Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects

NCT ID: NCT07049107

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2025-07-31

Brief Summary

This study is a single-center, open-label, sequential drug interaction study

The primary objectives are:

To evaluate the pharmacokinetic effects of HRS-8427 injection on the liver drug enzymes CYP2B6 substrate bupropion and CYP3A4 substrate midazolam in healthy subjects.

Conditions

Health Volunteer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HRS-8427

Group Type: EXPERIMENTAL

HRS-8427

Intervention Type: DRUG

HRS-8427

Interventions

HRS-8427

HRS-8427

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy subjects aged 18 to 45 years old (including 18 and 45 years old, based on the time of signing the informed consent form), both male and female.

2. The weight of female subjects was ≥45 kg, the weight of male subjects was ≥50 kg, and the body mass index (BMI) was within the range of 19.0-26.0 kg/m2

3. The female subjects were not in the pregnancy or lactation period, and the pregnancy examination results before the test were negative; Male or female subjects agreed to take the investigator-approved effective contraceptive measures during the trial as required by the investigator.

4. Before the trial, a thorough understanding of the nature, significance, potential benefits, possible inconveniences and potential risks of the trial was obtained. The participant voluntarily participated in this clinical trial, was able to communicate well with the researcher, comply with the requirements of the entire study, and signed a written informed consent form.

Exclusion Criteria

1. Those with a history of allergies to food, drugs, etc., especially those known to be allergic to β -lactam antibacterial drugs and midazolam, bupropion, or those with an allergic constitution.

2. Have had or are currently suffering from diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, musculoskeletal system and nervous system, etc.

3. Conforming to the contraindications of midazolam use or not suitable for midazolam use .

4. Comply with the contraindications for bupropion use or are not suitable for bupropion use .

5. The 12-lead electrocardiogram was abnormal and was judged by the researcher as unsuitable to participate in this study .

6. Laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), physical examination, vital signs (ears, blood pressure, pulse, respiration), and chest X-ray results, etc., which are judged by clinicians as abnormal and of clinical significance .

7. Those with positive infectious disease tests (human immunodeficiency virus antibody, hepatitis B surface antigen, anti-hepatitis C virus antibody, anti-Treponema pallidum specific antibody).

8. Those who have undergone major surgical operations within the three months prior to screening; Or those who have undergone surgery that may affect the in vivo process or safety evaluation of the studied drug; Or those who plan to undergo surgical operations during the research period.

9. Those who have participated in drug clinical trials as subjects and taken the investigational drug within 3 months prior to screening, or who plan to participate in other clinical trials during this study period .

10. Those who have used any inducers or inhibitors of CYP2B6 and CYP3A enzymes within one month before taking the study drug for the first time.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiangya Hospital Central South University

Changsha, Hunan, China

Countries

China

Central Contacts

Yuanyuan Huang

Role: CONTACT

yuanyuan.huang@hengrui.com

18036618522

Other Identifiers

HRS-8427-105

Identifier Type: -

Identifier Source: org_study_id