Clinical trial NCT04589455: Pharmacokinetics of CBD From a Hennep Extract
Official title: Determination of Pharmacokinetics and Food-effect of CBD From a Hennep Extract in Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CBD Pharmacokinetics
Keywords: CBD
pharmacokinetics
hennep extract
food-effect
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Becanex
First posted: 2020-10-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Rationale: Cannabidiol (CBD) is a non-hallucinogenic plant compound of Cannabis sativa L. and has gained attention for its potential health purposes, favorable safety profile and low abuse potential. Mainly sold as food supplements, CBD-containing preparations of different composition, concentration and quality are widely available in the Netherlands via druggist stores or via Internet. However, CBD- containing preparations do not yet have a novel food status and most EU countries are currently applying a tolerance policy for CBD present in- or derived from hemp products low in THC. Likewise, there are no approved health claims for CBD, which leads to a situation that products sold by official drugstores do not contain any indication for use. Last but not least, products are not subject to any official quality control which creates a situation that consumers are unaware of the CBD content and potential contamination of the product they purchase. Getting novel food status would an important step in better regulation. Such a procedure requires a well-documented safety assessment. As part of this assessment the pharmacokinetics of CBD need to be assessed. The aim of the present study is therefore to investigate the pharmacokinetics of CBD after single oral administration of a full-spectrum hemp extract. As fatty food is reported to increase CBD oral bioavailability, we will also study the effect of a high-fat meal.

Objective: To determine the pharmacokinetics of CBD following oral administration of a novel oil-based hemp extract containing 70 mg CBD and to study the effects of a high-fat meal on the oral bioavailability of CBD.

Study design: Single dose randomized crossover intervention study Study population: healthy human volunteers, men and women from 18 to 60 years old with a BMI from 18 to 25 kg/m2.

Intervention (if applicable): In a random order, research subjects receive a single dose of hemp extract containing 70 mg CBD in soft gel capsules, both in a fasting state and with a high-fat meal.

Main study parameters/endpoints: The plasma-time curve of CBD (quantitively) and 2 of its metabolites (semi-quantitatively) after intake of the Becanex natural hemp extract. These data will be evaluated studied applying descriptive pharmacokinetic analysis (maximum peak height (Cmax), time-to-peak (Tmax), Half-life (T1/2) and area-under-the-curve (AUC)). Relative bioavailability in the fed versus fasted state will be determined by dividing individual AUC values.


Eligibility criteria: Inclusion criteria:

* BMI between 18,5 and 25 kg/m2
* Age between 18 and 60 years
* Weight above 50 kg
* Good general health (based on general health questionnaire)
* Veins suitable for blood sampling
* Able to speak Dutch
* Pertinent willingness to abstain from using any hemp product (including recreational Cannabis) 2 weeks prior and the entire study period.

Exclusion Criteria:

* Is currently suffering from a disease
* Has had any gastrointestinal condition/disease within the 3 months prior to the intervention
* Haemoglobin (Hb) level \< 8.5 mmol/L for men and \< 7.5 for women
* Has used medication in the two months before and/or during the intervention. Oral contraceptives and occasional use of NSAIDs or paracetamol (\<max 3 a week on average) is allowed.
* Reported weight loss or weight gain of \> 2 kg in the month prior to the intervention
* Use of herbal dietary supplements (excluding vitamins and minerals) or grapefruit products, 2 weeks before the first testday and in between the testdays.
* Allergic to products that are provided as part of the standardised diet
* Following a specific diet (e.g. vegetarian, gluten free)
* (History of) drug abuse, in this case meaning \>1 x per month use of recreational drugs
* Cannabis use in the 14 days preceding the first test day.
* Smoking
* Alcohol consumption of \>10 standardised glasses per week.
* Recent or planned blood donation (\<3 month prior to first study day or during intervention)
* Have been pregnant or breastfeeding in the last 6 months, or plan to become pregnant during the study
* (If applicable) In case of using contraceptives, not willing to delay the break between two packets of the conception pill during which a woman gets her period during the study period.
* Personnel of Wageningen University, department of Human Nutrition and Health,
* Currently participating in other research or was participating in another study within 1 month of the intervention or within 3 months if invasive procedures were used.

Primary outcomes:
measure: Relative bioavailability of CBD in a fed versus a fasted state
timeFrame: 48 hours
measure: Area under the curve (AUC)
timeFrame: 48 hours
measure: Maximum concentration (Cmax)
timeFrame: 48 hours
measure: Time to peak (Tmax)
timeFrame: 48 hours
measure: Half life (t1/2)
timeFrame: 48 hours
Secondary outcomes:
measure: Area under the curve (AUC)
timeFrame: 48 hours
measure: Maximum concentration (Cmax)
timeFrame: 48 hours
measure: Time to peak (Tmax)
timeFrame: 48 hours
measure: Half life (t1/2)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University, Division of Human Nutrition
Study officials:
affiliation: Wageningen University
name: Ringer Witkamp, PhD
role: PRINCIPAL_INVESTIGATOR
References: