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

NCT06106126 | Unknown

• 1 other identifier: GST-HG171-I-03
• Study Type: interventional
• Target: 32
• 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 renal 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 (predose), 0.25,0.5 ,0.75,1 ,1.25,1.5,2 ,3 ,4 ,6 ,8 ,12,24 ,48 and 72 hours post-dose

Secondary Outcomes (1)

• AEs

  up to Day 10

Study Arms (4)

Mild renal impairment

OTHER

Drug: GST-HG171 Tablets

Moderate renal impairment

OTHER

Drug: GST-HG171 Tablets

Severe renal impairment

OTHER

Drug: GST-HG171 Tablets

Normal Renal Function

OTHER

Drug: GST-HG171 Tablets

Interventions

GST-HG171 Tablets DRUG

150mg GST-HG171 100mg Tablets and ritonavir

Mild renal impairment; Moderate renal impairment; Normal Renal Function; Severe renal impairment

Eligibility Criteria

• Age: 18 Years - 70 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 70 (including both ends) on the date of signing the informed consent, both male and female;
• Male subjects weigh at least 50 kg and female subjects weigh at least 45 kg; Body mass index (BMI) 18-32 kg/m2 (including both ends);
• Subjects with normal renal function should also meet all of the following conditions:
• Physical examination, vital signs and electrocardiogram are normal or abnormal without clinical significance;
• The glomerular filtration rate should meet the following criteria: Subjects with normal renal function: GFR≥90 mL/min;
• The following demographic matching criteria must be met during screening:
• The body weight was matched with that of the renal impairment group, with an average of ±10 kg;
• Age matching was performed with the renal impairment group, with the mean ±10 years old;
• Gender matching was performed with the group of renal impairment, with the mean ±1 case;
• Subjects with renal impairment should also meet all of the following conditions:
• Have chronic kidney disease (CKD), have any indicators of kidney injury or have a GFR less than 60 mL/min for more than 3 months (outpatient medical records, inpatient records or laboratory records can be used as evidence);
• The glomerular filtration rate shall meet the following criteria: Subjects with mild renal impairment (stage CKD2) : 60-89 mL/min (including values at both ends), subjects with moderate renal impairment (stage CKD3) : 30-59 mL/min (including values at both ends), subjects with severe renal impairment (stage CKD4) : 15-29 mL/min (including both ends);

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;
• Those who donated blood ≥400 mL within 3 months before screening, or donated blood ≥200 mL within 1 month before screening, or received blood transfusion or used blood products;
• Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening;
• A history of difficulty swallowing or any gastrointestinal disorder affecting drug absorption, including frequent nausea or vomiting due to any etiology;
• A strong or medium acting inducer or inhibitor of CYP3A enzyme, a strong P-gp inhibitor or P-gp inducer used within 1 month before screening;
• Those who had been vaccinated within 14 days prior to screening or planned to be vaccinated during the study period;
• Smokers who smoked at least 10 cigarettes a day in the 3 months before screening;
• had taken a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or had 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;
• A history of drug or substance abuse and/or alcoholism (14 units of alcohol per week: 1 unit = 285 mL for beer, 25 mL for spirits, or 100 mL for wine);
• had taken any products containing alcohol or had tested positive for alcohol breath test within 24 hours before receiving the study drug;
• Positive urine drug screening (morphine, cannabis);
• Pregnant or lactating women or women of childbearing age who have tested positive for pregnancy;
• Active HBV or HCV infection, HIV-positive, or treponema pallidum antibody positive and rapid plasma response (RPR) positive (RPR only for treponema pallidum antibody positive);
• Participants who have participated in clinical trials of drugs or medical devices within 3 months prior to screening (subject to drug acceptance);
• had taken any prescription drugs, over-the-counter drugs, any vitamin products or herbs in the 14 days prior to screening;

Sponsors & Collaborators

• Fujian Akeylink Biotechnology Co., Ltd.: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: October 30, 2023
• Study Start: February 10, 2023
• Primary Completion: February 28, 2024
• Study Completion: March 1, 2024
• Last Updated: October 30, 2023

Record last verified: 2022-12

Locations

CN (1)