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CompletedNCT04461756Updated Jul 10, 2020

Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

A Phase 1 interventional study of PPP001 in Healthy Volonteers, sponsored by Tetra Bio-Pharma. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-10.

Sponsored by Tetra Bio-Pharma · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Nov 2018, registered Mar 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volonteers
03

In context

Lead sponsor

Tetra Bio-Pharma is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    inhaled THC/CBD (PPP001)

    Drug: PPP001

Interventions

  • DrugPPP001

    inhalation (vape)

06

What researchers measure

Primary outcomes

  1. Assessment of adverse events [Safety and Tolerability]

    To evaluate treatment-related adverse events of PPP001

    Time frame: over 5 days

  2. Biochemistry test results [Safety and Tolerability]

    Number of subjects with alkaline phosphatase and alanine aminotransferase (ALT) increase

    Time frame: over 5 days

  3. Temperature [Safety and Tolerability]

    Oral temperature in Celsius

    Time frame: over 5 days

  4. Pulse rate [Safety and Tolerability]

    Pulse rate (in beats per minute)

    Time frame: over 5 days

  5. Blood pressure [Safety and Tolerability]

    Blood pressure (systolic/diastolic blood pressure in mm Hg)

    Time frame: over 5 days

  6. Clinically significant ECG abnormalities [Safety and Tolerability]

    Number of subjects with clinically significant ECG abnormalities (measured with a 12-lead ECG)

    Time frame: over 5 days

  7. Plasma concentrations of delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)

    Time frame: over 5 days

  8. Plasma concentrations of 11-OH-delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)

    Time frame: over 5 days

  9. Plasma concentrations of cannabidiol produced by PPP001 were determined. (pharmacokinetics)

    Time frame: over 5 days

07

Study locations

1 site
  • Alta sciences
    Montreal, Quebec, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04461756
Lead sponsor
Tetra Bio-Pharma
Collaborators
Algorithme Pharma Inc
Responsible party
Sponsor
First posted
Jul 8, 2020
Start date
Nov 1, 2018
Primary completion
Nov 24, 2018
Completion
Nov 24, 2018
Last update
Jul 10, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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