A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet
Condition: Japanese Healthy Adult Male
Intervention: TAK-438 OD; TAK-438
Intervention description: TAK-438 OD tablet; TAK-438 tablet
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the BE of single oral dose of TAK-438 OD 20
      milligram (mg) tablet without water and TAK-438 20 mg tablet with water (Study 1), and
      TAK-438 OD 20 mg tablet with water and TAK-438 20 mg tablet with water (Study 2) in Japanese
      healthy adult male participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator or sub-investigator, the participant is capable of
             understanding and complying with protocol requirements.

          2. The participant signs and dates a written, informed consent form prior to the
             initiation of any study procedures.

          3. The participant is a healthy Japanese adult male, aged 20 to 60 years, inclusive, at
             the time of informed consent.

          4. The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) from
             18.5 to 25.0 kilogram per square meter (kg/m^2), inclusive at Screening.

          5. The participant must be a current nonsmoker who has not used tobacco- or
             nicotine-containing products (example, nicotine patch) for at least 6 months prior to
             the start of study drug administration in Period 1.

          6. The participant must be judged to be in good health by the investigator, based on
             clinical evaluations including laboratory safety tests, medical history, physical
             examination, 12-lead electrocardiogram (ECG), and vital sign measurements performed at
             the Screening Visit and prior to the start of study drug administration in Period 1.

        Exclusion Criteria:

          1. The participant has received any investigational compound within 16 weeks (112 days)
             prior to the start of study drug administration in Period 1.

          2. The participant has received TAK-438 in a previous clinical study or as a therapeutic
             agent.

          3. The participant is an immediate family member of or a 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.

          4. The participant has uncontrolled, clinically significant neurologic, cardiovascular,
             pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease
             or other abnormality (other than the disease being studied), which may impact the
             ability of the participant to participate in the study or potentially confound its
             results.

          5. The participant has hypersensitivity to any component of TAK-438 OD tablet or TAK-438
             tablet.

          6. The participant has a positive urine drug result for drugs of abuse at Screening.

          7. The participant has a history of drug or alcohol abuse within 2 years prior to the
             Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout
             the study.

          8. The participant has taken any excluded medication, supplements, or food products
             during the specified time periods.

          9. The participant 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.

         10. The participant has a history of cancer, except basal cell carcinoma which has been in
             remission for at least 5 years prior to Day 1.

         11. The participant has a positive test result for hepatitis B virus surface antigen
             (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV)
             antibody/antigen, or serological reactions for syphilis at Screening.

         12. The participant has poor peripheral venous access.

         13. The participant has undergone whole blood collection of at least 200 milliliter (mL)
             within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the
             start of study drug administration in Period 1.

         14. The participant has undergone whole blood collection of at least 800 mL in total
             within 52 weeks (364 days) prior to the start of study drug administration in Period
             1.

         15. The participant has undergone blood component collection within 2 weeks (14 days)
             prior to the start of study drug administration in Period 1.

         16. The participant has a Screening or Check-in (Day -1) ECG that was abnormal (clinically
             significant).

         17. The participant has abnormal Screening laboratory values that suggest a clinically
             significant underlying disease or participant with the following laboratory
             abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
             above the upper limits of normal (ULN).

         18. The participant who, in the opinion of the investigator or sub-investigator, is
             unlikely to comply with the protocol or is unsuitable for any other reason.