A Study With [18F]MNI-1054 to Determine Lysine -Specific Demethylase 1A (LSD1) Brain Enzyme Occupancy of TAK-418 After Single-Dose Oral Administration in Healthy Participants
Condition: Healthy Volunteers
Intervention: TAK-418; [18F]MNI-1054 (radiotracer)
Intervention description: TAK-418 orally.; [18F]MNI-1054 injection.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to determine brain LSD1 enzyme occupancy and the relationship of
      occupancy to TAK-418 dose and plasma exposure after single oral dosing of TAK-418 in healthy
      participants using [18F]MNI-1054 positron emission tomography (PET) imaging.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant must have a body mass index (BMI) greater than or equal to (>=) 18.5
             and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2) at the
             screening visit.

          2. The participant must be a current nonsmoker at screening as demonstrated by negative
             cotinine test.

          3. The participant has adequate circulation to both hands for safe placement of arterial
             lines (as determined by Allen's test).

        Exclusion Criteria:

          1. Has a known hypersensitivity to any component of the formulation of TAK-418 or related
             compounds, including [18F]MNI-1054.

          2. The participant has a positive alcohol or drug screen.

          3. The participant has a history of alcohol consumption exceeding 2 standard drinks per
             day on average (1 glass is approximately equivalent to the following: beer [354
             milliliter (mL)/12 ounce (oz)], wine [118 mL/4 oz], or distilled spirits [29.5 mL/1
             oz] per day).

          4. The participant consumes excessive amounts, defined as greater than 6 servings (1
             serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola,
             energy drinks, or other caffeinated beverages per day.

          5. The participant has a substance abuse disorder.

          6. The participant cannot tolerate venipuncture or has poor venous access that would
             cause difficulty in collecting blood samples.

          7. The participant has contraindications to undergoing magnetic resonance imaging (MRI)
             examination including but not limited to implants, such as implanted cardiac
             pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular
             foreign body, implanted neural stimulators, central nervous system aneurysm clips, and
             other medical implants that have not been certified for MRI, or history of
             claustrophobia in MRI.

          8. The participant has clinically significant abnormal findings on brain MRI scan that in
             the opinion of the investigator may interfere with the interpretation of the PET
             imaging.

          9. The participant has experienced an acute illness within 10 days before the screening
             visit.

         10. The participant has a risk of suicide according to the investigator's clinical
             judgement per the Columbia-Suicide Severity Rating Scale at screening or has made a
             suicide attempt in the 12 months before screening.

         11. The participant has luteinizing hormone, follicle stimulating hormone (FSH), or
             estradiol levels that are clinically abnormal.

         12. The participant has existing skin rashes that can be diagnosed as dermatitis.