The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol

NCT ID: NCT05742724

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-11
• Study Completion Date: 2025-03-01

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

THC/CBD

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

Group Type: EXPERIMENTAL

Tetrahydrocannabinol-Cannabidiol Combination

Intervention Type: DRUG

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

Interventions

Tetrahydrocannabinol-Cannabidiol Combination

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Medicinal Cannabis Research

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Walsh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

POT_GFR_PK_001

Identifier Type: -

Identifier Source: org_study_id