A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Participants
Condition: Healthy Volunteer
Intervention: TAK-935; Placebo
Intervention description: TAK-935 Tablets; TAK-935 placebo-matching tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of TAK-935 with single ascending doses (Part 1) and multiple doses with
      titration (Part 2).
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant must understand the study procedures and agree to participate by
             providing written informed consent.

          2. The participant must be willing and able to comply with all study procedures and
             restrictions.

          3. The participant must be a Japanese healthy adult male or female, aged 20 to 55 years,
             inclusive, at the time of informed consent.

          4. The participant must have a body mass index (BMI) >=18.5 and =<25.0 kg/m^2 at the
             Screening Visit.

          5. The participant must be a current nonsmoker who has not used tobacco- or
             nicotine-containing products (eg, nicotine patch) for at least 6 months prior to the
             first dose of study drug or first invasive procedure.

          6. The participant must be judged to be in good health by the investigator, based on
             clinical evaluations including laboratory safety tests, medical history, physical
             examination, 12-lead electrocardiogram, and vital sign measurements performed at the
             Screening Visit and prior to the first dose of study drug.

          7. The participant must meet the following birth control requirements:

               -  Is a male participant who is sterile or agrees to use an appropriate method of
                  contraception, including a condom with spermicidal cream or jelly, from the first
                  dose of study drug until 90 days after the last dose of study drug. No
                  restrictions are required for a vasectomized male participant provided the
                  participant is at least 1-year postbilateral vasectomy procedure prior to the
                  first dose of study drug. A male participant whose vasectomy procedure was
                  performed less than 1 year prior to the first dose of study drug must follow the
                  same restrictions as a nonvasectomized man. Appropriate documentation of surgical
                  procedure should be provided.

               -  Is a male participant who agrees to not donate sperm from the first dose of study
                  drug until 90 days after the last dose of study drug.

               -  Is a female participant of nonchildbearing potential, defined by at least 1 of
                  the following criteria:

                    1. Postmenopausal (defined as 12 months of spontaneous amenorrhea in females
                       aged >45 years or >=6 months of spontaneous amenorrhea in females aged >45
                       years with serum follicle-stimulating hormone [FSH] levels >40 mIU/mL).
                       Appropriate documentation of follicle-stimulating hormone levels should be
                       required.

                    2. Hysterectomy and/or bilateral oophorectomy with appropriate documentation of
                       surgical procedure.

                    3. Had a tubal ligation with appropriate documentation of surgical procedure.

                    4. Congenital conditions such as uterine aplasia etc.

        Exclusion Criteria:

          1. Has a history of clinically significant endocrine, gastrointestinal (including
             motility disorder and intestinal obstruction), cardiovascular (including arrhythmia),
             hematological, hepatic, immunological, renal, respiratory, genitourinary, major
             neurological (including stroke, epileptic seizure), or degenerative ophthalmological
             abnormalities or diseases

          2. Has participated in another investigational trial within 4 weeks or 5 half-lives
             (whichever is longer) before the pretrial visit (Screening). The 4-week or 5
             half-lives window will be derived from the date of the last trial procedure and/or AE
             related to the trial procedure in the previous trial to the pretrial/Screening Visit
             of the current trial.

          3. Is an employee or immediate family member (eg, spouse, parent, child, sibling) of the
             sponsor.

          4. Has a history of cancer (malignancy).

          5. Has any lifetime history of a suicide attempt, or have suicidal ideation or, any
             suicidal behavior within 12 months, or who are at significant risk to commit suicide,
             as judged by the investigator using the Columbia Suicide Severity Rating Scale
             (C-SSRS) or is clinically judged by the investigator to be at risk for suicide.

          6. Has a history of significant multiple and/or severe allergies (eg, food, drug, latex
             allergy) or has had an anaphylactic reaction or significant intolerability to
             prescription or nonprescription drugs or food.

          7. Has a positive alcohol or drug screen.

          8. Had major surgery, donated or lost whole blood prior to the start of study drug
             administration as any of below:

             For both male and female participants, >=200 mL within 4 weeks (28 days) For male
             participants, >=400 mL within 12 weeks (84 days), >=800 mL in total within 52 weeks
             (364 days) For female participants, >=400 mL within 16 weeks (112 days). >=400 mL in
             total within 52 weeks (364 days)

          9. Had gastrointestinal surgery that could impact the absorption of study drug.

         10. Has a history of a major psychiatric disorder as diagnosed utilizing Diagnostic and
             Statistical Manual of Mental Disorders, 5th Edition criteria.

         11. Has a known hypersensitivity to any component of the formulation of TAK-935 or related
             compounds.

         12. Is unable to refrain from or anticipates the use of any medication, including
             prescription and nonprescription drugs or herbal remedies, beginning approximately 7
             days before administration of the initial dose of study drug, throughout the trial
             (including washout intervals between trial periods), until the Follow-up Visit.

         13. 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.

         14. 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.

         15. Has a substance abuse disorder.

         16. Has a QTcF >450 msec confirmed with one repeat testing, at the Screening Visit.

         17. Had abnormal Screening or Day -1 laboratory values that suggested a clinically
             significant underlying disease or participant with the following laboratory
             abnormalities: ALT and/or AST >1.5 time ULN.

         18. Has tested positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus
             (HCV) antibody, HIV antibody/antigen, or serologic reactions for syphilis at
             Screening.

         19. In the opinion of the investigator, is unlikely to comply with the protocol or is
             unsuitable for any other reason.