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Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

Primary Purpose

Nausea Post Chemotherapy, Vomiting, Cancer Pain

Status
Not yet recruiting
Phase
Phase 1
Locations
Colombia
Study Type
Interventional
Intervention
Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator
Sponsored by
LaSanta S A S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nausea Post Chemotherapy focused on measuring Dronabinol, THC, Cannabinoids, Cannabigerol, Cannabichromene, Pharmacokinetic and pharmacodynamic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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). -

Sites / Locations

  • Lasanta S A S

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Dronabinol 5mg/mL

THC F1

THC F2

THC F3

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetic assessment profile of THC formulations
Pharmacokinetics of THC by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf)) [ Time Frame: 0 hours (pre-dose), as well as at 0.12, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose ]
Pharmacodynamic assessment profile of THC formulations: BPI
Brief pain inventory (BPI); The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The questions ask participants to rate their pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."
Pharmacodynamic assessment profile of THC formulations: DEQ
Drug Effects Questionnaire (DEQ);is used in studies of acute subjective response (SR) to a variety of substances. The DEQ consists of 11 questions: "Feel Drug", "Feel High", "Like Drug", and "Want More", "dislike the sensation", "any sensations", "feel a head rush", "like drug effect", "dislike any effects". To calculate the DEQ- 'Good Drug Effects'. Each question was measured on a scale with a minimum score of 0 and a maximum score of 100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome
No significant nausea in terms of the proportion of subjects with no significant nausea
To investigate THC oral formulations in terms of the proportion of patients with no significant nausea (none or mild nausea) following initiation of oral formulations of THC (dronabinol) in post-chemotherapy patients

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Evaluate the Safety and Tolerability of Oral Formulations of THC, Number of AEs during 14 days for healthy subjects and 20 days for post-chemotherapy patients vs active drug phase vs. Dronabinol active comparator
Global Quality of Life (QoL) of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire
EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials. Self-reported symptoms related to treatment. Each item is rated on a response scale 1 = not at all to 4 = very much and refer to the time frame "during the last days" EORTC QLQ-C30

Full Information

First Posted
February 14, 2022
Last Updated
January 31, 2023
Sponsor
LaSanta S A S
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1. Study Identification

Unique Protocol Identification Number
NCT05272865
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
October 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LaSanta S A S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea Post Chemotherapy, Vomiting, Cancer Pain, Cancer Related Pain, Neoplasms
Keywords
Dronabinol, THC, Cannabinoids, Cannabigerol, Cannabichromene, Pharmacokinetic and pharmacodynamic

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dronabinol 5mg/mL
Arm Type
Active Comparator
Arm Description
Drug: Dronabinol (SYNDROS) Oral solution of SYNDROS (5 mg/mL)
Arm Title
THC F1
Arm Type
Experimental
Arm Description
Drug: THC Oral solution of THC (5 mg/mL)
Arm Title
THC F2
Arm Type
Experimental
Arm Description
Drug: THC:CBG Oral solution of THC (5 mg/mL) & CBG (5 mg/mL)
Arm Title
THC F3
Arm Type
Experimental
Arm Description
Drug: THC:CBC Oral solution of THC (5 mg/mL) & CBC (5 mg/mL)
Intervention Type
Drug
Intervention Name(s)
Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator
Other Intervention Name(s)
Administration of different Cannabis oral formulations with THC as compared with Active comparator (DRONABINOL)
Intervention Description
Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy.
Primary Outcome Measure Information:
Title
Pharmacokinetic assessment profile of THC formulations
Description
Pharmacokinetics of THC by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf)) [ Time Frame: 0 hours (pre-dose), as well as at 0.12, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose ]
Time Frame
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
Title
Pharmacodynamic assessment profile of THC formulations: BPI
Description
Brief pain inventory (BPI); The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The questions ask participants to rate their pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."
Time Frame
Post-chemotherapy patients for at least 20 days with a daily report
Title
Pharmacodynamic assessment profile of THC formulations: DEQ
Description
Drug Effects Questionnaire (DEQ);is used in studies of acute subjective response (SR) to a variety of substances. The DEQ consists of 11 questions: "Feel Drug", "Feel High", "Like Drug", and "Want More", "dislike the sensation", "any sensations", "feel a head rush", "like drug effect", "dislike any effects". To calculate the DEQ- 'Good Drug Effects'. Each question was measured on a scale with a minimum score of 0 and a maximum score of 100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome
Time Frame
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
Title
No significant nausea in terms of the proportion of subjects with no significant nausea
Description
To investigate THC oral formulations in terms of the proportion of patients with no significant nausea (none or mild nausea) following initiation of oral formulations of THC (dronabinol) in post-chemotherapy patients
Time Frame
Post-chemotherapy patients for at least 20 days with a daily report
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Evaluate the Safety and Tolerability of Oral Formulations of THC, Number of AEs during 14 days for healthy subjects and 20 days for post-chemotherapy patients vs active drug phase vs. Dronabinol active comparator
Time Frame
14 days for healthy subjects, 20 days for post-chemotherapy patients
Title
Global Quality of Life (QoL) of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire
Description
EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials. Self-reported symptoms related to treatment. Each item is rated on a response scale 1 = not at all to 4 = very much and refer to the time frame "during the last days" EORTC QLQ-C30
Time Frame
at least 20 days for post-chemotherapy patients

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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). -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aura L Pinzon Galvis, PharmB
Phone
+57 3132624024
Email
apinzon@lasanta.com
Facility Information:
Facility Name
Lasanta S A S
City
Bogotá
ZIP/Postal Code
110231
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andres Turizo Smith, PharmB
Phone
+ 57 3012050949
Email
andturizosm@unal.edu.co
First Name & Middle Initial & Last Name & Degree
Andres Turizo Smith, PharmB
First Name & Middle Initial & Last Name & Degree
Carlos Rodriguez Martinez, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

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