A Phase 1 interventional study of ASP015K in Bioavailability of ASP015K, Healthy Subjects and Pharmacokinetics of ASP015K, sponsored by Astellas Pharma Global Development, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-16.
Sponsored by Astellas Pharma Global Development, Inc. · Phase 1 and Interventional
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.
Astellas Pharma Global Development, Inc. is the lead sponsor of 204 studies on the registry; 25 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 38 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ASP015K administered as a single tablet under fasting conditions.
Drug: ASP015K
ASP015K administered via multiple tablets under fasting conditions
Drug: ASP015K
ASP015K administered as a single tablet under fed conditions
Drug: ASP015K
oral tablet
Pharmacokinetic parameter of ASP015K: Cmax
Maximum Concentration (Cmax)
Time frame: Day 1-4 of each treatment period
Pharmacokinetic parameter of ASP015K: AUClast
Area Under the Curve from time zero to the last measurable time (AUClast)
Time frame: Day 1-4 of each treatment period
Pharmacokinetic parameter of ASP015K: AUCinf
Area Under the Curve from time zero extrapolated to infinity (AUCinf)
Time frame: Day 1-4 of each treatment period
Composite of pharmacokinetic parameters of ASP015K: tmax, t1/2
Time to Maximum Concentration (tmax), apparent terminal elimination half-life (t1/2)
Time frame: Day 1-4 of each treatment period
Composite of pharmacokinetic parameters of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2
Time frame: Day 1-4 of each treatment period
Safety assessed by adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examinations and vital sign measurements
Time frame: Up to Day 4 in each treatment period
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Global Development, Inc.