NCT07132957

A Study of AL8326 in Healthy Subjects

A Phase I Study to Evaluate the Mass Balance of 14C-labeled AL8326 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Advenchen Laboratories Nanjing Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This experiment plans to enroll 6-8 healthy male subjects in China, and ultimately collect complete test samples and data from at least 6 subjects as the standard. On the first day of the experiment, each subject orally took a single dose of \[14C\] AL8326 oral formulation containing approximately 60mg (200 μ Ci). During the experiment, whole blood, plasma, urine, and fecal samples were collected at designated time points/time periods.

Detailed description

This experiment adopts a single center, open label, non randomized, single dose trial design. By measuring the total radioactivity, calculate the ratio of total radioactivity in whole blood to plasma of \[14C\] AL8326, pharmacokinetic parameters, recovery rate, and excretion pathway data of total radioactivity in plasma. At the same time, by identifying the spectra of radioactive metabolites and the structures of major metabolites in plasma, urine, and feces, the main metabolic elimination pathways and characteristics of AL8326 in the human body were obtained, as well as the circulating metabolites that are close to or higher than 10% of the total radioactive exposure in plasma.

Conditions

• Small Cell Lung Cancer
• Solid Tumors

Interventions

Type	Name	Description
DRUG	14C-labeled AL8326	Oral, About 60mg (200μCi) of 14C-labeled AL8326

Timeline

• Start date: 2025-02-21
• Primary completion: 2025-05-17
• Completion: 2025-05-17
• First posted: 2025-08-20
• Last updated: 2025-08-20

Locations

1 site across 1 country: China