Drug interaction check: how does itraconazole change HS-10506 levels?
NCT ID NCT07535970
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
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