NCT01430065

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

A Phase 1, Open Label, Single Sequence, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus 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 effects of ASP015K on Tacrolimus 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

• Pharmacokinetics of ASP015K
• Drug Interactions
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ASP015K	oral
DRUG	Tacrolimus	oral

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2011-09-07
• Last updated: 2011-09-07

Locations

1 site across 1 country: United States