CBD Cannabis Extract: Pharmacokinetic Studies

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Mississippi, Oxford
• Treatments: Cannabidiol; Epidiolex

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