Clinical trial NCT02549027: A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)
Official title: A Crossover Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Polysomnography
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-09-14
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo
timeFrame: 1 to 9 hours post dose, within each treatment period
measure: LPS Following Single Doses of MK-6096 and Placebo
timeFrame: 1 to 9 hours post dose, within each treatment period
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 14 days after the last dose of study drug (Up to approximately 42 days)
measure: Number of Participants Who Discontinued Study Due to an AE
timeFrame: Up to 14 days after the last dose of study drug (Up to approximately 42 days)
Secondary outcomes:
measure: Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo
timeFrame: 1 to 9 hours post dose, within each treatment period
measure: WASO Following Single Doses of MK-6096 and Placebo
timeFrame: 1 to 9 hours post dose, within each treatment period
measure: Change From Baseline in Choice Reaction Time (CRT) Following Single Doses of MK-1064 and Placebo
timeFrame: Pre-dose and 10 hours post dose, within each treatment period
measure: Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo
timeFrame: Pre-dose and 10 hours post dose, within each treatment period
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: