A Clinical Study to Evaluate the Drug Interaction Between YZJ-1139 Tablets and Escitalopram Oxalate Tablets

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Central Nervous System
• Intervention / Treatment: Drug: YZJ-1139 tablets; Drug: Escitalopram oxalate tablets; Drug: YZJ-1139 simulated tablets

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • The Second Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Drug: YZJ-1139 tablets; YZJ-1139 tablets are administered orally single dose; Drug: Escitalopram oxalate tablets; •oral tablet, QD; Drug: YZJ-1139 simulated tablets; oral tablet, QD
Placebo Comparator: Group B	Drug: Escitalopram oxalate tablets; •oral tablet, QD; Drug: YZJ-1139 simulated tablets; oral tablet, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
saccade eye movement test	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.	From Day 1 to Day 11
body swing test	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.	From Day 1 to Day 11
selective reaction time test	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.	From Day 1 to Day 11
number symbol conversion test	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.	From Day 1 to Day 11
word memory test	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.	From Day 1 to Day 11
Maximum Observed Plasma Concentration (Cmax) of YZJ-1139	Cmax is defined as the maximum concentration of drug.	From Day 1 to Day 11
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of YZJ-1139	AUC0-t is defined as the concentration of drug from time zero to the last observable concentration.	From Day 1 to Day 11
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of YZJ-1139	AUC0-∞ is defined as the concentration of drug extrapolated to infinite time.	From Day 1 to Day 11
Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib	Tmax is defined as the time (observed time point) of Cmax.	From Day 1 to Day 11
Apparent Terminal Elimination Half-life (t1/2) of Entrectinib		From Day 1 to Day 11
Apparent Oral Clearance (CL/F) of Entrectinib	CL/F is defined as the apparent oral clearance following administration of the drug.	From Day 1 to Day 11
The Apparent Volume of Distribution (Vz/F) of Entrectinib	Vz/F is defined as the apparent volume of distribution of the drug.	From Day 1 to Day 11
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		From Day 1 to Day 16

Collaborators and Investigators

• Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2024
• Primary Completion (Actual): September 19, 2024
• Study Completion (Actual): November 4, 2024

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amines; Nitriles; Propylamines; Benzofurans; Escitalopram
• Other Study ID Numbers: YZJ-1139-1-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No