CannabisPhase 1NCT06149988
Comparative PK Study Of THC/CBD Formulations
A Phase 1 study testing THC/CBD S.E powder and THC/CBD oil in people with Cannabis, run by CapSoil at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- What is being tested?
- THC/CBD S.E powder and THC/CBD oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Aug 2023to 1 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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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).
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Laniado Hospital
Netanya, 42150
Vered Hermush, M.D., +972544399513, vhermush@laniado.org.il
About this study
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.
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.
- Conditions
- Cannabis
- Being tested
- THC/CBD S.E powder, THC/CBD oil
- Keywords
- Powder, Oil
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THC/CBD S.E powderDrug
A single dose of THC/CBD S.E powder- 500 mg, given orally.
THC/CBD oilDrug
Followed by a 30-day washout- A single dose of THC/CBD oil- 8 mg, given orally (equivalent dose to the powder).
| Study group | Role | What they receive |
|---|---|---|
| Single dose of THC/CBD S.E powder | Experimental | On visit 1: Subjects will receive a single dose of THC/CBD S.E powder- 500 mg, given orally. Receives: Drug: THC/CBD S.E powder |
| a single dose of THC/CBD oil | Active comparator | 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). Receives: Drug: THC/CBD oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
By tracking Incidence of advert events (AEs), defined and graded according to the NCI-issued Common Terminology Criteria for Adverse Events (CTCAE).
Measured: though study completion, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start27 Aug 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CapSoil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vered Hermush, M.D., Principal investigator, Laniado Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149988
- Sponsor's protocol ID
- V1022022
- Status last verified
- Nov 2023
- First submitted
- 22 Oct 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06149988
- Acronym / sponsor ID
- V1022022
- Conditions
- Cannabis
- Keywords
- Powder, Oil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- CapSoilUniversity, hospital or other
- Study start
- 27 Aug 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose of THC/CBD S.E powder | Experimental | Drug: THC/CBD S.E powderOn 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 comparator | Drug: THC/CBD oilOn visit 2 (30 days later): Subjects will receive a single dose of THC/CBD oil- 8 mg, given orally (equivalent dose to the powder). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THC/CBD S.E powderA single dose of THC/CBD S.E powder- 500 mg, given orally. | Drug | Single dose of THC/CBD S.E powder |
| THC/CBD oilFollowed by a 30-day washout- A single dose of THC/CBD oil- 8 mg, given orally (equivalent dose to the powder). | Drug | a single dose of THC/CBD oil |
Primary outcome
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 30 days
Measured by Tmax.
1 secondary outcome
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).
Time frame: though study completion, 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vered Hermush, M.D. principal investigator
Laniado Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THC/CBD S.E powder and THC/CBD oil in people with Cannabis, run by CapSoil at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafi Ezra (+972522579044, rafi@capsoil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.