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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Assessment of adverse events [Safety and Tolerability]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
inhaled THC/CBD (PPP001)
干预措施: PPP001 (Drug)
结局指标
主要结局
Assessment of adverse events [Safety and Tolerability]
时间窗: over 5 days
To evaluate treatment-related adverse events of PPP001
Biochemistry test results [Safety and Tolerability]
时间窗: over 5 days
Number of subjects with alkaline phosphatase and alanine aminotransferase (ALT) increase
Temperature [Safety and Tolerability]
时间窗: over 5 days
Oral temperature in Celsius
Pulse rate [Safety and Tolerability]
时间窗: over 5 days
Pulse rate (in beats per minute)
Blood pressure [Safety and Tolerability]
时间窗: over 5 days
Blood pressure (systolic/diastolic blood pressure in mm Hg)
Clinically significant ECG abnormalities [Safety and Tolerability]
时间窗: 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)
时间窗: over 5 days
Plasma concentrations of 11-OH-delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)
时间窗: over 5 days
Plasma concentrations of cannabidiol produced by PPP001 were determined. (pharmacokinetics)
时间窗: over 5 days
次要结局
未报告次要终点