Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT02549027
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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02549027
Study Brief:
Protocol Section:
NCT02549027