Healthy SubjectsPhase 1NCT03936907
Comparison of Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis (MGC) Orally Disintegrating Tablets With Buccal Sativex®, in Healthy Adult Volunteers
A Phase 1 study testing OWCP Orally Disintegrating Tablet and Sativex in people with Healthy Subjects, run by One World Cannabis Ltd. at 1 site in Israel.
Trial summary
This is a preliminary study designed to assess the safety and properties of a new oral formulation containing the two most common cannabinoids used for medicinal purposes - Tetrahydrocannabinol (THC) and Cannabidiol (CBD). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- OWCP Orally Disintegrating Tablet and Sativex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Apr 2019to 18 Jul 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who provide written informed consent to participate in the study.
- Subjects who agree to have their name and details disclosed to the Israeli Ministry of Health and other responsible official authorities, as per the local legal requirement for participation in a THC study.
- Body Mass Index (BMI) ranging from 18 to <30 kg/m2.
- Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs, ECG and a physical examination.
- No history of either recurrent or current buccal disorders (e.g. aphthae, xerostomia, infections).
- Supine blood pressure and heart rate within normal limits (systolic 90-140 mmHg; diastolic 50-90 mmHg, heart rate 45-100 beats per minute). No evidence of orthostatic hypotension.
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- No clinically significant abnormalities in clinical laboratory parameters (hematology, blood chemistry, or urinalysis).
- Negative HIV 1/2, HBSAg, HCV serology tests at Screening.
- Subjects who agree to use an effective method of contraception during the course of the study. These include condom, having undergone a vasectomy or abstain from sexual intercourse.
- No known history of alcohol or drug abuse. Negative urinary screen for drugs of abuse as determined on the Screening visit and on admission before dosing.
- Willing to abstain from cannabis use 30 days before and throughout the study duration.
- Subjects must agree not to engage in potentially hazardous activities such as operating machinery, working at heights (e.g. maintenance and construction, climbing a ladder) throughout the study duration.
- Subjects must agree to abstain from driving from time of drug administration until 3 weeks after dosing.
- Subjects must agree to eat all the food and beverages provided during the study, and only these meals.
- Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study.
Who cannot join
- Known history of significant medical disorders including: cardiac, gastroenterological, hepatic, renal, endocrine, neurological, hematological, neoplastic, immunological, skeletal (or other) that, as per the medical judgment of the principal investigator, could interfere with the execution and/or results of the study or contraindicates administration of the study medications.
- History of fainting or recurrent dizziness.
- History of epilepsy/seizures.
- History of any significant psychiatric disorder i.e., mania, depression, or schizophrenia.
- Any known or suspected history or family history of schizophrenia, or other psychotic illness, history of severe personality disorder or other severe significant psychiatric disorder other than reactive depression.
- Known hypersensitivity to cannabinoids (including cannabis extracts), excipients of tablet or of Sativex.
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- Any history of cannabis dependence.
- Any history of adverse events associated with cannabis intoxication.
- A history of drug or alcohol abuse, or a history of regular alcohol consumption (by declaration) within 6 months of the study, defined as an average weekly intake of >14 drinks. One drink is equivalent to 12 grams of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- Positive urine drug of abuse test on Screening and on admission to the CRC before dosing.
- A positive alcohol breath test on admission to the CRC before dosing.
- History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis).
- Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at the Screening visit.
- Liver disease or liver injury manifested by clinically significant abnormal liver function tests
- Subjects receiving concomitant antipsychotic, sedative, hypnotic or other psychoactive drugs.
- Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements including St. John's Wort within 14 days prior to anticipated dosing; subjects who had treatment with any known enzyme-altering agent (e.g. CYP3A4 inducers or inhibitors), within 30 days of dosing. Paracetamol for symptomatic relief of pain is allowed until 24 hours prior to study drug administration.
- Any acute illness (e.g. acute infection) within 72 hours prior to study drug administration that is considered of significance by the Principal Investigator.
- Oral piercing of the tongue, inner lip or cheek.
- Presence of mouth ulcerations or any abnormalities of the oral cavity.
- Unwilling to abstain from smoking throughout the in-house stay at the CRC.
- Unwilling to abstain from alcohol use throughout the in-house stay at the CRC.
- Subjects who refuse to avoid strenuous physical activity throughout in-house stay in the CRC.
- Participation in another clinical trial with drugs received within 3 months prior to first dosing (calculated from the previous study's last dosing date).
- Subjects who donated blood in the 3 months or received blood or plasma derivatives in the 6 months preceding study drug administration.
- Subjects with an inability to communicate well with the investigators and CRC staff (i.e., language problem, poor mental development or impaired cerebral function).
- Inability to fast or consume the food provided in the study (including any known food allergies or food restrictions such as lactose intolerance or gluten-free diet).
- Subjects who are non-cooperative or unwilling to attend scheduled clinic visits and/or comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Randomized, Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis - Orally Disintegrating Tablets (MGC-ODT) With Buccal Sativex®, in Healthy Adult Volunteers
This is a preliminary study designed to assess the safety and properties of a new oral formulation containing the two most common cannabinoids used for medicinal purposes - Tetrahydrocannabinol (THC) and Cannabidiol (CBD). The formulation is designed to disintegrate sublingually in order to enhance absorption of these ingredients by circumventing first-pass metabolism by the liver (and probably also by the intestinal mucosal cells) as well as gastric acid degradation, thus allowing a rapid onset and more intensive pharmacological effect.
Read the detailed description
This is a single-center, open-label, single-dose, crossover, randomized, pharmacokinetic study in healthy male adults.
Sixsteen (16) subjects will participate in the study. Each subject will undergo screening procedures within 28 days prior to dosing, to assess his eligibility to participate in the study.
Eligible subjects will participate in two dosing periods. They will be randomized to one of two administration sequences - AB or BA. In each period subjects will be admitted to the clinic on the evening before dosing. On the next morning, under fasting conditions they will receive one of the following administrations, according to a randomization list:
- Administration A: A single tablet of Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5mg THC and 5 mg CBD (Test Formulation)
- Administration B: Sativex® spray X 2 actuations (1 under the tongue and 1 inside the cheek administered within 2 min) - Reference Product [Each 100 μL spray contains 2.7 mg THC and 2.5 mg CBD, total per administration: 5.4 mg THC and 5.0 mg CBD] A taste assessment questionnaire will be filled in by the subjects 2 minutes after drug administration (immediately following water administration).
Dosing will be followed by Pharmacokinetic (PK ) blood sampling for 24 hours and Adverse Events (AE) monitoring for the next 24 hours, at time points specified below.
A washout period of at least 2 weeks is required between the dosings.
An End-of Study (EOS)/Safety Follow-up visit will take place 7-10 days after the last dose of study treatment.
- Conditions
- Healthy Subjects
- Being tested
- OWCP Orally Disintegrating Tablet, Sativex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OWCP Orally Disintegrating TabletDrug
Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5 mg THC and 5 mg CBD
SativexDrug
Sativex® Oromucosal Spray
| Study group | Role | What they receive |
|---|---|---|
| Orally Disintegrating MGC-ODT Tablet | Experimental | Administration of a single tablet of Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5mg THC and 5 mg CBD Receives: Drug: OWCP Orally Disintegrating Tablet |
| Sativex® | Active comparator | Sativex® spray X 2 actuations (1 under the tongue and 1 inside the cheek administered within 2 min) - Reference Product [Each 100 μL spray contains 2.7 mg THC and 2.5 mg CBD, total per administration: 5.4 mg THC and 5.0 mg CBD] Receives: Drug: Sativex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter- Tmax determined from plasma concentrations of THC, 11-hydroxy-THC and CBD.
he amount of time requires for THC, 11-hydroxy-THC and CBD to reach to maximum concentration in serum
Measured: 24 hours post dosing
Pharmacokinetic parameter -Cmax determined from plasma concentrations of THC, 11-hydroxy-THC and CBD.
Mean highest observed plasma concentration of THC, 11-hydroxy-THC and CBD after dosing.
Measured: 24 hours post dosing
Pharmacokinetic parameter- AUC0-t (area under the plasma concentration-time curve) determined from plasma concentrations of THC, 11-hydroxy-THC and CBD.
Measured: 24 hours post dosing
Pharmacokinetic parameter- T½ determined from plasma concentrations of THC, 11-hydroxy-THC and CBD.
The time required for the concentration of THC, 11-hydroxy-THC and CBD to reach half of its original value
Measured: 24 hours post dosing
Pharmacokinetic parameter- kel determined from plasma concentrations of THC, 11-hydroxy-THC and CBD.
Elimination rate constant K - The rate at which THC, 11-hydroxy-THC and CBD are removed from the body determined by their plasma concentration.
Measured: 24 hours post dosing
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerabilityof MGC-ODTand Sativex® ]
Safety
Measured: 2 weeks post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start15 Apr 2019
- Primary completion18 Jul 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Sequence ABBA
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- One World Cannabis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936907
- Sponsor's protocol ID
- OWC-ODP12
- Other IDs
- 20185282
- Status last verified
- Apr 2019
- First submitted
- 12 Feb 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Randomized, Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis - Orally Disintegrating Tablets (MGC-ODT) With Buccal Sativex®, in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03936907
- Acronym / sponsor ID
- OWC-ODP12
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- One World Cannabis Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 3 May 2019 (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.
This is a preliminary study designed to assess the safety and properties of a new oral formulation containing the two most common cannabinoids used for medicinal purposes - Tetrahydrocannabinol (THC) and Cannabidiol (CBD). The formulation is designed to disintegrate sublingually in order to enhance absorption of these ingredients by circumventing first-pass metabolism by the liver (and probably also by the intestinal mucosal cells) as well as gastric acid degradation, thus allowing a rapid onset and more intensive pharmacological effect.
Detailed description
This is a single-center, open-label, single-dose, crossover, randomized, pharmacokinetic study in healthy male adults.
Sixsteen (16) subjects will participate in the study. Each subject will undergo screening procedures within 28 days prior to dosing, to assess his eligibility to participate in the study.
Eligible subjects will participate in two dosing periods. They will be randomized to one of two administration sequences - AB or BA. In each period subjects will be admitted to the clinic on the evening before dosing. On the next morning, under fasting conditions they will receive one of the following administrations, according to a randomization list:
- Administration A: A single tablet of Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5mg THC and 5 mg CBD (Test Formulation)
- Administration B: Sativex® spray X 2 actuations (1 under the tongue and 1 inside the cheek administered within 2 min) - Reference Product [Each 100 μL spray contains 2.7 mg THC and 2.5 mg CBD, total per administration: 5.4 mg THC and 5.0 mg CBD] A taste assessment questionnaire will be filled in by the subjects 2 minutes after drug administration (immediately following water administration).
Dosing will be followed by Pharmacokinetic (PK ) blood sampling for 24 hours and Adverse Events (AE) monitoring for the next 24 hours, at time points specified below.
A washout period of at least 2 weeks is required between the dosings.
An End-of Study (EOS)/Safety Follow-up visit will take place 7-10 days after the last dose of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequence ABBA
| Arm | Type | Receives |
|---|---|---|
| Orally Disintegrating MGC-ODT Tablet | Experimental | Drug: OWCP Orally Disintegrating TabletAdministration of a single tablet of Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5mg THC and 5 mg CBD |
| Sativex® | Active comparator | Drug: SativexSativex® spray X 2 actuations (1 under the tongue and 1 inside the cheek administered within 2 min) - Reference Product [Each 100 μL spray contains 2.7 mg THC and 2.5 mg CBD, total per administration: 5.4 mg THC and 5.0 mg CBD] |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Subjects who provide written informed consent to participate in the study.
- Subjects who agree to have their name and details disclosed to the Israeli Ministry of Health and other responsible official authorities, as per the local legal requirement for participation in a THC study.
- Body Mass Index (BMI) ranging from 18 to <30 kg/m2.
- Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs, ECG and a physical examination.
- No history of either recurrent or current buccal disorders (e.g. aphthae, xerostomia, infections).
Key exclusion criteria (27 listed)
- Known history of significant medical disorders including: cardiac, gastroenterological, hepatic, renal, endocrine, neurological, hematological, neoplastic, immunological, skeletal (or other) that, as per the medical judgment of the principal investigator, could interfere with the execution and/or results of the study or contraindicates administration of the study medications.
- History of fainting or recurrent dizziness.
- History of epilepsy/seizures.
- History of any significant psychiatric disorder i.e., mania, depression, or schizophrenia.
- Any known or suspected history or family history of schizophrenia, or other psychotic illness, history of severe personality disorder or other severe significant psychiatric disorder other than reactive depression.
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 |
|---|---|---|
| OWCP Orally Disintegrating TabletMedical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5 mg THC and 5 mg CBD | Drug | Orally Disintegrating MGC-ODT Tablet |
| SativexSativex® Oromucosal Spray | Drug | Sativex® |
Primary outcome
Pharmacokinetic parameter- Tmax determined from plasma concentrations of THC, 11-hydroxy-THC and CBD.
Time frame: 24 hours post dosing
he amount of time requires for THC, 11-hydroxy-THC and CBD to reach to maximum concentration in serum
Pharmacokinetic parameter -Cmax determined from plasma concentrations of THC, 11-hydroxy-THC and CBD.
Time frame: 24 hours post dosing
Mean highest observed plasma concentration of THC, 11-hydroxy-THC and CBD after dosing.
Pharmacokinetic parameter- AUC0-t (area under the plasma concentration-time curve) determined from plasma concentrations of THC, 11-hydroxy-THC and CBD.
Time frame: 24 hours post dosing
Pharmacokinetic parameter- T½ determined from plasma concentrations of THC, 11-hydroxy-THC and CBD.
Time frame: 24 hours post dosing
The time required for the concentration of THC, 11-hydroxy-THC and CBD to reach half of its original value
Pharmacokinetic parameter- kel determined from plasma concentrations of THC, 11-hydroxy-THC and CBD.
Time frame: 24 hours post dosing
Elimination rate constant K - The rate at which THC, 11-hydroxy-THC and CBD are removed from the body determined by their plasma concentration.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerabilityof MGC-ODTand Sativex® ]
Time frame: 2 weeks post dosing
Safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 OWCP Orally Disintegrating Tablet and Sativex in people with Healthy Subjects, run by One World Cannabis 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 15 inclusion and 27 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 24 Jul 2019. 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 parameter- Tmax determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. (time frame: 24 hours post dosing). The study lists 6 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 24 Jul 2019.