Pharmacokinetic Study of HS-10365 Capsule in Subjects with Hepatic Impairment and Normal Hepatic Function

NCT06823258 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-10365-110
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be conducted in subjects with moderate Hepatic Impairment, mild hepatic Impairment and normal hepatic function. The study will be conducted in two stages. Based on the research results of moderate hepatic Impairment and matched control subjects with normal hepatic function, the sponsor will make a comprehensive analysis to decide whether it is necessary to conduct a study on the mild hepatic Impairment and matched control subjects with normal hepatic function

Conditions

NSCLC (advanced Non-small Cell Lung Cancer)

Outcome Measures

Primary Outcomes (3)

• Peak plasma concentration (Cmax) of HS-10365

  From the first dose (Day 0) up to Day 6

• Pharmacokinetic parameters AUC0-t of HS-10365

  From the first dose (Day 0) up to Day 6

• Pharmacokinetic parameters AUC0-∞ of HS-10365

  From the first dose (Day 0) up to Day 6

Secondary Outcomes (3)

• Safety : the Incidence rate of AE related to Clinical symptoms

  From the first dose (Day 0) up to Day 6

• Safety：the incidence rate of Laboratory ABNORMALITIES

  From the first dose (Day 0) up to Day 6

• the incidence rate of adverse events/serious adverse events

  From the first dose (Day 0) up to Day 6

Study Arms (2)

Arm A: HS-10365 160mg

EXPERIMENTAL

Participants with Hepatic Impairment will receive HS-10365 160mg administered orally

Drug: HS-10365

Arm B: HS-10365 160mg

EXPERIMENTAL

Participants with normal hepatic function will receive HS-10365 160mg administered orally

Drug: HS-10365

Interventions

HS-10365 DRUG

HS-10365 administered orally once at D1

Arm A: HS-10365 160mg; Arm B: HS-10365 160mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants must meet all of the following conditions:
• Voluntarily sign an informed consent form before the start of activities related to this study, understand the procedures and methods of this study, and be willing to strictly follow the clinical study protocol to complete this study;
• The subjects agree to have no plans to conceive or donate sperm/eggs within 6 months from the signing of the informed consent form until the last administration, and voluntarily adopt effective contraceptive measures (non-pharmacological contraceptive measures were taken during the study period, as detailed in Appendix 1);
• On the day of signing the informed consent form, both males and females must be at least 18 years old;
• The weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg; Body mass index (BMI) 18-33 kg/m2 (including both ends);
• Creatinine clearance rate (calculated using the Cockcroft Gault formula, see Appendix 2) ≥ 60 mL/min.
• Subjects with normal hepatic function must also meet all of the following conditions:
• \) When screening, the following demographic matching criteria must be met:
• BMI matching with the matched hepatic impairment group, with a mean within ± 15% range;
• Age matching with the matched hepatic impairment group, with a mean of ± 5 years;
• Gender matching with the matched hepatic impairment group，with the same number of individuals for each gender;
• Subjects with liver dysfunction must also meet all of the following conditions:
• Chronic liver injury caused by primary liver disease (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.) in subjects with hepatic impairment classified as A or B by Child Pugh grading (see Appendix 3 for Child Pugh grading).
• Researchers determine that the hepatic function status of the subjects has been stable for at least 2 months based on their clinical symptoms and other examination results available during screening (as determined by the researchers).
• Individuals who have a stable medication regimen for treating hepatic impairment, complications, and other accompanying diseases for at least 14 days prior to taking the investigational drug, and whose medication does not require adjustment (including medication type, dosage, or frequency, except for diuretics, insulin, and other medications); Or those who have not taken medication.

You may not qualify if:

• During the screening period, 12 lead electrocardiogram results showed QT interval prolongation (male QTcF\>470 ms; female QTcF\>480 ms);
• Individuals at increased risk of QT interval prolongation (such as heart failure, congenital long QT syndrome, family history of long QT syndrome, refractory hypokalemia, or unexplained sudden death in immediate family members under 40 years old);
• Severe or poorly controlled hypertension, including a history of hypertensive crisis or hypertensive encephalopathy; Within 2 weeks prior to the first administration, adjustments were made to antihypertensive medication due to poor blood pressure control; During the screening period, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg;
• Individuals who are prone to allergic reactions or have an allergic constitution (such as those who are allergic to pollen, two or more drugs/foods), or those who are known to be allergic to the study drug or any component of the study drug;
• Individuals who have participated in any other clinical trials within the previous 3 months and have used study drugs or plan to participate in other clinical trials during the study period (those who have not been given the study drug or placebo after enrollment may be included);
• Individuals who have donated blood or lost blood ≥ 400 mL within the first 3 months of screening, or have received blood transfusions or used blood products, or intend to donate blood during the trial period or within 1 month after the trial ends;
• Individuals who have used strong or moderate inducers or inhibitors of P-gp and/or CYP3A4 enzymes and/or P-gp, BCRP, MATE1 or MATE2-K substrates within the previous month of screening (see Appendix 4);
• Prior to administration, any proton pump inhibitors (PPIs), H2 receptor antagonists, local antacids, oral alkaline drugs, or other drugs that reduce gastric acid secretion were used, and HS-10365 was administered within 7 half lives of the aforementioned drugs;
• Individuals who have consumed a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, and/or caffeinated beverages (an average of 8 or more cups per day, 200 mL per cup) within 2 weeks prior to administration;
• Individuals who consume grapefruit or grapefruit products within 48 hours prior to taking the investigational drug;
• Screening for alcoholics within the first 3 months, i.e. those who consume more than 14 units of alcohol per week (1 unit=360 mL of beer, 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine) or have a positive alcohol screening result;
• Individuals who smoke an average of 10 or more cigarettes per day within the first 3 months of screening, or who cannot stop using any tobacco products during the trial period;
• Individuals with a history of drug use, substance abuse, or a positive urine drug test;
• Individuals who have used vaccines or plan to use vaccines during the study period within 14 days prior to taking the investigational drug;
• Pregnant or lactating women, or women of childbearing age who test positive for pregnancy;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Nanya, Doctor

CONTACT

86-15804302611; wangny@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: February 12, 2025
• Study Start: February 28, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 12, 2025

Record last verified: 2024-12