A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers

Chronic Hepatitis B Clinical Trial

Official title:

A Single-center, Single-arm, Open-label, Fixed-sequence, Self-controlled Study of the Effects of HRS5091 on the Pharmacokinetics of Midazolam, S-warfarin, Omeprazole, Digoxin and Rosuvastatin in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05273775
• Other study ID #: HRS5091-102
• Status: Completed
• Phase: Phase 1
• Start date: April 29, 2022
• Est. completion date: June 23, 2022

Study information

• Verified date: December 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a drug-drug interaction study conducted in healthy volunteers to evaluate the effect of HRS5091 on CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP and OATP1B1, using midazolam, s-warfarin, omeprazole, digoxin and rosuvastatin as probe drugs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 23, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent;

2. Healthy subjects aged 18~50 (including 18 and 50 years old);

3. Body weight = 50 kg, body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26 kg/m2) (BMI= weight (kg)/height2 (m2));

4. Give informed consent not to have a family plan for six months after the last dose, and agree to take effective contraception.

Exclusion Criteria:

1. Has the medicine or food allergy history, or is the allergic constitution person;

2. Inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors affecting drug use and absorption;

3. QTCF > 450 ms in 12-lead ECG examination or other abnormal conditions judged by the researchers to have clinical significance;

4. Hepatitis B surface Antigen (HBSAG), Hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, syphilis antibody test positive;

5. Those who smoked more than 5 cigarettes per day within 3 months before screening and could not stop using any tobacco products during the trial period;

6. Regular drinkers who had consumed more than 14 units of alcohol per week (1 unit = 285 ml of beer, 25 ml of spirits, or 100 ml of wine) during the six months prior to screening and could not stop using any alcoholic product during the trial; positive Breath test for alcohol;

7. Having a history of drug abuse, drug dependence (consultation) or positive urine drug abuse screening before drug administration;

8. Anyone who has undergone any surgery within 6 months prior to screening;

9. Clinical trial participants who have participated in any drug or medical device within 3 months prior to screening (subject to the intervention of the experimental drug or medical device);10.Blood donation (or blood loss) within 3 months before screening and the amount of blood donation (or blood loss)=400 ml, or receiving blood transfusion.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• HRS5091 Tablets
HRS5091 Tablets once daily
• Midazolam Maleate Tablets
Midazolam Maleate Tablets single dose
• Warfarin Sodium Tablets
Warfarin Sodium Tablets single dose
• Omeprazole Enteric Capsules
Omeprazole Enteric Capsules single dose
• Vitamin K1 Tablets
Vitamin K1 Tablets once daily
• Digoxin Tablets
Digoxin Tablets single dose
• Rosuvastatin Calcium Tablets
Rosuvastatin Calcium Tablets single dose

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091		Days 1-27
Primary	AUC0-t,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091		Days 1-27
Primary	AUC0-8,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091		Days 1-27
Secondary	Tmax,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091		Days 1-27
Secondary	t1/2,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091		Days 1-27
Secondary	CL/F,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091		Days 1-27
Secondary	Vz/F,PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091		Days 1-27
Secondary	Number of subjects with adverse events and severity of adverse events		Up to 56 days