A Study to Evaluate the Effect of Food on LY2216684
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: LY2216684
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the effect of food on LY2216684. There will be 2 study periods each
      lasting up to 5 days. There will be at least 7 days between the two doses and a follow up
      will occur at least 7 days after the last dose. Screening is required within 30 days prior to
      the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects: Agree to use a reliable method of birth control during the study and
             for 1 month following the last dose of study drug.

          -  Female subjects: Are women of child-bearing potential who test negative for pregnancy
             at the time of enrollment, have used a reliable method of birth control for 4 weeks
             prior to administration of study drug, and agree to use a reliable method of birth
             control during the study and for 1 month following the last dose of study drug; or
             women not of child-bearing potential due to surgical sterilization (hysterectomy,
             bilateral oophorectomy, or tubal ligation) or menopause [at least 1 year without
             menses or 6 months without menses and a follicle stimulating hormone (FSH) >40 mIU/mL
             (milli-international-units/milliliter)]

          -  All Subjects:

               -  Are overtly healthy as determined by medical history and physical examination

               -  Have a body weight >50 kg (kilogram)

               -  Have clinical laboratory test results within normal reference range for the
                  population or investigator site, or results with acceptable deviations that are
                  judged to be not clinically significant by the investigator

               -  Have venous access sufficient to allow for blood sampling as per the protocol

               -  Are reliable and willing to make themselves available for the duration of the
                  study and are willing to follow study procedures

               -  Have given written informed consent approved by Lilly and the institutional
                  review board (IRB) governing the site

               -  Have normal blood pressure (BP) and pulse rate (sitting position)

               -  Are willing to eat all components in the standard high-fat meal

        Exclusion Criteria:

          -  Are currently enrolled in, have completed or discontinued within the last 30 days
             from, a clinical trial involving an investigational product other than the
             investigational product used in this study; 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 LY2216684, related compounds, or any components of the
             formulation

          -  Are persons who have previously received the investigational product in this study,
             have completed or withdrawn from this study or any other study investigating LY2216684
             within 6 months prior to Screening

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  Have a history of suicidal ideation or suicide attempts

          -  Have a history of/or current 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

          -  Show evidence of hepatitis C and/or positive hepatitis C antibody

          -  Show evidence of hepatitis B and/or positive hepatitis B surface antigen

          -  Are women with a positive pregnancy test or women who are lactating

          -  Intend to use over-the-counter or prescription medication within 14 days prior to
             dosing unless deemed acceptable by the investigator and sponsor's medical monitor,
             except for influenza vaccinations

          -  Have donated blood of more than 500 mL (milliliter) within the last month

          -  Have an average weekly alcohol intake that exceeds 21 units per week (males) or 14
             units per week (females), or are unwilling to stop alcohol consumption from 48 hours
             prior to dosing in each period until discharge in each period [1 unit = 12 oz (ounces)
             or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]

          -  Consume 5 or more cups of coffee (or other beverages or foods of comparable caffeine
             content) per day, on a habitual basis, or are unwilling to stop caffeine consumption
             from 48 hours prior to dosing in each period until discharge in each period

          -  Subjects must adhere to the smoking restrictions of the Clinical Research Unit (CRU)
             while a resident of the CRU

          -  Have consumed grapefruit or grapefruit-containing products, starfruit, or pomegranates
             7 days prior to enrollment or are unwilling to avoid them during the study

          -  Subjects determined to be unsuitable by the investigator for any reason

          -  Have a documented or suspected history of glaucoma