A Study on the Effects of LY2409021 on the Electrical Impulses of the Heart
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: LY2409021; Placebo; Moxifloxacin
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Part A: The purpose of Part A of the study is to look at the electrocardiogram (ECG) effects
      due to blood sugar changes after a meal compared to when LY2409021 is also given with a meal.

      Part B: The purpose of Part B is to evaluate the effect of LY2409021, when given at a dose
      level much higher than what would normally be given, on the electrical activity of the heart
      as measured by ECG in relation to placebo and moxifloxacin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  are overtly healthy males or females, as determined by medical history and physical
             examination

          -  female participants: women not of child-bearing potential due to surgical
             sterilization (hysterectomy alone or at least 6 weeks postsurgical bilateral
             oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical
             history, or menopause Women with an intact uterus are deemed postmenopausal if they
             are >=45 years old, have not taken hormones or oral contraceptives within the last
             year, had cessation of menses for at least 1 year, or have had 6 to 12 months of
             amenorrhea with follicle-stimulating hormone levels consistent with postmenopausal
             state

          -  have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m^2),
             inclusive, at screening

          -  have a fasting blood glucose between 54 to 110 milligrams per deciliter (mg/dL) (3.0
             to 6.1 millimoles per liter [mmol/L])

          -  have a clinically normal screening electrocardiogram (ECG) with a measurable QT
             interval as judged by central reader, which allows accurate measurements of QT
             interval

          -  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

          -  are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures

          -  have normal blood pressure and pulse rate (supine) at screening, or with minor
             deviations judged to be acceptable by the investigator

          -  have given written informed consent approved by Lilly and the ethical review board
             (ERB) governing the site

          -  serum magnesium and potassium equal to or above the lower limit of normal

        Exclusion Criteria:

          -  are currently enrolled in or have completed or discontinued within the last 30 days
             (from screening) from a clinical trial involving an investigational product; 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 LY2409021, related compounds or any components of the
             formulations, or to moxifloxacin

          -  are persons who have previously received the investigational product in this study,
             have completed or withdrawn from this study or any other study investigating LY2409021

          -  personal or family history of long QT syndrome

          -  family history of sudden unexplained death or cardiac death in a family member under
             60 years of age

          -  personal history of unexplained syncope within the last year

          -  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

          -  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 (including mineral supplements and herbal medicine) or
             prescription medication within 7 days prior to dosing

          -  have donated blood of more than 500 milliliters (mL) within the last month

          -  have an average weekly alcohol intake that exceeds 21 units per week (males) and 14
             units per week (females) (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of
             wine; 1.5 oz or 45 mL of distilled spirits), or are unwilling to comply with alcohol
             restrictions during the study (that is, refrain from alcohol consumption from 24 hours
             prior to dosing until the completion of each treatment period and to consume no more
             than 2 units of alcohol per day between treatment periods)

          -  are participants who smoke more than 10 cigarettes per day and/or are unable to abide
             by the study restrictions for smoking/tobacco use (that is, refrain from smoking for
             approximately 2 hours prior to each ECG timepoint or for a total of approximately 12
             hours)

          -  are participants who are unable to abide by the study restrictions for
             caffeine/xanthine use (that is, refrain from consuming caffeine/xanthine containing
             drinks and foods [such as coffee, tea, cola, and chocolate] on days on which ECGs are
             performed, and maintain consistent consumption habits on all other days of the study)