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Drug interaction check: how does itraconazole change HS-10506 levels?

NCT ID NCT07535970

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial will test 20 healthy Chinese adults to see if taking itraconazole (a common antifungal) changes how the body processes HS-10506, an experimental drug. Participants will take HS-10506 alone and then again with itraconazole. The goal is to measure drug levels in the blood, not to treat any disease.

What this could mean

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

Active substance
HS-10506 and itraconazole
What this could lead to
If successful, this study will help determine safe dosing of HS-10506 when taken with itraconazole, guiding future trials.
What could go wrong
This is a very early, small study in healthy people, not patients. It only measures drug levels, not effectiveness or safety for any disease.

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jul 2026

An estimate. End dates often move.

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. Sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse events, and self-report the ability to complete the study in accordance with the trial regulations; 2. Adult males and females (aged between 18 and 45 years, inclusive of boundary values, calculated on the date of signing the informed consent form); 3. Participant's Body Mass Index (BMI) = weight (kg) / height² (m²) within the range of 19.0-26.0 kg/m² (inclusive of boundary values); male participants weigh ≥ 50 kg, female participants weigh ≥ 45 kg; 4. Agree to practice highly effective contraception from the signing of the informed consent form until 3 months after the last dose, and have no plans for pregnancy or sperm/egg donation during this period (only non-drug contraceptive measures are permitted during the trial). Exclusion Criteria: 1. Those with clinically significant abnormalities in physical examination, vital signs, oxygen saturation, 12-lead electrocardiogram, clinical laboratory tests, etc., deemed by the investigator as unsuitable for enrollment; 2. Positive results for any one or more of hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum(TP)specific antibody during the screening period; 3. 12-lead electrocardiogram results during the screening period showing QTcF\>450.00 ms for males or QTcF\>470.00 ms for females; 4. Previous or current presence of severe diseases of the nervous system, psychiatric system, digestive system, circulatory system, respiratory system (e.g., anatomical abnormalities of the airway, congenital microstomia with macroglossia, mandibular hypoplasia; chronic obstructive pulmonary disease or sleep apnea syndrome), urinary system, endocrine and metabolic system, immune system, hematological system, etc., assessed by the investigator as unsuitable for participation in this study; 5. Current or past history of psychiatric disorders or brain dysfunction, or assessment of suicide risk using the Columbia-Suicide Severity Rating Scale (C-SSRS), or self-injurious behavior or suicide attempt within one year before screening, or current suicide risk based on the investigator's clinical judgment; 6. Current or past history of severe gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, reflux esophagitis, etc.); 7. Evidence of previous ventricular dysfunction, such as congestive heart failure (CHF)or a history of CHF; 8. History of surgery within 3 months before screening, or planned surgery during the trial period, or surgery that may affect drug absorption, distribution, metabolism, or excretion, deemed by the investigator as unsuitable for enrollment; 9. Participation in any other clinical trial involving any investigational drug or device within 3 months before screening, or within 7 half-lives of another investigational drug before screening, whichever is longer; 10. Prone to allergic reactions, or allergic constitution(e.g., allergies to pollen, two or more drugs/foods), or known allergy to components of HS-10506 tablets or itraconazole capsules; 11. History of drug abuse, drug dependence, or use of illicit drugs within 5 years before screening, or positive drug abuse screening results; 12. Frequent alcohol consumption within 3 months before screening (i.e., consuming more than 14 units of alcohol per week; 1 unit = 14 g alcohol, equivalent to 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine, equivalent to 10 bottles of beer, 500 mL spirits, or 3 bottles of wine per week), or inability to stop consuming alcoholic products during the trial, or positive alcohol breath test; 13. Average daily smoking of more than 5 cigarettes within 3 months before screening, or inability to stop using any tobacco products during the trial; 14. Excessive consumption of tea, coffee, and/or caffeinated beverages within 3 months before screening (average of more than 8 cups per day; 1 cup = 200 mL); 15. Significant blood loss(≥200 mL)or blood donation within 3 months before screening, or plans for blood donation during the study or within 3 months after the study; 16. Use of any drugs affecting CYP3A, CYP2C19 enzymes, or drugs altering gastric acid \[proton pump inhibitors (PPIs), H2 receptor antagonists, topical antacids, oral alkaline drugs, etc.\] within 30 days before the first dose of investigational product(or within 7 times the corresponding elimination half-life, whichever is longer); 17. Use of any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements(excluding topical preparations with local effects) within 14 days before the first dose of investigational product, or use of any drug within 7 half-lives (whichever is longer); 18. Consumption of grapefruit or grapefruit products within 48 hours before the first dose of investigational product; 19. Vaccination within 30 days before the first dose of investigational product, or planned use of vaccines during the study or within two weeks after the study; 20. Significant changes in diet or sleep habits within 4 weeks before screening, assessed by the investigator as unsuitable for participation in this study; 21. Female participants who are pregnant, breastfeeding, or have a positive pregnancy test result within 1 month before screening or during the trial period; 22. Unprotected sexual intercourse within 14 days before screening; 23. Special dietary requirements, inability to comply with a unified diet, or difficulty swallowing; 24. Intolerance to venipuncture/indwelling needle blood collection or fear of needles/blood; 25. Inability to complete the study for other reasons or deemed unsuitable for participation by the investigator.

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As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012, China

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