A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
Condition: Healthy Volunteers
Intervention: TAK-925; TAK-925 Placebo; Modafinil; Modafinil Placebo
Intervention description: TAK-925 intravenous infusion.; TAK-925 placebo-matching given as saline intravenous infusion.; Modafinil tablets.; Modafinil placebo-matching tablet.
Intervention MeSH terms: Modafinil
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to determine the effect of TAK-925 after a single intravenous
      dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the
      maintenance of wakefulness (MWT) in sleep-deprived healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be a nonsmoker who has not used tobacco- or nicotine-containing products (example,
             nicotine patch) for at least 6 months before study drug administration of the initial
             dose of study drug.

          2. Have regular sleep-wake habits (example, routinely spending 6.5 to 8 hours sleeping
             nightly, not oversleeping by more than 3 hours on weekends, that is, total sleep not
             more than 11 hours) as determined by investigator interviews and confirmed in 5-day
             actigraphy records and whom regularly fall asleep between 9:30 PM and 12:00 AM.

          3. Be willing to have actigraphy monitoring during the week before randomization and in
             each interval.

        Exclusion Criteria:

          1. Has a positive alcohol or drug screen.

          2. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1
             glass is approximately equivalent to: beer [354 milliliter per (mL/)12 ounces], wine
             (118 mL/4 ounces), or distilled spirits (29.5 mL/1 ounce)] per day).

          3. Has excessive sleepiness defined by a self-reported Epworth Sleepiness Scale score at
             screening greater than 10; irregular work hours; or routine night-shift work within 1
             month before randomization.

          4. Currently experiencing or having a history of any known/suspected sleep disorder, any
             disorder associated with excessive daytime somnolence (EDS), or any diagnosis
             interfering with assessment of sleepiness.

          5. Abnormal findings on the initial polysomnography (PSG) conducted on Day -1 (check-in),
             as specified in the study manual.

          6. Traveled across 2 or more time zones 2 weeks or less before screening.

          7. Caffeine consumption of more than 400 milligram per day (mg/day) for 2 weeks before
             screening (1 serving of coffee is approximately equivalent to 120 mg of caffeine).