| Eligibility |
Inclusion Criteria:
- Understands and provides written informed consent prior to the initiation of any
protocol-specific procedures.
- Able to comprehend and willing to comply with the requirements of the protocol.
- Healthy male or female adult, 19 to 45 years of age, inclusive, at Screening.
- Regular sleep pattern (usual bedtime between 21:00 and 00:00).
- Score <10 on Epworth Sleepiness Scale at Screening.
- Able to reliably perform study assessments at Screening (On practice scenario, SDLP no
higher than 1 standard deviation greater than the mean for normal healthy adults
completing the practice scenario and subject has 7 or more correct hits on the Divided
Attention task; CogScreen SDC Correct no less than 1 standard deviation below the mean
for healthy adults); demonstrates the ability to understand task instructions at
Screening; and is physically (e.g., adequate manual dexterity, vision, and hearing)
and cognitively capable of performing study tasks at Screening.
- Possesses (and is willing to provide) a valid driver's license and is an active
driver.
- Determined to be (by self-report) an active cannabis user with use of at least once
per month over the preceding 90 days.
- Willing to abstain from cannabis use (other than study drug) beginning at the end of
Screening until discharge from NADS on Day 2 of Treatment Period 3.
- Female subjects must meet one of the following criteria: 1) If of childbearing
potential, female subjects agree to use two contraceptive regimens or remain abstinent
during the study; or 2) if of non-childbearing potential, female subjects should be
surgically sterile or in a menopausal state.
Exclusion Criteria:
- A significant history and/or presence of hepatic, renal, cardiovascular, pulmonary,
neurological, psychiatric, gastrointestinal, hematological, immunologic,
ophthalmologic, metabolic, or oncological disease, or any other medical issue that
would, in the opinion of the Investigator, present undue risk for the subject in the
study.
- A history of suicidal behavior within 24 months of Screening, has answered YES to
questions 3, 4, or 5 on the C-SSRS at Screening or at any clinic admission, or is
currently at risk of suicide in the opinion of an Investigator.
- A recent history (within 6 months prior to Screening) of substance use disorder
(including alcohol) (as judged by the Investigator) or regularly consumes >2 alcoholic
drinks/day during the last 3 months prior to Screening (1 alcoholic drink is
approximately equivalent to: beer [284 mL], wine [125 mL/4 ounces], or distilled
spirits [25 mL/1 ounce]). Subjects who consume 3 drinks per day but less than 14
drinks per week may be enrolled at the discretion of the Investigator.
- Demonstrates simulator sickness questionnaire scores which are indicative of simulator
sickness as defined in the driving simulation operations manual.
- Regularly consumes excessive amounts of caffeine, defined as greater than 6 servings
of coffee, tea, cola, or other caffeinated beverages per day.
- Smokes more than 10 cigarettes or e-cigarettes, or 3 cigars or pipes per day, or is
unable to refrain from smoking during study visits.
- Has been exposed to an investigational drug or device within the 30 days, or 5 half
lives (if known), whichever is longer, prior to Screening.
- Has used a prescription or over-the-counter medication known to cause sedation within
7 days prior to Admission for Period 1 and is unwilling or unable to refrain from
sedating medication use during study participation.
- Has used any benzodiazepine, barbiturate, or GABAA modulator (e.g., eszopiclone,
zopiclone, zaleplon, and zolpidem) within 28 days prior to Admission for Period 1 or
is unwilling or unable to refrain from medication use during study participation.
- Has a history of hepatitis B surface antigen, hepatitis C antibodies, or human
immunodeficiency virus (HIV) antibodies 1 or 2.
- Is pregnant or breastfeeding at Screening or any clinic admission or will attempt to
become pregnant at any time during study participation.
- Has a clinically significant abnormal finding on 6-lead electrocardiogram (ECG) at
Screening or at any clinic admission. The ECG may be repeated once for confirmatory
purposes if initial values obtained exceed the limits specified.
- Has a positive urine test for drugs of abuse (other than tetrahydrocannabinol (THC))
or Breath Alcohol Concentration (BrAC) > 0.0 at Screening or any admission.
- Has any clinically significant abnormal physical examination finding at Screening or
any clinic admission.
- Participates in night shift work.
- Has traveled across =1 time zone in the 2 weeks prior to Admission for Period 1 or is
expected to travel across =1 time zone during the study.
- Is investigative site personnel or their immediate families (spouse, parent, child, or
sibling whether biological or legally adopted).
|
