A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor
NCT01899105 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2014-04-03
Summary
This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.
Conditions
Interventions
- DRUG
-
lumacaftor
- DRUG
-
ivacaftor
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-07-31
- Primary Completion
- 2013-08-31
- Completion
- 2013-08-31
Countries
- United States
Study Locations
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