NCT05503147

Sativex® and Gentamicin for Optimized Pharmagological Treatment in Older Patients (CanPan)

A Pharmacological Trial With Sativex® and Gentamicin for Optimized Phamacological Treatment of Older Patients With Focus on Appetite Stimulation and Renal Risk Drugs

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: Ove Andersen · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Malnutrition and inappropriate prescribing of renally excreted drugs are common among older persons and are associated with severe consequences such as complicated courses of treatment, mortality, and reduced quality of life. The overall purpose of CanPan is to optimize treatment of older persons with malnutrition with a focus on appetite stimulation and optimized prescribing of renal risk drugs. The CanPan trial consists of two sub-studies. Substudy 1 will provide knowledge on appetite and appetite stimulation and together, sub study 1 and 2 will offer unique knowledge on how body composition, renal function and biomarkers of organ function influence pharmacokinetics for a highly lipophilic (Sativex®) and hydrophilic (Hexamycin®) drug in older medical patients with malnutrition.

Detailed description

The CanPan trial consists of sub study 1 and sub study 2. Subjects who meet all the inclusion criteria and none of the exclusion criteria are invited to participate in both sub studies. Sub study 1 consist of trial days 1 and 2 and sub study 2 consists of trial day 3. Sub study 1: Sub study 1 is a double-blinded, randomized, placebo-controlled, multidose, crossover trial that evaluates the appetite stimulating effect as well as the pharmacokinetics of Sativex®. The primary purpose of sub study 1 is to 1) uncover whether Sativex® has appetite stimulating properties defined as increased energy intake compared to placebo, 2) to develop a pharmacokinetic-pharmacodynamic model, and gain knowledge about the effect of Sativex® on other markers of appetite, the intraocular pressure of the eye and safety parameters. In sub study 1, subjects receive both Sativex® and placebo. Both Sativex® and placebo are administered as an oromucosal spray. Sativex consists of 2.7 mg tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) per dose of spray (Cannabis sativa L. extract, cannabis leaf and flower). Subjects receive three dose of spray two times during a trial day. Trial day 1 is planned \<14 days after inclusion and there is a 2-week break between trial days 1 and 2 due to a wash-out period. Follow-up visits/phonecalls are made on days 1, 2 and 7 after trial days 1 and 2. Sub study 2: Sub-study 2 is a single-dose pharmacokinetic study using gentamicin (Hexamycin®) as a renally excreted model drug. The purpose of sub study 2 is to compare the prediction accuracy of clearance estimates between eGFRpanel (creatinine-cystatinC-beta-2\_microglobulin-beta\_trace\_protein, eGFRcomb (creatinine-cystatinC), eGFRcreatinine (creatinine), uCrCl (24-hour urine creatinine clearance) and mGFR (measured GFR) as covariates in population based pharmacokinetic modeling of gentamicin. On trial day 3, gentamicin is used as the model substance for a drug that is excreted \> 90% renally. Gentamicin is administered as a single dose of 5 mg/kg as an intravenous injection (bolus). The marketed drug, Hexamycin® (40 mg / mL), is used for this purpose. Trial day 3 is held within 4 weeks after trial day 2. Follow-up visits are made on day 1 and 2 after trial day 3.

Conditions

• Malnutrition
• Anorexia
• Cannabis
• Aging
• Emergency Service, Hospital
• Renal Function
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Sativex	Sativex® is administered as an oromucosal spray and consists of 2.7 mg tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) per dosis spray (Cannabis sativa L. extract, cannabis leaf and flower). The dose (3 sprays) is administered twice, at breakfast and lunch, respectively, with approximately 4 hours between each administration.

Timeline

• Start date: 2022-03-24
• Primary completion: 2023-08-01
• Completion: 2023-09-01
• First posted: 2022-08-16
• Last updated: 2022-09-21

Locations

1 site across 1 country: Denmark