Drug-Drug Interaction Between THC and AEF0117

Who can take part

• Healthy males and females of any race, 21 to 55 years old, both inclusive
• Subjects must use highly effective contraception; Participants who engage in heterosexual sex must use highly effective contraception during the entire trial period. Male participants should refrain from donating sperm or planning a pregnancy throughout the trial. Female participants who are heterosexually active are eligible if: they use highly effective contraception or are post-menopausal and with a negative pregnancy test. Use of hormonal contraception must have been stable for 3 months prior to screening and expected to be unchanged during the trial
• Body mass index (BMI) between 20.0 and ≤35.0 kg/m2 at screening
• Be informed of the nature of the trial and provide written informed consent
• Be legally competent and able to communicate effectively (in English) with trial personnel
• Cannabis smoker (use ≥1 day the last 2 months and ≤2 days/week) who agrees to abstain from cannabis (except for what is provided by investigators) for 3 days prior to and including Day 1 and Day 8 of the study, and while in the clinic

Who cannot take part

• History of COVID-19 within 4 weeks prior to Day 1, or positive COVID 19 test if required according to standard procedures at the site
• Use of any prescription or over-the-counter drug therapy, including psychoactive and/or psychotropic medication, herbal or homeopathic supplements unapproved by the sponsor within 2 weeks prior to receiving the trial drug (for drugs with an elimination half-life greater than 10 days, this will be extended to 60 days)
• Use of bodybuilding supplements, any food supplement or topical product containing pregnenolone, or any other steroid, including phytosteroids
• Use of a diet or supplements (e.g., St. John's Wort), or food and fruit juices (e.g., grapefruit juice, Sevilla oranges) known to induce or inhibit hepatic drug metabolism within 2 weeks prior to receiving the trial drug and until the follow-up visit, unless approved by the sponsor's medical monitor
• Use of an investigational drug or product, or participation in a drug trial within the last 90 days prior to receiving the trial drug
• Participation in a previous trial with AEF0117 within the last 3 months prior to screening
• Severe learning disability, brain damage, or pervasive developmental disorder
• Any disease or condition that according to the investigator's medical judgment might compromise the cardiovascular, hematologic, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems
• a) A history of alcohol- or substance use disorders within the past 2 years, recent or current regular use of any illicit drugs except cannabis. In case of a positive drug screen (except for cannabis) at screening, a negative test is required at re-screening; The alcohol breath test and urine drug screen at predose Day 1 must be negative (including for cannabis, a level of THC-COOH <100 ng/mL is allowed)
• A history of or current serious mental illness including active or recent suicidal ideation, severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder), and/or an abnormal Columbia-Suicide Severity Rating Scale (C-SSRS) result (i.e., a C-SSRS score of ≥3)
• A history of difficulty donating blood or inadequate venous access
• Allergies to the trial drug and known allergies to corn or corn derivatives
• Any clinical laboratory values assessed as clinically significant by the investigator
• A corrected QT interval (Fridericia's correction, QTcF) >450 msec for males and >470 msec for females
• Clinically significant anemia or low hemoglobin (levels <9 g/dL) at screening, donation of >250 mL of blood or plasma or received any blood and plasma for medical/surgical reasons within the 30 days prior to receiving trial drug, or intention to donate blood or plasma within 1 month after receiving trial drug
• Blood pressure outside normal range (140/80 mmHg systolic/diastolic) and considered potentially clinically significant by the investigator
• Tobacco smokers who smoke more than 5 cigarettes per day or use an equivalent daily amount of other tobacco products and are not willing to abstain from tobacco smoking during the inpatient visits
• Legal status that would interfere with participation
• Unable to follow the restrictions outlined in the protocol