TAK-020 Relative Bioavailability and Food Effect Study in Healthy Participants
Condition: Healthy
Intervention: TAK-020 Captisol Oral Solution; TAK-020 CCT; TAK-020 SDT; TAK-020 IRT; TAK-020 CCT; TAK-020 Solid Formulation
Intervention description: TAK-020 solution.; TAK-020 co-crystal tablet; TAK-020 Solid dispersion tablet.; TAK-020 immediate release tablet.; TAK-020 co-crystal tablet.; TAK-020 solid formulation
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the relative bioavailability of solid oral
      formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation
      and to evaluate the food effect and potentially the dose proportionality of the optimal oral
      solid formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is capable of understanding and complying with protocol requirements.

          2. Is legally acceptable representative signs and dates a written, informed consent form
             and any required privacy authorization prior to the initiation of any study procedures
             including requesting that a participant fast for any laboratory evaluations.

          3. Is a healthy adult male or female.

          4. Is aged 18 to 55 years, inclusive, at the time of informed consent and first study
             medication dose.

          5. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) between 18 and 32
             kilogram per square meter (kg/m^2), inclusive at Screening and Day -1.

          6. Male participant who is nonsterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of informed
             consent throughout the duration of the study and for 90 days after last dose of study
             medication.

          7. 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 and throughout the duration of the study and until the next
             menstrual period or 90 days after exit from the study, whichever is first. If the next
             menstrual period is delayed, a pregnancy test will be required for exclusion of
             pregnancy.

        Exclusion Criteria:

          1. Has received any investigational compound within 30 days prior to Screening.

          2. Is an immediate family member, study site employee, or is in a dependent relationship
             with a study site employee who is involved in the conduct of this study (example,
             spouse, parent, child, sibling) or may consent under duress.

          3. Has a known hypersensitivity to any component of the formulation of TAK-020, Captisol,
             or related compounds.

          4. Has a positive urine drug result for drugs of abuse or a positive breath alcohol
             screen at Screening or Check-in (Day -1).

          5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse (defined as 4 or more alcoholic units per day) within 1 year prior to the
             Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout
             the study.

          6. Has taken any excluded medication, supplements, or food products listed in Prohibited
             Medications and Foods table.

          7. If female, is pregnant or lactating or intending to become pregnant before, during or
             within 3 months after exit from this study (90 days post last dose); or intending to
             donate ova during such time period.

          8. If male, the participant intends to donate sperm during the course of this study or
             for 90 days after the last dose of study drug.

          9. 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.

         10. Has current or recent (within 6 months) gastrointestinal disease that would be
             expected to influence the absorption of drugs (that is, a history of malabsorption,
             esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once
             per week] occurrence of heartburn, or any surgical intervention [example,
             cholecystectomy]).

         11. Has a history of cancer, except basal cell carcinoma which has been in remission for
             at least 5 years prior to Day 1.

         12. 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. Cotinine test is positive at Screening or Check-in (Day -1).

         13. Has poor peripheral venous access.

         14. Has donated or lost 450 mililiter (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.

         15. Has a Screening or Check-in (Day -1) abnormal (clinically significant) ECG. Entry of
             any participant with an abnormal (not clinically significant) ECG must be approved,
             and documented by signature by the principal investigator or medically qualified
             subinvestigator.

         16. Has QT interval with Fridericia correction method (QTcF) greater than (>) 430
             millisecond (msec) for men and >450 msec for women or PR outside the range of 120 to
             220 msec confirmed upon repeat testing within a maximum of 30 minutes, at the
             Screening Visit or Check-in (Day -1).

         17. Has abnormal Screening or Day -1 laboratory values that suggest a clinically
             significant underlying disease or participant with the following lab abnormalities:

               1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.2* the
                  upper limit of normal (ULN).

               2. Positive screen test for drugs of abuse.

               3. Positive blood screen for hepatitis B surface antigen (HBsAg), hepatitis C virus
                  (HCV), or human immunodeficiency virus-1 or -2 antibodies (test done at Screening
                  visit only).

               4. A positive test for tuberculosis (TB) (QuantiFERON) (test done at Screening Visit
                  only).

         18. Vaccination with any live vaccine within 4 weeks of study drug administration.