A Study of Baricitinib (LY3009104) in Healthy Chinese Participants
Condition: Healthy
Intervention: Baricitinib; Placebo
Intervention description: Administered orally.; Administered orally.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to investigate the safety and tolerability of the study
      drug known as baricitinib in healthy Chinese participants. The study will measure how the
      body absorbs, breaks down and gets rid of baricitinib. The study will last about 20 days, not
      including screening. This study is for research purposes only, and is not intended to treat
      any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy Chinese males agreed to use methods of birth control or are
             postmenopausal Chinese females, as determined by medical history and physical
             examination

          -  Have a body mass index of 19.0 to 24.0 kilograms per meter squared (kg/m²), 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 given written informed consent approved by Lilly and the ethical review board
             (ERB) governing the site.

        Exclusion Criteria:

          -  Have a history of adverse drug reactions or "drug allergy" to more than 3 types of
             systemically administered medications.

          -  Have an abnormality in the 12-lead electrocardiogram (ECG).

          -  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.

          -  Have a history of stomach or intestinal surgery.

          -  Current or recent history (<30 days prior to screening of a clinically significant
             bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial
             infection.

          -  Have an absolute neutrophil count (ANC) less than 2000 cell/microliter (μL) (2 x
             109/liter [L]).

          -  Have current herpes zoster or simplex within 90 days prior to the first dose,

          -  Have evidence of active or latent tuberculosis (TB)

          -  Have used or intend to use over-the-counter, prescription medication, or Chinese
             herbal preparation within 14 days prior to dosing and during the study.

          -  Have consumed grapefruit, grapefruit juice, or grapefruit products within 7 days prior
             to the first dose or are unwilling to abide by the grapefruit restrictions during the
             study.