> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/pharmacokinetic-and-pharmacodynamic-evaluation-of-97407555-e1c5-42be-af3c-7690a7ced03a > Record changed: 2026-10-13 # Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC NCT05272865 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) Participants 334 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) Lead sponsor LaSanta S A S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) Start date 2023-08-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Short title** Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Official title** Pharmacokinetic and Pharmacodynamic Evaluation of 3 Standard Formulations of Δ9-THC in Healthy Volunteers and Post-chemotherapy Patients in Colombia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) ## Dates **Completion date** 2024-10-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **First posted** 2022-03-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Registry last updated** 2023-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Primary completion date** 2024-02-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Start date** 2023-08-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) ## Size and sites **Participants** 334 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Planned participants** 334 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Lead sponsor** LaSanta S A S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) ## Identifiers **Registry ID** NCT05272865 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **ClinicalTrials.gov ID** NCT05272865 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Other **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) ## Outcomes ### Primary outcomes 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 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 \\\] 2. Pharmacodynamic assessment profile of THC formulations: BPI Timeframe: 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." 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 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 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 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 1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Timeframe: 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 2. Global Quality of Life (QoL) of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire Timeframe: 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 ### Exclusion criteria 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). - Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) ## Sites - Lasanta S A SBogotá, Colombia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272865) ## Related records ### Drugs (1) - [Dronabinol](https://trialight.com/data/asset/dronabinol-b3414807-1cde-4111-8024-a7a366127956.md) ### Lead sponsors (1) - [LaSanta S A S](https://trialight.com/data/company/lasanta-s-a-s-e5995b08-a58f-48e5-b113-724af47ed0c2.md) ### Targets (1) - [CNR1](https://trialight.com/data/target/cnr1-48d3113c-29b0-54a7-95e5-e98fe846a8e6.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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