Excretion and side effects for tetrahydrocannabinol and cannabidiol (Sativex) among patients with chronic kidney disease and patients on dialysis.

Phase 1

• Conditions: Chronic kidney disease; MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2019-002786-35-DK
• Lead Sponsor: Charlotte Uggerhøj Andersen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-19
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

- Written informed consent, age =18 years and competent.
- For fertile women defined as amenorrhea for less than 12 months: Negative HCG pregnancy test before study start.
- For fertile and sexual active participants: Use of safe contraception under and 3 months after the study, i.e. intrauterine device or hormonal contraception (oral, implantable, transdermal, intravaginal, injectable). Sterile or infertile study participants are exempted from the demand to use contraception. To be considered as sterile or infertile one must generally be surgical sterilised (vasectomy/ bilateral tubectomy, hysterectomy and bilateral oophorectomy) or postmenopausal, defined as amenorrhea for 12 months, as a minimum, before study inclusion.
- For participants using hormonal contraception: Informed about and expressed acceptance of use of an additional barrier method e.g. male condom during and 3 months after the study.
- For male participants with fertile partners: Informed about and expressed acceptance of use of condom during and 3 months after the study.
- Dependent on the study participant subgroup: For group 1: eGFR =30 mL/min and >15 mL/min. For group 2: eGFR =15 mL/min. For group 3: eGFR >60 mL/min. For group 4: chronic kidney disease and treatment with dialysis.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

- Psychiatric disorder with psychotic symptoms or risk of psychotic symptoms, including schizophrenia as well as schizophrenia in the closest biologic family or previous suicide attempt.
- Alcohol abuse or other abuse.
- Treatment with benzodiazepines, benzodiazepine-like medication, opioids or warfarin.
- Treatment with or other use of products containing THC and/or CBD within 2 months.
- Treatment with strong inhibitors/inducers of CYP3A4, CYP2C19 or CYP2C9 or medicinal products with known potential of clinical significant interaction with THC and/or CBD, which cannot be paused or substituted for a period of five half-lives of the specific medicine before and during the study.
- Known unstable angina pectoris, known heart failure with ejection fraction <20%, known treatment-resistant hypertension grade 3 (systolic =175 mmHg or diastolic =105 mmHg) or significantly impaired liver function.
- Pregnancy or breastfeeding.
- Known epilepsy.
- Known allergic reaction to any of the ingredients in Sativex.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the pharmacokinetics for tetrahydrocannabinol and cannabidiol (Sativex) among patients with chronic kidney disease compared healthy volunteers.;Secondary Objective: To investigate the occurrence of side effects for tetrahydrocannabinol and cannabidiol (Sativex) among patients with chronic kidney disease compared healthy volunteers.;Primary end point(s): The primary endpoint is the AUC (area under the curve) of THC measured in blood from Sativex is administrated until 24 hours post-dosing.;Timepoint(s) of evaluation of this end point: The AUC is measured from Sativex is administrated until 24 hours post-dosing. Blood samples are drawn: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dosing.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Maximum concentration (Cmax) and time to maximum concentration (Tmax) of THCA, THC, 11-OH-THC, THC-COOH, THC-COOH-gluc, CBDA, CBD and 7-OH-CBD in blood.<br>- AUC of THCA, 11-OH-THC, THC-COOH, THC-COOH-gluc, CBDA, CBD and 7-OH-CBD in blood over 24 hours. <br>- The total excretion in urine and dialysate (for group 4) of THCA, THC, 11-OH-THC, THC-COOH, CBDA, CBD and 7-OH-CBD over 24 hours.<br>- The prevalence of side effects in the first 24 hours after the medicine is administrated, assessed on a numeric rating scale (NRS) from 0 to 10.;Timepoint(s) of evaluation of this end point: The end points is measured from Sativex is administrated until 24 hours post-dosing.