NCT05267769已完成1 期
Clinical Trial on Pharmacokinetics and Tolerability of AP707
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evaluation of pharmacokinetic parameter of THC (area under the curve)
研究概览
简要总结
Brief Summary:This study aims to investigate the uptake of AP707, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.
详细描述
Pharmacokinetic parameters and tolerability of AP707 is studied over 24 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent form
- •Male at the age of 30 - 60 years at study start
- •Body mass index of 18 to 30 kg/m2
- •Non-smoker, no use of any tobacco products,
- •Good general health status (Karnofsky Score = 100; see Annex 1, page 59)
- •Current ECG without abnormal findings (no significant alterations from normal values, especially with regard to the QT interval (QTcF < 450 ms)
- •Physical examination, medical history without exclusionary findings
- •Pulse rate between 50 and 90 bpm
- •Blood pressure between systolic 90 - 140 mmHg, diastolic 50 - 90 mmHg
- •Lab values for liver function (ALT, AST, AP, Bilirubin total) within normal ranges
- •Lab value for renal function (S-Creatinine, eGFR according to CKD-EPI) within normal range
- •Negative test result on HIV I, HIV II, hepatitis B cell surface antigen, hepatitis C antibody
- •Negative test result of urine screening for Cannabis and substance abuse
排除标准
- •Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
- •Use of Cannabis products within the last 8 weeks
- •Use of opioids
- •Former or present dependency (e.g. to alcohol, medicinal products, drugs)
- •Participation in another clinical trial within the last four weeks prior to study inclusion
- •Former or present mental illnesses such as severe depression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder
- •Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)
- •Body temperature ≥ 38°C
- •Present cardiovascular, respiratory, diabetic, or cancer disease
- •Hepatitis A, B, C or other liver and renal disease
- •Other diseases or conditions that do not allow the participant to assess the nature and scope, and possible consequences of participating in this clinical trial
- •Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)
- •Taking any pharmaceutical products (including any medication interacting with metabolism of THC, e.g. St. John's wort)
研究组 & 干预措施
Verum
Experimental
AP707 single dose oromucosal application
干预措施: AP707 (Drug)
结局指标
主要结局
Evaluation of pharmacokinetic parameter of THC (area under the curve)
时间窗: 24 hours
Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product
Evaluation of pharmacokinetic parameter of THC (maximum observed drug concentration)
时间窗: 24 hours
Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product
Evaluation of pharmacokinetic parameter of THC (time to reach maximum drug concentration)
时间窗: 24 hours
Pharmacokinetic outcome of THC measured 0 to 24 hours after application of investigational product
次要结局
- Evaluation of pharmacokinetic parameter of THC (half-life associated with the terminal slope)(24 hours)
- Evaluation of pharmacokinetic parameter of 11-OH-THC (maximum observed drug concentration)(24 hours)
- Evaluation of pharmacokinetic parameter of THC (area under the curve from 0 to 24 hours)(24 hours)
- Evaluation of pharmacokinetic parameter of THC (last drug concentration above quantification limits)(24 hours)
- Evaluation of pharmacokinetic parameter of THC (time of last drug concentration above quantification limits)(24 hours)
- Evaluation of pharmacokinetic parameter of 11-OH-THC (time to reach maximum drug concentration)(24 hours)
- Evaluation of pharmacokinetic parameter of 11-OH-THC (last drug concentration above quantification limits)(24 hours)
- Adverse events (AE)(24 hours)
- Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve)(24 hours)
- Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from timepoint zero to quantification limits)(24 hours)
- Evaluation of pharmacokinetic parameter of THC (area under the curve from timepoint zero to quantification limits)(24 hours)
- Psychotropic drug effects measured by questionnaire(24 hours)
- Evaluation of pharmacokinetic parameter of 11-OH-THC (area under the curve from 0 to 24 hours)(24 hours)
- Evaluation of pharmacokinetic parameter of 11-OH-THC (time of last drug concentration above quantification limits)(24 hours)
- Evaluation of pharmacokinetic parameter of 11-OH-THC (half-life associated with the terminal slope)(24 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Clinical Trial on Pharmacokinetic and Tolerability of AP701PharmacokineticTolerabilitySafetyNCT04708795CannaXan GmbH15
已完成
2 期
A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219)Post-operative NauseaPost-operative VomitingNCT01732458Merck Sharp & Dohme LLC229
已完成
1 期
A Trial of SHR6508 in Secondary HyperparathyroidismSecondary HyperparathyroidismNCT05221008Shanghai Hengrui Pharmaceutical Co., Ltd.54
已完成
1 期
Etude (Study) Phase I Enox - UnFractionated Heparin (UFH)ThrombosisNCT00622115Sanofi72
已完成
1 期
A Safety Study of LY3526318 in Healthy ParticipantsHealthyNCT04682119Eli Lilly and Company16