NCT01121198

A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy Subjects

ASP1941 Phase I Study -Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male Subjects-

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.

Detailed description

This study consists of two parts. In part-1, a single oral dose of ASP1941 or placebo is administered to healthy adult male subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adult males. In part-2, ASP1941 or placebo are is administered by a multiple dose regimen.

Conditions

• Healthy Volunteer
• Pharmacokinetics of ASP1941

Interventions

Type	Name	Description
DRUG	ASP1941	oral
DRUG	placebo	oral

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2010-05-12
• Last updated: 2010-05-12

Locations

1 site across 1 country: Japan