NCT01486017

A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015K

A Phase 1, Single-Dose, Open-Label, 3-Period, Randomized Crossover Study to Assess the Relative Bioavailability Across Three Strengths of a New ASP015K Tablet Formulation in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the relative bioavailability and pharmacokinetic profiles from three strengths of a new tablet formulation of ASP015K and to evaluate the safety and tolerability after a single dose of three different strengths of a new tablet formulation.

Detailed description

Eligible subjects will be admitted on Day-1 and remain confined on the unit for 16 days. Each subject will receive a single dose of study drug per the defined treatment periods on the mornings of Day 1, Day 6 and Day11. There will be a minimum of 5 days between each consecutive dose group. Any subject discontinuing the study prior to completion should have all end of study evaluations completed.

Conditions

• Bioavailability of ASP015K
• Pharmacokinetics of ASP015K
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ASP015K	oral

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-12-06
• Last updated: 2011-12-06

Locations

1 site across 1 country: United States