NCT01190670

A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus

A Phase 1, Open Label, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus After Separate and Concomitant Administration to Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.

Detailed description

This is a 2-part study. Part 1 is a 2-sequence, drug interaction study to determine the effect of two different ASP015K doses on the pharmacokinetics of oral tacrolimus. Part 2 is a 1-sequence drug interaction study to determine the effect of the higher dose ASP015K on the pharmacokinetics of IV tacrolimus.

Conditions

• Healthy
• Pharmacokinetics of ASP015K and Tacrolimus

Interventions

Type	Name	Description
DRUG	Tacrolimus	Oral and Intravenous
DRUG	ASP015K	Oral

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-08-30
• Last updated: 2010-10-14

Locations

1 site across 1 country: United States