NCT01364987

Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy Volunteers

A Phase 1, Open Label, Single Sequence, Drug Interaction Study of the Pharmacokinetics of ASP015K and Mycophenolate Mofetil (MMF) After Separate and Concomitant Administration to Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study characterizes the pharmacokinetic effect of ASP015K on mycophenolate mofetil in healthy volunteers.

Detailed description

The subjects will be confined to the unit for 13 days and have a brief follow-up visit to obtain hematology blood samples. Numerous blood and urine samples will be taken to determine the pharmacokinetics of the drugs.

Conditions

• Healthy Subjects
• Drug Interactions
• Pharmacokinetics of ASP015K

Interventions

Type	Name	Description
DRUG	ASP015K	oral
DRUG	Mycophenolate Mofetil	oral

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2011-06-03
• Last updated: 2011-06-03

Locations

1 site across 1 country: United States