NCT06574100 Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults
| NCT ID | NCT06574100 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Saskatchewan |
| Condition | Pharmacokinetics |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-10-26 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-10-26 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Payam Dehghani, MD
PRINCIPAL INVESTIGATOR
Pasqua Hospital
Frequently Asked Questions
Who can join the NCT06574100 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 35 Years, studying Pharmacokinetics. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06574100 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06574100 currently recruiting?
Yes, NCT06574100 is actively recruiting participants. Contact the research team at abs915@usask.ca for enrollment information.
Where is the NCT06574100 trial being conducted?
This trial is being conducted at Saskatoon, Canada.
Who is sponsoring the NCT06574100 clinical trial?
NCT06574100 is sponsored by University of Saskatchewan. The principal investigator is Payam Dehghani, MD at Pasqua Hospital. The trial plans to enroll 20 participants.