Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC (NCT05272865) | Clinical Trial Compass
UnknownPhase 1/2
Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC
Colombia334 participantsStarted 2023-08-15
Plain-language summary
Study based on the pharmacokinetic, pharmacodynamic, safety and stability evaluation of 3 standardized formulations of THC, to be used in healthy volunteers and post-chemotherapy patients as an adjuvant in the symptomatic treatment of the latter in discomfort associated with cancer treatment, with the aim of possible new therapeutic entities.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Being a person \> 18 years of age
✓. Have the ability to understand the requirements of the study and be willing to give written informed consent
✓. Agree to abide by study restrictions and return for required evaluations.
✓. Signed written informed consent.
✓. Being a person \> 18 years of age
✓. Be a patient with documented chemotherapy treatment.
✓. Patients with any of the following cancers: breast, prostate, lung, colorectal, cervical, gastric and liver cancer.
✓. Have a life expectancy \>1 year
Exclusion criteria
✕. Recreational or medicinal use of cannabinoids in the last 3 months.
✕. Uses of current medications such as: immunomodulators, antibiotics, corticosteroids
✕. Hypersensitivity to any component of the investigational product.
✕. Patients prescribed dronabinol between arrival and prior to screening/randomization
✕. Pregnancy or lactation
✕. Liver pathologies and/or CYP2A3, CYP2C9 and CYP2C19 polymorphisms
What they're measuring
1
Pharmacokinetic assessment profile of THC formulations
Timeframe: 48 hours with a replicate 7 days after the first dose in healthy subjects and the same time but with successive doses in post-chemotherapy patients
2
Pharmacodynamic assessment profile of THC formulations: BPI
Timeframe: Post-chemotherapy patients for at least 20 days with a daily report
3
Pharmacodynamic assessment profile of THC formulations: DEQ
Timeframe: 48 hours with a replicate of 7 days after the first dose in healthy subjects and on the other hand post-chemotherapy patients for at least 20 days with a daily report
4
No significant nausea in terms of the proportion of subjects with no significant nausea
Timeframe: Post-chemotherapy patients for at least 20 days with a daily report