CannabisPhase 1POT-GFR-PKNCT05742724
The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol
A Phase 1 study testing Tetrahydrocannabinol-Cannabidiol Combination in people with Cannabis and Chronic Kidney Diseases, run by McMaster University at 1 site in Canada.
Trial summary
POT-GFR-PK is a single dose pharmacokinetic study oral tetrahydrocannabinol (THC) and cannabidiol (CBD) in healthy adult controls and individuals with chronic kidney disease including those treated with in-center hemodialysis. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis, Chronic Kidney Diseases, Dialysis
- What is being tested?
- Tetrahydrocannabinol-Cannabidiol Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jan 2024to 1 Mar 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult age>25 years
- estimated glomerular filtration rate (eGFR)>60ml/min/1.73m2 or eGFR<60ml/min/1.73m2 by the CKD Epidemiology Collaboration equation including in-center hemodialysis at least 2x weekly for a minimum of 3 hours per treatment via a tunnelled catheter treated >90 days
- agree to take the medication as directed in the study
- provides informed consent
Who cannot join
- body mass index <20 or >35kg/m2
- physical dependence on any drug other than caffeine or nicotine
- history of clinically significant adverse event associated with cannabis intoxication
- history of psychosis or mania or any active major psychiatric disorder
- recent (within 30 days) use of any cannabinoid (natural or synthetic) identified by self-report or urine drug screen for cannabinoids
- taking any medication with known interactions with THC or CBD via cytochrome P450 (CYP) CYP2C9, CYP2C19 and CYP4A6 or CYP2D4 (e.g. anti-epileptic drugs, calcineurin inhibitors, anti-fungal)
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- evidence of liver dysfunction (ALT less than 3 times upper limit of normal, bilirubin below upper limit of normal, international normalized ratio<1.5)
- pregnant or breastfeeding women
- change in ideal body weight or dry weight in the last 4 weeks
- intradialytic hypotension (systolic blood pressure<90mmHg) requiring an intervention in the previous 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pharmacokinetics of Oral Tetrahydrocannabinol and Cannabidiol Across the Spectrum of Glomerular Filtration Rate: a PharmacoKinetic Study
POT-GFR-PK is a single dose pharmacokinetic study oral tetrahydrocannabinol (THC) and cannabidiol (CBD) in healthy adult controls and individuals with chronic kidney disease including those treated with in-center hemodialysis.
Read the detailed description
Adults aged greater than 25 years including 6 with eGFR>60ml/min/1.73m2, 6 eGFR 30-59ml/min/1.73m2, 6 eGFR <30ml/min/1.73m2 (CKD Epidemiology Collaboration equation) and 6 receiving in-center hemodialysis at least 2x weekly via a tunnelled catheter will receive THC 0.1mg/kg and CBD 2mg/kg by mouth in the form of MediPharm Labs-001 (MPL-001) (50mg CBD/2mg THC per 1mL). In healthy controls and participants with chronic kidney disease, blood samples will be collected at t=0, 1, 2, 3, 3.5 and 4 hours post THC/CBD administration. In participants receiving in-center hemodialysis, blood samples will be collected at t=0, 1, 2, 3, 3.5 and 4 hours post THC/CBD administration and during hemodialysis at t=0, 60, 120, 180 minutes and 15 minutes prior to the end of hemodialysis (at a reduced pump speed with blood flow 50-100ml/min) and 60 minutes post-hemodialysis. A 24 hour urine will be collected in all participants except those receiving hemodialysis without any residual urine output. Dialysate samples will be collected at 1,2,3 hours during hemodialysis and at the end of hemodialysis. Blood samples will also be collected at 24 and 48 hours. Plasma, urine and dialysis cannabinoids (THC, CBD and their metabolites) will be quantified using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry.
- Conditions
- Cannabis, Chronic Kidney Diseases, Dialysis
- Being tested
- Tetrahydrocannabinol-Cannabidiol Combination
- Keywords
- Pharmacokinetics
- Medical subject headings
- Marijuana Abuse, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetrahydrocannabinol-Cannabidiol CombinationDrug
Oral THC 0.1mg/kg and CBD 2.5mg/kg
| Study group | Role | What they receive |
|---|---|---|
| THC/CBD | Experimental | Oral THC 0.1mg/kg and CBD 2.5mg/kg Receives: Drug: Tetrahydrocannabinol-Cannabidiol Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tetrahydrocannabinol and its metabolites maximum concentration (Cmax)
Maximum concentration (Cmax)
Measured: 48 hours
Tetrahydrocannabinol and its metabolites time to Cmax
Time to Cmax
Measured: 48 hours
Tetrahydrocannabinol and its metabolites last detection time
Last detection time
Measured: 48 hours
Tetrahydrocannabinol and its metabolites area under the curve
Area under the curve
Measured: 48 hours
Tetrahydrocannabinol and its metabolites renal clearance
Renal clearance
Measured: 48 hours
Tetrahydrocannabinol and its metabolites dialytic clearance
Dialytic clearance
Measured: 48 hours
Cannabidiol and its metabolites maximum concentration (Cmax)
Maximum concentration (Cmax)
Measured: 48 hours
Cannabidiol and its metabolites time to Cmax
Time to Cmax
Measured: 48 hours
Cannabidiol and its metabolites last detection time
Last detection time
Measured: 48 hours
Cannabidiol and its metabolites area under the curve
Area under the curve
Measured: 48 hours
Cannabidiol and its metabolites renal clearance
Renal clearance
Measured: 48 hours
Cannabidiol and its metabolites dialytic clearance
Dialytic clearance
Measured: 48 hours
Other cannabinoids and their metabolites maximum concentration (Cmax)
Maximum concentration (Cmax)
Measured: 48 hours
Other cannabinoids and their metabolites time to Cmax
Time to Cmax
Measured: 48 hours
Other cannabinoids and their metabolites last detection time
Last detection time
Measured: 48 hours
Other cannabinoids and their metabolites area under the curve
Area under the curve
Measured: 48 hours
Other cannabinoids and their metabolites renal clearance
Renal clearance
Measured: 48 hours
Other cannabinoids and their metabolites dialytic clearance
Dialytic clearance
Measured: 48 hours
Secondary outcomes (3)
Adverse events
Weakness, fatigue, pain, falls, abnormal coordination, numbness or tingling, sedation, sleepiness, tremor, confusion, disorientation, dissociation, abnormal speech, muscle spasms, nausea, vomiting, diarrhea, altered mood, depression, euphoric mood, hallucinations, blurred vision, dizziness, imbalance, palpitations, hypotension, syncope, urinary tract infection, allergic reactions, shortness of breath, lung infection, fever, sweatiness, headache
Measured: 48 hours
Blood pressure
Systolic and diastolic blood pressure in mmHg
Measured: 48 hours
Heart rate
Heart rate in beats per minute
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start11 Jan 2024
- Primary completion16 Feb 2024
- Study completion1 Mar 2025 (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.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Medicinal Cannabis Research
- Responsible party
- Sponsor
- Investigators
- Michael Walsh, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742724
- Sponsor's protocol ID
- POT_GFR_PK_001
- Acronym
- POT-GFR-PK
- Status last verified
- Nov 2024
- First submitted
- 11 Jan 2023
- Last updated
- 20 Nov 2024
- 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics of Oral Tetrahydrocannabinol and Cannabidiol Across the Spectrum of Glomerular Filtration Rate: a PharmacoKinetic Study
- ClinicalTrials.gov ID
- NCT05742724
- Acronym / sponsor ID
- POT-GFR-PK / POT_GFR_PK_001
- Conditions
- Cannabis, Chronic Kidney Diseases, Dialysis
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Center for Medicinal Cannabis Research
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 24 Feb 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.
POT-GFR-PK is a single dose pharmacokinetic study oral tetrahydrocannabinol (THC) and cannabidiol (CBD) in healthy adult controls and individuals with chronic kidney disease including those treated with in-center hemodialysis.
Detailed description
Adults aged greater than 25 years including 6 with eGFR>60ml/min/1.73m2, 6 eGFR 30-59ml/min/1.73m2, 6 eGFR <30ml/min/1.73m2 (CKD Epidemiology Collaboration equation) and 6 receiving in-center hemodialysis at least 2x weekly via a tunnelled catheter will receive THC 0.1mg/kg and CBD 2mg/kg by mouth in the form of MediPharm Labs-001 (MPL-001) (50mg CBD/2mg THC per 1mL). In healthy controls and participants with chronic kidney disease, blood samples will be collected at t=0, 1, 2, 3, 3.5 and 4 hours post THC/CBD administration. In participants receiving in-center hemodialysis, blood samples will be collected at t=0, 1, 2, 3, 3.5 and 4 hours post THC/CBD administration and during hemodialysis at t=0, 60, 120, 180 minutes and 15 minutes prior to the end of hemodialysis (at a reduced pump speed with blood flow 50-100ml/min) and 60 minutes post-hemodialysis. A 24 hour urine will be collected in all participants except those receiving hemodialysis without any residual urine output. Dialysate samples will be collected at 1,2,3 hours during hemodialysis and at the end of hemodialysis. Blood samples will also be collected at 24 and 48 hours. Plasma, urine and dialysis cannabinoids (THC, CBD and their metabolites) will be quantified using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THC/CBD | Experimental | Drug: Tetrahydrocannabinol-Cannabidiol CombinationOral THC 0.1mg/kg and CBD 2.5mg/kg |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult age>25 years
- estimated glomerular filtration rate (eGFR)>60ml/min/1.73m2 or eGFR<60ml/min/1.73m2 by the CKD Epidemiology Collaboration equation including in-center hemodialysis at least 2x weekly for a minimum of 3 hours per treatment via a tunnelled catheter treated >90 days
- agree to take the medication as directed in the study
- provides informed consent
Key exclusion criteria (10 listed)
- body mass index <20 or >35kg/m2
- physical dependence on any drug other than caffeine or nicotine
- history of clinically significant adverse event associated with cannabis intoxication
- history of psychosis or mania or any active major psychiatric disorder
- recent (within 30 days) use of any cannabinoid (natural or synthetic) identified by self-report or urine drug screen for cannabinoids
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 |
|---|---|---|
| Tetrahydrocannabinol-Cannabidiol CombinationOral THC 0.1mg/kg and CBD 2.5mg/kg | Drug | THC/CBD |
Primary outcome
Tetrahydrocannabinol and its metabolites maximum concentration (Cmax)
Time frame: 48 hours
Maximum concentration (Cmax)
Tetrahydrocannabinol and its metabolites time to Cmax
Time frame: 48 hours
Time to Cmax
Tetrahydrocannabinol and its metabolites last detection time
Time frame: 48 hours
Last detection time
Tetrahydrocannabinol and its metabolites area under the curve
Time frame: 48 hours
Area under the curve
Tetrahydrocannabinol and its metabolites renal clearance
Time frame: 48 hours
Renal clearance
Tetrahydrocannabinol and its metabolites dialytic clearance
Time frame: 48 hours
Dialytic clearance
Cannabidiol and its metabolites maximum concentration (Cmax)
Time frame: 48 hours
Maximum concentration (Cmax)
Cannabidiol and its metabolites time to Cmax
Time frame: 48 hours
Time to Cmax
Cannabidiol and its metabolites last detection time
Time frame: 48 hours
Last detection time
Cannabidiol and its metabolites area under the curve
Time frame: 48 hours
Area under the curve
Cannabidiol and its metabolites renal clearance
Time frame: 48 hours
Renal clearance
Cannabidiol and its metabolites dialytic clearance
Time frame: 48 hours
Dialytic clearance
Other cannabinoids and their metabolites maximum concentration (Cmax)
Time frame: 48 hours
Maximum concentration (Cmax)
Other cannabinoids and their metabolites time to Cmax
Time frame: 48 hours
Time to Cmax
Other cannabinoids and their metabolites last detection time
Time frame: 48 hours
Last detection time
Other cannabinoids and their metabolites area under the curve
Time frame: 48 hours
Area under the curve
Other cannabinoids and their metabolites renal clearance
Time frame: 48 hours
Renal clearance
Other cannabinoids and their metabolites dialytic clearance
Time frame: 48 hours
Dialytic clearance
3 secondary outcomes
Adverse events
Time frame: 48 hours
Blood pressure
Time frame: 48 hours
Heart rate
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- 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.
Michael Walsh, MD, PhD principal investigator
McMaster University
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 Tetrahydrocannabinol-Cannabidiol Combination in people with Cannabis and Chronic Kidney Diseases, run by McMaster University 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 4 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Tetrahydrocannabinol and its metabolites maximum concentration (Cmax) (time frame: 48 hours). The study lists 18 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 20 Nov 2024.