NCT04667429已完成1 期
A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study of HEC83518 Tablets in Healthy Chinese Subjects
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
- 57
- 试验地点
- 1
- 主要终点
- Adverse event
研究概览
简要总结
Multiple Dose Safety, Tolerability, PK ，PD and Food Effect Study of HEC83518 in Healthy Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Ascending Multiple Dose Study is Double-blind design; Food Effect Study is open-label design.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are willing and are able to provide a written informed consent to participate in the study.
- •Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
- •Subjects aged between 18 and 45 (both inclusive) years old.
- •Healthy volunteers have a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
- •Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
排除标准
- •Subjects with a heart rate ≥100 beats per minute or ≤ 60 beats per minute at screening or baseline.
- •Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
- •Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of stroke, epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
- •Subjects with history of sleep-related illness.
- •Subjects with history of severe involuntary hypoglycemia
- •Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
- •Use of any prescription or non-prescription medications within 14 days prior to initial dosing,or Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
- •Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
- •Positive results from urine drug screen test.
- •History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test.
- •Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
- •Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
- •Subjects who plan to receive or have had organ transplants.
- •Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential. 15 Subjects who participated in another clinical trial within 3 months prior to initial dosing.
- •16.Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
研究组 & 干预措施
Food effect
Experimental
HEC83518 40mg will be administered fasted, or with high-fat meal for once.
干预措施: Food (Other)
Multiple Ascending Doses-HEC83518 20mg
Experimental
HEC83518 20mg will be administered before sleep for 15 days .
干预措施: HEC83518 (Drug)
Multiple Ascending Doses-HEC83518 40mg
Experimental
HEC83518 40mg will be administered before sleep for 15 days .
干预措施: HEC83518 (Drug)
Multiple Ascending Doses-HEC83518 80mg
Experimental
HEC83518 80mg will be administered before sleep for 15 days .
干预措施: HEC83518 (Drug)
Multiple Ascending Doses-placebo
Placebo Comparator
Placebo will be administered before sleep for 15 days .
干预措施: placebo (Drug)
结局指标
主要结局
Adverse event
时间窗: up to 34 days
To assess the safety and tolerability of therapy
次要结局
- Time to peak(tmax)(up to 72 hours)
- The Apparent Clearance (CL/F)(up to 72 hours)
- Food Effect on the AUC(up to 72 hours)
- Maximum Plasma Concentration ( Cmax)(up to 72 hours)
- Food Effect on the Cmax(up to 72 hours)
- The Mean Residence Time#(MRT)(up to 72 hours)
- The Accumulation Ratio(R)(up to 60 hours)
- Area under the concentration versus time curve (AUC) from time zero to infinity(AUC0-∞ )(up to 72 hours)
- Apparent volume of distribution(Vz/F)(up to 72 hours)
- Apparent terminal elimination half-life(t½)(up to 72 hours)
研究者
研究点 (1)
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