NCT01430078

A Study to Assess the Bioavailability of ASP015K

A Phase 1, Open-Label, 4-Way Crossover Regional Drug Absorption Study to Assess the Bioavailability of ASP015K in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to assess the bioavailability of ASP015K within the gastrointestinal tract.

Detailed description

Each subject will participate in four separate study periods. In each period, subjects will be admitted to the clinical unit approximately seven hours on the day prior to being given study drug. Subjects will remain at the clinical research unit for the next 24 hours after they have received study drug. Subjects will return to the clinical research unit at 36 and 48 hours after they have received study drug to give blood samples. There will be a minimum of a four day "washout" period, between each study period. Under certain circumstances, subjects may be asked to return to the clinical research unit for an additional study period.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ASP015K	oral tablet
DRUG	ASP015K	solution via oral capsule

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2011-09-07
• Last updated: 2011-09-07

Locations

1 site across 1 country: United Kingdom