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HealthyPhase 1NCT04261166

A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract

A Phase 1 study testing A1, A2 and A3 in people with Healthy, run by Breath of Life International Pharma Ltd at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight fasting designed to study the safety and PK of medicated drops and tablet formulation for sublingual administration. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
A1, A2 and A3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteIsrael
Study dates
24 Jul 2019to 24 Oct 2022
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 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy, male or female, between 18 and 45 years of age (inclusive).
  • Body mass index (BMI) between 20-30 kg/m2 (both inclusive)
  • No recent cannabis usage within 30 days from screening
  • Normal rage hepatic functions
  • No electrolytes abnormalities
  • Vital signs at screening (after five minutes resting measured in the supine position) within the following ranges:
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  • Body temperature between 35.0 to 37.5 °C
  • Systolic blood pressure, 90 to 150 mmHg*
  • Diastolic blood pressure, 60 to 90 mmHg*
  • Pulse rate, 50 to 90 beats per minute*.
  • *Blood pressure and pulse rate will be taken again in a standing position. After two minutes standing, there shall be no more than a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure, associated with clinical manifestation of postural hypotension).

Who cannot join

  • Blood donation within 90 days
  • History of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastroenterology, endocrine, immunology, dermatologic, neurologic or psychiatric disorders
  • Subjects with a history of alcohol, drug abuse, chronic cannabis use within 2 years of study
  • Pregnant women
  • Subjects who used any prescription or OTC medication in the past 14 days with the exception of paracetamol or ibuprofen.
  • Sexually active males whose partner is of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP. Sexually active females of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP
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  • Pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
  • Subjects who had postural drop of > 20 mmHg in systolic blood pressure at screening
  • Patients with heart failure,
  • Subjects with a history of psychotic state in the past or anxiety disorder,
  • Subjects at age of less than 30 years with a history of psychiatric disease in a first-degree family member
  • Subjects with a history of addiction or drug abuse

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Ziv Medical Center

    Safed, 13100

Other trials in Israel

About this study

Official title: A Phase I Open Label Study to Assess the Single Dose Pharmacokinetics and Safety of Sublingual Administration of Tablets and Medicated Drops of Plant Cannabis Extract

This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight fasting designed to study the safety and PK of medicated drops and tablet formulation for sublingual administration.

Conditions
Healthy
Being tested
A1, A2, A3, A4, A5

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A1Drug

    Also called Celixir 20 T1/C20- CBD 20%, THC 1%

    Medical Cannabis oil diluted in Olive oil. CBD 36.6 mg, THC 1.8 mg (6 drops)

  • A2Drug

    Also called Telixir 10 T2/C10 - CBD 2%, THC 10%

    Medical Cannabis oil diluted in Olive oil. CBD 0.6 mg, THC 3.1 mg (1 drop)

  • A3Drug

    Also called Equatir 10 T10/C10 - CBD 10%, THC 10%

    Medical Cannabis oil diluted in Olive oil. CBD 3.1 mg. THC 3.1 mg (1 drop)

  • A4Drug

    Also called C18T0.9 in MCT oil - CBD 18%, THC 0.9%

    Medical Cannabis (oil diluted in MCT oil). CBD 34.8 mg, THC 1.7 mg (6 drops)

  • A5Drug

    Also called T10/C2 - CBD 2%, THC 10%

    Medical Cannabis oil (diluted in MCT oil). CBD 0.6 mg, THC 3.1 mg (1 drop)

  • B1Drug

    Also called Tablet: CBD 40 mg, THC 2 mg

    Sublingual tablets. CBD 40 mg, THC 2 mg (1 tablet)

  • B2Drug

    Also called Tablet: CBD 30 mg, THC 5 mg

    Sublingual tablets. CBD 30 mg, THC 5 mg (1 tablet)

  • B3Drug

    Also called Tablet: CBD 40 mg

    Sublingual tablets. CBD 40 mg (1 tablet)

  • B4Drug

    Also called Tablet: CBD 40 mg

    Sublingual tablets. CBD 40 mg (1 tablet)

Study groups in NCT04261166
Study groupRoleWhat they receive
Single doseExperimentalSingle dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4
Receives: Drug: A1; Drug: A2; Drug: A3; Drug: A4; Drug: A5; Drug: B1; Drug: B2; Drug: B3; Drug: B4
Cross-Over food effectExperimental2 doses: fasted and fed state with the same product: A1, A4, A5, B4
Receives: Drug: A1; Drug: A4; Drug: A5; Drug: B4
Cross-Over product comparisonExperimental2 doses: in fasted state comparing A1 to A4
Receives: Drug: A1; Drug: A4
Cross-over route of administration comparisonExperimental2 doses: in fasted state comparing oral administration to sublingual administration of A4
Receives: Drug: A4

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic analysis of Cmax

    Measured: 0-12 hours post dose

  2. Pharmacokinetic analysis of Tlag

    Measured: 0-12 hours post dose

  3. Pharmacokinetic analysis of Tmax

    Measured: 0-12 hours post dose

  4. Pharmacokinetic analysis of AUC(0-t)

    Measured: 0-12 hours post dose

  5. Pharmacokinetic analysis of AUC(0-∞)

    Measured: 0-12 hours post dose

  6. Pharmacokinetic analysis of %AUC extrapolated

    Measured: 0-12 hours post dose

  7. Pharmacokinetic analysis of T1/2

    Measured: 0-12 hours post dose

  8. Pharmacokinetic analysis of clearance from plasma (Cl/F)

    Measured: 0-12 hours post dose

  9. Pharmacokinetic analysis of ratio of the Volume of distribution based on the terminal phase to the bioavailability (Vz/F)

    Measured: 0-12 hours post dose

  10. Pharmacokinetic analysis of clearance from plasma dose normalized Cmax

    Measured: 0-12 hours post dose

  11. Pharmacokinetic analysis of dose normalized AUC

    Measured: 0-12 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study start24 Jul 2019
  3. Primary completion24 Oct 2022
  4. Study completion24 Oct 2022

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04261166
Sponsor's protocol ID
BOL-PK-ST-02
Status last verified
Dec 2022
First submitted
4 Feb 2020
Last updated
8 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing A1, A2 and A3 in people with Healthy, run by Breath of Life International Pharma Ltd 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 11 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: finished, as of the sponsor's last update on 8 Dec 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic analysis of Cmax (time frame: 0-12 hours post dose). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04261166.

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 8 Dec 2022.

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Clinical Trial NCT04261166 | AzTrials