InsomniaPhase 1NCT06671470
A Drug-drug Interaction Study of YZJ-1139 Tablets and Ticagrelor Tablets in Healthy Subjects
A Phase 1 study testing YZJ-1139 tablets and Ticagrelor Tablets in people with Insomnia, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
Primary Objective : To evaluate the effect of ticagrelor tablets on the pharmacokinetic characteristics of YZJ-1139 in healthy subjects; Secondary Objective: To evaluate the safety of ticagrelor tablets in combination with YZJ-1139 tablets in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- YZJ-1139 tablets and Ticagrelor Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2024to 15 Oct 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
- Subjects who are able to understand and are willing to strictly follow the clinical trial protocol to complete this trial and sign the informed consent form; 2) Male and female subjects aged 18~45 years (including cut-off value); 3) Male weight ≥ 50.0kg, female weight ≥ 45.0kg, body mass index (BMI) within the range of 19.0~26.0kg/m2 (including the cut-off value); 4) normal or abnormal physical examination, vital signs, 12-lead ECG, laboratory tests are not clinically significant; 5) Good health, those who with no respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, psychiatric system history of serious and chronic diseases; 6) Subjects (including partners) have no fertility plan, sperm/egg donation plan and voluntarily use adequate contraception from signing informed consent and within 3 months after the last dose.
Who cannot join
- Allergies: Those with a history of two or more drug or food allergies in the past; or those who are known to be allergic to YZJ-1139 tablets and test concomitant drugs and excipients;
- Those who have difficulty swallowing tablets, or those who have special dietary requirements and cannot accept the standard diet provided by the research center;
- Those who cannot tolerate venipuncture, or have a history of fainting blood or needles;
- Those who have a history or current narcolepsy, obstructive sleep apnea, complex sleep behaviors (such as sleepwalking, dream driving, etc.), severe unconscious hypoglycemia, stroke, epilepsy and other psychiatric neurological diseases (including anxiety, depression, etc.), convulsive diseases, cataplexy;
- Those with bleeding tendency (such as recent trauma, recent surgery, coagulation dysfunction, active or recent intestinal bleeding), have a history of active pathological bleeding, intracranial hemorrhage, or other diseases that can change or increase bleeding tendency (peptic ulcer, Henoch-Schonlein purpura, lupus erythematosus, etc.);
- Those who with abnormal clinical significance in the determination of hepatitis B surface antigen, hepatitis C virus antibody, hepatitis C virus core antigen, human immunodeficiency virus (HIV) antigen antibody combined detection, and treponema pallidum specific antibody determination;
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- Regular drinkers within 6 months prior to screening, i.e., drinking an average of more than 14 units of alcohol per week (1 unit ≈ 360mL of beer or 45mL of spirits with 40% alcohol or 150mL of wine) or > alcohol breath test results during the screening period0mg/100mL;
- Those who have used soft drugs (such as marijuana) within 3 months before screening or taken hard drugs (such as cocaine, amphetamines, phencyclidine ) within 1 year before screening; or those with a history of substance abuse; or those who have a positive drug abuse screen at screening;
- Those who have smoked ≥5 cigarettes per day within 3 months before screening or cannot stop using any tobacco products during the trial;
- Those who have donated blood or lost a large amount of blood (> 400mL) within 3 months prior to screening, received blood transfusion or used blood products;
- Those who have participated in any clinical trial and been given investigational drugs or investigational medical devices within 3 months prior to screening; or those who plan to participate in other clinical trials during the study period;
- Those who have undergone surgical procedures within 30 days prior to screening, or who plan to undergo surgical procedures during the study;
- Received vaccination within 30 days prior to screening, or planned vaccination during the trial;
- Use of any drug that inhibits or induces hepatic metabolism of the drug within 28 days prior to screening (e.g.: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines);
- Those who have taken any prescription drugs, over-the-counter drugs, health products, vitamins, or Chinese herbal medicines within 14 days before screening;
- Consumption of grapefruit, pomelo, dragon fruit, mango and other fruits or related products that affect metabolic enzymes within 7 days before screening;
- Intake of caffeine- or xanthine-rich beverages or foods (such as coffee, strong tea, chocolate, cola, etc.) within 24 hours before administration;
- Female subjects who are lactating or have a positive pregnancy result;
- Those who have sudden acute illness or new concomitant medication from the screening stage to before enrollment;
- In the opinion of the investigator, the subject is not suitable for inclusion in this trial for other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Interaction Study of YZJ-1139 Tablets With Ticagrelor Tablets
Primary Objective :
To evaluate the effect of ticagrelor tablets on the pharmacokinetic characteristics of YZJ-1139 in healthy subjects;
Secondary Objective:
To evaluate the safety of ticagrelor tablets in combination with YZJ-1139 tablets in healthy subjects.
- Conditions
- Insomnia
- Being tested
- YZJ-1139 tablets, Ticagrelor 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
Oral dose 20 mg
Ticagrelor TabletsDrug
Oral dose 90 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: YZJ-1139 tablets; Drug: Ticagrelor Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of YZJ-1139(Cmax)
To evaluate the potential effect of multiple oral doses of ticagrelor on the single-dose PK of YZJ-1139. Maximum observed concentration (Cmax).
Measured: 48 hours
Pharmacokinetics of YZJ-1139 (AUC0-∞)
To evaluate the potential effect of multiple oral doses of ticagrelor on the single-dose PK of YZJ-1139. Area under the concentration-time curve (AUC) from time zero to infinity.
Measured: 48 hours
Pharmacokinetics of YZJ-1139 (AUC0-t)
To evaluate the potential effect of multiple oral doses of ticagrelor on the single-dose PK of YZJ-1139. Area under the concentration-time curve (AUC) time zero to last quantifiable concentration.
Measured: 48 hours
Secondary outcomes (1)
Number of participants with adverse events
The safety and tolerability of YZJ-1139 alone and in combination with ticagrelor will be examined.
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start22 Aug 2024
- Primary completion13 Sep 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Single dose
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT06671470
- Sponsor's protocol ID
- YZJ-1139-1-13
- 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
Publications
Huang X, Chen Y, Jin L, Kong Y, Bao F, Wang R. Drug-drug interaction between ticagrelor and fazamorexant: pharmacokinetic alterations in healthy subjects from a phase I, open-label, fixed-sequence study. BMC Pharmacol Toxicol. 2026 Jul 22. doi: 10.1186/s40360-026-01186-0. Online ahead of print.
PubMed 42482263
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
- Drug Interaction Study of YZJ-1139 Tablets With Ticagrelor Tablets
- ClinicalTrials.gov ID
- NCT06671470
- Acronym / sponsor ID
- YZJ-1139-1-13
- Conditions
- Insomnia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 4 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 effect of ticagrelor tablets on the pharmacokinetic characteristics of YZJ-1139 in healthy subjects;
Secondary Objective:
To evaluate the safety of ticagrelor tablets in combination with YZJ-1139 tablets in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single dose
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: YZJ-1139 tablets, Drug: Ticagrelor Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects who are able to understand and are willing to strictly follow the clinical trial protocol to complete this trial and sign the informed consent form; 2) Male and female subjects aged 18~45 years (including cut-off value); 3) Male weight ≥ 50.0kg, female weight ≥ 45.0kg, body mass index (BMI) within the range of 19.0~26.0kg/m2 (including the cut-off value); 4) normal or abnormal physical examination, vital signs, 12-lead ECG, laboratory tests are not clinically significant; 5) Good health, those who with no respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, psychiatric system history of serious and chronic diseases; 6) Subjects (including partners) have no fertility plan, sperm/egg donation plan and voluntarily use adequate contraception from signing informed consent and within 3 months after the last dose.
Key exclusion criteria (20 listed)
- Allergies: Those with a history of two or more drug or food allergies in the past; or those who are known to be allergic to YZJ-1139 tablets and test concomitant drugs and excipients;
- Those who have difficulty swallowing tablets, or those who have special dietary requirements and cannot accept the standard diet provided by the research center;
- Those who cannot tolerate venipuncture, or have a history of fainting blood or needles;
- Those who have a history or current narcolepsy, obstructive sleep apnea, complex sleep behaviors (such as sleepwalking, dream driving, etc.), severe unconscious hypoglycemia, stroke, epilepsy and other psychiatric neurological diseases (including anxiety, depression, etc.), convulsive diseases, cataplexy;
- Those with bleeding tendency (such as recent trauma, recent surgery, coagulation dysfunction, active or recent intestinal bleeding), have a history of active pathological bleeding, intracranial hemorrhage, or other diseases that can change or increase bleeding tendency (peptic ulcer, Henoch-Schonlein purpura, lupus erythematosus, etc.);
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 tabletsOral dose 20 mg | Drug | Group A |
| Ticagrelor TabletsOral dose 90 mg twice daily | Drug | Group A |
Primary outcome
Pharmacokinetics of YZJ-1139(Cmax)
Time frame: 48 hours
To evaluate the potential effect of multiple oral doses of ticagrelor on the single-dose PK of YZJ-1139. Maximum observed concentration (Cmax).
Pharmacokinetics of YZJ-1139 (AUC0-∞)
Time frame: 48 hours
To evaluate the potential effect of multiple oral doses of ticagrelor on the single-dose PK of YZJ-1139. Area under the concentration-time curve (AUC) from time zero to infinity.
Pharmacokinetics of YZJ-1139 (AUC0-t)
Time frame: 48 hours
To evaluate the potential effect of multiple oral doses of ticagrelor on the single-dose PK of YZJ-1139. Area under the concentration-time curve (AUC) time zero to last quantifiable concentration.
1 secondary outcome
Number of participants with adverse events
Time frame: 13 days
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.
- Derived from this study: PubMed 42482263Huang X, Chen Y, Jin L, Kong Y, Bao F, Wang R. Drug-drug interaction between ticagrelor and fazamorexant: pharmacokinetic alterations in healthy subjects from a phase I, open-label, fixed-sequence study. BMC Pharmacol Toxicol. 2026 Jul 22. doi: 10.1186/s40360-026-01186-0. Online ahead of print.
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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 and Ticagrelor Tablets in people with Insomnia, 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 1 inclusion and 20 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. 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?
Pharmacokinetics of YZJ-1139(Cmax) (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06671470, which also lists 1 linked publication.
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.