NSCLC (advanced Non-small Cell Lung Cancer)
Conditions
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
Interventions
DRUGHS-10365
HS-10365 administered orally once at D1
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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 conditions: 1. 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; 2. 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); 3. On the day of signing the informed consent form, both males and females must be at least 18 years old; 4. 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); 5. 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: 1\) When screening, the following demographic matching criteria must be met: 1. BMI matching with the matched hepatic impairment group, with a mean within ± 15% range; 2. Age matching with the matched hepatic impairment group, with a mean of ± 5 years; 3. 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: 1. 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). 2. 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). 3. 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.
Exclusion criteria
* All participants who meet the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Contacts
Primary ContactNanya, Doctor
Outcome results
None listed