Study to Determine D-amino Acid Oxidase Brain Enzyme Occupancy of TAK-831 After Single-dose Oral Administration
Condition: Healthy
Intervention: TAK-831; [18F]PGM299
Intervention description: TAK-831 oral suspension.; [18F]PGM299 injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 25 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to determine the relationship between TAK-831 dose, plasma
      exposure, extent and duration of brain D-amino acid oxidase (DAO) enzyme occupancy following
      single oral dosing of TAK-831 in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is capable of understanding and complying with protocol requirements.

          2. Signs and dates a written, informed consent form and any required privacy
             authorization prior to the initiation of any study procedures.

          3. Is in good health as determined by physical examination, electrocardiogram (ECG), and
             laboratory evaluations.

          4. Is a healthy male aged 25 to 55 years, inclusive, at the time of informed consent and
             first injection of the PET tracer.

          5. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0
             kilogram per square meter (kg/m^2), inclusive, at Screening.

          6. Agrees to use adequate contraception from signing of informed consent throughout the
             duration of the study and for 90 days after last dose.

        Exclusion Criteria:

          1. Has received any investigational compound or device within 3 months or 5 half-lives,
             whichever is longer, prior to Check-in for 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 uncontrolled, clinically significant (CS), neurologic (including seizure
             disorder), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal
             (GI), urologic, immunologic, or endocrine disease or psychiatric disorder, or other
             abnormality, which may impact the ability of the participant to participate or
             potentially confound the study results.

          4. Has a known hypersensitivity to any component of the formulation of TAK-831 or related
             compounds, or to [18 F]PGM299 or to any of its components.

          5. Has a positive urine or breath test result for drugs of abuse (defined as any illicit
             drug use), ethanol (alcohol), or cotinine at Screening, Check-in for Baseline
             Imaging/Confinement Period 1, or Check-in for the Treatment/Confinement Period 2 (Day
             -1) for a participant participating in Set A or at Screening, Check-in for Tracer TEST
             PET Imaging/Confinement Period 1, or Check-in for RE-TEST PET Imaging/Confinement
             Period 2 for a participant participating in Set B.

          6. Has a history of drug abuse (defined as any illicit drug use) or a history of ethanol
             (alcohol) abuse within 1 year prior to the screening visit or is unwilling to agree to
             abstain from ethanol (alcohol) and drugs throughout the study.

          7. Has taken any medication, supplements, or food products during the time periods listed
             in the excluded medications and dietary products table.

          8. Intends to donate sperm during the course of this study or for 90 days after the last
             dose of study medication.

          9. Has evidence of current cardiovascular, central nervous system, hepatic, or
             hematopoietic disease; renal, metabolic or endocrine dysfunction; serious allergy,
             asthma, hypoxemia, hypertension, or allergic skin rash; or there is any finding in the
             participant's medical history, physical examination, or safety laboratory tests giving
             reasonable suspicion of a disease that would contraindicate taking TAK-831 or a
             similar drug in the same class, which might interfere with the conduct of the study.
             This includes, but is not limited to, peptic ulcer disease and cardiac arrhythmias.

         10. Has current or recent (within 6 months) GI disease that would be expected to influence
             the absorption of drugs (that is, a history of malabsorption), any surgical
             intervention known to impact absorption (example, bariatric surgery or bowel
             resection), esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent
             (more than once per week) occurrence of heartburn.

         11. Has a history of cancer, except basal cell carcinoma that has been in remission for at
             least 5 years prior to Day 1.

         12. Has a positive test result for hepatitis B virus surface antigen (HBsAg), hepatitis C
             virus (HCV) antibody (HCAB), or human immunodeficiency virus (HIV) infection at
             Screening.

         13. Has used nicotine-containing products (including but not limited to cigarettes, pipes,
             cigars, chewing tobacco, nicotine patch or nicotine gum) within 44 days prior to
             Check-in for Confinement Period 1. Cotinine test is positive at Screening, or Check-in
             for Confinement Period 1, or Confinement Period 2.

         14. Has poor peripheral venous access.

         15. Has an abnormal Allen's test in either upper extremity.

         16. Has donated or lost 450 milliliter (mL) or more of his blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 90 days prior to
             Confinement Period 1.

         17. Has an abnormal CS ECG at Screening, Check-in for Confinement Period 1, or at Check-in
             for Confinement Period 2. Entry of any participant with an abnormal (not clinically
             significant [NCS]) ECG must be approved and documented by signature of the
             coordinating investigator or delegate.

         18. Has a supine blood pressure outside the ranges of 100 to 140 millimeter of mercury (mm
             Hg) for systolic and 50 to 90 mm Hg for diastolic, confirmed with 1 repeat testing
             within a maximum of 30 minutes, at the Screening Visit, Check-in for Confinement
             Period 1, or Confinement Period 2.

         19. Has a resting heart rate outside the range of 50 to 90 beats/minute, confirmed with 1
             repeat testing within a maximum of 30 minutes, at the Screening Visit, Check-in for
             Confinement Period 1, or Confinement Period 2.

         20. Has a Fridericia's Correction Formula (QTcF) - QTcF interval greater than (>) 450
             millisecond (msec) or PR outside the range of 120 to 220 msec, confirmed with 1 repeat
             testing within a maximum of 30 minutes, at the Screening Visit, Check-in for
             Confinement Period 1, or Confinement Period 2.

         21. Has abnormal Screening laboratory values that suggest a CS underlying disease or the
             following laboratory abnormalities: Alanine Aminotransferase (ALT) and/or Alanine
             serum transaminase AST >1.5*upper limit of normal (ULN).

         22. Has a risk of suicide according to the investigator's clinical judgment (example, per
             Columbia-Suicide Severity Rating Scale [C-SSRS]) or has made an attempt in the
             previous 6 months.

         23. Has had a seizure or convulsion (lifetime), including absence seizure and febrile
             convulsion.

         24. In the opinion of the investigator, is unlikely to comply with the protocol or is
             unsuitable for any other reason.

         25. Has had previous exposure to ionizing radiation such that, in combination with the
             exposure from this study, their exposure will be >10 millisievert (mSv) for the
             previous year.

         26. Has a contraindication to medical resonance imaging (MRI) based on the standard MRI
             screening questionnaire. Contraindications include ferromagnetic foreign bodies
             (example, shrapnel, ferromagnetic fragments in the orbital area), certain implanted
             medical devices (example, aneurysm clips, cardiac pacemakers) or claustrophobia.

         27. Has findings on screening brain MRI scan that will potentially compromise participant
             safety or the scientific integrity of the study data, if the participant were to
             participate in this study.

         28. Has prolonged prothrombin time (PT) or activated partial thromboplastin time (PTT) or
             reduced platelet count (less than [<] 100*10^9/Liter [L]).