Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

NCT05272865 | Unknown Phase 1

• 1 other identifier: 1171735
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea Post Chemotherapy; Vomiting; Cancer Pain; Cancer Related Pain; Neoplasms

Keywords

Dronabinol; THC; Cannabinoids; Cannabigerol; Cannabichromene; Pharmacokinetic and pharmacodynamic

Outcome Measures

Primary Outcomes (4)

• 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)) \[ Time Frame: 0 hours (pre-dose), as well as at 0.12, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose \]

  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."

  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

  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

  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

  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

  at least 20 days for post-chemotherapy patients

Study Arms (4)

Dronabinol 5mg/mL

ACTIVE COMPARATOR

Drug: Dronabinol (SYNDROS) Oral solution of SYNDROS (5 mg/mL)

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)

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)

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)

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

Interventions

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

Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy.

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

Dronabinol 5mg/mL; THC F1; THC F2; THC F3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• LaSanta S A S: lead

Study Sites (1)

Lasanta S A S

Bogotá, 110231, Colombia

Location

MeSH Terms

Conditions

Vomiting; Cancer Pain; Neoplasms

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Aura L Pinzon Galvis, PharmB

CONTACT

+57 3132624024; apinzon@lasanta.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 10, 2022
• Study Start: August 15, 2023
• Primary Completion: February 15, 2024
• Study Completion: October 17, 2024
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

CO (1)