Who is sponsoring NCT02111317?

NCT02111317 is sponsored by Astellas Pharma Global Development, Inc..

What condition does NCT02111317 study?

NCT02111317 studies Healthy Subjects, Pharmacokinetics of ASP015K.

What drugs are being tested in NCT02111317?

Interventions: ASP015K, verapamil.

What is the status of NCT02111317?

NCT02111317 is currently COMPLETED.

Last reviewed 2014-04-07 · How we verify

A Phase 1, Open-label, Single-Sequence, Crossover Drug Interaction Study to Evaluate the Effect of Verapamil on the Pharmacokinetics of ASP015K in Healthy Adult Subjects

NCT02111317 Phase 1 COMPLETED

The purpose of this study is to evaluate the effect of verapamil, a P-glycoprotein (P-gp) inhibitor, on the pharmacokinetics of ASP015K. This study will also assess the safety and tolerability of ASP015K administered alone and also and in combination with verapamil.

Details

Lead sponsor	Astellas Pharma Global Development, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2013-10
Completion	2013-11

Conditions

Healthy Subjects
Pharmacokinetics of ASP015K

Interventions

ASP015K
verapamil

Primary outcomes

Pharmacokinetics of ASP015K: Maximum concentration (Cmax) — Days 1-4 and Days 12-15
Pharmacokinetics of ASP015K: Area under the concentration-time curve (AUC) from time of dosing to the last quantifiable concentration (AUClast) — Days 1-4 and Days 12-15
Pharmacokinetics of ASP015K: AUC from the time of dosing extrapolated to time infinity (AUCinf) — Days 1-4 and Days 12-15

Countries

United States