A Study of Evacetrapib With Selected Statins in Healthy Chinese Participants
Condition: Healthy Volunteers
Intervention: Evacetrapib; Simvastatin; Atorvastatin
Intervention description: Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Atorvastatin; Simvastatin; Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to investigate how the body responds to evacetrapib and to
      evaluate the safety and the effect of evacetrapib, alone and in combination with selected
      statins, in healthy Chinese participants. The study has 2 parts. Part one will last up to 4
      weeks and part two will last up to 5 weeks, not including screening. Participants may only
      enroll in one part.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are native Chinese and living in China.

          -  Are overtly healthy males or females as determined by medical history and physical
             examination.

          -  Female participants:

               -  Women not of child-bearing potential

               -  Women of child-bearing potential must correctly use 2 forms of reliable
                  contraception to avoid getting pregnant during the study and for 3 months after
                  the study is completed.

          -  Body Mass Index: 19.0 to 24.0 kilogram per square meter (kg/m^2)

          -  BP and pulse rate at both supine and standing positions of approximately a systolic BP
             ≤ 140 millimeter of mercury (mm Hg), and diastolic BP ≤ 90 mm Hg

          -  Participants with untreated hypercholesterolemia may be included if not on an herbal
             or other traditional Chinese medicines (TCM)

          -  Have no known liver disease

          -  Have given written informed consent

        Exclusion Criteria:

          -  Are currently enrolled in a clinical trial involving an investigational product (IP)
             or off-label use of a drug or device, or are concurrently enrolled in any other type
             of medical research judged not to be scientifically or medically compatible with this
             study.

          -  Have known allergies to evacetrapib, simvastatin, or atorvastatin, related compounds
             or any components of the formulation

          -  Have previously completed or withdrawn from this study or any other study
             investigating evacetrapib, and have previously received the IP within 3 months.

          -  Have a history within the last year or presence of cardiovascular, respiratory,
             hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic 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 significant active neuropsychiatric disease.

          -  Regularly use known drugs of abuse

          -  Are women with a positive pregnancy test or women who are lactating.

          -  Have used or intend to use over-the-counter or prescription medications (including
             vitamins/mineral supplements) or TCM 14 days prior to the first dose and during the
             study.

               -  Hormonal contraceptives are permitted.

          -  Use of any drugs or substances that are known to be substrates, inducers, or
             inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1), or of any other
             transporters involved in simvastatin or atorvastatin disposition, or of any drugs or
             substances that are known to be strong inducers or inhibitors of cytochrome P450 3A
             (CYP3A) within 30 days prior to the first dose and throughout the study.

          -  Donated blood of >400 mL within the last month.

          -  Drink alcoholic beverages with intake that exceeds 28 units per week (males) and 21
             units per week (females), or are unwilling to stop alcohol consumption 48 hours prior
             to dosing until discharge from the clinical research unit (CRU) (1 unit = 12 oz or 360
             mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).

          -  Are unwilling to comply with the dietary requirements/restrictions during the study