Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578455
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
A Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Open-Label 4-Way Crossover Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 powdercapsule 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
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
Detailed Description:
CBD and Δ9-THC are the most abundant extracts from the Cannabis sativa plant Δ9-THC is typically associated with psychotropic effects due to its affinity for cannabinoid receptor types 1 and 2 CBD possesses a low affinity and lack of function at these receptors therefore there is an interest in its potential health benefit without the psychoactive properties and adverse reactions that arise from Δ9-THC use Only few studies have characterized the PK effects and the safety of oral CBD administration As CBD is a lipophilic molecule consuming CBD with a lipid formulation may increase its exposure Additionally CBD is known to have poor bioavailability when taken orally because it is rapidly metabolized by the liver to 7-hydroxycannabidiol 7-OH-CBD and then to cannbidiol-7-oic acid 7-COOH-CBD which may reduce the potency of CBD Formulation strategies for orally consumed CBD products are being investigated to by-pass one or both of these limitations and improve the bioavailability of CBD Epidyolex a purified form of CBD is delivered in a solution of sesame oil which aids absorption Epidyolex marketed and sold in the US and Canada as Epidiolex is currently the only marketed CBD monotherapy with US FDA and Health Canada approval and is approved for treatment of certain types of epilepsy However administration of CBD in oil form is not ideal for consumers as it is not always convenient or precise Delivery of CBD in a powdercapsule form may provide a more efficient method of CBD consumption
The test product will be CBD-NE a novel formulation of CBD in a powder form This product will be investigated in healthy adults as its PK profile is not yet characterized in humans This study is designed to be a randomized crossover comparator control trial to evaluate the PK profile and safety of CBD-NE compared to Epidyolex in healthy adults under both fed and fasted conditions
Two study products CBD-NE and Epidyolex will be administered under both fed and fasted conditions Participants will be randomized in a 1111 ratio to one of 4 treatment sequences There will be a total of 4 treatment periods consisting of 2 consecutive days and one washout period Each dose will be followed by a minimum 14-day maximum of 28-day washout period with the last dose followed by a follow-up phone call which will occur within the timeframe of the longest washout period over the study For the fed state participants will consume a high-fat high-calorie breakfast within the 30 minutes prior to dosing
Pharmacokinetic blood sampling will occur pre-dose and at 025 h 05 h 075 h 10 h 15 h 20 h 30 h 40 h 50 h 60 h 80 h 120 h and 240 h post-dose
Blood samples collected will be used to assess the PK profiles of CBD-NE and Epidyolex PK parameters measured will include maximum concentration in plasma Cmax time to reach maximum concentration Tmax elimination half-life T12 area under the plasma concentration-time curve over 24 hours AUC0-24 area under the plasma concentration-time curve from zero to infinity AUCinf and AUC0-24AUCinf for CBD 7-OH-CBD and 7-COOH-CBD Safety endpoints will be assessed throughout the study and will include reports of adverse events 12-lead ECG vital signs safety laboratory assessments and abbreviated physical exam
The test product will be CBD-NE a novel formulation of CBD in a powder form This product will be investigated in healthy adults as its PK profile is not yet characterized in humans This study is designed to be a randomized crossover comparator control trial to evaluate the PK profile and safety of CBD-NE compared to Epidyolex in healthy adults under both fed and fasted conditions
Two study products CBD-NE and Epidyolex will be administered under both fed and fasted conditions Participants will be randomized in a 1111 ratio to one of 4 treatment sequences There will be a total of 4 treatment periods consisting of 2 consecutive days and one washout period Each dose will be followed by a minimum 14-day maximum of 28-day washout period with the last dose followed by a follow-up phone call which will occur within the timeframe of the longest washout period over the study For the fed state participants will consume a high-fat high-calorie breakfast within the 30 minutes prior to dosing
Pharmacokinetic blood sampling will occur pre-dose and at 025 h 05 h 075 h 10 h 15 h 20 h 30 h 40 h 50 h 60 h 80 h 120 h and 240 h post-dose
Blood samples collected will be used to assess the PK profiles of CBD-NE and Epidyolex PK parameters measured will include maximum concentration in plasma Cmax time to reach maximum concentration Tmax elimination half-life T12 area under the plasma concentration-time curve over 24 hours AUC0-24 area under the plasma concentration-time curve from zero to infinity AUCinf and AUC0-24AUCinf for CBD 7-OH-CBD and 7-COOH-CBD Safety endpoints will be assessed throughout the study and will include reports of adverse events 12-lead ECG vital signs safety laboratory assessments and abbreviated physical exam
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None