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A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215

Healthy Clinical Trial

Official title:
A Phase 1 Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215

Clinical Trial Summary

The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function. This study will also assess the safety and tolerability of single-dose ASP2215 in subjects with mild and moderate hepatic impairment and matched control subjects.

Clinical Trial Description

Subjects will be admitted to the site one day before each study drug administration (i.e. Day -1) and confined at the site till the collection of post-dose PK samples (Day 21). For subjects with hepatic impairment, subject will discharge on Day 21, and will visit the clinical unit on Day 24 (±1 day) and Day 28 (±1 day) for collection of post-dose PK samples. End of study Visit For Healthy subjects will take place 1 to 5 days following collection of last PK sample. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02571816
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 1
Start date October 23, 2015
Completion date March 5, 2016
View Details
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