Cancer Pain, Cancer Related Pain, Nausea Post Chemotherapy, Neoplasms, Vomiting
Conditions
Keywords
Dronabinol, THC, Cannabinoids, Cannabigerol, Cannabichromene, Pharmacokinetic and pharmacodynamic
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.
Interventions
DRUGPharmacokinetic 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.
Sponsors
LaSanta S A S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Colombia
Contacts
Primary ContactAura L Pinzon Galvis, PharmB
Outcome results
None listed