Single Dose Study in Healthy Participants to Investigate the Safety and Absorption of LY2584702
Condition: Healthy Participants
Intervention: LY2584702 Reference Formulation; LY2584702 Test Formulation; Placebo
Intervention description: Administered orally; Administered orally; Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a single-centre, placebo-controlled, two-part study in healthy participants.

      Part A will be a single dose, single period, placebo-controlled pilot study to explore the
      safety, tolerability, absorption and pharmacodynamic [effect of drug on a biological
      marker-phospho-S6 (pS6) levels in skin biopsies] of a single dose of 25 milligrams (mg)
      LY2584702 Reference formulation (RF). Part B is a single dose, placebo-controlled, 4-period
      crossover study to primarily evaluate the absorption of the Test Formulation (TF) in
      comparison with the (RF) of LY2584702.
    

Eligibility criteria:

        Inclusion Criteria:

        Male participants:

        • Agree to use a reliable method of birth control during the study and for at least 1 month
        following the last dose of study drug

        Female participants:

        • Women not of childbearing potential due to surgical sterilization (hysterectomy or
        bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are
        deemed postmenopausal if they are greater than or equal to 45 years old, who have not taken
        hormones or oral contraceptives within the last year, and had cessation of menses for at
        least 1 year, or who have had 6 to 12 months of amenorrhea with follicle-stimulating
        hormone (FSH) levels consistent with postmenopausal state.

        All participants:

          -  have a screening body mass index (BMI) of 18.5 to 32.0 kilograms per square meter
             (kg/m^2), inclusive

          -  have clinical laboratory test results within the normal range for the population or
             investigator site, or with abnormalities deemed clinically insignificant by the
             investigator. In particular, participants should have normal or near normal screening
             liver tests at the discretion of the investigator

          -  have normal blood pressure and pulse rate (supine) at screening, or with minor
             deviations judged to be acceptable by the investigator

          -  have venous access sufficient to allow 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 ethical review board
             (ERB) governing the site

        Exclusion Criteria

        All participants:

          -  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. Participants that participate in Part A of this study may participate in
             Part B of the study if the first dosing in Part B is >30 days after the dose of
             LY2584702 or placebo in Part A.

          -  have known allergies to LY2584702, or related compounds

          -  have an abnormality in the 12-lead electrocardiogram (ECG) [including but not limited
             to Bazett's corrected QT (QTcB) interval >450 milliseconds (msec) for men and >470
             msec for women]

          -  have a history within the last 2 years 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

          -  have a history of drug or alcohol abuse, or regularly use known drugs of abuse

          -  show evidence of human immunodeficiency virus infection and/or positive human
             immunodeficiency virus (HIV) antibodies

          -  show evidence of hepatitis B and/or positive hepatitis B surface antigen

          -  intend to use over-the-counter or prescription medication within 14 days prior to
             dosing or during the study

          -  use of herbal supplements, grapefruit juice, grapefruits, Seville orange juice,
             Seville oranges, or Starfruit within 7 days prior to study dosing or intended use
             during the study

          -  have donated blood of more than 450 milliliters (mL) within the last 3 months

          -  have an average weekly alcohol intake that exceeds 21 units per week (males) and 14
             units per week (females), or are unwilling to stop alcohol consumption from prior to
             dosing until the completion of each study period [ 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]

        Applicable for Part A only:

        • have known allergies to lignocaine, adrenaline, tetracycline, or related compounds, which
        will be used in the skin biopsy procedure