a single oral dose and when it is given as a single oral dose in&#xD;
      combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is&#xD;
      used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other&#xD;
      infections). Each participant will complete both study periods.&#xD;
&#xD;
      The study will last about 34 days. Screening is required within 28 days before study drug is&#xD;
      given.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219</measure>
    <time_frame>Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219</measure>
    <time_frame>Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>LY2835219</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of LY2835219</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY2835219 + Rifampin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of LY2835219 with rifampin orally, once daily for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY2835219</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>LY2835219</arm_group_label>
    <arm_group_label>LY2835219 + Rifampin</arm_group_label>
    <other_name>abemaciclib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifampin</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>LY2835219 + Rifampin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overtly healthy sterile males or surgically sterile females or postmenopausal females&#xD;
&#xD;
          -  Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have participated in a clinical trial involving investigational product within the&#xD;
             last 30 days&#xD;
&#xD;
          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the&#xD;
             investigator, increases the risks associated with participating in the study&#xD;
&#xD;
          -  Have an abnormal blood pressure&#xD;
&#xD;
          -  Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C&#xD;
&#xD;
          -  Have donated blood of more than 500 milliliters (mL) within the last month&#xD;
&#xD;
          -  Have used or intend to use over-the-counter or prescription medication including&#xD;
             herbal medications within 7 days prior to dosing or during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75247</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <results_first_submitted>October 27, 2017</results_first_submitted>
  <results_first_submitted_qc>October 27, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 2, 2018</results_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 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>Rifampin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This is an open-label, 2-period, fixed-sequence study</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LY2835219 Then LY2835219 + Rifampin</title>
          <description>Single oral dose of 200 milligrams (mg) LY2835219 on Day 1 in Period 1. Once daily (QD) doses of 600 mg of Rifampin for 6 days (Day 1 through Day 6) in Period 2.Single oral dose of 200 mg of LY2835219 with 600 mg Rifampin orally, QD on Day 7 in Period 2. QD doses of 600 mg Rifampin was continued for 7 days in Period 2 after coadministration with LY2835219 dose.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1 (Day 1; Day 2 to Day 9 Washout)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of LY2835219</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2 (Day 1 to Day 6)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Rifampin</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2 (Day 7 to Day 14)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received LY2835219 + Rifampin</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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>LY2835219 Alone, Then Rifampin, Then LY2835219 + Rifampin</title>
          <description>Single oral dose of 200 mg LY2835219 on Day 1 in Period 1. Day 2 through Day 9 in Period 1 is washout. QD doses of 600 mg of Rifampin for 6 days (Day 1 through Day 6) in Period 2.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
          </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="58.8" spread="7.4"/>
                  </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="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219</title>
        <time_frame>Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours</time_frame>
        <population>All participants who received at least 1 dose of study drug and have evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>200 mg LY2835219</title>
            <description>Single oral dose of 200 mg LY2835219</description>
          </group>
          <group group_id="O2">
            <title>200 mg LY2835219 + 600 mg Rifampin</title>
            <description>Single oral dose of 200 mg of LY2835219 with 600 mg rifampin orally, QD for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219</title>
          <population>All participants who received at least 1 dose of study drug and have evaluable PK data.</population>
          <units>nanogram per milliliter (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="24"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134" spread="45"/>
                    <measurement group_id="O2" value="10.5" spread="58"/>
                  </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>Superiority or Other</non_inferiority_type>
            <param_type>Ratio of Geometric Least Squares Means</param_type>
            <param_value>0.0771</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0671</ci_lower_limit>
            <ci_upper_limit>0.0886</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219</title>
        <time_frame>Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours</time_frame>
        <population>All participants who received at least 1 dose of study drug and have evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>200 mg LY2835219</title>
            <description>Single oral dose of 200 mg LY2835219</description>
          </group>
          <group group_id="O2">
            <title>200 mg LY2835219 + 600 mg Rifampin</title>
            <description>Single oral dose of 200 mg of LY2835219 with 600 mg rifampin orally, QD for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219</title>
          <population>All participants who received at least 1 dose of study drug and have evaluable PK data.</population>
          <units>nanogram x hour per mL (ng x 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="24"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4570" spread="53"/>
                    <measurement group_id="O2" value="229" spread="48"/>
                  </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>Superiority or Other</non_inferiority_type>
            <param_type>Ratio of Geometric Least Squares Means</param_type>
            <param_value>0.0467</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0376</ci_lower_limit>
            <ci_upper_limit>0.0581</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>LY2835219</title>
          <description>Single oral dose of 200 mg LY2835219 Day 1, period 1.</description>
        </group>
        <group group_id="E2">
          <title>Rifampin</title>
          <description>Single oral, QD doses of 600 mg of Rifampin for 6 days Day 1 to Day 6 in period 2</description>
        </group>
        <group group_id="E3">
          <title>LY2835219 + Rifampin</title>
          <description>Single oral dose of 200 mg of LY2835219 with 600 mg rifampin orally, QD on Day 7 of period 2.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.0</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="8" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </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 Clinical Research Organization (CRO) and its third party contractors shall not publish, discuss or release data emanating from a Study without Lilly's express written permission.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT02256267
org study id: 15174
secondary id: I3Y-MC-JPBF
nct id: NCT02256267
lead sponsor: 
has dmc: No
The aim of this two-period study is to compare how much of the study drug gets into the blood
      stream when it is given as a single oral dose and when it is given as a single oral dose in
      combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is
      used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other
      infections). Each participant will complete both study periods.

      The study will last about 34 days. Screening is required within 28 days before study drug is
      given.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219
time frame: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
measure: PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219
time frame: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
arm group label: LY2835219
arm group type: Experimental
description: Single oral dose of LY2835219
arm group label: LY2835219 + Rifampin
arm group type: Experimental
description: Single oral dose of LY2835219 with rifampin orally, once daily for 14 days
intervention type: Drug
intervention name: LY2835219
description: Administered orally
arm group label: LY2835219
arm group label: LY2835219 + Rifampin
other name: abemaciclib
intervention type: Drug
intervention name: Rifampin
description: Administered orally
arm group label: LY2835219 + Rifampin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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
responsible party type: Sponsor
mesh term: Rifampin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 