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

Hengrui Medicine

Status and phase: Not yet enrolling; Phase 1

Conditions: Assisted Reproduction; Uterine Fibroids; Endometriosis

Treatments: Drug: SHR7280 Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06949124

SHR7280-108

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment Group

Experimental group

Treatment:

Drug: SHR7280 Tablets