A Study to Measure the Amount of Evacetrapib That Enters the Blood Stream in Healthy Participants
Condition: Healthy Volunteers
Intervention: Evacetrapib Tablet; Evacetrapib Intravenous
Intervention description: Oral administration; Intravenous administration
Intervention MeSH terms: Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evacetrapib (study drug) is an investigational drug being developed with the aim to help
      people at high risk of heart problems in the future.

      In this study we will be comparing how much of the study drug gets into the blood stream when
      it is given as a single dose (in tablet form) compared to an intravenous injection (given
      directly into a vein via a small needle).

      The study is expected to last at least 15 days for each participant, not including screening.
      Screening will occur up to 28 days before the study drug is given.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination

          -  Female participants are post menopausal women or women not of child bearing potential
             due to surgical sterilization (at least 6 weeks after surgical hysterectomy, bilateral
             oophorectomy, or tubal occlusion) confirmed by medical history, or menopause

          -  Have a body mass index (BMI) of less than 32 kilograms per square meter (kg/m^2)

          -  Have given written informed consent approved by Eli Lilly and Company and the ethical
             review board (ERB) governing the site

        Exclusion Criteria:

          -  Have known allergies to evacetrapib, related compounds or any components of the
             formulation, intolerance to alcohol containing products, or history of significant
             allergic disease as determined by the investigator

          -  Have an abnormal blood pressure as determined by the investigator

          -  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

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  Are 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 the first dose and
             during the study. The use of topical medicine, provided there is no evidence of
             chronic dosing with risk of systemic exposure, and occasional acetaminophen is
             acceptable

          -  Have donated blood of more than 500 milliliter (mL) within the last 3 months

          -  Are unwilling to comply with the dietary requirements/restrictions during the study:

               -  Consume only the meals provided during the inpatient appointments,

               -  Refrain from eating any food or drinking any beverages containing grapefruit,
                  grapefruit juice, Seville oranges, Seville orange juice, star fruit, pomelo, or
                  commercial apple juice or orange juice for at least 7 days prior to the first
                  dose