NCT06574100

Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This project is aimed at understanding whether a new fast-dissolving cheek-administered cannabidiol strip will be absorbed better into the body than cannabidiol powder. The results of this study will help guide dosage formulation choices as well as dosing regimens in NFL athletes for concussion management.

Detailed description

Cannabis formulations are typically administered by the oral route of administration. This route represents the most common administration route for most pharmaceuticals due to the ease of administration and convenience. Inhalational products are not acceptable for the sport's athlete population due to potential damage to lung tissues. Topical products do not have adequate bioavailability to meet our therapeutic objectives. Our PK studies, then, need to employ the same dosage form and route of administration we expect to use in future clinical efficacy trials. Given the low bioavailability expected with CBD oral formulations, we wish to assess two different formulations and the relative extent of CBD absorption. Our future planned CBD intervention studies in athletes will require use of larger doses of CBD. The formulation with the larger bioavailability will help to reduce the overall size of the dose utilized and therefore reduce the amount of product exposure in our clinical intervention studies. This will increase the likelihood that a Cannabis company can supply the necessary amount of product and reduce the overall cost associated with the studies. Generally speaking, based on current literature published around CBD administration for therapeutic application, higher doses of CBD (i.e., 50mg/kg/d) were found to correlate to more positive outcomes than lower doses (i.e., 1mg/kg/d). Assuming an average weight of 70 kg, a 1000 mg dose would be around 14.29 mg/kg, and a 3000 mg dose around 42.86 mg/kg. This will allow us to investigate the pharmacokinetics of CBD on both ends of the hypothetical efficacy trend. Studies have examined single orally administered doses up to 6000 mg with no serious adverse effects reported.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Cannabidiol	Patients in the first arm cross-over will receive either a single bolus dose of 250mg buccally administered or 1000mg CBD powder and cross over to vice-versa after 21 days.
DRUG	Cannabidiol	Patients will be randomised to receive 3000mg oral CBD fasting or Fed, they will the cross over to the other group 21 days following the first administration.

Timeline

• Start date: 2024-10-26
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2024-08-27
• Last updated: 2025-03-30

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study