This innovative study had two objectives. First, to determine the safety and tolerability of PPP001 following its administration over one day and seven consecutive days when smoked/inhaled using a specialized delivery device, as intended for therapeutic use. Second, to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of tetrahydrocannabinol (THC) and cannabidiol (CBD).
This was a first-in-human, single-center, double-blind, placebo-controlled, randomized within dose study to assess safety, tolerability, PK and PD of single and multiple ascending doses of cannabis by smoking/inhalation in a total of 48 healthy male and female participants.
The PK and PD results showed that the very fast onset of action will make PPP001 suitable for the treatment of breakthrough pain, and might produce a sustained therapeutic effect after hopefully diminishing the pain. An amendment was made to the dose titration and was successful in greatly reducing the adverse events experienced on the first day of dosing.
The PK and PD profiles seen were very promising for PPP001 to potentially be effective for the treatment of pain, and definitely warrant the continuation of the drug’s clinical development.