Antibiotic interaction study for prostate cancer drug completed
NCT ID NCT07014488
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This completed Phase 1 study tested how the antibiotic rifampicin changes the way the body processes HRS-5041, an experimental drug for prostate cancer. Sixteen healthy men took HRS-5041 with and without rifampicin to measure drug levels and safety. The goal was to understand potential drug interactions before testing HRS-5041 in patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-5041 tablets and rifampicin capsules
- What this could lead to
- If successful, this study could help determine the right dose of HRS-5041 when taken with rifampicin, potentially improving future prostate cancer treatment.
- What could go wrong
- This is a very early, small study in healthy people, not patients. It only looks at drug levels, not whether HRS-5041 works for prostate cancer. Results may not apply to patients.
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
-
16 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
-
Aug 2025
- 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 55 years
- Sex
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Male participants only
- 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. Males aged 18-55 years (inclusive). 2. Male participants whose partner was a woman of childbearing potential were required to use contraception from the time they provided written informed consent until 3 months after the last dose of the investigational product. 3. Weight ≥ 50 kg and body mass index (BMI) : 19-28 kg/m2 (inclusive). 4. Participants were able to communicate well with the investigators, understand and comply with the requirements of the study, and sign the informed consent form. Exclusion Criteria: 1. Patients who have had or are currently suffering from any clinically serious diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry or metabolic system or any other diseases that may interfere with the test results. 2. Patients who had undergone surgery within 6 months before screening or who were scheduled to undergo surgery during the study or who had undergone any previous surgery affecting gastrointestinal absorption (including gastrectomy, bowel resection, or gastric contraction). 3. Patients who had donated blood or had massive blood loss (≥400 mL), received blood transfusion, or used blood products within 3 months before screening. 4. Allergic constitution, including severe drug allergy or history of drug allergy; He had a history of allergy to HRS-5041 tablets, rifampicin, or their excipients. 5. History of drug abuse within 1 year before screening; Those with positive urine drug abuse screening. 6. Who participated in any clinical trial and took a study drug within 3 months before the first dose. 7. Drinking more than 14 units of alcohol per week in the 6 months prior to screening (1 unit = 285 mL for beer, 25 mL for spirits, or 100 mL for wine); Or have taken alcohol-containing products 48 hours before administration; Or positive alcohol breath test at baseline. 8. Patients with abnormal vital signs and judged by the investigator to be clinically significant. 9. HCV (hepatitis C virus) antibody positive, HIV antibody positive, HBsAg positive, syphilis antibody positive. 10. Those who have special requirements for diet and cannot abide by the uniform diet. 11. Patients with a history of needle fainting and blood fainting, difficulty in blood collection or inability to tolerate venous puncture blood collection.
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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
-
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, 250014, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?