Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

NCT04461756 | Completed Phase 1

• 1 other identifier: PPP001-Ph1-03
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volonteers

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

inhaled THC/CBD (PPP001)

EXPERIMENTAL

Drug: PPP001

Interventions

PPP001 DRUG

inhalation (vape)

inhaled THC/CBD (PPP001)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Tetra Bio-Pharma: lead
• Algorithme Pharma Inc: collaborator

Study Sites (1)

Alta sciences

Montreal, Quebec, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: July 8, 2020
• Study Start: November 1, 2018
• Primary Completion: November 24, 2018
• Study Completion: November 24, 2018
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

CA (1)