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CBD Cannabis Extract: Pharmacokinetic Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280289
Recruitment Status : Not yet recruiting
First Posted : February 21, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
University of Mississippi, Oxford

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: cannabidiol extract Early Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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).

Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: CBD Cannabis Extract: Pharmacokinetic Studies
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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 Name: cannabidiol, CBD




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280289


Contacts
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Contact: Bill Gurley, Ph. D. 662-915-7130 bjgurley@olemiss.edu
Contact: Kerri Harrison 662-915-2103 kaharri6@olemiss.edu

Locations
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United States, Mississippi
University of Mississippi
University, Mississippi, United States, 38677
Sponsors and Collaborators
University of Mississippi, Oxford
Investigators
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Principal Investigator: Bill Gurley, Ph. D. Principal Scientist, National Center for Natural Products Research
Additional Information:
Publications of Results:
Borchardt D. Hemp cannabis product sales projected to hit $1 billion in 3 years. Forbes 2017, August, 23.
(Harvey et al; Ujvary and Hanus; Jiang et al; Huestis, etc.1999): CBD is a potent inhibitor of CYP450 isozymes, primarily CYP2C and CYP3A isoforms, in in vitro and animal models
H.R.2 - Agriculture Improvement Act of 2018, Public Law No: 115-334, Dec. 20, 2018.
Personal statement from principal investigator, Dr. John Ingram, Dept. of Pediatrics, University of Mississippi Medical Center on his experience with "Cannabidiol (CBD) Cannabis Extract Oral Solution for Drug Resistant Pediatric Epilepsy (Compassionate Use)," April 18, 2018.

Other Publications:
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Responsible Party: University of Mississippi, Oxford
ClinicalTrials.gov Identifier: NCT04280289    
Other Study ID Numbers: CBD Study 1
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Mississippi, Oxford:
CBD
cannabidiol extract
cannabidiol
CBDE
pharmacokinetics
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epidiolex
Anticonvulsants