A Study of Baricitinib in Healthy Japanese Participants
Condition: Healthy Participants
Intervention: Baricitinib
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: 16.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to understand the relationship of 3 different dosage forms of
      baricitinib. This study will also explore the effect of food on how the body absorbs
      baricitinib. This study will last about 5 weeks, not including screening. Screening is
      required within 28 days prior to the date of first dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy Japanese male and female (women not of child-bearing potential or
             after menopause), as determined by medical history and physical examination

          -  Have a body mass index (BMI) of 18.5 to 29.9 kilogram per square meter (kg/m^2)

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures

        Exclusion Criteria:

          -  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 an abnormal blood pressure 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; of
             constituting a risk when taking the study medication; or of interfering with the
             interpretation of data

          -  Are women who are pregnant or lactating

          -  Have used or intend to use over-the-counter or prescription medication, including
             herbal medications, within 14 days prior to dosing and during the study.

          -  Have donated blood of more than 400 milliliter (mL) in the last 12 weeks (males) or in
             the last 16 weeks (females), or any blood donation (including apheresis) within the
             last 4 weeks, or total volume of blood donation within 12 months is 1200 mL (males) or
             800 mL (females) at screening.

          -  Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14
             units per week (females), or are unwilling to abide by alcohol restrictions

          -  Are participants who currently smoke more than 10 cigarettes per day (or equivalent in
             tobacco or nicotine products) or are unwilling to abide by smoking restrictions

          -  Have a current or recent history of a clinically significant bacterial, fungal,
             parasitic, viral (not including rhinopharyngitis), or mycobacterial infection

          -  Have an absolute neutrophil count (ANC) less than 2000 cells/microliter (µL)