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Completed

NCT Number: NCT04280289

CBD Cannabis Extract: Pharmacokinetic Studies

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Mississippi

University, Mississippi, 38677, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cannabidiol extract

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Mississippi, Oxford

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2020
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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