NCT01872013

Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects

Randomized, Double-blinded, Placebo-controlled, Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.

Detailed description

In each step (lowest dose, middle dose, highest dose), subjects are randomly assigned in a double blinded manner to receive either ASP7991 (n=9) or Placebo (n=3) and are administered repeatedly. Once daily, the subjects are administered ASP7991 or placebo orally 30 minutes after breakfast with 150 mL water for 7 days. After the each step the sponsor evaluates the safety in the blinded manner for deciding an escalation to the step.

Conditions

• Healthy
• Pharmacokinetics of ASP7991

Interventions

Type	Name	Description
DRUG	ASP7991	oral
DRUG	Placebo	oral

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2013-06-07
• Last updated: 2013-06-07

Locations

1 site across 1 country: Japan