A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease
Condition: Liver Diseases; Hepatic Insufficiency
MeSH terms: Liver Diseases; Hepatic Insufficiency; Liver Failure
Intervention: Baricitinib
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to measure how much of the study drug called baricitinib
      gets into the blood stream and how long it takes the body to get rid of it. Healthy
      participants and those with liver disease may enroll. The study will last about 7 days for
      each participant, not including screening.
    

Eligibility criteria:

        Inclusion Criteria for ALL Participants:

          -  Male participants agree to use 2 reliable methods of birth control with female
             partners of child-bearing potential during the study and for at least 3 months
             following the last dose of study drug

          -  Women not of child-bearing potential due to surgical sterilization (at least 6 weeks
             after surgical bilateral oophorectomy with or without hysterectomy or at least 6 weeks
             after confirmed tubal occlusion/tubal ligation) confirmed by medical history or
             menopause

          -  Menopausal women with spontaneous amenorrhea for at least 12 months, not induced by a
             medical condition and by medications and have a follicle-stimulating hormone (FSH)
             level greater than 40 milli-international units per milliliter (mIU/mL) (unless the
             participant is taking hormone replacement therapy [HRT])

          -  Have a body mass index of 18.5 to 40.0 kilograms per square meter (kg/m^2) inclusive
             at the time of screening

        Additional Inclusion Criteria for Healthy Participants:

          -  Are overtly healthy participants, have normal hepatic function and have stable chronic
             medical conditions

          -  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

        Additional Inclusion Criteria for Hepatically Impaired Participants:

          -  Participants with hepatic impairment classified as Child-Pugh score A or B (mild
             [Group 3, if enrolled] or moderate [Group 2] impairment, respectively). Must have a
             diagnosis of chronic hepatic impairment (greater than 6 months), with no clinically
             significant changes within 90 days prior to study drug administration (Day 1).
             Participants may have mild stable baseline medical conditions for which neither the
             condition nor treatments received would negatively impact the health of the
             participant or study conduct

          -  Clinical laboratory test results with deviations that are judged by the investigator
             to be compatible with the hepatic impairment of the participant, or of no additional
             clinical significance for this study

        Exclusion Criteria for ALL Participants:

          -  Have received, within the last 30 days, an investigational product as part of a
             clinical trial, or are concurrently enrolled in any other type of medical research
             judged not to be scientifically or medically compatible with this study

          -  Persons who have previously completed or withdrawn from study investigating
             baricitinib, and have previously received the investigational product

          -  Women with a positive pregnancy test or who are lactating

          -  Have a current or recent history (less than 30 days prior to screening and/or less
             than 45 days prior to admission to the clinical research unit) of a clinically
             significant bacterial, fungal, parasitic, viral (excluding rhinopharyngitis), or
             mycobacterial infection

          -  Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to
             the first dose

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  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

        Additional Exclusion Criteria for Healthy Participants:

          -  Show evidence of acute or chronic liver disease

          -  Show evidence of hepatitis B and/or positive hepatitis B and/or positive hepatitis B
             surface antigen

          -  Show evidence of hepatitis C and/or positive hepatitis C antibody

          -  Intend to use over-the-counter or prescription medication and/or herbal supplements
             within 14 days prior to dosing and during the study

        Additional Exclusion Criteria for Liver Impaired Participants:

          -  Have creatinine clearance less than or equal to 50 milliliter per minute (mL/min)
             using the Cockcroft and Gault formula

          -  Show evidence of spontaneous bacterial peritonitis within 6 month of dosing

          -  Have had variceal bleeding within 3 months of check in

          -  Show evidence of severe hyponatremia (sodium less than 120 millimolar per liter
             (mmol/L)

          -  Have severe encephalopathy (Grade 3 to 4)

          -  Have moderate to severe ascites (moderately hepatically impaired participants only)

          -  Show presence of a portal shunt

          -  Have hemoglobin less than 9.0 grams per deciliter (g/dL)

          -  Have serum bilirubin greater than 15 milligrams per deciliter (mg/dL)