Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

Healthy Volonteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04461756
• Other study ID #: PPP001-Ph1-03
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2018
• Est. completion date: November 24, 2018

Study information

• Verified date: July 2020
• Source: Tetra Bio-Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 24, 2018
• Est. primary completion date: November 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volonteers
• Marijuana Abuse

Intervention

Drug:
• PPP001
inhalation (vape)

Locations

Country	Name	City	State
Canada	Alta sciences	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Tetra Bio-Pharma	Algorithme Pharma Inc

Country where clinical trial is conducted

Canada, 

Outcome

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