drugset / Trial / NCT01886209

Phase 1 PK Interaction Study Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects

NCT01886209

Phase 1 Completed 28 enrolled Vertex Pharmaceuticals Incorporated
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to evaluate the effect of VX-509 on the pharmacokinetics (PK) of corticosteroids (prednisone or methylprednisolone) and the effect of corticosteroids on the PK of VX-509 and its metabolite. The study will also evaluate the safety and tolerability of VX-509 when coadministered with each of these corticosteroids.

Timeline

Start
2013-06
Primary completion
2013-08
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisolone Other / unclassified 8 mg
Subject Prednisone Other / unclassified 10 mg
Subject decernotinib Small molecule 200 mg

Indications

No indication recorded.