Clinical trial NCT06149988: Comparative PK Study Of THC/CBD Formulations
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cannabis
Keywords: Powder
Oil
Lead sponsor: CapSoil
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 30 days
measure: 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.
timeFrame: 30 days
measure: 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
timeFrame: 30 days
measure: 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.
timeFrame: 30 days
Secondary outcomes:
measure: 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).
timeFrame: though study completion, 30 days
Other outcomes:
measure: Minimum blood concentration (Cmin)
timeFrame: though study completion, 30 days
measure: Bioavailability
timeFrame: though study completion, 30 days
Locations:
city: Netanya
country: Israel
facility: Laniado Hospital
Study officials:
affiliation: Laniado Hospital
name: Vered Hermush, M.D.
role: PRINCIPAL_INVESTIGATOR
References: