Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

A Phase I Exploratory Study to Assess the Pharmacokinetics of Single Inhaled Dose of Cannabis (Delta-9-Tetrahydrocannabinol / Cannabidiol) Administered by Vaporization Using a 4-Day Dose Titration In Healthy Male And Female Volunteers

The primary objective of this study was to evaluate the pharmacokinetics (PK) of THC, 11-OH-THC and CBD following a single inhaled dose of PPP001 administered by vaporization.

The secondary objective of this study was to determine the safety and tolerability of THC and CBD after a single inhaled dose of PPP001 administered by vaporization in healthy volunteers.

Inclusion Criteria:

• Body mass index within 21.0 to 32.0 kg/m2, inclusively
• A light-, non- or ex-smoker of nicotine
• A history of recreational cannabis use (at least 10 times in the last 5 years)
• Consumed cannabis in the last 3 months before Day 1 of the study, but not within 1 month before Day 1 of the study
• Presence of intact oral mucosa
• Able to follow instructions at the training vaporizing session
• Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must have been without clinical significance, as determined by an investigator
• No clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs), or ECG, as determined by an investigator