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CompletedNCT05273775Updated Dec 23, 2022

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

A Phase 1 interventional study of HRS5091 Tablets and Midazolam Maleate Tablets in Chronic Hepatitis B, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-23.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Chronic Hepatitis B

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03

In context

Hepatitis B, Chronic

954 studies on the registry are indexed under Hepatitis B, Chronic; 147 are open to participants now.

This study's enrollment of 22 is below the median of 100 across 692 interventional studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 570 studies on the registry; 85 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.

Browse Jiangsu HengRui Medicine Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    single arm

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

    Drug: HRS5091 Tablets · Drug: Midazolam Maleate Tablets · Drug: Warfarin Sodium Tablets · Drug: Omeprazole Enteric Capsules · Drug: Vitamin K1 Tablets · Drug: Digoxin Tablets · Drug: Rosuvastatin Calcium Tablets

Interventions

  • DrugHRS5091 Tablets

    HRS5091 Tablets once daily

  • DrugMidazolam Maleate Tablets

    Midazolam Maleate Tablets single dose

  • DrugWarfarin Sodium Tablets

    Warfarin Sodium Tablets single dose

  • DrugOmeprazole Enteric Capsules

    Omeprazole Enteric Capsules single dose

  • DrugVitamin K1 Tablets

    Vitamin K1 Tablets once daily

  • DrugDigoxin Tablets

    Digoxin Tablets single dose

  • DrugRosuvastatin Calcium Tablets

    Rosuvastatin Calcium Tablets single dose

06

What researchers measure

Primary outcomes

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

    Time frame: Days 1-27

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

    Time frame: Days 1-27

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

    Time frame: Days 1-27

Secondary outcomes

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

    Time frame: Days 1-27

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

    Time frame: Days 1-27

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

    Time frame: Days 1-27

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

    Time frame: Days 1-27

  5. Number of subjects with adverse events and severity of adverse events

    Time frame: Up to 56 days

07

Study locations

1 site
  • The Second Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510260, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2022 to primary completion in Jun 2022, 1 month.

Of 74 industry-sponsored phase 1 interventional studies under Hepatitis B, Chronic, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's 1 month is below that.

Counting every sponsor, half of 81 studies reached it within 18 months; a quarter within 9 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2022
First posted
Mar 10, 2022
StartActual
Apr 29, 2022
Primary completionActual
Jun 23, 2022
CompletionActual
Jun 23, 2022
Last update
Dec 23, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05273775
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Mar 10, 2022
Start date
Apr 29, 2022
Primary completion
Jun 23, 2022
Completion
Jun 23, 2022
Last update
Dec 23, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Midazolam · Warfarin · Digoxin

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