The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human

ALK-POSITIVE NSCLC Clinical Trial

Official title: A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]Ensartinib (X-396) After a Single Oral 200mg (100µCi) Dose in Healthy Chinese Male Subjects

Status Recruiting

Clinical Trial Summary

This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] Ensartinib in healthy Chinese male subjects. The study will be conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the completion date of plasma, urine and feces sampling on the 3rd day post-dose and onwards. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 4-6 subjects will be adjusted according to the pilot study.

Clinical Trial Description

Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing (D-2). On the morning of Day 1 before dosing, subjects will be transferred to nuclear medical ward. And after an overnight fast of at least 10 h, subjects will receive a single oral dose of 200 mg (100 μCi) of [14C]Ensartinib as an oral suspension. Then, after two days of the dosing, subjects will be transferred back to Phase I Clinical Unit ward and confined to this unit until blood or excreta sampling and safety monitoring at the designated time points or intervals are complete ;

Related Conditions & MeSH terms

• ALK-POSITIVE NSCLC

• NCT number: NCT03804541
• Study type: Interventional
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: Feng Shao
• Phone: +8613851691161
• Email: shaofengnj@163.com
• Status: Recruiting
• Phase: Phase 1
• Start date: December 28, 2018
• Completion date: October 2019