A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants
Condition: Healthy Volunteers
Intervention: Baricitinib; Ketoconazole; Fluconazole
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Fluconazole; Ketoconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to look at the effect of ketoconazole and fluconazole on
      how much baricitinib gets into the blood stream. The study will also look at the tolerability
      of baricitinib and ketoconazole when given together and the tolerability of baricitinib and
      fluconazole when given together.

      Participants will be recruited into 1 of 2 treatment groups (Group A or Group B). Each
      treatment group will participate in 2 study periods. Participants will take baricitinib alone
      in 1 period and baricitinib with either ketoconazole or fluconazole in the other period. This
      study will last approximately 7 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy as determined by medical history and physical examination

          -  Female participants 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

          -  Have a body mass index of 18 to 29 kilograms per square meter (kg/m^2), inclusive, at
             screening

        Exclusion Criteria:

          -  Participants who have previously completed or withdrawn from this study or any other
             study investigating baricitinib, and have previously received the study drug

          -  Have known allergies to baricitinib, ketoconazole, fluconazole, related compounds, or
             any components of the baricitinib, ketoconazole, or fluconazole formulations, or
             history of significant atopy

          -  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 current or recent history [less than 30 days prior to screening and/or less
             than 45 days prior to day of admission to Clinical Research Unit (CRU)] of a
             clinically significant bacterial, fungal, parasitic, viral (not including
             rhinopharyngitis), or mycobacterial infection

          -  Have alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline
             phosphatase, total bilirubin, or gamma glutamyl transferase (GGT) values above the
             upper limit of the reference range for the local laboratory at screening or day of
             admission to CRU

          -  Have an absolute neutrophil count (ANC) less than 2 times 10^9 per liter (L) [2000
             cells per microliter (μL)] at screening or day of admission to CRU. For abnormal
             values, a single repeat will be allowed

          -  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 Day 1 until discharge from the CRU

          -  Have used or intend to use any drugs or substances that are known to be substrates,
             inhibitors, or inducers of cytochrome P450 (CYP) 3A4, CYP2C9, or CYP2C19 within 30
             days prior to dosing and throughout the study