Healthy VolunteersPhase 1NCT03201835
5-Way Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of New Oral Cannabinoid Formulations Administered as Single Doses, With Buccal Sativex®, in Healthy Volunteers
A Phase 1 study testing PNL-THC:CBD soft gelatin capsule, Sativex and CBD hard capsule dose 1 in people with Healthy Volunteers, run by PhytoTech Therapeutics, Ltd. at 1 site in Israel.
Trial summary
The primary objective of the study was to evaluate the safety and tolerability of novel oral capsules containing THC and/or CBD, following a single administration to healthy volunteers. 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 Volunteers
- What is being tested?
- PNL-THC:CBD soft gelatin capsule, Sativex and CBD hard capsule dose 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Sep 2015to 6 Jun 2016
- 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
- Healthy men between 18 and 45 years (inclusive) of age.
- Subjects who provide written informed consent to participate in the study.
- Body Mass Index (BMI) 19 to <30 kg/m2 and weight ranging between 65-85 kg.
- Non-smoking and no use of any tobacco or nicotine products (by declaration) for a period of at least 6 months prior to screening visit
- Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
- Supine blood pressure and heart rate within normal limits (blood pressure: systolic 90-140 mmHg; diastolic 50-90 mmHg, heart rate 50- 100 beats per minute (bpm)) on Screening visit.
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- Electrocardiogram (ECG) with no clinically significant abnormalities recorded at screening visit. Investigator assessment/discretion in cases of borderline results is allowed.
- Negative HIV, Hepatitis B and Hepatitis C serology tests at screening.
- No clinically significant abnormalities in hematology, blood chemistry, or urinalysis lab tests at screening.
- No known history of alcohol or drug abuse. Negative urinary screen for drugs of abuse determined on Screening visit and on admission before each dosing (urine THC will be measured only before first dosing).
- Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study.
- Subjects must agree to abstain from driving from first drug administration until 3 weeks after last dosing.
- Subject 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.
- Willing to abstain from cannabis use 30 days before and throughout the study duration.
Who cannot join
- Known hypersensitivity to cannabinoids (including cannabis extracts), excipients or capsules.
- Any history of adverse events associated with cannabis intoxication or dependence.
- Known/suspected history or family history of psychiatric disorders
- History of fainting or recurrent dizziness
- History of epilepsy/seizures.
- Documented history or ongoing symptoms of any gastrointestinal disorder involving motility, gastric acid or gastric emptying or malabsorption, including but not limited to, peptic ulcer disease, gastroesophageal reflux, dyspepsia, gastroparesis, chronic diarrhea, chronic constipation, gall bladder disease, pancreatitis, lactose intolerance and celiac disease.
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- History of esophageal, gastric, biliary, or intestinal surgery (excluding herniotomy and appendectomy which are not related to gastrointestinal disorders).
- Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
- Presence of mouth ulcerations or any abnormalities of the oral cavity.
- Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at screening visit.
- Used cannabinoids or a cannabinoid-based medicine within 30 days prior to receiving study medication.
- Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements within 14 days prior to anticipated first dosing; subjects who had treatment with any known enzyme-altering agent (e.g. CYP450 inducers or inhibitors), within 30 days of first dosing. Paracetamol or for symptomatic relief of pain is allowed until 24 hours prior to first study drug administration.
- Known drug hypersensitivity or history of idiosyncratic reactions to any drug.
- Subjects with an abnormal diet, who had made substantial changes to eating habits within 30 days of the study,
- History of drug or alcohol abuse in the last two years.
- Any acute illness (e.g. acute infection) within 48 hours prior to the first study drug administration that is considered of significance by the investigator.
- 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 who refuse to avoid strenuous physical activity within 48 hours prior to each drug administration and throughout in-house stay in the CRC.
- Subjects with an inability to communicate well with the investigators and CRC staff (i.e., language problem, poor mental development or impaired cerebral function).
- Subjects who are non-cooperative or unwilling to sign informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, 5-Way Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of New Oral Cannabinoid Formulations Administered as Single Doses, With Buccal Sativex®, in Healthy Volunteers
The primary objective of the study was to evaluate the safety and tolerability of novel oral capsules containing THC and/or CBD, following a single administration to healthy volunteers. The secondary objective of the study was to compare the pharmacokinetic profiles of THC, THC metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational oral formulations with Sativex® Oromucosal Spray.
Read the detailed description
Fifteen (15) healthy male volunteers received, following an overnight fasting and a standard breakfast, a single dose of either one of five administrations: PNL-THC:CBD, P-PNL-THC:CBD, CBD10 hard capsule, CBD100 hard capsule, Sativex® spray X 4. There was a wash-out period of no less than 4 days between each dosing.
Subjects underwent screening procedures within 21 days prior to first dosing, to assess their eligibility to participate in the study. Eligible subjects were admitted to the Clinical Research Center (CRC) in the evening before each study drug administration and will remained in-house for 24 hours after dosing. Following an overnight fast of at least 10 hours, the subjects received a standard meal within 30 minutes prior to dosing. Blood samples for PK were drawn at the specified time points. The subjects were monitored for safety, and AEs were recorded throughout the study. An End-of Study (EOS)/Safety Follow-up visit took place on 7-10 days after the last dose of study treatment.
- Conditions
- Healthy Volunteers
- Being tested
- PNL-THC:CBD soft gelatin capsule, Sativex, CBD hard capsule dose 1, P-PNL-THC:CBD soft gelatin capsule, CBD hard capsule dose 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNL-THC:CBD soft gelatin capsuleDrug
3 soft capsules, containing a total of 10.8 mg THC and 10 mg CBD (Each capsule contains 3.6 mg THC and 3.3 mg CBD)
SativexDrug
spray X 4 actuations
CBD hard capsule dose 1Drug
1 hard capsule containing 10 mg CBD
P-PNL-THC:CBD soft gelatin capsuleDrug
2 soft capsules containing a total of 7.2 mg THC, 6.7 mg CBD and 20 mg piperine (Each capsule contains 3.6 mg THC, 3.3 mg CBD and 10 mg piperine)
CBD hard capsule dose 2Drug
1 hard capsule containing 100 mg CBD
| Study group | Role | What they receive |
|---|---|---|
| PNL-THC:CBD soft gelatin capsule | Experimental | 3 soft capsules, containing a total of 10.8 mg THC and 10 mg CBD (Each capsule contains 3.6 mg THC and 3.3 mg CBD) Receives: Drug: PNL-THC:CBD soft gelatin capsule |
| P-PNL-THC:CBD soft gelatin capsule | Experimental | 2 soft capsules containing a total of 7.2 mg THC, 6.7 mg CBD and 20 mg piperine (Each capsule contains 3.6 mg THC, 3.3 mg CBD and 10 mg piperine) Receives: Drug: P-PNL-THC:CBD soft gelatin capsule |
| CBD hard capsule dose 1 | Experimental | 1 hard capsule containing 10 mg CBD Receives: Drug: CBD hard capsule dose 1 |
| CBD hard capsule dose 2 | Experimental | 1 hard capsule containing 100 mg CBD Receives: Drug: CBD hard capsule dose 2 |
| Sativex® | Active comparator | spray X 4 actuations, Each 100 μL spray contains 2.7 mg THC and 2.5 mg CBD, total per administration: 10.8 mg THC and 10 mg CBD Receives: Drug: Sativex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, severity, and duration of adverse events (AEs), including clinically significant laboratory abnormalities after administration of the study drugs
To evaluate the safety and tolerability of novel oral capsules containing THC and/or CBD, following a single administration to healthy volunteers. By evaluating frequency, severity, and duration of adverse events (AEs), including clinically significant laboratory abnormalities after administration of the study drugs
Measured: during 8 weeks from screening
Secondary outcomes (5)
Calculating pharmacokinetics Tmax
To compare the pharmacokinetic profiles of THC, THC metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational oral formulations with Sativex® Oromucosal Spray, The following parameters will be evaluated for each subject's plasma:Tmax.
Measured: 0-24 hours for each treatmet arm
Calculating pharmacokinetics Cmax
To compare the pharmacokinetic profiles of THC, THC metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational oral formulations with Sativex® Oromucosal Spray, The following parameters will be evaluated for each subject's plasma: Cmax
Measured: 0-24 hours for each treatmet arm
Calculating pharmacokinetics AUCT
To compare the pharmacokinetic profiles of THC, THC metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational oral formulations with Sativex® Oromucosal Spray, The following parameters will be evaluated for each subject's plasma: AUCT.
Measured: 0-24 hours for each treatmet arm
Calculating pharmacokinetics AUCInf
To compare the pharmacokinetic profiles of THC, THC metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational oral formulations with Sativex® Oromucosal Spray, The following parameters will be evaluated for each subject's plasma: AUCInf
Measured: 0-24 hours for each treatmet arm
Calculating pharmacokinetics T½.
To compare the pharmacokinetic profiles of THC, THC metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational oral formulations with Sativex® Oromucosal Spray, The following parameters will be evaluated for each subject's plasma: T½.
Measured: 0-24 hours for each treatmet arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start24 Sep 2015
- Primary completion6 Dec 2015
- Study completion6 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoTech Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201835
- Sponsor's protocol ID
- CS-PYL-001
- Status last verified
- Sep 2017
- First submitted
- 13 Jun 2017
- Last updated
- 20 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, 5-Way Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of New Oral Cannabinoid Formulations Administered as Single Doses, With Buccal Sativex®, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03201835
- Acronym / sponsor ID
- CS-PYL-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PhytoTech Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2015 (actual)
- Primary completion
- 6 Dec 2015 (actual)
- Study completion
- 6 Jun 2016 (actual)
- First posted
- 28 Jun 2017 (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.
The primary objective of the study was to evaluate the safety and tolerability of novel oral capsules containing THC and/or CBD, following a single administration to healthy volunteers. The secondary objective of the study was to compare the pharmacokinetic profiles of THC, THC metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational oral formulations with Sativex® Oromucosal Spray.
Detailed description
Fifteen (15) healthy male volunteers received, following an overnight fasting and a standard breakfast, a single dose of either one of five administrations: PNL-THC:CBD, P-PNL-THC:CBD, CBD10 hard capsule, CBD100 hard capsule, Sativex® spray X 4. There was a wash-out period of no less than 4 days between each dosing.
Subjects underwent screening procedures within 21 days prior to first dosing, to assess their eligibility to participate in the study. Eligible subjects were admitted to the Clinical Research Center (CRC) in the evening before each study drug administration and will remained in-house for 24 hours after dosing. Following an overnight fast of at least 10 hours, the subjects received a standard meal within 30 minutes prior to dosing. Blood samples for PK were drawn at the specified time points. The subjects were monitored for safety, and AEs were recorded throughout the study. An End-of Study (EOS)/Safety Follow-up visit took place on 7-10 days after the last dose of study treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PNL-THC:CBD soft gelatin capsule | Experimental | Drug: PNL-THC:CBD soft gelatin capsule3 soft capsules, containing a total of 10.8 mg THC and 10 mg CBD (Each capsule contains 3.6 mg THC and 3.3 mg CBD) |
| P-PNL-THC:CBD soft gelatin capsule | Experimental | Drug: P-PNL-THC:CBD soft gelatin capsule2 soft capsules containing a total of 7.2 mg THC, 6.7 mg CBD and 20 mg piperine (Each capsule contains 3.6 mg THC, 3.3 mg CBD and 10 mg piperine) |
| CBD hard capsule dose 1 | Experimental | Drug: CBD hard capsule dose 11 hard capsule containing 10 mg CBD |
| CBD hard capsule dose 2 | Experimental | Drug: CBD hard capsule dose 21 hard capsule containing 100 mg CBD |
| Sativex® | Active comparator | Drug: Sativexspray X 4 actuations, Each 100 μL spray contains 2.7 mg THC and 2.5 mg CBD, total per administration: 10.8 mg THC and 10 mg CBD |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy men between 18 and 45 years (inclusive) of age.
- Subjects who provide written informed consent to participate in the study.
- Body Mass Index (BMI) 19 to <30 kg/m2 and weight ranging between 65-85 kg.
- Non-smoking and no use of any tobacco or nicotine products (by declaration) for a period of at least 6 months prior to screening visit
- Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
Key exclusion criteria (21 listed)
- Known hypersensitivity to cannabinoids (including cannabis extracts), excipients or capsules.
- Any history of adverse events associated with cannabis intoxication or dependence.
- Known/suspected history or family history of psychiatric disorders
- History of fainting or recurrent dizziness
- History of epilepsy/seizures.
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 |
|---|---|---|
| PNL-THC:CBD soft gelatin capsule3 soft capsules, containing a total of 10.8 mg THC and 10 mg CBD (Each capsule contains 3.6 mg THC and 3.3 mg CBD) | Drug | PNL-THC:CBD soft gelatin capsule |
| Sativexspray X 4 actuations | Drug | Sativex® |
| CBD hard capsule dose 11 hard capsule containing 10 mg CBD | Drug | CBD hard capsule dose 1 |
| P-PNL-THC:CBD soft gelatin capsule2 soft capsules containing a total of 7.2 mg THC, 6.7 mg CBD and 20 mg piperine (Each capsule contains 3.6 mg THC, 3.3 mg CBD and 10 mg piperine) | Drug | P-PNL-THC:CBD soft gelatin capsule |
| CBD hard capsule dose 21 hard capsule containing 100 mg CBD | Drug | CBD hard capsule dose 2 |
Primary outcome
Frequency, severity, and duration of adverse events (AEs), including clinically significant laboratory abnormalities after administration of the study drugs
Time frame: during 8 weeks from screening
To evaluate the safety and tolerability of novel oral capsules containing THC and/or CBD, following a single administration to healthy volunteers. By evaluating frequency, severity, and duration of adverse events (AEs), including clinically significant laboratory abnormalities after administration of the study drugs
5 secondary outcomes
Calculating pharmacokinetics Tmax
Time frame: 0-24 hours for each treatmet arm
Calculating pharmacokinetics Cmax
Time frame: 0-24 hours for each treatmet arm
Calculating pharmacokinetics AUCT
Time frame: 0-24 hours for each treatmet arm
Calculating pharmacokinetics AUCInf
Time frame: 0-24 hours for each treatmet arm
Calculating pharmacokinetics T½.
Time frame: 0-24 hours for each treatmet arm
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 20 Sep 2017.
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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 PNL-THC:CBD soft gelatin capsule, Sativex and CBD hard capsule dose 1 in people with Healthy Volunteers, run by PhytoTech Therapeutics, 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 14 inclusion and 21 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 20 Sep 2017. 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?
Frequency, severity, and duration of adverse events (AEs), including clinically significant laboratory abnormalities after administration of the study drugs (time frame: during 8 weeks from screening). 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 20 Sep 2017.