To Compare the Pharmacokinetic (PK) Differences of HS-10504 Between Participants With Hepatic Impairment and Participants With Normal Hepatic FunctionPhase 1NCT07836504

A Pharmacokinetic Study of HS-10504 in Participants With Hepatic Impairment and Normal Hepatic Function.

A Phase 1 study testing HS-10504 in people with To Compare the Pharmacokinetic (PK) Differences of HS-10504 Between Participants With Hepatic Impairment and Participants With Normal Hepatic Function, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

This is a two-part single-center, open-label, parallel, single-dose pharmacokinetic study of HS-10504 in participants with hepatic impairment and normal hepatic function. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: To Compare the Pharmacokinetic (PK) Differences of HS-10504 Between Participants With Hepatic Impairment and Participants With Normal Hepatic Function
What is being tested?: HS-10504
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: No sites listed yet
Study dates: 30 Sep 2026to 30 Oct 2027
Phase: Phase 1

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All participants must meet ALL of the following criteria to be eligible for this study:
Provide written informed consent before any study related procedures, have a full understanding of the study, its procedures, and possible adverse events, and express a willingness and ability to comply with the protocol requirements.
Be male or female adults.
Agree to practice highly effective contraception from the time of signing the informed consent form until 6 months after the last dose of study drug (only non pharmacological contraceptive measures are allowed during the study), and refrain from attempting to conceive or donate sperm/eggs during this period.
Participants with normal hepatic function must meet the following criterion to be eligible for this study:
1. Participants in the normal hepatic function group should be matched with those in the hepatic impairment group for body mass index (BMI), age, and sex.

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Participants with hepatic impairment must meet the following criteria to be eligible for this study:
Chronic liver injury caused by primary liver disease;
The investigator judges that the participant's hepatic function status is stable based on the participant's clinical symptoms and other available examination results at screening;
Have had a stable medication regimen for the treatment of hepatic impairment, complications, and other concomitant diseases for at least 14 days prior to administration of the investigational product, with no need for dose adjustment; or have not been on any such medication.

Who cannot join

Participants who meet any of the following criteria will not be enrolled in this study:
Have participated in any other clinical trial and used any investigational drug/device within 3 months prior to screening;
Have a history of surgery within 3 months prior to screening, or have planned surgery during the study period, or have undergone surgery that may affect drug absorption, distribution, metabolism, or excretion;
Have experienced significant blood loss or blood donation within 3 months prior to screening, or blood loss ≥200 mL within 1 month, or have planned blood donation during the study period;
Have used strong or moderate inhibitors or inducers of CYP3A4/5, CYP2C8, and CYP2D6 within 30 days prior to the first dose of the investigational product, or have used albumin within 14 days prior to the first dose;
Have a history of, or currently have, severe diseases of the nervous, psychiatric, digestive, circulatory, respiratory, urinary systems, etc., or have developed a new illness before administration of the investigational product, which is assessed by the investigator as unsuitable for participation in this study;

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Have a history of severe allergy, are prone to allergic reactions, or have an allergic constitution, or are known to be allergic to any component of the investigational product;
Have regularly consumed alcohol within 3 months prior to screening or are unable to refrain from alcohol consumption during the study period, or have a positive alcohol breath test at screening;
Have smoked an average of >5 cigarettes per day within 3 months prior to screening, or are unable to refrain from using any tobacco products during the study period;
Have consumed excessive amounts of tea, coffee, and/or caffeinated beverages within 3 months prior to screening;
Have a history of drug abuse, drug dependence, or illicit drug use within 5 years prior to screening, or have a positive drug abuse screening test;
Are lactating women within 1 month prior to screening or during the study period, or have a positive pregnancy test;
Have had unprotected sexual intercourse within 14 days prior to screening;
Have special dietary requirements, are unable to comply with a uniform diet, or have difficulty swallowing;
Are unable to tolerate venipuncture or indwelling needle blood sampling, or have a history of needle phobia or blood phobia;
Are unable to complete the study for other reasons, or are judged by the investigator as unsuitable for participation.
Participants with normal hepatic function who meet any of the following exclusion criteria will be excluded:
History of hepatic impairment;
Clinically significant abnormalities in physical examination, vital signs, 12 lead ECG, or clinical laboratory tests at screening that are judged by the investigator as unsuitable for enrollment;
Use of any prescription drugs, over the counter drugs, herbal medicines, or health supplements within 14 days prior to the first dose of the investigational product, or use of any drug without a washout period of at least 7 half lives.
Participants with hepatic impairment who meet any of the following exclusion criteria will be excluded:
The participant has any of the following conditions that, in the investigator's assessment, makes them unsuitable for participation in this trial: ① history of liver transplantation; ② history of partial hepatectomy; ③ suspected or confirmed hepatocellular carcinoma or other malignancies; ④ hepatic failure; ⑤ bleeding from esophageal and gastric varices within 3 months prior to screening; ⑥ diseases such as biliary cirrhosis or extrahepatic biliary obstruction; ⑦ coexisting overt hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
Apart from the primary liver disease itself, the participant has a history of or currently has other severe systemic organ diseases or clinically significant laboratory abnormalities that, in the investigator's judgment, make them unsuitable for participation in this trial.

About this study

This is a two-part single-center, open-label, parallel, single-dose pharmacokinetic study of HS-10504 in participants with hepatic impairment and normal hepatic function.

Read the detailed description

In each part, two treatment groups were set up (Group A: participants with moderate hepatic impairment; Group B: participants with normal hepatic function), and 8 participants (both males and females) were enrolled in each group. On Day 1, a single oral dose of 400 mg HS-10504 tablet was administered in the fasting state.

Conditions: To Compare the Pharmacokinetic (PK) Differences of HS-10504 Between Participants With Hepatic Impairment and Participants With Normal Hepatic Function
Being tested: HS-10504
Keywords: Phase I, Hepatic impairment, HS-10504

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HS-10504Drug
HS-10504:On Day 1, a single oral dose of 400 mg HS-10504 tablet was administered in the fasting state.

Study groups in NCT07836504
Study group	Role	What they receive
Participants with hepatic impairment	Experimental	Not described Receives: Drug: HS-10504
Participants with normal hepatic function	Experimental	Not described Receives: Drug: HS-10504

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of PK parameters of HS-10504: Cmax
To evaluate the Cmax of HS-10504 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504: AUC0-t
To evaluate the AUC0-t of HS-10504 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504: AUC0-∞
To evaluate the AUC0-∞ of HS-10504 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504

Secondary outcomes (35)

Evaluation of PK parameters of HS-10504 and metabolite M6-2: Cmax.
To evaluate the Cmax of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: AUC0-t.
To evaluate the AUC0-t of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: AUC0-∞.
To evaluate the AUC0-∞ of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: Tmax.
To evaluate the Tmax of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: t1/2z.
To evaluate the t1/2z of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: λz.
To evaluate the λz of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: CL/F.
To evaluate the CL/F of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: Vz/F.
To evaluate the Vz/F of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: MRT0-t.
To evaluate the MRT0-t of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: MRT0-∞
To evaluate the MRT0-∞ of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: fu.
To evaluate the fu of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: Cmax,Unbound.
To evaluate the Cmax,Unbound of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: AUC0-t,Unbound.
To evaluate the AUC0-t,Unbound of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2: AUC0-∞,Unbound.
To evaluate the AUC0-t,Unbound of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Evaluation of PK parameters of HS-10504 and metabolite M6-2:CL/F,Unbound .
To evaluate the CL/F,Unbound of HS-10504 and metabolite M6-2 in participants with hepatic impairment and normal hepatic function
Measured: 216 hours after administration of HS-10504
Adverse events
To evaluate the Occurrence of adverse events
Measured: Up to end of the study, approximately 3 months.
vital signs(blood pressure)
To evaluate the vital signs(blood pressure) of HS-10504 in participants with hepatic impairment and normal hepatic function
Measured: Up to end of the study, approximately 3 month.
vital signs( Pulse)
To evaluate the vital signs(Pulse) of HS-10504 in participants with hepatic impairment and normal hepatic function
Measured: Up to end of the study, approximately 3 month.
vital signs(body temperature)
To evaluate the vital signs( body temperature) of HS-10504 in participants with hepatic impairment and normal hepatic function
Measured: Up to end of the study, approximately 3 month.
Number of participants with clinical laboratory tests(complete blood count (CBC))
To evaluate the clinical laboratory tests(complete blood count (CBC)) of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
Number of participants with urinalysis
To evaluate the abnormal of urinalysis of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
Number of participants with abnormal blood chemistry
To evaluate the abnormal of blood chemistry of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
Number of participants with abnormal coagulation tests
To evaluate the abnormal of coagulation tests of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
12-lead electrocardiogram（ heart rate）
To evaluate the 12-lead electrocardiogram（heart rate） of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
12-lead electrocardiogram（PR）
To evaluate the 12-lead electrocardiogram（PR） of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
12-lead electrocardiogram（RR）
To evaluate the 12-lead electrocardiogram（RR） of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
12-lead electrocardiogram（QRS duration）
To evaluate the 12-lead electrocardiogram（QRS duration） of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
12-lead electrocardiogram（QTcF）
To evaluate the 12-lead electrocardiogram（ QTcF） of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
Number of participants with abnormal general inspection
To evaluate the abnormal of general inspection of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
Number of participants with abnormal head and neck
To evaluate the abnormal of head and neck of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
Number of participants with abnormal lymph nodes
To evaluate the abnormal of lymph nodes of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
Number of participants with abnormal chest
To evaluate the abnormal of chest of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
Number of participants with abnormal abdomen
To evaluate the abnormal of abdomen of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
Number of participants with abnormal spine and extremities
To evaluate the abnormal of spine and extremities of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.
Number of participants with abnormal neurological examination
To evaluate the abnormal of neurological examination of HS-10504 in participants with hepatic impairment and normal hepatic function.
Measured: Up to end of the study, approximately 3 month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 202630 Oct 2027

First posted23 Sep 2026
Study start30 Sep 2026 (estimated)
Primary completion25 Sep 2027 (estimated)
Study completion30 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for To Compare the Pharmacokinetic (PK) Differences of HS-10504 Between Participants With Hepatic Impairment and Participants With Normal Hepatic FunctionStudies of the same condition, open and under way.
More trials run by Jiangsu Hansoh Pharmaceutical 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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07836504
Sponsor's protocol ID: HS-10504-116
Status last verified: Jul 2026
First submitted: 11 Sep 2026
Last updated: 23 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No