Healthy Volonteers
Conditions
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.
Interventions
DRUGPPP001
inhalation (vape)
Sponsors
Algorithme Pharma Inc
Tetra Bio-Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemistry test results [Safety and Tolerability] | over 5 days | Number of subjects with alkaline phosphatase and alanine aminotransferase (ALT) increase |
| Assessment of adverse events [Safety and Tolerability] | over 5 days | To evaluate treatment-related adverse events of PPP001 |
| 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 | — |
Countries
Canada
Outcome results
None listed