NCT01187186

A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941

A Phase 1, Open-Label, Single-Dose Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with normal hepatic function based on the Child-Pugh Classification (CPC).

Detailed description

Study drug will be orally administered on Day 1. Subjects will be admitted to the clinic until completion of clinic discharge procedures on Day 7 with an outpatient follow-up visit 6-9 days after clinic discharge.

Conditions

• Liver Disease

Interventions

Type	Name	Description
DRUG	ASP1941	oral

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-08-23
• Last updated: 2010-10-07

Locations

1 site across 1 country: United States