A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single and Multiple Oral Dose of TAK-418 in Healthy Female Participants
Condition: Healthy Volunteers
Intervention: TAK-418; TAK-418 Matching Placebo
Intervention description: TAK-418 capsules.; TAK-418 matching placebo capsules.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to characterize safety and tolerability of TAK-418 in
      non-Japanese and Japanese healthy female participants when administered at single or multiple
      (once daily [QD]) oral doses.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has a body mass index (BMI) greater than or equal to (>=) 18.5 and less than or equal
             to (<=) 30.0 kilogram per square meter (kg/m^2) at the Screening Visit. (Cohorts 1 to
             4 only).

          2. Is a nonsmoker who has not used tobacco- or nicotine-containing products (example,
             nicotine patch) for at least 6 months before administration of the first dose of trial
             drug or invasive procedure.

          3. The participant either is of nonchildbearing potential, OR, if of childbearing
             potential, is using a highly effective method of contraception with low user
             dependency during the entire duration of the study.

        For Cohorts 5 and 6 (Japanese participants) only:

        1. Has a BMI >=18.0 and <= 26.0 kg/m^2, at the Screening Visit.

        Exclusion Criteria:

          1. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C
             antibody (HCV), or human immunodeficiency virus (HIV) antibody/antigen, at Screening.

          2. Had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL])
             within 4 weeks before the Screening Visit.

          3. 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).

          4. 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.

          5. Has a substance abuse disorder.

          6. Has risk of suicide according to the investigator's clinical judgment per
             Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or has made a suicide
             attempt in the 6 months before Screening.

          7. Has luteinizing hormone (LH), follicle-stimulating hormone (FSH), or estradiol levels
             that are clinically abnormal.

          8. Has a resting heart rate outside of the range of 50 to 100 beats per minute, confirmed
             on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in
             (Day -1).

        For Cohort 3 only (includes CSF sample collection):

          1. Has had CSF collection performed within 30 days before Check-in (Day -1).

          2. Has significant vertebral deformities (scoliosis or kyphosis) that, in the opinion of
             the investigator, may interfere with the lumbar puncture procedure.

          3. Has a local infection at the puncture site.

          4. Has thrombocytopenia or other suspected bleeding tendencies noted before the
             procedure.

          5. Has developed signs and symptoms of spinal radiculopathy, including lower extremity
             pain and paresthesia.

          6. Has any focal neurological deficit that might suggest an increase in intracranial
             pressure.

          7. Has any abnormal finding on ophthalmological assessment/fundoscopy indicative of
             raised intracranial pressure (that is, optic disc swelling/edema; or [uncontrolled]
             hypertensive retinopathy).

          8. Regularly has moderate-to-severe headaches requiring analgesics.

          9. Has any bleeding abnormality or history of bleeding abnormalities.

         10. Has abnormal coagulation tests (prothrombin time [PT]/international normalized ratio
             [INR], partial thromboplastin time [PTT]) at Screening.