NCT01899105

A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor

A Phase 1, Randomized, Single-Dose, Open-Label Crossover Study to Investigate the Effect of Food on the Relative Bioavailability of 2 Fixed-Dose Combinations of Lumacaftor and Ivacaftor Tablet Formulations in Healthy Adult Subjects

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

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

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	lumacaftor
DRUG	ivacaftor

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-07-15
• Last updated: 2014-04-03

Locations

1 site across 1 country: United States