INTERVENTIONALUNKNOWNNCT05272865

Pharmacokinetic and Pharmacodynamic Evaluation of 3 Standard Formulations of Δ9-THC in Healthy Volunteers and Post-chemotherapy Patients in Colombia

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-02-01

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE1, PHASE2
Enrollment: 334 (ESTIMATED)
Start date: 2023-08-15
Sponsor: LaSanta S A S
Design: RANDOMIZED · PARALLEL · OTHER
Locations: 1
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Interventions

What was registered

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.

Administration of different Cannabis oral formulations with THC as compared with Active comparator (DRONABINOL)

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Accepted

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). -

primary outcomes

primary measures

Pharmacokinetic assessment profile of THC formulations

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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 outcomes

secondary measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame: 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

Time frame: 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

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 8e12ec09-a3c8-4de7-8f03-0cec6c108c96
Retrieved: 11/09/2026, 14:54:39
SHA-256: b9d6e64413868d7d8d6da7cb48dd36b1e40a78066c65440913be606a1ed30b15

Protocol only - no registry results posted

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator

Population and criteria

Inclusion criteria

Inclusion criteria

Exclusion criteria

Exclusion criteria

primary measures

Pharmacokinetic assessment profile of THC formulations

Pharmacodynamic assessment profile of THC formulations: BPI

Pharmacodynamic assessment profile of THC formulations: DEQ

No significant nausea in terms of the proportion of subjects with no significant nausea

secondary measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Global Quality of Life (QoL) of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire

Locally readable linked articles