Cannabidiol (CBD) is well tolerated by human subjects in clinical study
“Strong animal data is always promising for new mechanisms and treatments, however that does not always translate to clinical significance or improvement for patients. Cannabidiol (CBD) is growing in popularity and new studies are showing the safety of this newer treatment in real world settings. CBD has great potential not only as a mono-therapy, but also as a combination therapy in various therapeutic areas.”
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
Objective: This trial assessed the safety, tolerability, and pharmacokinetics of CBD oral solution in healthy adult volunteers, as well as the effect of food on CBD pharmacokinetics parameters.
Design: 56 patients, ages 18-45, were randomized into 3 treatment arms and placebo groups:
– Single Ascending Dose
– Multiple Dose
– Food Effect
Results: CBD was generally well tolerated. Diarrhea, nausea, headache, and somnolence were the most common adverse events (AEs) across all trial arms, with an increased incidence of some gastrointestinal and nervous system disorder AEs (most notably diarrhea and headache) apparent in subjects taking CBD compared with placebo. All AEs were of mild or moderate severity; none were severe or serious. There were no deaths or discontinuations in the trial.
Conclusion: CBD was generally well tolerated. Most AEs were mild in severity; none were severe or serious. There were no clinically significant findings for laboratory parameters, physical examination, vital signs, ECF, or body weight in any of the arms. The safety and PK profile support twice-daily administration of CBD and there were no signs of drug withdrawal syndrome during the trial.
Study: 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
“It should be noted that the CBD used in the study was highly purified and patients should be advised to verify the source of their CBD products to assure a pure product from reliable manufacturing.”