A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935
Condition: Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents
MeSH terms: Epilepsy
Intervention: TAK-935; [18F]MNI-792 (tracer)
Intervention description: TAK-935 oral solution.; [18F]MNI-792 injection.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy, Positron Emission Tomography, Brain enzyme occupancy, Cholesterol 24S-hydroxylase, CH24H

Summary:

      The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H)
      enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron
      emission tomography (PET) ligand [18F]MNI-792 and PET imaging and to determine the
      relationship of occupancy to TAK-935 exposure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, 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 including requesting
             that a participant fast for any laboratory evaluations.

          3. Is a healthy male or female and aged 19 to 55 years, inclusive, at the time of
             informed consent and first study medication dose.

          4. 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.

          5. A female of non-bearing potential (example post-menopausal by history; or history of
             hysterectomy, bilateral salpingectomy, or oophorectomy).

        Exclusion Criteria:

          1. Have a known history or evidence of a clinically significant disorder (including
             neurologic and psychiatric), or disease that in the opinion of the study investigator
             would pose a risk to the participant safety or interfere with the study evaluation,
             procedures or completion.

          2. Contraindication to magnetic resonance imaging (MRI) based on the standard MRI
             radiography screening questionnaire.

          3. Had exposure to any radiation greater than (>) 15 millisievert (mSv)/year (example,
             occupational or radiation therapy) within the previous year prior to Baseline imaging.

          4. Has a known hypersensitivity to any component of the formulation of TAK-935 or related
             compounds, or to [18F]MNI-792 or to any of its components.

          5. Clinically significant abnormal findings on brain MRI scan or findings on brain MRI
             that may interfere with the interpretation of the PET imaging.

          6. Use of any over-the-counter, herbal, or prescription medications or supplements within
             30 days prior to baseline imaging.