TAK-935 Multiple Rising Dose Study in Healthy Participants
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: TAK-935; Placebo
Intervention description: TAK-935 oral solution; TAK-935 placebo-matching oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of
      multiple rising doses of TAK-935 in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

        All Cohorts

          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 including requesting
             that a participant fast for any laboratory evaluations.

          3. Is a healthy male or female aged 18 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 and Day -1.

          5. Male participant who is non-sterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of informed
             consent throughout the duration of the study and for 30 days after last dose.

          6. Female participant of childbearing potential who is sexually active with a
             non-sterilized male partner agrees to use routinely adequate contraception from
             signing of informed consent and throughout the duration of the study, and for 30 days
             after the last dose.

          7. Can complete the CogState Battery at Screening.

             Additional Inclusion Criteria for Participants undergoing cerebrospinal fluid (CSF)
             Sampling (Part 2 only):

          8. Agrees to spinal tap procedures for CSF collection.

        Exclusion Criteria:

        All Cohorts

          1. Has received any investigational compound within 30 days prior to randomization.

          2. Has received TAK-935 in a previous clinical study or as a therapeutic agent.

          3. Has a significant history of uncontrolled, clinically significant neurologic
             (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic,
             gastrointestinal, urologic, immunologic, endocrine disease or psychiatric disorder or
             endocrine disease or other abnormality or any significant results from physical
             examinations, or clinical laboratory results which may impact the ability of the
             participant to participate or potentially confound the study results. It is the
             responsibility of the investigator to assess the clinical significance; however,
             consultation with the Takeda Medical Monitor may be warranted.

          4. Has a known hypersensitivity to any component of the formulation of TAK-935.

          5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse within 1 year prior to the screening visit or is unwilling to agree to abstain
             from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of
             beer or a single measure of spirits or 1 small glass of wine.

          6. Has taken any excluded medication, supplements, or food products during the time
             periods listed in the Excluded Medications and Dietary Products table.

             Additional Exclusion Criteria for Participants undergoing CSF sampling (Part 2)

          7. Has CSF collection performed within 30 days prior to check-in (Day -3).

          8. Has a known hypersensitivity to the anesthetic or its derivatives used during CSF
             collection, or any medication used to prepare the area of lumbar puncture.

          9. Has significant vertebral deformities (scoliosis or kyphosis) which, in the opinion of
             the investigator, may interfere with lumbar puncture procedure.

         10. Has a history of clinically significant back pain and/or injury.

         11. Has local infection at the puncture site.