Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT05269706
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2022-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Pharmacokinetic Profile of CBD
Sponsor:
Yasmin Hurd
Organization:
Study Overview
Official Title:
Cannabidiol in the Treatment of Opioid Use Disorder
Status:
COMPLETED
Status Verified Date:
2025-02
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:
The goal of the current study is to evaluate the bioavailability of CBD in normal healthy Individuals. This is an open cross-overdesign study in healthy individuals to assess the safety and pharmacokinetic (PK) effects of cannabidiol.
Detailed Description:
The goal of this study is to determine the pharmacokinetics and pharmacodynamic profile of CBD in normal healthy individuals under standard and high fat fed conditions.
CBD has recently gained significant attention as a potential treatment for various disorders. One aspect for consideration in the development of CBD medication in capsule form is the poor bioavailability of cannabinoids such as CBD to obtain clinically effective doses since only \~4-6% of CBD is absorbed orally. This study will investigate the potential of CBD in a formulation in a capsule to enhance bioavailability, reduce the incidence of gastrointestinal side effects, reduce first pass metabolism and enhance onset time. This PK study will be conducted with standard meal and high fat conditions in normal healthy volunteers in a cross-over design, separated by a washout period of 1 week. Healthy volunteers are defined as having no significant health-related issues (i.e., the absence of significant medical, psychosocial, or emotional conditions) that are verified by clinical and psychiatric assessments.
The study will first evaluate in healthy volunteers the PK, tolerability and safety profiles of a new CBD formulation designed to improve bioavailability.
Test conditions and order:
1. 200 mg CBD (standard meal)
2. 400 mg CBD (standard meal)
3. 400 mg Epidiolex (standard meal)
4. 400 mg CBD (high fat meal)
Blood samples will be taken at -60,15, 30, 45 and 60 min and1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours associated with administration of the CBD capsules.
Monitoring period for PK: 24 hours (plasma and urine PK). Participation in 4 test conditions for a duration of approximately 4 weeks and a 1-week follow-up assessment.
Total length of in-house stay is 12 hours, with participants returning the following day for 24-hour time point procedures.
CBD has recently gained significant attention as a potential treatment for various disorders. One aspect for consideration in the development of CBD medication in capsule form is the poor bioavailability of cannabinoids such as CBD to obtain clinically effective doses since only \~4-6% of CBD is absorbed orally. This study will investigate the potential of CBD in a formulation in a capsule to enhance bioavailability, reduce the incidence of gastrointestinal side effects, reduce first pass metabolism and enhance onset time. This PK study will be conducted with standard meal and high fat conditions in normal healthy volunteers in a cross-over design, separated by a washout period of 1 week. Healthy volunteers are defined as having no significant health-related issues (i.e., the absence of significant medical, psychosocial, or emotional conditions) that are verified by clinical and psychiatric assessments.
The study will first evaluate in healthy volunteers the PK, tolerability and safety profiles of a new CBD formulation designed to improve bioavailability.
Test conditions and order:
1. 200 mg CBD (standard meal)
2. 400 mg CBD (standard meal)
3. 400 mg Epidiolex (standard meal)
4. 400 mg CBD (high fat meal)
Blood samples will be taken at -60,15, 30, 45 and 60 min and1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours associated with administration of the CBD capsules.
Monitoring period for PK: 24 hours (plasma and urine PK). Participation in 4 test conditions for a duration of approximately 4 weeks and a 1-week follow-up assessment.
Total length of in-house stay is 12 hours, with participants returning the following day for 24-hour time point procedures.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: