NCT03627520

A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Sulfatinib

Single-center, Open and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 300 mg /100 μCi [14C] Sulfatinib in Chinese Adult Male Healthy Volunteers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, open label and single-dose clinical trail, to explore the body mass balance and identify the major metabolites in Chinese adult male healthy volunteers after a single oral dose of \[14C\]Sulfatinib, to obtain the pharmacokinetic parameters of plasma and observe the safety of healthy volunteers after a single oral dose of \[14C\]Sulfatinib.

Detailed description

In order to determine the optimal time point for sample collection, this study will be divided into two stages: the first stage, two volunteers will be enrolled, the volunteers should stop collecting the corresponding samples by the investigators based on radioactive test results, safety results combined with the actual comprehensive situation. And in the second stage sample collection time for another four volunteers will be determined and adjusted according to the results of the first stage.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[14C]Sulfatinib	300 mg Sulfatinib with 100 µCi \[14C\]

Timeline

• Start date: 2018-04-02
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2018-08-13
• Last updated: 2019-04-23

Locations

1 site across 1 country: China