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

NCT06949124 | Completed Phase 1

• 1 other identifier: SHR7280-108
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Uterine Fibroids; Assisted Reproduction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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.

Study Arms (1)

Treatment Group

EXPERIMENTAL

Drug: SHR7280 Tablets

Interventions

SHR7280 Tablets DRUG

SHR7280 tablets.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhongnan hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Endometriosis; Leiomyoma

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: April 28, 2025
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

CN (1)