Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects
Condition: Healthy Volunteers
Intervention: TAK-831; Placebo
Intervention description: TAK-831 Tablets.; TAK-831 Matching Placebo Tablets.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and
      pharmacodynamics of TAK-831 when administered as single or multiple oral doses in healthy
      adult Asian participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant must understand the study procedures and agree to participate by
             providing written informed consent (for Chinese participants, an interpreter should be
             present as necessary).

          2. The participant must be willing and able to comply with all study procedures and
             restrictions.

          3. The participant must be male or female (of nonchildbearing potential) aged 20 to 55
             years, inclusive, at the Screening.

          4. The participant must have a body mass index (BMI) >=18.5 kg/m^2 and =<25.0 kg/m^2 at
             the Screening.

          5. The participant must be a current nonsmoker who has not used tobacco- or
             nicotine-containing products (e.g., nicotine patch) for at least 6 months prior to the
             Screening.

          6. Chinese participants are defined as participants who were born in mainland China, and
             their biological parents and grandparents must all have been of Chinese origin (for
             Cohort 3 only).

          7. Chinese participants who have lived out of China for more than 5 years must not have
             significantly modified their diets since leaving China (for Cohort 3 only).

          8. The participant must be judged to be in good health by the investigator, based on
             clinical evaluations including laboratory tests, medical history, full physical
             examination, 12-lead electrocardiogram, and vital sign measurements performed at the
             Screening and prior to the first dose of study drug.

          9. The participant must meet the birth control requirements.

        Exclusion Criteria:

          1. The participant has a history of clinically significant endocrine, gastrointestinal
             (including motility disorder and intestinal obstruction), cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, or genitourinary, or
             presents with major neurological (including stroke and chronic seizures) abnormalities
             or diseases.

          2. The participant has participated in another investigational trial within 4 weeks
             before the pretrial visit (Screening). The 4-week window will be derived from the date
             of the last trial procedure and/or adverse event (AE) related to the trial procedure
             in the previous trial to the Screening Visit of the current trial.

          3. The participant is an employee or immediate family member (e.g., spouse, parent,
             child, sibling) of the sponsor.

          4. The participant has a history of cancer (malignancy).

          5. The participant has a history of significant multiple and/or severe allergies (e.g.,
             food, drug, latex allergy) or has had an anaphylactic reaction or significant
             intolerability to prescription or nonprescription drugs or food.

          6. The participant has a positive alcohol or drug or immunological screen.

          7. The participant is of childbearing potential or lactating.

          8. The participant had major surgery, received or lost 1 unit of blood (approximately 500
             milliliters [mL]) within 8 weeks prior to the first dose of study drug.

          9. The participant with any gastrointestinal (GI) surgery that could impact upon the
             absorption of study drug.

         10. The participant has a known hypersensitivity to any component of the formulation of
             TAK-831 or related compounds.

         11. The participant 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 trial drug,
             throughout the trial (including washout intervals between trial periods), until the
             Follow-up Visit.

         12. The participant has a history of alcohol consumption exceeding 2 standard drinks per
             day on average (1 glass is approximately equivalent to: beer [354 mL/12 ounces], wine
             [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce] per day).

         13. The participant who 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.

         14. The participant has a history of drug abuse.

         15. The participant has a (QT interval with Fridericia's correction method) QTcF >450
             milliseconds (msec) (males) or >470 msec (females) or PR outside the range of 120 to
             220 msec at the Screening Visit or Check-in.