NCT07014488CompletedPhase 1
A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Oral HRS-5041 in Healthy Subjects
A Single-center, Single-arm, Open-label, Fixed-sequence Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Oral HRS-5041 in Healthy Subjects
Source: ClinicalTrials.gov · Last updated 10 Sept 2025
Brief summary (registry, in English)
The study was designed to evaluate the pharmacokinetic effects of Rifampicin on HRS-5041 after oral administration of HRS-5041 tablets in healthy subjects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 3 Jun 2025
- Start date
- 20 Jun 2025
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT07014488
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 16
- From 20 Jun 2025 to the primary completion date, 1 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Patients who had donated blood or had massive blood loss (≥400 mL), received blood transfusion, or used blood products within 3 months before screening.
- Who participated in any clinical trial and took a study drug within 3 months before the first dose.
- 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.
Other illness
- 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.
- 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.
- History of drug abuse within 1 year before screening; Those with positive urine drug abuse screening.
- HCV (hepatitis C virus) antibody positive, HIV antibody positive, HBsAg positive, syphilis antibody positive.
- Patients with a history of needle fainting and blood fainting, difficulty in blood collection or inability to tolerate venous puncture blood collection.
Other
- Patients with abnormal vital signs and judged by the investigator to be clinically significant.
- Those who have special requirements for diet and cannot abide by the uniform diet.
Who the study is looking for
- Males aged 18-55 years (inclusive).
- 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.
- Weight ≥ 50 kg and body mass index (BMI) : 19-28 kg/m2 (inclusive).
- Participants were able to communicate well with the investigators, understand and comply with the requirements of the study, and sign the informed consent form.
Age in the registry: 18 years to 55 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.