A study to assess the pharmacokinetic of cannabidiol (CBD) following use of vapour, oral pouch, edible and chew CBD Products
- Conditions
- Pharmacokinetics of of CBD in healthy adult subjectsNot Applicable
- Registration Number
- ISRCTN12046333
- 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. 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 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 be willing to refrain from consuming alcohol within 24 hours prior to admission
7. At Screening, subjects must be current experienced vapers and current daily users of CBD with at least 6 months use history. Product use status will be based on subject self reporting and confirmed with product use history questionnaires at screening
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 one of the contraceptive methods
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 with spermicide) in addition to another highly effective method of contraception used by their female partners or to refrain from donating sperm from Admission until at least 90 days after the last product use.
2. Female subjects who are pregnant or breastfeeding. This will be confirmed at Screening and Admission. Any female subject who becomes pregnant during this study will be withdrawn.
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 currently smoke >5 cigarettes per day (or equivalent for other types of tobacco/nicotine containing products) as reported at Screening.
6. Subjects who are self-reported non-inhalers (vapers who draw smoke/aerosol from the e-cigarette into the mouth and throat but who do not inhale). Subjects who are determined as non-inhalers at Screening will be excluded.
7. Subjects who are planning to quit using CBD products or quit vaping, during the study or postponing a quit attempt in order to participate in the study.
8. Presence of braces, partials, dentures, or any dental work that could, in the opinion of the PI, affect the conduct of the study (including missing molars).
9. Presence or history of significant form of oral and/or pharyngeal inflammation, oral lesions and/or gum disease or temporomandibular joint dysfunction.
10. Subjects who 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.
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 used prescription or over-the-counter (OTC) bronchodilator medication (e.g., inhaled or oral ß adrenergic agonists) to treat a chronic condition within the 12 months prior to Admission and throughout the study.
15. Subjects who have received any medications or substances (except for CBD and/or nicotine containing products) 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 Admissi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method <br> 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<br> 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<br> 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<br> 4. Body temperature (thermometer; °C) at 0, 5 min, 0.5, 1, 2, 4, and 8 hrs<br> 5. Product use data (including DML, puff number and use count for the vapour product, and MLE for the oral pouch)<br>