Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

NCT ID: NCT05272865

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2024-10-17

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.

Conditions

Nausea Post Chemotherapy; Vomiting; Cancer Pain; Cancer Related Pain; Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dronabinol 5mg/mL

Drug: Dronabinol (SYNDROS) Oral solution of SYNDROS (5 mg/mL)

Group Type: ACTIVE_COMPARATOR

Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator

Intervention Type: DRUG

Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy.

THC F1

Drug: THC Oral solution of THC (5 mg/mL)

Group Type: EXPERIMENTAL

Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator

Intervention Type: DRUG

Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy.

THC F2

Drug: THC:CBG Oral solution of THC (5 mg/mL) \& CBG (5 mg/mL)

Group Type: EXPERIMENTAL

Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator

Intervention Type: DRUG

Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy.

THC F3

Drug: THC:CBC Oral solution of THC (5 mg/mL) \& CBC (5 mg/mL)

Group Type: EXPERIMENTAL

Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator

Intervention Type: DRUG

Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy.

Interventions

Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator

Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy.

Intervention Type: DRUG

Other Intervention Names

Administration of different Cannabis oral formulations with THC as compared with Active comparator (DRONABINOL)

Eligibility Criteria

Inclusion Criteria

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.

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

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).

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). -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LaSanta S A S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lasanta S A S

Bogotá, , Colombia

Countries

Colombia

Central Contacts

Aura L Pinzon Galvis, PharmB

Role: CONTACT

apinzon@lasanta.com

+57 3132624024

Facility Contacts

Andres Turizo Smith, PharmB

Role: primary

andturizosm@unal.edu.co

+ 57 3012050949

Other Identifiers

1171735

Identifier Type: -

Identifier Source: org_study_id