Status:
COMPLETED
A Phase 1 Clinical Study to Evaluate the Effects of SHR7280 on the Pharmacokinetics of Midazolam, S-warfarin, Omeprazole, Digoxin, and Rosuvastatin in Healthy Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Endometriosis
Uterine Fibroids
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effects of SHR7280 on the pharmacokinetics of midazolam, S-warfarin, omeprazole, digoxin and rosuvastatin in healthy subjects.
Eligibility Criteria
Inclusion
- Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol.
- Males aged 18-45 years (inclusive).
- Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG).
- Weight ≥ 50 kg and body mass index (BMI) : 19-26 kg/m2 (inclusive).
- Informed consent was obtained and patients did not plan to have children within 3 months after the last dose of medication, and they agreed to use highly effective contraception.
Exclusion
- Those with clinically significant abnormalities in physical examination, vital signs (respiration, temperature, pulse), other laboratory tests, chest imaging, abdominal ultrasound, etc.
- Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and syphilis antibody positive.
- Patients with any previous diseases that increase the risk of bleeding.
- Patients with previous chronic or severe medical history or existing diseases of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, and mental system, who were judged by the investigators to be not suitable for the trial.
- History of blood donation or blood loss ≥ 400 mL or blood transfusion within 3 month before screening.
- Subjects with other factors considered by the investigator to be ineligible for the study.
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06949124
Start Date
April 28 2025
End Date
June 5 2025
Last Update
September 10 2025
Active Locations (1)
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1
Zhongnan hospital of Wuhan University
Wuhan, Hubei, China, 430071