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.

Study Overview

• Status: Completed
• Conditions: Healthy Volonteers
• Intervention / Treatment: Drug: PPP001

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Alta sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: inhaled THC/CBD (PPP001)	Drug: PPP001; inhalation (vape)

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

Collaborators and Investigators

• Sponsor: Tetra Bio-Pharma
• Collaborators: Algorithme Pharma Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): November 24, 2018
• Study Completion (ACTUAL): November 24, 2018

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (ACTUAL): July 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: PPP001-Ph1-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No