CBD Cannabis Extract: Pharmacokinetic Studies

University of Mississippi, Oxford

Status and phase: Completed; Early Phase 1

Conditions: Epilepsy

Treatments: Drug: cannabidiol extract

Study type: Interventional

Funder types: Other

Identifiers

NCT04280289

CBD Study 1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Cannabidiol extract

Experimental group

Description:

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

Treatment:

Drug: cannabidiol extract