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Clinical trial

The Pharmacokinetics of Oral Tetrahydrocannabinol and Cannabidiol Across the Spectrum of Glomerular Filtration Rate: a PharmacoKinetic Study

ID
Name
POT_GFR_PK_001
Description
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.
Trial arms
Trial start
2023-01-11
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Tetrahydrocannabinol-Cannabidiol Combination
Oral THC 0.1mg/kg and CBD 2.5mg/kg
Arms:
THC/CBD
Size
24
Primary endpoint
Tetrahydrocannabinol and its metabolites maximum concentration (Cmax)
48 hours
Tetrahydrocannabinol and its metabolites time to Cmax
48 hours
Tetrahydrocannabinol and its metabolites last detection time
48 hours
Tetrahydrocannabinol and its metabolites area under the curve
48 hours
Tetrahydrocannabinol and its metabolites renal clearance
48 hours
Tetrahydrocannabinol and its metabolites dialytic clearance
48 hours
Cannabidiol and its metabolites maximum concentration (Cmax)
48 hours
Cannabidiol and its metabolites time to Cmax
48 hours
Cannabidiol and its metabolites last detection time
48 hours
Cannabidiol and its metabolites area under the curve
48 hours
Cannabidiol and its metabolites renal clearance
48 hours
Cannabidiol and its metabolites dialytic clearance
48 hours
Other cannabinoids and their metabolites maximum concentration (Cmax)
48 hours
Other cannabinoids and their metabolites time to Cmax
48 hours
Other cannabinoids and their metabolites last detection time
48 hours
Other cannabinoids and their metabolites area under the curve
48 hours
Other cannabinoids and their metabolites renal clearance
48 hours
Other cannabinoids and their metabolites dialytic clearance
48 hours
Eligibility criteria
Inclusion Criteria: 1. adult age\>25 years 2. 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 3. agree to take the medication as directed in the study 4. provides informed consent Exclusion Criteria: 1. body mass index \<20 or \>35kg/m2 2. physical dependence on any drug other than caffeine or nicotine 3. history of clinically significant adverse event associated with cannabis intoxication 4. history of psychosis or mania or any active major psychiatric disorder 5. recent (within 30 days) use of any cannabinoid (natural or synthetic) identified by self-report or urine drug screen for cannabinoids 6. 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) 7. evidence of liver dysfunction (ALT less than 3 times upper limit of normal, bilirubin below upper limit of normal, international normalized ratio\<1.5) 8. pregnant or breastfeeding women 9. change in ideal body weight or dry weight in the last 4 weeks 10. intradialytic hypotension (systolic blood pressure\<90mmHg) requiring an intervention in the previous 4 weeks
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}
Updated at
2023-02-24

1 organization

1 product

3 indications

Organization
McMaster University
Product
Tetrahydrocannabinol-Cannabidiol Combination
Indication
cannabis
Indication
Chronic Kidney Disease
Indication
Kidney Failure