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

Primary Purpose

Chronic Hepatitis B

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HRS5091 Tablets

Midazolam Maleate Tablets

Warfarin Sodium Tablets

Omeprazole Enteric Capsules

Vitamin K1 Tablets

Digoxin Tablets

Rosuvastatin Calcium Tablets

About this trial

This is an interventional basic science trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent;
Healthy subjects aged 18~50 (including 18 and 50 years old);
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));
Give informed consent not to have a family plan for six months after the last dose, and agree to take effective contraception.

Exclusion Criteria:

Has the medicine or food allergy history, or is the allergic constitution person;
Inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors affecting drug use and absorption;
QTCF > 450 ms in 12-lead ECG examination or other abnormal conditions judged by the researchers to have clinical significance;
Hepatitis B surface Antigen (HBSAG), Hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, syphilis antibody test positive;
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;
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;
Having a history of drug abuse, drug dependence (consultation) or positive urine drug abuse screening before drug administration;
Anyone who has undergone any surgery within 6 months prior to screening;
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.

Sites / Locations

The Second Affiliated Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

HRS5091 + probe drugs (Midazolam Maleate Tablets+Warfarin Sodium Tablets+ Omeprazole Enteric Capsules+ Digoxin Tablets+ Rosuvastatin Calcium) + Vitamin K1 Tablets

Outcomes

Primary Outcome Measures

Cmax，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

AUC0-t，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

AUC0-∞，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

Secondary Outcome Measures

Tmax，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

t1/2，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

CL/F，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

Vz/F，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

Number of subjects with adverse events and severity of adverse events

Full Information

NCT ID

NCT05273775

First Posted

March 1, 2022

Last Updated

December 22, 2022

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05273775

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

April 29, 2022 (Actual)

Primary Completion Date

June 23, 2022 (Actual)

Study Completion Date

June 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Single-center, single arm, open-label, fixed sequence, self-control

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single arm

Arm Type

Experimental

Arm Description

HRS5091 + probe drugs (Midazolam Maleate Tablets+Warfarin Sodium Tablets+ Omeprazole Enteric Capsules+ Digoxin Tablets+ Rosuvastatin Calcium) + Vitamin K1 Tablets

Intervention Type

Drug

Intervention Name(s)

HRS5091 Tablets

Intervention Description

HRS5091 Tablets once daily

Intervention Type

Drug

Intervention Name(s)

Midazolam Maleate Tablets

Intervention Description

Midazolam Maleate Tablets single dose

Intervention Type

Drug

Intervention Name(s)

Warfarin Sodium Tablets

Intervention Description

Warfarin Sodium Tablets single dose

Intervention Type

Drug

Intervention Name(s)

Omeprazole Enteric Capsules

Intervention Description

Omeprazole Enteric Capsules single dose

Intervention Type

Drug

Intervention Name(s)

Vitamin K1 Tablets

Intervention Description

Vitamin K1 Tablets once daily

Intervention Type

Drug

Intervention Name(s)

Digoxin Tablets

Intervention Description

Digoxin Tablets single dose

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin Calcium Tablets

Intervention Description

Rosuvastatin Calcium Tablets single dose

Primary Outcome Measure Information:

Title

Cmax，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

Time Frame

Days 1-27

Title

AUC0-t，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

Time Frame

Days 1-27

Title

AUC0-∞，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

Time Frame

Days 1-27

Secondary Outcome Measure Information:

Title

Tmax，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

Time Frame

Days 1-27

Title

t1/2，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

Time Frame

Days 1-27

Title

CL/F，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

Time Frame

Days 1-27

Title

Vz/F，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091

Time Frame

Days 1-27

Title

Number of subjects with adverse events and severity of adverse events

Time Frame

Up to 56 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent; Healthy subjects aged 18~50 (including 18 and 50 years old); 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)); Give informed consent not to have a family plan for six months after the last dose, and agree to take effective contraception. Exclusion Criteria: Has the medicine or food allergy history, or is the allergic constitution person; Inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors affecting drug use and absorption; QTCF > 450 ms in 12-lead ECG examination or other abnormal conditions judged by the researchers to have clinical significance; Hepatitis B surface Antigen (HBSAG), Hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, syphilis antibody test positive; 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; 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; Having a history of drug abuse, drug dependence (consultation) or positive urine drug abuse screening before drug administration; Anyone who has undergone any surgery within 6 months prior to screening; 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.

Facility Information:

Facility Name

The Second Affiliated Hospital of Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510260

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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