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Completed

NCT Number: NCT06949124

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

SHR7280 Tablets

Drug

SHR7280 tablets.

Primary outcomes

  1. Maximum concentration (Cmax)

    Time frame: 0 to anticipated 29 days.

  2. Area under the curve from time 0 to infinity (AUC0-∞)

    Time frame: 0 to anticipated 29 days.

  3. Area under the curve from time 0 to time t (AUC0-t)

    Time frame: 0 to anticipated 29 days.

Secondary outcomes

  1. Time to reach the maximum concentration (Tmax)

    Time frame: 0 to anticipated 29 days.

  2. Half-life (t1/2)

    Time frame: 0 to anticipated 29 days.

  3. Apparent clearance (CL/F)

    Time frame: 0 to anticipated 29 days.

  4. Adverse events (AEs)

    Time frame: Baseline up to Day 29.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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