Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Atorvastatin; Pravastatin; Rosuvastatin; Filgotinib
Intervention description: Administered as single dose tablet orally.; Administered as single dose tablet orally.; Administered as single dose tablet orally.; Administered as tablet orally once daily for 11 days.
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Pravastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to evaluate the effect of filgotinib on a mixed
      organic anion transporting polypeptide/cytochrome P450 3A (OATP/CYP3A), OATP/ breast cancer
      resistance protein (BCRP), and OATP substrates using phenotypic probes.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Be a nonsmoker. The use of nicotine or nicotine-containing products must be
             discontinued 90 days prior to the first dose of study drug.

          -  Have a calculated body mass index (BMI) of greater than or equal to (≥) 19.0 and less
             than or equal to (≤) 30.0 kilogram per meter square (kg/m^2) at screening.

          -  Have a creatinine clearance (CLcr) ≥ 90 milliliters per minute (mL/min) (using the
             Cockcroft-Gault method) based on serum creatinine and actual body weight as measured
             at screening and upon admission.

          -  Female participants of childbearing potential must have a negative serum pregnancy
             test at screening and a negative urine pregnancy test at clinic admission.

          -  Male participants must be surgically sterile.

          -  Male participants and female participants of childbearing potential who engage in
             heterosexual intercourse must agree to use protocol-specified method(s) of
             contraception.

          -  Screening laboratory evaluations and 12-lead electrocardiogram (ECG) evaluations must
             be without clinically significant abnormalities as assessed by the investigator.

          -  Have liver biometric tests such as alanine aminotransferase (ALT), aspartate
             aminotransferase (AST), alkaline phosphatase, and total bilirubin below the upper
             limit of normal at screening.

          -  Must be willing and able to comply with all study requirements.

          -  Must, in the opinion of the investigator, be in good health based upon medical history
             and physical examination, including vital signs.

          -  Participants must not have donated blood within 56 days of study entry or plasma
             within 7 days of study entry and must refrain from blood donation from clinic
             admission, throughout the study period, and continuing for at least 30 days following
             the last dose of study drug.

        Key Exclusion Criteria:

          -  Positive serum pregnancy test (Female participants).

          -  Lactating female.

          -  Have received any investigational drug/device within 30 days prior to study dosing (or
             within 5 half-lives of the drug, whichever is longer).

          -  Have current alcohol or substance abuse judged by the investigator to potentially
             interfere with participant compliance or participant safety, or a positive drug or
             alcohol test at screening or admission.

          -  Have a positive test result for human immunodeficiency virus type 1 (HIV-1) antibody,
             hepatitis B virus (HBV) surface antigen (HBsAg), or hepatitis C virus (HCV) antibody
             at screening.

          -  Have positive Coronavirus Disease 2019 (COVID-19) Real-Time Reverse.

          -  Transcriptase-Polymerase Chain Reaction (RT-PCR) testing on screening and admission.

          -  Have poor venous access that limits phlebotomy.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.