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Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

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ClinicalTrials.gov Identifier: NCT05272865
Recruitment Status : Not yet recruiting
First Posted : March 10, 2022
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
LaSanta S A S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nausea Post Chemotherapy Vomiting Cancer Pain Cancer Related Pain Neoplasms Drug: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetic and Pharmacodynamic Evaluation of 3 Standard Formulations of Δ9-THC in Healthy Volunteers and Post-chemotherapy Patients in Colombia
Estimated Study Start Date : December 15, 2022
Estimated Primary Completion Date : September 15, 2023
Estimated Study Completion Date : August 17, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dronabinol 5mg/mL
Drug: Dronabinol (SYNDROS) Oral solution of SYNDROS (5 mg/mL)
 Drug: 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.
Other Name: Administration of different Cannabis oral formulations with THC as compared with Active comparator (DRONABINOL)
Experimental: THC F1
Drug: THC Oral solution of THC (5 mg/mL)
 Drug: 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.
Other Name: Administration of different Cannabis oral formulations with THC as compared with Active comparator (DRONABINOL)
Experimental: THC F2
Drug: THC:CBG Oral solution of THC (5 mg/mL) & CBG (5 mg/mL)
 Drug: 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.
Other Name: Administration of different Cannabis oral formulations with THC as compared with Active comparator (DRONABINOL)
Experimental: THC F3
Drug: THC:CBC Oral solution of THC (5 mg/mL) & CBC (5 mg/mL)
 Drug: 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.
Other Name: Administration of different Cannabis oral formulations with THC as compared with Active comparator (DRONABINOL)


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic assessment profile of THC formulations [ 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 ]
    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 ]

  2. Pharmacodynamic assessment profile of THC formulations: BPI [ Time Frame: Post-chemotherapy patients for at least 20 days with a daily report ]
    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."

  3. Pharmacodynamic assessment profile of THC formulations: DEQ [ 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 ]
    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

  4. No significant nausea in terms of the proportion of subjects with no significant nausea [ Time Frame: Post-chemotherapy patients for at least 20 days with a daily report ]
    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 :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 14 days for healthy subjects, 20 days for post-chemotherapy patients ]
    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

  2. Global Quality of Life (QoL) of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire [ Time Frame: at least 20 days for post-chemotherapy patients ]

    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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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). -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05272865


Contacts
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Contact: Aura L Pinzon Galvis, PharmB +57 3132624024 apinzon@lasanta.com

Locations
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Colombia
Lasanta S A S
Bogotá, Colombia, 110231
Principal Investigator: Andres Turizo Smith, PharmB         
Principal Investigator: Carlos Rodriguez Martinez, M.D.         
Sponsors and Collaborators
LaSanta S A S
More Information
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Responsible Party: LaSanta S A S
ClinicalTrials.gov Identifier: NCT05272865    
Other Study ID Numbers: 1171735
First Posted: March 10, 2022    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LaSanta S A S:
Dronabinol
THC
Cannabinoids
 Cannabigerol
Cannabichromene
Pharmacokinetic and pharmacodynamic
Additional relevant MeSH terms:
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Vomiting
Cancer Pain
Signs and Symptoms, Digestive
Pain
Neurologic Manifestations
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists