Clinical trial NCT06680531: A Clinical Study to Evaluate the Drug Interaction Between YZJ-1139 Tablets and Escitalopram Oxalate Tablets
Official title: A Clinical Study to Evaluate the Drug Interaction Between YZJ-1139 Tablets and Escitalopram Oxalate Tablets
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Insomnia
Central Nervous System
Lead sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Drug interaction
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged 18 to 45 years (inclusive);
2. 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);
3. Subjects with normal physical examination, vital signs, 12-lead ECG and laboratory tests results or abnormal but no clinical significance;
4. 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;
5. 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;
6. 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.

Exclusion Criteria:

1. 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;
2. Subjects with difficulty swallowing tablets and special dietary requirements who cannot accept a unified diet;
3. Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting;
4. Subjects who have undergone surgery within 30 days prior to screening, or plan to undergo surgery during the study;
5. 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;
6. 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)）;
7. 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;
8. Subjects with a history of drug abuse, drug use within 6 months before screening, or positive drug abuse screening;
9. 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;
10. 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;
11. 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;
12. 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;
13. 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;
14. Subjects who have received vaccination within 30 days prior to screening, or plan to receive vaccination during the study;
15. 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);
16. Subjects who have taken any prescription drugs, over-the-counter drugs, health products, vitamins, and Chinese herbal medicines within 14 days before administration;
17. Subjects who have consumed grapefruit, pomelo, pitaya, mango and other fruits or related products affecting metabolic enzymes within 14 days before administration;
18. 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;
19. Lactating women, or women who test positive for pregnancy;
20. Subjects with acute illness from screening period to pre-dose;
21. Those who, in the opinion of the investigator, are not suitable for inclusion.

Primary outcomes:
measure: saccade eye movement test
timeFrame: From Day 1 to Day 11
measure: body swing test
timeFrame: From Day 1 to Day 11
measure: selective reaction time test
timeFrame: From Day 1 to Day 11
measure: number symbol conversion test
timeFrame: From Day 1 to Day 11
measure: word memory test
timeFrame: From Day 1 to Day 11
measure: Maximum Observed Plasma Concentration (Cmax) of YZJ-1139
timeFrame: From Day 1 to Day 11
measure: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of YZJ-1139
timeFrame: From Day 1 to Day 11
measure: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of YZJ-1139
timeFrame: From Day 1 to Day 11
measure: Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib
timeFrame: From Day 1 to Day 11
measure: Apparent Terminal Elimination Half-life (t1/2) of Entrectinib
timeFrame: From Day 1 to Day 11
measure: Apparent Oral Clearance (CL/F) of Entrectinib
timeFrame: From Day 1 to Day 11
measure: The Apparent Volume of Distribution (Vz/F) of Entrectinib
timeFrame: From Day 1 to Day 11
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 to Day 16
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
Study officials:
References: