A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Oral HRS-5041 in Healthy Subjects

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study how a medication called Rifampicin affects the way another drug, HRS-5041, is processed in the body when taken by healthy men. The main goal is to understand how these two drugs interact, which is important for developing effective treatments for prostate cancer.

To participate in this study, you need to be a healthy male aged 18 to 55 years who weighs at least 50 kg and has a body mass index (BMI) between 19 and 28. You must also be able to communicate well with the study team and follow the study requirements. Participants will take HRS-5041 tablets, and they may need to use contraception if their partners are women who can become pregnant. It's important to note that individuals with significant health issues, recent surgeries, or certain allergies will not be eligible for this study. If you join, you can expect to undergo health assessments and follow specific guidelines throughout the trial. The study is not yet recruiting, but it aims to help improve prostate cancer treatments in the future.

Gender

MALE

Eligibility criteria

• 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.