A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064 (MK-1064-001)
Condition: Pharmacokinetics
Intervention: MK-1064; Placebo
Intervention description: Dose for each period administered as oral MK-1064 tablets (1, 10 and 50 mg strengths); Dose for each period administered as oral placebo tablets matching active MK-1064 tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
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 study is to evaluate the
      safety, pharmacokinetics and pharmacodynamics of rising, single oral doses MK-1064 in
      healthy, young, male participants. The primary pharmacokinetic hypothesis is that at least
      one dose of MK-1064 that is generally safe and well tolerated produces an average MK-1064
      plasma concentration from 0 to 4 hours of ≥2.2 μM. Since this is an early Phase I assessment
      of MK-1064 in humans, the study protocol allows for modifications to the outlined dose,
      dosing regimen and/or clinical or laboratory procedures, if required to address study
      objectives and/or to ensure appropriate safety monitoring of participants.
    

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
             approximately 6 months

        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 legs syndrome, or narcolepsy of any duration

          -  Participant has experienced poor quality sleep (including difficulty falling asleep,
             difficulty staying asleep) for at least 4 of 7 nights per week in the past 30 days
             prior to screening

          -  Participant works a night shift and is not able to avoid night shift work a minimum of
             1 week before each treatment period

          -  Participant has traveled across 3 or more time zones (transmeridian travel) in the
             last 2 weeks prior to study

          -  Unwilling or unable to consume a standard high fat breakfast

          -  History of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, or genitourinary
             abnormalities or diseases

          -  History of seizures, epilepsy, stroke, peripheral neuropathy, or other clinically
             significant neurological disease 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) or participated in another investigational study within 4 weeks prior to screening

          -  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

          -  Is a regular user of sedative-hypnotic agents