Recruiting
Phase 1

CBD Formulations

Sponsor:

University of Saskatchewan

Code:

NCT06574100

Conditions

Pharmacokinetics

Eligibility Criteria

Sex: Male

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Cannabidiol

Cannabidiol

Study Details

Brief 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.

Conditions

Pharmacokinetics

Study ID

NCT06574100

Start date

Oct 26, 2024

Status verified date

Mar, 2025

Completion date

Nov, 2025

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age 18 - 35 years old
2. Clinical labs within the stated normal range of the Royal University Hospital Test Centre, or values outside the stated normal range that are not of clinical significance as determined by the qualified investigator.
3. No clinically significant disease on medical history or clinically significant findings on physical examination including vital signs as determined by the qualified investigator.
4. Ability to stay in the clinic trial unit for 13 hours on the day of each single oral dose.
5. Ability to return for blood draws in the subsequent days.

Exclusion Criteria:

1. History or presence of significant gastrointestinal, liver or kidney disease or any other condition known to interfere with drug pharmacokinetics including bioavailability or increase risk of adverse effects.
2. History or presence of serious cardiovascular disease, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure
3. Males whose partners are trying to conceive (i.e. male subjects intending to start a family during the study period)
4. Lack of medically acceptable contraception by participants whose female partners have childbearing potential for the duration of the study.
5. Personal or family history of schizophrenia or any other psychotic disorder
6. Current or past drug or alcohol dependence or abuse
7. Use of Cannabis-based therapy within 2 months (Participants who have previously used a Cannabis-based therapy may be included if they have a 2-month period without use of Cannabis-based therapy prior to enrolment in the study)
8. Use of recreational Cannabis within 2 months (Participants who have previously used recreational Cannabis may be included if they have a 2-month period without use of recreational Cannabis prior to enrolment in the study)
9. Use of psychotropic medications with serotonergic activity (e.g. Selective Serotonin Reuptake Inhibitors, Tricyclic Antidepressants, Atypical Neuroleptics) within one week
10. Use of narcotic medications (e.g. Codeine, Morphine, Oxycontin) within one week
11. Use of any other medication known to interact with medicinal Cannabis within one week.
12. Allergy or known intolerance to any of the compounds within the study preparation.
13. Resting heart rate HR < 50 bpm or > 100 bpm or seated blood pressure < 100/60 or higher than 140/90
14. Inability of study participants to attend and complete all study visits
15. Bleeding disorder
16. Known low hematocrit

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Single Oral Dose Administration of 250mg Buccally or 1000 mg Orally of two CBD formulations

participants receiving the buccal formulation will be required to receive 10 strips by the cheeks, they will be instructed to only swallow at maximum once every 2 mins for the first 5 mins. This is to minimize the amount of CBD that will be carried into the GIT. This buccal administration group will receive 2 strips at a time, one on each cheek side, following 5 mins of dissolving, patients will receive 100mL of water to swish the residue in their mouths and swallow, then receive another pair of strips to repeat the process for a total of 5 times over the course of 30 minutes (i.e., 10 strips total). The group receiving the 1000mg oral CBD extract will mimic the buccal group in that they will receive that dose over the course of 30 minutes in 5 parts, 200mg per part, and will drink 100mL of water to accompany its administration

active comparator: Single Oral Dose Administration of 3000mg CBD Extract in Fed vs Fasting

In the fasting group, participants will be asked to fast overnight (at least 10 hours fast) but are allowed to drink water.In the fed state group, participants will start their meal 30 minutes prior to receiving the dose. The meal will consist of high caloric (800-1000 Cal), high fat (\~50% of total calories), with protein, and carbohydrates (\~150 kcal, and \~250 kcal, respectively) content. No food will be administered 4 hours after the dose, and no water will be given 1 hour prior to dose administration and 1 hour after administration. The dose will be given however with a total of 235 mL of water.

Interventions

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.

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.

Primary outcome measure

  • Pharmacokinetic Parameters [ Time Frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over ]
  • Pharmacokinetic Parameters [ Time Frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over ]
  • Pharmacokinetic Parameters [ Time Frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over ]
  • Pharmacokinetic Parameters [ Time Frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over ]
  • Pharmacokinetic Parameters [ Time Frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over ]
  • Pharmacokinetic Parameters [ Time Frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over ]
  • Pharmacokinetic Parameters [ Time Frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over ]
  • Pharmacokinetic Parameters [ Time Frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over ]
  • Pharmacokinetic Parameters [ Time Frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over ]

Central Contacts and Locations

Central contacts

Locations

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 5E5

Contacts

Principal Investigator:

Jane Alcorn, DVM;PhD

More Information

Sponsor

University of Saskatchewan

Last update posted

Mar 30, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2025-03-30.