Status:
COMPLETED
Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers
Lead Sponsor:
Tetra Bio-Pharma
Collaborating Sponsors:
Algorithme Pharma Inc
Conditions:
Healthy Volonteers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04461756
Start Date
November 1 2018
End Date
November 24 2018
Last Update
July 10 2020
Active Locations (1)
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1
Alta sciences
Montreal, Quebec, Canada