InsomniaPhase 1NCT06680531
A Clinical Study to Evaluate the Drug Interaction Between YZJ-1139 Tablets and Escitalopram Oxalate Tablets
A Phase 1 study testing YZJ-1139 tablets, Escitalopram oxalate tablets and YZJ-1139 simulated tablets in people with Insomnia and Central Nervous System, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Central Nervous System
- What is being tested?
- YZJ-1139 tablets, Escitalopram oxalate tablets and YZJ-1139 simulated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2024to 4 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)）;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
About this study
Primary Objective：
- 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.
- Conditions
- Insomnia, Central Nervous System
- Being tested
- YZJ-1139 tablets, Escitalopram oxalate tablets, YZJ-1139 simulated tablets
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YZJ-1139 tabletsDrug
YZJ-1139 tablets are administered orally single dose
Escitalopram oxalate tabletsDrug
•oral tablet, QD
YZJ-1139 simulated tabletsDrug
oral tablet, QD
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: YZJ-1139 tablets; Drug: Escitalopram oxalate tablets; Drug: YZJ-1139 simulated tablets |
| Group B | Placebo comparator | Not described Receives: Drug: Escitalopram oxalate tablets; Drug: YZJ-1139 simulated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Day 1 to Day 11
Maximum Observed Plasma Concentration (Cmax) of YZJ-1139
Cmax is defined as the maximum concentration of drug.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Day 1 to Day 11
Apparent Terminal Elimination Half-life (t1/2) of Entrectinib
Measured: 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.
Measured: 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.
Measured: From Day 1 to Day 11
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start31 Aug 2024
- Primary completion19 Sep 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug interaction
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680531
- Sponsor's protocol ID
- YZJ-1139-1-14
- Status last verified
- Jun 2026
- First submitted
- 31 Oct 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Drug Interaction Between YZJ-1139 Tablets and Escitalopram Oxalate Tablets
- ClinicalTrials.gov ID
- NCT06680531
- Acronym / sponsor ID
- YZJ-1139-1-14
- Conditions
- Insomnia, Central Nervous System
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective：
- 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Drug interaction
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: YZJ-1139 tablets, Drug: Escitalopram oxalate tablets, Drug: YZJ-1139 simulated tablets |
| Group B | Placebo comparator | Drug: Escitalopram oxalate tablets, Drug: YZJ-1139 simulated tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YZJ-1139 tabletsYZJ-1139 tablets are administered orally single dose | Drug | Group A |
| Escitalopram oxalate tablets•oral tablet, QD | Drug | Group A, Group B |
| YZJ-1139 simulated tabletsoral tablet, QD | Drug | Group A, Group B |
Primary outcome
saccade eye movement test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From Day 1 to Day 11
Apparent Oral Clearance (CL/F) of Entrectinib
Time frame: 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
Time frame: 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)
Time frame: From Day 1 to Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YZJ-1139 tablets, Escitalopram oxalate tablets and YZJ-1139 simulated tablets in people with Insomnia and Central Nervous System, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
saccade eye movement test (time frame: From Day 1 to Day 11). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.