Epilepsy
Conditions
Keywords
CBD, cannabidiol extract, cannabidiol, CBDE, pharmacokinetics
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).
Interventions
DRUGcannabidiol extract
The test article CBD Cannabis Extract Oral Solution will be manufactured by the University of Mississippi National Center for Natural Products Research (NCNPR) at the Coy Waller Laboratory under FDA Current Good Manufacturing Practices. The drug product, derived from hemp and containing less than 0.3% of Δ9-tetrahydrocannabinol, is no longer a Drug Enforcement Agency (DEA) controlled substance. DEA registrations are not required for the manufacturing, handling or dispensing of these clinical test materials
Sponsors
University of Mississippi, Oxford
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD). | 0- 72 hours | This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers |
| Urine concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD). | 0- 72 hours | This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of distribution (Vd),up to 72 hours after Cannabis extract administration. | 0-72 hours | This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers |
| Volume of distribution at steady state (Vdss),up to 72 hours after Cannabis extract administration. | 0-72 hours | This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers. |
| Terminal elimination rate constant (ke), half-life (t1/2), up to 72 hours after Cannabis extract administration. | 0-72 hours | This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers. |
| 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. | 0-72 hours | This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers |
| Maximum serum concentration (Cmax), up to 72 hours after Cannabis extract administration. | 0-72 hours | This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers. |
| Time to reach Cmax (Tmax), up to 72 hours after Cannabis extract administration. | 0-72 hours | This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers. |
| Mean residence time (MRT), up to 72 hours after Cannabis extract administration. | 0-72 hours | This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers. |
| Clearance (Cl/F) up to 72 hours after Cannabis extract administration. | 0-72 hours | This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers |
Countries
United States
Outcome results
None listed