Comparative PK Study Of THC/CBD Formulations
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.
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2023
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 27, 2023
CompletedFirst Submitted
Initial submission to the registry
October 22, 2023
CompletedFirst Posted
Study publicly available on registry
November 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedNovember 29, 2023
November 1, 2023
5 months
October 22, 2023
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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 Outcomes (1)
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
Other Outcomes (2)
Minimum blood concentration (Cmin)
though study completion, 30 days
Bioavailability
though study completion, 30 days
Study Arms (2)
Single dose of THC/CBD S.E powder
EXPERIMENTALOn visit 1: Subjects will receive a single dose of THC/CBD S.E powder- 500 mg, given orally.
a single dose of THC/CBD oil
ACTIVE COMPARATOROn visit 2 (30 days later): Subjects will receive a single dose of THC/CBD oil- 8 mg, given orally (equivalent dose to the powder).
Interventions
A single dose of THC/CBD S.E powder- 500 mg, given orally.
Followed by a 30-day washout- A single dose of THC/CBD oil- 8 mg, given orally (equivalent dose to the powder).
Eligibility Criteria
You may qualify if:
- Subjects must be 21-65 years old.
- Subjects must have a signed study informed consent before any procedure.
- 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.
- 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.
You may not qualify if:
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to THC/CBD.
- Has an underlying medical condition that would preclude study participation.
- Chronic use of medications for underlying medical conditions.
- Use of any medications within 24 hours prior to treatment visit.
- Is currently participating in another study of an investigational agent/medical device.
- Has known psychiatric or substance abuse disorders that would interfere with participating in the study.
- Patients who previously suffered from dysfunction of the: liver, kidneys, heart, blood vessels and immune system (such as transplant recipients or patients undergoing chemotherapy).
- Patients who previously suffered from depression or anxiety.
- Medical history of high blood pressure, low blood pressure or diabetes.
- Patients who experience difficulties in performing daily activities.
- Current cannabis use or positive THC urine test results.
- Pregnant or lactating female subjects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CapSoillead
Study Sites (1)
Laniado Hospital
Netanya, 42150, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vered Hermush, M.D.
Laniado Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2023
First Posted
November 29, 2023
Study Start
August 27, 2023
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
November 29, 2023
Record last verified: 2023-11