A study measuring cannabidiol uptake to the bloodstream from novel cannabidiol-containing food products
- Conditions
- CBD uptake in healthy adult subjectsNot Applicable
- Registration Number
- ISRCTN69161830
- Lead Sponsor
- British American Tobacco (United Kingdom)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 36
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 e.g. 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.
6. Subjects will have a urinary cotinine level <200 ng/ml.
7. Subjects will be willing to refrain from consuming alcohol within 24 hours prior to admission.
8. Subjects must be willing to use the study products and use only the products provided to them during clinical confinement, and to abstain from any other CBD product use when instructed.
9. Female subjects must be of non-childbearing potential or must use appropriate contraceptive methods.
Subjects will be excluded from the study if they meet any of the following criteria at screening and admission, unless otherwise stated:
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.
2. Female subjects who are pregnant or breastfeeding. This will be confirmed at Screening and admission.
3. Subjects who have donated:
3.1. =400 ml of blood within 90 days prior to admission.
3.2. Plasma within 90 days prior to admission.
3.3. Platelets within 6 weeks prior to admission.
3.4. 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 smoke or use other types of tobacco/nicotine-containing products in the month prior to screening, as reported at screening.
6. Subjects who self-report they are not able or are unwilling to abstain from caffeine for the duration of confinement without withdrawal symptoms.
7. Presence of braces, partials, dentures, or any dental work that could, in the opinion of the PI, affect the conduct of the study.
8. Presence or history in the last 6 months of a significant form of oral and/or pharyngeal inflammation, oral lesions and/or gum disease or temporomandibular joint dysfunction.
9. Subjects who are unable to chew study products.
10. Subjects who:
10.1. Have a significant history of alcoholism or drug/chemical abuse within 24 months prior to screening, as determined by the PI or an appropriately qualified designee.
10.2. Drink alcohol in excess of 21 units per week for males or 14 units per week for females, with one unit = 150 ml of wine or 360 ml of beer or 45 ml of 45% alcohol
11. Subjects who have a positive urine drugs of abuse or alcohol screen (confirmed by repeat) at screening or admission. Subjects with a positive result for cannabinoids will not be excluded.
12. Subjects who have consumed grapefruit, grapefruit juice, Seville oranges, marmalade, pomelo containing products, within 14 days prior to admission and then throughout the entire study duration.
13. Subjects who:
13.1. Are carriers of the hepatitis B surface antigen (HBsAg)
13.2. Are carriers of the hepatitis C antibody
13.3. Have a positive result for the test for human immunodeficiency virus (HIV) antibodies.
14. Subjects who have received any medications or substances (except for CBD) which are known to be strong inducers or moderate or strong inhibitors of CYP3A4 or CYP2C19 enzymes and/or P gp within 28 days (for inducers, including St. John’s Wort) or 14 days (for inhibitors) prior to admission and throughout the study.
15. Subjects who perform strenuous physical activity (exceeding the subject’s normal activity levels) within 7 days prior to screening or admission and who are not willing to abstain from strenuous physical activity while in-house.
16. Subjects who have been on a diet incompatible with the on study diet, in the opinion of the PI or an appropriately qualified designee, within the 30 days prior to start of and throughout the study
17. Subjects who are unable to communicate effectively with the PI/study staff (i.e., language problem, poor mental development, or impaired cerebral function).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum plasma CBD and 7-OH-CBD concentration (Cmax) and area under the plasma concentration versus time curve 0 to 24 hours (AUC 0-24 hrs), measured by LC-MS/MS after collection of blood samples at pre-use, 0,15, 30 minutes, 1, 1.5, 2, 2.5, 3.5, 4, 4.5, 6, 12 and 24 hours
- Secondary Outcome Measures
Name Time Method 1. Maximum plasma CBD and 7-OH-CBD time to Cmax (Tmax) 0 to 24 hours (AUC 0-24 hrs), measured by LC-MS/MS after collection of blood samples at pre-use, 0,15, 30 minutes, 1, 1.5, 2, 2.5, 3.5, 4, 4.5, 6, 12 and 24 hours<br>2. Maximum plasma 7-COOH-CBD concentration (Cmax), time to Cmax (Tmax) and area under the plasma concentration versus time curve 0 to 24 hours (AUC 0-24 hrs), measured by LC-MS/MS after collection of blood samples at pre-use, 0,15, 30 minutes, 1, 1.5, 2, 2.5, 3.5, 4, 4.5, 6, 12 and 24 hours<br>3. Baseline differences in product experience measured using a questionnaire at pre-use, 30 minutes, 1, 1.5, 2, 2.5, 3.5, 4, 4.5, 6, 12 and 24 hours<br>4. Overall product liking measured using a questionnaire at 30 mins, 4 and 24 hours