Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Healthy Volonteers

Intervention / Treatment
-----------------
* Drug: PPP001


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inhaled THC/CBD (PPP001)<br> | Drug: PPP001<br>* inhalation (vape)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events [Safety and Tolerability] | To evaluate treatment-related adverse events of PPP001 | over 5 days | 
| Biochemistry test results [Safety and Tolerability] | Number of subjects with alkaline phosphatase and alanine aminotransferase (ALT) increase | over 5 days | 
| Temperature [Safety and Tolerability] | Oral temperature in Celsius | over 5 days | 
| Pulse rate [Safety and Tolerability] | Pulse rate (in beats per minute) | over 5 days | 
| Blood pressure [Safety and Tolerability] | Blood pressure (systolic/diastolic blood pressure in mm Hg) | over 5 days | 
| Clinically significant ECG abnormalities [Safety and Tolerability] | Number of subjects with clinically significant ECG abnormalities (measured with a 12-lead ECG) | over 5 days | 
| Plasma concentrations of delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics) |  | over 5 days | 
| Plasma concentrations of 11-OH-delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics) |  | over 5 days | 
| Plasma concentrations of cannabidiol produced by PPP001 were determined. (pharmacokinetics) |  | over 5 days |