Clinical trial NCT04280289: CBD Cannabis Extract: Pharmacokinetic Studies
Official title: CBD Cannabis Extract: Pharmacokinetic Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Epilepsy
Keywords: CBD
cannabidiol extract
cannabidiol
CBDE
pharmacokinetics
Lead sponsor: University of Mississippi, Oxford
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a single center, prospective, Phase I PK trial. A total of 10 healthy subjects will be enrolled into the study. This study will evaluate the pharmacokinetics of CBDE.

The PK of CBD, 9-tetrahydrocannabinol (THC) and their principal metabolites will be determined after a single CBDE dose delivering 2.5 mg/kg CBD. ). CBDE will be provided in liquid concentration of 50mg/ml in sesame seed oil (SSO).
Primary purpose: BASIC_SCIENCE

Brief summary: The initial goal is to ascertain the pharmacokinetic (PK) profile of CBD (cannabidiol) after a single dose of CBDE (cannabidiol extract), although the plan is to extend these studies to multiple dose administrations in the future, since it is likely that (cannabidiol) and/or its metabolites will show some accumulation. These studies will provide detailed information that will inform the continuation and expansion of CBDE in other research projects.

Detailed description: The objective is to determine the PK profile of CBD(cannabidiol) , its metabolites, and minor phytocannabinoids after single dose administration of CBDE (at 2.5 mg/kg CBD). Attainment of this goal will provide essential information on phytocannabinoid disposition and dosing regimen optimization. To accomplish this objective, the working hypothesis that complex phytochemical mixtures present in full spectrum hemp extracts (FSHEs), as exemplified by CBDE, differ from purified CBD-containing products with regard to PK, will be tested. The approach to testing this working hypothesis will be to use liquid chromatography-mass spectrometry (LC/MS) to both characterize the phytocannabinoid concentration-time profiles following CBDE administration (single and multiple dosing).

Eligibility criteria: Inclusion Criteria:

* Normal, healthy adults aged 21 to 55 years

Exclusion Criteria:

* Allergy to sesame oil/products

  * Obese: BMI is 35 or higher
  * Smoker (tobacco \& marijuana use \[smoking or use of oral hemp/CBD products\])
  * Currently any taking prescriptions medication(s) \[with exception of oral contraceptives\] or over-the-counter medications/supplements
  * Consuming botanical/non-botanical dietary supplements (3 days prior to study)
  * Known history of cardiac, liver, kidney or hematological disease, diabetes
  * Autoimmune disorders
  * Known history of Neurologic/Psychiatric disorders
  * Report of an active infection
  * Subject is pregnant or breast-feeding, or is expecting to conceive during the study
  * Subjects of child bearing potential will use (or is currently using) during the study, one of the following acceptable methods of contraception:

Male sterilization (vasectomy) Female sterilization (tubal ligation, hysterectomy) Intrauterine service intrauterine device (IUD) or other implant Oral contraceptive, injectable contraceptive Contraceptive patch/ring Diaphragm Male condom Sponge/spermicide

Primary outcomes:
measure: Plasma concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).
timeFrame: 0- 72 hours
measure: Urine concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).
timeFrame: 0- 72 hours
Secondary outcomes:
measure: Area-under-the-concentration-time profiles (AUC), and area-under-the moment curve (AUMC), for CBD (cannabidiol) , up to 72 hours after Cannabis extract administration.
timeFrame: 0-72 hours
measure: Clearance (Cl/F) up to 72 hours after Cannabis extract administration.
timeFrame: 0-72 hours
measure: Volume of distribution (Vd),up to 72 hours after Cannabis extract administration.
timeFrame: 0-72 hours
measure: Volume of distribution at steady state (Vdss),up to 72 hours after Cannabis extract administration.
timeFrame: 0-72 hours
measure: Terminal elimination rate constant (ke), half-life (t1/2), up to 72 hours after Cannabis extract administration.
timeFrame: 0-72 hours
measure: Mean residence time (MRT), up to 72 hours after Cannabis extract administration.
timeFrame: 0-72 hours
measure: Maximum serum concentration (Cmax), up to 72 hours after Cannabis extract administration.
timeFrame: 0-72 hours
measure: Time to reach Cmax (Tmax), up to 72 hours after Cannabis extract administration.
timeFrame: 0-72 hours
Other outcomes:
Locations:
city: University
country: United States
facility: University of Mississippi
state: Mississippi
Study officials:
affiliation: Principal Scientist, National Center for Natural Products Research
name: Bill Gurley, Ph. D.
role: PRINCIPAL_INVESTIGATOR
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