A study to assess the pharmacokinetic of cannabidiol (CBD) following use of vapour, oral pouch, edible and chew CBD Products

INTERVENTION: Duration of intervention – single ad libitum use of fixed puff over 30 minutes (vapour arm only) Follow up ‐ within 1 week of discharge from clinic# Randomisation ‐ This is an open label study. Each subject will be assigned a unique identification number upon screening. Subjects who complete the study screening assessments and meet all the eligibility criteria will be assigned a unique randomisation identification number at the time of the first study product use on Day 1 of Period 1, different from the screening number, and will receive the corresponding product, according to a randomisation scheme. All subjects (n=36) will receive Arms G, H, and I; half of the subjects (n=18) will also receive Arms A, B, and C, and the other half (n=18) will receive Arms D, E, and F. The sequences to be used in the randomisation will be ABICHG, BCAGIH, CGBHAI, GHCIBA, HIGACB, IAHBGC, DEIFHG, EFDGIH, FGEHDI, GHFIED, HIGDFE, and IDHEGF. Dosages – a) Vuse (Vype) ePod EPOD2.0_SBR_TF189A60 (ad libitum; fasted): 60 mg/ml CBD b) Vuse (Vype) ePod EPOD2.0_SBR_TF189A60 (ad libitum; fed state): 60 mg/ml CBD c) Vuse (Vype) ePod EPOD2.0_SBR_TF184N00 (ad libitum; fasted): 0 mg/ml CBD (Placebo) d) Vuse (Vype) ePod EPOD2.0_SBR_TF189A60 (fixed; fasted): 60 mg/ml CBD e) Vuse (Vype) ePod EPOD2.0_SBR_TF189A60 (fixed; fed state): 60 mg/ml CBD f) Vuse (Vype) ePod EPOD2.0_SBR_TF184N00 (fixed; fasted): 0 mg/ml CBD (Placebo) g) Velo ORAL_ORC_TF057A12 (ad libitum; fed state): 12 mg/pouch CBD h) Prototype Edible MELT_CV_TF006A30 (ad libitum; fed state): 30 mg/piece CBD i) Prototype Chew CONDITION: Pharmacokinetics of of CBD in healthy adult subjects ; Not Applicable PRIMARY OUTCOME: Plasma PK parameters for CBD, 7‐OH–CBD, and 7‐COOH CBD: Cmax, Tmax, and AUC0‐t measured using a validated liquid chromatography tandem mass spectrometry (LC‐MS/MS) method according to applicable local standard operating procedures (SOPs) at 0, 5 min, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24, 32, 48 hrs relative to start of product use. SECONDARY OUTCOME: ; 1. VAMS scores and derived parameters (Emax and TEmax) assessed using a VAMS questionnaire at 0, 0.5, 1, 2, 4, 8 hours relative to product use; 2. Product satisfaction scores assessed using a product satisfaction questionnaire at 5 min, 0.25, 0.5, 4 and 8 hours relative to product use; 3. Blood pressure (sphygmomanometer; mmHg) and heart rate (bpm) (Emax and TEmax) at 0, 5 min, 0.5, 1, 2, 4, 6, 8, 12, 24, 32 hrs; 4. Body temperature (thermometer; °C) at 0, 5 min, 0.5, 1, 2, 4, and 8 hrs; 5. Product use data (including DML, puff number and use count for the vapour product, and MLE for the oral pouch); INCLUSION CRITERIA: 1. 21 to 55 years of age, inclusive, demonstrated by appropriate proof of identification 2.1. Body mass index (BMI) of 18.5 to 30.0 kg/m², inclusive. 2.2. body weight exceeding 52 kg (males) or 45 kg (females). 3. In good health, as judged by the PI or an appropriately qualified designee based on: 3.1. Medical history 3.2. Physical examination 3.3. Vital signs assessment 3.4. 12‐lead ECG 3.5. Clinical laboratory evaluations 3.6. Lung function tests 4. Subjects will have given their written informed consent to participate in the study and will have agreed to abide by the study restrictions 5. Subjects must demonstrate the ability to comprehend the informed consent form (ICF), be able to communicate well with the PI or an appropriately qualifi