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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronabinol 5mg/mL | Active Comparator | Drug: Dronabinol (SYNDROS) Oral solution of SYNDROS (5 mg/mL) |
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| THC F1 | Experimental | Drug: THC Oral solution of THC (5 mg/mL) |
|
| THC F2 | Experimental | Drug: THC:CBG Oral solution of THC (5 mg/mL) & CBG (5 mg/mL) |
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| THC F3 | Experimental | Drug: THC:CBC Oral solution of THC (5 mg/mL) & CBC (5 mg/mL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator | Drug | Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ] | 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 |
| 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." | Post-chemotherapy patients for at least 20 days with a daily report |
| 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 | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14 days for healthy subjects, 20 days for post-chemotherapy patients |
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Inclusion Criteria:
Inclusion criteria for healthy volunteers
In order to be eligible to be admitted to this study, healthy volunteers must:
Inclusion criteria for patients
In order to be eligible to be admitted to this study, patients must:
Exclusion Criteria:
Exclusion criteria for healthy volunteers
To be eligible to be admitted to this study, the participant and/or patient must not:
Exclusion criteria for patients
To be eligible to be admitted to this study, the participant and/or patient must not:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aura L Pinzon Galvis, PharmB | Contact | +57 3132624024 | apinzon@lasanta.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lasanta S A S | Bogotá | 110231 | Colombia |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D000072716 | Cancer Pain |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Post-chemotherapy patients for at least 20 days with a daily report |
| 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 | at least 20 days for post-chemotherapy patients |
| D009461 | Neurologic Manifestations |