Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC (NCT05272865) | Clinical Trial Compass
UnknownPhase 1/2
Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC
Colombia334 participantsStarted 2023-08-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Being a person \> 18 years of age
. Have the ability to understand the requirements of the study and be willing to give written informed consent
. Agree to abide by study restrictions and return for required evaluations.
. Signed written informed consent.
. Being a person \> 18 years of age
. Be a patient with documented chemotherapy treatment.
. Patients with any of the following cancers: breast, prostate, lung, colorectal, cervical, gastric and liver cancer.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
2
Pharmacodynamic assessment profile of THC formulations: BPI
Timeframe: Post-chemotherapy patients for at least 20 days with a daily report
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
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