Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

• Status: Completed
• Trial end date: 2018-11-24
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tetra Bio-Pharma
• Collaborator: Algorithme Pharma Inc

Criteria

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