Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010)
Condition: Apnea, Sleep
MeSH terms: Apnea; Sleep Apnea Syndromes
Intervention: MK-7288; Placebo to MK-7288; Modafinil; Placebo to modafinil
Intervention description: one or two 10 mg capsules, orally, single dose; one or two capsules, orally, single dose; two 100 mg tablets, orally, single dose; two 100 mg tablets, orally, single dose
Intervention MeSH terms: Modafinil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime
      sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS)
      who are compliant with effective nasal continuous positive airway pressure (nCPAP) therapy.
      The goal of this study is to determine the effect of MK-7288 after single dose administration
      on promoting wakefulness as measured by sleep latency on Maintenance of Wakefulness Tests,
      and on driving performance as measured by standard deviation of lane position in simulated
      driving (country vigilance driving).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants are of non-child-bearing potential.

          -  Male participants who have female partner(s) of child-bearing potential must agree to
             use a medically acceptable method of contraception during the study.

          -  Participant has an International Classification of Sleep Disorders diagnosis of
             Obstructive Sleep Apnea/Hypopnea Syndrome.

          -  Participant has excessive daytime sleepiness.

          -  Participant has been using nCPAP treatment for at least 2 months.

          -  Participant reported total sleep time of >6 hours on at least 4 out of 7 nights each
             week

          -  Participant is willing to stay at the sleep laboratory for 5 overnight stays.

          -  Participant is willing to limit caffeine and alcohol consumption during the study.

          -  Participant has a valid driver's license in the past 5 years and has had at least 1
             year of driving experience within the past 3 years.

          -  Participant's regular bedtime is between 9:00 p.m. and 12:00 a.m.

        Exclusion Criteria:

          -  Participant has a history of cancer.

          -  Participant has any history of a significant neurological disorder.

          -  Participant has moderate or severe persistent asthma.

          -  Participant has a history of any of the following sleep disorders: narcolepsy, primary
             insomnia, Circadian rhythm sleep disorder, shift work sleep disorder, parasomnia
             including nightmare disorder, sleep terror disorder, rapid eye movement (REM)
             behavioral disorder, and sleepwalking disorder, periodic limb movement disorder, or
             restless leg syndrome.

          -  Participant consumes more than 10 cigarettes a day or routinely smokes during the
             night.

          -  Participant, in the opinion of the investigator, has a history or current evidence of
             any condition, therapy, lab abnormality or circumstances that might confound the
             results of the study, or interfere with participation for the full duration of the
             study.