NCT06764147已完成1 期
Phase 1 Pharmacokinetic Study of Methoxyethyl Etomidate Hydrochloride for Injection With a Single Dose in Elderly Subjects
Ahon Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2023年12月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters
研究概览
简要总结
16 subjects were divided into two groups: One group consisted of healthy non-elderly subjects aged 18-64 years (including boundary value). The other group was healthy elderly subjects, aged ≥65 years old, of which no less than 3 cases were ≥75 years old, with 8 subjects in each group.Healthy non-elderly subjects will be included as matched control subjects. The gender of healthy non-elderly subjects was consistent with that of healthy elderly subjects. The mean body weight of the healthy non-elderly subjects was within the range of the mean body weight of the healthy elderly subjects ±10 kg.
All patients received a single intravenous injection of 0.8mg/kg ET-26. To evaluate the pharmacokinetic characteristics of ET-26 and provide guidance for the clinical application of ET-26-hcl.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •healthy adult male and female subjects aged ≥18 years;
- •Body weight: body mass index (BMI) between 19.0 and 28.0 kg/m2 (including the cut-off value), with a body weight of at least 50 kg for male subjects and 45 kg for female subjects;
- •Blood pressure of healthy subjects should be between 90-139/60-89 mmHg, heart rate and pulse should be between 55-100 beats/min
- •The subjects had good communication with the investigators, signed the informed consent form voluntarily, and were able to complete the trial according to the protocol.
排除标准
- •Auxiliary examination:
- •If the results of physical examination, vital signs, color Doppler echocardiography (only for healthy elderly subjects), cortisol test, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine) and 12-lead electrocardiogram were abnormal and clinically significant by investigator evaluation;
- •potentially difficult airway (modified Mallampati score III-IV);
- •hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
- •Medication history:
- •use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before screening;
- •use of any prescribed medication within 14 days before dosing;
- •use of over-the-counter drugs, Chinese herbal medicines or food supplements such as vitamins and calcium supplements within 7 days before administration;
- •History of disease and surgery:
- •have a history of any clinically serious diseases or diseases or conditions considered by the investigators to be likely to affect the results of the trial, including but not limited to a history of circulatory, respiratory, endocrine, nervous, digestive, urinary, or hematologic, immune, psychiatric, or metabolic diseases;
- •patients with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders;
- •patients who underwent any surgery within 6 months before screening;
- •Allergic constitution, such as known allergic history to two or more substances; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;
- •Living habits:
- •binge drinking or regular drinking in the 6 months before screening, i.e. more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Or with a positive alcohol breath test at baseline;
- •if they smoked more than 5 cigarettes per day in the 3 months before screening or could not quit smoking during the study;
- •with drug abuse or drug abuse history in the past three months; Or the baseline urine drug test was positive;
- •habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages and inability to quit during the trial;
- •those who have difficulty in blood collection, can not tolerate venipuncture, and can not tolerate arterial blood collection (e.g. Allen's test positive);
- •participated in any other clinical trial (including drug and device clinical trial) within 3 months before screening;
- •vaccinated within 1 month before screening or planned to be vaccinated during the trial period;
- •pregnant or lactating women;
- •those who planned to give birth or donate sperm during the trial and half a year after the completion of the trial, or those who did not agree that the subjects and their spouses should take strict contraceptive measures during the trial and half a year after the completion of the trial;
- •had blood loss or donation >400 mL within 3 months before screening, or received blood transfusion within 1 month;
- •subjects with any factors considered by the investigator to be ineligible for the trial.
研究组 & 干预措施
Non-elderly group
Experimental
aged 18-64 years (including boundary value)
干预措施: ET-26HCl (Drug)
Elderly group
Experimental
aged ≥65 years old, of which no less than 3 cases were ≥75 years old
干预措施: ET-26HCl (Drug)
结局指标
主要结局
Pharmacokinetic parameters
时间窗: immediately after infusion to 24 hours after infusion
AUC0-t
次要结局
- Pharmacodynamic indicators(BIS score was measured within 60 minutes before administration as baseline value,was performed every 1 minute±5second within 5minutes of administration and every 2minutes±30seconds after 5minutes of administration)
- Pharmacodynamic indicators：Eyelash reflex(every 1 minute± 5seconds during the first 5minutes of administration and every 2minutes ±30seconds after 5minutes of administration)
研究者
研究点 (1)
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