NCT05272865

Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: LaSanta S A S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-15
• Primary completion: 2024-02-15
• Completion: 2024-10-17
• First posted: 2022-03-10
• Last updated: 2023-02-01

Locations

1 site across 1 country: Colombia