A Study of Baricitinib and Simvastatin in Healthy Participants
Condition: Healthy Volunteers
Intervention: Baricitinib; Simvastatin
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Simvastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are to determine the effects of baricitinib on the time it takes
      to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is
      when given alone and in combination with simvastatin. Side effects will be documented. The
      study will last approximately 7 days from the first dose to the end of the study (not
      including screening or follow-up).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 confirmed by medical history, or menopause

          -  Have a body mass index of 18.0 to 29.0 kilograms per meter squared (kg/m^2), inclusive

          -  Have clinical laboratory test results within the normal reference range

          -  Have normal renal function

          -  Have normal blood pressure and pulse rate

        Exclusion Criteria:

          -  Are currently enrolled in a clinical trial involving a study drug or off-label use of
             a drug or device, or are concurrently enrolled in any other type of medical research

          -  Have completed or discontinued within the last 90 days from a clinical trial involving
             a study drug

          -  Have previously completed or withdrawn from this study or any other study
             investigating baricitinib, and have previously received baricitinib

          -  Have known allergies to baricitinib, simvastatin, related compounds, or any components
             of the baricitinib or simvastatin formulations, or history of significant atopy

          -  Have an abnormality in the 12-lead electrocardiogram (ECG)

          -  Have a history of, or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine (including hypothyroidism), hematological, or neurological
             disorders

          -  Have current or recent history of myalgia or muscle weakness

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Have a current or recent history 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
             the first dose

          -  Have an absolute neutrophil count (ANC) less than 2 × 10^9/liters (L) [2000
             cells/microliter (μL)] at screening or day prior to first dose of study drug. 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 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 (including salicylate drugs)
             and/or herbal supplements within 14 days prior to dosing and during the study or
             intended use of vitamin supplements from Day 1 until discharge from the Clinical
             Research Unit (CRU)

          -  Have consumed or intend to consume grapefruit or grapefruit-containing products within
             14 days prior to the first dose and throughout the study

          -  Have donated or lost blood of more than 500 milliliters (mL) within the last 3 months

          -  Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21
             units per week (females), or are unwilling to stop alcohol consumption from 48 hours
             prior to the first dose until discharge from the CRU at the end of Period 2

          -  History of, in the opinion of the investigator, excessive methylxanthine use within
             the previous 6 months, such as greater than (>)6 cups of coffee (or equivalent) per
             day

          -  Currently smoke more than 10 cigarettes per day