Healthy VolonteersPhase 1NCT04461756
Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers
A Phase 1 study testing PPP001 in people with Healthy Volonteers, run by Tetra Bio-Pharma at 1 site in Canada.
Trial summary
The primary objective of this study was to evaluate the pharmacokinetics (PK) of THC, 11-OH-THC and CBD following a single inhaled dose of PPP001 administered by vaporization. The secondary objective of this study was to determine the safety and tolerability of THC and CBD after a single inhaled dose of PPP001… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volonteers
- What is being tested?
- PPP001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2018to 24 Nov 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index within 21.0 to 32.0 kg/m2, inclusively
- A light-, non- or ex-smoker of nicotine
- A history of recreational cannabis use (at least 10 times in the last 5 years)
- Consumed cannabis in the last 3 months before Day 1 of the study, but not within 1 month before Day 1 of the study
- Presence of intact oral mucosa
- Able to follow instructions at the training vaporizing session
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must have been without clinical significance, as determined by an investigator
- No clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs), or ECG, as determined by an investigator
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Exploratory Study to Assess the Pharmacokinetics of Single Inhaled Dose of Cannabis (Delta-9-Tetrahydrocannabinol / Cannabidiol) Administered by Vaporization Using a 4-Day Dose Titration In Healthy Male And Female Volunteers
The primary objective of this study was to evaluate the pharmacokinetics (PK) of THC, 11-OH-THC and CBD following a single inhaled dose of PPP001 administered by vaporization.
The secondary objective of this study was to determine the safety and tolerability of THC and CBD after a single inhaled dose of PPP001 administered by vaporization in healthy volunteers.
- Conditions
- Healthy Volonteers
- Being tested
- PPP001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPP001Drug
inhalation (vape)
| Study group | Role | What they receive |
|---|---|---|
| inhaled THC/CBD (PPP001) | Experimental | Not described Receives: Drug: PPP001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse events [Safety and Tolerability]
To evaluate treatment-related adverse events of PPP001
Measured: over 5 days
Biochemistry test results [Safety and Tolerability]
Number of subjects with alkaline phosphatase and alanine aminotransferase (ALT) increase
Measured: over 5 days
Temperature [Safety and Tolerability]
Oral temperature in Celsius
Measured: over 5 days
Pulse rate [Safety and Tolerability]
Pulse rate (in beats per minute)
Measured: over 5 days
Blood pressure [Safety and Tolerability]
Blood pressure (systolic/diastolic blood pressure in mm Hg)
Measured: over 5 days
Clinically significant ECG abnormalities [Safety and Tolerability]
Number of subjects with clinically significant ECG abnormalities (measured with a 12-lead ECG)
Measured: over 5 days
Plasma concentrations of delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)
Measured: over 5 days
Plasma concentrations of 11-OH-delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)
Measured: over 5 days
Plasma concentrations of cannabidiol produced by PPP001 were determined. (pharmacokinetics)
Measured: over 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Nov 2018
- Primary completion24 Nov 2018
- Study completion24 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolonteersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetra Bio-Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Algorithme Pharma Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461756
- Sponsor's protocol ID
- PPP001-Ph1-03
- Status last verified
- Jul 2020
- First submitted
- 10 Mar 2020
- Last updated
- 10 Jul 2020
- 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 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Exploratory Study to Assess the Pharmacokinetics of Single Inhaled Dose of Cannabis (Delta-9-Tetrahydrocannabinol / Cannabidiol) Administered by Vaporization Using a 4-Day Dose Titration In Healthy Male And Female Volunteers
- ClinicalTrials.gov ID
- NCT04461756
- Acronym / sponsor ID
- PPP001-Ph1-03
- Conditions
- Healthy Volonteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tetra Bio-PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Algorithme Pharma Inc
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 24 Nov 2018 (actual)
- Study completion
- 24 Nov 2018 (actual)
- First posted
- 8 Jul 2020 (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 this study was to evaluate the pharmacokinetics (PK) of THC, 11-OH-THC and CBD following a single inhaled dose of PPP001 administered by vaporization.
The secondary objective of this study was to determine the safety and tolerability of THC and CBD after a single inhaled dose of PPP001 administered by vaporization in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inhaled THC/CBD (PPP001) | Experimental | Drug: PPP001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Body mass index within 21.0 to 32.0 kg/m2, inclusively
- A light-, non- or ex-smoker of nicotine
- A history of recreational cannabis use (at least 10 times in the last 5 years)
- Consumed cannabis in the last 3 months before Day 1 of the study, but not within 1 month before Day 1 of the study
- Presence of intact oral mucosa
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PPP001inhalation (vape) | Drug | inhaled THC/CBD (PPP001) |
Primary outcome
Assessment of adverse events [Safety and Tolerability]
Time frame: over 5 days
To evaluate treatment-related adverse events of PPP001
Biochemistry test results [Safety and Tolerability]
Time frame: over 5 days
Number of subjects with alkaline phosphatase and alanine aminotransferase (ALT) increase
Temperature [Safety and Tolerability]
Time frame: over 5 days
Oral temperature in Celsius
Pulse rate [Safety and Tolerability]
Time frame: over 5 days
Pulse rate (in beats per minute)
Blood pressure [Safety and Tolerability]
Time frame: over 5 days
Blood pressure (systolic/diastolic blood pressure in mm Hg)
Clinically significant ECG abnormalities [Safety and Tolerability]
Time frame: over 5 days
Number of subjects with clinically significant ECG abnormalities (measured with a 12-lead ECG)
Plasma concentrations of delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)
Time frame: over 5 days
Plasma concentrations of 11-OH-delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)
Time frame: over 5 days
Plasma concentrations of cannabidiol produced by PPP001 were determined. (pharmacokinetics)
Time frame: over 5 days
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 10 Jul 2020.
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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 PPP001 in people with Healthy Volonteers, run by Tetra Bio-Pharma at 1 site in Canada.
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 8 inclusion and 0 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 10 Jul 2020. 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 Canada. 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?
Assessment of adverse events [Safety and Tolerability] (time frame: over 5 days). The study lists 9 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 10 Jul 2020.