Food Effect Study of Febuxostat XR in Healthy Participants
Condition: Gout
Intervention: Febuxostat XR
Intervention description: Febuxostat XR capsules
Intervention MeSH terms: Febuxostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the effect of food on the bioavailability of
      febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the
      pharmacokinetics (PK) of febuxostat after single oral doses of 40 and 80 mg febuxostat XR.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has an estimated glomerular filtration rate ≥90 mL/min.

          2. Weighs at least 50 kg (110 pounds) and has a body mass index (BMI) from 18.0 to 30.0
             kg/m^2, inclusive, at Screening.

          3. A male participant who is nonsterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from the signing of the
             informed consent throughout the duration of the study and for 30 days after the last
             dose.

          4. A female participant of childbearing potential who is sexually active with a
             nonsterilized male partner agrees to use routinely adequate contraception from signing
             of informed consent throughout the duration of the study and for 30 days after the
             last dose.

          5. Able to attend all the visits scheduled in the study.

          6. Willing to refrain from strenuous exercise from Day -1 until Study Exit (Day 3 of
             Period 3).

        Exclusion Criteria:

          1. Hypersensitivity to Febuxostat or to any of the components of the formulation.

          2. Has received any investigational compound within 30 days prior to the first dose of
             study medication.

          3. Has received febuxostat in a previous clinical study or as a therapeutic agent.

          4. Has uncontrolled, clinically significant disease or other abnormality, which may
             impact the ability of the participant to participate or potentially confound the study
             results.

          5. Has a known hypersensitivity to any xanthine oxidase (XO) inhibitor, xanthine
             compounds, Febuxostat or any component of the formulation of Febuxostat tablets, or to
             caffeine.

          6. Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1
             of Period 1).

          7. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain
             from alcohol and drugs throughout the study.

          8. Is pregnant or lactating or intending to become pregnant before, during, or within 30
             days post last dose; or intending to donate ova during such time period.

          9. Intends to impregnate others or donate sperm during the course of this study or for 30
             days post last dose.

         10. Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic
             disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy,
             asthma, hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding
             in the participant's medical history, physical examination, or safety laboratory tests
             giving reasonable suspicion of a disease that would contraindicate taking febuxostat
             XR, or a similar drug in the same class, or a disease that might interfere with the
             conduct of the study. This includes, but is not limited to, peptic ulcer disease,
             seizure disorders, and cardiac arrhythmias.

         11. Has current or recent (within 6 months) gastrointestinal disease that would be
             expected to influence the absorption of drugs (ie, a history of malabsorption,
             esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once
             per week] occurrence of heartburn, or any surgical intervention [eg,
             cholecystectomy]).

         12. Has a history of cancer, except basal cell carcinoma that has been in remission for at
             least 5 years prior to Day 1 of Period 1.

         13. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus
             (HCV) antibody or a known history of human immunodeficiency virus infection.

         14. Has used nicotine-containing products (including, but not limited to, cigarettes,
             pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 28 days prior
             to Check-in (Day -1 of Period 1) or is unwilling to agree to abstain from
             nicotine-containing products. Cotinine test is positive at Screening or Check-in (Day
             1 of Period 1).

         15. Has poor peripheral venous access.

         16. Has donated or lost 450 mL or more of his or her blood volume (including
             plasmapheresis) or had a transfusion of any blood product within 30 days prior to Day
             1 of Period 1.

         17. Has a Screening abnormal (clinically significant) electrocardiogram (ECG).

         18. Has abnormal Screening or Day -1 of Period 1 laboratory values that suggest a
             clinically significant underlying disease or participant with the following lab
             abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
             >1.5 x the upper limit of normal.