The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol (POT-GFR-PK)

McMaster University

Status and phase: Active, not recruiting; Phase 1

Conditions: Chronic Kidney Diseases; Dialysis; Cannabis

Treatments: Drug: Tetrahydrocannabinol-Cannabidiol Combination

Study type: Interventional

Funder types: Other

Identifiers

NCT05742724

POT_GFR_PK_001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

THC/CBD

Experimental group

Description:

Oral THC 0.1mg/kg and CBD 2.5mg/kg

Treatment:

Drug: Tetrahydrocannabinol-Cannabidiol Combination