Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of ivacaftor (VX-770) on lung clearance index (LCI) in subjects aged 6 years and older with cystic fibrosis (CF) who have the G551D-CFTR mutation on at least 1 allele.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics
• Treatments: Ivacaftor

Criteria

Inclusion Criteria:

• Male or female subjects with confirmed diagnosis of CF

• Must have the G551D-CFTR mutation in at least 1 allele

• FEV1 >90% of predicted normal for age, gender, and height

Exclusion Criteria:

• Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within the 30 days prior to screening

• Use of inhaled hypertonic saline treatment within 2 weeks of the Period 1, Day 1 visit