Sign in

NCT06949124CompletedPhase 1

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

A Single-center, Single-arm, Open-label, Fixed-sequence, Self-controlled Clinical Study to Evaluate the Effects of SHR7280 on the Pharmacokinetics of SHR7280 and Midazolam, S-warfarin, Omeprazole, Digoxin, and Rosuvastatin in Healthy Subjects

Source: ClinicalTrials.gov · Last updated 10 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
20 (actual)
First submitted
22 Apr 2025
Start date
28 Apr 2025
Primary completion date
5 Jun 2025
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
NCT number
NCT06949124

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 20
  • From 28 Apr 2025 to the primary completion date, 5 Jun 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 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.

Other illness

  • 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.

Lab values

  • Those with clinically significant abnormalities in physical examination, vital signs (respiration, temperature, pulse), other laboratory tests, chest imaging, abdominal ultrasound, etc.

Other

  • Subjects with other factors considered by the investigator to be ineligible for the study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 45 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongnan Hospital of Wuhan University
Coordinator of this site? Confirm its status
WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.