A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
Condition: Idiopathic Hypersomnia
MeSH terms: Disorders of Excessive Somnolence; Idiopathic Hypersomnia
Intervention: TAK-925; TAK-925 Placebo
Intervention description: TAK-925 IV infusion.; TAK-925 placebo-matching IV infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the safety and tolerability of administering a
      single intravenous (IV) infusion dose of TAK-925 to adult participants with idiopathic
      hypersomnia (IH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. A diagnosis of IH, as defined by the International Classification of Sleep Disorders-3
             (ICSD-3) as verified by a previous nocturnal polysomnography (nPSG) and multiple sleep
             latency test (MSLT) study performed within the last 10 years.

          2. Onset of hypersomnia between 10 and 30 years of age.

          3. Seven consecutive days of actigraphy supported by a sleep diary obtained prior to the
             nPSG (Study Day -2) shows an average nightly sleep duration of greater than or equal
             to (>=) 420 minutes during the participant's normal nocturnal sleep period.

          4. nPSG (Study Day -2) demonstrates that participant does not have other comorbid sleep
             disorders or clinically significant nocturnal hypoxemia (oxygen saturation ≤80% for
             ≥5% of total sleep time) and that their Apnea-Hypopnea Index (AHI) is less than or
             equal to (<=) 10 per hour, their periodic limb movement arousal index (PLMAI)
             <=15/hour, and that their total sleep time is >=6.5 hours.

          5. Participants taking medication for treatment of excessive daytime sleepiness (EDS)
             must be willing to discontinue medication prior to randomization into the study.

          6. Body mass index (BMI) of 18 through 33 kilogram per square meter (kg/m^2) inclusive.

          7. Epworth Sleepiness Scale (ESS) score >=11 at screening and on Day -2.

          8. Blood pressure (BP) must be <140 mmHg (systolic) and <90 mmHg (diastolic) at screening
             and Study Day -2.

        Exclusion Criteria:

          1. Average nightly sleep duration is <=8 hours (480 minutes) and has insufficient sleep
             syndrome as evidenced by sleeping >2 hours/night more on "off-days" relative to "work
             days" as determined by actigraphy and sleep diary obtained prior to the nPSG (Study
             Day -2).

          2. Positive urine screen for drugs of abuse and/or positive alcohol test at screening and
             Study Day -2.

          3. Resting heart rate (HR) outside of the range of 40 to 90 beats pper minute (bpm) off
             stimulants.

          4. Screening electrocardiogram (ECG) reveals a QT interval with Fridericia correction
             method >450 ms (men) or >470 ms (women).

          5. Usual bedtime later than 24:00 (midnight) or an occupation requiring nighttime shift
             work or variable shift work within the past 6 months, or travel with significant jet
             lag within 14 days before Study Day -2.

          6. History of a sleep disorder other than IH, based on interviews at the screening visit,
             such as obstructive sleep apnea (OSA), restless legs syndrome, or periodic limb
             movements of sleep (PLMS) associated with arousals.

          7. Use of any over-the-counter (OTC) or prescription medications with stimulating
             properties within 7 days prior to dosing or 5 half-lives (whichever is longer) that
             could affect the evaluation of EDS or use of sodium oxybate within 3 months of
             screening.

          8. Nicotine dependence that is likely to have an effect on sleep (e.g., a participant who
             routinely awakens at night to smoke) and/or an unwillingness to discontinue all
             smoking and nicotine use during the confinement portion of the study (Day -2 to Day
             4).

          9. Caffeine consumption of more than 600 mg/day for 7 days before Study Day 1 (1 serving
             of coffee is approximately equivalent to 120 mg of caffeine) and/or unwilling to
             discontinue all caffeine during the confinement portion of the study (Day -2 to Day
             4).

         10. Alcohol use that is likely to have an effect on sleep and/or an unwillingness to
             discontinue all alcohol use from 72 hours before check-in through discharge on Study
             Day 4.

         11. History of epilepsy or seizures, including having had a single seizure or a history of
             childhood febrile seizures or has a clinically significant history of head trauma.

         12. Answered "YES" on Questions 4 or 5 on the Suicidal Ideation subscale of the Columbia
             Suicide Severity Rating Scale (C-SSRS) at screening (defined period as 3 months prior
             to screening) or evidence of suicidal behavior within 6 months of screening as
             measured by the Suicidal Behavior subscale of the C-SSRS.

         13. Diagnosis of major depressive disorder (DSM-5), within the past 6 months or Beck
             Depression Inventory II (BDI-II) total score of >16 at the screening visit.

         14. History of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or
             arteriovenous malformation.

         15. Known coronary artery disease, a history of myocardial infarction, angina, cardiac
             rhythm abnormality, or heart failure.