Four-way crossover study to determine the safety, tolerability, and pharmacokinetics of ECs315 administered as a single or multiple sublingual wafer and oil to healthy volunteers

INTERVENTION: A dose of ECs315 WaferiX equivalent to 10 mg CBD sublingually A dose of ECs315 WaferiX equivalent to 20 mg CBD sublingually A dose of ECs315 (5%) Oil equivalent to 10 mg CBD sublingually Sativex® 4 actuations (equivalent to 10 mg CBD, 10.8 mg THC) as oromucosal spray Cohort 1: receives a single dose of ECs315 WaferiX equivalent to 5 mg CBD sublingually (n=6). Cohort 2: receives a single dose of each of 10 and 20 mg of WaferiX, 10 mg of Oil and Sativex in a randomised crossover design, with each dose separated by 3 days (n=12). Cohort 3: A daily dose of ECs315 WaferiX equivalent to 20 mg CBD will be administered sublingually for 5 days (multiple dose) to a cohort of 6 patients. The dose will be administered as 10 mg Waferix twice a day. The investigational products will be administered by site staff. Subjects are required to stay in the centre for the duration of the study. CONDITION: Chemotherapy Induced nausea and vomiting PRIMARY OUTCOME: To assess the safety and tolerability of single and multiple sublingual dose of ECs315 in healthy volunteers. ; ; Safety and tolerability will be evaluated from spontaneously reported or observed adverse events, scheduled physical examinations, vital signs, 12‐lead ECGs, and clinical laboratory results SECONDARY OUTCOME: To determine and compare the pharmacokinetics (PK) of ECs315 sublingual wafer and oral oil with buccal Sativex® in healthy subjects after various doses given as single and multiple sublingual wafer and single sublingal dose of ECs315 oil. ; ; At predetermined times, blood and urine samples will be obtained for the determination of the CBD PK after sublingual administration of ECs315. Descriptive statistics will be employed to compare the PK parameters of CBD after administration of ECs315 in wafer and oil formulation and Sativex. ; ; Cmax, AUC, tmax, hlaf life and clearance of CBD will be calculated for each subject. INCLUSION CRITERIA: ‐ Medically healthy, determined by non‐clinically significant laboratory profiles, medical history, vital signs, physical examination, 12‐lead ECG at screening as deemed by the Principal Investigator and/or Sponsor Medical Monitor. ‐ No history of cardiac disease. ‐ Resting heart rate, as measured by ECG in the range of 40 and 100 bpm inclusive. ‐ No active or chronic diseases/disorders, no history of hospitalization for illness within the six months prior to enrolment into study, and no major surgery within the 6 months prior to enrolment into study. ‐ Must have a body mass index in the range of 18 to 32 kg/m2 inclusive and body weight greater or equal 50 kg. ‐ Females must be non‐pregnant, non‐lactating, or postmenopausal for at least 1 year (as confirmed by follicle‐stimulating hormone [FSH]), or surgically sterile for at least 6 months prior to dosing. ‐ Must be non‐smokers for at least six months and/or not on nicotine containing produ