No condition, novel food application N/A
Conditions
Interventions
None listed
Sponsors
British American Tobacco (Investments) Ltd
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subjects will be: 1.1. males or females. 1.2. 19 to 55 years of age, inclusive, demonstrated by appropriate proof of identification. 1.3. Non-smoker and non-nicotine user who has not smoked or used tobacco/nicotine-containing products eg e-cigarettes, heated tobacco products, nicotine pouches or nicotine replacement therapy in the last month. 2. Subjects will have a: 2.1. body mass index (BMI) of 18.5 to 32.0 kg/m2, inclusive. 2.2. body weight exceeding 52.0 kg (males) or 45.0 kg (females). 3. Subjects will be 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 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 qualified designee, understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the PI or an appropriately qualified designee. Further criteria apply
Exclusion criteria
Exclusion criteria: 1. Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a barrier method of contraception (i.e., a condom) in addition to another highly effective method of contraception used by their female partners or to refrain from donating sperm from admission until the end of the study (see Section 4.4.6). 2. Female subjects who are pregnant or breastfeeding. This will be confirmed at Screening and admission. 3. Subjects who have donated: a. >=400 mL of blood within 90 days prior to admission. b. plasma within 90 days prior to admission. c. platelets within 6 weeks prior to admission. d. bone marrow within the last 6 months prior to admission. 4. Subjects who have an acute illness (e.g., upper respiratory tract infection, viral infection, etc.) requiring treatment within 4 weeks prior to admission. 5. Subjects who currently smoke or use equivalent for other types of tobacco/nicotine containing products in the month as reported at screening. Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma PK parameters for CBD and 7-OH-CBD: Cmax and AUC0-24 hr | — |
Secondary
| Measure | Time frame |
|---|---|
| o Plasma PK parameters for CBD and 7-OH-CBD: Tmax o Plasma PK parameters for 7-COOH-CBD: Cmax, Tmax and AUC0-24 hr o Change from baseline differences in product experience scores o Overall product liking scores o Safety endpoints, including: o Physical examination o Vital signs o Electrocardiograms (ECGs) o Clinical laboratory evaluations o Columbia-Suicide Severity Rating Scale (C-SSRS) o Adverse events (AEs)/serious adverse events (SAEs) recording | — |
Countries
Netherlands
Outcome results
None listed