NCT01225211

Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation

A Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Lumacaftor	Tablet
DRUG	Ivacaftor	Tablet.
DRUG	Lumacaftor Placebo	Matching placebo tablet.
DRUG	Ivacaftor Placebo	Matching placebo tablet.

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2010-10-20
• Last updated: 2015-10-05
• Results posted: 2015-10-05

Locations

55 sites across 7 countries: United States, Australia, Belgium, France, Germany, New Zealand, United Kingdom