A Study of Lanabecestat (LY3314814) in Healthy Participants
Condition: Healthy
Intervention: Lanabecestat
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to measure how much of a new tablet formulation of lanabecestat
      gets into the blood stream and how long it takes the body to get rid of it, compared to the
      current tablet formulation of lanabecestat. The effect of a high fat meal on how quickly the
      body absorbs the new tablet formulation will also be evaluated. In addition any side effects
      of the study drug using both the new and current tablet formulations will be evaluated. The
      study will last about 22 days, with screening required within 30 days prior to the start of
      the study.
    

Eligibility criteria:

        Inclusion Criteria:

        - Male participants: Will be sterile (including vasectomy) or agree to use an effective
        method of birth control and will not donate sperm during the study and for 3 months
        following the last dose of the investigational product

        - Female participants: Women not of childbearing potential due to surgical sterilization or
        confirmed by medical history or menopause

        - Are able to eat a high-fat, high-calorie meal within the defined time limit and abide by
        the food restrictions throughout the study

        Exclusion Criteria:

          -  Have a history of or current, significant ophthalmic disease, as determined by the
             investigator or ophthalmologist

          -  Have vitiligo or any other clinically significant disorder of skin pigmentation as
             determined by the investigator or dermatologist

          -  History or presence of gastrointestinal, hepatic or renal disease or any other
             condition known to interfere with absorption, distribution, metabolism or excretion of
             drugs

          -  History of previous or ongoing psychiatric disease/condition

          -  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, or have
             a history of significant dysrhythmias or atrioventricular (AV) block (including first
             degree AV block). Participants with history of persistent PR interval greater than
             (>)200 milliseconds (msec) will be excluded

          -  Have prolonged Fridericia-corrected QT interval (QTcF) of >470 msec

          -  Have a clinically significant abnormal blood pressure or heart rate (supine) as
             determined by the investigator

          -  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

          -  Are unwilling to comply with the dietary requirements/restrictions during the study

          -  Evidence of active renal disease (e.g, diabetic renal disease, polycystic kidney
             disease) or calculated creatinine clearance <50 milliliters per minute (mL/min)