A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)
Condition: Polysomnography
Intervention: MK-1064; MK-6096; Placebo
Intervention description: Oral MK-1064 tablets (10 and 50 mg strengths); Oral MK-6096 tablets (5 mg strength); Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study is
      to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS) as
      measured by polysomnography (PSG) in healthy young male participants, and to evaluate the
      safety and tolerability of single oral doses of MK-1064 and MK-6096 in healthy young male
      participants. The primary efficacy hypothesis is that at least one dose of MK-1064 is
      superior to placebo in decreasing LPS in healthy male participants as assessed by PSG.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) ≤31 kg/m^2

          -  In good health based on medical history, physical examination, vital sign
             measurements, and laboratory safety tests

          -  Nonsmoker and has not used nicotine or nicotine-containing products for at least 6
             months

          -  No history of any sleep disorder

          -  Has not used prescription or over the counter sedation or alerting medication in 4
             weeks prior to screening

          -  Participant has a usual bedtime between 8:00 PM and 12:00 AM

          -  Participant has total sleep duration of ≥6.5 and ≤9 hours during the 4 weeks prior to
             screening

          -  Male participants with female partner(s) of child-bearing potential must agree to use
             a medically acceptable method of contraception during the study and for 90 days after
             the last dose of study drug

        Exclusion Criteria:

          -  Mentally or legally incapacitated, significant emotional problems at screening or
             expected during the conduct of the study or history of a clinically significant
             psychiatric disorder within the last 10 years

          -  History of any persistent sleep abnormality (including difficulty falling asleep,
             difficulty staying asleep) lasting for 3 months or more, or history of obstructive
             sleep apnea, restless leg syndrome, or narcolepsy

          -  History of clinically significant sleep disorders within the last 5 years

          -  History of circadian rhythm sleep disorder, clinically important parasomnia, or
             primary insomnia

          -  History of repeated falls or fractures secondary to falling within the past 2 years

          -  Participant works a night shift and is not able to avoid night shift work a minimum of
             1 week prior to screening and for the duration of the study

          -  Participant has traveled across 3 or more time zones (transmeridian travel) in the
             last 2 weeks prior to study

          -  Is a regular user of sedative-hypnotic agents

          -  History of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, or genitourinary
             abnormalities or diseases

          -  History of stroke, peripheral neuropathy, chronic seizures or other clinically
             significant neurological disorder or cognitive impairment

          -  History of cancer

          -  History of cataplexy

          -  Participant is unable to refrain from or anticipates the use of any medication,
             including prescription and non-prescription drugs or herbal remedies, beginning
             approximately 2 weeks prior to administration of the initial dose of study drug and
             throughout the study

          -  Participant consumes >3 servings of alcohol a day

          -  Participant consumes >6 caffeine servings a day

          -  Participant has had major surgery, donated or lost 1 unit of blood (approximately 500
             mL) within 4 weeks prior to screening, or participated in another investigational
             study within 3 months prior to first dose of study drug

          -  History of significant multiple and/or severe allergies or has had an anaphylactic
             reaction or significant intolerability to prescription or non-prescription drugs or
             food

          -  Is currently a regular user of any illicit drugs or has a history of drug (including
             alcohol) abuse within 2 years of screening