CBD Cannabis Extract: Pharmacokinetic Studies

Early Phase 1CompletedNCT04280289

University of Mississippi, Oxford10 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

cannabidiol extractDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Mississippi

University, Mississippi, United States

Outcomes

Primary Outcomes

Plasma concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).