Pharmacokinetic and Pharmacodynamic Evaluation of 3 Standard Formulations of Δ9-THC in Healthy Volunteers and Post-chemotherapy Patients in Colombia

1171735

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.

2023-08-15

2024-02-15

2024-10-17

Not yet recruiting

Early phase I

334

Inclusion Criteria: Inclusion criteria for healthy volunteers In order to be eligible to be admitted to this study, healthy volunteers must: 1. Being a person \> 18 years of age 2. Have the ability to understand the requirements of the study and be willing to give written informed consent 3. Agree to abide by study restrictions and return for required evaluations. 4. Signed written informed consent. Inclusion criteria for patients In order to be eligible to be admitted to this study, patients must: 1. Being a person \> 18 years of age 2. Be a patient with documented chemotherapy treatment. 3. Patients with any of the following cancers: breast, prostate, lung, colorectal, cervical, gastric and liver cancer. 4. Have a life expectancy \>1 year 5. Have the ability to understand the requirements of the study and be willing to give written informed consent 6. Agree to abide by study restrictions and return for required evaluations Exclusion Criteria: Exclusion criteria for healthy volunteers To be eligible to be admitted to this study, the participant and/or patient must not: 1. Recreational or medicinal use of cannabinoids in the last 3 months. 2. Uses of current medications such as: immunomodulators, antibiotics, corticosteroids 3. Hypersensitivity to any component of the investigational product. 4. Patients prescribed dronabinol between arrival and prior to screening/randomization 5. Pregnancy or lactation 6. Liver pathologies and/or CYP2A3, CYP2C9 and CYP2C19 polymorphisms 7. Opioid hypersensitivity 8. Obesity 9. Patients who have undergone concomitant immunotherapy with chemotherapy 10. Cannabinoid Hyperemesis Syndrome (CHS). Exclusion criteria for patients To be eligible to be admitted to this study, the participant and/or patient must not: 1. Patients who are null by mouth (NPO) at the time of randomization or who are expected to be NPO within the next 48 hours 2. Patients who have received or are expected to receive neuraxial/locoregional blocks for pain in the next 48 hours. 3. Recreational or medicinal use of cannabinoids in the last 3 months. 4. Uses of current medications such as: immunomodulators, antibiotics, corticosteroids 5. Hypersensitivity to any component of the investigational product. 6. Patients prescribed dronabinol between arrival and prior to screening/randomization 7. Pregnancy or lactation 8. Liver pathologies and/or CYP2A3, CYP2C9 and CYP2C19 polymorphisms 9. Opioid hypersensitivity 10. Obesity 11. Patients who have undergone concomitant immunotherapy with chemotherapy 12. Cannabinoid Hyperemesis Syndrome (CHS). -

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 334, 'type': 'ESTIMATED'}}

2023-02-01