ACTRN12616001437459已完成1 期
A double-blind Phase I study to investigate safety, tolerability, andpharmacokinetics of single and repeated escalating doses of the NK1 receptor antagonistEU-C-001 given as intravenous infusions and as oraladministrations in healthy male subjects
PresSura Neuro Ltd0 个研究点目标入组 114 人开始时间: 2016年10月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •Gender Male
- •-Age: Between 18 and 45years
- •-Weight: 55–95 kg
- •-BMI: 19–29 kg/m2
- •-Medical history without clinically relevant pathologies
- •-Physical examination parameters without signs of clinically relevant pathologies
- •-Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) <450 ms
- •-Values for hematology and for biochemistry tests of blood and urine within the normal
- •range or showing no clinically relevant deviation as judged by the medical investigator
- •(in particular normal values for ALT, AST, gamma-GT)
- •-Subjects must be willing to practice a medically approved method of contraception
- •(e.g., condom in combination with hormonal contraception or intrauterine device or a
- •diaphragm after the first drug administration and for one month after participation in
- •the study or are vasectomized since > 6 months or has a partner being sterilized since
- •> 6 months
- •- Having given written informed consent before any study-related activities are carried
排除标准
- •-Evidence of clinically relevant pathology or disease
- •-Evidence of moderate or severe hypertension, hypotension or orthostatic hypotension
- •(fall in systolic blood pressure of >15 mmHg on standing up from semi-supine)
- •-Unwilling and/or incapable of giving informed consent
- •- Any history of clinically important psychiatric illness eg history of depression treated
- •with antidepressant or of any clinically important neurological or neuro-muscular
- •disorders and/or epilepsy
- •- Acute or chronic gastrointestinal disorders
- •- Presence or history of endocrine disorders
- •-Known hypersensitivity to the study drug or constituent of the study drug
- •- History of immediate hypersensitivity to any drug,
- •- Strict vegetarian or vegan
- •- Regular treatment with medications during three months prior to randomisation
- •- Receipt of any prescription or non-prescription medication, complementary therapies
- •including multi-vitamin preparations within 7 -10 days prior to randomization and for
- •the duration of the study with the exception of paracetamol at a dose less than or equal
- •to 2g per day
- •- Participation in a clinical study within 90 days prior to randomization or within 7 halflives
- •of a previous investigational agent
- •- Having already received EU-C-001
- •- Donation of blood within 90 days prior to randomisation
- •- Receipt of blood, blood products or plasma derivates one year prior to randomisation
- •- History of use of tobacco or nicotine-containing products within the past three months
- •- Any history of alcohol abuse or drug addiction
- •- Positive results at screen for drugs of abuse (cocaine, amphetamine /
- •methamphetamine, tetrahydrocannabiol, opiates) or alcohol (breath test) at screening
- •or on admission
- •- Positive screen results for HBsAg, anti-HCV, or anti-HIV1&2
- •- Consumption of abnormal quantities of coffee or tea or other caffeinated drinks (i.e.,
- •more than 5 cups per day [1 cup = 150 ml])
- •-Any disease which in the Investigator’s opinion would exclude the subject from the
研究者
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