Trials / Active Not Recruiting
Active Not RecruitingNCT05742724
The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol
The Pharmacokinetics of Oral Tetrahydrocannabinol and Cannabidiol Across the Spectrum of Glomerular Filtration Rate: a PharmacoKinetic Study
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- McMaster University · Academic / Other
- Sex
- All
- Age
- 25 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tetrahydrocannabinol-Cannabidiol Combination | Oral THC 0.1mg/kg and CBD 2.5mg/kg |
Timeline
- Start date
- 2024-01-11
- Primary completion
- 2024-02-16
- Completion
- 2025-03-01
- First posted
- 2023-02-24
- Last updated
- 2024-11-20
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05742724. Inclusion in this directory is not an endorsement.