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

Primary Purpose

Cannabis, Chronic Kidney Diseases, Dialysis

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Tetrahydrocannabinol-Cannabidiol Combination
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cannabis focused on measuring Pharmacokinetics

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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) pregnant or breastfeeding women change in ideal body weight or dry weight in the last 4 weeks intradialytic hypotension (systolic blood pressure<90mmHg) requiring an intervention in the previous 4 weeks

Sites / Locations

  • St. Joseph's Healthcare HamiltonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

THC/CBD

Arm Description

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

Outcomes

Primary Outcome Measures

Tetrahydrocannabinol and its metabolites maximum concentration (Cmax)
Maximum concentration (Cmax)
Tetrahydrocannabinol and its metabolites time to Cmax
Time to Cmax
Tetrahydrocannabinol and its metabolites last detection time
Last detection time
Tetrahydrocannabinol and its metabolites area under the curve
Area under the curve
Tetrahydrocannabinol and its metabolites renal clearance
Renal clearance
Tetrahydrocannabinol and its metabolites dialytic clearance
Dialytic clearance
Cannabidiol and its metabolites maximum concentration (Cmax)
Maximum concentration (Cmax)
Cannabidiol and its metabolites time to Cmax
Time to Cmax
Cannabidiol and its metabolites last detection time
Last detection time
Cannabidiol and its metabolites area under the curve
Area under the curve
Cannabidiol and its metabolites renal clearance
Renal clearance
Cannabidiol and its metabolites dialytic clearance
Dialytic clearance
Other cannabinoids and their metabolites maximum concentration (Cmax)
Maximum concentration (Cmax)
Other cannabinoids and their metabolites time to Cmax
Time to Cmax
Other cannabinoids and their metabolites last detection time
Last detection time
Other cannabinoids and their metabolites area under the curve
Area under the curve
Other cannabinoids and their metabolites renal clearance
Renal clearance
Other cannabinoids and their metabolites dialytic clearance
Dialytic clearance

Secondary Outcome Measures

Adverse events
Weakness, fatigue, pain, falls, abnormal coordination, numbness or tingling, sedation, sleepiness, tremor, confusion, disorientation, dissociation, abnormal speech, muscle spasms, nausea, vomiting, diarrhea, altered mood, depression, euphoric mood, hallucinations, blurred vision, dizziness, imbalance, palpitations, hypotension, syncope, urinary tract infection, allergic reactions, shortness of breath, lung infection, fever, sweatiness, headache
Blood pressure
Systolic and diastolic blood pressure in mmHg
Heart rate
Heart rate in beats per minute

Full Information

First Posted
January 11, 2023
Last Updated
February 14, 2023
Sponsor
McMaster University
Collaborators
Center for Medicinal Cannabis Research
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1. Study Identification

Unique Protocol Identification Number
NCT05742724
Brief Title
The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol
Acronym
POT-GFR-PK
Official Title
The Pharmacokinetics of Oral Tetrahydrocannabinol and Cannabidiol Across the Spectrum of Glomerular Filtration Rate: a PharmacoKinetic Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Center for Medicinal Cannabis Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis, Chronic Kidney Diseases, Dialysis
Keywords
Pharmacokinetics

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
THC/CBD
Arm Type
Experimental
Arm Description
Oral THC 0.1mg/kg and CBD 2.5mg/kg
Intervention Type
Drug
Intervention Name(s)
Tetrahydrocannabinol-Cannabidiol Combination
Intervention Description
Oral THC 0.1mg/kg and CBD 2.5mg/kg
Primary Outcome Measure Information:
Title
Tetrahydrocannabinol and its metabolites maximum concentration (Cmax)
Description
Maximum concentration (Cmax)
Time Frame
48 hours
Title
Tetrahydrocannabinol and its metabolites time to Cmax
Description
Time to Cmax
Time Frame
48 hours
Title
Tetrahydrocannabinol and its metabolites last detection time
Description
Last detection time
Time Frame
48 hours
Title
Tetrahydrocannabinol and its metabolites area under the curve
Description
Area under the curve
Time Frame
48 hours
Title
Tetrahydrocannabinol and its metabolites renal clearance
Description
Renal clearance
Time Frame
48 hours
Title
Tetrahydrocannabinol and its metabolites dialytic clearance
Description
Dialytic clearance
Time Frame
48 hours
Title
Cannabidiol and its metabolites maximum concentration (Cmax)
Description
Maximum concentration (Cmax)
Time Frame
48 hours
Title
Cannabidiol and its metabolites time to Cmax
Description
Time to Cmax
Time Frame
48 hours
Title
Cannabidiol and its metabolites last detection time
Description
Last detection time
Time Frame
48 hours
Title
Cannabidiol and its metabolites area under the curve
Description
Area under the curve
Time Frame
48 hours
Title
Cannabidiol and its metabolites renal clearance
Description
Renal clearance
Time Frame
48 hours
Title
Cannabidiol and its metabolites dialytic clearance
Description
Dialytic clearance
Time Frame
48 hours
Title
Other cannabinoids and their metabolites maximum concentration (Cmax)
Description
Maximum concentration (Cmax)
Time Frame
48 hours
Title
Other cannabinoids and their metabolites time to Cmax
Description
Time to Cmax
Time Frame
48 hours
Title
Other cannabinoids and their metabolites last detection time
Description
Last detection time
Time Frame
48 hours
Title
Other cannabinoids and their metabolites area under the curve
Description
Area under the curve
Time Frame
48 hours
Title
Other cannabinoids and their metabolites renal clearance
Description
Renal clearance
Time Frame
48 hours
Title
Other cannabinoids and their metabolites dialytic clearance
Description
Dialytic clearance
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Adverse events
Description
Weakness, fatigue, pain, falls, abnormal coordination, numbness or tingling, sedation, sleepiness, tremor, confusion, disorientation, dissociation, abnormal speech, muscle spasms, nausea, vomiting, diarrhea, altered mood, depression, euphoric mood, hallucinations, blurred vision, dizziness, imbalance, palpitations, hypotension, syncope, urinary tract infection, allergic reactions, shortness of breath, lung infection, fever, sweatiness, headache
Time Frame
48 hours
Title
Blood pressure
Description
Systolic and diastolic blood pressure in mmHg
Time Frame
48 hours
Title
Heart rate
Description
Heart rate in beats per minute
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) pregnant or breastfeeding women change in ideal body weight or dry weight in the last 4 weeks intradialytic hypotension (systolic blood pressure<90mmHg) requiring an intervention in the previous 4 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Walsh, MD, PhD
Phone
905-522-1155
Ext
35016
Email
lastwalsh1975@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
David Collister, MD, PhD
Phone
780-492-8618
Email
dtcollister@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Walsh, MD, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Walsh, MD, PhD
Phone
905-522-1155
Ext
35016
Email
lastwalsh1975@gmail.com
First Name & Middle Initial & Last Name & Degree
David Collister, MD, PhD
Phone
780-492-8618
Email
dtcollister@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol

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