NCT07002281

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Henan Genuine Biotech Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

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

Timeline

• Start date: 2024-07-22
• Primary completion: 2024-10-10
• Completion: 2025-03-20
• First posted: 2025-06-03
• Last updated: 2025-06-03

Locations

1 site across 1 country: China