CBD Cannabis Extract: Pharmacokinetic Studies

November 18, 2024 updated by: University of Mississippi, Oxford
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • University, Mississippi, United States, 38677
        • University of Mississippi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cannabidiol extract

10 healthy subjects (5 female, 5 male), will be enrolled into the study. Each subject will receive a single CBDE dose delivering 2.5 mg/kg CBD, after consumption of a standardized meal.

Nine (9mL) of blood for PK analysis, at each of the following timepoints: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the study drug administration.

Urine will be collected at the following timepoints: Predose, 0-4 hrs, 4-8 hrs, 8-12 hrs, 12-24 hrs, 24-36 hrs, 36-48 hrs, and 48-72 hrs for PK analysis
Drug: cannabidiol 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
Other Names:
  • cannabidiol, CBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).
Time Frame: 0- 72 hours
This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers
0- 72 hours
Urine concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).
Time Frame: 0- 72 hours
This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers
0- 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 0-72 hours
This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers
0-72 hours
Clearance (Cl/F) up to 72 hours after Cannabis extract administration.
Time Frame: 0-72 hours
This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers
0-72 hours
Volume of distribution (Vd),up to 72 hours after Cannabis extract administration.
Time Frame: 0-72 hours
This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers
0-72 hours
Volume of distribution at steady state (Vdss),up to 72 hours after Cannabis extract administration.
Time Frame: 0-72 hours
This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers.
0-72 hours
Terminal elimination rate constant (ke), half-life (t1/2), up to 72 hours after Cannabis extract administration.
Time Frame: 0-72 hours
This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers.
0-72 hours
Mean residence time (MRT), up to 72 hours after Cannabis extract administration.
Time Frame: 0-72 hours
This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers.
0-72 hours
Maximum serum concentration (Cmax), up to 72 hours after Cannabis extract administration.
Time Frame: 0-72 hours
This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers.
0-72 hours
Time to reach Cmax (Tmax), up to 72 hours after Cannabis extract administration.
Time Frame: 0-72 hours
This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers.
0-72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi, Oxford

Investigators

  • Principal Investigator: Bill Gurley, Ph. D., Principal Scientist, National Center for Natural Products Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBD Study 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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