NCT05742724Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 20 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 11 Jan 2023
- Start date
- 11 Jan 2024
- Primary completion date
- 16 Feb 2024
- Lead sponsor
- McMaster University
- Diseases
- Chronic kidney disease
- NCT number
- NCT05742724
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From 11 Jan 2024 to the primary completion date, 16 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- physical dependence on any drug other than caffeine or nicotine
- 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)
- intradialytic hypotension (systolic blood pressure\<90mmHg) requiring an intervention in the previous 4 weeks
Other illness
- history of clinically significant adverse event associated with cannabis intoxication
- history of psychosis or mania or any active major psychiatric disorder
Lab values
- evidence of liver dysfunction (ALT less than 3 times upper limit of normal, bilirubin below upper limit of normal, international normalized ratio\<1.5)
Other
- body mass index \<20 or \>35kg/m2
- pregnant or breastfeeding women
- change in ideal body weight or dry weight in the last 4 weeks
Who the study is looking for
- 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
Age in the registry: 25 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Joseph's Healthcare Hamilton Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.