NCT01929577

A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects

A Phase 1, Single-Dose, Open-Label, 3-Period, Randomized Crossover Study to Assess the Relative Bioavailability Between Two ASP015K Tablet Formulations and the Food Effect on a New Tablet Formulation in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the relative bioavailability of ASP015K under fasting conditions after single-dose administration between a test-tablet formulation and a reference-tablet formulation. This study will also evaluate the food effect on bioavailability of the test formulation, and evaluate the safety and tolerability after single-dose administration of the test- and reference-tablet formulations.

Conditions

• Bioavailability of ASP015K
• Healthy Subjects
• Pharmacokinetics of ASP015K
• Food Effect of ASP015K

Interventions

Type	Name	Description
DRUG	ASP015K	oral tablet

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-08-28
• Last updated: 2013-09-16

Locations

1 site across 1 country: United States