A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users

Inclusion Criteria:

1. Healthy male or female subjects 18 to 55 years of age, inclusive.

2. Body mass index (BMI) within the range of 19.0 to 32.0 kg/m2, inclusive, and a minimum
weight of 50.0 kg.

3. Current recreational drug users who have used benzodiazepines for recreational
(non-therapeutic) purposes (i.e., for psychoactive effects) at least 5 times in the
past year and used benzodiazepines at least once in the 12 weeks before Screening.

4. Female subjects of childbearing potential with male sexual partners must be using and
willing to continue using medically acceptable contraception (as specified in Section
4.5.2) for at least 1 month prior to Screening (at least 3 months for oral and
transdermal contraceptives) and for at least 30 days after the last study drug
administration.

5. Female subjects of non-childbearing potential must meet the criteria specified in
Section 4.5.2.

6. Male subjects with female sexual partners of childbearing potential must be using and
willing to continue using medically acceptable contraception (as specified in Section
4.5.2) from Screening and for at least 30 days after the last study drug
administration.

7. Able to speak, read, and understand English sufficiently to allow completion of all
study assessments.

8. Must understand and provide written informed consent, prior to the initiation of any
protocol-specific procedures.

9. Must be willing to comply with the requirements and restrictions of the study.

Exclusion Criteria:

1. Substance or alcohol dependence within the past 2 years, as defined by the Diagnostic
and Statistical Manual of Mental Disorders - Fourth Edition - Text Revision (DSM
IV-TR), and/or has ever participated or plans to participate in a substance or alcohol
rehabilitation program to treat their substance or alcohol dependence (excluding
nicotine and caffeine).

2. Heavy smoker (>20 cigarettes per day) and/or is unable to abstain from smoking or
unable to abstain from the use of prohibited nicotine-containing products for at least
10 hours during the in-clinic periods (including e-cigarettes, pipes, cigars, chewing
tobacco, nicotine-topical patches, nicotine gum, or nicotine lozenges).

3. History or presence of clinically significant abnormality as assessed by physical
examination, medical history (including cholecystectomy), ECGs, vital signs, or
laboratory values, which in the opinion of the investigator would jeopardize the
safety of the subject or the validity of the study results.

4. History or presence of myasthenia gravis, severe hepatic insufficiency, severe
respiratory insufficiency, sleep apnea syndrome, or acute narrow angle glaucoma.

5. Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

6. Evidence of clinically significant hepatic or renal impairment including alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5× the upper limit of
normal (ULN), or bilirubin >1× ULN. Repeat safety laboratory tests are allowed once
for Screening, unless the principal investigator and sponsor agree to an additional
repeat.

7. Donation or loss of more than 500 mL whole blood within 30 days preceding entry into
the Treatment Phase.

8. Difficulty with venous access or unsuitable or unwilling to undergo catheter
insertion.

9. Female subjects who are currently pregnant (have a positive pregnancy test) or
lactating or who are planning to become pregnant within 30 days of last study drug
administration.

10. History of severe allergic reaction (including anaphylaxis) to any substance, or
previous status asthmaticus.

11. Subject history of allergy, hypersensitivity, or DRESS syndrome to any drug product
including anti-convulsants (e.g., alprazolam, carbamazepine) or related drugs (e.g.,
other benzodiazepines) or known excipients of any of the drug products in this study.
History of a first degree relative with a serious cutaneous drug-induced adverse
reaction.

12. Subjects with any history of suicidal ideation or suicidal behavior, as assessed by
the Columbia-Suicide Severity Rating Scale (C SSRS; baseline version).

13. Use of a prohibited medication or investigational drug, including exposure to any
drugs associated with DRESS syndrome (e.g., allopurinol, minocycline, abacavir,
lamotrigine) in the 6 months prior to Screening.

14. Use of a prohibited medication, as specified in Section 4.5.1.

15. Treatment with an investigational drug within 5 times the elimination half-life, if
known (e.g., a marketed product), or within 30 days (if the elimination half-life is
unknown) prior to the first study drug administration or is concurrently enrolled in
any research judged not be scientifically or medically compatible with this study.

16. An employee of the sponsor or research site personnel directly affiliated with this
study or their immediate family member defined as a spouse, parent, child or sibling,
whether biological or legally adopted.

17. A subject who has pending legal charges or is on probation.

18. A subject who, in the opinion of the investigator or designee, is considered
unsuitable or unlikely to comply with the study protocol for any reason.

19. Anyone who has previously been exposed to cenobamate (prior to participation in this
study).