Comparative PK Study Of THC/CBD Formulations

Cannabis Clinical Trial

Official title:

A Phase I, Single Center Crossover Study, Evaluating the Pharmacokinetic Profile and Safety of Self-emulsified THC/CBD Powder Compared With Equivalent Dose of THC/CBD Oil, Orally Administered.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149988
• Other study ID #: V1022022
• Status: Recruiting
• Phase: Phase 1
• Start date: August 27, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: November 2023
• Source: CapSoil
• Contact: Rafi Ezra
• Phone: +972522579044
• Email: rafi[@]capsoil.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase I, single center crossover study. The goal of this clinical trial is to learn about self-emulsified THC/CBD powder compared with equivalent dose of THC/CBD oil, orally administerd in healthy volunteers. The main question it aims to answer is: •If the pharmacokinetics profile of one dose of THC/CBD Self emulsified (S.E powder) compares to THC/CBD oil (equivalent dose). The secondary is: •If the use of THC/CBD S.E powder is tolerable and safe at least as THC/CBD oil. Participants will receive a single dose of THC/CBD S.E powder followed by a 30-day washout period and then a single dose of THC/CBD oil.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subjects must be 21-65 years old.

2. Subjects must have a signed study informed consent before any procedure.

3. Subjects must have a cannabis license as detailed at procedure No. 106 of the IMC-GCO , license will be issued and approved by PI at screening visit after signing on informed consent.

4. Female subjects must be of non-childbearing potential or, if of childbearing potential, must have a negative urine pregnancy test at screening, visit 1 and visit 2.

Exclusion Criteria:

1. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to THC/CBD.

2. Has an underlying medical condition that would preclude study participation.

3. Chronic use of medications for underlying medical conditions.

4. Use of any medications within 24 hours prior to treatment visit.

5. Is currently participating in another study of an investigational agent/medical device.

6. Has known psychiatric or substance abuse disorders that would interfere with participating in the study.

7. Patients who previously suffered from dysfunction of the: liver, kidneys, heart, blood vessels and immune system (such as transplant recipients or patients undergoing chemotherapy).

8. Patients who previously suffered from depression or anxiety.

9. Medical history of high blood pressure, low blood pressure or diabetes.

10. Patients who experience difficulties in performing daily activities.

11. Current cannabis use or positive THC urine test results.

12. Pregnant or lactating female subjects

Related Conditions & MeSH terms

• Cannabis

Intervention

Drug:
• THC/CBD S.E powder
A single dose of THC/CBD S.E powder- 500 mg, given orally.
• THC/CBD oil
Followed by a 30-day washout- A single dose of THC/CBD oil- 8 mg, given orally (equivalent dose to the powder).

Locations

Country	Name	City	State
Israel	Laniado Hospital	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
CapSoil

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Minimum blood concentration (Cmin)	Cmin, by using model independent analytical methods.	though study completion, 30 days
Other	Bioavailability	By using model independent analytical methods.	though study completion, 30 days
Primary	To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 1.a) THC/CBD S.E powder and oil exposure as measured by Cmax.	Measured by Cmax.	30 days
Primary	To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 1.b) THC/CBD S.E powder and oil exposure as measured by AUC.	Measured by AUC.	30 days
Primary	To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 2. THC/CBD S.E and oil powder half life	t1/2, should be determined by using model independent analytical methods.	30 days
Primary	To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 3. THC/CBD S.E powder and oil onset of action and time to reach maximum blood concentration as measured by Tmax.	Measured by Tmax.	30 days
Secondary	To demonstrate that the use of THC/CBD S.E powder is tolerable and safe at least as THC/CBD oil: Incidence of advert events (AEs), defined and graded according to the NCI-issued Common Terminology Criteria for Adverse Events (CTCAE).	By tracking Incidence of advert events (AEs), defined and graded according to the NCI-issued Common Terminology Criteria for Adverse Events (CTCAE).	though study completion, 30 days