NCT04314804

Safety and Pharmacokinetics of Smoked Cannabis in Healthy Patients

A Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9- Tetrahydrocannabinol/Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers/Fasting State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Tetra Bio-Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

No actual human data for pharmacokinetics, metabolism, safety, pharmacodynamics, nor efficacy parameters are available for inhaled medical cannabis. This study was designed to investigate the innocuity and tolerability levels as well as the pharmacokinetic profile of this combination when smoked/inhaled as intended in clinical therapeutic use (i.e. patients with neuropathic pain). Consecutive dosing (over a period of 7 days) should allow to test the tolerability of chronic administration. In addition, the impact of the THC/cannabidiol pharmacological activity on the cognition activity, cognitive test will be performed before and throughout the treatment and compared to the plasma levels of THC/cannabidiol following single and multiple dosing.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PPP001	1 pellet smoked up to 3 times a day with titanium pipe (280 mg dried cannabis pellet - 9% THC / 2% CBD per pellet)
COMBINATION_PRODUCT	Placebo	1 pellet smoked up to 3 times a day with titanium pipe (280 mg dried cannabis pellet - 0% THC / 0.6% CBD per pellet)

Timeline

• Start date: 2017-03-01
• Primary completion: 2017-11-08
• Completion: 2017-11-16
• First posted: 2020-03-19
• Last updated: 2020-03-25

Locations

1 site across 1 country: Canada