A Phase 1, 2-Part, Open-Label, Pilot Trial to Assess the Relative Bioavailability of 3 Formulations of Cannabidiol (CBD) under FASTED (Part A) and FED (Part B) conditions in Healthy Adult Male Subjects.

Exclusion Criteria22

• Any clinically significant illness or disease (in the opinion the Investigator) as determined by their medical and surgical history, physical examination, 12-lead ECG, vital signs and clinical laboratory determinations.
• History of inherent cardiac abnormalities based on the opinion of the Investigator.
• Clinically significant ECG abnormalities (QTcF > 450 ms), or clinically significant vital sign abnormalities (systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 50 or over 90 mmHg, HR less than 45 or over 100 bpm, or RR less than 8 or over 22 resp/min) at screening.
• Any laboratory test results deemed clinically significant by the Investigator or positive test serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at screening.
• Presence of current psychiatric condition, suicide ideations or psychiatric condition requiring pharmacological management within the last 6 months, presence of current or history of psychosis/schizophrenia and bipolar disorders.
• History of gastrointestinal disorders which may have impacted absorption, distribution, metabolism and/or excretion of the IPs (such a cholecystitis, cholecystectomy, Gilbert’s syndrome).
• Positive urine drug screen, urine cotinine test at screening or Day -1, 7±7, 14±7 and 28±7
• Positive alcohol breath test at screening or at admissions on Days 1, 7±7, 14±7 and 28±7.
• Known allergic reactions to any excipient in the formulations.
• History of significant drug abuse within 1 year prior to screening or use of drugs such as marijuana within 1 month prior to the screening visit or drugs such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives within 1 year prior to screening.
• Patients with current or past history of acute or chronic liver disease of any aetiology
• Active hepatitis – chronic or acute
• History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit that exceeds 14 units of alcohol per week (1 unit = 150 mL of wine, 375 mL of mid strength beer, or 30 mL of distilled alcohol 40%).
• Use of medications for the timeframes specified below, with the exception of medications exempted by the PI on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
• a) Prescription medications within 14 days prior to the first dose until end of the study;
• b) Any vaccination, within 1 month prior to the first dose through to EOS;
• c) Over-the-counter products and natural health products (including herbal remedies such as St. John’s wort, homeopathic and traditional medicines), within 7 days prior to the first dose up to EOS, with the exception of the occasional use of paracetamol (up to 2 g daily) and ibuprofen (up to 1.2 g daily). Probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements are allowed;
• d) Any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first dose.
• Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or a minimum of 5 half-lives, whichever is longer) prior to the first dose, administration of a biological product in the context of a clinical research study within 90 days prior to the first dose, or concomitant participation in an investigational study involving no drug or device administration.
• Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 4 weeks prior to dosing.
• Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure.
• Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.