Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Liver Function

NCT06106113 | Completed Phase 1

• 1 other identifier: GST-HG171-I-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• Maximum observed plasma concentration (Cmax) for GST-HG171

  Maximum observed plasma GST-HG171 concentration.

  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

Secondary Outcomes (1)

• AEs

  up to Day 7

Study Arms (3)

Mild hepatic impairment

OTHER

150 mg GST-HG171

Drug: GST-HG171 Tablets

Moderate hepatic impairment

OTHER

150 mg GST-HG171

Drug: GST-HG171 Tablets

healthy subjects with normal hepatic function

OTHER

150 mg GST-HG171

Drug: GST-HG171 Tablets

Interventions

GST-HG171 Tablets DRUG

150mg GST-HG171 Tablets

Mild hepatic impairment; Moderate hepatic impairment; healthy subjects with normal hepatic function

Eligibility Criteria

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

You may qualify if:

• All subjects are required to meet all of the following conditions
• 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;
• 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;
• Age range from 18 to 65 (including both ends) on the date of signing the informed consent, both male and female;
• 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);
• Creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 mL/min;
• Subjects with normal liver function should also meet all of the following conditions:
• The following demographic matching criteria must be met during screening:
• Body weight was matched with that of the group with liver function impairment, with an average of ±10 kg;
• Age matching was performed between the group with liver function impairment, the mean was ±10 years old;
• 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:
• 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;
• Cirrhosis was clinically diagnosed;
• 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;

You may not qualify if:

• Allergic constitution, including severe drug allergy or history of drug allergy, known allergy to the study drug or any component of the study drug;
• During the screening period, electrocardiogram showed QTc interphase (QTcF) \>470 msec for males and \>480 msec for females (corrected according to Fridericia's standard);
• A history of dysphagia or any gastrointestinal disorder affecting drug absorption, including frequent nausea or vomiting due to any etiology;
• Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening;
• Those who had been vaccinated within 14 days prior to screening or planned to be vaccinated during the study period;
• Those who donated blood or lost more than 200 mL of blood within 3 months prior to screening, or intended to donate blood during the trial or within 1 month after the trial;
• A strong or medium acting inducer or inhibitor of CYP3A enzyme, a strong P-glycoprotein (P-gp) inhibitor or inducer used within 1 month before screening;
• D1 had taken 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 (more than 8 cups of 200 mL per cup per day on average) in the 2 weeks prior to administration;
• Binge drinkers in the 3 months preceding screening, i.e. those who consume more than 14 units of alcohol per week (1 unit = 360 mL beer, or 45 mL spirits with 40% alcohol by volume, or 150 mL wine) or those who test positive for alcohol; Smokers who smoked at least 10 cigarettes a day in the 3 months before screening;
• Those who have a history of drug use, or drug abuse, or test positive for drug abuse;
• Pregnant or lactating women or women of childbearing age who have tested positive for pregnancy;
• Patients who cannot tolerate venipunction or have a history of fainting needle and fainting blood;
• History of liver injury;
• Have been or are currently suffering from any clinically serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatric and metabolic abnormalities, or any other disease that may interfere with the test results;
• Physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal color ultrasound and other abnormalities were judged by researchers to have clinical significance;

Sponsors & Collaborators

• Fujian Akeylink Biotechnology Co., Ltd.: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Related Publications (1)

• Zhou J, Zhang H, Chen H, Zhang G, Mao J, Zhang T, Tang Y, Yan W, Li C, Ding Y, Jin Q. Pharmacokinetics and safety of GST-HG171, a novel 3CL protease inhibitor, in Chinese subjects with impaired and normal liver function. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0053924. doi: 10.1128/aac.00539-24. Epub 2024 Jul 11.

  PMID: 38990016 DERIVED

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 29, 2022
• First Posted: October 30, 2023
• Study Start: December 15, 2022
• Primary Completion: February 6, 2023
• Study Completion: May 30, 2023
• Last Updated: October 30, 2023

Record last verified: 2022-12

Locations

CN (1)