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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT03012334
Eligibility Criteria:
Inclusion Criteria:
* Able and willing to voluntarily consent to participate in this study and provide written informed consent prior to start of any study-specific procedures.
* Males and females between the ages of 21 and 50 years of age (inclusive). No more than 60% of one gender will be enrolled in the study.
* Body Mass Index (BMI) between 18 and 32 kilograms per meter squared (kg/m²) (inclusive).
* Participant is able to reliably perform study assessments (Standard Deviation of Lateral Position (SDLP) no higher than 1 standard deviation greater than the mean for normal healthy adults completing the practice scenario; Symbol Digit Coding (SDC) Correct no less than 1 standard deviation below the mean for healthy adults in their age range); demonstrates the ability to understand task instructions, and is physically capable (e.g., adequate manual dexterity, vision, and hearing) and cognitively capable of performing study tasks.
* Participant possesses a valid driver's license and is an active driver. Drives a minimum of 10,000 miles (about 16,000 km) per year for the previous 3 years.
* Participant must also demonstrate simulator sickness questionnaire scores which are not indicative of simulator sickness as defined in the driving simulation operations manual.
* Participant has a regular sleep pattern, is not engaged in shift-work, and in general, has at least 7 hours of sleep each night (bedtime occurs between 21:00 and 24:00 hours).
* Participant has a score \< 10 on the Epworth Sleepiness Scale.
* Use of a medically highly effective form of birth control during the study and for thirty (30) days:
* Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
* History or presence of clinically significant condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the study results.
* A history within 2 years of, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the participant's sleep.
* A history of difficulty either falling asleep or staying asleep in the previous 3 months, that is considered clinically significant by the investigator.
* Participant has a history or diagnosis of any of the following conditions:
* Primary or secondary insomnia
* Narcolepsy
* Cataplexy (familial or idiopathic)
* Circadian Rhythm Sleep Disorder
* Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and rapid eye movement behavior disorder
* Sleep-related Breathing Disorder (obstructive or central sleep apnea syndrome, central alveolar hypoventilation syndrome)
* Periodic Limb Movement Disorder
* Restless Legs Syndrome
* Primary Hypersomnia
* Excessive Daytime Sleepiness (EDS)
* Participant has visual or auditory impairment which in the opinion of the investigator would interfere with study related procedures or study conduct.
* Expected to use any other medication or dietary supplement to promote sleep including over- the-counter sleep medications, during their participation in the study.
* Participant consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages per day.
* Participant has traveled across 1 or more time zones (transmeridian travel) in the last 2 weeks prior to randomization or is expected to travel across 1 or more time zones during the study.
* Expected to work on a rotating shift during their participation in the study.
* Participant works a night shift.
* History or presence of seizure disorder.
* History of urinary retention, angle closure glaucoma, or increased ocular pressure.
* History of gastrointestinal tract surgery, except for appendectomy.
* Has abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at Screening, that are considered clinically significant by the investigator.
* Presence of out-of-range cardiac interval on the screening ECG or other clinically significant ECG abnormalities
* History of orthostatic hypotension, fainting spells, or blackouts, that are considered clinically significant by the investigator.
* The presence of chronic or acute infections, that are considered clinically significant by the investigator.
* History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the study as judged by the Investigator.
* Use of psychoactive prescription or non-prescription medications, psychoactive nutritional supplements or herbal preparations within 2 weeks or 5 half-lives (whichever is longer) of admission to the clinical research unit (CRU) on Day -1.
* Has received any previous study drug within 30 days prior to the first dose of this study drug.
* Is a smoker of more than 10 cigarettes or eCigarettes, or 3 cigars or 3 pipes per day, and is unable to refrain from smoking while confined to the CRU.
* Has any history of dependency or treatment for substance abuse within the past 2 years.
* Participant with a history of alcoholism or who consumes excessive amounts of alcohol.
* Participants who consume alcohol on a regular basis (i.e., ≥ 5 times/week) before bedtime will be excluded from the study.
* Inability to comply with the dietary regimen of the clinical research center.
* Pregnancy / positive pregnancy test.
* Planning to become pregnant during the study or within 1 month of study completion.
* Inability to use adequate contraception during the study. It is recommended that adequate contraception be used for 30 days following completion of the study.
* Has a positive screen for alcohol or other drugs of abuse (amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
* Has a history for Hepatitis B, Hepatitis C , or Human Immunodeficiency Virus (HIV) at Screening or has been previously treated for Hepatitis B, Hepatitis C, or HIV.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT03012334
Study Brief:
Protocol Section:
NCT03012334