A Study of LY2409021 Formulations and the Effect of Food
Condition: Healthy Volunteers
Intervention: LY2409021 Reference Form; LY2409021 Test-Med Formulation (medium particle size); LY2409021 Test-High Formulation (high particle size); LY2409021 Test-Low Formulation (low particle size)
Intervention description: Administered orally; Administered orally; Administered orally; Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers; Bioavailability

Summary:

      The purposes of this study are to compare how much of LY2409021 enters the bloodstream and
      how long the body takes to get rid of the drug when different formulations of LY2409021 are
      given, and when LY2409021 is taken with or without food.

      The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of
      3 formulations of LY2409021. Participants in each cohort will receive the same all 3
      formulations using a randomized sequence crossover design. There is a washout period of at
      least 14 days between dosing periods.

      There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not
      begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be
      determined by the outcome of the interim analysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be healthy male or a healthy female who cannot become pregnant

          -  Must have body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²),
             inclusive

          -  Blood pressure as well as blood and urine laboratory test results must be acceptable
             for the study

          -  The veins must be suitable for easy blood collection

          -  Must be willing to be available for the whole study and be willing to follow study
             procedures

        Exclusion Criteria:

          -  Were in another new drug or medical research study in the last 30 days

          -  Have previously taken part in this study or any other study with LY2409021

          -  Have taken LY2409021, or drugs similar to LY2409021 before and was found to be
             allergic to the drug

          -  Currently have or used to have health problems or laboratory test results that in the
             opinion of the doctor, could interfere with understanding the results of this study

          -  Electrocardiogram (ECG) readings are not suitable for the study

          -  Are infected with hepatitis B

          -  Are infected with human immunodeficiency disease virus (HIV)

          -  Are using or intend to use over-the-counter medication or prescription medications
             within 14 days, from the start of the first study dosing until end of study

          -  Have a regular alcohol intake greater than 21 units per week (males) and 14 units per
             week (females) or are not willing to abstain from alcohol while in the research unit

          -  Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while
             at the clinic

          -  Have a history of drug or alcohol abuse

          -  Have donated 450 milliliters (mL) or more of blood in the last 3 months

          -  Are unwilling or unable to comply with dietary requirements/restrictions during the
             study

          -  The study doctor thinks the participant should not participate for any other reasons