A Study to Measure Baricitinib (LY3009104) Absorption in Healthy Participants
Condition: Healthy Volunteers
Intervention: Baricitinib; [^13C4D3^15N]-baricitinib
Intervention description: 4 milligrams (mg) administered orally; 4 micrograms (μg) administered intravenously (IV)
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare how much baricitinib (study drug) gets into the blood
      stream when it is given as a single dose (in tablet form) and as an intravenous infusion
      (injection given directly into a vein via a small needle). Each participant in the study will
      make four visits to the investigator site over the course of about 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination

          -  Male participants: agree to use 2 reliable methods of birth control with female
             partners of childbearing potential during the study and for at least 3 months
             following the last dose of study drug

          -  Female participants: women not of childbearing potential due to surgical sterilization
             (at least 3 months after surgical hysterectomy, bilateral oophorectomy with or without
             hysterectomy, or bilateral tubal occlusion/ligation) confirmed by medical history, or
             menopause. Menopausal women are women with spontaneous amenorrhea for at least 12
             months, not induced by a medical condition such as anorexia nervosa and not taking
             medications during the amenorrhea that induced the amenorrhea (eg, oral
             contraceptives, hormones, gonadotropin releasing hormone, anti estrogens, selective
             estrogen receptor modulators, or chemotherapy). Menopausal status should be confirmed
             by a follicle stimulating hormone (FSH) level greater than 40 international units per
             liter (IU/L) at screening. Female participants who have been sterilized by tubal
             ligation will be required to use contraception from the time of screening until 28
             days after the last dose of study drug

          -  Have a body mass index of 18.0 to 32.0 kilogram per meter square (kg/m^2), inclusive,
             at screening

          -  Have venous access sufficient to allow for blood sampling and (IV) administration of
             study drug

        Exclusion Criteria:

          -  Are participants who have previously completed or withdrawn from this study or any
             other study investigating baricitinib, and have previously received baricitinib

          -  Have known allergies to baricitinib, related compounds, or any components of the
             formulation, or history of significant atopy

          -  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

          -  Have a history or presence 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

          -  Have a current or recent history (<30 days prior to screening and/or <45 days prior to
             day before study drug administration) of a clinically significant bacterial, fungal,
             parasitic, viral (not including rhinopharyngitis), or mycobacterial infection

          -  Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to
             dosing

          -  Have an absolute neutrophil count (ANC) less than 2 × 109/liter (L) (2000 cells per
             microliter [cells/μL]) at screening or day before study drug administration. For
             abnormal values, a single repeat will be allowed

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  Show evidence of hepatitis C infection and/or positive hepatitis C antibody

          -  Show evidence of hepatitis B infection and/or positive hepatitis B surface antigen

          -  Are women who are pregnant or lactating

          -  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

          -  Intend to use over-the-counter or prescription medication and/or herbal supplements
             within 14 days prior to dosing and during the study (with the exception of occasional
             paracetamol, which will be permitted at the discretion of the investigator), or
             intended use of vitamin supplements from study drug administration until discharge
             from the Clinical Research Unit (CRU)