Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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 Names:
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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 Names:
|
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 Names:
|
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 Names:
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic assessment profile of THC formulations [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 ]
- Pharmacodynamic assessment profile of THC formulations: BPI [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."
- Pharmacodynamic assessment profile of THC formulations: DEQ [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
- No significant nausea in terms of the proportion of subjects with no significant nausea [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
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [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
- Global Quality of Life (QoL) of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire [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
Criteria
Inclusion Criteria:
Inclusion criteria for healthy volunteers
In order to be eligible to be admitted to this study, healthy volunteers must:
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Being a person > 18 years of age
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Have the ability to understand the requirements of the study and be willing to give written informed consent
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Agree to abide by study restrictions and return for required evaluations.
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Signed written informed consent.
Inclusion criteria for patients
In order to be eligible to be admitted to this study, patients must:
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Being a person > 18 years of age
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Be a patient with documented chemotherapy treatment.
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Patients with any of the following cancers: breast, prostate, lung, colorectal, cervical, gastric and liver cancer.
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Have a life expectancy >1 year
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Have the ability to understand the requirements of the study and be willing to give written informed consent
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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:
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Recreational or medicinal use of cannabinoids in the last 3 months.
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Uses of current medications such as: immunomodulators, antibiotics, corticosteroids
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Hypersensitivity to any component of the investigational product.
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Patients prescribed dronabinol between arrival and prior to screening/randomization
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Pregnancy or lactation
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Liver pathologies and/or CYP2A3, CYP2C9 and CYP2C19 polymorphisms
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Opioid hypersensitivity
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Obesity
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Patients who have undergone concomitant immunotherapy with chemotherapy
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Cannabinoid Hyperemesis Syndrome (CHS).
Exclusion criteria for patients
To be eligible to be admitted to this study, the participant and/or patient must not:
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Patients who are null by mouth (NPO) at the time of randomization or who are expected to be NPO within the next 48 hours
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Patients who have received or are expected to receive neuraxial/locoregional blocks for pain in the next 48 hours.
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Recreational or medicinal use of cannabinoids in the last 3 months.
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Uses of current medications such as: immunomodulators, antibiotics, corticosteroids
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Hypersensitivity to any component of the investigational product.
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Patients prescribed dronabinol between arrival and prior to screening/randomization
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Pregnancy or lactation
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Liver pathologies and/or CYP2A3, CYP2C9 and CYP2C19 polymorphisms
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Opioid hypersensitivity
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Obesity
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Patients who have undergone concomitant immunotherapy with chemotherapy
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Cannabinoid Hyperemesis Syndrome (CHS). -
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Lasanta S A S | Bogotá | Colombia | 110231 |
Sponsors and Collaborators
- LaSanta S A S
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1171735