Open-label Study to Evaluate the Pharmacokinetics and Safety of VER-01after Single and Multiple Administration of Different Doses to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-t
研究概览
简要总结
Evaluation of pharmacokinetics, tolerability and safety of VER-01 in healthy volunteers
详细描述
Determination of the single and multiple dose pharmacokinetic profile of VER-01 in healthy volunteers.
Single dose: 6 subjects each will receive VER-01 corresponding to 2.5 mg (Group A), 5 mg (Group B), 10 mg (Group C) or 20 mg THC (Group D) in the morning.
Multiple dose: 6 Subjects each receive VER-01 corresponding to 5 mg (Group E) or 10 mg (Group F) THC in the morning and in the evening on 4 consecutive days. A third group (Group G) receives VER-01 corresponding to 12.5 mg THC in the morning and 20 mg THC in the evening on 4 consecutive days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers
- •Age: 18-45 years
- •BMI: 19-30 kg/m²
- •Body weight ≥ 50 kg
- •volunteers in good general condition based on medical history, physical examination, resting ECG and clinical laboratory tests
- •Willingness of men to use a reliable method of contraception and not to donate sperm during and at least 3 months after the last intake of the study product
- •Understanding of the German language, ability to give consent and compliance
- •The subject has understood the instructions to avoid changes in lifestyle and eating habits
- •Signed patient information and written informed consent form of the study participant
排除标准
- •Consumption of cannabis-based products within 30 days prior to study start
- •Well-known strong adverse events in connection with cannabis consumption
- •Known allergy to cannabis, sesame seeds, or derivative products
- •alcohol/drug/medication abuse or physical dependence on opioids, barbiturates, amphetamines, cocaine or benzodiazepines within the last 10 years or current intake of methadone
- •Positive drug test for illegal substances and/or alcohol test at time T0
- •Heavy smokers (>10 cigarettes/day)
- •Heavy caffeine consumers (>450 mg caffeine/day equal to approx. 5-6 cups of filter coffee)
- •Drastic change in diet within 30 days before study start
- •Mental illness (psychoses, schizophrenia, bipolar disorder, severe depression, anxiety disorder, suicide)
- •Mental illness (psychoses, schizophrenia, bipolar disorder, severe depression, anxiety disorder, suicide) in a first-degree relative (parents and children)
- •subjects with orthostatic hypotension during screening (drop in systolic blood pressure by ≥20 mmHg after change of position)
- •Cardiovascular event within the last 3 months, untreated hypertension, untreated hypothyroidism, surgery within the last 2 months
- •cardiac insufficiency
- •Subjects with a serious disease or disorder which, in the opinion of the investigator, does not allow safe participation in the study from a medical point of view
- •Intake of prescription drugs within the last 14 days, over-the-counter test products within the last 7 days before the start of the study or during the study period
- •Eating of grapefruit products is not allowed during the study and 10 days before the first intake of the study product
- •Participation in another clinical trial in the period of 90 days before the start of the trial
- •Existing desire to have children or planned sperm donation (within the duration of the study and 3 months after end of the study)
- •Planned blood donation
- •No ability to consent
- •Subject is in a dependency/employment relationship with the sponsor or investigator or other persons who may be under pressure.
研究组 & 干预措施
VER-01 single dose (2.5 mg THC)
PK profile is investigated after oral intake of a single dose VER-01 corresponding to 2.5 mg THC (Group A).
干预措施: VER-01 (Drug)
VER-01 single dose (5 mg THC)
PK profile is investigated after oral intake of a single dose VER-01 corresponding to 5 mg THC (Group B).
干预措施: VER-01 (Drug)
VER-01 single dose (10 mg THC)
PK profile is investigated after oral intake of a single dose VER-01 corresponding to 10 mg THC (Group C).
干预措施: VER-01 (Drug)
VER-01 single dose (20 mg THC)
PK profile is investigated after oral intake of a single dose VER-01 corresponding to 20 mg THC (Group D).
干预措施: VER-01 (Drug)
VER-01 multiple dose (5 mg THC)
PK profile is investigated after oral intake of VER-01 corresponding to 5 mg THC in the morning and 5 mg THC in the evening on 4 consecutive days (Group E).
干预措施: VER-01 (Drug)
VER-01 multiple dose (10 mg THC)
PK profile is investigated after oral intake of VER-01 corresponding to 10 mg THC in the morning and 10 mg THC in the evening on 4 consecutive days (Group F).
干预措施: VER-01 (Drug)
VER-01 multiple dose (12.5 / 20 mg THC)
PK profile is investigated after oral intake of VER-01 corresponding to 12.5 mg THC in the morning and 20.5 mg THC in the evening on 4 consecutive days (Group F).
干预措施: VER-01 (Drug)
结局指标
主要结局
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-t
时间窗: Group A-D: Day 1; Group E-G: Day 1 and 4
Analysis of the AUC 0-t (AUC from time 0 to 24 hours) of THC over a defined period of time.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-∞
时间窗: Group A-D: Day 1; Group E-G: Day 1 and 4
Analysis of AUC 0-∞ (AUC from time 0 extrapolated to infinity) of THC over a defined period of time.
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - C max
时间窗: Group A-D: Day 1; Group E-G: Day 1 and 4
Analysis of C max (maximum plasma concentration) of THC over a defined period of time.
次要结局
- Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - λ z(Group A-D: Day 1; Group E-G: Day 1 and 4)
- Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - t 1/2(Group A-D: Day 1; Group E-G: Day 1 and 4)
- Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - AUC 0-t(Group A-D: Day 1; Group E-G: Day 1 and 4)
- Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - C max(Group A-D: Day 1; Group E-G: Day 1 and 4)
- Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - T max(Group A-D: Day 1; Group E-G: Day 1 and 4)
- Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - V area/F(Group A-D: Day 1; Group E-G: Day 1 and 4)
- Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - AUC 0-∞(Group A-D: Day 1; Group E-G: Day 1 and 4)
- Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - C L/F(Group A-D: Day 1; Group E-G: Day 1 and 4)