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

NCT06574100 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: NFL-CBD-02Bio-4317286992
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• Pharmacokinetic Parameters

  relative bioavailability (F)

  1 week of samples will be collected. 2 week washout. Then another week of samples after cross over

• Pharmacokinetic Parameters

  time to maximum plasma concentration (Tmax)

  1 week of samples will be collected. 2 week washout. Then another week of samples after cross over

• Pharmacokinetic Parameters

  maximum plasma concentration (Cmax)

  1 week of samples will be collected. 2 week washout. Then another week of samples after cross over

• Pharmacokinetic Parameters

  log-linear terminal phase rate constant (k)

  1 week of samples will be collected. 2 week washout. Then another week of samples after cross over

• Pharmacokinetic Parameters

  area under the plasma concentration versus time curve (AUC)

  1 week of samples will be collected. 2 week washout. Then another week of samples after cross over

• Pharmacokinetic Parameters

  absorption rate constant (ka)

  1 week of samples will be collected. 2 week washout. Then another week of samples after cross over

• Pharmacokinetic Parameters

  apparent clearance (Cl/F)

  1 week of samples will be collected. 2 week washout. Then another week of samples after cross over

• Pharmacokinetic Parameters

  apparent volume of distribution (Vd/F)

  1 week of samples will be collected. 2 week washout. Then another week of samples after cross over

• Pharmacokinetic Parameters

  half-life

  1 week of samples will be collected. 2 week washout. Then another week of samples after cross over

Secondary Outcomes (14)

• Safety of the drug using the Integrated Addendum to ICH E6(R1)

  During the first week of administration and the 4th week of administration

• Safety of the drug using the Integrated Addendum to ICH E6(R1)

  During the first week of administration and the 4th week of administration

• Safety of the drug using the Integrated Addendum to ICH E6(R1)

  During the first week of administration and the 4th week of administration

• Optimal washout periods

  3 weeks

• Tolerability of the drug using the Integrated Addendum to ICH E6(R1)

  During the first week of administration and the 4th week of administration

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: Cannabidiol

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

ACTIVE COMPARATOR

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.

Drug: Cannabidiol

Interventions

Cannabidiol DRUG

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.

Also known as: One formulation will be a powder the other will be buccal strips

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - 35 years old
• 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.
• No clinically significant disease on medical history or clinically significant findings on physical examination including vital signs as determined by the qualified investigator.
• Ability to stay in the clinic trial unit for 13 hours on the day of each single oral dose.
• Ability to return for blood draws in the subsequent days.

You may not qualify if:

• 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.
• History or presence of serious cardiovascular disease, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure
• Males whose partners are trying to conceive (i.e. male subjects intending to start a family during the study period)
• Lack of medically acceptable contraception by participants whose female partners have childbearing potential for the duration of the study.
• Personal or family history of schizophrenia or any other psychotic disorder
• Current or past drug or alcohol dependence or abuse
• 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)
• 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)
• Use of psychotropic medications with serotonergic activity (e.g. Selective Serotonin Reuptake Inhibitors, Tricyclic Antidepressants, Atypical Neuroleptics) within one week
• Use of narcotic medications (e.g. Codeine, Morphine, Oxycontin) within one week
• Use of any other medication known to interact with medicinal Cannabis within one week.
• Allergy or known intolerance to any of the compounds within the study preparation.
• Resting heart rate HR \< 50 bpm or \> 100 bpm or seated blood pressure \< 100/60 or higher than 140/90
• Inability of study participants to attend and complete all study visits
• Bleeding disorder

Sponsors & Collaborators

• University of Saskatchewan: lead
• University of Regina: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5E5, Canada

RECRUITING

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Payam Dehghani, MD

  Pasqua Hospital

  PRINCIPAL INVESTIGATOR

• Jane Alcorn, DVM;PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

• Abdul Salama, PharmD

  University of Saskatchewan

  STUDY DIRECTOR

Central Study Contacts

Abdul Salama, PharmD

CONTACT

3065600094; abs915@usask.ca

Jane Alcorn, DVM;PhD

CONTACT

(306) 966-6365; jane.alcorn@usask.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean and Professor at the College of Pharmacy and Nutrition

Model Details: We plan this study as a single-site (potentially multi-site), randomized, two-arm study, with one arm being a two-sequence crossover, single buccal, or oral dose in fasted healthy male adults, and the second arm being a two-sequence cross-over, single high oral dose PK study in fasted vs fed-state healthy male adults. Participants will be randomized into four groups (n = 16 in Arm 1, 8 per group (2 groups), all males; n = 4 in Arm 2, 2 per group (2 groups) all males) (ages 18 - 35) based on which formulation each group will receive. Individuals in study arm 1 will complete the study in the fasted state (10 hours of fasting). Individuals in study arm 2 will follow the fed-state protocol as outlined by the United States FDA's bioequivalent studies guideline

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: August 27, 2024
• Study Start: October 26, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

CA (1)