Clinical trial NCT05272865: Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC
Official title: Pharmacokinetic and Pharmacodynamic Evaluation of 3 Standard Formulations of Δ9-THC in Healthy Volunteers and Post-chemotherapy Patients in Colombia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Nausea Post Chemotherapy
Vomiting
Cancer Pain
Cancer Related Pain
Neoplasms
Keywords: Dronabinol
THC
Cannabinoids
Cannabigerol
Cannabichromene
Pharmacokinetic and pharmacodynamic
Lead sponsor: LaSanta S A S
Sponsor class: INDUSTRY
First posted: 2022-03-10
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 adjuvant in the symptomatic treatment of the latter in discomfort associated with cancer treatment, with the aim of possible new therapeutic entities.

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 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.

Eligibility criteria: 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). -

Primary outcomes:
measure: 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
measure: Pharmacodynamic assessment profile of THC formulations: BPI
timeFrame: Post-chemotherapy patients for at least 20 days with a daily report
measure: 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
measure: 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
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 14 days for healthy subjects, 20 days for post-chemotherapy patients
measure: Global Quality of Life (QoL) of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire
timeFrame: at least 20 days for post-chemotherapy patients
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Lasanta S A S
Study officials:
References: