Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers
- Registration Number
- NCT04461756
- Lead Sponsor
- Tetra Bio-Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description inhaled THC/CBD (PPP001) PPP001 -
- Primary Outcome Measures
Name Time Method Assessment of adverse events [Safety and Tolerability] over 5 days To evaluate treatment-related adverse events of PPP001
Biochemistry test results [Safety and Tolerability] over 5 days Number of subjects with alkaline phosphatase and alanine aminotransferase (ALT) increase
Temperature [Safety and Tolerability] over 5 days Oral temperature in Celsius
Pulse rate [Safety and Tolerability] over 5 days Pulse rate (in beats per minute)
Blood pressure [Safety and Tolerability] over 5 days Blood pressure (systolic/diastolic blood pressure in mm Hg)
Clinically significant ECG abnormalities [Safety and Tolerability] over 5 days 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) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Alta sciences
🇨🇦Montreal, Quebec, Canada