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Clinical Trial Summary

An open-label, multicenter, single-dose, single-period, sequential study to assess the effect of moderate renal impairment on the pharmacokinetics of surufatinib.


Clinical Trial Description

An open-label, multicenter, single-dose, single-period, sequential study with the primary objective of assessing the effect of moderate renal impairment on the PK of surufatinib following administration of 300mg single oral dose. The secondary objective is to evaluate the safety in subjects with moderate renal impairment and subjects with normal renal function following a single oral dose of 300mg surufatinib. Approximately 16 subjects will be enrolled ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04755088
Study type Interventional
Source Hutchmed
Contact
Status Completed
Phase Phase 1
Start date February 12, 2021
Completion date August 21, 2021

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