Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

Tetra Bio-Pharma

Status and phase

Completed

Phase 1

Conditions

Healthy Volonteers

Treatments

Drug: PPP001

Study type

Interventional

Funder types

Industry

Identifiers

NCT04461756

PPP001-Ph1-03

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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