A Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions

Summary

Cannabidiol (CBD), derived from the Cannabis sativa plant, is being investigated for its potential health benefit without the psychoactive properties and adverse reactions that arise from the use of delta-9-tetrahydrocannabinol (Δ9-THC). Few studies have characterized the pharmacokinetic (PK) effects and safety of oral CBD administration. Epidiolex (Epidyolex), an oil form of CBD, is the only marketed monotherapy approved by the United States Food and Drug Administration (FDA) and Health Canada. Delivery of a CBD in a powder/capsule form may provide a more efficient method for consumers. The goal of this study is to characterize the PK profile of the test product, CBD-NE (a capsule formulation) compared to Epidyolex under both fasted and fed conditions. Each participant will receive a dose of each product under both fed and fasted conditions in a crossover design.

Timeline

Start

2024-08-30

Primary completion

2024-11-20

Completion

2024-12-16

Publications

• Background Legare CA, Raup-Konsavage WM, Vrana KE. Therapeutic Potential of Cannabis, Cannabidiol, and Cannabinoid-Based Pharmaceuticals. Pharmacology. 2022;107(3-4):131-149. doi: 10.1159/000521683. Epub 2022 Jan 28.
• Background Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, Scheffer IE, Thiele EA, Wright S; Cannabidiol in Dravet Syndrome Study Group. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. N Engl J Med. 2017 May 25;376(21):2011-2020. doi: 10.1056/NEJMoa1611618.
• Background Knaub K, Sartorius T, Dharsono T, Wacker R, Wilhelm M, Schon C. A Novel Self-Emulsifying Drug Delivery System (SEDDS) Based on VESIsorb(R) Formulation Technology Improving the Oral Bioavailability of Cannabidiol in Healthy Subjects. Molecules. 2019 Aug 16;24(16):2967. doi: 10.3390/molecules24162967.
• Background Huestis MA, Solimini R, Pichini S, Pacifici R, Carlier J, Busardo FP. Cannabidiol Adverse Effects and Toxicity. Curr Neuropharmacol. 2019;17(10):974-989. doi: 10.2174/1570159X17666190603171901.
• Background Berl V, Hurd YL, Lipshutz BH, Roggen M, Mathur EJ, Evans M. A Randomized, Triple-Blind, Comparator-Controlled Parallel Study Investigating the Pharmacokinetics of Cannabidiol and Tetrahydrocannabinol in a Novel Delivery System, Solutech, in Association with Cannabis Use History. Cannabis Cannabinoid Res. 2022 Dec;7(6):777-789. doi: 10.1089/can.2021.0176. Epub 2022 Jul 5.
• Background Taylor L, Gidal B, Blakey G, Tayo B, Morrison G. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Dose, and Food Effect Trial of the Safety, Tolerability and Pharmacokinetics of Highly Purified Cannabidiol in Healthy Subjects. CNS Drugs. 2018 Nov;32(11):1053-1067. doi: 10.1007/s40263-018-0578-5.
• Background Abbotts KSS, Ewell TR, Butterklee HM, Bomar MC, Akagi N, Dooley GP, Bell C. Cannabidiol and Cannabidiol Metabolites: Pharmacokinetics, Interaction with Food, and Influence on Liver Function. Nutrients. 2022 May 21;14(10):2152. doi: 10.3390/nu14102152.
• Background Britch SC, Babalonis S, Walsh SL. Cannabidiol: pharmacology and therapeutic targets. Psychopharmacology (Berl). 2021 Jan;238(1):9-28. doi: 10.1007/s00213-020-05712-8. Epub 2020 Nov 21.
• Background Peng J, Fan M, An C, Ni F, Huang W, Luo J. A narrative review of molecular mechanism and therapeutic effect of cannabidiol (CBD). Basic Clin Pharmacol Toxicol. 2022 Apr;130(4):439-456. doi: 10.1111/bcpt.13710. Epub 2022 Feb 6.
• Bendik I, Beck M, Manderna A, Roos FF, Wang J, McCarthy D, Schweiggert C, Besheer A, Baisley J, Misic Z, Mussler B, Kuttenkeuler A, Piomelli D, Peter S. Comparative Pharmacokinetics and Safety of Cannabidiol in a Powder Formulation, CBtru(R), vs an Oil-Based Formulation, Epidyolex(R), Under Fasted and Fed Conditions in Healthy Participants: A Randomized Open-Label Cross-Over Phase I Study. CNS Drugs. 2026 May;40(5):709-723. doi: 10.1007/s40263-026-01280-1. Epub 2026 Mar 26.

Drugs

Indications

No indication recorded.