Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

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

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.

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 effectiveness comparing with the reference product (Dronabinol 5mg/mL), formulations derived from cannabis for the management of nausea, vomiting post chemotherapy and exploratory in cancer pain.

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). -