Status:
UNKNOWN
Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC
Lead Sponsor:
LaSanta S A S
Conditions:
Nausea Post Chemotherapy
Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 adjuva...
Detailed Description
This evaluation project of 3 oral formulations of Δ9-THC will be carried out in two phases: Phase I evaluation of bioequivalences in healthy subjects and Phase II evaluation of safety and effectivenes...
Eligibility Criteria
Inclusion
- Inclusion criteria for healthy volunteers
- In order to be eligible to be admitted to this study, healthy volunteers must:
- 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.
- Inclusion criteria for patients
- In order to be eligible to be admitted to this study, patients must:
- 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
- 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
Exclusion
- Exclusion criteria for healthy volunteers
- To be eligible to be admitted to this study, the participant and/or patient must not:
- 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
- Opioid hypersensitivity
- Obesity
- Patients who have undergone concomitant immunotherapy with chemotherapy
- Cannabinoid Hyperemesis Syndrome (CHS).
- Exclusion criteria for patients
- To be eligible to be admitted to this study, the participant and/or patient must not:
- Patients who are null by mouth (NPO) at the time of randomization or who are expected to be NPO within the next 48 hours
- Patients who have received or are expected to receive neuraxial/locoregional blocks for pain in the next 48 hours.
- 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
- Opioid hypersensitivity
- Obesity
- Patients who have undergone concomitant immunotherapy with chemotherapy
- Cannabinoid Hyperemesis Syndrome (CHS). -
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 17 2024
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT05272865
Start Date
August 15 2023
End Date
October 17 2024
Last Update
February 1 2023
Active Locations (1)
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1
Lasanta S A S
Bogotá, Colombia, 110231