NCT06286839

Study of Cannabidiol (CBD) in Healthy Volunteers

An Open-Label Parallel Phase I Study Evaluating Multiple Ascending Dose Pharmacokinetics and Acute Immunomodulatory Potential of a Novel Oral Cannabidiol (CBD) Formulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: NextEvo Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This was a prospective, single-centre, open label, randomized, two-arm, parallel design study to evaluate the effect of four-weeks consumption of active study product on primary endpoint in healthy adults

Detailed description

Cannabidiol (CBD), a non-psychoactive component of Cannabis sativa L., has been purported to have a variety of beneficial physiological effects including but not limited to, pain relief, anti-anxiety, anti-seizure, anti-depressant, anti-oxidant, and anti-inflammatory. Despite the enthusiasm of the CBD industry for these claims, the empirical evidence supporting favourable physiological responses is inconsistent. These discrepancies may in part be explained by differences in CBD bioavailability when administered orally that in turn may be influenced by non-standardized CBD formulation, and/or the body size and composition of the recipient. The purpose of this study was to test the bioavailability of two doses of a novel CBD formation given twice per day for three consecutive days in healthy study subjects and explore their potential acute anti-inflammatory properties as assessed by highly sensitive immunologic assays. The rationale for conducting the study was to evaluate the pharmacokinetic (PK) profile of a novel formulation of CBD designed to improve bioavailability given at two dose levels twice per day for three consecutive days. Although previous studies conducted in healthy study subjects have documented the safety and PK profile for a single dose of the test product, multiple ascending dose studies have not yet been conducted. In addition to evaluating multiple ascending dose PK, the pharmacodynamic properties of the CBD were assessed using ex vivo lipopolysaccharides (LPS) stimulated whole blood assays and high sensitivity serum cytokine assays.

Conditions

• Immune System and Related Disorders
• Immune System Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cannabidiol (CBD)	Cannabidiol (CBD), a non-psychoactive component of Cannabis sativa L.

Timeline

• Start date: 2022-05-12
• Primary completion: 2022-10-28
• Completion: 2022-12-14
• First posted: 2024-02-29
• Last updated: 2024-02-29

Locations

1 site across 1 country: United States