drugset / Trial / NCT04464551

The Absorption, Metabolism and Excretion of [14C]D-0316 in Human

NCT04464551

Phase 1 Unknown 4 enrolled Betta Pharmaceuticals 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 \[14C\] D-0316 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 2-4 subjects will be adjusted according to the pilot study

Timeline

Start
2020-12-05
Primary completion
2021-08
Completion
2021-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Befotertinib Small molecule 75 mg Oral