A Clinical Study to Evaluate the Drug Interaction Between YZJ-1139 Tablets and Escitalopram Oxalate Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- saccade eye movement test
研究概览
简要总结
Primary Objective：
1) To evaluate the pharmacodynamic interaction between YZJ-1139 tablets and Escitalopram oxalate tablets in healthy subjects; 2) To evaluate the pharmacokinetic interaction between YZJ-1139 tablets and Escitalopram oxalate tablets in healthy subjects; To observe the safety of YZJ-1139 tablets taken together with Escitalopram oxalate tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Male or female subjects aged 18 to 45 years (inclusive);
- •Weight ≥ 50.0 kg for males, or ≥ 45.0 kg for females, and body mass index (BMI) in the range of 19.0 ~ 28.0 kg/m2 (inclusive);
- •Subjects with normal physical examination, vital signs, 12-lead ECG and laboratory tests results or abnormal but no clinical significance;
- •Subjects who are in good health and have no history of serious or chronic diseases such as respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system;
- •Subjects of childbearing potential (including partners) have no family planning or donate sperm/eggs from 2 weeks before screening to 3 months after dosing, and voluntarily take appropriate contraceptive measures;
- •Subjects who are able to understand and willing to complete the study in strict compliance with the clinical protocol and sign the informed consent form.
排除标准
- •Allergic constitution, such as those with a known history of allergies to two or more drugs or foods, or those with a history of allergies to experimental drugs or excipients;
- •Subjects with difficulty swallowing tablets and special dietary requirements who cannot accept a unified diet;
- •Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting;
- •Subjects who have undergone surgery within 30 days prior to screening, or plan to undergo surgery during the study;
- •Individuals with a history of paroxysmal sleep disorder, obstructive sleep apnea, complex sleep behavior (such as dream walking, driving in dreams, etc.), severe unconscious hypoglycemia, stroke, epilepsy, and other psychiatric disorders (including anxiety, depression, etc.), convulsive diseases, and sudden onset of illness;
- •Known to have QT prolongation or congenital QT syndrome or screening period electrocardiogram showed QTc interval (QTcF)>450 msec in males and>470 msec in females（QTcF= QT/(RR^0.33)）;
- •Those who are positive in any index screening of hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum-specific antibody, and human immunodeficiency virus antibody;
- •Subjects with a history of drug abuse, drug use within 6 months before screening, or positive drug abuse screening;
- •Subjects who frequently consume alcohol within 3 months prior to screening, i.e., consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% spirits, alcohol or 150 mL of wine), or who cannot stop using any alcohol products during the study, or whose alcohol breath test result > 0.0 mg/100 mL;
- •Subjects who have donated blood or experienced massive blood loss (> 400 mL) within 3 months prior to screening, received blood transfusions or used blood products, planned to donate blood during the trial period or within 1 month after the end of the trial;
- •Subjects who have consumed excessive tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup ≈ 250 mL) daily during the 3 months before screening;
- •Subjects smoke an average of 5 or more cigarettes per day within 3 months prior to screening, or those who cannot stop using any tobacco products during the study;
- •Subjects who have participated in any clinical trial and have used clinical trial drugs or medical device within 3 months prior to screening, or plan to participate in other clinical trials during the study;
- •Subjects who have received vaccination within 30 days prior to screening, or plan to receive vaccination during the study;
- •Subjects who have used any drugs that inhibit or induce hepatic metabolism of drugs within 30 days prior to admission (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines);
- •Subjects who have taken any prescription drugs, over-the-counter drugs, health products, vitamins, and Chinese herbal medicines within 14 days before administration;
- •Subjects who have consumed grapefruit, pomelo, pitaya, mango and other fruits or related products affecting metabolic enzymes within 14 days before administration;
- •Subjects who have ingested caffeine-rich or xanthine-rich beverages or foods (such as coffee, strong tea, chocolate, cola, etc.) within 48 h before administration;
- •Lactating women, or women who test positive for pregnancy;
- •Subjects with acute illness from screening period to pre-dose;
- •Those who, in the opinion of the investigator, are not suitable for inclusion.
研究组 & 干预措施
Group A
干预措施: Escitalopram oxalate tablets (Drug)
Group B
干预措施: Escitalopram oxalate tablets (Drug)
Group A
干预措施: YZJ-1139 tablets (Drug)
Group A
干预措施: YZJ-1139 simulated tablets (Drug)
Group B
干预措施: YZJ-1139 simulated tablets (Drug)
结局指标
主要结局
saccade eye movement test
时间窗: From Day 1 to Day 11
Saccadic eye movements were evaluated by using a computer-based electronystagmography system.To assess the change in scores for escitalopram oxalate tablets combined with YZJ-1139 tablets relative to YZJ-1139 tablets simulant and YZJ-1139 tablets.
body swing test
时间窗: From Day 1 to Day 11
Body swing test was measured with an apparatus, which integrates the amplitude of unidirectional body sway. To assess the change in scores for escitalopram oxalate tablets combined with YZJ-1139 tablets relative to YZJ-1139 tablets simulant and YZJ-1139 tablets.
selective reaction time test
时间窗: From Day 1 to Day 11
Subjects selected buttons in different directions according to Chinese character prompts on a computer screen,assess the change in scores for escitalopram oxalate tablets combined with YZJ-1139 tablets relative to YZJ-1139 tablets simulant and YZJ-1139 tablets.
number symbol conversion test
时间窗: From Day 1 to Day 11
Subjects click the corresponding number according to the corresponding relationship between the given symbol and the number. To assess the change in scores for escitalopram oxalate tablets combined with YZJ-1139 tablets relative to YZJ-1139 tablets simulant and YZJ-1139 tablets.
word memory test
时间窗: From Day 1 to Day 11
Subjects recall presented words at specific times.To assess the change in scores for escitalopram oxalate tablets combined with YZJ-1139 tablets relative to YZJ-1139 tablets simulant and YZJ-1139 tablets.
Maximum Observed Plasma Concentration (Cmax) of YZJ-1139
时间窗: From Day 1 to Day 11
Cmax is defined as the maximum concentration of drug.
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of YZJ-1139
时间窗: From Day 1 to Day 11
AUC0-t is defined as the concentration of drug from time zero to the last observable concentration.
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of YZJ-1139
时间窗: From Day 1 to Day 11
AUC0-∞ is defined as the concentration of drug extrapolated to infinite time.
Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib
时间窗: From Day 1 to Day 11
Tmax is defined as the time (observed time point) of Cmax.
Apparent Terminal Elimination Half-life (t1/2) of Entrectinib
时间窗: From Day 1 to Day 11
Apparent Oral Clearance (CL/F) of Entrectinib
时间窗: From Day 1 to Day 11
CL/F is defined as the apparent oral clearance following administration of the drug.
The Apparent Volume of Distribution (Vz/F) of Entrectinib
时间窗: From Day 1 to Day 11
Vz/F is defined as the apparent volume of distribution of the drug.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From Day 1 to Day 16
次要结局
未报告次要终点