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HealthyPhase 1NCT07002281

[14C] Mass Balance Clinical Trial of Azvudine in Healthy Male Subjects

A Phase 1 study testing [14C]Azvudine suspension in people with Healthy, run by Henan Genuine Biotech Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 (RdRp). Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
[14C]Azvudine suspension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
22 Jul 2024to 20 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult male subjects aged 18~45 years old;
  • Body mass index (BMI) within the range of 18.0-30.0 (including the critical value) (BMI = weight (kg) / height 2 (m2)), the weight should be ≥ 50.0kg;
  • Subjects who are judged by the investigator to be in good health, with normal results of physical examination, vital signs, electrocardiogram, and laboratory examinations or abnormal but without clinical significance;
  • Subjects who have no fertility plan during the study period and within 1 year after the end of the trial and agree to take effective non-drug contraceptive measures during the trial (except for those who have taken permanent contraceptive measures, such as vasectomy, etc.), and have no sperm donation plan;
  • Subjects who are willing to follow the visits, study treatments, laboratory tests, and other study-related procedures and requirements specified in the study protocol, understand and sign the informed consent form.

Who cannot join

  • Those who are allergies, with a history of drug or food allergies, especially those who are allergic to any of the ingredients in this product and excipients;
  • Those who are positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), or treponema pallidum antibody;
  • Those who cannot tolerate venipuncture blood collection and/or have a history of blood sickness and needle sickness;
  • Those who have a history of mental illness, family history of mental illness, or chronic or serious diseases of the central nervous system, cardiovascular, liver, kidney, lung, metabolic, blood, bone and other systems;
  • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal (ULN);
  • Glomerular filtration rate< 90 mL/min/1.73m2;
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  • Patients with long QT syndrome or its family history, or QTcF interval (Fridericia's correction) > 450 ms; Intraventricular block or left and right bundle branch block and/or QRS>120 ms; Frequent ventricular ectopic beats (1 premature ventricular contraction occurred on any 10-second ECG during the screening period≥); or abnormal resting heart rate (>100 bpm);
  • Previous or current swallowing dysfunction, active gastrointestinal diseases (such as chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease) or other diseases that significantly affect drug absorption, distribution, metabolism and excretion;
  • Hemorrhoids or perianal disease accompanied by regular/hematochezia;
  • Those who have donated blood within 3 months before screening, or have lost ≥ 200 ml of blood, or plan to donate blood during the study period;
  • Those who have been vaccinated with the new crown vaccine within 2 weeks before screening or other vaccines within 3 months before screening or plan to be vaccinated during the trial;
  • Intake of > 6 servings of coffee, tea, cola, energy drinks, or other caffeinated products per day within 3 months prior to screening (one serving ≈ 120 mg of caffeine); or ingestion of foods or drinks containing high levels of caffeine, xanthines, alcohol, flavonoids (such as: grapefruit (juice), grapefruit (juice), orange (juice), etc.) within 24 hours before administration;
  • Use of any drug that inhibits or induces hepatic drug metabolism enzymes within 1 month before administration (such as: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - SSRIs antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, etc.);
  • Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and health care products within 14 days before administration;
  • Those who have participated in other clinical trials within 3 months before screening;
  • Smoking more than 5 cigarettes per day within 3 months before screening, or unable to comply with the prohibition of smoking during the study;
  • Those who have a history of alcoholism within 12 months before screening (drinking ≥ 14 units of alcohol per week: 1 unit = 360 mL of beer, or 45 mL of spirits, or 150 mL of wine) or those who have a positive alcohol breath test before enrollment;
  • Known or suspected history of drug abuse (e.g., morphine, methamphetamine, ketamine, methylenedioxyamphetamine, tetrahydrocannabinolic acid, cocaine, etc.), or positive test for addictive substances;
  • Surgical surgery within 3 months prior to screening, or planned surgical surgery during the current study period;
  • Participated in radiolabeled clinical trials within 1 year before screening;
  • Workers who require long-term exposure to radioactive conditions, or who have had significant radioactive exposure within 1 year before the test (≥ 2 chest/abdominal CT examinations, or ≥ 3 other types of X-ray examinations);
  • The investigator judges that there are other circumstances that make subjects unsuitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Jishuitan Hospital

    Beijing

Other trials in China

About this study

Official title: A Single-center, Open-label, Single-dose Clinical Trial to Evaluate the Absorption, Metabolism, and Excretion of 3 mg/100 μCi [14C]Azvudine Suspension in Vivo in Healthy Male Subjects

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 (RdRp).

This trial uses a single-center, open-label, single-dose adaptive design aimed at investigating the pharmacokinetic characteristics of total radioactivity of [14C]-labeled Azvudine in whole blood and plasma of healthy male subjects, to quantitatively analyze the total radioactivity in exhaled gas and excreta of healthy male subjects after oral administration of [14C]Azvudine suspension, to obtain data on the mass balance in the human body, and to determine the main excretion routes. Biological sample collection and safety examination will be performed in this trial.

Conditions
Healthy
Being tested
[14C]Azvudine suspension
Keywords
Azvudine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]Azvudine suspensionDrug

    A single oral dose of 3 mg/100 μCi of [14C]Azvudine suspension is given orally on an empty stomach.

Study groups in NCT07002281
Study groupRoleWhat they receive
Healthy male subjectsExperimentalNot described
Receives: Drug: [14C]Azvudine suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of total radioactive material in whole blood and plasma

    Measured: Up to 96 hours post-dose

  2. Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of total radioactive material in whole blood and plasma

    Measured: Up to 96 hours post-dose

  3. Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of total radioactive material in whole blood and plasma

    Measured: Up to 96 hours post-dose

  4. Pharmacokinetics (PK): Elimination half-life (t1/2) of total radioactive material in whole blood and plasma

    Measured: Up to 96 hours post-dose

  5. The total radioactivity allocation ratio

    Measured: Up to 96 hours post-dose

  6. The total radioactivity and the percentage to the total administered dose

    Measured: Up to 168 hours post-dose

Secondary outcomes (6)

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Azvudine and its metabolites in plasma

    Measured: Up to 96 hours post-dose

  2. Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Azvudine and its metabolites in plasma

    Measured: Up to 96 hours post-dose

  3. Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of Azvudine and its metabolites in plasma

    Measured: Up to 96 hours post-dose

  4. Pharmacokinetics (PK): Elimination half-life (t1/2) of Azvudine and its metabolites in plasma

    Measured: Up to 96 hours post-dose

  5. Percentage of Azvudine metabolites in plasma to total exposed AUC

    Measured: Up to 96 hours post-dose

  6. Occurrence of Adverse Events

    Clinical presentation characteristics, severity, onset time, duration of adverse events, management measures, outcomes, and the correlation with the investigational drug.

    Measured: From enrollment to the end of the study on Day 22.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start22 Jul 2024
  3. Primary completion10 Oct 2024
  4. Study completion20 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002281
Sponsor's protocol ID
GQ-FNC-111
Status last verified
May 2025
First submitted
13 May 2025
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]Azvudine suspension in people with Healthy, run by Henan Genuine Biotech Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Maximum Concentration (Cmax) of total radioactive material in whole blood and plasma (time frame: Up to 96 hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07002281.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.

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