A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Participants
Condition: Healthy Volunteers
Intervention: TAK-123
Intervention description: TAK-123 infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the PK, safety and tolerability of phenylacetate and
      benzoate after intravenous administration of TAK-123 in Japanese healthy adult male
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant is capable of understanding and complying with protocol requirements
             in the opinion of the investigator or sub-investigator.

          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 is aged 20 to 45 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.

          6. The participant is sterile, vasectomized or agrees to use an appropriate method of
             contraception throughout the treatment period.

        Exclusion Criteria:

          1. The participant has received any investigational drugs within 90 days before screening
             for this study (including the cases that at least 5 times the elimination half-lives
             of any investigational drugs have not yet passed).

          2. The participant previously received TAK-123, its ingredients, or related compound
             before participation in this study except for the cases where benzoic acid is ingested
             as a food additive.

          3. The participant is an employee of the study site, or immediate family member, 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 who may be forced to provide
             consent.

          4. The participants have previous or current history of diseases that may affect the
             participation in this study or study results, including uncontrolled, clinically
             relevant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic,
             gastrointestinal, endocrine, hematologic, immune, skin disease or psychiatric
             disorder.

          5. The participant has a history of multiple episodes or severe allergies (example, food,
             drug, latex allergy), or has had an anaphylactic reaction or significant intolerance
             to prescription drugs, over-the-counter (OTC) drugs or foods.

          6. The participant has had an anaphylactic reaction to active ingredients or additives of
             TAK-123, ondansetron or additives of ondansetron, or salicylic acid associated with
             the intravenous administration of TAK-123.

          7. The participant has a positive urine drug test at the time of screening.

          8. The participant has a history of drug abuse (defined as any illicit drug use) or has a
             history of alcohol dependence within 2 years before the start of screening or is
             unwilling to agree to abstain from alcohol and drugs throughout the study.

          9. The participant consumes 6 or more servings of caffeinated beverages (containing about
             720 milligram [mg] of caffeine or more) such as coffee, tea, cola, or energy drinks
             per day.

         10. The participant is a smoker who smoked cigarettes or used nicotine-containing products
             (such as nicotine patch) within 6 months before the study drug administration.

         11. The participant has a history of cancer.

         12. The participant has a positive test result for any of the following at the time of
             screening: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody,
             human immunodeficiency virus (HIV) antibody/antigen, serological test for syphilis.

         13. The participant has poor peripheral venous access.

         14. 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.

         15. 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.

         16. The participant has undergone blood component collection within 2 weeks (14 days)
             prior to the start of the study drug administration.

         17. The participant has any clinically relevant abnormality in vital signs or 12-lead
             electrocardiogram (ECG) at screening or predose of Day 1.

         18. The participant has abnormal laboratory test values at screening indicating clinically
             relevant underlying disease, or showing alanine aminotransferase (ALT) and/or
             aspartate aminotransferase (AST) >1.5 × upper limit of normal (ULN).

         19. The participant has been on an abnormal diet (example, excessive drinking and eating
             or starvation condition) during the four weeks (28 days) prior to the start of the
             study drug administration in the opinion of the investigator or sub-investigator.

         20. The participant who used or plans to use excluded concomitant medications,
             supplements, or dietary products during the predefined period in this study.

         21. The participant is unlikely to comply with the protocol requirements or is unsuitable
             as a participant of this study for any other reason in the opinion of the investigator
             or sub-investigator.