drugset / Trial / NCT04810533

The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers

NCT04810533

Phase 1 Completed 6 enrolled Nanjing Sanhome Pharmaceutical, Co., Ltd.
NaSingle-groupOpen-labelOther

Summary

This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of \[14C\] SH-1028 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 collection time of plasma, urine and feces sampling post-dose. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 2-4 subjects will be adjusted according to the pilot study.

Timeline

Start
2020-05-13
Primary completion
2021-03-05
Completion
2021-03-05

Drugs

EvaluationDrugModalityDoseRoute
Subject ORITINIB Small molecule 200 mg Oral

Indications

No indication recorded.