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Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

Primary Purpose

Healthy Volonteers

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
PPP001
Sponsored by
Tetra Bio-Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volonteers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alta sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

inhaled THC/CBD (PPP001)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 10, 2020
Last Updated
July 8, 2020
Sponsor
Tetra Bio-Pharma
Collaborators
Algorithme Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04461756
Brief Title
Safety and Pharmacokinetics of Vaped Cannabis 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 24, 2018 (Actual)
Study Completion Date
November 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tetra Bio-Pharma
Collaborators
Algorithme Pharma Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volonteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Alta sciences
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

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