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Conditions
Brief summary
This si a single-center, non-randomized, open, parallel, single-dose trial was designed to evaluate the safety and pharmacokinetic characteristics of GST-HG171 tablets in subjects with impaired liver function.
Interventions
150mg GST-HG171 Tablets
Sponsors
Fujian Akeylink Biotechnology Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
All subjects are required to meet all of the following conditions 1. Voluntarily sign informed consent prior to the start of activities related to this study, be able to understand the procedures and methods of this study, and be willing to strictly follow the clinical trial protocol to complete this study; 2. Subjects (including their partners) are willing to have no family planning and voluntarily take highly effective contraception within 6 months after the last study drug administration; 3. Age range from 18 to 65 (including both ends) on the date of signing the informed consent, both male and female; 4. Male subjects should weigh no less than 50 kg and female subjects should weigh no less than 45 kg; Body mass index (BMI) 18-32 kg/m2 (including both ends); 5. Creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 mL/min; Subjects with normal liver function should also meet all of the following conditions: 6. The following demographic matching criteria must be met during screening: 1. Body weight was matched with that of the group with liver function impairment, with an average of ±10 kg; 2. Age matching was performed between the group with liver function impairment, the mean was ±10 years old; 3. Gender matching was performed with liver function impairment group, and the mean was ±1 case; Subjects with impaired liver function should also meet all of the following conditions: 7. Chronic liver injury caused by primary liver diseases (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.), liver insufficiency patients with Child-Pugh grade A or B; 8. Cirrhosis was clinically diagnosed; 9. Stable medication regimen for liver dysfunction, complications and other concomitant diseases for at least 14 days prior to taking the study drug, and no adjustment of medication (including type, dosage or frequency of medication) is required; Or have not used drugs;
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) for GST-HG171 | Day 1 at 0 (pre-dose) ,0.25 ,0.5 ,0.75 ,1 ,1.25 ,1.5 ,2 ,3 ,4 ,6 ,8 ,12 ,24 and 48 hours post-dose | Maximum observed plasma GST-HG171 concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AEs | up to Day 7 | To evaluate the safety and tolerability of GST-HG171 tablets after a single oral administration in subjects with mild and moderate liver impairment and normal liver function |
Countries
China
Outcome results
None listed