Chronic Hepatitis BPhase 1NCT05273775
A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers
A Phase 1 study testing HRS5091 Tablets, Midazolam Maleate Tablets and Warfarin Sodium Tablets in people with Chronic Hepatitis B, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- HRS5091 Tablets, Midazolam Maleate Tablets and Warfarin Sodium Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2022to 23 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
About this study
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
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.
- Conditions
- Chronic Hepatitis B
- Being tested
- HRS5091 Tablets, Midazolam Maleate Tablets, Warfarin Sodium Tablets, Omeprazole Enteric Capsules, Vitamin K1 Tablets
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS5091 TabletsDrug
HRS5091 Tablets once daily
Midazolam Maleate TabletsDrug
Midazolam Maleate Tablets single dose
Warfarin Sodium TabletsDrug
Warfarin Sodium Tablets single dose
Omeprazole Enteric CapsulesDrug
Omeprazole Enteric Capsules single dose
Vitamin K1 TabletsDrug
Vitamin K1 Tablets once daily
Digoxin TabletsDrug
Digoxin Tablets single dose
Rosuvastatin Calcium TabletsDrug
Rosuvastatin Calcium Tablets single dose
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | HRS5091 + probe drugs (Midazolam Maleate Tablets+Warfarin Sodium Tablets+ Omeprazole Enteric Capsules+ Digoxin Tablets+ Rosuvastatin Calcium) + Vitamin K1 Tablets Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Measured: Days 1-27
AUC0-t，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Measured: Days 1-27
AUC0-∞，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Measured: Days 1-27
Secondary outcomes (5)
Tmax，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Measured: Days 1-27
t1/2，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Measured: Days 1-27
CL/F，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Measured: Days 1-27
Vz/F，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Measured: Days 1-27
Number of subjects with adverse events and severity of adverse events
Measured: Up to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start29 Apr 2022
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, single arm, open-label, fixed sequence, self-control
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273775
- Sponsor's protocol ID
- HRS5091-102
- Status last verified
- Dec 2022
- First submitted
- 1 Mar 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05273775
- Acronym / sponsor ID
- HRS5091-102
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, single arm, open-label, fixed sequence, self-control
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | 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 TabletsHRS5091 + probe drugs (Midazolam Maleate Tablets+Warfarin Sodium Tablets+ Omeprazole Enteric Capsules+ Digoxin Tablets+ Rosuvastatin Calcium) + Vitamin K1 Tablets |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS5091 TabletsHRS5091 Tablets once daily | Drug | single arm |
| Midazolam Maleate TabletsMidazolam Maleate Tablets single dose | Drug | single arm |
| Warfarin Sodium TabletsWarfarin Sodium Tablets single dose | Drug | single arm |
| Omeprazole Enteric CapsulesOmeprazole Enteric Capsules single dose | Drug | single arm |
| Vitamin K1 TabletsVitamin K1 Tablets once daily | Drug | single arm |
| Digoxin TabletsDigoxin Tablets single dose | Drug | single arm |
| Rosuvastatin Calcium TabletsRosuvastatin Calcium Tablets single dose | Drug | single arm |
Primary outcome
Cmax，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
AUC0-t，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
AUC0-∞，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
5 secondary outcomes
Tmax，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
t1/2，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
CL/F，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
Vz/F，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091
Time frame: Days 1-27
Number of subjects with adverse events and severity of adverse events
Time frame: Up to 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS5091 Tablets, Midazolam Maleate Tablets and Warfarin Sodium Tablets in people with Chronic Hepatitis B, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax，PK parameters of midazolam, s-warfarin, omeprazole, digoxin, rosuvastatin before and after oral administration of HRS5091 (time frame: Days 1-27). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.