Comparative PK Study Of THC/CBD Formulations
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single dose of THC/CBD S.E powder On visit 1: Subjects will receive a single dose of THC/CBD S.E powder- 500 mg, given orally. |
Drug: THC/CBD S.E powder
A single dose of THC/CBD S.E powder- 500 mg, given orally.
|
| Active Comparator: a single dose of THC/CBD oil On visit 2 (30 days later): Subjects will receive a single dose of THC/CBD oil- 8 mg, given orally (equivalent dose to the powder). |
Drug: 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).
|
Outcome Measures
Primary Outcome Measures
- 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. [30 days]
Measured by Cmax.
- 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. [30 days]
Measured by AUC.
- 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 [30 days]
t1/2, should be determined by using model independent analytical methods.
- 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. [30 days]
Measured by Tmax.
Secondary Outcome Measures
- 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). [though study completion, 30 days]
By tracking Incidence of advert events (AEs), defined and graded according to the NCI-issued Common Terminology Criteria for Adverse Events (CTCAE).
Other Outcome Measures
- Minimum blood concentration (Cmin) [though study completion, 30 days]
Cmin, by using model independent analytical methods.
- Bioavailability [though study completion, 30 days]
By using model independent analytical methods.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects must be 21-65 years old.
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Subjects must have a signed study informed consent before any procedure.
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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.
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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
Exclusion Criteria:
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A history of allergic reactions attributed to compounds of similar chemical or biologic composition to THC/CBD.
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Has an underlying medical condition that would preclude study participation.
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Chronic use of medications for underlying medical conditions.
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Use of any medications within 24 hours prior to treatment visit.
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Is currently participating in another study of an investigational agent/medical device.
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Has known psychiatric or substance abuse disorders that would interfere with participating in the study.
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Patients who previously suffered from dysfunction of the: liver, kidneys, heart, blood vessels and immune system (such as transplant recipients or patients undergoing chemotherapy).
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Patients who previously suffered from depression or anxiety.
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Medical history of high blood pressure, low blood pressure or diabetes.
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Patients who experience difficulties in performing daily activities.
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Current cannabis use or positive THC urine test results.
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Pregnant or lactating female subjects
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laniado Hospital | Netanya | Israel | 42150 |
Sponsors and Collaborators
- CapSoil
Investigators
- Principal Investigator: Vered Hermush, M.D., Laniado Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V1022022