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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis; Uterine Fibroids; Assisted Reproduction
• Intervention / Treatment: Drug: SHR7280 Tablets

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. Males aged 18-45 years (inclusive).
3. Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG).
4. Weight ≥ 50 kg and body mass index (BMI) : 19-26 kg/m2 (inclusive).
5. 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:

1. Those with clinically significant abnormalities in physical examination, vital signs (respiration, temperature, pulse), other laboratory tests, chest imaging, abdominal ultrasound, etc.
2. Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and syphilis antibody positive.
3. Patients with any previous diseases that increase the risk of bleeding.
4. 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.
5. History of blood donation or blood loss ≥ 400 mL or blood transfusion within 3 month before screening.
6. Subjects with other factors considered by the investigator to be ineligible for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group	Drug: SHR7280 Tablets; SHR7280 tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration (Cmax)	0 to anticipated 29 days.
Area under the curve from time 0 to infinity (AUC0-∞)	0 to anticipated 29 days.
Area under the curve from time 0 to time t (AUC0-t)	0 to anticipated 29 days.

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to reach the maximum concentration (Tmax)	0 to anticipated 29 days.
Half-life (t1/2)	0 to anticipated 29 days.
Apparent clearance (CL/F)	0 to anticipated 29 days.
Adverse events (AEs)	Baseline up to Day 29.

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): June 5, 2025

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Endometriosis; Leiomyoma
• Other Study ID Numbers: SHR7280-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No