Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim

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 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).