A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy Participants
Condition: Healthy
Intervention: TAK-831 Tablet T2; Placebo; TAK-831 Suspension
Intervention description: Tak-831 tablets.; TAK-831 placebo-matching suspension.; TAK-831 Suspension.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
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 evaluate the safety and tolerability of TAK-831 when
      administered as multiple oral doses at escalating dose levels in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has at least 45 kg weight and has a body mass index (BMI) from 18.0 to 30.0 kilogram
             per square meter (kg/m^2), inclusive at Screening.

          2. The participant is a healthy male or female not of childbearing potential adult who is
             aged 18 to 55 years, inclusive, at the time of informed consent and first study drug
             dose.

          3. A 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 90 days plus half-lives (95 days)
             after last study drug dose.

          4. A female participant with no childbearing potential, defined as a participant that has
             been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or
             who is postmenopausal (defined as continuous amenorrhea of at least 12 months and
             follicle stimulating hormone [FSH] greater than [>] 40 international unit per liter
             [IU/L]).

        Exclusion Criteria:

          1. Has a positive urine drug result for drugs of abuse (defined as any illicit drug use)
             at Screening or Check-in.

          2. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse (defined as >3 drinks per day) within 5 years before the Screening visit or is
             unwilling to agree to abstain from alcohol and drugs throughout the study. (1 drink=12
             ounce [oz]. beer=5 oz. wine=1.5 oz. liquor.)

          3. Has a QT interval with Fridericia's correction method (QTcF) >450 milliseconds (ms)
             (male participants) or >470 ms (female participants) or PR outside the range of 120 to
             220 ms, confirmed with 1 repeat testing, at the Screening Visit or Check-in. When
             triplicate electrocardiogram (ECG) assessments are collected, the mean of the 3 QTcF
             and PR values should be used to assess this criterion.

          4. Has a positive test result for hepatitis B surface antigen (HBsAg), anti- human
             chorionic gonadotropin (HCV), or human immunodeficiency virus (HIV) antibody/antigen
             at Screening.

          5. Has used nicotine-containing products (including but not limited to cigarettes, pipes,
             cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days before
             Check-in. Cotinine test is positive at Screening or Check-in.

          6. Has poor peripheral venous access.

          7. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 45 days before the
             first dose of study medication.

          8. Has a Screening or Check-in abnormal (clinically significant) ECG. Entry of any
             participant with an abnormal (not clinically significant) ECG must be approved and
             documented by signature by the principal investigator or designee.

          9. Has a supine blood pressure outside 90 to 140 millimeter of mercury (mm Hg) for
             systolic and 50 to 90 mm Hg for diastolic, confirmed on repeat testing within a
             maximum of 30 minutes, at the Screening Visit or Check-in.

         10. Has a resting heart rate outside 40 to 100 beats per minute confirmed on repeat
             testing within a maximum of 30 minutes, at the Screening Visit or Check-in (heart rate
             from the ECG does not apply).

         11. Has a risk of suicide according to the Investigator's clinical judgment (example, per
             Columbia-Suicide Severity Rating Scale [C-SSRS]), or has scored "yes" on item 4 or
             item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in
             the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for
             the "Non-Suicidal Self-Injurious Behavior", if this behavior occurred in the past 2
             years.

             Additional Exclusion Criteria for Cohort(s) with cerebrospinal fluid (CSF) Collection:

         12. Has had CSF collection performed within 30 days before Check-in.

         13. Has a history of clinically significant back pain and/or injury.

         14. Has local infection at the puncture site.

         15. Has thrombocytopenia or other suspected bleeding tendencies noted before procedure.

         16. Has developed signs and symptoms of spinal radiculopathy, including lower extremity
             pain and paresthesia.

         17. Has any focal neurological deficit that might suggest an increase in intracranial
             pressure.

         18. Has any abnormal findings on ophthalmological assessment/fundoscopy suggestive of
             raised intracranial pressure (that is, optic disc swelling/edema; (uncontrolled)
             hypertensive retinopathy).

         19. Suffers regularly from moderate to severe headaches requiring analgesics.

         20. Has lower spinal malformations (on physical examination or lumbar spine radiography),
             local spinal infection, or other abnormalities that would exclude lumbar puncture
             (LP).