A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet
Condition: Hypertension
MeSH terms: Hypertension
Intervention: TAK-536TCH
Intervention description: TAK-536TCH tablets
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: Pharmacological therapy

Summary:

      This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of
      single oral dose of TAK-536TCH final formulation tablet in healthy adult male participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. In the opinion of the investigator and subinvestigator, 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. 4. The participant is aged 20 to
             35 years, inclusive at the time of informed consent.

             5. The participant weighs at least 50.0 kg and has a body mass index (BMI) from 18.5
             to 25.0 kilograms per square meter (kg/m^2), inclusive at Screening.

        Exclusion Criteria:

          1. Participant has systolic blood pressure less-than (<) 90 millimeters of mercury (mmHg)
             at Screening.

          2. Participant has suspected hypotension and associated physical findings, such as
             dizziness postural, facial pallor, or cold sweats based on evaluation/physical
             examination at Screening, on Day -1 of Period 1, or up to administration on the Period
             1.

          3. The participant has received any study drug within 16 weeks (that is [i.e.], 112 days)
             prior to study drug administration of Period 1.

          4. The participant has received TAK-491*, TAK-536, amlodipine, or hydrochlorothiazide in
             a previous clinical study or as a therapeutic agent.

          5. The participant has uncontrolled, clinically significant neurologic, cardiovascular,
             pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, or endocrine
             disease, or other abnormality (other than the disease studied), which could impact the
             ability of the participant to participate or potentially confound the study results.

          6. Participant has a known hypersensitivity to drugs.

          7. Participant has a positive urine drug result for drugs of abuse at Screening.

          8. 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 was unwilling to agree
             to abstain from alcohol and drugs throughout the study.

          9. Participant required any prohibited concomitant drugs, vitamins, or food products
             listed in the prohibited concomitant drugs and foods table.

         10. Participant has current or recent (within 6 months) gastrointestinal disease that
             would be expected to influence the absorption of drugs (i.e., a history of
             malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent
             [more than once per week] occurrence of heartburn, or any surgical intervention [e.g.,
             cholecystectomy]).

         11. Participant has a history of cancer.

         12. Participant has a positive test result for hepatitis B surface antigen (HBsAg),
             hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen,
             or serological reactions for syphilis at Screening.

         13. Participant has poor peripheral venous access.

         14. Participant has undergone whole blood collection of at least 200 mL within 4 weeks (28
             days) or at least 400 mL within 12 weeks (84 days) prior to study drug administration
             in Period 1.

         15. Participant has undergone whole blood collection of at least 800 mL in total within 52
             weeks (364 days) prior to study drug administration in Period 1.

         16. Participant has undergone blood component collection within 2 weeks (14 days) prior to
             study drug administration in Period 1.

         17. Participant has a hemoglobin value of less than 12.5 g/dL in laboratory testing at
             Screening or prior to study drug administration in Period 1.

         18. Participant has a clinically significant ECG abnormality at Screening or prior to
             study drug administration in Period 1.

         19. Participant has abnormal laboratory values at Screening or prior to study drug
             administration of Period 1 that suggest a clinically significant underlying disease or
             participant with the following lab abnormalities: alanine aminotransferase (ALT) or
             aspartate aminotransferase (AST) is >1.5-fold the upper limits of normal range.

         20. Participant who, in the opinion of the investigator, is unlikely to comply with the
             protocol or is unsuitable for any other reason.