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

NCT07002281 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-06-03

No results posted yet for this study

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).

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

Interventions

DRUG

[14C]Azvudine suspension

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

Sponsors & Collaborators

  • Henan Genuine Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2024-10-10
Completion
2025-03-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07002281 on ClinicalTrials.gov