NCT01686217

A Phase I Study to Compare 3 Different Strengths of an Extended Release Formulation of ASP015K to an Immediate Release Formulation of ASP015K

A Phase 1, Open-Label, Randomized, Parallel Dose Group Study to Compare the Pharmacokinetic Profiles of Three Different Strengths of ASP015K Extended Release Formulation With ASP015K Immediate Release Formulation and to Evaluate Food Effect on Extended Release Strengths in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (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 compare the pharmacokinetics (PK) profiles of three different strengths of ASP015K extended release formulation and an immediate release formulation and to evaluate food effect on extended release strengths in healthy volunteers.

Detailed description

Study involves 3 parallel groups. Subjects in each group will receive 3 single-dose treatments with a washout period of at least 7 days separating the dosing between two consecutive treatments. Dosing conditions include both fed and fasted conditions.

Conditions

• Pharmacokinetics of ASP015K
• Food Effect
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ASP015K ER	oral extended release (ER) at three dosing levels
DRUG	ASP015K IR	oral immediate release (IR)

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-09-17
• Last updated: 2015-09-01

Locations

1 site across 1 country: United States