Safety of Co-Administered CHI-554 and Alcohol

Exclusion Criteria

• •Women who are pregnant, lactating, breastfeeding, or planning a pregnancy.
• •Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception (abstinence or the use of a highly effective method of contraception, including hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, or intrauterine device) from at least 21 days prior to the first dose of study medication until 28 days after the last dose of study medication.
• •Has a history of epilepsy, hepatitis, clinically significant hepatic or renal impairment, or human immunodeficiency virus.
• •Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for 28 days prior to the Screening Visit.
• •Current use of any known hepatotoxic medication.
• •Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP.
• •Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP (e.g., coconut; coconut oil; medium-chain triglycerides).
• •Has taken a medication with likely CBD-interactions, including warfarin, clobazam, valproic acid, phenobarbital, mTOR inhibitors, oral tacrolimus, and St. John's Wort within 28 days of the Screening Visit or during the study.
• •Has taken grapefruit products and/or Seville oranges within the 7 days prior to the first Experimental Visit.
• •Has used cannabis, synthetic cannabinoid or cannabinoid analogues (e.g., dronabinol, nabilone), hemp products, synthetic cannabinoid receptor agonists (e.g., Spice, K2), or any CBD- or THC-containing product (e.g., Sativex, Epidiolex) within 28 days of the Screening Visit or during the study.
• •Has a past or current severe Alcohol Use Disorder as assessed by the Structured Clinical Interview Diagnostic (SCID) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) at the Screening Visit.
• •Has a past or current diagnosis of a significant psychiatric disorder, or current use of illicit drugs, as assessed by the SCID at the Screening Visit that would, in the opinion of the Investigator, affect the subject's ability to comply with the study requirements.
• •Endorses current suicidal intent as assessed by the SCID at the Screening Visit.
• •Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study.
• •Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
• •Has a positive result on an alcohol breath test or urine drug screen for benzodiazepines, PCP, barbiturates, antidepressants, cocaine, amphetamine, methamphetamine, THC, and opiates at the Screening Visit or at any Experimental Visit.
• •Self-reports current use of nicotine-containing products or nicotine replacement products as assessed by the SCID at the Screening Visit.
• •Anyone with a history of hypersensitivity to cannabidiol will not be enrolled in the study. - To avoid any potential drug-drug interactions, participants must not be taking any of the following at any time during study participation: CYP3A4 or CYP2C19 Inducers, CYP1A2, CYP2B6, CYP2C8, CYP2C9, and CYP2C19 Substrates (e.g.,, theophylline, or tizanidine), CYP2B6 substrates (e.g., bupropion, efavirenz), uridine 5'-diphospho-glucuronosyltransferase 1A9 (UGT1A9) substrates (e.g., diflunisal, propofol, fenofibrate), and UGT2B7 substrates (e.g., gemfibrozil, lamotrigine, morphine, lorazepam), CYP2C8 and CYP2C9 (e.g., phenytoin) substrates, drugs that are metabolized by (i.e., are substrates of) CYP2C19 (e.g., diazepam), stiripentol, everolimus, sirolimus, tacrolimus, digoxin, and Valproate.