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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07836504

Enrollment

Registered

2026-09-23

Start date

2026-09-30

Completion date

2027-10-30

Last updated

2026-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Phase I, Hepatic impairment, HS-10504

Brief 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.

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.

Interventions

DRUGHS-10504

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* All participants must meet ALL of the following criteria to be eligible for this study: 1. 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. 2. Be male or female adults. 3. 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. Participants with hepatic impairment must meet the following criteria to be eligible for this study: 1. Chronic liver injury caused by primary liver disease; 2. 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; 3. 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.

Exclusion criteria

* Participants who meet any of the following criteria will not be enrolled in this study: 1. Have participated in any other clinical trial and used any investigational drug/device within 3 months prior to screening; 2. 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; 3. 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; 4. 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; 5. 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; 6. 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; 7. 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; 8. 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; 9. Have consumed excessive amounts of tea, coffee, and/or caffeinated beverages within 3 months prior to screening; 10. 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; 11. Are lactating women within 1 month prior to screening or during the study period, or have a positive pregnancy test; 12. Have had unprotected sexual intercourse within 14 days prior to screening; 13. Have special dietary requirements, are unable to comply with a uniform diet, or have difficulty swallowing; 14. Are unable to tolerate venipuncture or indwelling needle blood sampling, or have a history of needle phobia or blood phobia; 15. 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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 24, 2026