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OpenTrials
Completed

NCT Number: NCT04461756

Safety and Pharmacokinetics of Vaped Cannabis in Healthy 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.

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Key information

Conditions

Healthy Volonteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alta sciences

Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PPP001

Drug

inhalation (vape)

Primary outcomes

  1. Assessment of adverse events [Safety and Tolerability]

    Time frame: over 5 days

    To evaluate treatment-related adverse events of PPP001

  2. Biochemistry test results [Safety and Tolerability]

    Time frame: over 5 days

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

  3. Temperature [Safety and Tolerability]

    Time frame: over 5 days

    Oral temperature in Celsius

  4. Pulse rate [Safety and Tolerability]

    Time frame: over 5 days

    Pulse rate (in beats per minute)

  5. Blood pressure [Safety and Tolerability]

    Time frame: over 5 days

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

  6. Clinically significant ECG abnormalities [Safety and Tolerability]

    Time frame: over 5 days

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

  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

Sponsors and collaborators

Lead sponsor

Tetra Bio-Pharma

Industry

Collaborators

  • Algorithme Pharma Inc

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 8, 2020
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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