A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Dec… (NCT07001436) | Clinical Trial Compass
RecruitingPhase 1
A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects
China40 participantsStarted 2025-05-20
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old and ≤ 70 years old, regardless of gender;
✓. Body mass index (BMI) within the range of 18.0-30.0 (including the critical value) (BMI = weight (kg) / height 2 (m2)), the weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg;
✓. Females of childbearing potential must have taken reliable and highly effective contraceptive measures and have a negative baseline blood pregnancy test at screening, and are willing to use appropriate and efficient methods of contraception after signing the informed consent form until 3 months after the last dose of the test drug; Male study participants who are willing to do so for the duration of the trial and for 3 months after the last dose of the trial drug Have no plans to have children and voluntarily use highly effective contraception, or have been surgically sterilized;
✓. Understand and sign the informed consent form.
✓. The health condition is judged by the investigator to be good, and the results of vital signs, physical examination, electrocardiogram, and laboratory examination are normal or abnormal, and there is no clinical significance;
✓. Those who have not taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health care products within 14 days before screening;
✓. Meet the classification standard of glomerular filtration rate of 90≤GFR\<130 ml/min;
What they're measuring
1
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Azvudine
Timeframe: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
2
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from the First Dose to the Last Blood Collection Point (AUC0-t) of Azvudine
Timeframe: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
3
Pharmacokinetics (PK): Area Under the Concentration-Time Curve Extrapolated from the Initial Administration to Infinity (AUC0-∞) of Azvudine (if applicable)
Timeframe: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
✓. Study participants with mild or moderate decline in GFR were matched with the following demographic characteristics: age (mean ± 10 years), weight (mean ±10kg), and gender (±1 cases).
Exclusion criteria
✕. Allergies, especially those who are allergic to any of the ingredients in this product and excipients;
✕. Those who have undergone gastrointestinal resection in the past, or suffer from digestive diseases that will affect the absorption, distribution, metabolism and excretion of drugs;
✕. Those who have a history of drug abuse within 12 months before screening or those who have tested positive for addictive substances before enrollment;
✕. Those with fever or infectious diseases at the time of screening;
✕. Those who have participated in other clinical trials within 3 months before screening;
✕. Those who have a history of smoking addiction within 12 months before screening (the average number of cigarettes per day ≥5);
✕. Those who have a history of alcohol abuse within 12 months before screening (drinking ≥ 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 150mL of wine) or positive alcohol breath test (test value \>0mg/100mL) before enrollment;
✕. Those who have lost blood or donated 200mL of blood ≥ within 8 weeks before screening;