Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286839
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2023-10-07
Brief Title:
Study of Cannabidiol CBD in Healthy Volunteers
Sponsor:
NextEvo Inc
Organization:
NextEvo Inc
Study Overview
Official Title:
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None