Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

NCT05272865
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Phase
Phase 1/Phase 2
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Recruitment status
Unknown
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Participants
334
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Lead sponsor
LaSanta S A S
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Start date
2023-08-15
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Number of sites
1
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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.
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Short title
Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC
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Official title
Pharmacokinetic and Pharmacodynamic Evaluation of 3 Standard Formulations of Δ9-THC in Healthy Volunteers and Post-chemotherapy Patients in Colombia
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2024-10-17
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First posted
2022-03-10
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Registry last updated
2023-02-01
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Primary completion date
2024-02-15
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Start date
2023-08-15
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Participants
334
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Participant count basis
Estimated
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Planned participants
334
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
LaSanta S A S
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05272865
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ClinicalTrials.gov ID
NCT05272865
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Other
Masking
No masking
Sources for study design
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  1. 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

    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

    Timeframe: 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

    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

    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

    Timeframe: 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

  1. 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

    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

    Timeframe: 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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

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 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). -
Sources for eligibility
clinicaltrials.gov

  • Lasanta S A SBogotá, Colombia
Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Targets (1)