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

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

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Chronic liver injury caused by primary liver disease;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

32 Participants

are divided into 2 treatment groups

Group A: Participants with hepatic impairmentExperimental treatment 1 intervention

Group B: Participants with normal hepatic functionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Evaluation of PK parameters of HS-10504: Cmax

To evaluate the Cmax of HS-10504 in participants with hepatic impairment and normal hepatic function

Time frame