NCT02571816

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	ASP2215	oral

Timeline

• Start date: 2015-10-23
• Primary completion: 2016-03-05
• Completion: 2016-03-05
• First posted: 2015-10-08
• Last updated: 2024-11-05

Locations

1 site across 1 country: United States