A Relative Bioavailability and Food Effect Study of New Formulations
Condition: Chronic Inflammatory Disorder; Arthritis, Rheumatoid
MeSH terms: Arthritis, Rheumatoid
Intervention: LY3009104
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this trial is to assess the effect of 3 formulations on the relative
      bioavailability of LY3009104. Participants will receive single dose of LY3009104 on 4
      separate occasions with and without food. Safety evaluation and serial pharmacokinetic (PK)
      samples will be collected during each treatment period. Approximately 5 to 7 days of washout
      period between each treatment and a follow-up visit will occur approximately 5 to 7 days
      after the last dose of study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males or females as determined by medical history and physical
             examination

          -  Have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2),
             inclusive, at screening

          -  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 normal blood pressure and pulse rate as determined 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 given written informed consent approved by Lilly and the ethical review board
             (ERB) governing the site

        Male Participants:

          -  Agree to use two forms of highly effective methods of birth control [oral, injectable,
             or implanted hormonal contraceptives; condom with spermicidal
             foam/gel/film/cream/suppository; occlusive cap (diaphragm or cervical/vault caps) with
             spermicidal foam/gel/film/cream/suppository; intrauterine device; intrauterine system,
             for example, progestin releasing coil; and vasectomised male (with the appropriate
             post-vasectomy documentation of the absence of sperm in the ejaculate)] with female
             partners of childbearing potential during the study and for at least 3 months
             following the last dose of study drug

        Female participants:

          -  Are women of non-childbearing potential, defined as: women with Mayer Rokitansky
             Kuster Hauser Syndrome (also referred to as Clinical Absence of Uterus and Vagina), or
             women who have had surgical sterilization (hysterectomy or bilateral oophorectomy or
             tubal ligation), or women greater than 60 years of age, or women greater than 40 and
             less than 60 years of age who have had a cessation of menses for at least 12 months
             and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential
             [FSH ≥40 milli-international units per milliliter (mIU/mL)]

        Exclusion Criteria:

          -  Are currently enrolled in, or have completed or discontinued within the last 30 days
             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 a history of adverse drug reactions or "drug allergy" to more than 3 types of
             systemically administered medications (all penicillins and cephalosporins may be
             considered 1 type of medication for this purpose)

          -  Are participants who have previously received the investigational product in this
             study, have completed or withdrawn from this study or any other study investigating
             LY3009104

          -  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

          -  Current or recent history (<30 days prior to screening and/or <45 days prior to
             Check-in) of a clinically significant bacterial, fungal, parasitic, viral (not
             including rhinopharyngitis), or mycobacterial infection

          -  Have an absolute neutrophil count (ANC) less than 2000 cells per microliter (cell/μL).
             For abnormal values, a single repeat will be allowed

          -  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

          -  Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to
             the first dose

          -  Have been exposed to a live vaccine within 12 weeks prior to the first dose or
             expected to need/receive a live vaccine (including herpes zoster vaccination) during
             the course of the study

          -  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

          -  Intend to use over-the-counter or prescription medication and herbal supplements
             within 14 days prior to dosing and during the study

          -  Intend to use vitamins and mineral supplements within 2 days prior to dosing and
             during the study

          -  Have donated blood of more than 450 milliliters (mL) within the previous 3 months

          -  Have consumed grapefruit, starfruit, pomelos, or products containing these fruits, 7
             days prior to the first dose and during the study

          -  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 for 48 hours
             prior to admission in each period until the 48 hour PK sample has been collected [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]

          -  Have used any tobacco-containing or nicotine-containing products (including but not
             limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine
             lozenges, or nicotine gum) within 6 months prior to enrollment