Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

Tetra Bio-Pharma12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volonteers

Interventions

PPP001DRUG

inhalation (vape)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Alta sciences

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Assessment of adverse events [Safety and Tolerability]

To evaluate treatment-related adverse events of PPP001

Time frame: over 5 days

Biochemistry test results [Safety and Tolerability]

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

Time frame: over 5 days

Temperature [Safety and Tolerability]

Oral temperature in Celsius

Time frame: over 5 days

Pulse rate [Safety and Tolerability]

Pulse rate (in beats per minute)

Time frame: over 5 days

Blood pressure [Safety and Tolerability]

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

Time frame: over 5 days

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

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

Time frame: over 5 days

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

Time frame: over 5 days

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

Time frame: over 5 days

Data from ClinicalTrials.gov

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