NCT01886209

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

An Open-Label, Phase 1 Study to Examine the Pharmacokinetic Interactions Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug Interactions

Interventions

Type	Name	Description
DRUG	Prednisone
DRUG	VX-509
DRUG	Methylprednisolone

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-06-25
• Last updated: 2013-08-14

Locations

1 site across 1 country: United States