Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Heart drug may alter sleep medication levels in the body

NCT ID NCT06671470

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study examines whether ticagrelor, a heart medication, changes how the body absorbs and processes YZJ-1139, an experimental insomnia treatment. Healthy volunteers aged 18 to 45 will take YZJ-1139 alone and then with ticagrelor to compare drug levels and safety. The goal is to understand potential interactions before the sleep drug is used in people who also need heart medication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
YZJ-1139 and ticagrelor
What this could lead to
If successful, this could help determine safe dosing when YZJ-1139 is taken with ticagrelor.
What could go wrong
This is an early-phase drug interaction study in healthy people, not patients with insomnia. Results may not predict real-world use or effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

27 people

The number who actually took part.

Started

Aug 2024

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. Exclusion Criteria: 1. 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; 2. Those who have difficulty swallowing tablets, or those who have special dietary requirements and cannot accept the standard diet provided by the research center; 3. Those who cannot tolerate venipuncture, or have a history of fainting blood or needles; 4. 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; 5. 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.); 6. 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; 7. 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; 8. 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; 9. Those who have smoked ≥5 cigarettes per day within 3 months before screening or cannot stop using any tobacco products during the trial; 10. 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; 11. 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; 12. Those who have undergone surgical procedures within 30 days prior to screening, or who plan to undergo surgical procedures during the study; 13. Received vaccination within 30 days prior to screening, or planned vaccination during the trial; 14. 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); 15. Those who have taken any prescription drugs, over-the-counter drugs, health products, vitamins, or Chinese herbal medicines within 14 days before screening; 16. Consumption of grapefruit, pomelo, dragon fruit, mango and other fruits or related products that affect metabolic enzymes within 7 days before screening; 17. Intake of caffeine- or xanthine-rich beverages or foods (such as coffee, strong tea, chocolate, cola, etc.) within 24 hours before administration; 18. Female subjects who are lactating or have a positive pregnancy result; 19. Those who have sudden acute illness or new concomitant medication from the screening stage to before enrollment; 20. In the opinion of the investigator, the subject is not suitable for inclusion in this trial for other reasons.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Insomnia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Shulan (Hangzhou) Hospital

    Huangzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.