Nausea Post ChemotherapyPhase 1/2NCT05272865
Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC
A Phase 1/2 study testing Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator in people with Nausea Post Chemotherapy and Vomiting, run by LaSanta S A S at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nausea Post Chemotherapy, Vomiting, Cancer Pain
- What is being tested?
- Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteColombia
- Study dates
- 15 Aug 2023to 17 Oct 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible to be admitted to this study, healthy volunteers must:
- 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.
- In order to be eligible to be admitted to this study, patients must:
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- 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.
- Have a life expectancy >1 year
- 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
Who cannot join
- To be eligible to be admitted to this study, the participant and/or patient must not:
- Recreational or medicinal use of cannabinoids in the last 3 months.
- Uses of current medications such as: immunomodulators, antibiotics, corticosteroids
- Hypersensitivity to any component of the investigational product.
- Patients prescribed dronabinol between arrival and prior to screening/randomization
- Pregnancy or lactation
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- Liver pathologies and/or CYP2A3, CYP2C9 and CYP2C19 polymorphisms
- Opioid hypersensitivity
- Obesity
- Patients who have undergone concomitant immunotherapy with chemotherapy
- Cannabinoid Hyperemesis Syndrome (CHS).
- To be eligible to be admitted to this study, the participant and/or patient must not:
- Patients who are null by mouth (NPO) at the time of randomization or who are expected to be NPO within the next 48 hours
- Patients who have received or are expected to receive neuraxial/locoregional blocks for pain in the next 48 hours.
- Recreational or medicinal use of cannabinoids in the last 3 months.
- Uses of current medications such as: immunomodulators, antibiotics, corticosteroids
- Hypersensitivity to any component of the investigational product.
- Patients prescribed dronabinol between arrival and prior to screening/randomization
- Pregnancy or lactation
- Liver pathologies and/or CYP2A3, CYP2C9 and CYP2C19 polymorphisms
- Opioid hypersensitivity
- Obesity
- Patients who have undergone concomitant immunotherapy with chemotherapy
- Cannabinoid Hyperemesis Syndrome (CHS). -
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Lasanta S A S
Bogotá, 110231
Andres Turizo Smith, PharmB, + 57 3012050949, andturizosm@unal.edu.co
Andres Turizo Smith, PharmB
About this study
Official title: 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.
Read the 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.
- Conditions
- Nausea Post Chemotherapy, Vomiting, Cancer Pain, Cancer Related Pain, Neoplasms
- Being tested
- Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator
- Keywords
- Dronabinol, THC, Cannabinoids, Cannabigerol, Cannabichromene, Pharmacokinetic and pharmacodynamic
- Medical subject headings
- Vomiting, Cancer Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparatorDrug
Also called Administration of different Cannabis oral formulations with THC as compared with Active comparator (DRONABINOL)
Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Dronabinol 5mg/mL | Active comparator | Drug: Dronabinol (SYNDROS) Oral solution of SYNDROS (5 mg/mL) Receives: Drug: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator |
| THC F1 | Experimental | Drug: THC Oral solution of THC (5 mg/mL) Receives: Drug: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator |
| THC F2 | Experimental | Drug: THC:CBG Oral solution of THC (5 mg/mL) \& CBG (5 mg/mL) Receives: Drug: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator |
| THC F3 | Experimental | Drug: THC:CBC Oral solution of THC (5 mg/mL) \& CBC (5 mg/mL) Receives: Drug: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ]
Measured: 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."
Measured: 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
Measured: 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
Measured: Post-chemotherapy patients for at least 20 days with a daily report
Secondary outcomes (2)
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
Measured: 14 days for healthy subjects, 20 days for post-chemotherapy patients
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
Measured: at least 20 days for post-chemotherapy patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start15 Aug 2023 (estimated)
- Primary completion15 Feb 2024 (estimated)
- Study completion17 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea Post ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LaSanta S A S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272865
- Sponsor's protocol ID
- 1171735
- Status last verified
- Jan 2023
- First submitted
- 14 Feb 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Evaluation of 3 Standard Formulations of Δ9-THC in Healthy Volunteers and Post-chemotherapy Patients in Colombia
- ClinicalTrials.gov ID
- NCT05272865
- Acronym / sponsor ID
- 1171735
- Conditions
- Nausea Post Chemotherapy, Vomiting, Cancer Pain, Cancer Related Pain, Neoplasms
- Keywords
- Dronabinol, THC, Cannabinoids, Cannabigerol, Cannabichromene, Pharmacokinetic and pharmacodynamic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- LaSanta S A SIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (estimated)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 17 Oct 2024 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dronabinol 5mg/mL | Active comparator | Drug: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparatorDrug: Dronabinol (SYNDROS) Oral solution of SYNDROS (5 mg/mL) |
| THC F1 | Experimental | Drug: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparatorDrug: THC Oral solution of THC (5 mg/mL) |
| THC F2 | Experimental | Drug: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparatorDrug: THC:CBG Oral solution of THC (5 mg/mL) \& CBG (5 mg/mL) |
| THC F3 | Experimental | Drug: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparatorDrug: THC:CBC Oral solution of THC (5 mg/mL) \& CBC (5 mg/mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (24 listed)
- Recreational or medicinal use of cannabinoids in the last 3 months.
- Uses of current medications such as: immunomodulators, antibiotics, corticosteroids
- Hypersensitivity to any component of the investigational product.
- Patients prescribed dronabinol between arrival and prior to screening/randomization
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparatorAlso: Administration of different Cannabis oral formulations with THC as compared with Active comparator (DRONABINOL)Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy. | Drug | Dronabinol 5mg/mL, THC F1, THC F2, THC F3 |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator in people with Nausea Post Chemotherapy and Vomiting, run by LaSanta S A S at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aura L Pinzon Galvis, PharmB (+57 3132624024, apinzon@lasanta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.