A Study of Baricitinib and Rifampicin in Healthy Participants
Condition: Healthy Volunteers
Intervention: Baricitinib; Rifampicin
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Rifampin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are to look at what effect multiple doses of rifampicin have on a
      single dose of baricitinib and to look at the safety and tolerability of these drugs. Side
      effects will be documented. The study will last approximately 31 days from the first dose to
      the end of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females

          -  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
             (at least 3 months after surgical hysterectomy, bilateral oophorectomy with or without
             hysterectomy, or bilateral tubal occlusion/ligation) confirmed by medical history, or
             menopause. Menopausal women are women with spontaneous amenorrhea for at least 12
             months, not induced by a medical condition such as anorexia nervosa and not taking
             medications during the amenorrhea that induced the amenorrhea (for example, oral
             contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective
             estrogen receptor modulators, or chemotherapy). Menopausal status should be confirmed
             by a follicle-stimulating hormone (FSH) level greater than 40 international units per
             liter (IU/L) at screening [unless the participant is taking hormone replacement
             therapy (HRT)]

          -  Have a body weight of ≥60 kilograms (kg) at the time of screening

          -  Have clinical laboratory test results within normal reference range

          -  Have normal renal function

          -  Have normal blood pressure and pulse rate (supine position)

          -  Have venous access sufficient to allow for blood sampling

        Exclusion Criteria:

          -  Are currently enrolled in, have completed, or discontinued within the last 90 days
             from a clinical trial involving a study drug, or are concurrently enrolled in any
             other type of medical research judged not to be scientifically or medically compatible
             with this study

          -  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, rifampicin, related compounds, or any components
             of the baricitinib or rifampicin formulations, or history of significant atopy

          -  Have a history of or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders

          -  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 48 hours prior
             to the first dose and until completion of the safety follow-up assessment [Day 18 ± 1;
             1 unit = 12 ounces (oz) or 360 milliliters (mL) of beer; 5 oz or 150 mL of wine; 1.5
             oz or 45 mL of distilled spirits]

          -  Have a history of, in the opinion of the investigator, excessive methylxanthine use
             within previous 6 months, such as greater than (>)6 cups of coffee (or equivalent) per
             day

          -  Currently smoke more than 10 cigarettes per day or are unable to abide by Clinical
             Research Unit (CRU) restrictions

          -  Are unwilling to refrain from using soft contact lenses from the start of the second
             treatment period until after the final follow-up