Phase 1
Completed N=20
A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)
Polysomnography
Source: ClinicalTrials.gov NCT02549027 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo — 4.27; 3.68; 2.67; 17.93 minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo |
4.27; 3.68; 2.67; 17.93 | — |
| PRIMARY LPS Following Single Doses of MK-6096 and Placebo |
0.87; 17.79 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) |
4; 4; 7; 3; 3 | — |
| PRIMARY Number of Participants Who Discontinued Study Due to an AE |
0; 0; 0; 0; 0 | — |
| SECONDARY Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo |
22.41; 18.01; 19.90; 26.41 | — |
| SECONDARY WASO Following Single Doses of MK-6096 and Placebo |
16.65; 26.41 | — |
| SECONDARY Change From Baseline in Choice Reaction Time (CRT) Following Single Doses of MK-1064 and Placebo |
408.79; 423.39; 418.83; 414.85; 17.25; 19.94 | — |
| SECONDARY Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo |
425.94; 417.81; 24.04; 14.74 | — |
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
Data sourced from ClinicalTrials.gov (NCT02549027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.