Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation
NCT01225211 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 312
Last updated 2015-10-05
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
Interventions
- DRUG
-
Lumacaftor
Tablet
- DRUG
-
Ivacaftor
Tablet.
- DRUG
-
Lumacaftor Placebo
Matching placebo tablet.
- DRUG
-
Ivacaftor Placebo
Matching placebo tablet.
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-10-31
- Primary Completion
- 2014-04-30
- Completion
- 2014-04-30
Countries
- United States
- Australia
- Belgium
- France
- Germany
- New Zealand
- United Kingdom
Study Locations
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