Actively Recruiting
A 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
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase. This trial uses a non-randomized, open-label, parallel, single-dose adaptive design aimed at investigating the effects of varying degrees of renal insufficiency on the pharmacokinetics, safety, and tolerability of a single oral dose of 3 mg Azvudine tablets in humans. On the first day of the study, a single oral dose of 3 mg ( 3 tablets ) of Azvudine tablets is taken orally on an empty stomach. Biological sample collection and safety examination will be performed in this trial.
CONDITIONS
Official 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 18 to 70 years, any gender
- Body mass index (BMI) between 18.0 and 30.0
- Men must weigh at least 50 kg; women must weigh at least 45 kg
- Females of childbearing potential must use effective contraception and have a negative pregnancy test at screening
- Males must use effective contraception or be surgically sterilized during the trial and for 3 months after
- Able to understand and sign informed consent
- Healthy participants must have good health and normal or clinically insignificant vital signs, physical exam, ECG, and lab results
- Healthy participants must not have taken any medications, herbal remedies, or supplements in the 14 days before screening
- Healthy participants must have a glomerular filtration rate (GFR) between 90 and less than 130 ml/min
- Participants with mild or moderate GFR decline matched by age, weight, and gender to healthy participants
- Participants with renal insufficiency must have stable kidney function for more than 3 months with two consistent GFR tests
- No clinically significant abnormalities in medical history, vital signs, physical exam, or labs except those related to kidney function
- Renal insufficiency participants must be on stable doses of other medications that do not affect study drug metabolism for at least 4 weeks
- Prohibited use of certain traditional medicines and specific drugs 2 weeks before and during the study
- Liver enzymes and bilirubin levels must be less than 1.5 times the upper normal limit
- Mild GFR decline: 60 to 89 ml/min; Moderate GFR decline: 30 to 59 ml/min
You will not qualify if you...
- Allergy to Azvudine or any ingredients
- History of gastrointestinal surgery or digestive diseases affecting drug absorption or metabolism
- History of drug abuse within 12 months or positive tests for addictive substances
- Fever or infectious disease at screening
- Participation in other clinical trials within 3 months
- History of smoking addiction (5 or more cigarettes daily) within 12 months
- History of alcohol abuse (14 or more units per week) or positive alcohol breath test
- Blood donation of 200 mL or more within 8 weeks
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis
- Pregnant or breastfeeding women
- Unable to tolerate blood collection or with poor blood vessels
- Vaccination within 3 months before screening or planned during the trial
- Investigator judgment of unsuitability
- Kidney transplant recipients
- Abnormal blood pressure or heart rate outside specified ranges
- Frequent hypoglycemia not caused by drugs
- Low albumin (<30 g/L) or hemoglobin (<9 g/dL)
- Uncontrolled or unstable serious diseases of cardiovascular, liver, lung, digestive, nerve, autoimmune, metabolic, musculoskeletal, or blood systems
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here