NCT01288885

First in Men Study of Single Oral Doses of ASP1941 in Healthy Subjects

A Double-blind, Placebo-controlled, Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food-effect of Single Oral Doses of ASP1941 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether the intake of food had an effect on the PK of ASP1941 (Part B).

Detailed description

This study consists of two parts. Part A is a double-blind, placebo controlled single dose escalation study to evaluate the safety and tolerability of single ascending doses of ASP1941. Part B is an open label, crossover design food-effect study to evaluate the effect of fed conditions on the PK of ASP1941.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ASP1941	Oral
DRUG	Placebo	Oral

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2011-02-03
• Last updated: 2011-02-03

Locations

1 site across 1 country: United Kingdom