NCT01675518

A Study to Assess the Safety, Pharmacological Effect and Plasma Concentration of ASP7991 After Single Oral Administration to Healthy Volunteers

A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Oral Administration of ASP7991 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (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, plasma concentration and pharmacodynamics of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991 in fasted and fed conditions are compared.

Detailed description

This study consists of two parts. In Part 1, the study will begin as a single rising dose escalation design under randomized double-blind and fasting conditions. In each dose group, volunteers will be randomized to receive an oral administration of either active drug (ASP7991) or placebo. The dose escalation will be determined after blinded safety assessment. Part 2 is a study to evaluate the effect of food intake. ASP7991 will be administered to volunteers under 2 conditions, fasting and fed, on 2-way crossover method.

Conditions

• Healthy
• Pharmacokinetics of ASP7991

Interventions

Type	Name	Description
DRUG	ASP7991	oral
DRUG	Placebo	oral

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-08-30
• Last updated: 2012-08-30

Locations

1 site across 1 country: Japan