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A Non-randomized, Open, Parallel, Single-dose Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects
Led by Henan Genuine Biotech Co., Ltd. · Updated on 2025-06-03
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of Azvudine, a nucleoside reverse transcriptase inhibitor and broad-spectrum RNA virus inhibitor, on people with mild to moderate renal insufficiency and healthy individuals. This Phase 1 trial aims to understand how different levels of kidney function affect the drug's behavior in the body, its safety, and how well it is tolerated. The study is sponsored by Henan Genuine Biotech Co., Ltd. and involves adult participants aged 18 to 70 years old. Participants receive a single oral dose of 3 mg Azvudine tablets (three tablets taken on an empty stomach) on the first day of the study. The trial includes three groups: those with mildly decreased kidney function, those with moderately decreased kidney function, and healthy volunteers matched by age, weight, and gender. The study uses an open-label, non-randomized, parallel design to monitor how the drug is processed in these groups. During the trial, blood and urine samples are collected up to 48 and 72 hours after dosing, respectively, to measure drug levels and other pharmacokinetic parameters. Safety exams and monitoring for any adverse effects occur from enrollment until day 4. Researchers evaluate outcomes such as maximum drug concentration, area under the concentration-time curve, and elimination half-life to understand the drug's behavior in participants with varying kidney function. The total study period includes screening, drug administration, and follow-up assessments.
CONDITIONS
Brief Title
A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old, any gender
- Body mass index (BMI) between 18.0 and 30.0, with minimum weight 50 kg for men and 45 kg for women
- Females of childbearing potential must use reliable contraception and have a negative pregnancy test; males must agree to use contraception or be sterilized
- Able to understand and sign informed consent
- Healthy participants must have normal or clinically insignificant vital signs, physical exam, ECG, and lab results
- Healthy participants must not have taken medications or supplements within 14 days before screening
- Healthy participants must have glomerular filtration rate (GFR) between 90 and less than 130 ml/min
- Participants with renal insufficiency must have stable kidney function for over 3 months with consistent GFR tests
- Renal insufficiency participants must have no clinically significant abnormalities except kidney impairment
- Renal insufficiency participants must have stable medication use that does not affect Azvudine metabolism for at least 4 weeks and agree to continue during the study
- Renal insufficiency participants must avoid certain medications like Chinese patent medicines and SGLT-2 inhibitors during screening and study
- Liver enzymes and bilirubin must be below 1.5 times the upper limit of normal
- Renal insufficiency participants must meet GFR criteria for mild (60-89 ml/min) or moderate (30-59 ml/min) decline
You will not qualify if you...
- Allergy to Azvudine or any ingredients
- History of gastrointestinal surgery or digestive diseases affecting drug processing
- Drug abuse within 12 months or positive test for addictive substances
- Fever or infectious diseases at screening
- Participation in other clinical trials within 3 months
- Smoking addiction within 12 months (5 or more cigarettes/day)
- Alcohol abuse within 12 months or positive breath test
- Blood donation or loss of 200 mL or more within 8 weeks
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis
- Pregnancy or breastfeeding
- Intolerance to blood collection procedures
- Vaccination within 3 months or planned vaccination during study
- Investigator judgment of unsuitability
- Kidney transplant history
- Blood pressure or heart rate outside specified ranges
- Frequent hypoglycemia not related to medication
- Low albumin (below 30 g/L) or low hemoglobin (below 9 g/dL)
- History of uncontrolled or unstable serious diseases affecting major body systems
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 days
Participants take a single oral dose of Azvudine tablets on an empty stomach and undergo pharmacokinetic and safety assessments.
Multiple visits for blood and urine sample collection up to 72 hours post-dose
Trial Site Locations
Total: 1 location
1
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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