Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions

Inclusion Criteria:

1. Subject signs an institutional review board (IRB) approved written informed consentand privacy language as per national regulations (e.g., Health Insurance Portabilityand Accountability Act authorization) before any study related procedures areperformed.
2. Subject is a healthy, non-smoking man or woman, 18 to 55 years of age, inclusive, whoweighs at least 50 kg (110 lbs) and has a body mass index of 18.5 to 33.0 kg/m2,inclusive, at Screening and check-in (Day -1).
3. Subject has normal medical history findings, clinical laboratory results, vital signmeasurements, 12-lead ECG results, and physical examination findings at screening or,if abnormal, the abnormality is not considered clinically significant (as determinedand documented by the investigator or designee).
4. Subject must have a negative test result for alcohol and illicit drugs at screeningand check-in (Day -1).
5. Participants must agree to refrain from using any of the following for the duration ofthe study: alcohol, nicotine containing products, marijuana or marijuana-derivedproducts, hemp or hemp-derived products, including CBD (except for provided studydrug), and illicit drugs of any kind.
6. Subject must test negative for severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) by a rapid antigen test at check-in for all study periods. If a subject'stest comes back as invalid, the test can be repeated.
7. Female subjects must be of non-childbearing potential (non-childbearing potentialincludes post-menopausal females defined as spontaneous amenorrhea for at least 12months with FSH in the post-menopausal range and females who have undergone ahysterectomy) or, if they are of childbearing potential, they must: 1) have negativeserum HCG at screening and check-in 2) have been strictly abstinent for 1 month beforecheck-in (Day -1) and agree to remain strictly abstinent for the duration of the studyand for at least 1 month after the last application of study drug; OR 3) be practicing 2 highly effective methods of birth control (as determined by the investigator ordesignee; one of the methods must be a barrier technique) from Screening until atleast 1 month after the end of the study.
8. Male subjects must agree to practice 2 highly effective methods of birth control (asdetermined by the investigator or designee) beginning at check-in (Day -1) until atleast 3 months after the last dose of study drug. Male subjects may not donate spermfor 90 days after the end of the study.
9. Subject agrees to and is highly likely (as determined by the investigator) to complywith the protocol defined procedures and to complete the study.

Exclusion Criteria:

1. Abnormal liver labs at screening on check-in (Day -1), defined as any of the following (tests may be repeated once for confirmation at screening and check-in):
2. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 ×ULN. (The ULN for ALT will be 33 U/L for males and 25 U/L for females.)
3. Total bilirubin (TBL) > ULN.
4. International normalized ratio (INR) > 1.3
5. Use or intend to use any medications/products in the 14 days prior to check-in (Day -1), unless deemed acceptable by the investigator
6. Subject is currently participating in another clinical study of an investigationaldrug or has been treated with any investigational drug within 30 days or 5 half-lives (whichever is longer) of dosing for this study.
7. Subject has used nicotine-containing products (e.g., cigarettes, cigars, chewingtobacco, snuff, electronic cigarettes) within 6 weeks of Screening. Subjects mustrefrain from using these throughout the study.
8. Subject has consumed alcohol, xanthine-containing products (e.g., tea, coffee,chocolate, cola), caffeine, kava melatonin, St Johns Wart, grapefruit, or grapefruitjuice within 24 hours of check-in. Subjects must refrain from ingesting thesethroughout the study.
9. Subject is unable to tolerate a controlled, quiet study conduct environment, includingavoidance of music, television, movies, games, and activities that may causeexcitement, emotional tension, or arousal during the prespecified time points (e.g.,before and during CBD dosing).
10. Subject has a history of consuming more than 14 units of alcoholic beverages per weekwithin 6 months before Screening, has a history of alcoholism ordrug/chemical/substance abuse within 2 years before Screening (Note: 1 unit = 12ounces of beer, 4 ounces of wine, or 1 ounce of spirits/hard liquor)
11. Subject has a positive test result for alcohol or drugs of misuse (amphetamines,barbiturates, benzodiazepines, cocaine, alcohol, opiates, phencyclidine, propoxyphene,and methadone) at Screening or Check-in (Day -1 [both Parts]; Day 10 [Part 2, morphineDDI]; Day 12 [Part 2, citalopram DDI]).
12. Subject has a positive test result for cannabinoids (THC) at screening or Day -1.
13. Subject has a history of opioid or narcotic misuse.
14. Subject has a history of suicidal ideation or previous suicide attempts
15. Subject has a history or evidence of a clinically significant disorder, condition, ordisease (e.g., cancer, human immunodeficiency virus [HIV], hepatic or renalimpairment) that, in the opinion of the investigator, would pose a risk to subjectsafety or interfere with the study evaluation, procedures, or completion.
16. Subject has any signs or symptoms that are consistent with Coronavirus Disease 2019 (COVID-19) per Center for Disease Control (CDC) recommendations at screening orcheck-in (Day -1). These include subjects with fever or chills, cough, shortness ofbreath or difficulty breathing, fatigue, muscle or body aches, headache, new loss oftaste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrheamay have COVID-19. In addition, the subject has any other findings suggestive ofCOVID-19 risk in the opinion of the investigator.
17. Subject has known or suspected allergies or sensitivities to the study drug or placebocomponents (e.g., sucralose, sesame).
18. Subjects with a documented hypersensitivity reaction to cannabidiol
19. Subjects with a documented medical history of clinical disorders related to mood,anxiety or panic, including diagnosed depression, generalized anxiety disorder orpanic attacks.
20. Subject has any condition possibly affecting study drug absorption (e.g., gastrectomy,Crohn's disease, irritable bowel syndrome). Uncomplicated cholecystectomies andappendectomies may be included at the investigator's discretion.
21. Subject has clinical laboratory test results (hematology, serum chemistry andurinalysis) at Screening or Check-In that are outside the reference ranges provided bythe clinical laboratory and considered clinically significant by the investigator.Tests may be repeated once for confirmation at both Screening and Check-In.
22. Subject has a positive test result at Screening for HIV 1 or 2 antibody, hepatitis Cvirus antibodies, or hepatitis B surface antigen.
23. Subject has a mean systolic blood pressure <85 or >145 mmHg or a mean diastolic bloodpressure <45 or >95 mmHg at either Screening or Check-in. Blood pressure will bemeasured in triplicate after the subject has been resting in a supine position for aminimum of 5 minutes.
24. Subject is unable or unwilling to undergo multiple venipunctures for blood samplecollection because of poor tolerability or is unlikely to complete the study due topoor venous access.
25. Female subject is currently pregnant or lactating or was within 3 months of the study.
26. Subject has had any significant blood loss, donated 1 unit (450 mL) of blood or more,or received a transfusion of any blood or blood products within 60 days, or donatedplasma within 7 days before Check-in.
27. Subject has any other condition that precludes his or her participation in the study (as determined by the investigator).