The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol (NCT05742724) | Clinical Trial Compass
Active — Not RecruitingPhase 1
The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol
Canada24 participantsStarted 2024-01-11
Plain-language 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.
Who can participate
Age range25 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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)
✕. evidence of liver dysfunction (ALT less than 3 times upper limit of normal, bilirubin below upper limit of normal, international normalized ratio\<1.5)
✕
What they're measuring
1
Tetrahydrocannabinol and its metabolites maximum concentration (Cmax)
Timeframe: 48 hours
2
Tetrahydrocannabinol and its metabolites time to Cmax
Timeframe: 48 hours
3
Tetrahydrocannabinol and its metabolites last detection time
Timeframe: 48 hours
4
Tetrahydrocannabinol and its metabolites area under the curve
Timeframe: 48 hours
5
Tetrahydrocannabinol and its metabolites renal clearance
Timeframe: 48 hours
6
Tetrahydrocannabinol and its metabolites dialytic clearance
Timeframe: 48 hours
7
Cannabidiol and its metabolites maximum concentration (Cmax)