NCT06360796

Study of Pharmacokinetics and Metabolism on [(14)C]ADC189

A Phase I Study to Investigate the Absorption, Metabolism, Excretion, and Safety of [(14)C]ADC189 in Healthy Chinese Male Volunteers

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

Summary

This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants.

Detailed description

This study adopted a single-center, open, non-randomized, single-dose design. Six to eight healthy Chinese male subjects were planned to be enrolled, and the final aim is to collect all required samples and data from at least 6 subjects. After each subject take a single oral dose of 45 mg (about 100 μCi) \[14C\]ADC189 on Day 1, whole blood, plasma, urine and feces samples were collected at specified time points during the study. The total radioactivity was measured to calculate the ratio of total radioactivity of whole blood to total radioactivity of plasma, pharmacokinetic parameters, recovery rate and excretion pathway data of total radioactivity in whole blood and plasma. Meanwhile, the radioactive metabolite spectrum and structural identification of main metabolites in plasma, urine and feces were performed to obtain the pathway and characteristics of main metabolic elimination of ADC189 in human body, as well as circulating metabolites ≥10% of total radioactivity exposure in plasma.

Conditions

• Pharmacokinetics
• Metabolism

Interventions

Type	Name	Description
DRUG	[(14)C]ADC189	Each subject take a single oral dose of about 45 mg (about 100 μCi) \[(14)C\]ADC189 on Day 1 of the study, and be observed by 504 hours.

Timeline

• Start date: 2023-11-24
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2024-04-11
• Last updated: 2025-01-20

Locations

1 site across 1 country: China