Study of Evacetrapib (LY2484595) and Warfarin in Healthy Participants
Condition: Healthy Volunteers
Intervention: Evacetrapib; Warfarin
Intervention description: Oral administration; Oral administration
Intervention MeSH terms: Warfarin; Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      All study participants will receive both warfarin and a study drug called evacetrapib. The
      main purpose of this study is to look at how much warfarin gets into the blood stream and how
      long it takes the body to get rid of warfarin when given both with and without evacetrapib.
      Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots
      when given with evacetrapib by measuring the time it takes for blood to clot and comparing it
      to an average of the international normalized ratio (INR). INR measures the time it takes for
      blood to clot and compares it to an average.

      The study will last approximately 5 weeks, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants have given written informed consent approved by Lilly and the ethical
             review board (ERB) governing the site

          -  A medical history and physical examination consistent with a being a healthy
             individual

          -  Male participants will use a reliable method of birth control (as deemed by the
             investigator) and not donate sperm during the study and for 3 months following the
             last dose of the investigational product

          -  Female participants are not of child-bearing potential due to surgical sterilization
             (at least 6 weeks after surgical hysterectomy, bilateral oophorectomy, or tubal
             ligation) confirmed by medical history, or post-menopausal

          -  Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

          -  Participants are predicted to be cytochrome P450 2C9 (CYP2C9) extensive metabolizers
             as determined by genotyping assessment

        Exclusion Criteria:

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that increases the risks
             associated with participating in the study

          -  Have an abnormal supine blood pressure

          -  Have a history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs; of
             constituting a risk when taking the study medication; or of interfering with the
             interpretation of data

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  Show evidence of hepatitis C and/or positive hepatitis C antibody or evidence of
             hepatitis B and/or positive hepatitis B surface antigen

          -  Women who are pregnant or are lactating

          -  Have used or intend to use over-the-counter or prescription medications (including
             vitamins/mineral supplements, herbal medicine) 14 days prior to enrollment and during
             the study

          -  Have consumed grapefruit, cranberries, or grapefruit- or cranberry-containing products
             within 7 days prior to the first dose of warfarin

          -  Have a history or presence of significant bleeding disorders that is, hematemesis,
             melena, severe or recurrent epistaxis, hemoptysis, clinically overt hematuria or
             intracranial hemorrhage, gastrointestinal ulcers with hemorrhage

          -  Have a personal or family history of coagulation or bleeding disorders or reasonable
             suspicion of vascular malformations, for example, cerebral hemorrhage, aneurysm or
             premature stroke (cerebrovascular accident less than 65 years of age)

          -  Have a history of major head trauma (with loss of consciousness) within the past year
             or minor head trauma (without loss of consciousness) within the last 3 months prior to
             screening or history of major surgery within 3 months of screening

          -  Have planned surgery within 14 days after the last day of dosing

          -  Have an international normalized ratio/prothrombin time (INR/PT), or activated partial
             thromboplastin time (aPTT) above the normal reference range or abnormal Protein S
             antigen and/or Protein C activity at screening