NCT05369858

A Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects

A Phase I Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] SKLB1028.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	[14C] SKLB1028	A single 150 mg oral dose of \[14C\] SKLB1028 containing approximately 120 microcurie of \[14C\] SKLB1028

Timeline

• Start date: 2021-08-06
• Primary completion: 2021-09-04
• Completion: 2021-09-11
• First posted: 2022-05-11
• Last updated: 2022-05-11

Locations

1 site across 1 country: China