A Phase 1 Food Effect Study of Azilsartan (TAK-536) Pediatric Formulation
Condition: Healthy Volunteers
Intervention: TAK-536
Intervention description: TAK-536 granule formulation
Intervention MeSH terms: Azilsartan medoxomil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess the PK of TAK-536 and effect of food on the PK
      following single oral administration of TAK-536 pediatric formulation 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 Japanese healthy adult male.

          4. The participant ages 20 to 35 years inclusive at the time of informed consent.

          5. The participant weighs at least 50.0 kilogram (kg), and has a Body Mass Index (BMI)
             between 18.5 and 25.0 kilogram per square meter (kg/m^2), inclusive, at Screening.

        Exclusion Criteria:

          1. The participant has suspected hypotension with associated physical findings, such as
             dizziness postural, facial pallor, or cold sweats based on evaluation/physical
             examination at Screening, on the day before the study drug administration (Day -1) in
             Period 1, or up to the study drug administration in Period 1.

          2. The participant has received any study drug within 16 weeks (112 days) prior to the
             study drug administration in Period 1.

          3. The participant has received TAK-536 or TAK-491 in a previous clinical study or as a
             therapeutic agent.

          4. The participant has uncontrolled, clinically significant neurologic, cardiovascular,
             pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other
             abnormality, which may impact the ability of the participant to participate or
             potentially confound the study results.

          5. The participant has a hypersensitivity to any component of the formulation of TAK-536
             or any ARB.

          6. The participant has a positive urine drug result for drugs of abuse (defined as any
             illicit drug use) at Screening.

          7. The participant has a history of drug abuse (defined as any illicit drug use) or a
             history of 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, dietary products or
             food products during the specified time periods.

          9. The participant has any current or recent (within 6 months prior to the start of the
             study drug administration in Period 1) gastrointestinal diseases 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).

         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 of Period 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 the 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 the study drug administration in
             Period 1.

         15. The participant has undergone blood component collection within 2 weeks (14 days)
             prior to the start of the study drug administration in Period 1.

         16. The participant has an abnormal (clinically significant) ECG at Screening or prior to
             the study drug administration in Period 1.

         17. The participant has abnormal laboratory values that suggest a clinically significant
             underlying disease, or participant with the following laboratory abnormalities at
             Screening or prior to the study drug administration in Period 1: Alanine
             Aminotransferase (ALT) and/or Aspartate Transaminase (AST) greater than (>) 1.5× 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.